July 30 2019 Food And Drug Administration
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July 30, 2019MedtronicMatthew LobeckSr. Regulatory Affairs Specialist8200 Coral Sea St NEMounds View, Minnesota 55112Re: K183547 Trade/Device Name: Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: July 3, 2019 Received: July 5, 2019Dear Matthew Lobeck:We have reviewed your Section 510(k) premarket notification of intent to market the device referencedabove and have determined the device is substantially equivalent (for the indications for use stated in theenclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, theenactment date of the Medical Device Amendments, or to devices that have been reclassified in accordancewith the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of apremarket approval application (PMA). You may, therefore, market the device, subject to the generalcontrols provisions of the Act. Although this letter refers to your product as a device, please be aware thatsome cleared products may instead be combination products. The 510(k) Premarket Notification Databaselocated at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combinationproduct submissions. The general controls provisions of the Act include requirements for annual registration,listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liability warranties. Weremind you, however, that device labeling must be truthful and not misleading
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may besubject to additional controls. Existing major regulations affecting your device can be found in the Code ofFederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcementsconcerning your device in the Federal Register
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDAhas made a determination that your device complies with other requirements of the Act or any FederalU.S. Food & Drug Administration10903 New Hampshire Avenue Doc ID# 04017.04.06Silver Spring, MD 20993www.fda.gov K183547 - Matthew Lobeck Page 2statutes and regulations administered by other Federal agencies. You must comply with all the Act'srequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) fordevices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (seehttps://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) forcombination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
For comprehensive regulatory information about medical devices and radiation-emitting products, includinginformation about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact theDivision of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. Seethe DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICEby email ([email protected]) or phone (1-800-638-2041 or 301-796-7100)
Sincerely, Mark S
Fellman -S Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological HealthEnclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2020 Indications for Use See PRA Statement below
510(k) Number (if known)K183547Device Name1. Marinr™ Steerable Intracardiac Electrode Catheter2. StableMapr™ Steerable Intracardiac Electrode CatheterIndications for Use (Describe)1. The Medtronic Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The Medtronic Marinrcatheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiologystudies
2. The Medtronic StableMapr catheter is intended for use in diagnostic electrophysiologic procedures. These catheters aredesigned for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies
Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED
This section applies only to requirements of the Paperwork Reduction Act of 1995
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [email protected] “An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF Changes to cEP Steerable Diagnostic Catheters K183547 Medtronic Confidential 1-173 K1835475.0 510(k) SummaryDate Summary Prepared: January 25, 2019Applicant: Medtronic 8200 Coral Sea Street Mail Stop MVS46 Mounds View, MN 55112 Establishment Registration No. 3001504994Official Correspondent: Matthew Lobeck Senior Regulatory Affairs Specialist Medtronic 8200 Coral Sea Street Mounds View, MN 55112 Telephone: 763.514.9515 Fax: 763.367.9903 Email: [email protected]Device Trade Name: 1. Marinr™ Steerable Intracardiac Electrode Catheter 2. StableMapr™ Steerable Intracardiac Electrode CatheterCommon Name: Diagnostic catheterClassification Name: Catheter, Electrode Recording, Or Probe, Electrode RecordingClassification & Panel: Class II, 21 CFR 870.1220, CardiovascularProduct Code: DRFPredicate Device: 1. Marinr™ Steerable Intracardiac Electrode Catheter (K951347, K931794) 2. StableMapr™ Steerable Intracardiac Electrode Catheter (K981642)Device Description: Medtronic diagnostic catheters are flexible radiopaque catheters constructed of extruded polymer over a stainless- steel braid. The catheters contain platinum-iridium sensing band electrodes and are designed for intracardiac recording or stimulation
This premarket notification covers changes impacting Medtronic diagnostic catheters, including labeling updates, packaging design and packaging material changes, and product requirement updates
1 K183547Intended Use: Medtronic diagnostic catheters are intended for use in diagnostic electrophysiologic procedures. The catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies
The intended use is unchanged with the proposed modifications and remains the same as that previously cleared under the respective 510(k)s
Indications for Use: 1. The Medtronic Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The Medtronic Marinr catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies
2. The Medtronic StableMapr catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies
The indications for use are unchanged with the proposed modifications and remains the same as those previously cleared under the respective 510(k)s
Comparison of The following changes are being implemented as part of thisTechnological premarket notification:Characteristics: Labeling Changes: • Inclusion of updated storage and transit condition information • General symbol updates, formatting and grammatical changes • Inclusion of contraindication and adverse event information • Various additional changes as part of general labeling improvements Packaging Changes: • Increase to shelf carton height • Relocation of labeling from shelf carton to product labels • Change to the material of the catheter tray • Change to catheter tray design for securement of catheter within packaging • Change to a material of the catheter pouch 2 K183547 • Change to dimensions of the catheter pouch • Increase to the page count of the IFU and warranty document • Addition of a protective literature bag • New label stocks for product labels and warranty document • Addition of a secondary shelf carton label and end cap seal Product Requirement Changes: This premarket notification includes updates to the following Product Requirement Specifications (PRS): PRS Attribute Impacted Products Product Requirements Biocompatibility All Corrosion resistance All Visual – Foreign Material All and Defects Visual - Butt Joint All Inspection Visual – Band Electrodes All Visual – Tip Assembly All Visual - Serial Number All Catheter outer diameter All Electrode Band Spacing All Working Length All Actuation force for linearly All activated controls Tip Springback All Reverse deflection StableMapr Steerable Intracardiac Electrode Catheter Extent & Rate of Tip All Deflection Proximal curve reach All Proximal curve planarity All Lateral deflection control Marinr Steerable Intracardiac Electrode Catheter Tip lateral deflection travel Marinr Steerable Intracardiac Electrode Catheter Distal tip stiffness All Proximal shaft flexibility in All 37°C Tip transition kinking All 3 K183547 Lateral Stability StableMapr Steerable Intracardiac Electrode Catheter Shaft Torque-ability All Joint – Tip Composite Marinr Steerable Intracardiac Electrode Catheter Joint- Proximal Shaft to All Distal Deflectable Tip Tubing Electrode path AC Marinr Steerable Intracardiac impedance Electrode Catheter Band Electrode Path DC All Resistance Simulated use: catheter StableMapr Steerable pushability Intracardiac Electrode Catheter Simulated use: catheter StableMapr Steerable shaft repeated torqueing Intracardiac Electrode Catheter Handle Control All Requirements Connector Interface All Requirements Packaging Requirements Packaging Configuration All Traceability All Material Sterilization All Compatibility Packaging Performance Marinr Steerable Intracardiac Electrode Catheter Sterile Barrier Integrity All Seal strength All Specified loading All configuration Storage and Shipping All Conditions Use Before Date All While this premarket notification covers changes to labeling, packaging design and materials, and product requirement specifications, there are no changes to the finished diagnostic catheter designs or materials. The manufacturing processes and inspections related to diagnostic catheter assemblies are also remaining unchanged. Compared to the predicate, the subject device features the: • Same intended use • Same indications for use • Same fundamental scientific technology 4 K183547 • Same finished catheter design and dimensions • Same user interface • Same materials of construction • Same manufacturing and sterilization processes The differences between the subject and predicate devices involve labeling, packaging, and product requirements only
The subject device design technology, performance characteristics, materials, shelf life and sterilization process are all unchanged
The proposed changes do not constitute a change in the fundamental scientific technology for the subject devices and do not raise new or different questions of safety and effectiveness. The subject devices do not provide a new therapy, and the intended use and indications for use remain unchanged and identical to the predicates. The modified subject devices described in this 510(k) submission are substantially equivalent to the predicate devices
Performance Data: Performance testing (bench) was completed in support of the proposed modifications. The results of the design verification testing completed in support of the proposed changes demonstrate that the diagnostic catheters in scope of this premarket notification meet all applicable proposed product requirements
To support the proposed product requirement changes in this premarket notification, the following tests were performed on test samples exposed to accelerated aging conditions equivalent to the product shelf life of 2 years: Product Requirement Testing: • Corrosion resistance testing • Visual inspections • Electrode band spacing measurement • Catheter shaft dimensional measurements • Actuation force testing • Tip springback testing • Catheter shaft reach, deflection, and planarity testing • Catheter shaft stiffness and flexibility testing • Kink resistance testing • Catheter shaft lateral stability testing • Catheter shaft torqueability testing • Catheter tensile testing • Electrode path impedance and resistance testing 5 K183547 • Simulated use testing for pushability and torqueability Packaging Requirement Testing: • Visual inspections • Sterilization pre-conditioning • Environmental pre-conditioning • Label legibility testing • Label durability testing • Bubble leak testingConclusion: This premarket notification is limited to labeling, packaging design and materials, and product requirement specifications for Medtronic diagnostic catheters. There are no changes to the intended use, indications for use, performance, or fundamental scientific technology, and the subject devices are considered substantially equivalent to the legally marketed predicate devices
1. The Medtronic Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The Medtronic Marinr catheter is designed for recording intracardiac electrograms and …
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