K Summary Food And Drug Administration
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510 (K) SummarySubmitter: Jostra AG Hechinger StrarJe 38 72145 Hirriingen GermanyContact Person: Kathleen Johnson P. 0. Box 218 Oxford, PA 19363 Phone: (610) 932-7738 Fax: (610) 932-7366Date Prepared: March 08, 2002Device Trade Name: Jostra Single Stage Venous Return CathetersCommonlUsual Name: Single Stage Venous CathetersClassification Names: Cardiopulmonary Bypass Vascular Catheter, Cannula and Tubing Cariopulmonary Bypass Adaptor, Stopcock, Manifold, or FittingPredicate Device: Medtronic DLP Single Stage Venous CannulaeDevice Description:The Jostra Single Stage Venous Catheters are single, sterile devices for sirigle useonly and not to be resterilized by the user. The catheters are to be used to divertblood from the patient to the extracorporeal circuit by draining blood from the InferiorVena Cava and the Superior Vena Cava. The catheters are made from polyvinylchloride (PVC) and range in size from 12 Fr.- 40 Fr with a variety of tips anci with orwithout attached connectors
Indications for use:The Jostra Single Stage Venous Return Catheters are designed to be usecl for thecollection of venous blood from the right side of the heart via the superior anc~inferiorvena cava during cardiopulmonary bypass surgery up to 6 hours or less
Statement of Technical Characteristics Comparison:The Jostra Single Stage Venous Cannulas have the same intended use and designas the Medtronic DLP Single Stage Venous Cannulas. The Jostra Single StageVenous Cannulas are available in sizes 12 Fr. - 40 Fr. The Medtronic DLP SingleStage Venous Cannulas range in sizes from 12 Fr. - 40 Fr. Comparative testing hasdemonstrated that the differences do not effect safety and effectiveness
007 Non-Clinical Testing:Biocompatibility and performance testing was performed to demonstrate substantialequivalency to the predicate device
Performance testing incIuded: Flow-Pressure curves Kink Resistance Bond Strength Leakage TestAdditionally, in-vitro testing was performed to determine the effects on cellularcomponents
Conclusion:Performance, and in-vitro testing demonstrate that the Jostra Single Stage VenousReturn Cannulas are “substantially equivalent” to the predicate devices in intendeduse, principles of operation, materials, design, and performance
008 8Q 48+3**’’=- ‘.*, DEPARTMENT OF HEALTH &HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 0 9 2003 Jostra AG c/o Ms. Kathleen Johnson Jostra-Bentley Corp
478 Media Road Oxford, PA 19363 Re: KO20784 Trade Name: Jostra Single Stage Venous Return Catheters Regulation Number: 2 1 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula and Tubing Regulatory Class: Class I1 (two) Product Code: DWF Dated: November 20,2002 Received: November 22,2002 Dear Ms. Johnson: We have reviewed your Section 5 1O(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)
You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listiii,; of’ devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration
If your device is classified (see above) into either class I I (Special (‘ontrols) 01-c l x s I l l 1’21 .I). I I may be subject to such additional controls. Existing niyiol- regulations afkcting ;.out. tic%& ICC c c ~ ~ i be found in the Code of Federal Regulations. ‘I’itle 21. Parts SO0 to 80s. I n : d d i [ i , ~ t ~I .I ) \ I I I ~ I ~ publish further announcements concerning your device in the Federai Register
Page 2 - Ms. Kathleen JohnsonPlease be advised that FDA’s issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements 01 thc Ac(or any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act’s requirements, including, but not limited to: registration and listing ( 2 1CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sctforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 of the Act); 2 1 CFR 1000-1050
This letter will allow you to begin marketing your device as described in your Section 5 1 0(k)premarket notification. The FDA finding of substantial equivalence of your device to a legallymarketed predicate device results in a classification for your device and thus, permits your deb iceto proceed to the market
If you desire specific advice for your device on our labeling regulation (2 1 CFR Part 80 1 ), pleasecontact the Office of Compliance at (301) 594-4646. Additionally, for questions on thepromotion and advertising of your device, please contact the Office of Compliance at(30 1) 594-4639. Also, please note the regulation entitled, “Misbranding by reference topremarket notification” (21CFR Part 807.97) you may obtain. Other general information on yourresponsibilities under the Act may be obtained from the Division of Small Manufacturers,International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597or at its Internet address http : //www . fda . qov/cdrh/dsma/dsmamain.html Sincerely yours, Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological HealthEnclosure P a g e 1 of 151O(k) Number:Device Name: Jostra Single Stage Venous Return CathetersIndications for UseT h e Jostra Single Stage Venous Return Catheters are designed to b e used for thecollection of venous blood from the right side of the heart via the superior End inferiorvena cava during cardiopulmonary bypass surgery up to 6 hours or less
(PLEAS€ DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-93) Prescription Use (Per 21 CFR 801.109) (Division Sign-off) Division of Cardiovascular Devices 510(k) Number [email protected] mfj 005
Medtronic DLP Single Stage Venous Cannulae The Jostra Single Stage Venous Catheters are single, sterile devices for sirigle use only and not to be resterilized by the user. The catheters …
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What is the function of the food and drug administration?
Food and Drug Administration. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices,...
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The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate.
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^ Stephen M. Hahn M.D., Commissioner of Food and Drugs - Food and Drug Administration (March 18, 2020). "Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections". FDA.gov. U.S. Food and Drug Administration.
What is the history of the food and drug administration?
History. In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.