K Summary Food And Drug Administration

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K summary food and drug administration

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Summary

510 (K) Summary
Submitter: Jostra AG
Hechinger StrarJe 38
72145 Hirriingen
Germany
Contact Person: Kathleen Johnson
P. 0. Box 218
Oxford, PA 19363
Phone: (610) 932-7738
Fax: (610) 932-7366
Date Prepared: March 08, 2002
Device Trade Name: Jostra Single Stage Venous Return Catheters
CommonlUsual Name: Single Stage Venous Catheters
Classification Names: Cardiopulmonary Bypass Vascular Catheter, Cannula and
Tubing
Cariopulmonary Bypass Adaptor, Stopcock, Manifold, or
Fitting
Predicate Device: Medtronic DLP Single Stage Venous Cannulae
Device Description:
The Jostra Single Stage Venous Catheters are single, sterile devices for sirigle use
only and not to be resterilized by the user. The catheters are to be used to divert
blood from the patient to the extracorporeal circuit by draining blood from the Inferior
Vena Cava and the Superior Vena Cava. The catheters are made from polyvinyl
chloride (PVC) and range in size from 12 Fr.- 40 Fr with a variety of tips anci with or
without attached connectors

Indications for use:
The Jostra Single Stage Venous Return Catheters are designed to be usecl for the
collection of venous blood from the right side of the heart via the superior anc~inferior
vena 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 design
as the Medtronic DLP Single Stage Venous Cannulas. The Jostra Single Stage
Venous Cannulas are available in sizes 12 Fr. - 40 Fr. The Medtronic DLP Single
Stage Venous Cannulas range in sizes from 12 Fr. - 40 Fr. Comparative testing has
demonstrated that the differences do not effect safety and effectiveness

007
Non-Clinical Testing:
Biocompatibility and performance testing was performed to demonstrate substantial
equivalency to the predicate device

Performance testing incIuded:
Flow-Pressure curves
Kink Resistance
Bond Strength
Leakage Test
Additionally, in-vitro testing was performed to determine the effects on cellular
components

Conclusion:
Performance, and in-vitro testing demonstrate that the Jostra Single Stage Venous
Return Cannulas are “substantially equivalent” to the predicate devices in intended
use, principles of operation, materials, design, and performance

008
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48
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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 Johnson
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean
that 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 must
comply with all the Act’s requirements, including, but not limited to: registration and listing ( 2 1
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
product 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 legally
marketed predicate device results in a classification for your device and thus, permits your deb ice
to proceed to the market

If you desire specific advice for your device on our labeling regulation (2 1 CFR Part 80 1 ), please
contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the
promotion 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 to
premarket notification” (21CFR Part 807.97) you may obtain. Other general information on your
responsibilities 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) 443-6597
or 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 Health
Enclosure
P a g e 1 of 1
51O(k) Number:
Device Name: Jostra Single Stage Venous Return Catheters
Indications for Use
T h e Jostra Single Stage Venous Return Catheters are designed to b e used for the
collection of venous blood from the right side of the heart via the superior End inferior
vena cava during cardiopulmonary bypass surgery up to 6 hours or less

(PLEAS€ DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
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,...

Who is in charge of fda?

The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate.

Who is the commissioner of the food and drug administration fda?

^ 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.