(304 days)
The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.
The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.
The Jostra Single Stage Venous Catheters are single, sterile devices for single 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 Caya 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 and with or without attached connectors.
This 510(k) summary describes a traditional medical device (venous catheter), not an AI/ML powered device. As such, many of the requested categories related to AI/ML device studies are not applicable.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria. The performance testing aimed to demonstrate "substantial equivalency" to the predicate device.
| Test Category | Acceptance Criteria (explicitly stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated (implied safe) | Performed, demonstrated substantial equivalency |
| Flow-Pressure curves | Not explicitly stated (implied comparable to predicate) | Performed, demonstrated substantial equivalency |
| Kink Resistance | Not explicitly stated (implied comparable to predicate) | Performed, demonstrated substantial equivalency |
| Bond Strength | Not explicitly stated (implied comparable to predicate) | Performed, demonstrated substantial equivalency |
| Leakage Test | Not explicitly stated (implied no leakage) | Performed, demonstrated substantial equivalency |
| Effects on Cellular Components | Not explicitly stated (implied no adverse effects) | In-vitro testing performed, demonstrated substantial equivalency |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical testing. It also does not specify the country of origin of the data or whether it was retrospective or prospective, as these tests are laboratory-based device performance tests rather than clinical studies on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a mechanical catheter and its performance is evaluated through physical and material properties testing, not through expert-reviewed data or ground truth labeling by medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert opinions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this medical device's performance is based on established engineering and materials testing standards and comparison to a legally marketed predicate device's performance characteristics.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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510 (K) Summary
JAN 0 9 2003
| Submitter: | Jostra AGHechinger Straße 3872145 HirrlingenGermany |
|---|---|
| Contact Person: | Kathleen JohnsonP. O. Box 218Oxford, PA 19363Phone: (610) 932-7738Fax: (610) 932-7366 |
| Date Prepared: | March 08, 2002 |
| Device Trade Name: | Jostra Single Stage Venous Return Catheters |
| Common/Usual Name: | Single Stage Venous Catheters |
| Classification Names: | Cardiopulmonary Bypass Vascular Catheter, Cannula andTubingCariopulmonary Bypass Adaptor, Stopcock, Manifold, orFitting |
| Predicate Device: | Medtronic DLP Single Stage Venous Cannulae |
Device Description:
The Jostra Single Stage Venous Catheters are single, sterile devices for single 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 Caya 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 and with or without attached connectors.
Indications for use:
The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the superior and 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 tesling has demonstrated that the differences do not effect safety and effectiveness.
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Non-Clinical Testing:
Biocompatibility and performance testing was performed to demonstrate substantial equivalency to the predicate device.
Performance testing included:
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.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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: K020784
Trade Name: Jostra Single Stage Venous Return Catheters Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: November 20, 2002 Received: November 22, 2002
Dear Ms. Johnson:
We have reviewed your Section 510(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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). 11 may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition. FI> \ max publish further announcements concerning your device in the Federal Register.
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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 of the Act 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 (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(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 device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 (301) 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,
A. R. D. Ziderman, M.P.
am D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ka20784
Page 1 of 1
510(k) Number:
Device Name: Jostra Single Stage Venous Return Catheters
Indications for Use
The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Optional Format 3-10-98)
Dedra Tiller
510(k) Number K020784
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).