(88 days)
The Jostra Arterial Cannulae (adults) are designed to be used as perfusion cannulae during extracorporeal circulation during cardiopulmonary bypass up to 6 hours or less.
The Jostra Adult Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the antic root or other large artery during extracorporeal circulation. to the cannulae are made from polyvinyl chloride (PVC) and range in size from 20fr. to 24fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for use on patients requiring more than 3L/Min. of blood flow.
The Jostra Adult Arterial Cannulae is a medical device designed for use in cardiopulmonary bypass procedures. The device's acceptance criteria and performance were assessed through a non-clinical testing study to demonstrate substantial equivalence to a predicate device, the Medtronic DLP Adult Arterial Cannulae.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Tested to demonstrate substantial equivalence to the predicate device. |
| Flow-Pressure curves | Performance testing included. |
| Kink Resistance | Performance testing included. |
| Bond Strength | Performance testing included. |
| Leakage Test | Performance testing included. |
| Effects on cellular components | In-vitro testing performed. |
| Safety and Effectiveness | Comparative testing demonstrated that differences from the predicate device do not affect safety and effectiveness. |
2. Sample Size and Data Provenance:
The document does not specify the exact sample sizes used for each individual performance test (Flow-Pressure curves, Kink Resistance, Bond Strength, Leakage Test, and in-vitro testing for cellular effects). The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given it is a premarket notification for a new device, the testing would typically be prospective, carried out by the manufacturer.
3. Number of Experts and Qualifications:
Not applicable. This was a non-clinical performance and biocompatibility study, not a clinical study involving expert judgment for ground truth.
4. Adjudication Method:
Not applicable. Adjudication methods are typically relevant for clinical studies involving multiple reviewers; this was non-clinical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The study focused on technical performance and biocompatibility rather than human reader performance with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone study of the device's performance was done. The non-clinical testing evaluated the device's physical properties and biocompatibility as a standalone entity. There is no mention of human-in-the-loop performance since the device is a physical cannula, not an AI or imaging diagnostic tool.
7. Type of Ground Truth Used:
The "ground truth" for this type of device is established through engineering and biological standards. For example:
- Performance Tests: The ground truth for flow-pressure curves, kink resistance, bond strength, and leakage tests would be established by validated engineering specifications and industry standards for cardiopulmonary bypass cannulae. The "truth" is whether the device meets these pre-defined physical and functional requirements.
- Biocompatibility: The ground truth is compliance with relevant biological safety standards (e.g., ISO 10993 series) and demonstration that the device material does not cause adverse biological reactions or affect cellular components.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical instrument, not an AI/machine learning model, so there is no "training set" in that context. The testing involved samples of the manufactured device.
9. How Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device. The "ground truth" for evaluating the performance and biocompatibility of the Jostra Adult Arterial Cannulae was based on established engineering principles, industry standards, and biological safety guidelines for similar medical devices. The predicate device (Medtronic DLP Adult Arterial Cannulae) also served as a benchmark for comparison.
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NOV 1 6 2001
510 (K) Summary
| Submitter: | Jostra AGHechinger Straße 3872145 HirrlingenGermany |
|---|---|
| Contact Person: | Kathleen JohnsonP.O. Box 218Oxford, PA 19363Phone: (610) 932-7738Fax: (610) 932-7366 |
| Date Prepared: | July, 27 2001 |
| Device Trade Name: | Jostra Adult Arterial Cannulae |
| Common/Usual Name: | Adult Arterial Cannulae |
| Classification Names: | Cardiopulmonary Bypass Vascular CannulaCardiopulmonary Bypass Adaptor, Stopcock, Manifold, orFitting |
| Predicate Device: | Medtronic DLP Adult Arterial Cannulae |
Device Description:
The Jostra Adult Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the antic root or other large artery during extracorporeal circulation. to the cannulae are made from polyvinyl chloride (PVC) and range in size from 20fr. to 24fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for use on patients requiring more than 3L/Min. of blood flow.
Indications for use:
The Jostra Adult Arterial Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracoproeal circuit to the patient during cardiopulmonary bypass up to 6 hours or less.
Statement of Technical Characteristics Comparison:
The Jostra Arterial Cannulae have the same intended use as the Medtronic DLP Cannulae Both the Jostra Arterial Cannulae and the Medtronic-DLP lines provide the user with the option of a curved or straight tip. The Jostra Arterial Cannulae come with a vent plug for safe de-airing and are available in 23cm length only. The Medtronic-DLP Arterial Cannula have an optional vent plug on models without a
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connector and range in length from 18cm to 33cm. Comparative testing has demonstrated that these differences do not affect safety and effectiveness.
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 Adult Arterial Cannulae are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Ms. Kathleen Johnson Jostra AG C/O Jostra-Bentlye Corporation 478 Media road Oxford, PA 19363
Re: K012774
Device Name: Jostra Arterial Perfusion Cannulae Regulation Number: 21 CFR 870.4210 Regulatory Class: Class II (two) Product Code: DWF Dated: July 25, 2001 Received: August 20, 2001
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, listing 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), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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Page 2 - Ms. Kathleen Johnson
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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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). Other general information on your responsibilities under the Act may be obtained from the O insion 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NOV 1 6 2001
Page 1 of 1
510(k) Number: K012774
Device Name: Arterial Cannulae (adults)
Indications for Use
The Jostra Arterial Cannulae (adults) are designed to be used as perfusion cannulae during extracorporeal circulation during cardiopulmonary bypass 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)
(Optional Format 3-10-98)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012774
006
§ 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).