(68 days)
The Jostra Antegrade Cardioplegia Cannulas are intended to be used to infuse blood and/or cardioplegia solution to the patient's myocardium, antegrade, via the aortic root, during cardiopulmonary bypass for 6 hours or less.
The Jostra Antegrade Cardioplegia Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to infuse blood or cardioplegia solution antegrade via the aortic root during extracorporeal circulation. The cannulas are made from polyurethane (PUR) in sizes 7 Fr., 9Fr., and 11 Fr., with or without vent lines and with an optional needle safety system.
The provided document describes a 510(k) premarket notification for the "Jostra Antegrade Cardioplegia Cannula" (K020515). This application demonstrates substantial equivalence to a predicate device, focusing on performance and biocompatibility. However, it does not describe an AI device or a study that establishes acceptance criteria for such a device.
The information requested in the prompt (acceptance criteria for AI, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is specific to studies evaluating Artificial Intelligence or machine learning systems. The provided text is for a medical device (a cannula), not a software algorithm or AI.
Therefore, I cannot fulfill the request as the input document does not contain information about an AI device or a study demonstrating its performance.
This document pertains to a medical device (cannula) and not an AI or machine learning system. Therefore, the requested information regarding acceptance criteria and studies for an AI device, including details like sample sizes for test/training sets, expert qualifications, MRMC studies, and standalone performance, is not applicable and cannot be extracted from the provided text.
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APR 2 4 2002
510 (K) Summary
| Submitter: | Jostra AGHechinger Straße 3872145 HirrlingenGermany |
|---|---|
| Contact Person: | Kathleen Johnson |
| Phone: (610) 932-7738 | |
| Fax: (610) 932-7366 | |
| Date Prepared: | January 25, 2002 |
| Device Trade Name: | Jostra Antegrade Cardioplegia Cannula |
| Common/Usual Name: | Antegrade Cardioplegia Cannula |
| Classification Names: | Cardiopulmonary Bypass Vascular CannulaCardiopulmonary Bypass Adaptor, Stopcock, Manifold, orFittingTrocar |
| Predicate Device: | Medtronic DLP Antegrade Cardioplegia Cannula |
Device Description:
The Jostra Antegrade Cardioplegia Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to infuse blood or cardioplegia solution antegrade via the aortic root during extracorporeal circulation. The cannulas are made from polyurethane (PUR) in sizes 7 Fr., 9Fr., and 11 Fr., with or without vent lines and with an optional needle safety system.
Indications for use:
The Jostra Antegrade Cardioplegia Cannulas are designed to infuse blood and/or cardioplegia solution antegrade via the aortic root during cardiopulmonary bypass up to 6 hours or less.
Statement of Technical Characteristics Comparison:
The Jostra Antegrade Cardioplegia Cannulas have the same intended use as the Medtronic DLP Antegrade Aortic Root Cannulas. Comparative testing has demonstrated that these differences do not affect 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.
Concluïsion:
Performance, and in-vitro testing demonstrate that the Jostra Antegrade Cardioplegia Cannulae are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathleen Johnson Regulatory Affairs, Submission Manager Jostra® AG Hechinger Straße 38 72145 Hirrlingen Germany
Re: K020515
Trade/Device Name: Jostra Antegrade Cardioplegia Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing. Regulatory Class: Class II Product Code: DWF Dated: January 25, 2002 Received: February 15, 2002
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave ro reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the encreases of 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 I ou may, aterere, mains 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 or any I 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 vou 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) 594-4586. 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 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Deb Tull
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: HD20515
Device Name: Jostra Antegrade Cardioplegia Cannulas
Indications for Use
. 184 2017
The Jostra Antegrade Cardioplegia Cannulas are intended to be used to infuse blood and/or cardioplegia solution to the patient's myocardium, antegrade, via the aortic root, during cardiopulmonary bypass for 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)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020515
· (Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)
§ 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).