The Jostra Retrograde Cardioplegia Cannulas are designed to infuse blood or cardioplegia arrest solution to the myocardial tissue retrograde via the coronary sinus during cardiopulmonary bypass up to 6 hours or less.

Device Description

The Jostra Retrograde 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 arrest solution retrograde via the coronary sinus during extracorporeal circulation. The cannulas are made from polyvinyl chloride (PVC) in size 14 Fr. with a variety of balloons, with or without pressure monitoring lines and a choice of stiff or flexible stylets.

AI/ML Overview

The provided text describes a 510(k) summary for the Jostra Retrograde Cardioplegia Cannula, which is a medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone performance metrics typical of a novel AI device.

Therefore, many of the requested categories for AI/algorithm-based studies (like expert consensus, sample sizes for training/test sets, MRMC studies, ground truth establishment methods) are not applicable to this type of device submission. The acceptance criteria here are based on standard engineering and biocompatibility tests to show the device functions safely and effectively, similar to the predicate.

Here's the information that can be extracted and a clear indication of what is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Device materials are not harmful to biological systems.	"Biocompatibility... was performed to demonstrate substantial equivalency to the predicate device." (Implies successful testing without specific metrics)
Flow-Pressure curves: Device maintains appropriate flow and pressure characteristics.	"Performance testing included: Flow-Pressure curves" (Implies satisfactory performance, no specific values reported)
Kink Resistance: Device resists kinking during use to ensure uninterrupted flow.	"Performance testing included: Kink Resistance" (Implies satisfactory performance, no specific values reported)
Bond Strength: Components of the device are securely attached.	"Performance testing included: Bond Strength" (Implies satisfactory performance, no specific values reported)
Leakage Test: Device maintains integrity and does not leak.	"Performance testing included: Leakage Test" (Implies satisfactory performance, no specific values reported)
Effects on Cellular Components: Device does not adversely affect cellular components during use.	"Additionally, in-vitro testing was performed to determine the effects on cellular components." (Implies no adverse effects, no specific metrics reported)
Substantial Equivalence: Device performs as safely and effectively as the predicate device.	"Performance, and in-vitro testing demonstrate that the Jostra Retrograde Cardioplegia Cannulae are 'substantially equivalent' to the predicate devices in intended use, principles of operation, materials, design, and performance."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided text. The testing mentioned refers to device engineering and material performance rather than a clinical "test set" of patient data.
Data Provenance: Not applicable in the context of clinical data. The tests are non-clinical, likely performed in a lab setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. Ground truth as typically understood for AI/diagnostic devices (e.g., expert consensus on medical images) is not relevant for this engineering-focused device submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC study was not done. This type of study is typically for diagnostic devices where human readers interpret patient data (e.g., medical images) with and without AI assistance. This device is a surgical cannula, not a diagnostic tool that involves human interpretation of results.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance: Not applicable. This is a physical medical device, not an algorithm, so the concept of "standalone performance" in this context is not relevant. The device itself is "standalone" in that it performs its intended function without requiring an AI algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For the non-clinical tests, the "ground truth" would be established by validated engineering standards, specifications, and test methods (e.g., known flow rates, material strength properties, biological compatibility standards). This is implicitly assumed rather than explicitly stated.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not use a "training set" in the sense of machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable.

Summary

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MAR 2 6 2002

510 (K) Summary

Submitter:

Jostra AG Hechinger Straße 38 72145 Hirrlingen Germany

Contact Person:

Kathleen Johnson Phone: (610) 932-7738 (610) 932-7366 Fax:

December 21, 2001 Date Prepared:

Device Trade Name:

Common/Usual Name: Retrograde Cardioplegia Cannula

Classification Names:

Cardiopulmonary Bypass Vascular Cannula Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Catheter Stylet Piston Svringe

Jostra Retrograde Cardioplegia Cannula

Predicate Device: Medtronic DLP Retrograde Cardioplegia Cannula

Device Description:

Indications for use:

Statement of Technical Characteristics Comparison:

The Jostra Retrograde Cardioplegia Cannulas have the same intended use as the Medtronic DLP Retrograde Cardioplegia 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.

Conclusion:

Performance, and in-vitro testing demonstrate that the Jostra Retrograde Cardioplegia Cannulae 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure embracing a globe. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2002

Ms. Kathy Johnson Regulatory Affairs, Submission Manager JOSTRA® AG c/o JOSTRA-Bentley Corporation 478 Media Road Oxford, PA 19363

Re: K014303

Trade Name: Jostra Retrograde Cardioplegia Cannula Regulation Number: 21 CFR 4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing. Regulatory Class: Class II (two) Product Code: DWF Dated: December 21, 2001 Received: December 31, 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 forth in the quality

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Page 2 - Ms. Kathy Johnson

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. Control provided in the marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince notification " 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) 594-4646. 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). Toganalers 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,

Dak Telle

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular And Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number:

Device Name: Jostra Retrograde Cardioplegia Cannulas

Indications for Use

indications for USE
The Jostra Retrograde Cardioplegia Cannulas are designed for the coronary The Jostra Rerograde Cardioplegia Cannarao al Sissue retrograde via the coronary
or cardioplegia arrest solution to the myocardial tissue retograde via the coronary of Cardloplegia an ook default to are bypass up to 6 hours or less.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number R014305

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 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).