The Jostra Pediatric 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.

Device Description

The Jostra Pediatric 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 aortic root or other large artery during extracorporeal circulation. The cannulaer are made from polyvinyl chloride (PVC) and range in size from 8fr. to 16fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for pediatric use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Jostra Pediatric Arterial Cannulae, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Biocompatibility	Performed, demonstrating substantial equivalency to predicate device.	No specific metrics provided, but comparison to a legally marketed predicate (Medtronic DLP Pediatric Arterial Cannulae) is the basis.
Flow-Pressure curves	Performed, demonstrating substantial equivalency to predicate device.	No specific metrics for curve shape, pressure limits, or flow rates are provided.
Kink Resistance	Performed, demonstrating substantial equivalency to predicate device.	No specific metrics for kink angle, force, or flow reduction are provided.
Bond Strength	Performed, demonstrating substantial equivalency to predicate device.	No specific metrics for bond strength (e.g., tensile strength, peel strength) are provided.
Leakage Test	Performed, demonstrating substantial equivalency to predicate device.	No specific metrics for leakage rate or pressure withstand are provided.
Effects on Cellular Components	In-vitro testing performed, demonstrating substantial equivalency to predicate device.	No specific metrics on cell lysis, activation, or count are provided.
Overall Safety and Effectiveness	Demonstrated through comparative testing that differences from the predicate (curved tip, vent plug) do not affect safety and effectiveness.	The statement directly addresses safety and effectiveness relative to the predicate, even with design variations.

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

Sample Size: Not specified. The document states "Performance testing included" a list of tests, but does not provide details on the number of cannulae tested for a "test set."
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective. Given the nature of medical device testing for 510(k) (pre-market notification), it would typically involve prospective, controlled laboratory testing.

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

This information is not applicable and not provided as this submission is for a physical medical device (cannulae) and not an AI/software device that requires expert-established ground truth for image or data interpretation. The "ground truth" for this device's performance is established by direct physical measurements and laboratory tests against engineering specifications and comparison to an established predicate device.

4. Adjudication Method for the Test Set

This information is not applicable as the testing involved direct physical measurements and comparison to a predicate device, not subjective interpretation requiring adjudication among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done?: No.
Effect size: Not applicable, as this is a physical medical device and not an AI system being evaluated for its impact on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Was it done?: Not applicable. This is not an AI/algorithm. The performance studies detailed are for the physical device itself.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily:

Engineering Specifications / Performance Standards: Implied for tests like kink resistance, bond strength, leakage, and flow-pressure curves.
Predicate Device Performance: The primary "ground truth" for substantial equivalence is the performance of the legally marketed Medtronic DLP Pediatric Arterial Cannulae. The Jostra device performance is directly compared to it across various attributes ("operation, materials, design, and performance").

8. Sample Size for the Training Set

Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

How established?: Not applicable, as there is no training set for this type of device submission.

Summary

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510 (K) Summary

Submitter:

Jostra AG Hechinger Straße 38 72145 Hirrlingen Germany

Contact Person: Kathleen Johnson Phone: (610) 932-7738 (610) 932-7366 Fax:
Date Prepared: June 21, 2001

Jostra Pediatric Arterial Cannulae Device Trade Name:

Common/Usual Name: Pediatric Arterial Cannulae

Classification Names: Cardiopulmonary Bypass Vascular Cannula Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting

Predicate Device: Medtronic DLP Pediatric Arterial Cannulae

Device Description:

Indications for use:

Statement of Technical Characteristics Comparison:

The Jostra Pediatric Cannulae have the same intended use as the Medtronic DLP Pediatric Cannulae. The wire-wound 8fr. to 16fr. Sizes from Medtronic are not available with a curved tip, and come with a "Flow-Guard" Style introducer. The Jostra Pediatric Cannulae provide the user with the option of a curved tip, and a vent plug for safe de-airing. 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 Peditorial vac Penomiance, and in viro cosing active the predicate devices in intended use, Ourinaliae are overation, materials, design, and performance.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 6 2001

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

Re: K012617

Trade Name: Jostra Arterial Perfusion Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing. Regulatory Class: Class II (two) Product Code: DWF Dated: June 29, 2001 Received: August 13, 2001

Dear Ms. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreours) is trgansjal the Medical Device Amendments, or to commerce proc to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, de noos mat ha re been 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 1 ou may, morelore, market of the Act include requirements for annual registration, listing of general controls pro vision 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 If your device is classinod (600 as controls. Existing major regulations affecting your device can may oe subject to basil acceral 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 r tease be actised alla i Drimination 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 odolar statutes and equirements, 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 form in and quinn 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) I mis letter will and in you is ought tinding of substantial equivalence of your device to a legally prematication - No 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 additionally 21 (301) 594-4646. Additionally, for questions on the promotion and advertising of Compilance at (301) 594-461 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regaration on the responsibilities under the Act may be obtained from the Other general mistmation of Small 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 0 6 2001

K012617

Page 1 of 1

510(k) Number:

Device Name: Arterial Cannulae (paediatric)

Indications for Use

indications for Soc The Jostia Fediatio Anonal Samulations are a circuit to the patient during cardiopulmonary bypass up to 6 hours or less.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Division of Cardiovasc...
510(k) Number K0/2617

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).