The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.

Device Description

The Stöckert Coronary Perfusion Cannulae are comprised of either a flexible plastic (PVC) or a malleable stainless steel body, with a soft silicone tip and either a ¼" barbed tubing connector or a luer lock. They are offered in various tip outer diameters ranging from 3.0 to 5.0 mm (9 to 15 Fr). The P605, P607, P615, and P617 Series Stöckert Coronary Perfusion Cannulae are 26 cm long. The P606, P616, and P618 Series Stöckert Coronary Perfusion Cannulae are 14 cm long.

AI/ML Overview

The provided text describes a 510(k) pre-market notification for the Stöckert Coronary Perfusion Cannulae. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria via a comprehensive study with defined endpoints.

Therefore, many of the requested elements for a study proving acceptance criteria are unfortunately not applicable or not explicitly detailed in the provided document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria with corresponding performance metrics for the Stöckert Coronary Perfusion Cannulae. Instead, it relies on demonstrating equivalence to a predicate device.

Acceptance Criteria (Not explicitly stated as such, but inferred from equivalency claim)	Reported Device Performance (Inferred from equivalency claim)
Intended Use Equivalence: To be used to cannulate the coronary ostium and deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.	The Stöckert Coronary Perfusion Cannulae are intended for the same use as the predicate Medtronic DLP Coronary Ostial Perfusion Cannulae.
Design Feature Equivalence: Similar design characteristics.	Comprised of flexible plastic (PVC) or malleable stainless steel body, soft silicone tip, and either a ¼" barbed tubing connector or a luer lock. Offered in various tip outer diameters (3.0 to 5.0 mm / 9 to 15 Fr) and lengths (14 cm or 26 cm). These features are stated to be equivalent to the predicate.
Performance Characteristic Equivalence: Similar performance in handling and function.	"In-vitro performance and biocompatibility tests demonstrate substantial equivalency." (Specific test results are not provided).
Biocompatibility Equivalence: Safe for contact with the body.	"In-vitro performance and biocompatibility tests demonstrate substantial equivalency." (Specific test results are not provided).

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

Sample Size: Not specified. The document states "In-vitro performance and biocompatibility tests," but does not provide details on the number of samples tested or the methodology.
Data Provenance: The tests were "in-vitro," meaning conducted in a lab setting rather than on human or animal subjects. The country of origin for the data is not explicitly stated, but the submitting company (Stöckert Instrumente GmbH) is based in Munich, Germany, so it is reasonable to infer the testing was likely conducted in Germany or by a contract lab on their behalf. The data is retrospective in the sense that the testing was completed before the submission.

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

Not applicable. For a 510(k) submission based on substantial equivalence and "in-vitro" testing, ground truth is established through adherence to recognized testing standards and comparison to the predicate device's characteristics, not through expert consensus on a test set in the way one might for an AI image analysis device.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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

No, this type of study was not done. MRMC studies are typically used to evaluate the diagnostic accuracy of AI algorithms and their impact on human reader performance, which is not relevant for this medical device (a coronary perfusion cannula).

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth or basis for the claims of substantial equivalence are:

Predicate Device Comparison: The Stöckert Coronary Perfusion Cannulae were compared to the Medtronic DLP Coronary Ostial Perfusion Cannulae in terms of intended use, design features, and performance characteristics.
In-vitro Testing: Biocompatibility and performance tests were conducted in a laboratory setting. The outcomes of these tests, demonstrating equivalent performance, serve as the "ground truth" for the claim of substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm that requires a training set.

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

Not applicable. This is not an AI algorithm.

Summary regarding this specific submission:

This 510(k) notification for the Stöckert Coronary Perfusion Cannulae primarily relies on demonstrating substantial equivalence to an existing predicate device (Medtronic DLP Coronary Ostial Perfusion Cannulae). The "study" mentioned consists of "In-vitro performance and biocompatibility tests," which are generally standard engineering and biological safety tests for medical devices. The details of these tests, including specific methodologies, raw data, acceptance criteria for those tests, and sample sizes, are not provided in the summary document but would have been part of the full 510(k) submission reviewed by the FDA. The FDA determined that, based on these tests and the comparison to the predicate, the device was substantially equivalent and could be marketed.

Summary

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510(k) Pre-Market Notification: Stöckert Coronary Perfusion Cannulae

OCT 1 1 2002

510(k) Summarv

SUBMITTER:	Stöckert Instrumente GmbHLindberghstrasse 25D-80939 Munich, Germany
CONTACT PERSON:	Mr. Helmut HöflDirector, Quality and Regulatory AffairsPhone: 49-89-323-010Fax: 49-89-323-01100
DATE PREPARED:	May 10, 2002
DEVICE TRADE NAME:	Stöckert Coronary Perfusion Cannulae
COMMON/USUAL NAME:	Antegrade Cardioplegia Cannulae
CLASSIFICATION NAME:	Cardiopulmonary Bypass Vascular Catheter, Cannula or Tubing
PREDICATE DEVICE:	Medtronic DLP Coronary Ostial Perfusion Cannulae

DEVICE DESCRIPTION:

INDICATIONS FOR USE

The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

In-vitro performance and biocompatibility tests demonstrate substantial equivalency of the Stöckert Coronary Perfusion Cannulae to the Medtronic DLP Coronary Ostial Perfusion Cannulae. The devices share the same intended use, design features, and performance characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three parallel lines that curve to form the shape of the bird's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2002

Stöckert Instrumente GmbH c/o Ms. Lynne Leonard Leonard Regulatory Consulting 20193 Goins Drive Morrison, CO 80465

Re: K022280

Stöckert Coronary Perfusion Cannulae Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: July 11, 2002 Received: July 15, 2002

Dear Ms. Leonard:

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 mav publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Lynne Leonard

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 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). 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,

R. Zaleski M.D.

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

Enclosure

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510(k) Pre-Market Notification: Stöckert Coronary Perfusion Cannulae

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Indications For Use

510(k) Number (If known): K022280

Device Name:

Stöckert Coronary Perfusion Cannulae

Indications For Use:

The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022880

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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).