The Stöckert V172-28 Venous Femoral Cannula is intended to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.

Device Description

The Stöckert V172-28 Venous Femoral Cannula is a sterile, non-pyrogenic device, for single use only, and is not to be resterilized by the user. The device is a polyvinyl chloride (PVC) wire reinforced Cannula with a non-wire reinforced proximal end for connecting the device to a cardiopulmonary bypass circuit. The Stöckert V172-28 Cannula is intended to be used to cannulate the femoral vessels during cardiopulmonary bypass surgery. During use, the cannula is inserted into the vena femoralis and advanced into the right atrium, allowing blood from the systemic circulation to enter the extracorporeal circuit. Insertion of the cannula into the vena femoralis during cardiopulmonary bypass surgery is an alternative method for insertion of a cannula into the superior or inferior vena cava.

The Stöckert V172-28 Cannula is 28 Fr and 90 cm in length, with a flexible proximal end that can accommodate a 1/2" connector. The cannula tube contains two sets of side holes, one set for drainage from the right atrium and one set for drainage from the inferior vena cava and hepatic veins. An obturator is provided with each cannula, which seals the inside of the cannula tube in the areas of the side holes to prevent blood leakage from the cannula during insertion. After insertion, the obturator is removed and discarded by the user.

AI/ML Overview

The provided text describes a 510(k) pre-market notification for a medical device, the Stöckert V172-28 Venous Femoral Cannula. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study to establish performance from scratch. Therefore, the information typically associated with AI/software device studies (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, ground truth types) is not present here.

Instead, the study performed is a series of engineering and biological tests demonstrating that the new device performs as safely and effectively as the predicate device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the Stöckert V172-28 Venous Femoral Cannula is "substantially equivalent to the Medtronic DLP Venous Femoral Cannula." This is the overarching acceptance criterion, meaning the new device must perform comparably to the predicate device in key functional areas. The "reported device performance" is implicitly that the Stöckert V172-28 meets this substantial equivalence through the tests listed.

Acceptance Criterion (Implicit)	Reported Device Performance (Demonstrated by)
Substantial Equivalence to Medtronic DLP Venous Femoral Cannula	- Pressure Drop test results comparable to predicate
	- Blood Trauma test results comparable to predicate
	- Leak test results comparable to predicate
	- Kink Resistance test results comparable to predicate

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

This information is not provided. For this type of device (a physical medical cannula), "test set" typically refers to the number of units tested for each characteristic (e.g., how many cannulas were subjected to pressure drop tests). The data provenance refers to whether the tests were conducted internally by the manufacturer or by an independent lab, and this detail is also not specified.

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

Not applicable for this type of device submission. "Ground truth" for a physical device like a cannula is established through objective engineering and biological test results, not expert consensus interpreting data like images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used in studies involving subjective interpretation of data (e.g., medical images), which is not the nature of these tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a physical medical device, not an AI or software device. Therefore, no MRMC study or AI assistance is relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth is established through objective quantitative measurements from the specified engineering and biological tests (Pressure Drop, Blood Trauma, Leak, Kink Resistance). The "ground truth" for each test would be the empirically measured outcome of the Stöckert V172-28 device compared against the expected performance or against the performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning model. There is no concept of a "training set."

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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510(k) Pre-Market Notification: Stöckert V172-28 Venous Femoral Cannula

KO22321 PG1 of 2

510(K) SUMMARY

OCT 0 9 2002

SUBMITTER:	Stöckert Instrumente GmbHLindberghstr.25D-80939 Munich Germany
APPLICANT:	COBE Cardiovascular, Inc.14401 W. 65th WayArvada, Colorado 80004-3599 USA
CONTACT PERSON:	Shawn RiedelRegulatory and Quality Assurance ManagerCOBE Cardiovascular, Inc.Arvada, Colorado USAPhone: (303) 467-6521Fax: (303) 467-6525Email: shawn.riedel@cobecv.com
DATE PREPARED:	11 July 2002
DEVICE TRADE NAME:	Stöckert V172-28 Venous Femoral Cannula
COMMON/USUAL NAME:	Cardiovascular Femoral Cannula
CLASSIFICATION NAME:	Cardiopulmonary Bypass Vascular Catheter, Cannula orTubing
PREDICATE DEVICE:	Medtronic DLP Venous Femoral Cannula

DEVICE DESCRIPTION:

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INDICATIONS FOR USE

The Stöckert V172-28 Venous Femoral Cannula is intended to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The Stöckert V172-28 Venous Femoral Cannula are substantially equivalent to the Medtronic DLP Venous Femoral Cannula. The following tests were performed to demonstrate substantial equivalency of the devices:

1. Pressure Drop
1. Blood Trauma
1. Leak
1. Kink Resistance

TRUTHFUL AND ACCURATE STATEMENT

A statement attesting to the truthfulness and accuracy of the information contained in this submission is attached as Appendix 11.

FURTHER INFORMATION

In the event that additional information is required, please contact the following individual at COBE Cardiovascular, Inc. the applicant of this 510(k) notification, submitting on behalf of the manufacturer and specification holder of the product, Stöckert Instrumente GmbH. Munich, Germany:

Shawn Riedel Manager, Regulatory and Quality Assurance COBE Cardiovascular, Inc. 14401 West 65" Way Arvada, Colorado 80004-3599 USA Phone: (303) 467-6521 Fax: (303) 467-6525 Email: shawn.riedel(@cobecv.com

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 9 2002

Stöckert Instrumente GmbH c/o Mr. Shawn Riedel COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599

Re: K022321

Stöckert V172-28 Venous Femoral Cannula Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: II (two) . Product Code: DWF Dated: July 12, 2002 Received: July 17, 2002

Dear Mr. Riedel:

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.

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Page 2 - Mr. Shawn Riedel

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,

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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KØ22321
4

Indications For Use

510(k) Number (If known): K020321

Device Name:

Stöckert V172-28 Venous Femoral Cannula

Indications For Use:

The Stöckert V172-28 Venous Femoral Cannula is intended to be used to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K022332

0005

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).