The Stockert V142 Series Venous Cannulae with Lighthouse Tip are intended to be used for cannulating the major venous vessels during cardiopulmonary bypass surgery.
The Stockert V142 Series Venous Cannulae with Lighthouse Tip are intended to be used for cannulating the superior or the inferior vena cava during standard cardiopulmonary bypass surgery.

Device Description

The Stockert V142 Series Venous Cannulae with Lighthouse Tip are sterile, non-pyrogenic devices, for single use only, and are not to be resterilized by the user. The devices are single stage, wire reinforced venous cannulae with a distal open lighthouse tip. They are intended to be used to can, ulate the venous vessels during cardiopulmonary bypass surgery.
The product will be offered for sale in various french sizes ranging from 28 Fr to 36 Fr.
The Stockert Venous Cannulae with Lighthouse Tip are composed of two components, the cannula tube and the lighthouse tip. Encapsulated within the cannulae outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking. The length of the device is, 40 cm.

AI/ML Overview

The provided text describes a 510(k) Pre-Market Notification for the Stockert Venous Cannulae with Lighthouse Tip. This type of notification establishes substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new, de novo device. Therefore, a direct table of acceptance criteria and reported device performance, as one might find for a novel device with defined thresholds, is not present. Instead, the study aims to demonstrate that the new device performs similarly to an already-approved predicate device.

Here's an analysis based on the provided text, addressing your questions where applicable within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state numerical acceptance criteria or detailed reported device performance in a table format. Instead, it lists the tests performed to demonstrate substantial equivalence to the predicate device, the Baxter Research Medical Inc. Single Stage Venous Return Cannula Wire Reinforced with Lighthouse Tip. The implicit "acceptance criteria" for a 510(k) submission like this is that the new device's performance in these tests is comparable to or better than the predicate device, thereby not raising new questions of safety or effectiveness.

Test Performed	Implicit Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (Summary from text)
1. Pressure Drop	Performance (e.g., flow rate vs. pressure drop characteristics) should be comparable to or better than the predicate device, ensuring adequate blood flow during cardiopulmonary bypass. The specific values would be held to be within a pre-defined range of the predicate device's performance.	The study included this test to show substantial equivalency. No specific performance data (e.g., "X mmHg pressure drop at Y L/min flow") is provided, but the FDA's clearance implies that the results were satisfactory for claiming substantial equivalence.
2. Blood Trauma	The device should not cause significantly more blood cell damage (e.g., hemolysis) than the predicate device.	The study included this test to show substantial equivalency. No specific performance data (e.g., "hemolysis rate of X%") is provided, but the FDA's clearance implies that the results were satisfactory for claiming substantial equivalence.
3. Leak	The device should be leak-free under conditions similar to or exceeding physiological and operational stresses.	The study included this test to show substantial equivalency. No specific performance data (e.g., "no leakage observed at X pressure") is provided, but the FDA's clearance implies that the results were satisfactory for claiming substantial equivalence.
4. Kink Resistance	The device should resist kinking to a degree comparable to or better than the predicate device, ensuring continuous and unobstructed flow.	The device description explicitly states it has an "helically wound stainless steel wire which allows the cannula tube to resist kinking." The study included a "Kink Resistance" test to demonstrate this property is comparable to the predicate. No specific performance data is provided, but the FDA's clearance implies satisfactory results.
5. Bond Strength	All bonded components (e.g., cannula tube to lighthouse tip) should maintain structural integrity under intended use conditions, comparable to or better than the predicate device.	The study included this test to show substantial equivalency. No specific performance data (e.g., "bond strength of X Newtons") is provided, but the FDA's clearance implies that the results were satisfactory for claiming substantial equivalence.
6. Dimensional Inspection Post-sterilization and Post-aging	The device dimensions should remain within specified tolerances after sterilization and accelerated aging processes, demonstrating stability and integrity over its intended shelf life.	The study included this test to show substantial equivalency. No specific performance data is provided, but the FDA's clearance implies that the results were satisfactory for claiming substantial equivalence, ensuring the device remains within functional dimensional limits after sterilization and aging.

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

The document does not specify the sample sizes for any of the tests performed (Pressure Drop, Blood Trauma, Leak, Kink Resistance, Bond Strength, Dimensional Inspection).

The data provenance is implicitly from the manufacturer's internal testing (Stockert Instrumente GmbH / COBE Cardiovascular, Inc.), conducted to support the 510(k) submission. The exact country of origin for the testing itself isn't specified, but the manufacturer is based in Germany and the applicant in the USA. Given this is product testing, it would be considered prospective data generation for the purpose of demonstrating substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of submission for a medical device (venous cannula) does not involve establishing ground truth through expert review in the sense of image interpretation or diagnostic accuracy. The "ground truth" here is the objective physical and mechanical performance of the device against established engineering and biological standards, and comparison to a predicate device. Therefore, no experts were used to establish ground truth in this context. The "experts" involved would be the engineers and scientists who conducted the testing and evaluated the results against the predicate and relevant standards.

4. Adjudication Method for the Test Set

Not applicable. As explained in point 3, this is not a study requiring adjudication of expert opinions for a test set. The evaluation is based on objective measurements from physical and mechanical tests.

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

Not applicable. MRMC studies are typically used to assess the diagnostic performance of imaging devices or algorithms, often comparing human readers with and without AI assistance. This submission is for a physical medical device (venous cannula) and does not involve diagnostic interpretation or AI.

6. Standalone (Algorithm Only) Performance

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

7. Type of Ground Truth Used

The "ground truth" in this context is the objective, measurable physical and mechanical performance characteristics of the device (e.g., actual pressure drop, actual blood trauma, actual bond strength values) as determined by laboratory testing. These values are then compared to the known or established performance of the legally marketed predicate device (Baxter Research Medical Inc. Single Stage Venous Return Cannula Wire Reinforced with Lighthouse Tip). The underlying "ground truth" for the predicate device would also be its objectively measured performance.

8. Sample Size for the Training Set

Not applicable. This submission is for a physical medical device and does not involve machine learning or a "training set."

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

Not applicable. As explained in point 8, there is no training set involved.

Summary

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510(k) Pre-Market Notification: Stockert Venous Cannulae with Lighthouse Tip

K 994209

	JUN 1 4 2000
510(k) Summary
SUBMITTER:	Stockert Instrumente GmbHDivision of Sorin Biomedica SpALilienthalalle 5-7D-80939 Munich Germany
APPLICANT:	COBE Cardiovascular, Inc.Division of Sorin Biomedica SpA14401 W. 65th WayArvada, Colorado 80004-3599 USA
CONTACT PERSON:	Lynne LeonardRegulatory Affairs ManagerCOBE Cardiovascular, Inc.Arvada, Colorado USAPhone: (303) 467-6586Fax: (303) 467-6429
DATE PREPARED:	November 22, 1999
DEVICE TRADE NAME:	Stockert V142 Series Venous Cannulae with Lighthouse Tip
COMMON/USUAL NAME:	Cardiovascular Venous Cannulae
CLASSIFICATION NAME:	Cardiopulmonary Bypass Vascular Catheter, Cannula or Tubing
PREDICATE DEVICE:	Baxter Research Medical Inc. Single Stage Venous Return CannulaWire Reinforced with Lighthouse Tip

DEVICE DESCRIPTION:

The product will be offered for sale in various french sizes ranging from 28 Fr to 36 Fr.

The Stockert Venous Cannulae with Lighthouse Tip are composed of two components, the cannula tube and the lighthouse tip. Encapsulated within the cannulae outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking. The length of the device is, 40 cm.

INDICATIONS FOR USE

The Stockert V142 Series Venous Cannulae with Lighthouse Tip are intended to be used for cannulating the major venous vessels during cardiopulmonary bypass surgery.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The Stockert Venous Cannulae with Lighthouse Tip are substantially equivalent to the Baxter Research Medical Inc. Single Stage Venous Return Cannula Wire Reinforced with Lighthouse Tip. The devices are both single stage, wire reinforced venous return cannulae with an open lighthouse tip on the distributed and

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without a connector on the proximal end. The Stockert Venous Cannulae are 40 cm in length, accept a 3/8" connector, and will be offered in sizes from 28 Fr. The Baxter RMM Venous Cannual cre 35 to 40 cm in length, accept a 3/8" connector, and are offered in sizes from 26 Fr to 40 Fr.

The following tests were performed to demonstrate substantial equivalency of the Stockert V142 Series Venous Cannulae with Lighthouse Tip to the Baxter Research Medical Inc. Single Stage Venous Return Cannula Wire Reinforced with Lighthouse Tip:

1. Pressure Drop
1. Blood Trauma
ന് Leak
1. Kink Resistance
1. Bond Strength
હ. Dimensional Inspection Post-sterilization and Post-aging

্থ

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a human figure or a symbol representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2000

Ms. Lynne Leonard Requlatory and Clinical Affairs Manager COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599

Re: K994209 Stockert V142 Series Venous Cannulae with Light Regulatory Class: II (two) Product Code: DWF Dated: May 12, 2000 Received: May 15, 2000

Dear Ms. Leonard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Leonard

This letter will allow you to begin marketing your device as described in rnis feecer were notification. The FDA finding of substantial your of the premains wire to a legally marketed predicate device results equivalence or 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and (301) 594-4648. (Jos) of your device, please contact the Office of Compliance at Also, please note the regulation entitled, "Misbranding (301) 594-4639. by reference to premarket notification" (21CFR 807.97). Other general by reference to promresponsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Brian E. Harvey

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications For Use

510(k) Number (if known): K994209

Device Name:

Stockert V142 Series Venous Cannulae with Lighthouse Tip

Indications For Use:

The Stockert V142 Series Venous Cannulae with Lighthouse Tip are intended to be used for cannulating the superior or the inferior vena cava during standard cardiopulmonary bypass surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beve R. Couperle E. Hany
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

C(k) Number

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).