COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT

K992906 · Olson Medical Sales, Inc. · DTL · Nov 10, 1999 · Cardiovascular

Device Facts

• Record ID: K992906
• Device Name: COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
• Applicant: Olson Medical Sales, Inc.
• Product Code: DTL · Cardiovascular
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.

Device Story

Adapters interconnect tubing, oxygenators, reservoirs, and filters in cardiopulmonary bypass circuits. Types include straight (with/without luer locks), large bore, three-way, and four-way connectors. Used in surgical settings by clinicians to establish pathways for blood and extracorporeal fluids. Device facilitates circuit assembly for extracorporeal support.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO-10993 for external communicating devices with circulating blood (limited exposure ≤ 24 hours). Sterilization validated per AAMI guidelines.

Technological Characteristics

Materials: polycarbonate, acrylic, Acrylonitrile-Butadiene-Styrene (ABS). Form factors: straight, large bore, three-way, four-way connectors. Sterilization: Ethylene oxide. Biocompatibility: ISO-10993 compliant.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures requiring extracorporeal support.

Regulatory Classification

Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Medtronics 'Y' adapter (K790563)
• Medtronics 3/16″ Large Bore Male adapter (K830728)

Submission Summary (Full Text)

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NOV I n 1999

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Section II

# Summary of Safety and Effectiveness Information Pertaining To Substantial Equivalence

| Device Common Name: | Adapters |
|----------------------|-----------------------------------------------------------------|
| Classification Name: | Adapter, Stopcock, Manifold, Fitting,<br>Cardiopulmonary Bypass |

### Intended Use:

The adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.

### Device Description:

The adapters are used in connecting oxygenators, reservoirs, filters, tubing, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support.

The adapters are of the following generic types: straight adapters with or without luer locking mechanisms (male and female), large bore adapters, three-way connectors, and four-way connectors.

The materials used in the manufacturing of these adapters includes polycarbonate, acrylic, and Acrylonitrile-Butadiene-Styrene (ABS). The cleared Medtronics adapters are comprised of plexiglas and Note: polyvinyIchloride.

### Substantial Equivalence:

The adapters presented in this 510(k) are substantially equivalent in intended use, design, technology and principles of operation, materials and performance to the cleared Medtronics "Y" adapter (K790563) and the Medtronics 3/16″ Large Bore Male adapter (K830728).

### Principle of Operation/Technology:

The adapters presented in this submission perform under the same principles as the cleared Medtronics components. Each is used to interconnect cardiopulmonary bypass components to provide a pathway for blood and other extracorporeal fluids.

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#### Section II

## Design/Materials:

Differences in design and materials between the adapters indicated in this submission and the cleared Medtronics adapters raise no new issues of safety and effectiveness.

### Performance:

The performance of the adapters presented in this submission is substantially equivalent to the performance of the Medtronics adapters.

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#### Section II

### Additional Safety Information

Sterilization conditions have been validated in accordance with AAMI quidelines to provide a Sterility Assurance Level (SAL) of 10 to the negative sixth.

Ethylene oxide residuals will not exceed the maximum residue limits imposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) contact duration]. The blood contacting materials were found to be biocompatible.

The expiration dating of the submitted components is controlled by the component with the shortest expiry that is included in a kit, or two years; whichever is the shortest duration.

#### Conclusion

The convenience kit components submitted in this 510(k) are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared devices indicated within. Differences between the submitted adapters and the cleared adapters do not raise any new issues of safety or effectiveness.

Olson Medical Sales' statement that this device is substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended to be the basis for a patent infringement action.

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#### Section II

# Summary of Safety and Effectiveness Information Pertaining To Substantial Equivalence

This Summary of Safety and Effectiveness was prepared on August 9, 1999.

Fax: [phone]

| This Summary was prepared by: | Garry A. Courtney<br>Regulatory Affairs Specialist |
|--------------------------------|-----------------------------------------------------------------------------------|
| This Summary was prepared for: | OLSON MEDICAL SALES<br>28 Howe Street<br>Ashland, MA 01721<br>Phone: [phone] |

.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with two snakes coiled around it.

NOV 1 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olson Medical Sales, Inc. Mr. Garry A. Courtney Requlatory Affairs Association Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921

Re : K992906 Components For Cardiovascular Procedure Kit Regulatory Class: II (TWO) Product Code: 74 DTL Dated: August 23, 1999 Received: August 30, 1999

Dear Mr. Courtney:

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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 - Mr. Garry A. Courtney

This letter will allow you to beqin marketinq your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

> Nancy C. bugdon for

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Components For Cardiovascular Procedure Kit Device Name:

Indications For Use:

The Adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.

> Garry A. Courtney Regulatory Affairs Associate Terumo Medical Corporation

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

Kylie L. Kumpera

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number * 992906

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