MCAS (MODULAR CLIP APPLIER SYSTEM)

K983744 · Applied Medical Resources · DSS · Jan 21, 1999 · Cardiovascular

Device Facts

• Record ID: K983744
• Device Name: MCAS (MODULAR CLIP APPLIER SYSTEM)
• Applicant: Applied Medical Resources
• Product Code: DSS · Cardiovascular
• Decision Date: Jan 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Applied Medical Modular Clip Applier System is indicated for ligation of tubular structures or vessels where a non-absorbable ligating device is indicated.

Device Story

Modular reposable surgical instrument for ligation of tubular structures or vessels. System consists of a reusable stainless steel clip applier and disposable, sterile, color-coded clip cartridges. Cartridges house 6-10 titanium clips in four sizes (small, medium, medium/large, large). Operated by surgeons in clinical/surgical settings. Unlike traditional appliers requiring manual loading of individual clips, this system uses a modular cartridge design to deliver multiple clips sequentially. Device facilitates vessel ligation; provides mechanical closure of structures; improves procedural efficiency by reducing manual clip loading.

Clinical Evidence

Bench testing only.

Technological Characteristics

Reusable stainless steel applier; disposable plastic/metal clip cartridges; titanium clips. Four sizes (small, medium, medium/large, large). Modular design; cartridge-based clip delivery. Sterilized disposable components.

Indications for Use

Indicated for ligation of tubular structures or vessels requiring non-absorbable ligating devices in patients undergoing surgical procedures.

Regulatory Classification

Identification

A vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other than intracranial vessels.

Predicate Devices

• Weck Closure System™ HEMOCLIP™

Submission Summary (Full Text)

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K983744

JAN 2 1 1999

## APPENDIX VIII 510(k) SUMMARY

| 510(k) NUMBER: | PENDING |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>26051 Merit Circle, Unit# 103<br>Laguna Hills, California 92653<br>[phone] Ext. 310 |
| CONTACT PERSON: | Howard V. Rowe |
| DATE OF PREPARATION: | October 22, 1998 |
| NAME OF DEVICE: | Applied Medical Modular Clip Applier System<br>(MCAS) |
| CLASSIFICATION NAME: | Cardiovascular Surgical Instrument 21 CFR<br>870.4500 Clip Applier, and 21 CFR 870.3250<br>Vascular Clip |
| TRADE NAME: | Not established to date. |

SUMMARY STATEMENT: The Applied Medical Modular Clip Applier System (MCAS) is substantially equivalent to the predicate Weck Closure System™ HEMOCLIP™ manufactured by Weck. The Applied Medical MCAS is a modular reposable device intended for ligation of tubular structures or vessels where a nonabsorbable ligating device is indicated.

The reusable clip applier is made of stainless steel and is similar to standard clip appliers and surgical clamp designs currently on the market. The disposable clip cartridge is made of various plastic and metal materials and will be sold sterile. The clip cartridges will be available in four sizes, small, medium/large, and large and will house six to ten titanium clips depending on the clip size to be used. The cartridges are color coded Yellow, Blue, Green and Orange respectively according to their size. The key difference between the Applied MCAS and the predicate device is the modular design which provides the user with multiple clips inside a cartridge which is loaded onto a reusable applier instead of manually loading individual clips into the applier during surgical procedures.

The Applied Medical Modular Clip Applier System passed all testing to demonstrate substantial equivalence to the predicate device and introduces no new safety and effectiveness issues when used as instructed.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1999

Mr. Howard V. Rowe Director, Regulatory Affairs Applied Medical Resources Corporation 26051 Merit Circle, Unit #103 Laguna Hills, CA 92653

Re: K983744 Trade Name: MCAS (Modular Clip Applier System) Regulatory Class: ı i Product Code: DSS Dated: October 22, 1998 Received: October 23, 1998

Dear Mr. Rowe:

·

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 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

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Page 2 - Mr. Howard V. Rowe

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.

This letter will allow you to begin marketing your device as described in your 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 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 (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## APPENDIX VII

## INDICATIONS FOR USE

Applied Medical Resources is providing this separate cover page for the Applied Medical Modular Clip Applier System "Indication for Use" as required.

Not Assigned 510(k) Number:

Applied Medical Modular Clip Applier System Device Name:

The Applied Medical Modular Clip Applier System is indicated for ligation Indications for Use: of tubular structures or vessels where a non-absorbable ligating device is indicated.

Signature:

Title: Director, Regulatory Affairs Date: 10-22-98

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-------------------------------------------------------------------|-----------------------------|
| Prescription Use | <div> <span>✓</span> </div> |
| (Per 21 CFR 801.109) | |
| | OR |
| Over-The-Counter Use | |
| | (Optional Format -2-96) |
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K983744 |