IMPLANTABLE CLIP FOR GENERAL SURGERY

K993135 · Applied Medical Resources · FZP · Dec 1, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993135
• Device Name: IMPLANTABLE CLIP FOR GENERAL SURGERY
• Applicant: Applied Medical Resources
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Dec 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Applied Medical Implantable Clip is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

Device Story

Implantable Clip is a sterile, single-use titanium device for ligation of tubular structures or vessels during laparoscopic and general surgery. System comprises a disposable cartridge containing 14 clips and a reusable handle. The handle provides the mechanical mechanism for storing, advancing, and delivering clips. Used with 11mm or larger trocar cannulas. Operated by surgeons in OR settings. Device provides mechanical occlusion of vessels; aids in hemostasis or structure closure. Benefits include secure ligation during minimally invasive or open procedures.

Clinical Evidence

Bench testing only. Testing included jaw occlusion force analysis, leak pressure tests on ligated vessels, and clip retention force measurements. Results demonstrated performance equivalent to predicate devices.

Technological Characteristics

Material: Implant-grade titanium. Form factor: Pre-packaged cartridge with 14 clips, used with a reusable handle. Delivery: Mechanical advancement and delivery system compatible with 11mm+ trocar cannulas. Sterilization: Sterile, single-use.

Indications for Use

Indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures for patients requiring surgical intervention.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• APPLIED MEDICAL CLIP APPLIER
• LIGACLIP™ ERCA, Ethicon, Inc.

Submission Summary (Full Text)

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### 510(k) SUMMAR Y

| 510(k) NUMBER: | PENDING |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>26051 Merit Circle, Unit # 104<br>Laguna Hills, California 92653<br>[phone] |
| CONTACT PERSON: | Anil Bhalani<br>Director of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | September 15, 1999 |
| NAME OF DEVICE: | Implantable Clip |
| CLASSIFICATION NAME: | Implantable Clip (21 CFR 878.4300) |
| TRADE NAME: | Not Determined |
| PREDICATE DEVICES: | 1. APPLIED MEDICAL CLIP APPLIER<br>2. LIGACLIP™ ERCA, Ethicon, Inc. |

INTENDED USE: The Applied Medical Implantable Clip is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

DEVICE DESCRIPTION: The Implantable Clip is a sterile single use device indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. The clip is manufactured from implant grade titanium. The clips are supplied pre-packaged in a preassembled cartridge loaded with 14 functional clips. The clip applier system used to deliver the clips consists of the disposable clip cartridge and a reusable handle which provide the mechanical mechanism for storing, advancing and delivering the implantable clips. The system is designed for use with an 11mm diameter or larger trocar cannula.

PERFORMANCE DATA SUMMARY: The performance and functional testing of the Implantable Clip included tests to analyze the jaw occlusion force of the clip appliers used with the clips discussed in this submission, leak pressure tests on vessels ligated by the clips and clip retention force of the clips. The performance and functional testing demonstrated that the Implantable Clip is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed.

LIGACLIP™ is a trademark of Ethicon, Inc.

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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Anil Bhalani Director of Regulatory Affairs and Clinical Programs Applied Medical Resources 26051 Merit Circle, #104 Laguna Hills. California 92653

DEC - 1 1999

Re: K993135 Trade Name: Implantable Clip Regulatory Class: II Product Code: FZP Dated: September 15, 1999 Received: September 20, 1999

Dear Mr. Bhalani:

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 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality 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. Anil Bhalani

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 regulation (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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours.

Nail R.P. Ogden

James E. Dillard II Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 993135

### INDICATIONS FOR USE

Applied Medical Resources is providing this separate cover page for the Implantable Clip "Indications for Use" as required.

Not assigned 510(k) Number:

Implantable Clip Device Name:

Indications for Use: The Applied Medical Implantable Clip is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

Signature: A.S. Bhal Title: Director RA/Clinical Programs Date: 9-15-99

NRO for

| (Division Sign-Off) Division of General Restorative Devices | |
|-------------------------------------------------------------|---------|
| 510(k) Number | K993135 |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The -Counter Use

(Optional Format 1-2-96)