WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER

K021808 · Weck · FZP · Aug 14, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021808
• Device Name: WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
• Applicant: Weck
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Aug 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.

Device Story

Sterile, single-use, automatic ligating clip applier; consists of handle, shaft containing 15 Hem-o-lok locking polymer clips, and jaw. Functions include clip feeding, positioning around vessel/tissue, and closure. Used in endoscopic or open surgery by surgeons. Device discarded after procedure; polymer clips remain in patient. Facilitates vessel/tissue ligation.

Clinical Evidence

Bench and animal testing performed. No clinical data provided.

Technological Characteristics

Single-use, sterile, mechanical clip applier. Contains 15 non-absorbable polymer clips. Available in endoscopic and open surgery configurations. Manual operation.

Indications for Use

Indicated for use in surgical procedures requiring ligation of vessels or tissue structures. Applicable to both endoscopic and open surgery. No specific age or gender restrictions provided.

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

• Weck Hem-o-lok clips
• U.S.S.C. AutoSuture Endoclip 5mm Disposable Clip Applier
• Weck reusable ligating clip appliers

Submission Summary (Full Text)

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## K021808

## PART 9 SUMMARY OF SAFETY AND EFFECTIVENESS

## 510(k) SUMMARY

Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Weck submits this summary of safety and effectiveness.

- Submitter Name, Address, and Date of Submission 1.
Brian Young Sr. Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, NC 27709 Telephone: [phone] Facsimile: [phone] May 13, 2002 Prepared:

- Name of the Device, Common, Proprietary (if known), and Classification 2. Implantable clip Classification Name: Common Name: Ligating clip Weck Hem-o-Lok® Automatic Ligating Clip Applier Proprietary Name:
- Identification of the legally marketed device to which the submitter claims 3. equivalence

The clips delivered by the proposed automatic applier described in this submission are substantially equivalent to Weck Hem-o-lok® clips. The delivery mechanism is substantially equivalent to the U.S.S.C. AutoSuture® Endoclip 5mm Disposable Clip Applier, and Weck reusable ligating clip appliers.

#### 4. Description of the Device

The Weck device is a sterile, single use, automatic ligating clip applier consisting of a handle, shaft containing 15 Hem-o-lok® locking polymer clips, and jaw. The major functions of the device are clip feeding, approximation (positioning the clip around the vessel), and closure. The applier is discarded after the surgical procedure whereas the applied non-absorbable polymer clips remain in the patient. Two models are offered: endoscopic and open surgery.

#### 5. Intended Use of the Device

Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures.

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Surgeons should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.

#### Summary of Technological Characteristics 6.

The technological characteristics are equivalent to the predicate devices. The results of bench and animal testing demonstrate that any differences between the new device and its predicates do not adversely affect performance or safety.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

AUG 1 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## Weck James Lucky

Vice-President, Regulatory Affairs and Quality Assurance 2917 Weck Drive Durham, North Carolina 27709

## Re: K021808

Trade/Device Name: Hem-o-Lok™ Automatic Ligating Clip Applier Regulation Number: 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: May 31, 2002 Received: June 3, 2002

Dear Mr. Lucky:

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.

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,

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Page 2 – Mr. James Lucky .

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 [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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

> Sincerely yours ia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO21808

# INDICATION FOR USE

## Statement of Indications For Use

New Application 510(k) Number (if known):

Hem-o-lok™ Automatic Ligating Clip Appliers Device Name:

Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeone should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.

* Note: The indications section of the labeling for the endoscopic model will refer to endoscopic use.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CRF 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Stupt. Rhodes

on of General. Restorative

510(k) Number K021808