HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240

K993157 · Weck Closure Systems · FZP · Dec 17, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993157
• Device Name: HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
• Applicant: Weck Closure Systems
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Dec 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Device Story

Hem-O-Lok® is a manually applied, nonabsorbable hemostatic clip; manufactured from polyacetal. Used by surgeons in clinical settings for vessel or tissue ligation to aid healing. Clips are housed in a cartridge, packaged in a rigid plastic blister with Tyvek lidding, and sold sterile. Operation involves manual application to encompass the target vessel or tissue structure completely. Device provides mechanical hemostasis through ligation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nonabsorbable ligating clip; material: polyacetal; sterilization: EtO (SAL 10^-6); form factor: cartridge-housed clips in blister packaging.

Indications for Use

Indicated for ligation of vessels or tissue structures in surgical procedures. 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

• Hem-O-Lok clips (K982941)

Submission Summary (Full Text)

{0}------------------------------------------------

# Premarket Notification [510(k)] Summary for Hem-O-Lok® Ligation Clips

#### Submitter Name, Address, and Date of Submission 1.

Brian Young Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, NC 27709

Telephone: [phone] Facsimile: [phone]

August 26, 1999 Submitted:

### Name of the Device, Common, Proprietary (if known), and Classification 2.

| Classification Name: | Implantable clip |
|----------------------|--------------------------|
| Common Name: | Ligating clip |
| Proprietary Name: | Hem-O-Lok® Ligating clip |

### Identification of the legally marketed device to which the submitter claims 3. equivalence

The Weck Closure Systems Hem-O-Lok® clip is substantially equivalent to Hem-O-Loke clips cleared under Weck's previous 510(k) filing number 982941.

#### 4. Description of the Device

Weck Closure System's Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-O-Lok® causes hemostasis through vessel ligation. The clip is nonabsorbable and is manufactured from polyacetal.

The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10°. The blister packs are fitted into an overpack carton which serves as the sales unit.

{1}------------------------------------------------

### Intended Use of the Device ನ.

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 structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

### Summary of Technological Characteristics 6.

The technological characteristics are the same as or equivalent to the predicate device. The polyacetal material used in the clips is shown to be biocompatible.

{2}------------------------------------------------

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, which is a common symbol used by the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 1999

Mr. Brian J. Young Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, North Carolina 27709

K993157 Re: Trade Name: Hem-O-Lok SMX Polymer Clips, Model 544220 Regulatory Class: II Product Code: FZP Dated: September 7, 1999 Received: September 21, 1999

Dear Mr. Young:

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 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.

{3}------------------------------------------------

## Page 2 - Mr. Brian J. Young

This letter will allow you to begin marketing vour 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.

Neil R.P. Ogden

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

Enclosure

{4}------------------------------------------------

### 2 Statement of indications for use

510(k) Number (if assigned): Device Name:

Hem-O-Lok® ligating clips

## INDICATIONS FOR USE

Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tion o box "higating onps should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

NRO for
(Division Sior Off)
Division of Ceneral Restorative Devices
510(k) Number K993157

Concurrence of CDRH, Office of Device Evaluation (ODE)

. . . .
. . . . . . .
. . . . . . . .

X Prescription use