HEM-O-LOK MODEL NUMBERS 523900, 523970

K982941 · Weck Closure Systems · FZP · Nov 19, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982941
• Device Name: HEM-O-LOK MODEL NUMBERS 523900, 523970
• Applicant: Weck Closure Systems
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Nov 19, 1998
• 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 match clip size to the size of the vessel or tissue structure to be ligated.

Device Story

Hem-O-Lok® ligating clips are nonabsorbable, manually applied hemostatic clips; used for vessel or tissue ligation to aid healing. Manufactured from polyacetal; supplied sterile in cartridges within rigid plastic blister packs. Used by surgeons in clinical/surgical settings. Device functions by mechanical ligation of vessels/tissues; provides hemostasis. Clinical benefit includes effective vessel/tissue closure during surgical procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

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 use in surgical procedures requiring ligation of vessels or tissue structures. Intended for use by surgeons who must match clip size to the specific vessel or tissue structure being ligated.

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 (K922186)

Submission Summary (Full Text)

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

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

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

Telephone: [phone] [phone] Facsimile:

Submitted : July 24, 1998

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

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

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

The Weck Closure Systems Hem-O-Lok® clip is substantially equivalent to Hem-O-Loke clips cleared under Bristol Myers' 510(k) number K922186.

#### 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 polyacctal.

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.

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## Page 2 / Hem-O-Lok® 510(k) Summary

#### ડ. Intended Use of the Device

Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should match clip size to the size of the vessel or tissue structure to be ligated.

#### 6. Summary of Technological Characteristics

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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure with three flowing lines forming the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 9 1998

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

Re: K982941 Trade Name: Hem-O-Lok® Ligating clips Regulatory Class: II Product Code: FZP Dated: July 30, 1998 Received: August 21, 1998

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 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 Regulations, 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. Brian J. Young

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/dsma/dsmamain.html".

Sincerely yours,

tp coley Or

~ Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 2 Statement of indications for use

K982941 510(k) Number (if assigned): Hem-O-Lok® ligating clips Device Name:

# INDICATIONS FOR USE

Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or riche-O-Lok "higating chips are miched sclip size to the size of the vessel or tissue structure to be ligated.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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