MILTEX LIGATING CLIP

K052018 · Miltex, Inc. · FZP · Nov 4, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052018
• Device Name: MILTEX LIGATING CLIP
• Applicant: Miltex, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Nov 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Miltex Ligating Clip is an extra-vascular, implanted device intended to occlude by compression blood flow within small, non-intracranial vessels. The clip is available in several sizes and the practitioner chooses the size of clip to fit the procedure, insuring that the tissue to be occluded fits completely within the clip.

Device Story

Miltex Ligating Clip is an extra-vascular, implantable device used to occlude blood flow in small, non-intracranial vessels. Constructed from CP Grade 1 titanium wire, the clip features a chevron shape with a heart-shaped cross-section. The inner surfaces contain longitudinal and angled transverse grooves to enhance tissue retention and occlusion. Distal flat surfaces on the clip legs facilitate proper alignment during closure to prevent scissoring. The device is supplied sterile in disposable, color-coded cartridge holders. It is intended for use by clinicians during surgical procedures; the practitioner selects the appropriate size to ensure complete tissue coverage within the clip. The device functions by mechanical compression of the vessel, providing a secure, permanent ligation.

Clinical Evidence

Bench testing only. The device was evaluated for biocompatibility, sterility, and mechanical performance (occlusion function) compared to the predicate device. No clinical data was required or provided.

Technological Characteristics

Material: CP Grade 1 titanium wire. Shape: Chevron, heart-shaped cross-section. Features: Longitudinal and angled transverse grooves for tissue retention; distal flat surfaces for alignment. Sizes: Small, medium, medium-large, large. Packaging: Sterile, disposable color-coded cartridge holders. Energy source: None (mechanical).

Indications for Use

Indicated for occlusion of blood flow in small, non-intracranial vessels via compression. For use by practitioners in surgical procedures requiring vessel ligation.

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

• Horizon™ Ligation System (K982313)

Submission Summary (Full Text)

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

page 1 of 2

FDA 510(k) Pre-Market Notification Miltex Ligating Clip

<052018
589

589 Davies Drive

phone [phone]
toll-free 800 221-1344
fax [phone]

www.miltex.com

Miltex.

Redefining Excellence

NGV - 4 2005

510(k) Summary [as required by 21 CFR 8807,92(c)]

510(k) Owner's Name and Address: Miltex, Inc. 589 Davies Drive York, PA 17402

Contact Information: Telephone [phone], Fax [phone] Contact Person: Lee Zagar, Vice President Quality Assurance and Regulatory Affairs Date Summary Prepared: September 12, 2005

Device Trade Name: Miltex Ligating Clip. Device Common Name: Ligating Clip. Classification Name: Clip, Vascular (21 CFR 870.3250, Product Code DSS)

Predicate Device: Horizon™ Ligation System by Weck Closure Systems- K982313

Device Description: The Miltex Ligating Clip is constructed exclusively of CP Grade 1 titanium wire having a heart-shaped cross-section. The clip is chevron-shaped. The inside (tissue-engaging) surfaccs of the clip legs have a longitudinal groove intersected by a number of angled transverse grooves. The longitudinal grooves do not extend fully to the distal ends of the legs, but leave distal flat surfaces at the ends of the legs. When the clip is closed, tissue will fill in the grooves, providing secure retention on the vessel. This feature also improves the occluding functions of the clip. The distal flat ends of the legs provide surfaces that will contact each other initially as the clip is closed. The contact of the distal flat surfaces will cause the legs to straighten in alignment with cach other, thereby minimizing the possibility of scissoring. Clips are available in 4 sizes: small, medium, medium-large, and large. The clips are packaged six per disposable cartridge holder. The clips and cartridge holder are supplied sterile. Cartridge holders are color-coded using the industry standard color-coding system.

Intended Use: The Miltex Ligating Clip is an extra-vascular, implanted device intended to occlude by compression blood flow within small, non-intracranial vessels. The clip is available in several sizes and the practitioner chooses the size of clip to fit the procedure, insuring that the tissue to be occluded fits completely within the clip.

Technological Characteristics: The Miltex Ligating Clip has the same technological characteristics as the predicate device. The clip is composed of the same titanium material as the predicate device. In shape, the Clip is the same as the predicate device. When closed, the Clip is virtually identical in size to the predicate device. The disposable holder is a plastic equivalent to the predicate device's.

Page 8-1. rev 1

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

jan 27

FDA 510(k) Pre-Market Notification Miltex Ligating Clip

Performance Data: When used with the appropriate clip applier, the Miltex Ligating Clip functions in the same manner as the predicate device to occlude blood vessels. The clip is biocompatible, is not endo-toxic, and is supplied sterile.

## Conclusion:

Because the Miltex Ligating Clip is composed of the same material, has the same design and dimensions, and is supplied sterile, it is as safe, as effective, and performs as well as the Horizon Ligation System (K982313).

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2005

Charles Weaver Regulatory Affairs Coordinator Miltex, Inc. 589 Davies Drive York, Pennsylvania 17402

Re: K052018

Trade/Device Name: Miltex Ligating Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: October 12, 2005 Received: October 13, 2005

Dear Mr. Weaver:

We have reviewed your Scction 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 10 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 gencral 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 fisting (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.

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

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/indcx.html.

Sincercly yours,

barbare Buchner
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known): K052018

Device Name: Miltex Ligating Clip

Indications for Usc:

The Miltex Ligating Clip is an extra-vascular, implanted device intended to occlude by compression blood flow within small, non-intracranial vessels. The clip is available in several sizes and the practitioner chooses the size of clip to fit the procedure, insuring that the tissue to be occluded fits completely within the clip.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
|-------------------------------------------------|---|--------|------------------------------------------------|--|
|-------------------------------------------------|---|--------|------------------------------------------------|--|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)

*Darban Bonerlubert Cloud D.R.f.* Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General Restorative, ^{Page 1 of 1}

and Neurological Devices

| 510(k) Number | R05 2018 |
|---------------|----------|
|---------------|----------|

Page 4-1