ANCHORAGE CLOSURE DEVICE

K073096 · Epitek, Inc. · GAT · Feb 7, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073096
• Device Name: ANCHORAGE CLOSURE DEVICE
• Applicant: Epitek, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Feb 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anchorage™ Closure Device facilitates placement of a pre-tied ligature for use in surgical applications where soft tissue must be approximated and/or ligated.

Device Story

Anchorage Closure Device is a single-use, one-piece system for delivering and deploying pre-tied sutures. Used in surgical settings by clinicians to approximate or ligate soft tissue. Device functions as a mechanical delivery tool for ligatures; no electronic or software components involved. Benefits include simplified tissue approximation/ligation during surgery.

Technological Characteristics

Single-use, one-piece mechanical delivery system for pre-tied sutures. Nonabsorbable poly(ethylene terephthalate) surgical suture material. Class II device per 21 CFR 878.5000.

Indications for Use

Indicated for use in surgical applications requiring soft tissue approximation and/or ligation via placement of a pre-tied ligature.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Genzyme Saph-Loop Ligating Loop (K022410)
• SentreHeart LARIAT Loop Applicator (K060721)

Submission Summary (Full Text)

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## 510(k) Summary Epitek Anchorage™ Closure Device

### APPLICANT:

Epitek, Inc. 4801 W. 81st St., Suite 105 Bloomington, MN 55437 USA

FEB - 7 Luci

| Contact Person: | Werner Hampl |
|-----------------|----------------------|
| Telephone: | [phone] |
| e-mail: | [e-mail] |
| Date Prepared: | October 31, 2007 |

#### DEVICE:

Proprietary Name: Anchorage Closure Device Common/Usual Name: Suture with integral deployment device Classification: Class II; 21 CFR 878.5000; Nonabsorbable poly(ethylene terephthalate) surgical suture: Product Code: GAT

## PREDICATE DEVICE:

The subject device is substantially equivalent (i.e., has the same intended use and technological characteristics) to the Genzyme Saph-Loop Ligating Loop (K022410) and SentreHeart LARIAT Loop Applicator (K060721).

### DEVICE DESCRIPTION:

The Anchorage Closure Device is a one piece, single-use system comprised of components used to deliver and deploy a pre-tied suture in order to achieve soft tissue approximation and/or ligation.

#### INDICATIONS FOR USE:

The Anchorage Closure Device facilitates placement of a pre-tied ligature for use in surgical applications where soft tissue must be approximated and/or ligated.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

#### Public Health Service

FEB -- 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Epitek, Inc % Mr. Werner Hampl Vice President, Regulatory Affairs And Quality Assurance 4801 West 81st Street, Suite 105 Bloomington, Minnesota 55437

Re: K073096

Trade/Device Name: Anchorage™ Closure Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture. Regulatory Class: Class II Product Code: GAT Dated: January 17, 2008 Received: January 17, 2008

Dear Mr. Hampl:

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. Werner Hampl

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/index.html.

Sincerely yours,

Mark M. Millman

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

Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Anchorage™ Closure Device

Indications for Use:

The Anchorage™ Closure Device facilitates placement of a pre-tied ligature for use in surgical applications where soft tissue must be approximated and/or ligated.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, PRestorative,

and Neurological Devices

| 510(k) Number | K073096 |
|---------------|---------|
|---------------|---------|

Confidential