NEOTRACT ANCHOR SYSTEM

K073651 · Neotract, Inc. · GAT · Feb 1, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073651
• Device Name: NEOTRACT ANCHOR SYSTEM
• Applicant: Neotract, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Feb 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NeoTract Anchor System is intended for the approximation of soft tissue in open surgical procedures.

Device Story

NeoTract Anchor System is a single-use delivery device for deploying up to two permanently implantable anchors. Each anchor consists of a nitinol tube connected by nonabsorbable monofilament suture to a stainless steel pin with a locking ring. Used in open surgical procedures by physicians to approximate soft tissue. The device functions as a mechanical fastener to hold tissue in place, aiding in surgical repair or reconstruction. Benefits include secure tissue approximation.

Clinical Evidence

No clinical data provided. Evidence consists of biocompatibility testing (ISO 10993-1:2003), bench testing (USP 30:2007, Class II Special Controls Guidance), and animal testing.

Technological Characteristics

Materials: Nitinol (tube), nonabsorbable monofilament (suture), stainless steel (pin/locking ring). Mechanical delivery system for permanent implant. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for soft tissue approximation in open surgical procedures. No specific patient population, age, or gender restrictions provided.

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

• NeoTract Anchor (K061700)

Submission Summary (Full Text)

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# Section 5: 510(k) Summary

K073651
Page 1 of 2

#### Device Information

| Category | Comments |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | NeoTract, Inc.<br>4473 Willow Rd., Suite 100<br>Pleasanton, CA 94588<br>Tel: [phone]<br>Fax: [phone] |
| Correspondent Contact<br>Information: | Suzan Moser<br>NeoTract, Inc.<br>4473 Willow Rd., Suite 100<br>Pleasanton, CA 94588<br>Tel: [phone]<br>Fax: [phone] |
| Device Common Name: | Surgical Suture |
| Device Classification & Codes: | Class II, GAT, GDW |
| Device Classification Name: | Nonabsorbable Poly(ethylene Terephthalate) Surgical<br>Suture |
| Device Proprietary Name: | NeoTract Anchor System |

#### Predicate Device Information

| Predicate Devices: | NeoTract Anchor |
|------------------------------------------|--------------------------------------|
| Predicate Device Manufacturer: | NeoTract, Inc. |
| Predicate Device Common Name: | Surgical Suture |
| Predicate Device Classification: | Nonabsorbable Polypropylene Surgical |
| | Suture |
| Predicate Device Classification & Codes: | Class II, GAW, GDW |

#### Date Summary Prepared

December 21, 2007

#### Description of Device

The NeoTract Anchor System consists of a single use delivery device that delivers up to two permanently implantable NeoTract Anchors. A NeoTract Anchor consists of one nitinol tube connected by nonabsorbable monofilament suture to a stainless steel pin with locking ring.

#### Intended Use

The NeoTract Anchor System is intended for the approximation of soft tissue in open surgical procedures.

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### Comparison to Predicate Device

The NeoTract Anchor System is substantially equivalent to the predicate device. NeoTract Anchor, K061700, in Indications for Use, Class, Principal Operator, Use Location, Operating Principle, Design, How Shipped, Reuse, and Sterilization Method.

The testing described below demonstrates that differences in the devices do not raise any issues of safety or effectiveness.

NeoTract concludes that the devices are substantially equivalent.

#### Summary of Supporting Data

Biocompatibility testing results demonstrate that the device is in compliance with ISO 10993-1:2003 - Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing.

Bench testing results demonstrate that the device is in compliance with USP 30:2007; Class II Special Controls Guidance Document Surgical Sutures; Guidance for Industry and FDA; the medical community expectations and the product labeling. Bench testing results also demonstrate that the device performance is substantially equivalent to the predicate device, the NeoTract Anchor (K061700).

Animal testing results further demonstrate that the device does not present any issues of safety or effectiveness in relation to its predicate, the NeoTract Anchor (K061700).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 1 2008

Neotract, Incorporated % Ms. Suzan Moser Vice President, Clinical and Regulatory Affairs 4473 Willow Road, Suite 100 Pleasanton, California 94588

Re: K073651

Trade/Device Name: NEOTRACT Anchor System Regulation Number: 21 CFR 878.5000, 21 CFR 878.4750 Regulation Name: Nonabsorbable polyamide surgical suture, Implantable staple. Regulatory Class: Class II Product Code: GAT, GDW Dated: December 21, 2007 Received: December 26, 2007

Dear Ms. Moser:

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. Iisting 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 – Ms. Suzan Moser

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 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 N. 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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## Section 4: Indications for Use Statement

K 073651 510(k) Number: This application

Device Name: NEOTRACT Anchor System

Indications For Use: The NeoTract Anchor System is intended for the approximation of soft tissue in open surgical procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rdelm

Page 1 of

(Division Sign-Off,
Division of General, Restorative,
and Neurological Devices