NEOTRACT ANCHOR

K061700 · Neotract, Inc. · GAW · Oct 26, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061700
• Device Name: NEOTRACT ANCHOR
• Applicant: Neotract, Inc.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Oct 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The NeoTract Anchor is a surgical device designed for tissue approximation during open surgical procedures. It functions as a mechanical fixation system to hold soft tissue in place. The device is intended for use by surgeons in an operating room setting. It provides a physical means to secure tissue, aiding in surgical closure or repair. The device utilizes well-characterized, previously cleared implant materials. Clinical benefit is derived from the reliable approximation of soft tissue, facilitating healing and surgical outcomes.

Clinical Evidence

Bench testing only. Simulated use and performance testing were conducted and compared to the predicate device. All components and subassemblies met required specifications.

Technological Characteristics

Mechanical tissue approximation device. Materials are well-characterized, previously cleared implant materials. Designed under a quality system compliant with 21 CFR 820.30.

Indications for Use

Indicated for approximation of soft tissue in open surgical procedures.

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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

• Onux Salute Stapler and Staples (K003522)

Submission Summary (Full Text)

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K061700 10/26/06

510(k) Premarket Notification
NeoTract Anchor
NeoTract, Inc.

TAB 4

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#### 510(k) Summary

NeoTract Anchor (REF 10230-01)

General Information

Classification Class II, Surgical Staple per 21 CFR § 878.4750

Trade Name

Submitter

NeoTract, Inc. 4473 Willow Road, Suite 100 Pleasanton, CA 34588

Tel. [phone]

Contact

Kevin F. MacDonald Regulatory Consultant

# Intended Use

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

## Predicate Devices

Onux Salute Stapler and Staples - K003522 (Davol® Salute® Fixation System)

#### Device Description

The NeoTract Anchor is designed to approximate tissue following open surgical procedures.

# Materials

The materials used in the manufacture of the NeoTract Anchor are well-characterized implant materials and are suitable for this use. The materials have been used in previously cleared products.

#### Testing Summary

Simulated use and performance testing was conducted on the NeoTract Anchor and compared to the predicate device, Onux Salute (Davol® Salute® Fixation System). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The NeoTract Anchor was designed under the NeoTract Quality System that is in complive to with 21CFR§820.30.

#### Summary of Substantial Equivalence

The NeoTract Anchor is substantially equivalent to the predicate device, the Onux Salute (Davol® Salute® Fixation System). The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Nec Tract, Inc. believes the NeoTract Anchor is substantially equivalent to existing legally marketed devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 26 2006

NeoTract, Inc. % Mr. Kevin F. MacDonald Clinical/Regulatory Consultant 4473 Willow Road, Suite 100 Pleasanton, California 94588

Re: K061700

Trade/Device Name: NeoTract Anchor (REF 10230-01) Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW, GDW, Dated: October 11, 2006 Received: October 12, 2006

Dear Mr. MacDonald:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bection 510(x) presidentially equivalent (for the indications for referenced above and nave acterially marketed predicate devices marketed in interstate commerce use stated in the enerobare) to region date of the Medical Device Amendments, or to devices that prior to May 20, 1970, and cordance with the provisions of the Federal Food, Drug, and Cosmetic have oven rectablines in approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general thereolor, mailier the device, dables requirements for annual registration, listing of devices, good controls provisions of the many and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassimod (600 above) and existing major regulations affecting your device can Inay be subject to such additional venusions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that i Dris issuanted evour device complies with other requirements of the Act that 1177 has mudes and regulations administered by other Federal agencies. You must comply or any I catal statues are regalized ing, but not limited to: registration and listing (21 CFR Part with an the Act 3 requirements, merading oursective requirements as set forth in the 807); fabeting (21 OF R Part 820); and if applicable, the electronic product and radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Kevin F. MacDonald

This letter will allow you to begin marketing your device as described in your Section 510(k)
I has and the market of the same of the spirales of your device to a legal This letter will allow you to begin maketing your dovice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the premarket notification. The PDA michig of substantial of 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
rst lead If you desire specific advice for your device at [phone]. Also, please note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please n contact the Office of Compliance at (2107278 of 107.97). You may obtain other
"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 general information on your responsibilities and its toll-free number [phone] or Manufacturers, International and Consumer Assistanto artist of the real of the new of thindustry/support/index.html.

Sincerely yours,

K. N. Mellem

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

Enclosure

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Response to FDA - October 22, 2006 Neo'fract, Inc. K061700 - NeoTract Anchor

# Indications for Use

K061700 510(k) Number (if known):

Device Name:

NeoTract Anchor (REF 10230-01)

Indications for Use:

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

Prescription Use X

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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CONFIDENTIAL