MANUAL TOUCHE SYSTEM

K022777 · Onux Medical, Inc. · GAQ · Nov 19, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022777
• Device Name: MANUAL TOUCHE SYSTEM
• Applicant: Onux Medical, Inc.
• Product Code: GAQ · General, Plastic Surgery
• Decision Date: Nov 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Manual Touché Suturing System has applications in gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).

Device Story

Manual Touché Suturing System is a single-use, disposable surgical instrument designed for placing 316 L stainless steel sutures. It functions as a manual alternative to powered suturing systems. The device is operated by a surgeon during gynecological, orthopaedic, general abdominal, endoluminal, open, or thoracic endoscopic procedures. It facilitates wound closure, anastomosis, hernia repair, ligation, and hemostasis. The surgeon manually manipulates the device to place sutures, providing a mechanical method for tissue approximation. By replacing powered components with manual controls for wire drive and jaw rotation, the device simplifies the surgical toolset while maintaining the clinical utility of stainless steel suture placement.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-use, disposable surgical instrument. Materials: 316 L stainless steel wire (4-0 USP, .006 in. diameter). Operation: Manual wire drive and manual jaw rotation. No electronic components or software. Form factor: Handheld surgical suturing tool.

Indications for Use

Indicated for surgical wound closure procedures including gynecological, orthopaedic, general abdominal, endoluminal, open, and thoracic endoscopic procedures such as anastomosis, hernia repair, ligation, and hemostasis.

Regulatory Classification

Identification

A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.

Special Controls

*Classification.* Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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

• Powered Touché Suturing System
• Salute Fixation System

Submission Summary (Full Text)

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NOV 1 9 2002

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# 510(k) Summary

8/16/02

| Onux Medical, Inc. Contact Person: | Ruthann DePietro |
|------------------------------------|--------------------------------------------------------------|
| Trade or Proprietary Name: | To be determined (Manual Touché) |
| Common or Usual Name: | Endoluminal suturing system |
| Classification Name: | Suture, nonabsorbable, steel, monofilament and multifilament |

### Devices to Which Equivalence is Claimed

The present device is substantially equivalent to the Powered Touché Suturing System and the Salute Fixation System.

#### Description of Subject Device

A single-use, surgical instrument for placing stainless steel sutures.

### Intended Use of Subject Device

The Manual Touché Suturing System has applications in gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).

| | Powered Touché | Manual Touché | Salute |
|------------------|---------------------------|--------------------------|---------------------------|
| Wire drive | Battery operated/dc motor | Manual | Manual |
| Wire type | 316 L Stainless steel | 316 L Stainless steel | 316 L Stainless steel |
| Wire diameter | 4-0 USP<br>.006 in. wire | 4-0 USP<br>.006 in. wire | .017 or .018 in. wire |
| Device usage | Reusable/Disposable | Disposable | Reusable/Disposable |
| Jaw manipulation | Manual | Manual | N/A |
| Jaw rotation | Battery operated/dc motor | Manual | Battery operated/dc motor |

### Comparison of Technical Aspects

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Ms. Ruthann DePietro Vice President, Quality and Regulatory Affairs Onux Medical. Inc. 5 Merrill Drive Hampton, NH 03842

Re: K022777

Trade/Device Name: The Manual Touché Suturing System Regulation Number: 878.4495 and 878.4800 Regulation Name: Stainless steel suture, Manual surgical instrument for general use Regulatory Class: II Product Code: GAO, HCF Dated: August 16, 2002 Received: August 21, 2002

Dear Ms. DePietro:

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 -- Ms. Ruthann DePietro

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Miriam L'Provost

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

Enclosure

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# Statement of Indications for Use

## INDICATIONS

The Manual Touché Suturing System has applications in gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).

Muriani C. Provost

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

510(k) Number________________________________________________________________________________________________________________________________________________________________