CONTOUR TRANSTAR CURVED CUTTER STAPLER SET

K053631 · Ethicon Endo-Surgery, Inc. · GDW · Jan 30, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053631
• Device Name: CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jan 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CONTOUR® TRANSTAR™ Curved Cutter Stapler and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

Device Story

Multifire, single-patient-use curved cutter stapler; used for transanal stapling and resection of anorectal tissue. Device features curved head; delivers three staggered rows of titanium staples with central knife; creates 30mm curved transection. Includes safety interlocks: prevents closure if reload used/missing; prevents firing unless closure trigger latched. Retaining pin holds tissue. Instrument reloadable up to seven times (eight firings total). Supplied with Circular Anal Dilator with Obturator and Access Suture Anoscope. Operated by surgeons in clinical/surgical settings. Provides mechanical resection and stapling to treat anorectal wall defects.

Clinical Evidence

Bench testing and preclinical laboratory evaluations performed. Clinical literature search conducted to support intended use. No clinical trial data provided.

Technological Characteristics

Titanium staples; multifire curved cutter stapler; 30mm curved staple line; mechanical operation; single-patient-use; sterile packaging. Includes reload cartridge module with knife blade, anvil, cutting washer, retaining pin, knife guide pin, and staple retainer. Green cartridge for 2.0mm compressed tissue thickness.

Indications for Use

Indicated for general surgical treatment of anorectal wall defects via transanal stapling and resection of mucosal and musculomucosal tissue.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• PROXIMATE® (currently marketed as CONTOUR®) 40mm Curved Cutter Stapler and Reloads
• PROXIMATE® HCS Hemorrhoidal Circular Stapler Set

Submission Summary (Full Text)

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K053631/1/2

JAN 3 0 2006

## 510(k) Summary

- Ethicon Endo-Surgery, Inc. Company 4545 Creek Road Cincinnati, OH 45242
- Contact Wendy L. Turner, RAC Group Manager, Regulatory Affairs Telephone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared December 28 , 2005

Trade Name: CONTOUR® TRANSTAR™ Curved Cutter Stapler Set Device Name Common or Usual Name: Curved Cutter Stapler Classification Name: Staple, Implantable [21 CFR 878.4750 (GDW)]

Predicate Devices PROXIMATE® (currently marketed as CONTOUR®) 40mm Curved Cutter Stapler and Reloads PROXIMATE® HCS Hemorrhoidal Circular Stapler Set

Device Description The CONTOUR® TRANSTAR™ Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts and staples. The device delivers three staggered rows of titanium staples, with a knife between the first and second row of staples, and creates a 30 mm curved transection. The device is designed with a feature that prevents closing if a used reload or no reload is in the instrument. Another feature is provided to prevent firing unless the closure trigger is latched in the closed position. A retaining pin holds tissue in place and can be positioned either manually or by squeezing the closure trigger. The instrument may be reloaded seven times, for a maximum of eight firings per instrument during a single procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on the patient side, one staggered row of staples on the specimen side, an anvil, a cutting washer, a retaining pin, a knife guide pin, and a staple retainer. Additional reload cartridges will be available in one size: a green cartridge for compressed tissue with a thickness of 2.0mm.

The CONTOUR® TRANSTAR™ Curved Cutter Stapler is packaged sterile as a single patient use device with two accessories, a Circular Anal Dilator with Obturator and an Access Suture Anoscope. This set is commonly referred to by the product code STR5G.

Indications for Use The CONTOUR® TRANSTAR™ Curved Cutter Stapler and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

Technological Characteristics The CONTOUR® TRANSTAR™ Curved Cutter Stapler is similar to the design of the predicate device, the PROXIMATE® (or CONTOUR®) 40mm Curved Cutter Stapler. The new device is different from the predicate device in that it produces a 30mm curved staple line.

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K053631²/₂

Performance Data. Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended. A clinical literature search was also conducted and the literature supports the intended use of the new device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2006

Ms. Wendy L. Turner, RAC Group Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K053631

Trade/Device Name: CONTOUR® TRANSTAR™ Curved Cutter Stapler Set Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: December 28, 2005 Received: December 29, 2005

Dear Ms. Turner:

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 docs 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

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## Page 2 - Ms. Turner

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.

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" (21 CFR 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/index.html.

Sincerely yours,

Barclay Brechin

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

Enclosure

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K05363j

## Indications for Use

510(k) Number (if known):

Device Name: CONTOUR® TRANSTAR™ Curved Cutter Stapler Set

Indications for Use:

The CONTOUR® TRANSTAR™ Curved Cutter Stapler and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Labare Buchar

Division of General, Restorative. and Neurological Devices

(Posted November 13, 2003)

KUS 363 510(k) Number_