PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES

K051301 · Ethicon Endo-Surgery, Inc. · GDW · Aug 30, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051301
• Device Name: PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Aug 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

Device Story

PROXIMATE PPH Hemorrhoidal Circular Stapler is a 33mm diameter surgical instrument used for the procedure for prolapse and hemorrhoids (PPH). The device allows surgeons to control tissue compression by adjusting the height of the closed staple. It is intended for use by surgeons in a clinical or operating room setting to treat hemorrhoidal disease. The device functions by stapling and excising tissue within the anal canal. It is not indicated for full rectal wall resection or STARR procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Circular stapler, 33mm diameter. Implantable staples. Mechanical actuation for tissue compression and stapling. Class II device (21 CFR 878.4750).

Indications for Use

Indicated for surgical treatment of hemorrhoidal disease throughout the anal canal. Contraindicated for full rectal wall resection and Stapled Transanal Rectal Resection (STARR) procedure.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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### 510(k) Summary

| <b>Company</b> | Ethicon Endo-Surgery, Inc. |
|----------------|----------------------------|
| | 4545 Creek Road |
| | Cincinnati, OH 45242 |

- Kimberly McCoy, RAC Contact Regulatory Affairs Associate I Telephone: [phone] [phone] Fax: Email: kmccoy(@eesus.jnj.com
Date Prepared May 18, 2005

### Device Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories Classification Name: Implantable Staples {21 CFR 878.4750 (GDW)]

PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories Predicate Device

The PROXIMATE PPH Hemorrhoidal Circular Stapler (PPH03) is Device Description available in a 33mm diameter size only . The instruments allow surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed for the procedure for prolapse and hemorrhoids (PPH).

Indications for Use The PROXIMATE PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

The following contraindications for PROXIMATE PPH Contraindications Hemorrhoidal Circular Stapler have been added to the labeling (package insert):

- Do not use the instrument for full rectal wall resection. .
- Do not use the instrument for the Stapled Transanal Rectal Resection . (STARR) procedure.

Technological and Performance Characteristics The technological and performance characteristics of the device remain unchanged ..

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The logo is black and white.

AUG 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kimberly McCoy, RAC Regulatory Affairs Associate I Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K051301

K01301
Trade/Device Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: August 8, 2005 Received: August 9, 2005

Dear Ms. McCoy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(s) pe device is substantially equivalent (for the indications ferenced above and nave determined by marketed predicate devices marketed in interstate Tor use stated in the encrosule) to 1976, the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, is excordance with the provisions of the Federal Food, DINEA devices mat have been recuire approval of a premarket approval application (PMA). allo Cosmetic Ac. (71ct) market the device, subject to the general controls provisions of the Act. The You may, dicierore, market the as rees, polyde requirements for annual registration, listing of general condols provisions of ractice, 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can may be subject to basil adala academians, Title 21, Parts 800 to 898. In addition, FDA may be found inther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Trass oc advised that I Drivisant that your device complies with other requirements of the Act mat I Dri has made a aond regulations administered by other Federal agencies. You must of ally it cochar statutes and regularents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2- Ms. Kimberly McCoy, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to oegin maxioning of substantial equivalence of your device to a legally premarket notification: "The 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 If you desire specific acres at [phone]. Also, please note the regulation entitled, Colliact the Ories of Compuners of the Researce (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Barbara Buehnd
for

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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## Indications for Use

510(k) Number (if known): KOS 130)

### Device Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories

Indications for Use:

The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

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)

(Posted November 13, 2003)

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Saubare Buehnd forsmxm

Division of General, Restoration. and Neurological Devices

510(k) Number K051301