PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03

K030411 · Ethicon Endo-Surgery, Inc. · GDW · Mar 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030411
• Device Name: PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Mar 20, 2003
• 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 single-use surgical instrument; facilitates delivery of circumferential, staggered, double-row of staples while simultaneously resecting segment of compressed soft tissue. Used in Procedure for Prolapse and Hemorrhoids (PPH). Operated by surgeons in clinical/surgical settings. Device provides mechanical stapling and resection to treat hemorrhoidal disease; benefits patient through standardized surgical intervention for prolapse and hemorrhoids.

Clinical Evidence

Bench testing only. Preclinical testing demonstrated the ability of the device to cut and staple intraluminal tissue in a manner similar to the predicate.

Technological Characteristics

Single-use, sterile, intraluminal circular stapler. Mechanical actuation for simultaneous stapling and tissue resection. No software or electronic components.

Indications for Use

Indicated for surgical treatment of hemorrhoidal disease throughout the anal canal.

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® HCS Hemorrhoidal Circular Stapler and Accessories (K991030)

Submission Summary (Full Text)

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## PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories (PPH03)

# 510(k) Summary of Safety and Effectiveness

MAR 2 0 2003

## Company:

Ethicon Endo-Surgery. Inc. 4545 Creek Rd. Cincinnati, OH 45242

#### Contact:

Name: Carol Sprinkle Title: Regulatory Affairs Specialist

#### Date Prepared:

February 6, 2003

## Name of Device:

Trade Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories Common Name: Intraluminal Stapler (ILS) Classification Name: Implantable Staple, General & Plastic Surgery Surgical Device

#### Predicate Device:

PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories (K991030).

## Device Description:

The PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories are a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids, from which the name of the modified device is derived.

### Indications for Use:

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

## Technological Characteristics:

The PROXIMATE PPH Hemorrhoidal Circular Stapler is similar to the predicate device, in that it is a single-use sterile device with the same intended use and basic technology.

### Performance Data

Preclinical testing demonstrated the ability of the PPH device to cut and staple intraluminal tissue in a manner similar to the predicate, thus meeting all the requirements of substantial equivalence.

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Public Health Service

MAR 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol Sprinkle Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K030411

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: February 6, 2003 Received: February 7, 2003

Dear Ms. Sprinkle:

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. Carol Sprinkle

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]. 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) you may obtain. 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,

Mark A. Mulkeran

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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510(k) Number (if known): KO30411

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.

Mark N. Milken

Division Sign-Off Division of General, I revocative and Neurological Devices

510(k) Number -

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