REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET

K103672 · Ethicon Endo-Surgery, LLC · GDW · Apr 8, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103672
• Device Name: REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
• Applicant: Ethicon Endo-Surgery, LLC
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

Device Story

Reusable circular stapler system for hemorrhoidal disease treatment. Components: reusable handle (200-use lifespan), disposable reload (anvil, knife, washer, staples), and accessory set (anal dilator, anoscope, introducer, suture threader). Surgeon operates device in clinical setting to perform surgical resection. Adjustable knob on handle allows compression setting for tissue thickness between 0.75 mm and 1.5 mm. Device delivers two staggered rows of staples and performs tissue resection via integrated knife. Output is a stapled anastomotic stoma. Benefits include standardized surgical repair of hemorrhoids.

Clinical Evidence

No clinical data. Bench testing verified performance of disposable reload and reusable handle after 200 simulated uses. Animal (porcine colon) testing evaluated pressure tolerance of anastomotic stoma; results met leak pressure acceptance criteria.

Technological Characteristics

System consists of reusable handle, single-use disposable reload, and accessory set. Anvil head diameter 32.5 mm. Features adjustable knob for tissue compression (0.75 mm to 1.5 mm). Delivers two staggered rows of staples. Mechanical operation. No software or electronic components.

Indications for Use

Indicated for surgical treatment of hemorrhoidal disease in the anal canal. Contraindicated for tissue thickness <0.75 mm or >1.5 mm, ischemic or necrotic tissue, full rectal wall thickness resection, or Stapled Transanal Rectal Resection (STARR).

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® PPH Hemorrhoidal Circular Stapler and Accessories (K051301)

Submission Summary (Full Text)

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K103672 page 1/2

510(k) Premarket Notification (Traditional) for Reusable PPH Circular Stapler, Disposable Reload & Accessory

## 510(k) Summary

APR - 8 2011

Ethicon Endo-Surgery, LLC Company: 475 Calle C Guaynabo, PR 00969

Contact: Dennis Hahn, RAC Director, Regulatory Strategic Initiatives Ethicon Endo-Surgery, Inc. Telephone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: December 16, 2010

Device Name: Reusable PPH Circular Stapler, Disposable Reload & Accessory Set

Common or Usual Name: Circular Stapler

Classification Name: Staple, Implantable

Predicate Device: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories (cleared under K051301)

Device Description: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set consists of a reusable circular stapler handle, a disposable reload (containing the anvil, knife, washer, and staples), and accessory set (consisting of the circular anal dilator, pursestring anoscope, anal introducer, and suture threader).

Indications for Use: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set has application throughout the anal to perform surgical treatment of hemorrhoidal disease.

## Contraindications for use:

- . Do not use where the combined compressed tissue thickness is less than 0.75 mm or greater than 1.5 mm, or where the internal diameter of the rectum will not accommodate the instrument and accessories. If the instrument is used on tissue less than 0.75mm or greater than 1.5 mm in thickness, an inadequate mucosal repair and inadequate hemostasis could result.
- Do not use the instrument on ischemic or necrotic tissue. .
- Do not use the instrument for full rectal wall thickness resection. ●
- Do not use the instrument for the Stapled Transanal Rectal Resection (STARR). ●

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K103672 page 2/2

510(k) Premarket Notification (Traditional) for Reusable PPH Circular Stapler, Disposable Reload & Accessory Set

Technological Characteristics: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set consists of three components: the reusable handle, the disposable reload, and the accessory set. The handle can be used for 200 applications. An adjustable knob on the handle adjusts the device for use on compressed tissue from 0.75 mm to 1.5 mm. The reload, which is designed for a single use, is made up of an anvil head with a diameter of 32.5 mm and two staggered rows of staples. Contained within the same sterile packaging as the reload, the disposable accessory set consists of a circular anal dilator, purse-string anoscope, anal introducer, and suture threader.

Performance Data: Bench testing was conducted to demonstrate and verify the performance of the disposable reload and the reusable handle after 200 simulated uses. Test results demonstrated the bench testing acceptance criteria were met.

Animal (tissue) testing was conducted to evaluate the pressure tolerance of an anastomotic stoma created in porcine colon. Testing results demonstrated that staple lines created by the stapler device met the leak pressure acceptance criteria.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Mr. Dennis Hahn, RAC 4545 Creek Road Cincinnati, Ohio 45242

APR - 8 2011

Re: K103672

Trade/Device Name: Reusable PPH Circular Stapler, Disposable Reload & Accessory Set Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: April 6, 2011 Received: April 7, 2011

Dear Mr. Hahn:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Dennis Hahn, RAC

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm faor the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Alo, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Part. 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Aing B. De. ter
for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation -Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K103672

Device Name: Reusable PPH Circular Stapler, Disposable Reload & Accessory Set

Indications for Use: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set has 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)

David Moore for MKM

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(Division Sig Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103672