PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES

K991030 · Ethicon Endo-Surgery, Inc. · GDW · May 17, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991030
• Device Name: PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: May 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

PROXIMATE® HCS Hemorrhoidal Circular Stapler is a 33 mm diameter surgical instrument used in the anal canal. Operated by surgeons, the device facilitates the surgical treatment of hemorrhoidal disease. It allows the surgeon to control tissue compression by adjusting the height of the closed staple. The device is designed to assist in insertion, operation, and removal during the procedure.

Clinical Evidence

Bench testing only. Pre-clinical laboratory evaluations demonstrated performance equivalent to the predicate device regarding pressure holding capability, staple form, and staple height.

Technological Characteristics

33 mm diameter circular stapler; manual mechanical actuation; adjustable staple height control; identical to predicate device.

Indications for Use

Indicated for patients requiring surgical treatment of hemorrhoidal disease within 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® Curved and Straight Intraluminal Staplers (K983536)

Submission Summary (Full Text)

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MAY 17 199

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## 510(k) Summary of Safety and Effectiveness (App. A)

| Contact | Edwin O. Billips, Senior Associate Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242 Telephone [phone] Fax [phone] |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | March 26, 1999 |
| Device | Name: Circular Stapler and accessories Classification Name: Endoscope and Accessories Common Name: Circular Stapler Trade Name /Proprietary Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and accessories |
| Legally marketed device | PROXIMATE® Curved and Straight Intraluminal Staplers (K983536). |
| Device description | PROXIMATE® HCS Hemorrhoidal Circular Stapler and accessories is available in a 33 mm diameter size only. The instruments allow the surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed to facilitate insertion, operation and removal.. |
| Intended use | The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. |

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## 510(k) Summary of Safety and Effectiveness (App. A)

| Indications<br>statement | The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories<br>have application throughout the anal canal to perform surgical treatment for<br>hemorrhoidal disease. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>characteristics | The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories<br>technological characteristics are identical to those described in the Predicate<br>Device. |
| Performance<br>data | Pre-clinical laboratory evaluations were performed to ensure that the device<br>can be used as designed. The studies demonstrated acceptable performance to<br>the Predicate Device in pressure holding capability, staple form and height as<br>well as other stapling parameters. |

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Public Health Service

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 1999

Mr. Edwin O. Billips, RAC Senior Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K991030

> Trade Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories Regulatory Class: II Product Code: GDW Dated: March 26, 1999 Received: March 29, 1999

Dear Mr. Billips:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Edwin O. Billips

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

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## Indications for Use Statement (App. C)

Following is the Indications for Use Statement: Statement

> 510(k) Number: K Device Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories

Indications for Use: The PROXIMATE® HCS Hemorrhoidal Circular Stapler and accessories has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter-Use
(Optional Format 1-2-96)

D. O'Dell

livision Sid ivision of G neral Restors 510(k) Number