REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS

K070930 · Sterilmed, Inc. · NLL · Oct 18, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070930
• Device Name: REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
• Applicant: Sterilmed, Inc.
• Product Code: NLL · General, Plastic Surgery
• Decision Date: Oct 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Reprocessed Reloadable AutoSuture GIA staplers are intended to be used in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and anastomosis. In addition the AutoSuture ENDO GIA Staplers may be used for transection of liver lissue, hepatic vasculature and biliary structures.

Device Story

Reprocessed endoscopic stapler; used in abdominal, gynecologic, pediatric, and thoracic surgery. Device places two triple-staggered rows of titanium staples while simultaneously dividing tissue between rows via integrated blade. Operated by surgeons in clinical settings. SterilMed reprocesses OEM AutoSuture GIA staplers; limits device to 8 firings per procedure (reduced from OEM 25) based on clinical input. Staple cartridges and implantable staples are not reprocessed. Device facilitates tissue resection, transection, and anastomosis; benefits include reduced surgical time and standardized tissue closure.

Clinical Evidence

Bench testing only. Includes process validation for cleaning and sterilization, device packaging validation, and visual/functional testing of all reprocessed units.

Technological Characteristics

Mechanical endoscopic stapler; titanium staples; manual actuation. Device dimensions vary by shaft length (63mm, 155mm, 255mm). Reprocessing includes cleaning and sterilization. No software or electronic components.

Indications for Use

Indicated for patients undergoing abdominal, gynecologic, pediatric, or thoracic surgery requiring tissue resection, transection, or anastomosis, including transection of liver tissue, hepatic vasculature, and biliary structures.

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

• AutoSuture GIA Endoscopic Stapler (K061095)

Submission Summary (Full Text)

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070930 pg 1 of 1

RILMED INC

# 510(K) PREMARKET NOTIFICATION SUBMISSION MARCH 30, 2007

For Reprocessed Autosuture Gia Endoscopic Staplers

## II. SUMMARY AND CERTIFICATION

0CT 1 8 2007

### A. 510(k) Summary

| Submitter: | SterilMed, Inc. |
|------------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Caroline Butterfield<br>11400 73rd Avenue North<br>Maple Grove, MN 55369<br>Ph: 888-856-4870<br>Fax: [phone] |
| Date Prepared: | March 30, 2007 |
| Trade Name: | Reprocessed AutoSuture GIA Endoscopic Staplers |
| Classification Name: | Staple, Implantable |
| Classification Number: | Class II, 21 CFR 878.4750 |
| Product Code: | NLL |

| Predicate<br>Devices: | The reprocessed AutoSuture GIA Endoscopic Staplers are substantially equivalent to the<br>AutoSuture GIA Endoscopic Stapler (K061095). |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | SterilMed's reprocessed AutoSuture GIA Endoscopic Stapler places two triple staggered rows<br>of titanium staples and the blade, contained in the reload, simultaneously divides the tissue<br>between the two rows. These devices allow for a maximum of 8 reloads in a single surgical<br>procedure. The OEM has specified that the subject staplers may be fired up to 25 times in a<br>single surgical procedure. SterilMed has lowered the number of firings allowed to 8 based<br>upon clinical input, the procedures these devices are used for and the maximum allowable<br>firings for similar devices of other manufactures.<br>Note: Only the stapler is the subject of this submission, the implantable staple and the staple<br>cartridge are not reprocessed and therefore are not included. |
| Intended Use: | |
| Functional and<br>Safety Testing: | Representative samples of reprocessed staplers are tested to demonstrate appropriate functional<br>characteristics. Process validation testing is performed to validate the cleaning and sterilization<br>procedures as well as device packaging. In addition, the manufacturing process includes visual<br>and validated functional testing of all products produced. |
| Conclusion: | The reprocessed endoscopic staplers are substantially equivalent to the GIA Endoscopic Stapler<br>(K061095) manufactured by AutoSuture.<br>This conclusion is based upon the devices' similarities in functional design (principle of<br>operation), materials, indications for use and methods of construction. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2007

SterilMed, Inc. % Mr. Dennis J. Toussaint Director, Regulatory Affairs 11400 73td Avenue North, Suite 100 Maple Grove, Minnesota 55369

Re: K070930

Trade/Device Name: Reprocessed AutoSuture GIA Endoscopic Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: NLL Dated: October 10, 2007 Received: October 11, 2007

Dear Mr. Toussaint:

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 - Mr. Dennis J. Toussaint

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" (21CFR 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,

Mark N. Melkerson De
Director
10
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
17

Center for Devices and Radiological Health

Enclosure

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# Devices Included in this Submission List of

| OEM | Model | Description | A MILL CLASS AND ALL ALL ALL PLAN A BLACK A STATUS A STATUS A FLA PARTY A BELL A FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA F<br>Reprocesso | SterilMed Part |
|------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| | | | | |
| | 030403 | GIA Universal 12mm dia., 63 | | Number AUT030403 |
| | | mm long shaft Endo GIA Universal 12mm dia., | | |
| AutoSuture | 030449 | | SterilMed, Inc. | AUT030449 |
| | | 155 mm long shaft | | |
| | EGIAUNIVXL | Endo GIA Universal XL – Long | | AUTEGIAUNIVXI |
| | | 12 mm dia., 255mm long shaft<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |

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070930 pg 1 of 1

510(K) PREMARKET NOTIFICATION SUBMISSION MARCH 30, 2007

For Reprocessed Autosuture Gia Endoscopic Staplers

# Indications for Use

510(k) Number (if known):

Device Name: Reprocessed AutoSuture GIA Endoscopic Staplers

Indications For Use:

The Reprocessed Reloadable AutoSuture GIA staplers are intended to be used in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and anastomosis. In addition the AutoSuture ENDO GIA Staplers may be used for transection of liver lissue, hepatic vasculature and biliary structures.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
|-------------------------------------------------|---|--------|------------------------------------------------|
|-------------------------------------------------|---|--------|------------------------------------------------|

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

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | 14070930 |
|---------------|----------|
|---------------|----------|

CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.