SURGISIS STAPLE LINE REINFORCEMENT II

K051048 · Cook Biotech, Inc. · FTM · Sep 23, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051048
• Device Name: SURGISIS STAPLE LINE REINFORCEMENT II
• Applicant: Cook Biotech, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SURGIS Staple Line Reinforcement II is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection, (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon, and colorectal procedures. The device may be used with anastomotic staplers or non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

Device Story

SURGISIS® Staple Line Reinforcement II is a porcine small intestinal submucosa (SIS) graft used as a surgical staple line bolster. Supplied in lyophilized strips, the device is surface-treated to adhere temporarily to stapler arms. During surgery, the clinician places the graft within the stapler to buttress and reinforce staple lines in lung, gastric, and bowel tissues. By providing mechanical reinforcement, the device helps prevent leaks and tissue damage at the staple site. It is intended for single-use in clinical settings by surgeons.

Clinical Evidence

No clinical data. Evidence consists of bench testing, biocompatibility testing, and viral inactivation testing to demonstrate safety and performance.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS). Form factor: Lyophilized strips (1.0 x 10.8 cm to 1.2 x 19.8 cm). Surface treatment: Adhesive for temporary attachment to stapler arms. Sterilization: Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients undergoing surgical procedures requiring staple line reinforcement, including lung resections (wedge, lobectomy, etc.), bariatric gastric procedures (bypass, banding), and small bowel, mesentery, colon, or colorectal surgeries. Intended for use with surgical staplers to repair soft tissue deficiencies.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• SURGIS Staple Line Reinforcement (K022044)
• SURGISIS® Soft Tissue Graft (K980431)
• Peri-Strips® Staple Line Reinforcement (K040119)
• Gore Seamguard® Bioabsorbable Staple Line Reinforcement Material (K032865)

Submission Summary (Full Text)

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KOS2048 1/2
14

510(k) Premarket Notification: SURGIS® Staple Line Reinforcement II

# 9. 510(K) SUMMARY

| Submitted By: | Mark Bleyer, President<br>Cook Biotech Incorporated<br>1425 Innovation Place<br>West Lafayette, IN 47906<br>Tel: [phone]<br>Fax: [phone]<br>April 22, 2005 |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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#### Names of Device:

| Trade Name: | SURGISIS® Staple Line Reinforcement II |
|--------------------------|------------------------------------------------|
| Common/Usual Name: | Surgical Mesh, Staple Line Bolster |
| Proposed Classification: | Surgical Mesh 21 CFR 878.3300 (79FTM) Class II |

### Intended Use:

SURGIS Staple Line Reinforcement II is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection, (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon, and colorectal procedures. The device may be used with anastomotic staplers or non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

#### Predicate Devices:

SURGIS® Staple Line Reinforcement II is similar to predicate devices, including the SURGIS Staple Line Reinforcement (K022044) and SURGISIS® Soft Tissue Graft (K980431) manufactured by Cook Biotech Incorporated, Peri-Strips® Staple Line Reinforcement (K040119) manufactured by Synovis Surgical Innovations, and Gore Seamguard® Bioabsorbable Staple Line Reinforcement Material (K032865) manufactured by W.L. Gore & Associates.

#### Device Description:

SURGIS® Staple Line Reinforcement II is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in strip sizes (unfolded) of 1.0 x 10.8 cm to 1.2 x 19.8 cm. The device is surface treated to allow it to temporarily adhere to the stapler arms, is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.

### Substantial Equivalence:

SURGIS Staple Line Reinforcement II is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of 510(k) substantial equivalence as shown through bench and biocompatibility testing.

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K0510484/2

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510(k) Premarket Notification: SURGISIS® Staple Line Reinforcement II

# Discussion of Tests and Test Results:

The material comprising the SURGIS® Staple Line Reinforcement II was subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, and mechanical characteristics to be sufficient.

# Conclusions Drawn from the Tests:

Outcomes from the evaluation of SURGISIS Staple Line Reinforcement II provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to predicate devices in terms of intended use and technological characteristics.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three stripes representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2005

Mr. Mark Bleyer President Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906

Re: K051048

Trade/Device Name: SURGISIS® Staple Line Reinforcement II Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: August 23, 2005 Received: August 24, 2005

Dear Mr. Bleyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use battler to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimer of provision to rial as a cordance 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 r ou mayy are so 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. Mark Bleyer

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anon-you've ough finding of substantial equivalence of your device to a legally premaince notification. The start 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 rryou don't specific darroliance 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 other general 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,

Fairbairn Buelud
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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K0510Yf

# Indications for Use

510(k) Number (if known):

Device Name: SURGISIS® Staple Line Reinforcement II

Indications for Use:

Surgisls® Staple Line Reinforcement II is intended for use as a prosthesis Surgical repair of soft tissue deficiencies using surgical staplers. for the Surgical repair of Solt tions and reinforcing staple lines during The device may be used for battlessing and and the ctomy, bullectomy, lung resection (c.g., weage rocomy, pneumonectomy/pneumectomy, bronemal reseouoli, ooginentions and excisions of the lung and pheumoreduction) and other the reinforcement of the gastric staple line during the bariatic surgical procedures of gastric bypall bound Staple line during the banainforcement of staple lines during small bowel, gastric banding, and for rollifered more . The device may be used with mesentery, colon, and ocronemastomotic staplers. The device is supplied sterile and is intended for one-time use.

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)

borbau buemts

Division of General, Restorative, and Neurological Devices

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510(k) Number K051048