MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT

K070405 · Cook Biotech, Inc. · FTM · Oct 17, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070405
• Device Name: MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
• Applicant: Cook Biotech, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Oct 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SURGISIS® SLR™ Staple Line Reinforcement 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 with non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

Device Story

SURGISIS® SLR™ is a surgical mesh prosthesis derived from porcine small intestinal submucosa (SIS). It functions as a buttress to reinforce staple lines during various surgical procedures, including lung, gastric, and colorectal resections. The device is supplied sterile on a foam applicator within a form-fitting tray. Unlike the predicate, this modified version features an integrated adhesive coating, eliminating the need for a separate hydrogel application to affix the device to stapler arms. It is intended for single-use by surgeons in clinical settings. By providing mechanical reinforcement to staple lines, the device aims to reduce tissue deficiencies and improve surgical outcomes.

Clinical Evidence

Bench testing only. Performance and biocompatibility testing demonstrated that the modified device functions as a staple line buttress equivalent to the predicate device.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS). Form factor: Sheet on foam applicator. Connectivity: None. Sterilization: Sterile. Features: Integrated adhesive coating for stapler attachment.

Indications for Use

Indicated for patients undergoing surgical procedures requiring soft tissue repair or staple line reinforcement, including lung resections (e.g., lobectomy, pneumonectomy), bariatric gastric procedures, and small bowel, mesentery, colon, or colorectal procedures.

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

• SURGISIS® SLR™ Staple Line Reinforcement (K051048)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2007

Cook Biotech Incorporated % MED Institute, Inc. Mr. Daniel J. Dillion 1400 Cumberland Avenue West Lafavette, Indiana 47906

Re: K070405

Trade/Device Name: Modified SURGISIS® SLR™ Staple Line Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: July 31, 2007 Received: August 1, 2007

Dear Mr. Dillion:

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 mav 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. Daniel J. Dillion

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
Director

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known):

Modified SURGISIS® SLR™ Staple Line Reinforcement Device Name:

Indications for Use: The SURGISIS® SLR™ Staple Line Reinforcement 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 with non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

Prescription Use XX (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use

(21 CRF 801 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)

l Restorative

(Division Sign of General, Restorative, Division rological Devices

Page 1 of 1

510(k) Number.

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#### 510(k) SUMMARY

Submitted By: Perry Guinn, Vice President, Quality Assurance and Regulatory Affairs

Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 [phone] February 9, 2007

#### Name of Device:

| Trade name: | SURGISIS ^® SLR ^TM Staple Line Reinforcement |
|-------------------------------|--------------------------------------------------------------------|
| Common/Usual Name: | Surgical Mesh |
| Proposed classification name: | Surgical Mesh |
| | 21 CFR 878.3300 (FTM) |
| | Class II |

#### Intended Use:

The SURGIS ® SLR" Staple Line Reinforcement 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, 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 with non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

### Predicate Device:

The predicate device for the modified SURGISIS® SLR™ Staple Line Reinforcement is the SURGIS SLR" Staple Line Reinforcement manufactured by Cook Biotech Incorporated (510(k) No. K051048), cleared for marketing on September 23, 2005.

### Device Description:

The SURGIS & SLR™ Staple Line Reinforcement device is produced from porcine small intestinal submucosa (SIS") that has been disinfected and treated for surgical use. The modified

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device is coated with an adhesive that eliminates the need for the application of a hydrogel to affix the device to the stapler arms. The device is supplied on a foam applicator, suspended in a form-fitting tray, and packaged in a sealed foil pouch to maintain sterility.

# Substantial Equivalence:

The modified SURGISIS ® SLR™ Staple Line Reinforcement is identical to the predicate SURGIS® SLR™ Staple Line Reinforcement in terms of its indications. The results of performance bench and biocompatibility testing demonstrate substantially equivalent safety and effectiveness.

# Discussion of Tests and Test Results:

The modified SURGIS ® SLR™ Staple Line Reinforcement device is substantially equivalent in its technological characteristics and performance testing to the predicate device. Furthermore, the device does not raise any new issues concerning patient safety.

## Conclusions Drawn from the Tests:

The results of tests conducted on the modified device support its ability to act as a buttress for reinforcement of soft tissue staple lines in the same manner as the predicate. These conclusions support a decision of substantial equivalence to the predicate device.