SURGISIS STAPLE LINE REINFORCEMENT

K022044 · Cook Biotech, Inc. · OXE · Aug 23, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022044
• Device Name: SURGISIS STAPLE LINE REINFORCEMENT
• Applicant: Cook Biotech, Inc.
• Product Code: OXE · General, Plastic Surgery
• Decision Date: Aug 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surgisis 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, 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. The device can also be used for abdominal and thoracic wall repair, muscle flap reinforcement, trans-abdominal rectal and vaginal prolapse repair, trans-abdominal reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). The Surgisis® Staple Line Reinforcement 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 Staple Line Reinforcement is a porcine small intestinal submucosa (SIS) prosthesis; used as a buttress material during surgical stapling procedures. Device is applied to staple lines in lung, gastric, and abdominal/thoracic wall surgeries; provides mechanical reinforcement to tissue. Used in OR by surgeons; supplied as sterile strips for one-time use. Benefits include reduced risk of staple line leakage or tissue tearing during resection or reconstruction. No complex electronics or software involved.

Clinical Evidence

Biocompatibility, disinfection, and performance characteristics were evaluated via bench testing in accordance with ISO 10993-1 standards. No clinical trial data provided; substantial equivalence established through bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS). Form factor: Sterile strips (1 x 10.7 cm, 1.2 x 13.2 cm, 1.2 x 17.3 cm). Biocompatibility: ISO 10993-1 compliant. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring soft tissue repair or reinforcement via surgical stapling, including lung resection, bariatric gastric procedures, abdominal/thoracic wall repair, muscle flap reinforcement, pelvic floor/prolapse repair, and hernia repair.

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® Soft Tissue Graft (K980431)
• Surgisis® Peripheral Vascular Patch (K001785)
• Peri-Strips® Staple Line Reinforcement-Strip (K983162)
• Seamguard® Staple Line Reinforcement Material (K010936)

Submission Summary (Full Text)

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## 510(k) Summary

#### July 13, 2012

#### Cook Biotech Incorporated

#### Surgisis® Staple Line Reinforcement

| Manufacturer Name: | Cook Biotech Incorporated<br>1425 Innovation Place<br>West Lafayette, Indiana 47906<br>Telephone: [phone]<br>FAX: [phone] |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|

#### Official Contact: Perry W. Guinn

### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | Surgisis® Staple Line Reinforcement |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Surgical mesh, collagen, staple line reinforcement<br>Mesh, surgical, non-synthetic, urogynecologic, for<br>apical vaginal and uterine prolapse, transabdominally<br>placed |
| Classification Regulations: | Class II, 21 CFR §878.3300 (OXE, PAJ) |

INTENDED USE:

The Surgisis 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, 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. The device can also be used for abdominal and thoracic wall repair, muscle flap reinforcement, trans-abdominal rectal and vaginal prolapse repair, trans-abdominal reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). The Surgisis Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

#### PREDICATE DEVICES:

The Surgisis Staple Line Reinforcement is similar to predicate devices, including the Surgisis® Soft Tissue Graft (K980431) and Surgisis® Peripheral Vascular Patch (K001785) manufactured by Cook Biotech Incorporated, the Peri-Strips® Staple Line Reinforcement-Strip (K983162) manufactured by Biovascular Incorporated, and the Seamguard® Staple Line Reinforcement Material (K010936) manufactured by W.L. Gore & Associates.

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#### DEVICE DESCRIPTION:

The Surgisis Stable Line Reinforcement is manufactured from porcine small intestinal submucosa and supplied in nominal strip sizes (unfolded) of 1 x 10.7 cm, 1.2 x 13.2 cm, and 1.2 x 17.3 cm. The device is packaged sterile, sealed double pouches.

#### SUBSTANTIAL EQUIVALENCE TO MARKETED DEVICES

The Surgisis Staple Line Reinforcement is similar with respect to intended use, materials and technological characteristics to the predicate device in terms of section 510(k) substantial equivalence, as shown biocompatibility testing (conducted in accordance to ISO 10993-1 standards), mechanical and clinical testing.

#### DISCUSSION OF TESTS AND TEST RESULTS:

The material comprising the Surgisis Staple Line Reinforcement was subjected to a panel of tests to assess biocompatibility, disinfection, and performance characteristics. The material met the test requirements, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.

#### CONCLUSIONS DRAWN FROM THE TESTS:

The Surgisis Staple Line Reinforcement is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure. The image is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cook Biotech, Incorporated % Mr. Mark Blever President 3055 Kent Avenue West Lafayette, Indiana 47906-1076

AUG 30 2012

Re: K022044

Trade/Device Name: Surgisis® Staple Line Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXE, FTM, PAJ Dated: June 20, 2002 Received: June 24, 2002

Dear Mr. Bleyer:

This letter corrects our substantially equivalent letter of August 23, 2002.

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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) 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 for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, 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 yours,

Mark A. Millman

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):

Surgisis Staple Line Reinforcement Device Name:

Indications For Use:

The Surgisis 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. The device can also be used for abdominal and thoracic wall repair, muscle flap reinforcement, transabdominal rectal and vaginal prolapse repair, trans-abdominal reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). The Surgisis® Staple Line Reinforcement 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 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)

Dainl Krone for MM
Division Sign Off

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K022044

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