SIS HERNIA GRAFT

K133306 · Cook Biotech, Inc. · FTM · Jul 23, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133306
• Device Name: SIS HERNIA GRAFT
• Applicant: Cook Biotech, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jul 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.

Device Story

SIS Hernia Graft is a bioabsorbable, multi-layered extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). Device layers are held together with biodegradable sutures to improve handling during implantation. Intended for surgical reinforcement of soft tissues and repair of hernias or body wall defects. Used by surgeons in clinical settings. Device is supplied sterile in a dried (lyophilized) state. Upon implantation, the graft acts as a scaffold for tissue remodeling; the SIS material is incorporated into the body and resorbed over time, while the resorbable sutures hold the layers together during the initial healing phase. Benefits include mechanical support for weakened tissue and promotion of natural tissue remodeling.

Clinical Evidence

No human clinical data. Evidence consists of bench testing and animal studies. Biocompatibility testing (ISO 10993-1) included genotoxicity, hemolysis, cytotoxicity, muscle implantation, reactivity, irritation, sensitization, systemic toxicity, and pyrogenicity. Mechanical testing confirmed adequate suture retention, burst, tensile, and tear strength. Animal studies in pigs (27-day and 6-month follow-up) demonstrated satisfactory remodeling, minimal inflammation, and well-tolerated tissue response. Mouse study confirmed robust vascular penetration (angiogenesis) comparable to sutureless controls.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS) consisting of Types I, III, IV, and VI collagen. Form: 8-layer lyophilized matrix, 0.1-1.5mm thickness. Dimensions: 5x8cm to 30x30cm. Features: Resorbable suture stitching for layer integrity. Biocompatibility: ISO 10993-1 compliant. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring reinforcement of soft tissues where weakness exists, specifically for the repair of a hernia or body wall defect.

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

• SIS Hernia Repair Device (K974540)
• SIS Hernia Repair Device (K062697)

Submission Summary (Full Text)

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# JUL 2 3 2014

# 510(k) Summary

## July 18, 2014

## Cook Biotech Incorporated

#### SIS Hernia Graft

Manufacturer Name:

Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906 Telephone: [phone] FAX: [phone]

Official Contact:

Perry W. Guinn

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

SIS Hernia Graft Surgical graft Class II, 21 CFR §878.3300 (FTM and OXK)

INDICATIONS FOR USE:

The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.

#### DEVICE DESCRIPTION:

The SIS Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at time of implant. The SIS Hernia Graft is identical in its base material to its predicate SIS Hernia Repair Device (K974540/K062697), also manufactured by Cook Biotech Incorporated.

The SIS Hernia Graft is substantially equivalent to its predicate in its technology in that it has the ability to be incorporated into the body. The device is substantially equivalent to its predicate in its intended use for reinforcement and repair of hernias or a body wall defect. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

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## EQUIVALENCE TO MARKETED DEVICES

The SIS Hernia Graft is substantially equivalent with respect to intended use, materials and technological characteristics to its predicate device in terms of section 510(k) substantial equivalence, as shown in biocompatibility testing (conducted in accordance to ISO 10993-1 standards), mechanical and pre-clinical testing.

## Biocompatibility testing

The following biocompatibility tests were performed on sterilized SIS devices, which are identical in base material composition to the SIS Hernia Graft (according to the ISO 10993-1 standard):

- Genotoxicity .
- Direct contact in vitro hemolysis .
- Cytotoxicity �
- Muscle implantation .
- Acute intracutaneous reactivity .
- Skin irritation ●
- ISO Sensitization .
- Acute systemic toxicity .
- Pyrogenicity ●
- LAL endotoxins .
- . Subchronic systemic toxicity

The results of these tests provided evidence that the SIS Hernia Graft meets biocompatibility requirements of the ISO standard.

#### Mechanical Testing

The SIS Hernia Graft material was tested for the following:

- Suture retention strength .
- . Burst strength
- Ultimate tensile strength .
- Tear strength .
- Stiffness test .

The results of the mechanical testing provided evidence that the SIS Hernia Graft provided adequate mechanical strength for its application.

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#### Animal Testing

A study was performed where the SIS Hernia Graft was implanted in a pig hernia model and examined for gross and histopathological results after 27 days. The results show that the device is well tolerated with minimal localized tissue response. A second pig hernia study used the SIS Hernia Graft as a control article and examined one and 6-months post-implant showed satisfactory remodeling characteristics with minimal inflammation. Another animal study in the mouse examined the angiogenesis of the SIS Hernia Graft showed that the sutured SIS performed as well as its sutureless control SIS with robust vascular penetration. The results of the studies show that the device is safe and biocompatible in its application.

#### Substantial Equivalence

See Table 1 for a comparison of the subject device and its predicate.

| Device | SIS Hernia Graft | SIS Hernia Repair Device | SIS Hernia Repair Device |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech Incorporated | Cook Biotech Incorporated | Cook Biotech Incorporated |
| 510(k) Number | K133306 | K974540 | K062697 |
| Intended Use | Intended for implantation to<br>reinforce soft tissues where<br>weakness exists. Indications<br>for use include the repair of a<br>hernia or body wall defect. | Intended to be implanted to<br>reinforce soft tissues where<br>weakness exists. Indications<br>for use include the repair of a<br>hernia or body wall defect. | Intended to be implanted to<br>reinforce soft tissues where<br>weakness exists. Indications<br>for use include the repair of a<br>hernia or body wall defect. |
| Material | Porcine small intestinal<br>submucosa (porcine)<br>Primarily Types I, III, IV and<br>VI collagen (constituents of<br>the extracellular matrix) | Porcine small intestinal<br>submucosa (porcine)<br>Primarily Types I, III, IV and<br>VI collagen (constituents of the<br>extracellular matrix) | Porcine small intestinal<br>submucosa (porcine)<br>Primarily Types I, III, IV and<br>VI collagen (constituents of the<br>extracellular matrix) |
| Dimensions | 5 x 8 cm to 30 x 30 cm | 5 x 8 cm to 20 x 30 cm | 1 x 3 to 20 x 30 cm |
| Thickness | 0.1 - 1.5mm | 0.1 - 1.5 mm | 0.1 - 1.5 mm |
| Type of drying | Lyophilized | Vacuum pressed | Vacuum pressed |
| Layers | 8 layers | 8 layers | 8 layers |
| Stitched<br>(resorbable<br>suture) | Yes | No | No |
| Biocompatible | Yes | Yes | Yes |

| Table 1 - Substantial Equivalence Comparison | |
|----------------------------------------------|--|
|----------------------------------------------|--|

While the SIS Hernia Graft is dried differently than the predicate SIS Hernia Repair Device, the SIS material is the same and exhibits similar incorporation and resorption characteristics when implanted. The suture stitching of the SIS Hernia Graft is intended to hold the layers of the device together during the implantation period and is resorbed without any effect on the SIS material.

CONCLUSION: The biocompatibility, mechanical, and animal tests performed on the SIS Hernia Graft show that the device is substantially equivalent to its predicate.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines representing support and care.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 23, 2014

Cook Biotech Incorporated Mr. Perry W. Guinn Vice President. Quality Assurance and Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906

Re: K133306

Trade/Device Name: SIS Hernia Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM. OXK Dated: June 10, 2014 Received: June 11, 2014

Dear Mr. Guinn:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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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Page 2 - Mr. Perry W. Guinn

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133306

Device Name SIS Hernia Graft

Indications for Use (Describe)

The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

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