KENSEY NASH ECM SURGICAL PATCH

K094061 · Kensey Nash Corporation · FTM · May 18, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K094061
• Device Name: KENSEY NASH ECM SURGICAL PATCH
• Applicant: Kensey Nash Corporation
• Product Code: FTM · General, Plastic Surgery
• Decision Date: May 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair, reinforcement in plastic and reconstructive surgery, and in the urological (excluding transvaginal repair of pelvic organ prolapse), and gastroenterological anatomy including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g., hiatal, femoral, paracolostomy, umbilical), urethral and vaginal prolapse repair (excluding transvaginal repair of pelvic organ prolapse), colon prolapse repair, rectal prolapse repair (excluding rectocele) using an abdominal approach, reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), bladder support, and sacrocolposuspension. The Kensey Nash ECM Surgical Patch is supplied sterile and intended for one time use.

Device Story

Kensey Nash ECM Surgical Patch is a resorbable, porcine-peritoneum-derived collagen surgical mesh; supplied dry (lyophilized) in sterile double-layer packaging; requires hydration before implantation. Used by surgeons in OR settings for soft tissue reinforcement in hernia, urological, gynecological, and gastroenterological procedures. Device provides mechanical support to weakened tissues; facilitates repair via reinforcement of primary closures. Benefits include structural support for soft tissue defects. No electronic or software components.

Clinical Evidence

Bench testing included tensile and suture retention testing. Biocompatibility testing performed per ISO 10993-1:2003 (cytotoxicity, sensitization, intracutaneous reactivity, systemic/sub-chronic toxicity, genotoxicity, implantation, pyrogenicity, hemolysis). In vivo studies included a sheep model for defect repair and a rabbit study for tissue reaction evaluation. Device passed all tests.

Technological Characteristics

Resorbable porcine-peritoneum-derived collagen surgical mesh. Supplied lyophilized (dry) for hydration prior to use. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for patients requiring soft tissue repair or reinforcement in plastic, reconstructive, urological, gynecological, and gastroenterological procedures where weakness exists. Procedures include hernia repair, suture line/muscle flap reinforcement, prolapse repair (rectal, urethral, vaginal), pelvic floor reconstruction, and bladder support. Contraindicated for transvaginal repair of pelvic organ prolapse.

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 (K992159)
• SurgiSiS (K034039)
• SurgiSiS (K062697)
• FortaFlex (K011025)
• FortaFlex (K020049)

Submission Summary (Full Text)

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## 510(k) Summary

| Submitted by: | Kensey Nash Corporation dba DSM Biomedical<br>735 Pennsylvania Drive<br>Exton, PA 19341 |
|-----------------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Lori Burns, MS, RAC<br>Manager Regulatory Affairs<br>Ph: [phone]<br>Fax: [phone] |
| Date Prepared:<br>510(K) #: | June 13, 2014<br>K094061 |
| Device: | |
| Trade Name: | Kensey Nash ECM Surgical Patch |
| Common/Usual Name: | Surgical Mesh |
| Proposed Classification: | 21 CFR 878.3300<br>FTM, OXH, OXE, PAJ, PAG |

Class II

## Device Description:

The Kensey Nash ECM Surgical Patch is a resorbable porcine-peritoneum-derived collagen surgical mesh intended for reinforcement of soft tissues. The device is supplied sterile in double-layer packages. The product is packaged dry (lyophilized) to be hydrated prior to use.

### Predicate Devices:

| Manufacturer | Device | 510(k)# |
|--------------------|-----------|---------|
| Cook, Inc. | SurgiSiS | K992159 |
| Cook, Inc. | SurgiSiS | K034039 |
| Cook, Inc. | SurgiSiS | K062697 |
| Organogenesis Inc. | FortaFlex | K011025 |
| Organogenesis Inc. | FortaFlex | K020049 |

#### Intended Use:

The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair, reinforcement in plastic and reconstructive surgery, and in the urological (excluding transvaginal repair of pelvic organ prolapse), and gastroenterological anatomy including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g., hiatal, femoral, paracolostomy, umbilical), urethral and vaginal prolapse repair (excluding transvaginal repair of pelvic organ prolapse), colon prolapse repair, rectal prolapse repair (excluding rectocele) using an abdominal approach, reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), bladder support, and sacrocolposuspension.

The Kensey Nash ECM Surgical Patch is supplied sterile and intended for one time use.

#### Performance Data:

Mechanical testing performed with KN ECM demonstrated equivalence of the device to legally marketed predicate devices. Mechanical test reports were completed for the following:

- . Tensile Testing
HEALTH · NUTRITION · MATERIALS

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- . Suture Retention
The following biocompatibility tests were conducted on the finished device according to the requirements of ISO 10993-1:2003, Biological evaluation of medical devices - Part 1:Evaluation and testing: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemolysis.

The device was evaluated in two in vivo studies; defects were repaired and evaluated in a sheep model and a rabbit study was performed to evaluate tissue reactions.

The Kensey Nash ECM Surgical Patch passed the requirements of all tests.

## Substantial Equivalence:

Performance Testing has confirmed that the Kensey Nash ECM Surgical Patch is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

June 16, 2014

Kensey Nash Corporation d.b.a. DSM Biomedical Ms. Lori Burns Manager, Regulatory Affairs 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K094061

Trade/Device Name: Kensey Nash ECM Surgical Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM. OXE. OXH. PAG. PAJ Dated: April 29, 2010 Received: April 30, 2010

Dear Ms. Burns:

This letter corrects our substantially equivalent letter of May 18, 2010.

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 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

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Page 2 - Ms. Lori Burns

device-related adverse events) (21 CFR 803); 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.

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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## Indications for Use

510(k) Number (if known) K094061

Device Name Kensey Nash ECM Surgical Patch

## Indications for Use (Describe)

The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair, reinforcement in plastic and reconstructive surgery, and in the urological, gynecological (excluding transvaginal repair of pelvic organ prolapse), and gastroenterological anatomy including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g., hiatal, femoral, paracolostomy, umbilical), urethral and vaginal prolapse repair (excluding transvaginal repair of pelvic organ prolapse repair, rectal prolapse repair (excluding rectocele) using an abdominal approach, reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), bladder support, and sacrocolposuspension.

The Kensey Nash ECM Surgical Patch is supplied sterile and intended for one time 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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Krause

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