MEDEOR MATRIX

K103787 · Kensey Nash Corp. · FTM · Feb 7, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103787
• Device Name: MEDEOR MATRIX
• Applicant: Kensey Nash Corp.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Feb 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Medeor™ Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications, and for reinforcement of the soft tissues, which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. Medeor Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. Medeor Matrix is intended for one time use.

Device Story

Medeor Matrix is a resorbable, porcine-derived collagen surgical mesh used for soft tissue reinforcement. Supplied sterile in dry or saline-hydrated form; labeling updated to allow hydration with autologous bodily fluids prior to implantation. Used by surgeons in clinical settings for hernia repair, thoracic wall defects, and tendon reinforcement. Device acts as a scaffold; does not replace native tissue or provide primary mechanical strength for tendon repairs, which rely on sutures or bone anchors. Benefits include reinforcement of weakened soft tissue sites. No changes to design or manufacturing process from predicate.

Clinical Evidence

Bench testing included biocompatibility (cytotoxicity, sensitization, reactivity, toxicity, genotoxicity, implantation, pyrogenicity, hemolysis), viral inactivation validation, tensile testing, and suture retention. Hydration testing performed with various fluids. In vivo studies conducted in sheep (defect repair) and rabbits (tissue reaction) confirmed safety and performance. No human clinical trial data presented.

Technological Characteristics

Resorbable porcine-derived collagen surgical mesh. Supplied sterile in double-layer peel-open packaging. Hydration options: saline or autologous bodily fluids. Biocompatibility per ISO 10993-1:2003. Mechanical properties include tensile strength and suture retention. No electronic components, software, or energy sources.

Indications for Use

Indicated for soft tissue reinforcement and repair in general surgery, including thoracic wall defects, hernia repair, muscle flap reinforcement, and plastic/reconstructive procedures. Also indicated for reinforcement of soft tissues repaired by sutures or anchors in tendons (rotator cuff, patellar, Achilles, biceps, quadriceps). Not intended to provide full mechanical strength for tendon repair; requires sutures/anchors for biomechanical support. Single use only.

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

• Medeor™ Matrix (K091499)
• KN ECM Surgical Patch (K094061)

Submission Summary (Full Text)

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# Kensey Nash

14103787

FEB - 7 2011

#### 510(k) Summary

| Submitted by: | Kensey Nash Corporation<br>735 Pennsylvania Drive<br>Exton, PA 19341<br>484-713-2100 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lori Burns, MS, RAC<br>Sr. Regulatory Affairs Specialist<br>Ph: [phone]<br>Fax: [phone] |
| Date Prepared:<br>510(K) #: | January 31, 2011<br>K103787 |
| Device: | |
| Trade Name: | Medeor™ Matrix |
| Common Name: | Surgical Mesh |
| Proposed Classification:<br>Product Code | 21 CFR 878.3300, Class II<br>FTM |
| Predicate Device: | Medeor™ Matrix (K091499) - Kensey Nash Corporation<br>KN ECM Surgical Patch (K094061) - Kensey Nash Corporation |

#### Device Description:

The purpose of this submission is to add hydration with autologous bodily fluids to the labeling of the Medeor Matrix device. Medeor Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues where weakness exists. The device is supplied sterile in double-layer peel-open packages. The device is packaged either dry or hydrated with saline. The device can be hydrated with saline or autologous bodily fluids prior to implantation.

### Intended Use:

Medeor™ Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications, and for reinforcement of the soft tissues,

1-800-524-1984

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# Kensey Nash

which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.

Medeor Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

Medeor Matrix is intended for one time use.

## Technological Characteristics:

There have been no changes to the design or manufacturing process of Medeor Matrix (K091499). Medeor Matrix is substantially equivalent to KN ECM Surgical Patch (K094061) with respect to its design, intended use and technological characteristics.

## Performance Data:

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 manufacturing methods have been tested by an independent laboratory to assure appropriate levels of viral inactivation.

Mechanical test reports were completed for the following:

- . Tensile Testing
- . Suture Retention

Hydration testing was performed using various hydration fluids.

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 Medeor Matrix surgical mesh passed the requirements of all tests.

### Substantial Equivalence:

Performance Testing has confirmed that Medeor Matrix 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

June 16, 2014

Kensey Nash Corporation Ms. Lori Burns Manager, Regulatory Affairs 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K103787

Trade/Device Name: Medeor™ Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXB, OXE, OXH, OWY Dated: December 22, 2010 Received: December 27, 2010

Dear Ms. Burns:

This letter corrects our substantially equivalent letter of February 7, 2011.

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

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# Kensev Nash

### Indications for Use Statement

510(k) Number: K103787

Medeor TM Matrix Device Name:

### Indications for Use:

Medeor Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications; and for reinforcement of the soft tissues, which are repaired by suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.

The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

The device is intended for single use only.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dain D. Kainebe MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

**510(k) Number** K103787