MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)

K091499 · Kensey Nash Corp. · FTM · Oct 22, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091499
• Device Name: MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)
• Applicant: Kensey Nash Corp.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Oct 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

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; urogynecological reinforcement (excluding transvaginal repair of pelvic organ prolapse) including but not limited to, rectal prolapse (excluding rectocele) using an abdominal approach, vaginal prolapse (excluding transvaginal repair of pelvic organ prolapse), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), 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 and repair. Supplied sterile in dry (lyophilized) or prehydrated (saline) forms. Applied by surgeons during general, urogynecological, or reconstructive procedures. Provides structural support to weakened tissues; used in conjunction with sutures or bone anchors for tendon repairs. Does not provide primary biomechanical strength for tendon repairs; serves as reinforcement. Intended for single-use only.

Clinical Evidence

Bench testing included tensile and suture retention testing. Biocompatibility testing performed per ISO 10993-1:2003 (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, sub-chronic toxicity, genotoxicity, implantation, pyrogenicity, hemolysis). In vivo studies conducted in sheep (defect repair) and rabbits (tissue reaction). All tests passed.

Technological Characteristics

Resorbable porcine-derived collagen surgical mesh. Supplied sterile in double-layer peel-open packaging. Available as lyophilized (dry) or prehydrated in saline. Biocompatibility evaluated per ISO 10993-1:2003.

Indications for Use

Indicated for patients requiring soft tissue reinforcement and repair in general surgery, including thoracic wall defects, muscle flaps, urogynecological procedures (abdominal approach only), hernia repair, and tendon reinforcement (rotator cuff, patellar, Achilles, biceps, quadriceps). Not for transvaginal pelvic organ prolapse 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

• BioBlanket™ (K061030)
• Strattice™ (K080353)

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>K091499 |
| Device: | |
| Trade Name: | Medeor Matrix |
| Common/Usual Name: | Surgical Mesh |
| Proposed Classification: | 21 CFR 878.3300<br>FTM, OXH, OXE, OXB, OWY, PAJ |

Class II

## Device Description:

Medeor™ Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues. The device is supplied sterile in double-layer peel-open packages. The product is either packaged dry (lyophilized) to be hydrated prior to use, or can be supplied prehydrated, packaged and sterilized in saline.

## Predicate Devices:

| Manufacturer | Device | 510(k)# |
|-------------------------|-------------|---------|
| Kensey Nash Corporation | BioBlanket™ | K061030 |
| Lifecell | Strattice™ | K080353 |

#### 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; urogynecological reinforcement (excluding transvaginal repair of pelvic organ prolapse) including but not limited to, rectal prolapse (excluding rectocele) using an abdominal approach, vaginal prolapse (excluding transvaginal repair of pelvic organ prolapse), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), 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.

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## Performance Data:

Mechanical testing performed with Medeor Matrix demonstrated equivalence of the device to legally cleared predicate devices. Mechanical test reports were completed for the following:

- . Tensile Testing
- 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.

Medeor Matrix 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 and Human Services. The logo features a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird-like figure.

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. Alyssa J. Schwarts, MS, RAC Regulatory Affairs Affairs 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K091499

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, PAJ Dated: October 12, 2009 Received: October 13, 2009

Dear Ms. Schwarts:

This letter corrects our substantially equivalent letter of October 22, 2009.

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. Alyssa J. Schwarts, MS. RAC

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) K091499

Device Name Medeor Matrix

## Indications for Use (Describe)

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; urogynecological reinforcement (excluding transvaginal repair of pelvic organ prolaps) including but not limited to, rectal prolapse (excluding rectocele) using an abdominal approach, vaginal prolapse (excluding transvaginal repair of pelvic organ prolapse), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), hemia 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 bone, provide biomechanical strength for the tendon repair.

Medeor Matrix is 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)

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## FOR FDA USE ONLY

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

# I Krause

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