MESO TENDON MATRIX

K133169 · Kensey Nash Corporation Dba Dsm Biomedical · OWY · Dec 20, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K133169
• Device Name: MESO TENDON MATRIX
• Applicant: Kensey Nash Corporation Dba Dsm Biomedical
• Product Code: OWY · General, Plastic Surgery
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Meso Tendon Matrix is intended for use in sports medicine procedures for the reinforcement and repair of soft tissue where weakness exists including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. Meso Tendon 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. Meso Tendon Matrix is supplied sterile and for one time use.

Device Story

Meso Tendon Matrix is a resorbable surgical mesh derived from porcine mesothelium tissue; intended for soft tissue reinforcement in sports medicine. Supplied dry in sterile double-layer packaging; hydrated by clinician with saline or autologous fluids (blood, bone marrow aspirate, platelet-rich plasma) prior to implantation. Used by surgeons in clinical settings to reinforce tendon repairs; does not provide primary biomechanical strength, which is supplied by sutures or bone anchors. Device acts as a scaffold to support natural tissue healing and remodeling. Benefits include reinforcement of weakened soft tissue during surgical repair procedures.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility testing per ISO 10993-1:2009 (cytotoxicity, sensitization, irritation, toxicity, genotoxicity, hemocompatibility), viral inactivation, residual chemical assessment, and biomechanical bench testing (tensile, burst, wet tear, suture retention). Animal implant studies confirmed normal tissue healing response and remodeling capability.

Technological Characteristics

Resorbable single-layer surgical mesh derived from porcine mesothelium. Sterilized via Ethylene Oxide. Supplied dry, hydrated with saline or autologous fluids before use. Biocompatibility per ISO 10993-1:2009. Shelf life 24 months. Single-use.

Indications for Use

Indicated for reinforcement and repair of soft tissue in sports medicine procedures where weakness exists, including rotator cuff, patellar, Achilles, biceps, and quadriceps tendons. Not intended to replace normal body structure or provide full mechanical strength for tendon repair; requires use of sutures or bone anchors for biomechanical strength.

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 (K103787)

Reference Devices

• Kensey Nash ECM Surgical Patch (K094061)

Submission Summary (Full Text)

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DEC 2 0 2013

Image /page/0/Picture/1 description: The image shows the logo for DSM, a company that specializes in bright science and brighter living. The logo consists of a circular graphic on the left, followed by the letters "DSM" in bold font. Above the logo is the text "K133169", which may be a product or document identifier. The overall image is simple and professional, conveying a sense of innovation and progress.

DSM Biomedical 735 Pennsylvania Drive Exton, PA 19341 USA

www.dsm.com/medical

# 510(k) SUMMARY

Submitted By:

Contact Person:

Date Prepared:

Device:

Trade Name: Common/Usual Name: Classification Name: Classification Regulation: Device Class: Device Code: Advisory Panel:

DSM Biomedical 735 Pennsylvania Drive Exton, PA 19341 Brianna Jordan Regulatory Specialist E: [e-mail] P: 484-713-2608 F: 484-713-2903 October 2, 2013

Meso Tendon Matrix Surgical Mesh Mesh, Surgical 21 CFR 878.3300 Class II

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------OW General and Plastic Surgery

Predicate:

K103787: Medeor Matrix [Kensey Nash Corporation]

#### Device Description:

Meso Tendon Matrix is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine mesothelium tissue. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.

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Image /page/1/Picture/0 description: The image shows a logo with the text "DSM" and the tagline "BRIGHT SCIENCE. BRIGHTER LIVING.". Above the logo, there is the text "K133169" and "Page 2/4". To the left of the text, there is a circular graphic with three curved shapes extending from the center.

#### Intended Use:

Meso Tendon Matrix is intended for use in sports medicine procedures for the reinforcement and repair of soft tissue where weakness exists including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. Meso Tendon 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.

Meso Tendon Matrix is supplied sterile and for one time use.

## Technological Characteristics:

The product design and function of Meso Tendon Matrix is substantially equivalent to the FDA cleared predicate device Medeor Matrix (K103787). Meso Tendon Matrix is identical regarding material composition to Kensey Nash ECM Surgical Patch (K094061), cleared May 10, 2010.

| Characteristic | Meso Tendon Matrix | Medeor Matrix<br>(K103787) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Meso Tendon Matrix is intended for<br>use in sports medicine procedures<br>for the reinforcement and repair of<br>soft tissue where weakness exists<br>including but not limited to, rotator<br>cuff, patellar, Achilles, biceps,<br>quadriceps and other tendons. Meso<br>Tendon Matrix is not intended to<br>replace normal body structure or<br>provide the full mechanical<br>strength to support tendon repair of<br>the rotator cuff, patellar, Achilles, | Medeor Matrix is indicated for use<br>in general surgical procedures for<br>the reinforcement and repair of soft<br>tissue where weakness exists<br>including but not limited to defects<br>of the thoracic wall, suture line<br>reinforcement and muscle flap<br>reinforcement; hernia repair; soft<br>tissue reconstructive procedures<br>including plastic and reconstructive<br>surgical applications and for<br>reinforcement of the soft tissues, |
| Characteristic | Meso Tendon Matrix | Medeor Matrix<br>(K103787) |
| | biceps, quadriceps, or other<br>tendons. Sutures, used to repair the<br>tear, and sutures or bone anchors<br>used to attach the tissue to the<br>bone, provide biomechanical<br>strength for the tendon repair.<br>Meso Tendon Matrix is supplied<br>sterile and for one time use. | which are repaired by suture or<br>suture anchors, including but not<br>limited to, rotator cuff, patellar,<br>Achilles, biceps, quadriceps and<br>other tendons. The device is not<br>intended to replace normal body<br>structure to provide the full<br>mechanical strength to support<br>tendon repair of the rotator cuff,<br>patellar, Achilles, biceps,<br>quadriceps, or other tendons.<br>Sutures used to repair the tear, and<br>sutures or bone anchors used to<br>attach the tissue to the bone<br>provide biomechanical strength for<br>the tendon repair. The device is<br>provided sterile and for one time<br>use. |
| Origin | Porcine tissue | Porcine tissue |
| Device<br>Characteristics | Resorbable single layer surgical<br>mesh | Resorbable single layer surgical<br>mesh |
| Biocompatibility | Yes | Yes |
| Reusable | Single Use Device | Single Use Device |
| Shelf Life | 24 months | 36 months |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide |
| Packaging | Double peel packages | Double peel packages |

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:

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Image /page/3/Picture/1 description: The image shows the DSM logo. The logo consists of a circular graphic on the left and the letters "DSM" on the right. Below the letters, the words "BRIGHT SCIENCE. BRIGHTER LIVING." are written. The logo is black and white.

## Biocompatibility and Performance Data:

Biocompatibility testing, biomechanical bench testing, characterization testing and in vivo performance testing have been conducted to evaluate the biological safety and biomechanical performance characteristics of Meso Tendon Matrix.

Biocompatibility testing was completed on the finished sterile device in accordance with the requirements of ISO 10993-1: 2009, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process. Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Hemocompatibility, Subacute Systemic Toxicity, and Chronic Systemic Toxicity. Other safety testing included a viral inactivation study and residual chemical assessment. Results indicate that the device's biocompatibility profile is acceptable.

Biomechanical testing included tensile strength, burst testing, wet tear testing, and suture retention testing. Testing results indicate that the device is equivalent to the predicate device and meets the requirements for its intended use.

Animal implant studies were performed to confirm the functionality and tissue response characteristics of the proposed device. Results indicate a normal tissue healing response and confirm the device's remodeling capability.

#### Substantial Equivalence:

Performance testing has confirmed that the Meso Tendon Matrix is substantially equivalent to the predicate device Medeor Matrix (K103787) with regard to material, intended use, principles of operation, and technological characteristics, pursuant to section 510(k).

HEALTH · NUTRITION · MATERIALS

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.

#### 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

Kensey Nash Corporation dba DSM Biomedical Ms. Brianna Jordan Regulatory Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341

December 20, 2013

Re: K133169

Trade/Device Name: Meso Tendon Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OWY Dated: October 2, 2013 Received: October 31, 2013

Dear Ms. Jordan:

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

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Page 2 - Ms. Brianna Jordan

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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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For 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: K133169

Device Name: Meso Tendon Matrix

Indications For Use:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Meso Tendon Matrix is indicated for use in sports medicine procedures for the reinforcement and repair of soft tissue where weakness exists including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.

Meso Tendon 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.

Meso Tendon Matrix is supplied sterile and for one time use.

Prescription Use × AND/OR AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K133169