(64 days)
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.
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.
Here's an analysis of the acceptance criteria and supporting studies for the Meso Tendon Matrix device, based on the provided text:
This document is a 510(k) summary for a medical device (Meso Tendon Matrix) seeking substantial equivalence to a predicate device (Medeor Matrix). The acceptance criteria are primarily demonstrated through equivalence to the predicate, rather than meeting specific performance thresholds against a diagnostic "ground truth" as would be the case for a diagnostic AI device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Acceptance Criteria | Reported Device Performance (Meso Tendon Matrix) | Evidence/Study |
|---|---|---|
| Biocompatibility: Acceptable biological safety profile (evaluated per ISO 10993-1:2009 for cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, hemocompatibility, subacute systemic toxicity, chronic systemic toxicity, viral inactivation, residual chemical assessment). | Acceptable biocompatibility profile. | Biocompatibility testing on finished sterile device in accordance with ISO 10993-1: 2009. Results indicate acceptable biocompatibility. |
| Biomechanical Performance: Equivalent to predicate device (Medeor Matrix) and meets requirements for intended use for tensile strength, burst testing, wet tear testing, and suture retention testing. | Device is equivalent to the predicate device and meets the requirements for its intended use for tensile strength, burst testing, wet tear testing, and suture retention. | Biomechanical bench testing, comparing to predicate. |
| Functionality and Tissue Response (in vivo): Normal tissue healing response and confirmed remodeling capability. | Normal tissue healing response and confirmed remodeling capability. | Animal implant studies. |
| Material Composition: Identical to Kensey Nash ECM Surgical Patch (K094061) and substantially equivalent to Medeor Matrix (K103787). | Porcine tissue, resorbable single layer surgical mesh. | Reported. The document states "Meso Tendon Matrix is identical regarding material composition to Kensey Nash ECM Surgical Patch (K094061), cleared May 10, 2010." and comparison table shows "Porcine tissue" for both proposed and predicate devices. |
| Technological Characteristics: Substantially equivalent to Medeor Matrix (K103787) regarding intended use, principles of operation, and technological characteristics (Origin, Device Characteristics, Biocompatibility, Reusable, Shelf Life, Sterilization Method, Packaging). | All listed characteristics are either identical or substantially equivalent to the predicate. Minor difference in Shelf Life (24 months vs. 36 months for predicate), which is an inherent characteristic and usually not considered a point of failure for substantial equivalence if the shorter shelf life is still clinically acceptable. | Performed performance testing (biocompatibility, biomechanical, in vivo) and comparison to predicate device characteristics as detailed in the table provided in the 510(k) summary. The summary explicitly states: "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)." |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility: The text does not specify the sample size for each test conducted under ISO 10993-1:2009. These typically involve standardized protocols where sample size is determined by the specific test method (e.g., number of cell cultures, animals per group).
- Biomechanical Testing: Not specified.
- Animal Implant Studies: Not specified.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing and studies conducted by DSM Biomedical or contracted testing facilities. Given the nature of these tests, it's prospective testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of device (surgical mesh) does not involve a "ground truth" established by experts in the sense of a diagnostic interpretation (e.g., radiologists reviewing images). Instead, acceptance criteria are based on objective, standardized scientific and engineering tests (biocompatibility, mechanical properties) and animal model outcomes for tissue response. The "ground truth" is established by the validated methods of these scientific tests themselves and the comparison to a legally marketed predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert interpretations. The "adjudication" is essentially the comparison of the test results to predefined acceptance criteria or to the predicate device's characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an AI or diagnostic imaging device. An MRMC study is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the sense that the device's inherent properties (biocompatibility, mechanical strength, in vivo tissue response) were tested independently without a "human-in-the-loop" component. The device itself is not an algorithm, so this question is interpreted as the device's performance being evaluated in a standalone manner.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's performance is established through:
- Compliance with International Standards: For biocompatibility, adherence to ISO 10993-1:2009.
- Objective Engineering Measurements: For biomechanical properties (tensile strength, burst, tear, suture retention).
- Observed Biological Response: In animal implant studies, observing normal tissue healing and remodeling.
- Comparison to Predicate Device: The primary "ground truth" for regulatory clearance is substantial equivalence to the Medeor Matrix (K103787) across material, intended use, principles of operation, and technological characteristics.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm requiring a training set. The "training" in a broad sense would be the research and development phase where materials were selected and manufacturing processes optimized, but this is not a data-driven "model training" process.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
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DEC 2 0 2013
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DSM Biomedical 735 Pennsylvania Drive Exton, PA 19341 USA
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: Brianna.Jordan@dsm.com 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(K103787) |
|---|---|---|
| Indications forUse | Meso Tendon Matrix is intended foruse in sports medicine proceduresfor the reinforcement and repair ofsoft tissue where weakness existsincluding but not limited to, rotatorcuff, patellar, Achilles, biceps,quadriceps and other tendons. MesoTendon Matrix is not intended toreplace normal body structure orprovide the full mechanicalstrength to support tendon repair ofthe rotator cuff, patellar, Achilles, | Medeor Matrix is indicated for usein general surgical procedures forthe reinforcement and repair of softtissue where weakness existsincluding but not limited to defectsof the thoracic wall, suture linereinforcement and muscle flapreinforcement; hernia repair; softtissue reconstructive proceduresincluding plastic and reconstructivesurgical applications and forreinforcement of the soft tissues, |
| Characteristic | Meso Tendon Matrix | Medeor Matrix(K103787) |
| biceps, quadriceps, or othertendons. Sutures, used to repair thetear, and sutures or bone anchorsused to attach the tissue to thebone, provide biomechanicalstrength for the tendon repair.Meso Tendon Matrix is suppliedsterile and for one time use. | which are repaired by suture orsuture anchors, including but notlimited to, rotator cuff, patellar,Achilles, biceps, quadriceps andother tendons. The device is notintended to replace normal bodystructure to provide the fullmechanical strength to supporttendon repair of the rotator cuff,patellar, Achilles, biceps,quadriceps, or other tendons.Sutures used to repair the tear, andsutures or bone anchors used toattach the tissue to the boneprovide biomechanical strength forthe tendon repair. The device isprovided sterile and for one timeuse. | |
| Origin | Porcine tissue | Porcine tissue |
| DeviceCharacteristics | Resorbable single layer surgicalmesh | Resorbable single layer surgicalmesh |
| Biocompatibility | Yes | Yes |
| Reusable | Single Use Device | Single Use Device |
| Shelf Life | 24 months | 36 months |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide |
| Packaging | Double peel packages | Double peel packages |
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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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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
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
§ 878.3300 Surgical mesh.
(a)
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.(b)
Classification. Class II.