(64 days)
No
The summary describes a resorbable surgical mesh for soft tissue reinforcement and repair. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is intended for reinforcing and repairing soft tissue where weakness exists, which falls under the definition of a therapeutic device.
No
The device is a resorbable surgical mesh intended to reinforce and repair soft tissue, not to diagnose medical conditions.
No
The device description clearly states it is a resorbable surgical mesh derived from porcine tissue, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is 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." This is a surgical implant used directly on the patient's body.
- Device Description: The description details a "resorbable surgical mesh intended to reinforce soft tissue where weakness exists." It is derived from porcine tissue and is implanted surgically.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The device is a surgical implant used for tissue repair, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OWY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
sports medicine procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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.
1
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 for
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, | 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, |
| Characteristic | Meso Tendon Matrix | Medeor Matrix
(K103787) |
| | 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. | which are repaired by suture or
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 to 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
provided sterile and for one time
use. |
| Origin | Porcine tissue | Porcine tissue |
| Device
Characteristics | Resorbable single layer surgical
mesh | Resorbable single layer surgical
mesh |
| Biocompatibility | Yes | Yes |
| Reusable | Single Use Device | Single Use Device |
| Shelf Life | 24 months | 36 months |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide |
| Packaging | Double peel packages | Double peel packages |
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:
3
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
4
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
5
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
6
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