(231 days)
Not Found
No
The device description and performance studies focus on the material properties and biological interactions of a surgical mesh, with no mention of AI or ML technologies.
No
The device is described as a surgical mesh to repair/reinforce soft tissue, hernias and/or body wall defects, acting as a scaffold. This function is structural and supportive, rather than actively treating a disease or therapeutic condition in itself.
No
Explanation: The device is a surgical mesh intended for soft tissue repair, not for diagnosing conditions. Its purpose is to repair existing weakness, not to identify it.
No
The device description clearly states it is comprised of ovine derived extracellular matrix devices combined with polypropylene, indicating a physical, implantable 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 is "as a surgical mesh to repair soft tissue where weakness exists." This describes a device used in the body during surgery, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a surgical mesh made of ovine tissue and polypropylene, designed for implantation. This is consistent with a surgical implant, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Ovine Tissue Matrix is intended for use as a surgical mesh to repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
The OTM family is comprised of ovine derived extracellular matrix devices combined with polypropylene. The device is individually packaged and supplied sterile in various sizes and thicknesses to address the complexity of the soft tissue repair. The device is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold to the patient.
The device is supplied "ready to use" in a peel pouch, and does not require rehydration or soaking prior to implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, hernias and/or body wall defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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, biomechanical bench, and in vivo performance testing have been conducted to evaluate the safety and performance characteristics of Ovine Tissue Matrices.
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, implantation, chronic toxicity, and pyrogenicity. 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 uniaxial tensile strength, ball burst strength, and suture retention. Results indicate that Ovine Tissue Matrices are equivalent to the predicate device and meet the requirements for their intended use.
An in vivo study has demonstrated the safety and effectiveness of Ovine Tissue Matrix in a model of soft tissue reinforcement.
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.
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 11, 2014
TELA Bio Incorporated Ms. Donna Stauffer Senior Regulatory Affairs Specialist 1 Great Valley Parkway, Suite 24 Malvern, Pennsylvania 19355
Re: K141053
Trade/Device Name: Ovine Tissue Matrix (OTM) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: November 19, 2014 Received: November 20, 2014
Dear Ms. Stauffer:
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
1
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141053
Device Name
Ovine Tissue Matrix (OTM)
Indications for Use (Describe)
Ovine Tissue Matrix is intended for use as a surgical mesh to repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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Image /page/4/Picture/0 description: The image shows the logo for "TELA BIO, INC. SURGICAL RECONSTRUCTION COMPANY". The logo features a stylized "T" with a circular design on the left side that has red accents. The rest of the logo is in black except for the "BIO" which is in red. The words "SURGICAL RECONSTRUCTION COMPANY" are in a smaller font and are located below the "BIO".
510(k) Number:
of of of Page
510(k) Summary
Submitted By: TELA Bio, Inc. 1 Great Valley Parkway, Suite 24 Malvern, PA 19355
Contact Person: Donna M. Stauffer, RAC Sr. Requlatory Affairs Specialist E: dstauffer@telabio.com P: (484) 320-2932 F: (610) 644-3769
Date Prepared: April 22, 2014
Device Information:
| Trade Name: | Ovine Tissue Matrix (OTM) Reinforced Bioscaffold |
|---|---|
| Common or Usual Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical (21 CFR §878.3300, Product Code FTM) |
| Predicate Device: | Endoform Reconstructive Template (K130547) |
Device Description:
The OTM family is comprised of ovine derived extracellular matrix devices combined with polypropylene. The device is individually packaged and supplied sterile in various sizes and thicknesses to address the complexity of the soft tissue repair. The device is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold to the patient.
The device is supplied "ready to use" in a peel pouch, and does not require rehydration or soaking prior to implant.
Intended Use:
Ovine Tissue Matrix is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or body wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The device is supplied sterile and is intended for single use only.
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Image /page/5/Picture/0 description: The image shows the logo for "OTELA BIO INC. SURGICAL RECONSTRUCTION COMPANY". The logo features a stylized "O" with red accents, followed by the letters "TELA" in black. To the right of "TELA" is the word "BIO" in red, with "INC." in smaller font above the words "SURGICAL RECONSTRUCTION COMPANY".
510(k) Number:
Page _ of _ of _ of
Summary of Technological Characteristics:
| Device | Ovine Tissue Matrix | Endoform Reconstructive
Template |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | TELA Bio, Inc. | Mesynthes, Ltd. |
| 510(k) Number | Proposed | K130547 |
| Indications for Use | Ovine Tissue Matrix is intended
for use as a surgical mesh to
reinforce and/or repair soft tissue
where weakness exists.
Indications for use include the
repair of hernias and/or body wall
defects that require the use of
reinforcing or bridging material to
obtain the desired surgical
outcome. | Endoform Reconstructive
Template is intended for use as a
surgical mesh to reinforce and/or
repair soft tissue where
weakness exists. Indications for
use include, but are not limited
to, the following procedures:
hernioplasty and repair of body
wall defects. The device allows
reinforcement or bridging of a
deficit to obtain the desired
surgical outcome. |
| Material | Ovine derived collagen and
associated ECM components
Collagen I
Collagen III
Polypropylene | Ovine derived collagen and
associated ECM components
Collagen I
Collagen III
Polyglycolic acid (PGA) |
| Design | Terminally sterilized | Terminally sterilized |
| Dimensions | Various sizes, up to 1000 cm² | Various sizes, up to 200 cm² |
| Thickness | Approx. 0.15-1.2 mm | Approx. 0.15-1.2 mm |
Biocompatibility and Performance Data:
Biocompatibility, biomechanical bench, and in vivo performance testing have been conducted to evaluate the safety and performance characteristics of Ovine Tissue Matrices.
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, implantation, chronic toxicity, and pyrogenicity. 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 uniaxial tensile strength, ball burst strength, and suture retention. Results indicate that Ovine Tissue Matrices are equivalent to the predicate device and meet the requirements for their intended use.
An in vivo study has demonstrated the safety and effectiveness of Ovine Tissue Matrix in a model of soft tissue reinforcement.
6
Image /page/6/Picture/0 description: The image shows the logo for "Tela Bio Surgical Reconstruction Company". The logo consists of the word "TELA" in large, bold, black letters, followed by the word "BIO" in red. Below the word "BIO" are the words "Surgical Reconstruction Company" in smaller, black letters. To the left of the word "TELA" is a circular graphic with a red section.
| 510(k) Number: | |
|---|---|
| Page | of |
Conclusion:
Ovine Tissue Matrix is substantially equivalent to Mesynthes' Endoform Reconstructive Template (K130547), which has been cleared by FDA for the same intended use and indications. In addition, OTM has similar technological characteristics and principles of operation as the predicate device.
The minor technological differences between OTM and the predicate device do not raise new questions of safety and effectiveness. Performance and preclinical data demonstrate that OTM is as safe and effective as the predicate device.