(58 days)
TephaFLEX mesh is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
The TephaFLEX mesh is a resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB). The mesh is prepared from non-dyed or dyed (D&C Violet #2) monofilament P4HB fiber that is knitted into a surgical mesh. It is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application.
This is a medical device submission (K113723) for TephaFLEX® Mesh, which is a surgical mesh. The provided document does not describe an AI/ML powered device, but rather a traditional medical device that undergoes mechanical and biological testing for safety and performance. Therefore, many of the requested fields related to AI/ML device studies will not be applicable.
Here's the breakdown of the information as it relates to the provided document:
Acceptance Criteria and Device Performance
The "Safety and Performance" section states that "Mechanical testing, in vivo animal testing, and biocompatibility testing, were performed based on recommendations identified in the FDA surgical mesh guidance document." The conclusion is that the mesh was determined to be "substantially equivalent to the predicate devices."
The specific acceptance criteria are not explicitly detailed in quantifiable targets within the provided summary, but rather by comparison to predicate devices and established guidance. The reported performance is that the device met these comparative standards.
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Mechanical Testing: | Comparative burst strength, suture pull-out strength, tensile strength, and tear resistance strength were characterized. The collected mechanical data determined the mesh to be substantially equivalent to the predicate devices. |
| In Vivo Animal Testing: | In vivo strength retention was characterized via a subcutaneous implantation study. The collected in vivo data determined the mesh to be substantially equivalent to the predicate devices. |
| Biocompatibility Testing: | Performed based on recommendations in FDA surgical mesh guidance. Results are not detailed but contribute to the overall conclusion of substantial equivalence. |
| Overall Conclusion: | The TephaFLEX mesh has been shown to be substantially equivalent to predicate devices based on indications for use, technological characteristics, and safety and performance testing. |
Study Details (as applicable)
Since this is a traditional medical device and not an AI/ML device, many of the requested fields are not applicable.
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Sample sizes used for the test set and the data provenance:
- The document mentions "in vivo animal testing" (subcutaneous implantation study) and "mechanical testing." Specific sample sizes for these tests are not provided in this summary.
- Data provenance (e.g., country of origin, retrospective/prospective) is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device relying on expert-established ground truth from images or data. The testing involves physical and biological evaluations.
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Adjudication method for the test set:
- Not applicable. The testing methods for mechanical and in vivo studies would follow standard scientific protocols for data collection and analysis, not expert adjudication in the context of diagnostic interpretation.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
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The type of ground truth used:
- For mechanical testing: The "ground truth" would be the direct physical measurement of properties like burst strength, tensile strength, etc., compared against specified benchmarks or predicate device performance.
- For in vivo animal testing: The "ground truth" would be the observed biological response and strength retention in the animal model, again compared to expected outcomes or predicate device performance.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that uses a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that uses a training set.
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Image /page/0/Picture/2 description: The image shows the word "tepha" in a stylized font. The letters are in lowercase and appear to be in a sans-serif typeface. A curved line underlines the word, starting from above the "t" and extending below the "a", creating a visual element that emphasizes the word.
840 Memorial Drive Cambridge, MA 02139 tel: (617) 995-5400 fax: (617) 995-5401
Section IX Summary of Safety and Effectiveness (Prepared on December 16, 2011)
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Tepha, Inc. is submitting the following summary of information respecting safety and effectiveness:
| Trade Name: | TephaFLEX® Mesh |
|---|---|
| Sponsor: | Tepha, Inc.99 Hayden Avenue, Suite 360Lexington, MA 02421 |
| Contact Person: | Mary P. LeGraw, V.P., Regulatory Affairs |
| Device Classification Name: | CFR §878.3300Surgical Mesh |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, thedevice classification is Class II, Performance Standards. |
| Predicate Devices: | TephaFLEX® Surgical Mesh, TephaFLEX® Composite Mesh, SupraMesh |
| Device Description: | The TephaFLEX mesh is a resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB). The mesh is prepared from non-dyed or dyed(D&C Violet #2) monofilament P4HB fiber that is knitted into a surgicalmesh. It is provided in single sheets of varying widths and lengths andmay be cut to the shape or size desired for a specific application. |
| Indications for Use: | TephaFLEX mesh is intended to reinforce soft tissue where weaknessexists in patients undergoing plastic and reconstructive surgery, or foruse in procedures involving soft tissue repair, such as for the repair ofhernia or other fascial defects that require the addition of a reinforcing orbridging material to obtain the desired surgical result. |
| Safety and Performance: | Mechanical testing, in vivo animal testing, and biocompatibility testing,were performed based on recommendations identified in the FDAsurgical mesh guidance document: The Guidance for the Preparation ofa Pre-market Notification Application for a Surgical Mesh. Specifically,comparative burst strength, suture pull-out strength, tensile strength andtear resistance strength was characterized. In vivo strength retention wascharacterized via a subcutaneous implantation study. The mechanicaland in vivo data collected determined the mesh to be substantiallyequivalent to the predicate devices. |
| Conclusion: | Based on the indications for use, technological characteristics, and safetyand performance testing, the TephaFLEX mesh has been shown to besubstantially equivalent to predicate devices under the Federal Food,Drug and Cosmetic Act. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tepha, Inc. % Ms. Mary P. LeGraw V.P., Regulatory Affairs 99 Hayden Avenue, Suite 360 Lexington, Massachusetts 02421
Re: K113723
Trade/Device Name: TephaFLEX® Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OOD Dated: January 17, 2012 Received: January 18, 2012
Dear Ms. LeGraw:
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
FEB 1 5 2012
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Page 2 - Ms. Mary P. LeGraw
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 forth in the quality systems (OS) 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 go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
E. Keith
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Unknown
TephaFLEX® Mesh Device Name:
Indications for Use:
TephaFLEX mesh is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Prescription Use: X (21 CFR 801 Subpart D) Over-The-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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9
Daniel Kinefor MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113723
§ 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.