(58 days)
TephaFLEX® Surgical Mesh, TephaFLEX® Composite Mesh, SupraMesh
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a resorbable mesh, with no mention of AI or ML technologies.
Yes
The device is intended to reinforce soft tissue, repair hernias, and other fascial defects, which are therapeutic applications.
No
The device is a surgical mesh intended for reinforcing soft tissue and repairing fascial defects, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical mesh made from poly-4-hydroxybutyrate (P4HB) fiber, which is a hardware component. The performance studies also focus on mechanical and in vivo testing of this physical mesh.
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 reinforcing soft tissue during surgical procedures (plastic and reconstructive surgery, hernia repair, fascial defects). This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a resorbable mesh made from P4HB, designed to be surgically implanted. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies focus on mechanical properties and in vivo performance in animal models, which are relevant for surgical implants, not IVDs.
In summary, the TephaFLEX light mesh is a surgical implant intended for tissue reinforcement, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
TephaFLEX light 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.
Product codes (comma separated list FDA assigned to the subject device)
OOD
Device Description
The TephaFLEX light 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, hernia or other fascial 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)
Mechanical testing, biocompatibility testing, and in vivo animal testing was performed based on recommendations identified in the FDA surgical mesh guidance document: The Guidance for the Preparation of a Pre-market Notification Application for a Surgical Mesh. Specifically, comparative burst strength, suture pull-out strength, tensile strength and tear resistance strength was characterized. In vivo strength retention was characterized via a subcutaneous implantation study. The mechanical and in vivo data collected determined the mesh to be substantially equivalent to the predicate devices.
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.
TephaFLEX® Surgical Mesh, TephaFLEX® Composite Mesh, SupraMesh
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
K11372)
Image /page/0/Picture/2 description: The image shows the word "tepha" in a bold, sans-serif font. A curved line starts above the "t", wraps around the word, and ends below the "a", creating a visual element that emphasizes the word. The text is black against a white background.
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® Light Mesh |
|---|---|
| Sponsor: | Tepha, Inc. |
| 99 Hayden Avenue, Suite 360 | |
| Lexington, MA 02421 | |
| Contact Person: | Mary P. LeGraw, V.P., Regulatory Affairs |
| Device Classification Name: | CFR §878.3300 |
| Surgical Mesh | |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the |
| device classification is Class II, Performance Standards. | |
| Predicate Devices: | TephaFLEX® Surgical Mesh, TephaFLEX® Composite Mesh, SupraMesh |
| Device Description: | The TephaFLEX light 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. | |
| Indications for Use: | TephaFLEX light 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. | |
| Safety and Performance: | Mechanical testing, biocompatibility testing, and in vivo animal testing |
| was performed based on recommendations identified in the FDA surgical | |
| mesh guidance document: The Guidance for the Preparation of a Pre- | |
| market Notification Application for a Surgical Mesh. Specifically, | |
| comparative burst strength, suture pull-out strength, tensile strength and | |
| tear resistance strength was characterized. In vivo strength retention was | |
| characterized via a subcutaneous implantation study. The mechanical | |
| and in vivo data collected determined the mesh to be substantially | |
| equivalent to the predicate devices. | |
| Conclusion: | Based on the indications for use, technological characteristics, and safety |
| and performance testing, the TephaFLEX light mesh has been shown to | |
| be substantially equivalent to predicate devices under the Federal Food, | |
| Drug and Cosmetic Act. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three overlapping, abstract shapes that resemble birds in flight or flowing water.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 5 2012
Tepha, Inc. % Ms. Mary P. LeGraw V.P., Regulatory Affairs 99 Hayden Avenue, Suite 360 Lexington, Massachusetts 02421
Re: K113721
Trade/Device Name: TephaFLEX® Light Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OOD Dated: January 27, 2012 Received: January 30, 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
2
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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,
Eunice Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K 11 3721
Indications for Use
510(k) Number (if known): Unknown
Device Name: TephaFLEX® Light Mesh
Indications for Use:
TephaFLEX light 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 AND/OR (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Daniel Kucera MXIM
(Division Sign-Off) Division of Surgical. Othonedic. and Restorative Devices
510(k) Number K113721
