(14 days)
Not Found
No
The 510(k) summary describes a surgical mesh and its intended use for soft tissue reinforcement and hernia repair. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on physical properties and mechanical strength.
Yes
The device is intended to reinforce soft tissues, repair hernias, and address other fascial defects, which are therapeutic interventions.
No
The device is a surgical mesh used to reinforce soft tissues and repair defects, not to diagnose a condition.
No
The device description clearly indicates it is a "Surgical Mesh," which is a physical implantable material, not software. The performance studies also describe physical testing of the mesh.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical mesh used for reinforcing soft tissues and repairing defects within the body. This is a therapeutic or structural device, not a diagnostic one.
- Device Description: The description reiterates the surgical application of the mesh.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on physical and mechanical properties of the mesh, not diagnostic accuracy metrics like sensitivity, specificity, or AUC.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
TephaFLEX® Surgical Mesh is intended wherever temporary wound support is required, to reinforce soft tissues where weakness exists or 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. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
TephaFLEX® Surgical Mesh is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists or 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. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, hernia or other fascial defects, vaginal, colon, rectal, pelvic floor, sacral
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)
Physical testing was performed on the TephaFLEX® surgical mesh which determined the TephaFLEX mesh to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions.
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.
K810428, K851086, K052225, K031995, K050332
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 shows the word "tepha" in a stylized font. The letters are in black, and the word is surrounded by a curved line that starts below the "t" and ends below the "a". The font is bold and sans-serif.
APR 1 3 2007
840 Memorial Drive Cambridge, MA 02139 tel: (617) 995-5400 fax: (617) 995-5401
Section X Summary of Safety and Effectiveness
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® Surgical Mesh |
|---|---|
| Sponsor: | Tepha, Inc. |
| 840 Memorial Drive | |
| Cambridge, MA 02139 | |
| Telephone: 617.995.5400 | |
| Fax: 617.995.5401 | |
| Device Classification Name: | CFR §878.3300 |
| Absorbable Poly-4-hydroxybutyrate (P4HB) 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: | Ethicon, Inc. - Vicryl Mesh - K810428, K851086 |
| Tepha, Inc. - TephaFLEX Absorbable Suture - K052225 | |
| MAST Biosurgery, Inc. - Surgi-Wrap Film - K031995, | |
| K050332 | |
| Device Description: | TephaFLEX® Surgical Mesh is to be used wherever |
| temporary wound support is required, to reinforce soft | |
| tissues where weakness exists or 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. This includes, but is not limited to the | |
| following procedures: vaginal prolapse repair, colon and | |
| rectal prolapse repair, reconstruction of the pelvic floor and | |
| sacral colposuspension. | |
| Safety and Performance: | Physical testing was performed on the TephaFLEX® |
| surgical mesh which determined the TephaFLEX mesh to | |
| be substantially equivalent to the mechanical strengths of | |
| the predicate devices under indication for use conditions. | |
| Conclusion: | Based on the indications for use, technological |
| characteristics, and safety and performance testing, the | |
| TephaFLEX® Surgical Mesh has been shown to be | |
| substantially equivalent to predicate devices under the | |
| Federal Food, Drug and Cosmetic Act. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tepha Incorporated % Ms. Mary P. LeGraw Director, Regulatory Affairs 840 Memorial Drive Cambridge, Massachusetts 02139
APR 1 3 2007
Re: K070894
Trade/Device Name: TephaFLEX® Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 29, 2007 Received: March 30, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Ms. Mary P. LeGraw
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Not Assigned
TephaFLEX® Surgical Mesh Device Name:
Indications for Use:
TephaFLEX® Surgical Mesh is intended wherever temporary wound support is required, to reinforce soft tissues where weakness exists or 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. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
Nul
Prescription Use: X (21 CFR 801 Subpart D) AND/OR
sion Signon of General, Restorative, d Neurological Devices
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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