(83 days)
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Not Found
No
The provided text describes a surgical film for tissue reinforcement and hernia repair. There is no mention of AI, ML, image processing, or any computational analysis of data that would indicate the use of such technologies. The performance studies described are physical and in vivo animal testing, not related to AI/ML model performance.
No
The device is a surgical film intended for temporary wound support and reinforcement of tissues, not for therapeutic treatment of a disease or condition.
No
This device is described as a surgical film intended for temporary wound support, tissue reinforcement, and repair of defects, which are therapeutic and structural functions, not diagnostic.
No
The device description clearly states it is a "surgical film" and describes physical and in vivo animal testing, indicating it is a physical medical device, not software.
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 device used in vivo (within the body) for surgical repair and reinforcement of tissues. IVDs are used in vitro (outside the body) to examine specimens from the body (like blood, urine, or tissue samples) to provide information about a person's health.
- Device Description: The description reinforces the in vivo application of the surgical film.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
- Anatomical Site: The anatomical sites mentioned (soft tissues, hernia, fascial defects, viscera) are all internal body structures, consistent with an in vivo surgical device.
This device is a surgical implant or material used directly in a surgical procedure, not a diagnostic tool used on samples outside the body.
N/A
Intended Use / Indications for Use
TephaFLEX® Surgical Film is intended for temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
Product codes (comma separated list FDA assigned to the subject device)
FTL, NWJ
Device Description
TephaFLEX surgical film is intended for temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential tissue attachment to the device in case of direct contact with the viscera.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Physical and in vivo animal testing was performed on the TephaFLEX surgical film which determined the film to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
II
Image /page/0/Picture/1 description: The image shows the word "tepha" in a simple, sans-serif font. The letters are closely spaced and have a slightly textured appearance, as if they were printed with a slightly worn-out printer. A curved line underlines the word, adding a subtle emphasis to the text.
NOV 2 9 2007
99 Hayden Avenue Suite 360 Lexington, MA 02421 Tel: 781.357.1700
Fax: 781.357.1701
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 Film |
|---|---|
| Sponsor: | Tepha, Inc. |
| 99 Hayden Avenue, Suite 360 | |
| Lexington, MA 02421 | |
| Telephone: 781.357.1700 | |
| Fax: 781.357.1701 | |
| 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: | MAST Biosurgery, Inc. - Surgi-Wrap Film |
| OsteoBiologics, Inc. -- PlastiFIIm | |
| Tepha, Inc. - TephaFLEX Absorbable Mesh | |
| Device Description: | TephaFLEX surgical film is intended for temporary wound |
| support, to reinforce soft tissues where weakness exists, or for | |
| the repair of hernia or other fascial defects that require the | |
| addition of a reinforcing material to obtain the desired surgical | |
| result. The absorbable protective film also may help minimize the | |
| potential tissue attachment to the device in case of direct contact | |
| with the viscera. | |
| Safety and Performance: | Physical and in vivo animal testing was performed on the |
| TephaFLEX surgical film which determined the film 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 film | |
| 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 & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized symbol. The symbol is a representation of a human figure or figures, possibly suggesting care or support. The overall design is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2007
Tepha, Inc. % Ms. Mary P. LeGraw Sr. Dirctor, Regulatory Affairs 99 Hayden Avenue Lexington, Massachusetts 02421
Re: K072520
Trade/Device Name: TephaFLEX® Surgical Film Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, NWJ Dated: October 30, 2007 Received: October 31, 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 (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.
2
Page 2 - Mr. Andrew Barriskill
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Millman
- 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): K072520
TephaFLEX® Surgical Film Device Name:
Indications for Use:
TephaFLEX® Surgical Film is intended for temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
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
Division of Ger and Neurologic
510(k) Number K072520