(83 days)
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.
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.
The provided text describes the regulatory clearance of a medical device, TephaFLEX® Surgical Film, through the 510(k) pathway. This pathway establishes substantial equivalence to a predicate device, rather than proving a device meets specific, quantitative acceptance criteria through a standalone study with a test set.
Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this document. The document focuses on demonstrating that TephaFLEX® Surgical Film is as safe and effective as existing legally marketed devices.
Here's an analysis based on the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present quantitative acceptance criteria (e.g., a specific tensile strength value that must be met) in the way one might find for a software algorithm or a diagnostic test. Instead, the "acceptance criterion" for 510(k) clearance is "substantial equivalence" to predicate devices. The performance is reported in terms of this equivalence:
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Mechanical strengths substantially equivalent to predicate devices under indication for use conditions. | "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." |
| Safety and effectiveness comparable to predicate devices. | "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..." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document refers to "Physical and in vivo animal testing." The exact number of films tested or animals used is not provided.
- Data Provenance: The testing appears to have been conducted by Tepha, Inc. ("Physical and in vivo animal testing was performed on the TephaFLEX surgical film"). The country of origin and whether it was retrospective or prospective are not specified, though in vivo animal testing would be prospective in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The "ground truth" in this context is the performance characteristics of the predicate devices, which were established prior to this submission. The comparison is against those established characteristics, not against a newly generated expert-derived ground truth for the TephaFLEX film itself.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" in the sense of a set of cases requiring adjudication. The comparison was based on physical and animal tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is typically performed for diagnostic devices or AI algorithms where human interpretation is involved. TephaFLEX® Surgical Film is a physical implantable device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Yes, in a sense. The "physical and in vivo animal testing" represents standalone performance evaluation of the device itself, separate from any human-in-the-loop interaction for its evaluation. It's not an algorithm, so "algorithm only" isn't the right terminology, but the device's inherent properties were tested directly.
7. The Type of Ground Truth Used
The "ground truth" used for comparison was the established mechanical strengths and safety/effectiveness profiles of the predicate devices:
- MAST Biosurgery, Inc. - Surgi-Wrap Film
- OsteoBiologics, Inc. -- PlastiFIIm
- Tepha, Inc. - TephaFLEX Absorbable Mesh
The TephaFLEX Surgical Film's performance was measured and compared against these existing devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
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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 360Lexington, MA 02421Telephone: 781.357.1700Fax: 781.357.1701 |
| Device Classification Name: | CFR §878.3300Surgical Mesh |
| Classification: | According to Section 13 of the Federal Food, Drug and CosmeticAct, the device classification is Class II, Performance Standards. |
| Predicate Devices: | MAST Biosurgery, Inc. - Surgi-Wrap FilmOsteoBiologics, Inc. -- PlastiFIImTepha, Inc. - TephaFLEX Absorbable Mesh |
| Device Description: | TephaFLEX surgical film is intended for temporary woundsupport, to reinforce soft tissues where weakness exists, or forthe repair of hernia or other fascial defects that require theaddition of a reinforcing material to obtain the desired surgicalresult. The absorbable protective film also may help minimize thepotential tissue attachment to the device in case of direct contactwith the viscera. |
| Safety and Performance: | Physical and in vivo animal testing was performed on theTephaFLEX surgical film which determined the film to besubstantially equivalent to the mechanical strengths of thepredicate devices under indication for use conditions. |
| Conclusion: | Based on the indications for use, technological characteristics,and safety and performance testing, the TephaFLEX surgical filmhas been shown to be substantially equivalent to predicatedevices 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 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.
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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
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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)
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Division of Ger and Neurologic
510(k) Number K072520
§ 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.