(64 days)
TephaFLEX® Surgical Film is intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, or gastrointestinal anatomy, 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. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
NOTE: The TephaFLEX Surgical Film is not intended to be placed transvaginally. The film should be placed abdominally when being used to reinforce soft tissues in the urological, gynecological or gastrointestinal anatomy.
TephaFLEX surgical film is intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, 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. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
Note: The TephaFLEX surgical mesh is not intended to be placed transvaginally The film should be placed abdominally when being used to reinforce soft tissues in the urological, gynecological or gastrointestinal anatomy
This looks like a 510(k) summary for a medical device (TephaFLEX® Surgical Film). Based on the provided text, the device is not an AI/ML powered device. Therefore, many of the requested fields (such as acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the safety and performance testing conducted for a traditional medical device prior to its 510(k) clearance by the FDA, demonstrating substantial equivalence to a predicate device.
Here's the information extracted from the provided text, focusing on the safety and performance aspects:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state specific numerical acceptance criteria for each test. Instead, it 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 reported performance is implicitly that the device met these recommendations and was found to be "substantially equivalent" to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with FDA surgical mesh guidance document | Mechanical testing, in vivo animal testing, and biocompatibility testing were performed as recommended in the FDA guidance document. |
| Comparative burst strength comparable to predicate(s) | "Comparative burst strength...was characterized." (Implied to be comparable or equivalent to predicate devices to achieve substantial equivalence). |
| Suture pull-out strength comparable to predicate(s) | "Suture pull-out strength...was characterized." (Implied to be comparable or equivalent to predicate devices to achieve substantial equivalence). |
| Tensile strength comparable to predicate(s) | "Tensile strength...was characterized." (Implied to be comparable or equivalent to predicate devices to achieve substantial equivalence). |
| Tear resistance strength comparable to predicate(s) | "Tear resistance strength...was characterized." (Implied to be comparable or equivalent to predicate devices to achieve substantial equivalence). |
| In vivo strength retention (via subcutaneous implantation study) | "In vivo strength retention was characterized via a subcutaneous implantation study." (Implied to be comparable or equivalent to predicate devices or acceptable for the intended use to achieve substantial equivalence). |
| Biocompatibility | "Biocompatibility testing...were performed based on recommendations identified in the FDA surgical mesh guidance document." (Implied to be acceptable for the intended use to achieve substantial equivalence). |
| Substantial Equivalence 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 under the Federal Food, Drug and Cosmetic Act." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text for any of the tests (mechanical, in vivo animal, or biocompatibility).
- Data Provenance: Not specified in the provided text. The in vivo study is described as a "subcutaneous implantation study" which implies a prospective animal study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This pertains to an AI/ML device where expert consensus is often used for ground truth. This is a traditional medical device submission based on physical and biological testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to expert assessment for AI/ML performance.
5. 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
- No. This is not an AI-powered device, and therefore no MRMC study with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical tests: The "ground truth" would be the direct measurements of burst strength, suture pull-out strength, tensile strength, and tear resistance, likely compared against a known standard or the predicate device's characteristics.
- For the in vivo animal study: The "ground truth" for strength retention would be the direct measurement of the device's remaining strength after a certain implantation period. Observations related to biocompatibility would likely be assessed through histological examination and other biological markers.
- For biocompatibility testing: The "ground truth" is established by standard biological assays and tests guided by ISO 10993 standards and FDA guidance, assessing phenomena like cytotoxicity, sensitization, irritation, genotoxicity, etc.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth associated with it in this context.
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K0916633
RAGE 1/1
99 Hayden Avenue Suite 360 Lexington, MA 02421 tel: (781) 357-1700 fax: (781) 357-1701
Image /page/0/Picture/2 description: The image shows the logo for TEPHA Medical Devices. The logo features a stylized graphic element above the text. The text "MEDICAL DEVICES" is printed in a smaller font size below the word TEPHA.
Section X Summary of Safety and Effectiveness (Prepared June 22, 2012)
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 |
| Contact Person: | Mary P. LeGraw, V.P., Regulatory Affairs |
| Device Classification Name: | CFR $878.3300 - OOD, PAJSurgical Mesh |
| Classification: | According to Section 13 of the Federal Food. Drug and Cosmetic Act, the deviceclassification is Class II, Performance Standards. |
| Predicate Devices: | Tepha, Inc. - TephaFLEX Surgical FilmTepha, Inc. - TephaFLEX Absorbable MeshMAST Biosurgery, Inc. - Surgi-Wrap Film |
| Device Description: | TephaFLEX surgical film is intended to be used wherever temporary woundsupport is required, to reinforce soft tissues where weakness exists in theurological, gynecological, or gastrointestinal anatomy, or for the repair of herniaor other fascial defects that require the addition of a reinforcing or bridgingmaterial to obtain the desired surgical result. The absorbable protective film alsomay help minimize the potential for tissue attachment to the device in case ofdirect contact with the viscera. |
| Note: The TephaFLEX surgical mesh is not intended to be placed transvaginallyThe film should be placed abdominally when being used to reinforce soft tissuesin the urological, gynecological or gastrointestinal anatomy | |
| Safety and Performance: | Mechanical testing, in vivo animal testing, and biocompatibility testing, wereperformed based on recommendations identified in the FDA surgical meshguidance document: The Guidance for the Preparation of a Pre-marketNotification Application for a Surgical Mesh. Specifically, comparative burststrength, suture pull-out strength, tensile strength and tear resistance strengthwas characterized. In vivo strength retention was characterized via asubcutaneous implantation study. |
| Conclusion: | Based on the indications for use, technological characteristics, and safety andperformance testing, the TephaFLEX surgical film has been shown to besubstantially equivalent to predicate devices under the Federal Food, Drug andCosmetic Act. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue
Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a blue abstract design that resembles an eagle or a human figure, with flowing lines suggesting movement or support.
Tepha, Incorporated % Ms. Mary P. LeGrew Vice President, Regulatory Affairs 99 Hayden Avenue, Suite 300 Lexington, Massachusetts 02421
AUG 2 4 2012
Re: K091633
Trade/Device Name: TephaFLEX® Surgical Film Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OOD, PAJ Dated: June 3, 2009 Received: June 4, 2009
4 2019
Dear Ms. LeGrew:
This letter corrects our substantially equivalent letter of August 7, 2009.
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 (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 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); 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.
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Page 2-Mary P. LeGrew
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.htm1
Sincerely yours,
cerely yours,
for
k N. Melkerson
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): K091633
TephaFLEX® Surgical Film Device Name:
Indications for Use:
TephaFLEX® Surgical Film is intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, or gastrointestinal anatomy, 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. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
NOTE: The TephaFLEX Surgical Film is not intended to be placed transvaginally. The film should be placed abdominally when being used to reinforce soft tissues in the urological, gynecological or gastrointestinal anatomy.
Prescription Use: X (21 CFR 801 Subpart D)
AND/OR
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 Kimefumm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091633
§ 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.