(64 days)
Not Found
Not Found
No
The summary describes a physical surgical film and its intended use, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to reinforce soft tissues, repair hernias, and provide temporary wound support, which are direct medical interventions to treat and manage physical conditions.
No
The device is a surgical film intended to provide temporary wound support, reinforce soft tissues, or repair defects, acting as a reinforcing or bridging material. It describes therapeutic and supportive uses, not diagnostic ones.
No
The device description clearly states it is a "surgical film" and mentions physical properties like "burst strength," "suture pull-out strength," "tensile strength," and "tear resistance strength," indicating it is a physical material, not software.
Based on the provided information, the TephaFLEX® Surgical Film is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside the body.
- TephaFLEX Surgical Film's Use: The description clearly states that the TephaFLEX Surgical Film is intended for surgical implantation within the body to provide temporary wound support, reinforce soft tissues, or repair defects. It is used inside the body during a surgical procedure.
The intended use, device description, and the nature of the performance studies (mechanical testing, in vivo animal testing, biocompatibility testing) all point to this being a surgically implanted medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OOD, PAJ
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological, gynecological, or gastrointestinal anatomy
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, in vivo animal testing, and biocompatibility testing, were 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.
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.
Not Found
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
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 360 | |
| Lexington, MA 02421 | |
| Telephone: 781.357.1700 | |
| Fax: 781.357.1701 | |
| Contact Person: | Mary P. LeGraw, V.P., Regulatory Affairs |
| Device Classification Name: | CFR $878.3300 - OOD, PAJ |
| 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: | Tepha, Inc. - TephaFLEX Surgical Film |
| Tepha, Inc. - TephaFLEX Absorbable Mesh | |
| MAST Biosurgery, Inc. - Surgi-Wrap Film | |
| Device Description: | 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 | |
| Safety and Performance: | Mechanical testing, in vivo animal testing, and biocompatibility testing, were |
| 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. | |
| 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
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.
2
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
3
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