(133 days)
Not Found
Not Found
No
The description focuses on the material properties and intended use of a surgical mesh, with no mention of AI or ML technologies.
Yes
The device is intended for implantation to repair, reinforce, and/or supplement soft tissue for various medical conditions, including defects, prolapse, and hernias, which directly contributes to the treatment or restoration of health.
No
This device is described as an implant for repairing, reinforcing, and supplementing soft tissue, and is processed pericardium surgical mesh. Its intended use is therapeutic (repair of defects), not diagnostic (identifying or characterizing disease).
No
The device description clearly states it is a "surgical mesh device" made from "borne pericardium," which is a physical, implantable material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for implantation to repair, reinforce, and supplement soft tissue in various surgical applications. This involves direct interaction with the patient's body during surgery.
- Device Description: The description details a surgical mesh made from processed animal tissue, designed to be implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body for structural repair.
N/A
Intended Use / Indications for Use
This device is intended for implantation to repair, reinforce and/or supplement soft tissue. This device is indicated for use in general and plastic surgery applications. This device is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include but are not limited to: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including but not limited to diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
These are borne pericardium surgical mesh devices processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. These devices consist of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, they have multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retain the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue; pericardial structures; abdominal and thoracic wall; pelvic floor
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)
Not Found
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
ADVANCING SCIENCE, SAFETY & INNOVATION
Attachment 6: 510(K) Summary
AUG 31 2009
| Submitted by: | Lisa Simpson |
|---|---|
| RTI Biologics, Inc. | |
| 11621 Research Circle | |
| Alachua, FL 32615 | |
| Phone: 386-418-8888 x4326 | |
| Fax: 386-418-1627 |
TUTOMESH®, TUTOPATCH® Proprietary Names:
Common Name: Surgical Mesh
FTM, General & Plastic Surgery Panel Product Code:
Code Section: 21 CFR 878.3300
Substantial Equivalence:
The proposed devices are substantially equivalent to predicate devices in materials, design, function, intended use and fundamental scientific technology.
Description:
These are borne pericardium surgical mesh devices processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. These devices consist of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, they have multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retain the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue.
Intended Use:
This device is intended for implantation to repair, reinforce and/or supplement soft tissue.
This device is indicated for use in general and plastic surgery applications. This device is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include but are not limited to: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including but not limited to diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
Summary of Technological Characteristics:
The proposed device has materials, design and function equivalent to predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
2009 SEP 9
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
RTI Biologics, Inc. % Mr. Travis Arola Regulatory Affairs Manager 11621 Research Circle, P.O. Box 2650 Alachua, Florida 32616
Re: K091142
Trade/Device Name: TUTOPATCH®, and TUTOMESH® Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: August 31, 2009 Received: August 31, 2009
Dear Ms. Simpson:
This letter corrects our substantially equivalent letter of August 31, 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 - Mr. Travis Arola
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Saubare Buchner
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
3
KO3ii4z
Attachment 3: Indications for Use
510(k) Number (if known):
Device Names: TUTOPATCH® TUTOMESH®
Indications for Use:
This device is intended for implantation to repair, reinforce and/or supplement soft tissue.
Prescription Use Over-The-Counter Use ਮ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Daniel Kranbu mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number: K091142