(17 days)
Not Found
Not Found
No
The device description focuses on the biological material and processing, with no mention of AI or ML.
No.
The device is a surgical mesh for repairing soft tissue deficiencies and pericardial structures, not for therapy in the sense of actively treating or curing a disease through therapeutic action. It serves as a structural component for repair.
No
The device description and intended use indicate it is a surgical mesh for repair and reconstruction of soft tissue, not for diagnosing medical conditions.
No
The device description clearly states that the device is a "bovine pericardium surgical mesh" 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 product is for surgical repair of tissues within the body (in vivo applications). IVDs are used to examine specimens taken from the body (in vitro) to provide information about a patient's health.
- Device Description: The description details a surgical mesh made from bovine pericardium, designed to be implanted in the body for structural support. This is consistent with a surgical implant, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, TUTOMESH® is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These products are indicated for use in general and plastic surgery applications. These products are intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
Product codes (comma separated list FDA assigned to the subject device)
79 FTL, FTM, MFX
Device Description
TUTOMESH® is a bovine pericardium surgical mesh processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. The TUTOMESH® device consists of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, it has a multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retains 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
pericardial structures, soft tissue (gastric, muscle flap, rectal, vaginal, pelvic floor, diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical)
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
RTI | BIOLOGICS
ADVANCING SCIENCE, SAFETY & INNOVATI
JUN 1 9 2008
Attachment 4: 510(K) Summary
May 30, 2008
Lisa Simpson Submitted by: RTI Biologics, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 x4326 Fax: 386-418-1627
Proprietary Names: TUTOMESH®
Surgical Mesh Common Name:
Product Code: 79 FTL, Orthopedics Panel
Code Section: 21 CFR 878.3300
Substantial Equivalence:
The TUTOMESH® device is substantially equivalent to predicate devices in materials, design, function, intended use and fundamental scientific technology.
Description:
TUTOMESH® is a bovine pericardium surgical mesh processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. The TUTOMESH® device consists of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, it has a multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue.
Intended Use:
These products are indicated for use in general and plastic surgery applications. These products are intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
Summary of Technological Characteristics: TUTOMESH® has materials, design and function equivalent to predicate devices.
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 a stylized eagle with its wings forming three curved lines. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2008
RTI Biologics, Inc. % Ms. Lisa Simpson Director of Regulatory Affairs 11621 Research Circle Alachua, Florida 32615
Re: K081538
Trade/Device Name: TUTOMESH® Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM, MFX Dated: May 30, 2008 Received: June 2, 2008
Dear Ms. Simpson:
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
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
Attachment 2: Indications for Use
510(k) Number (if known): KOG1538
Device Names: TUTOMESH®
Indications for Use:
These products are indicated for use in general and plastic surgery applications. These products are intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
Prescription Use X Over-The-Counter Use 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)
NeifRe Osde fdmxm
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number K081538