(165 days)
K00112, K90565, K91552
K00112, K90565, K91552
No
The description focuses on the material properties and construction of a surgical mesh, with no mention of AI or ML capabilities.
No
The device, TiMESH, is intended for the reinforcement of tissue during surgical repair of hernias and abdominal wall repair, which is a structural support function rather than a therapeutic one (e.g. treating a disease, restoring health, or alleviating symptoms).
No
The TiMESH is described as a non-absorbable polypropylene mesh intended for surgical reinforcement of tissue, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a non-absorbable polypropylene mesh, which is a physical hardware component, not software.
Based on the provided information, the TiMESH device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the TiMESH is for the "reinforcement of tissue during surgical repair" and is indicated for various types of hernias and abdominal wall repair. This describes a device used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a surgical mesh made of polypropylene, designed for implantation and tissue ingrowth. This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on biological samples to provide information about a person's health status. The TiMESH is a surgical implant used to physically repair tissue.
N/A
Intended Use / Indications for Use
The TiMESH/TiMESH-TC is specifically indicated for laparoscopic and open surgery for the repair of direct or indirect inguinal, femoral, umbilical, and incisional hernias; rectal, vaginal, and apical prolapses; and parietal reinforcement of tissues and abdominal wall repair. The TiMESH is specifically indicated for open surgery for the repair of direct or indirect inguinal and femoral hernias, pariental reinforcement of tissues, and abdominal wall repair. The TiMESH has the same indications as a combination of the predicate devices. TIMESH is a prescriptive device and should only be used by a licensed physician.
The TiMESH also known as TiMESH-TC is intended for the reinforcement of tissue during surgical repair. Specifically, the TiMESH is indicated for laparoscopic and open surgery for the repair of direct inguinal hernias, indirect inguinal hernias, femoral hernias, umbilical hernias, incisional hernias, parietal reinforcement of tissues and abdominal wall repair.
Product codes
FTL, OXJ
Device Description
TiMESH, also known as TiMESH-TC, hereinafter known as TiMESH/TiMESH-TC" is a non-absorbable polypropylene mesh constructed of warp knitted fabric made from monofilament polypropylene fibers with all around proprietary coating. The TiMESH is constructed using a warp-knit (not woven, not knitted) process.
This construction along with the proprietary coating allows the TiMESH to have the strength, flexibility, as well as durability and surgical adaptability to allow for necessary tissue ingrowth.
The TiMESH with its current construction provides for elasticity in all directions. The construction of the mesh permits the use of any size mesh without it's unraveling. The wetability allows for the proper adaptation of the mesh to various stresses that can be encountered in the body. The product is stenlized by using ethylene oxide gas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician / laparoscopic and open surgery
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)
The patient contact materials used in this device are common materials used in other medical devices as well as the predicate devices and have a long history of biocompatibility. This device complies with the requirements of AAMI/ANSI/ISO 10993, Biological Evaluation of Medical Devices". In addition, bench testing was conducted in accordance with the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K00112, K90565, K91552
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 2 9 2003
510(k) Summary
K031225
page 1/3
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is outlined below.
| Date Prepared: | April 12, 2003 (Revision 1 as of May 26, 2003) |
|---|---|
| Name of Submitter: | John E. Sawyer |
| Realistic Quality Solutions | |
| C/O: GfE Medizintechnik GmbH | |
| 6254 South 1280 East | |
| Salt Lake City, Utah 84121 | |
| (801) 685-7050 | |
| Realistic Quality Solutions has received authorization to submit this 510(k) on behalf of GfE Medizintechnik GmbH | |
| Device Proprietary Name: | TiMESH also known as TIMESH-TC |
| Classification Name: | Surgical Mesh per 21 CFR 878.3300 |
| Common/Usual Names: | Mesh, Metallic |
| Mesh, Non-Metallic | |
| Polypropylene (Absorbable Mesh) | |
| Polypropylene, (Non-Absorbable) Mesh | |
| Predicate Device: | The subject device has the same indications for use as the predicates. The main differences are; changes in the construction of the mesh and the coating of the mesh. |
| K00112
| 2 | Prolene Soft Mesh | Ethicon, Inc. |
|---|---|---|
| K90565 | ||
| 5 | NonAbsorbable | |
| Polypropylene Surgical | ||
| Mesh | United States | |
| Surgical Corp. | ||
| K91552 | ||
| 6 | Coated SURGIPRO | |
| Polypropylene Surgical | ||
| Mesh | United States | |
| Surgical Corp. |
PAGE 2-1 Revised
10
1
510(k) Summary (Continued)
K031225
Page 2/3
Device Description:
TiMESH, also known as TiMESH-TC, hereinafter known as TiMESH/TiMESH-TC" is a non-absorbable polypropylene mesh constructed of warp knitted fabric made from monofilament polypropylene fibers with all around proprietary coating. The TiMESH is constructed using a warp-knit (not woven, not knitted) process.
This construction along with the proprietary coating allows the TiMESH to have the strength, flexibility, as well as durability and surgical adaptability to allow for necessary tissue ingrowth.
The TiMESH with its current construction provides for elasticity in all directions. The construction of the mesh permits the use of any size mesh without it's unraveling. The wetability allows for the proper adaptation of the mesh to various stresses that can be encountered in the body. The product is stenlized by using ethylene oxide gas.
Intended Use:
The TiMESH/TiMESH-TC is specifically indicated for laparoscopic and open surgery for the repair of direct or indirect inguinal, femoral, umbilical, and incisional hernias; rectal, vaginal, and apical prolapses; and parietal reinforcement of tissues and abdominal wall repair. The TiMESH is specifically indicated for open surgery for the repair of direct or indirect inguinal and femoral hernias, pariental reinforcement of tissues, and abdominal wall repair. The TiMESH has the same indications as a combination of the predicate devices. TIMESH is a prescriptive device and should only be used by a licensed physician.
Indications Statement:
The TiMESH/TiMESH-TC The TiMESH, also known as TiMESH-TC, along with Ethicon Inc. Prolene Soft Mesh, U.S.S.C.'s NonAbsorbable Polypropylene Surgical Mesh and Coated SURGIPRO Polypropylene Surgical Mesh are intended to be used for the reinforcement of tissue during surgical repair. Thus, the TiMESH also known as TiMESH-TC mesh and all of the predicates have the same intended use. The TiMESH is specifically indicated for laparoscopic and open surgery for the repair of direct or indirect inguinal, femoral, umbilical, and incisional hernias; rectal, vaginal, and apical prolapses; and parietal reinforcement of tissues and abdominal wall repair.
PAGE 2-2 (Revised)
2
Page 3/3
510(k) Summary (Continued)
| Indications Statement Cont'd: | The TIMESH is specifically indicated for open surgery for the repair of direct or indirect inguinal and femoral hernias, parietal reinforcement of tissues, and abdominal wall repair. The TIMESH has the same indications as a combination of the predicate devices. TIMESH is a prescriptive device and should only be used by a licensed physician. |
|---|---|
| Technological Characteristics: | GfE Medizintechnik GmbH believes that the subject device is substantially equivalent to the predicate devices. The TIMESH/TIMESH-TC is constructed of the same materials as the predicate devices except for the coating. The Coating process allows the TIMESH to be more flexible than the predicates. |
| Performance Data: | The patient contact materials used in this device are common materials used in other medical devices as well as the predicate devices and have a long history of biocompatibility. This device complies with the requirements of AAMI/ANSI/ISO 10993, Biological Evaluation of Medical Devices". In addition, bench testing was conducted in accordance with the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh". |
| Conclusions: | Based on the information contained herein, we conclude that the changes are minor and that the subject device is substantially equivalent to the predicate devices. |
PAGE 2-3
Revised
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W(1)66-G609 Silver Spring, MI) 20993-0002
GfE Medizintechnik GmbH % Mr. John Sawyer President Realistic Quality Solutions 6254 South 1280 East Salt Lake City, Utah 84121
JUN 2 0 2012
Re: K031225
Trade/Device Name: TiMESH also known as TiMESH-TC Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, OXJ Dated: August 8, 2003 Received: August 12, 2003
Dear Mr. Sawyer:
This letter corrects our substantially equivalent letter of September 29, 2003
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
4
Page 2 - Mr. John Sawyer
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.
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/McdicalDevices/Safety/ReportaProblem/dcfault.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.htm.
Sincerely yours.
Jon
Mark N. Melkerson
Don No Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k): K031225
TIMESH Device Name:
- The TiMESH is intended for the reinforcement of Indications for Use: tissue during surgical repair. Specifically, the TiMESH is indicated for laparoscopic and open surgery for the repair of direct inguinal hernias, indirect inguinal hernias, femoral hernias, umbilical hernias, incisional hernias, parietal reinforcement of tissues and abdominal wall repair.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR Over the Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kune for MM
(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K031225