(66 days)
Not Found
No
The description focuses on the material properties and construction of a surgical mesh, with no mention of AI or ML.
Yes
The device is described as being used for the repair of abdominal wall hernia and uterological prolapse, which are therapeutic interventions.
No
The device is a surgical mesh used for the repair of hernias and other fascial deficiencies; it is a support material, not a diagnostic tool.
No
The device description clearly states it is a "non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene," indicating it is a physical hardware device, 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 the device is for the repair of hernias and fascial deficiencies. This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details a surgical mesh made of polypropylene, designed to be implanted in the body for structural support.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, uterological prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
Product codes
OTO, OTP
Device Description
Minimesh® is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Minimesh® polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling. Minimesh® polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall, uterological
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
Accelerated and real time stability studies have been conducted and support use of a three year expiration date for the product. The results of these studies demonstrate that Minimesh® polypropylene mesh, when stored under the conditions specified in the product labeling, can be used safely and effectively throughout this dating period (see Addendum A).
Key Metrics
Not Found
Predicate Device(s)
K041632 Minimesh® polypropylene mesh
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
K053361
Page 1 of 2
FEB 6 2006
MPATHY MEDICAL DEVICE:5 L. D. SPECIAL 5 : O(K) 05 336 1 : Modificiation
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| SUBMITTER | Mpathy Medical Devices, Ltd.
6.05 Kelvin Campus
West of Scotland Science Park
Glasgow G20 OSP
U.K. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Louis J. Mazzarese
(U.S. Agent for Mpathy Medical Devices Ltd.) |
| DATE PREPARED | January 30, 2006 |
| CLASSIFICATION | Polymeric Surgical Mesh (Product Code OTO) is a Class II device
per 21 CFR 878.3300 |
| COMMON NAME | Polymeric Surgical Mesh |
| PROPRIETARY NAME | Minimesh® polypropylene mesh |
| PREDICATE DEVICES | K041632 Minimesh® polypropylene mesh |
| DEVICE DESCRIPTION | Minimesh® is a non-absorbable polypropylene mesh constructed
from knitted monofilaments of extruded polypropylene. |
| | Minimesh® polypropylene mesh is constructed using a warp-knit
process to a unique design that permits the mesh to be cut into any
desired shape or size without unraveling. |
| | Minimesh® polypropylene mesh has the necessary strength,
flexibility, durability and surgical adaptability. These properties
permit the correct adaptation to the various stresses encountered in
the body. |
| | The device is supplied sterile. |
| INDICATIONS FOR USE | Minimesh® polypropylene mesh may be used for the repair of
abdominal wall hernia, including inguinal, femoral, and incisional,
uterological prolapse and other fascial deficiencies that require
support material. It may be used in open or laparoscopic
abdominal procedures or for repair by the vaginal route. |
Replacement Page 16 of 18 January 30, 2006
MINIME SHO®
1
K053361
Page 2 g2
MPATHY MEDICAL DEVICES I... D SPECIAL 5 1 O(K) 05:3361 : Modification
510(k) SUMMARY OF SAFETY & EFFECTIVENESS (Cont'd.)
TESTING
Accelerated and real time stability studies have been conducted and support use of a three year expiration date for the product. The results of these studies demonstrate that Minimesh® polypropylene mesh, when stored under the conditions specified in the product labeling, can be used safely and effectively throughout this dating period (see Addendum A).
Additional Page 16A of 18 January 30, 2006
MINIME SHI®
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are rendered in a thick, black line. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mpathy Medical Devices Ltd. % Mr. Louis J. Mazzarese Designated U.S. Agent 150 Aran Hill Road FAIRFIELD CT 06824
SEP 2 8 2012
K053361 Re: Trade/Device Name: Minimesh® polypropylene mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO, OTP Dated: January 5, 2006 Received: January 10, 2006
Dear Mr. Mazzarese:
This letter corrects our substantially equivalent letter of February 6, 2006.
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
3
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.
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" (21 CFR 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.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Perkins
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
MPATHY MEDICAL. DEVICES LTD. SPECIAL 510(K): MODIFICATION
Indications for Use
210(k) Number: ان جي جي جي جي
Device Name: Mpathy Medical Devices Ltd Minimesh® polypropylene mesh
Indications for Use:
MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, uterological prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
| Prescription Use | X |
|---|---|
| (Part 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 OF NEEDED)
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K053361 |
Page 14 of 18
MINIMESH®
Page 14 of 18