(154 days)
Not Found
No
The device description focuses on the material properties and construction of a surgical mesh, with no mention of AI or ML technologies.
Yes
The device is described as a mesh used for the repair of abdominal wall hernia and other fascial deficiencies, indicating its use in treating a medical condition.
No
The device description indicates it is a surgical mesh used for repairing hernias and fascial deficiencies, which is a treatment, not a diagnostic, function.
No
The device description clearly states it is a physical mesh constructed from knitted monofilaments of extruded polypropylene, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of hernias and fascial deficiencies, which are surgical procedures performed in vivo (within the body).
- Device Description: The device is a surgical mesh made of polypropylene, designed to provide structural support within the body.
- 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 to perform tests in vitro (outside the body) on 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 uterovaginal 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
DTO, 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.
It maintains excellent isotropic properties arising from its knitted construction.
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, inguinal, femoral, incisional uterovaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician
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
In addition appropriate tests have been conducted in accordance with the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh"
Key Metrics
Not Found
Predicate Device(s)
K001122, K905655, K020110, K013718
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
NOV 17 2004
Mpathy Medical Devices, Ltd. 510(k) Notification
KO41632
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| SUBMITTER | Mpathy Medical Devices, Ltd.
6.05 Kelvin Campus
West of Scotland Science Park
Glasgow G20 0SP
U.K. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Louis J. Mazzarese
(U.S. Agent for Mpathy Medical Devices Ltd.) |
| DATE PREPARED | 14 June 2004 |
| CLASSIFICATION | Polymeric Surgical Mesh (Product Code DTO) is a Class II
device per 21 CFR 878.3300 |
| COMMON NAME | Polymeric Surgical Mesh |
| PROPRIETARY NAME | Minimesh® polypropylene mesh |
| PREDICATE DEVICES | K001122 - Prolene® (Ethicon, Inc.)
K905655 – Non-Absorbable Polypropylene Surgical Mesh
(United States Surgical Corp)
K020110 - Surgical Mesh (Boston Scientific Corporation)
K013718 - Gynecare Gynemesh PS® (Ethicon Inc) |
| 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.
It maintains excellent isotropic properties arising from its knitted construction.
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. |
Minimesh®
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1
Mpathy Medical Devices, Ltd. 510(k) Notification
INTENDED USE
Minimesh® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal 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.
Minimesh® polypropylene mesh is a prescriptive device and should only be used by a licensed physician.
Minimesh® polypropylene mesh has the same indications as a combination of the predicate devices.
The patient contact materials used in this device are the same TESTING materials as the predicates detailed. Polypropylene has a long history of biocompatibility.
Minimesh polypropylene mesh complies with the requirements of ISO 10993 Biological Evaluation of Medical Devices. In addition appropriate tests have been conducted in accordance with the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh"
Minimesh®
Page 17 of 20
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the agency's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2012
Mypathy Medical Devices, Ltd. % Mr. Louis J. Mazzarese 150 Aran Hill Road FAIRFIELD CT 06824
Re: K041632 Trade/Device Name: Mpathy Medical Devices Ltd Minimesh® polypropylene mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO, OTP Dated: October 13, 2004 Received: October 14, 2004
Dear Mr. Mazzarese:
This letter corrects our substantially equivalent letter of November 17, 2004.
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
Page 2 -
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. 510(k) Notification
Indications for Use
510(k) Number :
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 uterovaginal 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)
Muriam C. Provost
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K041632
Minimesh®
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