(21 days)
Not Found
No
The summary describes a surgical mesh device and its placement tools, with no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on substantial equivalence to predicate devices based on biocompatibility and mechanical testing.
Yes
The device is indicated for the surgical treatment of female urinary stress incontinence, which is a medical condition, making it a therapeutic device.
No.
The document describes a surgical mesh for treating urinary stress incontinence, not a device used to diagnose a medical condition. Its intended use is for surgical treatment, not diagnosis.
No
The device description explicitly states it is a surgical mesh supplied with ancillary tools, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Omnisure™ Urethral Sling is a surgical mesh intended to be implanted in the body to treat urinary incontinence. It is a physical device used in vivo (within the living body) during a surgical procedure.
- Intended Use: The intended use is for the surgical treatment of a medical condition, not for analyzing specimens to diagnose or monitor.
The description clearly indicates it's a surgical implant, not a device for testing biological samples.
N/A
Intended Use / Indications for Use
Omnisure™ Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes
OTN
Device Description
Omnisure™ Urethral Sling is a surgical mesh intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The proprietary mesh is supplied along with ancillary tools for placement of the device.
The device is supplied sterile.
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
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)
K073647, K011251, K013355, K021263, K020663, K974098, K091180
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.
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K092203
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MPATHY MEDICAL DEVICES, LTD. OMNISURE URETHRAL SLING SPECIAL 510(K) NOTIFICATION
15. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS
AUG 1 2 2009
SUBMITTER Ms Melissa Peloquin Director of Office Administration Mpathy Medical Devices Inc. 175 Paramount Drive Raynham, MA 02767
CONTACT PERSON Dr Caroline Stretton Quality & Regulatory Affairs Director Mpathy Medical Devices, Ltd. 208 Wright Business Centre Lonmay Road Glasgow G33 4EL (United Kingdom)
DATE PREPARED 22 July 2009
Surgical Mesh (Product Code OTN) is a Class II device CLASSIFICATION per 21 CFR 878.3300
COMMON NAME Surgical Mesh
Omnisure™ Urethral Sling PROPRIETARY
NAME
- PREDICATE DEVICE K073647 - Minitape® Extra Urethral Sling (Mpathy Medical Devices) K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K974098 - TVT (Ethicon) K091180 - Minitape® O Urethral Sling (Mpathy Medical Devices)
Omnisure™ Urethral Sling is a surgical mesh intended DEVICE DESCRIPTION to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The proprietary mesh is supplied along with ancillary tools for placement of the device.
The device is supplied sterile. Omnisure™ Urethral Sling is indicated for the surgical INDICATIONS treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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092203
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MPATHY MEDICAL. DEVICES, LTD. OMNISURE URETHRAL SLING SPECIAL 510(K) NOTIFICATION
TECHNOLOGICAL CHARACTERISTICS
Omnisure™ Urethral Sling has the same intended use, general design, material and fundamental scientific technology as the predicate Minitape Extra Urethral Sling (K073647).
TESTING
The components of the Omnisure™ device are substantially equivalent to the predicate Minitape® Extra device (K073647), which has been subjected to biocompatibility and mechanical testing.
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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 three lines representing its wings and body. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mpathy Medical Devices, Ltd. % Mpathy Medical Devices, Inc. Ms. Melissa Peloquin Director of Office Administration 175 Paramount Drive RAYNHAM MA 02767
SEP 2 8 2012
Re: K092203 Trade/Device Name: Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: July 22, 2009 Received: July 22, 2009
Dear Ms. Peloquin:
This letter corrects our substantially equivalent letter of August 12, 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
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,
Benjamin R. Perkins
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K092203
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MPATHY MEDICAL DEVICES, LTD. OMNISURE URETHRAL SLING SPECIAL 510(K) NOTIFICATION
14.STATEMENT FOR INDICATIONS FOR USE
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Omnisure™ Urethral Sling
Indications for Use: Omnisure™ Urethral Sling is indicated for the surgical mulcations for Ose. Onlinisale Growner urethral hypermobility and/or intrinsic sphincter deficiency.
Prescription Use: Yes
DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
Daniel Kianefa Mku
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092203
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