(21 days)
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.
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.
The provided text describes a 510(k) premarket notification for the "Omnisure™ Urethral Sling" by Mpathy Medical Devices, Ltd. This submission is for a surgical mesh, which is a physical device, not a digital health product or an AI/ML-driven device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of device performance metrics like sensitivity, specificity, or AUC, as commonly applied to AI/ML devices, is not directly applicable here.
Instead, for a physical medical device like a surgical mesh, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device. This typically involves showing that the new device has the same intended use, technological characteristics (materials, design, fundamental scientific technology), and performs comparably in terms of safety and effectiveness.
Here's how the provided information addresses your request, framed within the context of a physical medical device:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly list "acceptance criteria" in the quantitative sense of an AI/ML device. Instead, the core "acceptance criterion" for a 510(k) is substantial equivalence to a legally marketed predicate device.
| Acceptance Criterion (for 510(k) Substantial Equivalence) | Reported Device Performance/Comparison |
|---|---|
| Intended Use (same as predicate) | "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." This matches the general indications for the predicate devices. |
| Technological Characteristics (same as predicate) | "Omnisure™ Urethral Sling has the same intended use, general design, material and fundamental scientific technology as the predicate Minitape® Extra Urethral Sling (K073647)." |
| Safety and Effectiveness (comparable to predicate) | "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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided documents do not detail a "test set" in the context of a clinical performance study with a specific sample size. For a 510(k) of this nature, clinical studies with detailed sample sizes and data provenance are often not required if substantial equivalence can be demonstrated through other means (e.g., comparison of materials, design, and non-clinical testing). The key testing mentioned is "biocompatibility and mechanical testing" which are laboratory-based and do not typically involve human "test sets" with specified provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this 510(k) submission. "Ground truth" in the context of AI/ML evaluation (established by experts) is not relevant for demonstrating substantial equivalence of a physical surgical mesh.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this 510(k) submission as there is no mention of a "test set" requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. MRMC studies are specific to evaluating diagnostic devices, particularly those involving human interpretation, often with AI assistance. This submission is for a surgical mesh, not a diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for demonstrating safety and effectiveness is typically established through:
- Predicate device's safety and effectiveness history: The predicate devices (Minitape® Extra Urethral Sling, SPARC Sling System, TVT) have established safety and effectiveness through their prior market clearance and clinical use.
- Non-clinical testing: "biocompatibility and mechanical testing" for the Omnisure™ device itself, demonstrating that its properties are comparable to the predicate.
- Clinical experience (if any) with similar materials/designs: Implied by the substantial equivalence argument, leveraging existing knowledge of surgical meshes.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/ML algorithm requiring a training set.
In summary: The provided 510(k) notification for the Omnisure™ Urethral Sling demonstrates that it meets the "acceptance criteria" (i.e., criteria for substantial equivalence to a predicate device) by asserting that it has the same intended use, general design, material, and fundamental scientific technology as the predicate device (Minitape® Extra Urethral Sling, K073647). This claim is supported by the fact that the components of the Omnisure™ device have undergone biocompatibility and mechanical testing to confirm their equivalence to the predicate. The FDA's issuance of the substantial equivalence letter (K092203) signifies that the device has met these regulatory "acceptance criteria."
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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
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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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§ 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.