The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Device Description

The I-STOP Device is comprised of a non-resorbable polypropylene material woven into a mesh with each end attached to a polyethylene clip, two technique-dependant stainless steel implantation needles and two polycarbonate needle handles. The device is EtO sterilized and intended for single-use only.

AI/ML Overview

This document describes a 510(k) premarket notification for the I-STOP™ Mid-Urethral Sling, asserting its substantial equivalence to a predicate device, the Tension Free Vaginal Tape (TVT) System.

Based on the provided text, the device's acceptance criteria and the study proving it meets these criteria are not explicitly defined in a quantitative manner typical for AI/ML device evaluations. This is a traditional medical device submission, not an AI/ML device submission, and therefore, the information requested for AI/ML performance metrics (such as sample sizes for test/training sets, ground truth methodology, expert qualifications, adjudication methods, or MRMC studies) is largely not applicable and not present in the given text.

The document focuses on demonstrating substantial equivalence to an existing predicate device based on technological characteristics and intended use, rather than presenting a performance study with acceptance criteria often seen for novel AI/ML diagnostics.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the regulatory standard of "substantial equivalence" to the predicate device. This means the new device must be as safe and effective as the predicate. The "reported device performance" is qualitative and based on clinical experience and biocompatibility testing rather than specific quantitative metrics.

Acceptance Criteria Category (Implied by Substantial Equivalence)	Reported Device Performance (from text)
Intended Use Equivalence	"The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD)." - Matches predicate's likely intended use.
Technological Characteristics Equivalence	"The new and predicate devices are technologically the same; they are polypropylene meshes implanted with stainless steel needles to provide urethral support for females patients with SUI." "The devices have similar implantation, sterilization, and storage requirements."
Safety	"Clinical experience with the I-STOP device has demonstrated that it successfully and safely functions as intended. Additional biocompatibility testing supports the safety profile of the I-STOP Sling."
Effectiveness	"Clinical experience with the I-STOP device has demonstrated that it successfully and safely functions as intended."
No new questions of safety or effectiveness	"In the few instances where the devices differ, no additional concerns about safety or effectiveness are raised."

Study Details (as inferable from the text, primarily noting absence of AI/ML specific details)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "Clinical experience with the I-STOP device" but does not provide details on the sample size, study design (retrospective/prospective), or data provenance for any specific clinical test set. This type of detail is not typically required for a 510(k) submission based on substantial equivalence when performance is demonstrated qualitatively and through biocompatibility.
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):
- Not applicable/Not specified. This is not an AI/ML diagnostic device where a ground truth for a test set would be established by experts in this manner. The performance is based on clinical outcomes and engineering principles.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. As above, this concept pertains to AI/ML evaluations for diagnostic accuracy.
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:
- No. This is a surgical implant device, not an AI-assisted diagnostic tool. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "truth" for this medical device's performance would be considered clinical outcomes data (success/failure in treating SUI, safety profile, absence of significant complications) and biocompatibility testing results. Specific details on how this "truth" was collected or adjudicated are not provided in this summary.
The sample size for the training set:
- Not applicable/Not specified. This device does not involve a "training set" in the AI/ML sense.
How the ground truth for the training set was established:
- Not applicable/Not specified. As above, no training set for AI/ML.

In summary, the provided document is a 510(k) submission for a non-AI surgical implant, focusing on regulatory substantial equivalence. It does not contain the detailed quantitative performance study information, expert qualifications, or ground truth methodologies typically associated with AI/ML diagnostic or assistive devices. The regulatory approval is based on the device's similarity to an already approved predicate device and general safety/effectiveness demonstrated through clinical experience and biocompatibility.

Summary

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Uroplasty, Inc. Premarket Notification [510(k)] Submission I-STOP™ Mid-Urethral Sling

OCT 1 7 2005

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K052175

Section 8: 510(k) Summary

Date Prepared	August 9, 2005
New Device Name	I-STOP™ Mid-Urethral Sling
Predicate Device	Tension Free Vaginal Tape (TVT) System; Ethicon, Inc. (K974098)
Contact	Uroplasty, Inc.2718 Summer Street NEMinneapolis, MN 55413-2820Telephone: (612) 378-1180, Facsimile: (612) 378-2027info.usa@uroplasty.com

Intended Use

The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Device Description

Indications Statement

The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency. Four different I-STOP models allow for implantation of the I-STOP mesh via retropublic (transvaginal or suprapubic) or transobturator (outside-in or inside-out) approaches.

Technological Characteristics

The new and predicate devices are technologically the same; they are polypropylene meshes implanted with stainless steel needles to provide urethral support for females patients with SUI. The devices have similar implantation, sterilization, and storage requirements. In the few instances where the devices differ, no additional concerns about safety or effectiveness are raised.

Performance

Clinical experience with the I-STOP device has demonstrated that it successfully and safely functions as intended. Additional biocompatibility testing supports the safety profile of the I-STOP Sling.

Conclusion

The I-STOP Mid-Urethral Sling is substantially equivalent to the predicate device, the Tension Free Vaginal Tape (TVT) from Ethicon, Inc. (K974098).

CONFIDENTIAL

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Michael Morrell, RAC Director of Regulatory Affairs SEP 2 8 2012 Uroplasty, Inc. 2718 Summer Street NE MINNEAPOLIS MN 55413

Re: K052175 Trade/Device Name: I-STOPTM Mid-Urethral Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: August 9, 2005 Received: August 11, 2005

Dear Mr. Morrell:

This letter corrects our substantially equivalent letter of October 17, 2005.

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/CDRH0ffices/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

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PREMARKET NOTIFICATION [510(k)] SUBMISSION I-STOP" MID-URETHRAL SLING

Indication for Usc Statement

510(k) Number:	K052175
New Device Name:	I-STOP™ Mid-Urethral Sling
Indication for Use:	The I-STOP Mid-Urethral Sling is intended for the treatment of femalestress urinary incontinence (SUI) due to urethral hypermobility and/orintrinsic sphincter deficiency (ISD).

X Prescription Use (Per 21 CFR 801.109)

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

(Please do not write below this line. Continue on another page if needed)

Concurrence of CDRH, Olfice of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K052175

Regulation Number and Section

§ 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.