The MiniArc® Pro Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Device Description

The MiniAre Pro Sling System is designed to treat female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is comprised of a piece of polypropylene monofilament mesh with polypropylene self-fixating tips (anchors), a mid-line mark, and elongation feedback system. The elongation feedback system is attached to the sling intraoperative adjustment/tensioning and allows for objective measurement of sling elongation during the implant procedure. The sling is intended to remain in the body as a permanent implant with the polypropylene self-fixating tips providing short-term fixation prior to tissue in-growth. The elongation feedback system is intended to be removed prior to closure of the vaginal incision. The delivery tool (needle) is designed to interface with the self-fixating tips and deliver it to the obturator internus muscle, retaining the self-fixating tip until it is selectively released by the physician.

AI/ML Overview

The provided 510(k) summary for the MiniArc® Pro Single-Incision Sling System does not detail specific acceptance criteria or a study proving that the device meets those criteria in the traditional sense of a clinical trial for a novel AI or diagnostic device. Instead, this submission is for a medical device that is demonstrated to be substantially equivalent to a predicate device already on the market.

Therefore, the "acceptance criteria" here refers to the criteria used to establish substantial equivalence with the predicate device, and the "study" is the non-clinical testing performed to show that the new device meets its own product specifications and performance requirements, which are comparable to the predicate device.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance
Indications for Use: Identical to predicate device	"The MiniArc Pro Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD)." - Identical to Predicate K100807.
Fundamental Scientific Technology: Identical to predicate device	"Self fixation urethral mesh sling" - Identical to Predicate K100807.
Material Composition (Mesh, Self-Fixating Tip): Identical to predicate device	"Polypropylene, Type I monofilament" for both mesh and self-fixating tip. - Identical to Predicate K100807.
Design Characteristics (Midline Mark, Delivery Tool Handle/Needle, Procedure): Highly similar to predicate device	Midline Mark: "Printed, Blue". Delivery Tool Handle: "Polycarbonate with over-mold". Delivery Tool Needle: "Stainless Steel with molded barb guards". Procedure: "Transobturator-like approach". - Identical to Predicate K100807.
Packaging Materials/Configuration: Identical to predicate device	"PETG tray and Tyvek lid", "Single sterile barrier configuration". - Identical to Predicate K100807.
Sterilization Method/Sterility Assurance Level (SAL): Identical to predicate device	"EO with SAL > 10^-6". - Identical to Predicate K100807.
Product Specifications and Performance Requirements (Bench Testing): Meets specified performance.	Successfully completed: Sterilization, Shelf Life, Biocompatibility, Performance Testing (Bench: Feedback System Repeatability, Attachment, Dimensional, Removal Force, Stiffness), Performance Testing (Cadaver: Physician Questionnaire, Cadaver Evaluation). - Results demonstrate compliance with product specifications and performance requirements.

Study Details

Given this is a 510(k) for substantial equivalence to a predicate device, the "study" is primarily a non-clinical assessment rather than a traditional clinical trial.

Sample size used for the test set and the data provenance:
- Test Set (Non-Clinical): Not explicitly stated in terms of specific numbers for each test, but categories of testing are listed.
  - Bench Testing: Conducted to assess characteristics like "Feedback System Repeatability," "Feedback System Attachment," "Feedback System Dimensional," "Feedback System Removal Force," and "Feedback System Stiffness." The exact number of samples for each of these tests is not provided in the summary.
  - Cadaver Testing: Performed for "Physician Questionnaire" and "Cadaver Evaluation." The number of cadavers or physicians involved is not specified.
- Data Provenance: The testing was conducted internally or by contracted labs as part of the device development and submission process. The country of origin is implicitly the United States, given the submitter is American Medical Systems located in Minnetonka, MN, and the submission is to the FDA. The tests are retrospective in the sense that they were completed prior to the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cadaver Performance Testing: A "Physician Questionnaire" and "Cadaver Evaluation" were performed. This implies medical experts (physicians) were involved in evaluating the device's performance in a cadaveric setting. The exact number and their qualifications (e.g., years of experience, specialty) are not specified in the summary.
Adjudication method for the test set:
- For the non-clinical tests, the adjudication method is typically predefined pass/fail criteria for each test (e.g., within a specified range for dimensional, sufficient removal force). No specific adjudication method like "2+1" or "3+1" (common in human-reader studies) is described, as it's not applicable to bench or cadaver testing of device mechanics.
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 medical device (surgical sling system), not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable here. The device's performance is intrinsically linked to its physical properties and intended use by a surgeon.
The type of ground truth used:
- For Bench Testing: The ground truth is engineering specifications, validated test methods, and predefined acceptance criteria (e.g., material properties, dimensional tolerances, force measurements). These are objective and measurable.
- For Cadaver Performance Testing: The ground truth would be based on expert opinion and observations from qualified physicians regarding the ease of use, deployment, and overall performance of the device in a simulated anatomical environment (cadaver).
The sample size for the training set:
- Not applicable. This is a physical medical device, not an algorithm that requires a "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth establishment in this context.

Summary

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510(k) Summary As required by 21CFR 807.92(c)

510(k) Number: K121641

Date Prepared:

August 2, 2012

Submitter Information:

Submitter's Name/ Address:

American Medical Systems 10700 Bren Road W. Minnetonka, MN 55343

Contact Person:

Renee Mellum Sr. Regulatory Affairs Associate Tel: 952-930-6458 Fax: 952-930-5785 Renee. Mellum(a)AmericanMedicalSystems.com

Alternate Contact:

Josh Clarin Manager, Regulatory Affairs Tel: 952-939-7072 Fax: 952-930-5785 Josh. Clarin(@AmericanMedicalSystems.com

Device Information:

Trade Name: Common Name: Classification Name:

Class: Product Code: MiniArc® Pro Single-Incision Sling System Surgical Mesh Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Single-Incision Mini-Sling Class II / 21 CFR & 878.3300 PAH

Predicate Device:

MiniArc Precise Single-Incision Sling System (K100807)

Device Description:

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7 2012

SEP

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510(k) Summary As required by 21CFR 807.92(c)

Indications for Use:

Comparison to the Predicate Device:

The MiniArc Pro Single-Incision Sling System intended use and indication for use is identical to that of the predicate device. In addition, the MiniArc Pro Single-Incision Sling System utilizes many of the same materials, design principles and fundamental scientific technology as the predicate K100807.

Device Characteristic	Subject Device:MiniArc Pro	Predicate Device:MiniArc PreciseK100807
Indications for Use	The MiniArc Pro Single-Incision SlingSystem is intended for the placement of asub-urethral mesh for the treatment offemale stress urinary incontinence (SUI)resulting from urethral hypermobilityand/or intrinsic sphincter deficiency(ISD).	The MiniArc Precise Single-Incision SlingSystem is intended for the placement of asub-urethral mesh for the treatment offemale stress urinary incontinence (SUI)resulting from urethral hypermobilityand/or intrinsic sphincter deficiency (ISD).
Device DesignMesh Assembly:• Mesh	Polypropylene, Type I monofilament	Polypropylene, Type I monofilament
Device DesignMesh Assembly:• Self-Fixating Tip	Polypropylene, Type I monofilament	Polypropylene, Type I monofilament
Device DesignMesh Assembly:• Midline Mark	Printed, Blue	Printed, Blue
Device DesignDelivery Tool:• Handle	Polycarbonate with over-mold	Polycarbonate with over-mold
Device DesignDelivery Tool:• Needle, material	Stainless Steel with molded barb guards	Stainless Steel with molded barb guards
Device DesignFeedback System	Polypropylene aperture, backer plate,removal suture, removal tab	Not Present
FundamentalTechnology	Self fixation urethral mesh sling	Self fixation urethral mesh sling
Procedure	Transobturator-like approach	Transobturator-like approach
PackagingMaterials	PETG tray and Tyvek lid	PETG tray and Tyvek lid
PackagingConfiguration	Single sterile barrier configuration	Single sterile barrier configuration

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510(k) Summary As required by 21CFR 807.92(c)

Device Characteristic	Subject Device:MiniArc Pro	Predicate Device:MiniArc PreciseK100807
Sterilization	EO with SAL > $10^{-6}$	EO with SAL > $10^{-6}$

Summary of Non-Clinical Testing:

Bench testing was performed to support this submission. Results of the testing demonstrate that the MiniArc Pro Single-Incision Sling System meets product specification and performance requirements.

The following testing has been successfully completed:

Sterilization .
Shelf Life .
Biocompatibility ●
Performance Testing (Bench) .
- Feedback System Repeatability O
- Feedback System Attachment O
- Feedback System Dimensional O
- Feedback System Removal Force 0
- Feedback System Stiffness O
Performance Testing (Cadaver) �
- Physician Questionnaire 0
- Cadaver Evaluation O

Clinical Testing:

No clinical testing was performed to support this Traditional Premarket Application.

Statement of Equivalence:

The MiniArc® Pro Single-Incision Sling System has the identical indications for use and fundamental scientific technology as the predicate device. Based on this and the design and engineering data provided in the pre-market notification, the MiniArc® Pro Single-Incision Sling System has been shown to be substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

Ms. Renee Mellum Senior Regulatory Affairs Associate American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343

SEP 7 2012

Re: K121641

Trade/Device Name: MiniArc® Pro Single-Incision Sling System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: August 3, 2012 Received: August 7, 2012

Dear Ms. Mellum:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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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 n you attp://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" (21CFR 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 K. Fisher

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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Section 4 510(k) Number: TBD K121641

Device Name: MiniArc® Pro Single-Incision Sling System

Indications for Use:

The MiniArc Pro Single-Incision Sling System is intended for the placement of a suburethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Prescription Use X (Per 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aran Whang
(Division Sign Off)

Gastro-Renal, and 0(k) Number

MiniArc Pro Single-Incision Sling System American Medical Systems June 1, 2012

Confidential

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.