Sparc System: Intended for the placement of pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and /or intrinsic sphincter deficiency.
Monarc®, Monarc® +, Monarc® C Systems: Intended for the placement of suburethral mesh for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and /or intrinsic sphincter deficiency.

Device Description

The Sparc, Monarc®, Monarc® +, and Monarc® C Systems are sterile, single use procedure kits that consist of two stainless steel, curved needle passers and a mesh sling assembly.

AI/ML Overview

This 510(k) summary (K081613) describes the Sparc System, Monarc® System, Monarc® + System, and Monarc® C System, which are surgical mesh devices intended for the treatment of female stress urinary incontinence (SUI). The submission focuses on demonstrating substantial equivalence to predicate devices based on biocompatibility and performance requirements.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of explicit acceptance criteria or detailed performance metrics. Instead, it makes a general statement: "The components of the Sparc, Monarc, Monarc +, and Monarc C Systems have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." This implies that the acceptance criteria were met by demonstrating equivalence to the predicate devices in these areas, but the specific metrics are not detailed in this summary.

Acceptance Criteria	Reported Device Performance
Biocompatibility requirements (Implicit: must be equivalent to predicate devices)	"The components... have been tested for biocompatibility... and found to be substantially equivalent to the predicate devices." (Specific test results or metrics are not detailed in this summary.)
Performance requirements (Implicit: must be equivalent to predicate devices for intended use)	"The components... have been tested for... performance requirements and found to be substantially equivalent to the predicate devices." (Specific performance metrics related to mechanical properties, mesh integrity, or other functional aspects for SUI treatment are not detailed in this summary.)

Sample size used for the test set and the data provenance:

The 510(k) summary does not provide any information about the sample size used for comparative testing or the data provenance (e.g., country of origin, retrospective/prospective). The statement suggests testing was performed on "components," which could imply bench testing rather than clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The submission relies on substantial equivalence to predicate devices based on non-clinical testing (biocompatibility and performance), not on establishing ground truth for a test set through expert review.
Adjudication method for the test set:

This information is not provided. Given the nature of the submission (substantial equivalence based on component testing), an adjudication method for a clinical test set would not typically be relevant or present.
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 information is not applicable as the device is a surgical mesh for stress urinary incontinence, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness metrics are present.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the device is a surgical mesh, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The concept of "ground truth" as typically applied in diagnostic or AI device evaluations is not directly applicable here. The "ground truth" in this context would implicitly be the established safety and efficacy of the predicate devices for their indicated uses, against which the new device components' biocompatibility and performance are compared. The summary does not detail the specific data or methods used to establish this "ground truth" for the predicates, though it would typically involve clinical data (outcomes data) and regulatory approvals of those predicates.
The sample size for the training set:

This information is not applicable as the device is not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established:

This information is not applicable as the device is not an AI/ML algorithm.

In summary, this 510(k) notification for surgical mesh devices primarily relies on demonstrating substantial equivalence to predicate devices through biocompatibility and in vitro performance testing of the components. It does not involve clinical studies with human participants, expert review of data, or AI/ML algorithm validation. Therefore, many of the requested details regarding clinical study design, expert involvement, and AI performance metrics are not relevant or provided in this type of submission.

Summary

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K081613

SEP 1 7 2008

Submitter:	American Medical Systems (AMS)10700 Bren Road WestMinnetonka, MN 55343
Contact Person:	Sarah PetersonPhone: 952.930.6431Fax: 952.930.5785
Device Common Name:	Surgical Mesh
Device Trade Name:	SPARCTM System, Monarc® System,Monarc® + System, and Monarc® C System
Device Classification/Classification Name:	Class II, 21 CFR Part 878.3300Surgical Mesh, polymeric (OTN)
Predicate Device:	SPARCTM System (K041948), Monarc® System,Monarc® + System, and Monarc® C System(K051530)
Indications for Use
Sparc System:	Intended for the placement of pubourethral sling for thetreatment of female stress urinary incontinence (SUI) resultingfrom urethral hypermobility and /or intrinsic sphincterdeficiency

510(k) Summary Statement

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Monarc®,Monarc® +,Monarc® CSystems:	Intended for the placement of suburethral mesh for thetreatment of female stress urinary incontinence (SUI) resultingfrom urethral hypermobility and /or intrinsic sphincterdeficiency.
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Device Description

The Sparc, Monarc®, Monarc® +, and Monarc® C Systems are sterile, single use procedure kits that consist of two stainless steel, curved needle passers and a mesh sling assembly.

Summary of Testing

The components of the Sparc, Monarc, Monarc +, and Monarc C Systems have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

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

SEP 2 8 20:2

American Medical Systems, Inc. % Ms. Sarah J. P. Meyer Regulatory Affairs Specialist 10700 Bren Road West MINNETONKA MN 55343

Re: K081613

Trade/Device Name: Sparc System, Monarc® System, Monarc® + System, and Monarc® C System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh

Regulatory Class: II Product Code: OTN Dated: September 4, 2008 Received: September 5, 2008

Dear Ms. Meyer:

This letter corrects our substantially equivalent letter of September 17, 2008.

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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K081613
pg 1 of 2

Indications for Use Statement

510(k) Number:(if known)
Device Name:	Monarc® System, Monarc® + System, and Monarc® CSystem
Indications For Use:	Intended for the placement of suburethral mesh forthe treatment of female stress urinary incontinence(SUI) resulting from urethral hypermobility and /orintrinsic sphincter deficiency.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number

`li 081 617

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Indications for Use Statement

510(k) Number: (if known)
Device Name:	Sparc System
Indications For Use:	Intended for the placement of pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and /or intrinsic sphincter deficiency.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Pecorative,
and Neur
510(k) Number L0811613

Page 3 of 3

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.