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 + and 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 device is a sterile, single use procedure kit consisting of: Two stainless steel, curved, 21-cm long, needle passers. One end of each . needle passer is keved to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. One piece of AMS Polypropylene sling mesh with attached connectors. The AMS . Polypropylene sling mesh is constructed of polypropylene monofilament that is precut to 1.1 cm width x 50 cm length. An absorbable tensioning suture is threaded into the length of the sling mesh to allow for tensioning adjustment of the sling mesh after placement in the patient is achieved. Two plastic sheaths that overlap in the center of the sling mesh cover the sling mesh and protect it during placement. The connectors are attached to the vaginal ends of the Sparc needle passers during the procedure. The AMS Polypropylene sling mesh is intended to remain in the body as a permanent implant and the mesh component is not absorbed or degraded by the action of tissue ingrowth or tissue enzymes.

The Monarc devices are sterile, single use procedure kits, each consisting of: Two stainless steel, curved needle passers. The tip portion of each needle . passer is configured to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. An assembly including one piece of loosely knitted polypropylene mesh, two . removable plastic insertion sheaths attached to the mesh, and two connectors attached to the insertion sheaths. The mesh is constructed of polypropylene monofilament. An absorbable tensioning suture is threaded into the length of the mesh to allow for tensioning adjustment of the mesh after placement in the patient is achieved. The plastic covering also affords convenient travel of the mesh through the tissue. The connectors are attached to the tip portions of the Monarc needle passers during the procedure. The loosely knitted polypropylene mesh is intended to remain in the body as a permanent implant. The mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.

AI/ML Overview

This document is a 510(k) summary for a medical device (Sparc™ Sling System and Monarc™, Monarc™ + and Monarc™ C Subfascial Hammock Systems). It is a regulatory submission for demonstrating substantial equivalence to a predicate device, not a study demonstrating device performance against specific acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not available within this document. The document primarily focuses on establishing that the proposed device is substantially equivalent to a previously cleared predicate device, meaning it has the same intended use, technological characteristics, and safety/effectiveness profile.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Not applicable. This document does not present a table of acceptance criteria or new device performance data. The basis of this 510(k) is that the "Proposed Device Description" and "Summary of the Technical Characteristics Compared to the Predicate Device(s)" state: "All characteristics of the proposed device are identical to those of the predicate, including design, material construction, manufacturing process, and intended use. There is no change to the technical characteristics for this 510(k)." This implies that the acceptance criteria and performance are presumed to be the same as the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not applicable. No new clinical or performance test set is described. This device is cleared based on substantial equivalence to a predicate, not new performance testing against a test set.

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):

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No test set or adjudication method is described.

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:

Not applicable. This document is for a surgical mesh system for SUI, not an AI software/device. Therefore, MRMC studies or AI involvement are irrelevant and not discussed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. No ground truth for device performance is described as this is a substantial equivalence submission, not a de novo performance study.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established:

Not applicable. No training set or ground truth for it is relevant or described.

Summary based on the provided text:

This 510(k) submission for the Sparc™ Sling System and Monarc™, Monarc™ + and Monarc™ C Subfascial Hammock Systems does not contain a study proving that the device meets specific acceptance criteria via new performance data. Instead, it relies on the principle of substantial equivalence to a previously cleared predicate device (Sparc Sling System and Monarc, Monarc + and Monarc C Subfascial Hammock device; K081613). The document explicitly states that the proposed device is identical in all characteristics (design, material, manufacturing, and intended use) to its predicate. Therefore, its safety and effectiveness are considered to be equivalent to the predicate, and no new performance studies are presented or required for this type of submission.

Summary

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	510(k) Summary
Date Prepared:	November 1, 2013
Submitter's Name/ Address:	American Medical Systems, Inc.10700 Bren Road WestMinnetonka, MN 55343	DEC 0 5 2013
Owner/Operator	American Medical Systems, Inc.10700 Bren Road WestMinnetonka, MN 55343Establishment Registration Number: 2183959
Manufacturing Site	American Medical Systems Ireland Ltd.Athlone Business and Technology Park, Unit AGarrycastle, Dublin RoadAthlone, Co. WestmeathIrelandFDA Establishment Registration Number: 3009433692
Sterilization	Synergy Heath Ireland Ltd.IDA Business & Technology ParkSraghTullamoreCo. OffalyIrelandFDA Establishment Registration Number: 3002807314

Submission Contact Information:

Primary Contact:	David H. MuellerPrincipal Regulatory Affairs SpecialistTelephone: (952)930-6577Fax Number: (952)939-5785David. Mueller@AMMD.com
Alternate Contact:	Melanie HessDirector, Regulatory AffairsTelephone: (952)939-6094Fax Number: (952)939-5785Melanie. Hess@americanmedicalsystems.com

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Proposed Device:

Device Proprietary Name:	Sparc™ Sling System and Monarc™, Monarc™ + and
	Monarc™ C Subfascial Hammock
Common Name:	Surgical Mesh
Classification Name:	Surgical Mesh, polymeric
Class:	Class II / 21 CFR 878.3300
Product Code:	OTN

Predicate Devices:

Sparc Sling System (Sparc) and Monarc, Monarc + and Monarc C Subfascial Hammock (Monarc) device; K081613

Proposed Device Description:

The Sparc and Monarc related device descriptions are as followed:

The Sparc device is a sterile, single use procedure kit consisting of:

Two stainless steel, curved, 21-cm long, needle passers. One end of each . needle passer is keved to allow for secure placement of the connectors. Each needle passer has a plastic handle attached.
One piece of AMS Polypropylene sling mesh with attached connectors. The AMS . Polypropylene sling mesh is constructed of polypropylene monofilament that is precut to 1.1 cm width x 50 cm length. An absorbable tensioning suture is threaded into the length of the sling mesh to allow for tensioning adjustment of the sling mesh after placement in the patient is achieved. Two plastic sheaths that overlap in the center of the sling mesh cover the sling mesh and protect it during placement. The connectors are attached to the vaginal ends of the Sparc needle passers during the procedure. The AMS Polypropylene sling mesh is intended to remain in the body as a permanent implant and the mesh component is not absorbed or degraded by the action of tissue ingrowth or tissue enzymes.

The Monarc devices are sterile, single use procedure kits, each consisting of:

Two stainless steel, curved needle passers. The tip portion of each needle . passer is configured to allow for secure placement of the connectors. Each needle passer has a plastic handle attached.
An assembly including one piece of loosely knitted polypropylene mesh, two . removable plastic insertion sheaths attached to the mesh, and two connectors attached to the insertion sheaths. The mesh is constructed of polypropylene

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monofilament. An absorbable tensioning suture is threaded into the length of the mesh to allow for tensioning adjustment of the mesh after placement in the patient is achieved. The plastic covering also affords convenient travel of the mesh through the tissue. The connectors are attached to the tip portions of the Monarc needle passers during the procedure. The loosely knitted polypropylene mesh is intended to remain in the body as a permanent implant. The mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.

Proposed Device Intended Use (Indication for Use):

Sparc Sling System (Sparc):

Intended for the placement of pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and for intrinsic sphincter deficiency.

Monarc, Monarc + and Monarc C Subfascial Hammock (Monarc) device: Intended for the placement of suburethral mesh for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and for intrinsic sphincter deficiency.

Summary of the Technical Characteristics Compared to the Predicate Device(s):

All characteristics of the proposed device are identical to those of the predicate, including design, material construction, manufacturing process, and intended use. There is no change to the technical characteristics for this 510(k).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

December 5, 2013

American Medical Systems, Inc. David H. Mueller Principal Regulatory Affairs Specialist 10700 Bren Road West Minnetonka, MN 55343

Re: K131229

Trade/Device Name: Sparc™ Sling System and MonarcTM, Monarc™ + and MonarcTM C Subfascial Hammock Systems

Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: November 1, 2013 Received: November 6, 2013

Dear David H. Mueller,

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.

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Page 2 - David H. Mueller

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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for

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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American Medical Systems K131229/ Amendment 1: Special 510(k) Submission Changes Being Effected Spare™ Sling System and Monarc™, Monarc™ + and Monarc™ C Subfascial Hammock

Section 4 Indication for Use Statement

510{k} Number: K131229

Device Name: Sparc™ Sling System and Monarc™, Monarc™ + and Monarc™ C Subfascial HammockSystems

Indications for Use:

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.

Prescription Use × (Per 21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2013.12.05 16:36:37 -05'00'

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.