(29 days)
The MONARC™ Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The MONARC Sling System is a sterile, single use procedure kit consisting of two stainless steel, 22cm spiral needle passers (also called insertion tools) and one AMS polypropylene sling mesh with attached dilating connectors. The dilating connectors attach to the keyed ends of the MONARC needle passers during the procedure to facilitate sling placement. A fixed absorbable PGA tensioning suture runs through the middle of the sling mesh. Two plastic sheaths overlap in the center of the sling mesh and protect it during placement.
This submission is a 510(k) premarket notification for a medical device called the MONARC™ Sling System. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed acceptance criteria and a study proving device performance against those criteria in the way envisioned by the request. As such, much of the requested information is not present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or quantitative performance metrics for the MONARC™ Sling System in the context of clinical outcomes or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to its predicate device. This type of submission would typically involve engineering tests and potentially animal studies, but not a human clinical trial with performance metrics.
2. Sample size used for the test set and the data provenance:
Not applicable. This document does not describe a clinical study with a "test set" for performance evaluation in the typical sense. It's a 510(k) submission focused on equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment is not described as this is not a diagnostic device study.
4. Adjudication method for the test set:
Not applicable.
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 is not an AI/diagnostic device study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm/AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established:
Not applicable.
Summary of what the document does provide regarding acceptance/equivalence:
- Device Description: The MONARC™ Sling System is a sterile, single-use procedure kit consisting of spiral needle passers and a polypropylene sling mesh with attached dilating connectors and an absorbable tensioning suture.
- Intended Use: Placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
- Comparison to Predicate Device: The fundamental scientific technology is unchanged from the SPARC™ Sling System (K011251, K013355, K020663, K021263). The primary change is the shape of the needle (spiral instead of curved). The sling mesh and absorbable suture remain the same.
- Supporting Information: A risk analysis and verification/validation activities were reported to substantiate equivalence and did not raise new questions of safety or effectiveness.
- Conclusion: The MONARC™ device is substantially equivalent to the predicate with respect to intended use and technological characteristics.
In the context of a 510(k) submission like this, "acceptance criteria" largely refer to the successful demonstration of substantial equivalence through design verification and validation activities (e.g., biocompatibility testing, sterility testing, mechanical testing of materials, and comparison to the predicate device's performance from existing data), as well as clinical safety and effectiveness through published literature or predicate device history. The document explicitly states that "verification and validation activity reported in this 510(k) application substantiate equivalence to the predicate." However, the specifics of these tests and their numerical acceptance criteria are not provided in this summary.
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AMERICAN MEDICAL SYSTEMS
510(k) SUMMARY
| Submitter's Name: | American Medical Systems, Inc. |
|---|---|
| Address: | 10700 Bren Road WestMinnetonka, MN 55343 |
| Tel: | 952-933-4666 |
| Fax: | 952-930-6496 |
| Contact Person: | David Worrell |
| Date of Summary Preparation: | October 15th, 2002 |
| Device Common Name: | Surgical Mesh, Sling, Urethral Sling |
| Device Trade Name: | MONARC™ Sling System |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Device: | SPARC™ Sling System - K011251, K013355,K020663, K021263 |
Device Description
The MONARC Sling System is a sterile, single use procedure kit consisting of two stainless steel, 22cm spiral needle passers (also called insertion tools) and one AMS polypropylene sling mesh with attached dilating connectors. The dilating connectors attach to the keyed ends of the MONARC needle passers during the procedure to facilitate sling placement. A fixed absorbable PGA tensioning suture runs through the middle of the sling mesh. Two plastic sheaths overlap in the center of the sling mesh and protect it during placement.
Indications for Use
The MONARC Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Comparison to Predicate Device
The fundamental scientific technology of the MONARC device is unchanged from the predicate device. The primary change to the device is the shape of the needle. The needle will have a spiral shape instead of a curved shape. The sling mesh and absorbable suture remain the same. The devices that were the subject of K020663 and K021263 will continue to be marketed.
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AMERICAN MEDICAL SYSTEMS
Supporting Information
A risk analysis for the MONARC device and the verification and validation activity reported in this 510(k) application substantiate equivalence to the predicate and did not raise any new questions of safety or effectiveness.
Conclusion
The MONARC device is substantially equivalent to the predicate with respect to intended use and technological characteristics.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
American Medical Systems, Inc. Mr. David WorreIl Sr. Regulatory Affairs Specialist 10700 Bren Road, West MINNETONKA MN 55343
SEP 2 8 2012
Re: K023516 Trade/Device Name: MonarcTM Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: October 17, 2002 Received: October 21,2002
Dear Mr. Worrell:
This letter corrects our substantially equivalent letter of November 19, 2002.
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,
Sincerely yours,
Benjamin R. Fuchs
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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INDICATIONS FOR USE ENCLOSURE
| 510(k) Number: | |
|---|---|
| ---------------- | -- |
Ko2.356.
Device Name:
MONARC™ Sling System
Indications for Use:
The MONARC™ Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
(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 General and Restorative Devices
510(k) Number K023516
Prescription Use
(Per 21 CFR801.109)
OR
Over the Counter Use
Muriam C. Picont
(Division Sign-Off) Division of General, Restorative and Neurological Devices
- 1 ()(k) Number _____________________________________________________________________________________________________________________________________________________________
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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.