(29 days)
Not Found
No
The device description and intended use clearly describe a physical surgical sling system and its insertion tools, with no mention of software, algorithms, or any technology related to AI or ML. The "Not Found" entries for AI/ML mentions and performance study details further support this conclusion.
Yes
The device is intended for the treatment of female stress urinary incontinence, which is a therapeutic purpose.
No
The device is described as a "Sling System" intended for the "placement of a pubourethral sling for the treatment of female stress urinary incontinence". It is a physical implant used for treatment, not for diagnosis.
No
The device description clearly outlines physical components such as stainless steel needle passers, polypropylene sling mesh, dilating connectors, and plastic sheaths, indicating it is a hardware-based medical device.
Based on the provided information, the MONARC™ Sling System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for the placement of a pubourethral sling for the treatment of female stress urinary incontinence. This is a surgical procedure performed in vivo (within the body) to treat a medical condition.
- Device Description: The device consists of surgical tools (needle passers) and an implantable mesh. These are physical devices used for surgical intervention, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. The MONARC™ Sling System is a surgical implant and delivery system.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OTN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K011251, K013355, K020663, K021263
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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AMERICAN MEDICAL SYSTEMS
510(k) SUMMARY
| Submitter's Name: | American Medical Systems, Inc. |
|---|---|
| Address: | 10700 Bren Road West |
| Minnetonka, 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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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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