(22 days)
Not Found
No
The description focuses on the physical components and intended use of a surgical sling system, with no mention of AI or ML.
Yes
The device is intended for the treatment of female stress urinary incontinence, which is a therapeutic purpose.
No
The device is a surgical sling system used to treat stress urinary incontinence, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it includes physical components such as stainless steel needle passers, polypropylene sling mesh, suture, and plastic sheaths. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical treatment of female stress urinary incontinence by placing a pubourethral sling. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device consists of surgical tools (needle passers), a sling mesh, suture, and protective sheaths. These are all components used in a surgical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are 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 SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are sterile, single use procedure kits that consist of two stainless steel, curved needle passers (also known as insertion tools); AMS polypropylene sling mesh and suture; and two plastic sheaths that cover and protect the sling mesh during placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethral
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)
The risk analysis and the verification/validation activities reported in this Special 510(k) application substantiate equivalence to the predicate devices and did not raise any new questions of safety or efficacy.
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.
K021263, K023516, K030123, K040538
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.
0
AUG 1 1 2004
Image /page/0/Picture/2 description: The image shows the logo for American Medical Systems. The logo consists of a stylized graphic to the left of the text "American Medical Systems". The graphic is made up of several parallel lines of varying lengths, arranged in a way that resembles a stylized building or structure.
510(k) Summary
Submitter:
10700 Bren Road West Minnetonka, Minnesota 55343 Date Prepared: July 19, 2004 Contact: Kristyn M. Benson Sr. Regulatory Affairs Specialist Proprietary Name: SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems Common Name: Surgical Mesh
Class II; OTN
American Medical Systems
Device Product Code & Classification:
Predicate Device:
SPARCTM Sling System (K021263) MONARC™ Sling System (K023516) BioArc SPTM Sling System (K030123) BioArc TOTM Sling System (K040538)
Device Description:
The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are sterile, single use procedure kits that consist of two stainless steel, curved needle passers (also known as insertion tools); AMS polypropylene sling mesh and suture; and two plastic sheaths that cover and protect the sling mesh during placement.
Intended Use:
The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are intended for the placement ofa pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Statement of Technological Comparison:
The risk analysis and the verification/validation activities reported in this Special 510(k) application substantiate equivalence to the predicate devices and did not raise any new questions of safety or efficacy.
SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems Special 510(k) Notification
Page 17 of 19
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the head, body, and wings. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Kristyn M. Benson Sr. Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343
SEP 28 2012
Re: K041948 Trade/Device Name: SPARCTM, MONARCTM, BioArc SpTM, and BioArc T1OTM Sling Systems Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: July 19, 2004 Received: July 20, 2004
Dear Ms. Benson:
This letter corrects our substantially equivalent letter of August 11, 2004.
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
2
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. Perkins
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
3
INDICATIONS FOR USE STATEMENT
(Pending)
SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Device Name: Sling Systems
Indications for Use:
510(k) Number:
The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are The SPARC™, MONAHO - , Bloxino of any and sling for the treatment of female Intended for the placemont one passerting from urethral hypermobility and/or intrinsic sphincter deficiency.
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)
Miriam C. Provost
al. Restorative, and Neurological Devices
510(k) Number K041948
SPARC™, MONARC™, BioArc SP1M, and BioArc TO™ Sling Systems Special 510(k) Notification
Page 8 of 19