(16 days)
Not Found
No
The device description details a surgical sling system with mechanical components and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes
The device is intended for the treatment of female stress urinary incontinence, which is a medical condition, making it a therapeutic device.
No
The device description and intended use clearly state that the SPARC™ Sling System is for the placement of a pubourethral sling to treat female stress urinary incontinence, indicating it is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components such as stainless steel needle passers, polypropylene sling mesh, and plastic sheaths and cystoscopy aids, indicating it is a hardware-based medical device.
Based on the provided information, the SPARC™ Sling System is not an IVD (In Vitro Diagnostic) device.
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 body, not a test performed on a sample taken from the body.
- Device Description: The device consists of surgical tools (needle passers), a surgical implant (polypropylene sling mesh), and optional aids for a surgical procedure (cystoscopy aids). None of these components are designed to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on in vitro analysis.
Therefore, the SPARC™ Sling System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"The SPARC™ 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
OTN
Device Description
The SPARC™ Sling System is a sterile, single use procedure kit consisting of:
- Two stainless steel, curved, 22-cm long, needle passers (also called insertion ● tools).
- One piece of AMS Polypropylene sling mesh with attached dilating ● connectors. The AMS Polypropylene sling mesh is constructed of polypropylene monofilament that is precut to 1.0cm width x 50cm length. A fixed blue polypropylene anchoring suture runs through the middle of the sling mesh. Two plastic sheaths that overlap in the center of the sling mesh, cover the sling mesh and protect it during placement.
Dilating connectors are attached to either end of the plastic sheaths. The dilating connectors are used to attach to the vaginal ends of the SPARC™ needle passers during the procedure to facilitate sling placement.
- Two blue colored plastic cystoscopy aids are included in the kit in order to ● facilitate cystoscopic viewing of the bladder. The use of these cystoscopy aids is optional.
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)
A risk analysis of the proposed modification and bench test data reported in this 510(k) application substantiate equivalence to the predicate and did not raise any new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SPARCTM Sling System - K011251
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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OCT 2 6 2001
Image /page/0/Picture/1 description: The image shows a logo with a stylized letter 'A' next to a series of vertical lines. The 'A' is filled with diagonal lines, creating a striped effect. To the right of the 'A', there are four vertical lines of varying heights, resembling a simplified building or structure. A small dot is positioned to the right of the vertical lines, adding a subtle detail to the overall design.
013355
AMERICAN MEDICAL SYSTEMS
| 510(k) SUMMARY |
|---|
| ----------------------- |
| Submitter's Name: | American Medical Systems, Inc. |
|---|---|
| Address: | 10700 Bren Road West |
| Minnetonka, MN 55343 | |
| Tel: | 952-930-6541 |
| Fax: | 952-930-6496 |
| Contact Person: | Ginger Sackett Glaser |
| Date of Summary Preparation: | October 5, 2001 |
| Device Common Name: | Surgical Mesh, Sling, Urethral Sling |
| Device Trade Name: | SPARCTM Sling System |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Device: | SPARCTM Sling System - K011251 |
Device Description
The SPARC™ Sling System is a sterile, single use procedure kit consisting of:
- Two stainless steel, curved, 22-cm long, needle passers (also called insertion ● tools).
- One piece of AMS Polypropylene sling mesh with attached dilating ● connectors. The AMS Polypropylene sling mesh is constructed of polypropylene monofilament that is precut to 1.0cm width x 50cm length. A fixed blue polypropylene anchoring suture runs through the middle of the sling mesh. Two plastic sheaths that overlap in the center of the sling mesh, cover the sling mesh and protect it during placement.
Dilating connectors are attached to either end of the plastic sheaths. The dilating connectors are used to attach to the vaginal ends of the SPARC™ needle passers during the procedure to facilitate sling placement.
- Two blue colored plastic cystoscopy aids are included in the kit in order to ● facilitate cystoscopic viewing of the bladder. The use of these cystoscopy aids is optional.
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Image /page/1/Picture/0 description: The image shows the words AMERICAN MEDICAL SYSTEMS in all caps. The words are in a bold, sans-serif font. The text is black and the background is white.
Indications for Use
The indication for use for the SPARC™ Sling System is not changing. It continues to read as follows:
"The SPARC™ 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 device will not change with the proposed alternative configuration of the device. A polypropylene suture identification loop with an attached silicone tab has been added for easier location of the portion of the tensioning suture that should be snipped after sling tensioning is complete,
Supporting Information
A risk analysis of the proposed modification and bench test data reported in this 510(k) application substantiate equivalence to the predicate and did not raise any new questions of safety or effectiveness.
Conclusion
The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance.
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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 image of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Ginger Sackett Glaser Senior Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343
SEP 28 2012
Re: K013355 Trade/Device Name: SPARCTM Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: October 9, 2001 Received: October 10, 2001
Dear Ms. Sackett Glaser:
This letter corrects our substantially equivalent letter of October 26, 2001.
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/Resourcesfor You/Industry/default.htm.
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
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INDiCATIONS FOR USE ENCLOSURE
| 510(k) Number: | K013355 |
|---|---|
| Device Name: | SPARC™ Sling System |
| Indications for Use: | The SPARC™ 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 | K013355 |
Prescription Use _______ OR Over the Counter Use _______
(Per 21 CFR801.109)
| (Division Sign-Off) Division of General, Restorative and Neurological Devices | |
|---|---|
| 510(k) Number | K013355 |
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