(27 days)
K011251, K01335
K011251, K01335
No
The device description and summary of performance studies focus on the physical components and mechanical function 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 medical condition, making it a therapeutic device.
No
The device description indicates that the SPARC™ Sling System is a surgical kit used for the "placement of a pubourethral sling for the treatment of female stress urinary incontinence," which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines multiple physical components, including stainless steel needle passers, polypropylene sling mesh, plastic sheaths, and dilating connectors. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description: The SPARC™ Sling System is a surgical implant and delivery system used to physically support the urethra for the treatment of stress urinary incontinence. It is implanted directly into the body.
- Intended Use: The intended use is for the surgical placement of a sling, not for testing samples outside the body.
The device is a surgical implant and its associated tools, not a diagnostic test.
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 1.0 cm 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. The proposed device that is the subject of this 510k will not include the cystoscopy aids.
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)
K011251, K01335
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.
0
MAR 2 8 2002
Image /page/0/Picture/1 description: The image contains handwritten text that appears to be a code or identifier. The text reads 'K020663 (P. 1 of 2)'. The characters are written in a casual, cursive style, and the text is likely a reference number or a page indicator within a document.
AMERICAN MEDICAL SYS"EMS
510(k) SUMMARY
| Submitter's Name: | American Medical Systems, Inc. |
|---|---|
| Address: | 10700 Bren Road West |
| Minnetonka, MN 55343 | |
| Tel: | 952-930-6120 |
| Fax: | 952-930-6496 |
| Contact Person: | Mark McIntyre |
| Date of Summary Preparation: | February 28, 2002 |
| Device Common Name: | Surgical Mesh, Sling, Urethral Sling |
| Device Trade Name: | SPARC™ Sling System |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Device: | SPARC™ Sling System - K011251, K01335 |
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 1.0 cm 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. The proposed device that is the subject of this 510k will not include the cystoscopy aids.
1
K020665(μ, ofα)
AMERICAN MEDICAL SYSTEMS
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 that was the subject of K013355 will continue to be marketed. The proposed alternate configuration will be a second product offering in this family of products. The needle passer handle will be modified to be permanently attached and more ergonomic. Additionally, texture will be added to the needle passer to make it easier to grip during the procedure. The packaging for the product will be changed from a double Tyvek pouch to a double tray system consisting of PETG trays and Tyvek lids. The proposed device package will not contain the cystoscopy aids. The sling mesh width has been increased from 1.0 cm to 1.1 cm.
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.
2
Image /page/2/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 symbol, with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Mark McIntyre Director, Regulatory Affairs American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K020663 Trade/Device Name: SPARCTM Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: February 28, 2002 Received: March 1, 2002
Dear Mr. McIntyre:
This letter corrects our substantially equivalent letter of March 28, 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
3
Page 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/ResourcesforYou/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 Eyaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE ENCLOSURE
SPARC™ Sling System
510(k) Number:
Device Name:
Indications for Use:
The SPARC™ Sling System is intended for the placement of a The SI ANO - Oling Oyotthent of female stress urinary pubodiethral sling for the the crom urethral hypermobility and/or intrinsic sphincter deficiency.
urian C. Provost
General, Restorative and Neurological Devices
510(k) Number K020663
(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 __
Prescription Use
(Per 21 CFR801.109)
OR
Over the Counter Use__________________________________________________________________________________________________________________________________________________________
3