(27 days)
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.
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.
The provided text describes a 510(k) submission for the SPARC™ Sling System, a surgical mesh device for treating female stress urinary incontinence. The submission focuses on comparing a modified version of the device to a previously cleared predicate device.
Based on the provided text, it is not possible to describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.
Here's why and what information can be extracted:
- No Acceptance Criteria or Performance Metrics: The document states, "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." It concludes, "The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance." This implies that the device was evaluated against the predicate's established safety and effectiveness, rather than specific numerical acceptance criteria being explicitly defined and reported for the modified device.
- No Clinical Study Details: The submission refers to "bench test data" but does not provide any details about specific studies, their methodology, sample sizes, or results that could be used to fill out the table or answer the detailed questions about ground truth, expert opinions, or MRMC studies. This is a common characteristic of 510(k) summary documents, which often refer to detailed data that would be in the full submission, but not in the public summary.
- Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove efficacy and safety through new, large-scale clinical trials with defined acceptance criteria for a new clinical claim.
Therefore, the requested table and detailed answers cannot be fully populated from the provided text.
However, I can provide a summary of what is mentioned in relation to the device's assessment:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate device (K011251, K01335) in: | The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance. |
| - Intended Use | (Not explicitly stated but implied that the intended use is the same as the predicate and remains "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.") |
| - Technological Characteristics | Bench test data and risk analysis indicated no new questions of safety or effectiveness, supporting equivalence. Specific changes include: modified, permanently attached, and ergonomic needle passer handle with added texture; change from double Tyvek pouch to double tray system; removal of cystoscopy aids; sling mesh width increased from 1.0 cm to 1.1 cm. |
| - Performance (Safety and Effectiveness comparable to predicate) | Bench test data and risk analysis indicated no new questions of safety or effectiveness, supporting equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: "Bench test data" is mentioned, implying laboratory or engineering testing. Country of origin and retrospective/prospective nature are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set or ground truth established by experts is described in this summary.
4. Adjudication method for the test set:
- Not applicable as no clinical test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a surgical sling, not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical sling, not an algorithm.
7. The type of ground truth used:
- Not applicable as no clinical ground truth is described. The assessment relied on "bench test data" and "risk analysis" to demonstrate equivalence to a predicate device.
8. The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. No training set or ground truth for it is mentioned.
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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 WestMinnetonka, 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.
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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.
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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
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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/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
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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__________________________________________________________________________________________________________________________________________________________
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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.