(23 days)
No
The device description details a surgical sling system with mechanical components and mesh, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as "intended for the placement of a The SFARO - Oling for the treatment of female stress urinary incontinence (SUI)", which clearly indicates a therapeutic purpose.
No
The device is a surgical sling system intended for the treatment of female stress urinary incontinence. Its function is to provide support for the urethra, not to diagnose a condition.
No
The device description clearly outlines a physical kit containing surgical tools (needle passers), a mesh implant, and other physical components. There is no mention of software as the primary or sole component.
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 sling. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The device consists of surgical tools (needle passers) and an implantable material (polypropylene sling mesh). These are used for a 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 body to diagnose, monitor, or screen for conditions. This device is a surgical implant and delivery system.
N/A
Intended Use / Indications for Use
The SPARC™ Sling System is intended for the placement of a The SFARO - Oling 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 as currently marketed 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 1.1 cm width x 50cm length. A fixed blue polypropylene tensioning 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.
- In K013355, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
MAY 1 5 2002
Image /page/0/Picture/1 description: The image shows a black and white drawing of a geometric shape. The shape appears to be a stylized representation of a building or structure, with a combination of vertical lines and angled sections. The drawing is simple and lacks detail, focusing on the basic form of the object.
AMERICAN MEDICAL SYSTEMS
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: | April 19, 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, K013351 |
| K020663 |
Device Description
The SPARC™ Sling System as currently marketed 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 1.1 cm width x 50cm length. A fixed blue polypropylene tensioning 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.
- In K013355, 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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Image /page/1/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 an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is 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
Mr. Mark McIntyre Director, Regulatory Affairs and Biostatistics American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K021263 Trade/Device Name: SPARCTM Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: April 19, 2002 Received: April 22, 2002
Dear Mr. McIntyre:
This letter corrects our substantially equivalent letter of May 15, 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 intenstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonton 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, FTDA 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,
Benjamin R. Rooks
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 '
Ko2/263
510(k) Number:
Device Name:
SPARC™ Sling System
Indications for Use:
The SPARC™ Sling System is intended for the placement of a The SFARO - Oling 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 _
Prescription Use (Per 21 CFR801.109)
OR
Over the Counter Use__________________________________________________________________________________________________________________________________________________________
miriam (
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number -