(15 days)
No
The summary describes a surgical sling kit and procedure, with no mention of AI or ML technology in the intended use, device description, or performance studies.
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, BioArc TO Subfascial Hammock, is described as a surgical sling used for the treatment of female stress urinary incontinence. Its function is to provide a suburethral graft, indicating a therapeutic or interventional purpose rather than a diagnostic one.
No
The device description explicitly states it is a kit consisting of stainless steel needle passers and a mesh sling assembly, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states that the BioArc TO Subfascial Hammock and BioArc SP Sling Kit are surgical implants used for the treatment of stress urinary incontinence. They are physically placed inside the body during a surgical procedure.
- Intended Use: The intended use is for the surgical treatment of a medical condition, not for testing or analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of a surgical implant or medical device used for treatment, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
BioArc TO Subfascial Hammock is intended for the placement of a suburethral graft for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and / or intrinsic sphincter deficiency.
Product codes
OTN, PAG
Device Description
The BioArc TO Subfascial Hammock is a suburethral sling procedure that uses a transobturator surgical approach to treat stress urinary incontinence. It is a sterile, single transobare kit consisting of two stainless steel helical shaped needle passers and a mesh sling assembly to which graft material is attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
suburethral
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
MAR 1 7 2004
Kψ4ψ538
| 2.6 | 510(k) Summary |
|---|---|
| Submitter: | American Medical Systems |
| 10700 Bren Road West | |
| Minnetonka, MN 55343 | |
| Phone: 952-933-4666 | |
| Fax: 952-930-6496 | |
| Contact Person: | Denise Thompson |
| Date Summary Prepared: | February 27, 2004 |
| Device Common Name: | Urethral Sling, Surgical Mesh |
| Device Trade Name: | BioArc TO™ Subfascial Hammock |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Device: | BioArc SP™ Sling Kit, K030123 |
| MONARC™ subfascial hammock, K023516 |
Device Description:
The BioArc TO Subfascial Hammock is a suburethral sling procedure that uses a transobturator surgical approach to treat stress urinary incontinence. It is a sterile, single transobare kit consisting of two stainless steel helical shaped needle passers and a mesh sling assembly to which graft material is attached.
Indications for Use:
BioArc TO Subfascial Hammock is intended for the placement of a suburethral graft for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and / or intrinsic sphincter deficiency.
Comparison to Predicate Device:
The BioArc TO brings two currently marketed AMS technologies, the BioArc SP Sling Kit and the Monarc subfascial hammock, together into one procedure.
The Indications for Use, fundamental scientific technology, surgical approach, sling placement, and materials are all the same as one of the two predicates.
Supporting Information:
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.
Conclusion:
The BioArc TO Subfascial Hammock is substantially equivalent to its predicates with respect to intended use, technological characteristics, and performance.
1
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 eagle with its wings outstretched, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle, emphasizing the department's name and national affiliation. The overall design is simple and professional, conveying a sense of authority and trustworthiness.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Denise Thompson Regulatory Specialist American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343
SEP 28 2022
Re: K040538 Trade/Device Name: AMS BioArc™ TO Subfascial Hammock AMS BioArc™ SP Sling Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN, PAG Dated: March 1, 2004 Received: March 2, 2004
Dear Ms. Thompson:
This letter corrects our substantially equivalent letter of March 17, 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
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Benjamin R. Fuchs
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
1.4