(23 days)
Not Found
No
The device description and intended use focus on a surgical sling kit with mechanical components and do not mention any AI/ML capabilities or data processing.
Yes
The device is intended for the treatment of female stress urinary incontinence, indicating a therapeutic purpose.
No
The device description states it is a "procedure kit consisting of two stainless steel. 22cm curved needle passers (also called insertion tools) and two AMS Polypropylene sling Y-mesh" and its intended use is for "the placement of a pubourethral sling for the treatment of female stress urinary incontinence". This describes a surgical tool for treatment, not a device used to provide diagnostic information.
No
The device description clearly outlines physical components like stainless steel needle passers, polypropylene mesh, clamps, sutures, and a plastic sheath, indicating it is a hardware-based medical device.
Based on the provided information, the BioArc™ SP Sling Kit is not an In Vitro Diagnostic (IVD) 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 samples taken from the body.
- Device Description: The device consists of surgical tools (needle passers) and an implantable mesh. These are instruments and materials used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
Therefore, the BioArc™ SP Sling Kit falls under the category of a surgical device or implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BioArc SP™ Sling Kit 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 BioArc SP Sling Kit is a sterile, single use procedure kit consisting of two stainless steel. 22cm curved needle passers (also called insertion tools) and two AMS Polypropylene sling Y-mesh. At one end of the sling Y-mesh, a clamp is attached by polypropylene suture to each leg of the "Y". The clamp is used for suturing a tissue graft to the sling Y-mesh. A dilating connector is attached to the opposite end of the sling Y-mesh. The dilating connector secures to the keyed end of the BioArc SP needle passer during the procedure to facilitate sling placement. A fixed polypropylene tensioning suture runs through the middle of each sling Y-mesh. A plastic sheath covers each sling Y-mesh and protects it during placement. The same suprapubic approach used to place the SPARC sling mesh is used to place the BioArc SP sling Y-mesh.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
SPARC™ Sling System - K011251, K013355, K020663, K021263
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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Image /page/0/Picture/0 description: The image shows a black and white drawing of an abstract symbol. The symbol is composed of vertical lines of varying heights, with a triangular shape on the left side. The lines are closely spaced and create a textured effect. The symbol appears to be stylized and lacks any clear representational meaning.
KC30123
AMERICAN MEDICAL SYSTEMS
510(k) SUMMARY
| Submitter's Name: | American Medical Systems, Inc. FEB 06 2003 |
|---|---|
| Address: | 10700 Bren Road West |
| Minnetonka, MN 55343 | |
| Tel: | 952-933-4666 |
| Fax: | 952-930-6496 |
| Contact Person: | David Worrell |
| Date of Summary Preparation: | January 13th, 2003 |
| Device Common Name: | Surgical Mesh, Sling, Urethral Sling |
| Device Trade Name: | BioArc SP™ Sling Kit |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Device: | SPARC™ Sling System - K011251, K013355, |
| K020663, K021263 |
Device Description
The BioArc SP Sling Kit is a sterile, single use procedure kit consisting of two stainless steel. 22cm curved needle passers (also called insertion tools) and two AMS Polypropylene sling Y-mesh. At one end of the sling Y-mesh, a clamp is attached by polypropylene suture to each leg of the "Y". The clamp is used for suturing a tissue graft to the sling Y-mesh. A dilating connector is attached to the opposite end of the sling Y-mesh. The dilating connector secures to the keyed end of the BioArc SP needle passer during the procedure to facilitate sling placement. A fixed polypropylene tensioning suture runs through the middle of each sling Y-mesh. A plastic sheath covers each sling Y-mesh and protects it during placement. The same suprapubic approach used to place the SPARC sling mesh is used to place the BioArc SP sling Y-mesh.
Indications for Use
The BioArc SP Sling Kit 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.
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Image /page/1/Picture/0 description: The image shows a black and white drawing of an abstract structure. The structure is composed of a triangular shape on the left, with diagonal lines filling the interior. To the right of the triangle, there are several vertical lines of varying heights, creating a sense of depth. A small dot is located to the right of the vertical lines.
AMERICAN MEDICAL SYSTEMS
Comparison to Predicate Device
The fundamental scientific technology of the BioArc SP Y-mesh and needle passers is unchanged from the predicate device(s). The primary change to the addition of the "Y" to one end of the sling mesh. The Y-end allows the physician to suture biologic graft material of their choice between the two pieces of 1.1cm x 22cm sling Y-mesh. The needle passers used with BioArc SP sling Y-mesh are the same as the ones used with SPARC sling mesh. BioArc SP sling Y-mesh uses the same suprapubic approach and surgical procedure for placement as the SPARC sling mesh.
Supporting Information
A risk analysis for the BioArc SP and the verification and validation activity reported in this Special 510(k) application substantiate equivalence to the predicate and did not raise any new questions of safety or effectiveness.
Conclusion
The BioArc SP Sling Kit is substantially 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 eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. David Worrell Sr. Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343
SEP 28 202
Re: K030123 Trade/Device Name: BioArc SP™ Sling Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: January 13, 2003 Received: January 14, 2003
Dear Mr. Worrell:
This letter corrects our substantially equivalent letter of February 6, 2003.
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
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 Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE ENCLOSURE
| 510(k) Number: | K434123 |
|---|---|
| Device Name: | BioArc™ SP Sling Kit |
| Indications for Use: | The BioArc™ SP Sling Kit 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 ________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR801.109)
OR
Over the Counter Use_
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices