(23 days)
No
The summary describes a mechanical bone anchor system and does not mention any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is intended for vaginal sling procedures to treat female urinary incontinence, which is a therapeutic purpose.
No
Explanation: The device description states its intended use is for soft tissue fixation by means of bone anchors in vaginal sling procedures, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a "Bone Anchor System" and describes physical components (bone anchors, staple). This indicates a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "soft tissue fixation to the pubic bone by means of bone anchors" for "vaginal sling procedures". This describes a surgical procedure performed on the patient's body.
- Device Description: The description details a "Bone Anchor System" designed for physical fixation within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not interact with or analyze biological specimens in this way.
The device is a surgical implant used directly in a medical procedure on a patient.
N/A
Intended Use / Indications for Use
The StapleTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors. It is indicated for vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes
MBI and HWC
Device Description
The StapleTac Bone Anchor System is substantially equivalent to Influence, Inc.'s MicroTac Bone Anchor System cleared under K990160 with respect to intended use, materials and performance of the bone anchors. The major difference between the two systems is that the anchor of the StapleTac Bone Anchor System is designed for sling fixation with a staple and without sutures in sling procedures only, while the predicate device is designed for use with sutures in both sling procedures and cystourethropexy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pubic bone
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)
Information on risk analysis of the modifications and performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness Influence, Inc.'s StapleTac Bone Anchor System 510(k) Number ﷼92277
This 510(k) notification is submitted by Influence, Inc., 900 Kearny Street, 5th floor, San Francisco, California 94133. The contact person is Peter Bick, M.D., President and CEO.
This 510(k) notification describes a device intended for soft tissue fixation to the pubic bone by means of bone anchors. It is indicated for vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The StapleTac Bone Anchor System is substantially equivalent to Influence, Inc.'s MicroTac Bone Anchor System cleared under K990160 with respect to intended use, materials and performance of the bone anchors. The major difference between the two systems is that the anchor of the StapleTac Bone Anchor System is designed for sling fixation with a staple and without sutures in sling procedures only, while the predicate device is designed for use with sutures in both sling procedures and cystourethropexy.
Information on risk analysis of the modifications and performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance.
Based on the performance data gathered, the device modifications do not raise any new questions of safety or effectiveness.
Based on the information provided the StapleTac Bone Anchor System is substantially equivalent to the MicroTac Bone Anchor System with respect to intended use, technological characteristics, and performance.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Mr. Jonathan S. Kahan, Esq. Representing Influence, Incorporated c/o Hogan & Hartson, LLP Columbia Square 555 Thirteenth Street, N.W. Washington, D.C. 20004
Re: K992277
Trade Name: StapleTac Bone Anchor System Regulatory Class: II Product Code: MBI and HWC Dated: June 14, 1999 Received: July 7, 1999
Dear Mr. Kahan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jonathan S. Kahan, Esq.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE ENCLOSURE
| 510(k) Number (if known): | K992277 |
|---|---|
| Device Name: | StapleTac Bone Anchor System. |
| Indications for Use: | The StapleTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors. It is indicated for vaginal sling procedures for the treatment of stress type (female) urinary incontinence 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 K992277
Prescription Use OR Over the Counter (Per 21 CFR 801.109) Use (Division Division of General Restorativ 9922
510(k) Number