(28 days)
The MicroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with sutures. It is indicated for cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The MicroTac Bone Anchor System, consisting of the MicroTac Bone Anchor and the MicroTac Bone Anchor Inserter. The inserter of the MicroTac Bone Anchor System is designed for single use and is manual.
The provided text describes a 510(k) submission for the MicroTac Bone Anchor System, comparing it to a predicate device (In-Tac Bone Anchor System). This document focuses on demonstrating substantial equivalence for a medical device, which is a different regulatory pathway than providing detailed clinical study results with acceptance criteria and specific performance metrics for AI/software-based devices.
Therefore, the input does not contain the information necessary to fill out the requested table or answer most of the questions, as the submission primarily discusses device modifications and risk analysis to show equivalence. It does not present a study with quantitative acceptance criteria for its performance in the context of AI or diagnostic accuracy.
However, I can extract information related to the device and its regulatory context:
Device Information:
- Device Name: MicroTac Bone Anchor System
- Intended Use: Soft tissue fixation to the pubic bone by means of bone anchors threaded with sutures.
- Indications for Use: Cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
- Predicate Device: Influence, Inc.'s In-Tac Bone Anchor System (cleared under K964953)
Response to Specific Questions based on the Provided Text:
As the provided text describes a 510(k) submission for a physical medical device (bone anchor system) and not an AI/software-based one, the requested detailed information about acceptance criteria, study design for AI models, ground truth establishment, expert adjudication, MRMC studies, or standalone performance for an algorithm is not applicable and therefore not available in this document.
The submission focuses on establishing substantial equivalence through risk analysis and performance testing related to the modifications from the predicate device. It indicates that "performance data gathered" and "performance testing" were used to demonstrate equivalence, but it does not provide specific quantitative acceptance criteria or detailed results in the format requested for an AI/diagnostic study.
Therefore, it's impossible to create the table or answer the specific questions as if this were a study proving an AI device meets acceptance criteria. The document's purpose is to show that the device modifications do not raise new questions of safety or effectiveness compared to a predicate device.
Summary of Unavailable Information:
- Acceptance Criteria Table: Not specified in the document.
- Device Performance: Not detailed in quantitative metrics that would align with AI/diagnostic studies. The document states "performance testing provided in the application demonstrates equivalence," but no data points are given.
- Sample Size (Test Set) and Data Provenance: Not applicable/not provided for an AI study.
- Number/Qualifications of Experts for Ground Truth: Not applicable/not provided.
- Adjudication Method: Not applicable/not provided.
- MRMC Comparative Effectiveness Study: Not applicable/not performed for this type of device submission.
- Standalone Performance (Algorithm Only): Not applicable, as this is a physical medical device.
- Type of Ground Truth: Not applicable/not provided (no diagnostic accuracy study).
- Sample Size (Training Set): Not applicable/not provided.
- How Ground Truth for Training Set was Established: Not applicable/not provided.
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2/16/99
510(k) Summary of Safety and Effectiveness Influence. Inc.'s MicroTac Bone Anchor System 510(k) Number K99D160
This 510(k) notification is submitted by Influence, Inc., 71 Stevenson Street, Suite 1120, San Francisco, California 94105. 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 threaded with sutures. It is indicated for cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The MicroTac Bone Anchor System is substantially equivalent to Influence, Inc.'s In-Tac Bone Anchor System cleared under K964953 with respect to intended use, materials and performance of the bone anchors. The major differences between the two systems are that the inserter of the MicroTac Bone Anchor System is designed for single use and is manual, while the predicate device is designed for multiple use and uses springs to deliver energy to the bone anchors.
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 MicroTac Bone Anchor System is substantially equivalent to the In-Tac 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 1999
Peter A. Bick, M.D. President and CEO Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105
Re: K990160 MicroTac Bone Anchor System Trade Name: Regulatory Class: II Product Codes: MBI and HXJ January 12, 1999 Dated: January 19, 1999 Received:
Dear Dr. Bick:
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 controls provisions The general controls provisions of the Act 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. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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 requlations.
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Page 2 - Peter A. Bick, M.D.
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 requlation (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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
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):
K990160_______________________________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
MicroTac Bone Anchor System, consisting of the MicroTac Bone Anchor and the MicroTac Bone Anchor Inserter
The MicroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with sutures. It is indicated for cystourethropexy and 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
Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use
34
Aiolla
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990
§ 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.