(28 days)
Not Found
No
The 510(k) summary describes a manual, mechanical bone anchor system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for soft tissue fixation to the pubic bone for cystourethropexy and vaginal sling procedures to treat female urinary incontinence, which are therapeutic interventions.
No
The device is described as a system for soft tissue fixation using bone anchors and sutures, indicated for surgical procedures related to urinary incontinence. This is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it consists of a "MicroTac Bone Anchor" and a "MicroTac Bone Anchor Inserter," which are physical hardware components.
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 threaded with sutures." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device consists of a bone anchor and an inserter, which are tools used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant and instrument used for structural support within the body.
N/A
Intended Use / Indications for Use
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.
Product codes
MBI, HXJ
Device Description
The MicroTac Bone Anchor System, consisting of the MicroTac Bone Anchor and the MicroTac Bone Anchor Inserter.
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. Based on the performance data gathered, the device modifications do not raise any new questions of safety or effectiveness.
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
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.
1
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.
2
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
3
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