MICROTAC-BONE ANCHOR SYSTEM

K990160 · Influence, Inc. · MBI · Feb 16, 1999 · Orthopedic

Device Facts

• Record ID: K990160
• Device Name: MICROTAC-BONE ANCHOR SYSTEM
• Applicant: Influence, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Feb 16, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

MicroTac Bone Anchor System facilitates soft tissue fixation to pubic bone; utilizes bone anchors threaded with sutures. System comprises bone anchors and manual, single-use inserter. Used by surgeons in clinical settings for cystourethropexy and vaginal sling procedures. Device provides mechanical fixation of soft tissue to bone to treat stress urinary incontinence. Replaces spring-loaded, multi-use inserter mechanism of predicate device with manual delivery system. Performance testing confirms equivalence in fixation strength and safety profile.

Clinical Evidence

Bench testing only; no clinical data provided. Performance testing demonstrated equivalence to the predicate device.

Technological Characteristics

System includes bone anchors and manual inserter. Single-use design. Materials and performance characteristics are equivalent to the predicate In-Tac system. No specific ASTM standards or software components described.

Indications for Use

Indicated for female patients with stress urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency undergoing cystourethropexy or vaginal sling procedures.

Regulatory Classification

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.

Predicate Devices

• In-Tac Bone Anchor System (K964953)

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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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