BONE ANCHOR SYSTEM III (BAS III)

K990295 · Boston Scientific Corp · MBI · Mar 5, 1999 · Orthopedic

Device Facts

• Record ID: K990295
• Device Name: BONE ANCHOR SYSTEM III (BAS III)
• Applicant: Boston Scientific Corp
• Product Code: MBI · Orthopedic
• Decision Date: Mar 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed bone anchor system is intended for use in procedures that require placement of a bone anchor for the purpose of soft tissue reinforcement and support inclusive of, but not limited to, suspending sutures and/or placement of a sling for the treatment of urinary stress incontinence attributable to hypermobility and/or intrinsic sphincter deficiency such as: Pubourethral, Urethrovesical, Pubovaginal, and bladder neck support/stabilization; Urethral and Vaginal prolapse repair; and reconstruction of the pelvic floor.

Device Story

Bone anchor system used for soft tissue reinforcement and support; facilitates suture suspension and sling placement. Used in surgical procedures for urinary stress incontinence, prolapse repair, and pelvic floor reconstruction. Operated by surgeons in clinical/OR settings. Device provides mechanical fixation to bone to stabilize soft tissues. Benefits include improved anatomical support and stabilization for patients with pelvic floor disorders.

Clinical Evidence

Bench testing only; performance characteristics compared to predicate devices.

Technological Characteristics

Metallic bone fixation fastener (smooth or threaded). Class II device per 21 CFR 888.3040.

Indications for Use

Indicated for patients requiring soft tissue reinforcement and support, including treatment of urinary stress incontinence due to hypermobility or intrinsic sphincter deficiency, urethral/vaginal prolapse repair, and pelvic floor reconstruction.

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.

Submission Summary (Full Text)

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5/5/99

Image /page/0/Picture/1 description: The image contains the logo for Boston Scientific Microvasive. The words "Boston Scientific" are stacked on top of each other in a serif font. Underneath "Scientific" is the word "MICROVASIVE" in a bold, sans-serif font.

K990295

Microvasive Urology

| 510(k) SUMMARY of Safety and Effectiveness<br>Section V. | |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Boston Scientific/ Microvasive<br>One Scientific Place<br>Natick, MA 01760-1537 |
| Contact Person: | Lorraine Hanley<br>Divisional Manager, Regulatory Affairs |
| Submission Date: | January 28, 1999 |
| Common/Usual Name: | Bone anchor |
| Trade/Proprietary Name: | TBD |
| Device Classification<br>and Name: | Class II:<br>CFR 888.3040; smooth or threaded metallic bone fixation fastener |
| Indications for Use: | The proposed bone anchor system is intended for use in procedures that<br>require placement of a bone anchor for the purpose of soft tissue<br>reinforcement and support inclusive of, but not limited to, suspending<br>sutures and/or placement of a sling for the treatment of urinary stress<br>incontinence attributable to hypermobility and/or intrinsic sphincter<br>deficiency such as: Pubourethral, Urethrovesical, Pubovaginal, and bladder<br>neck support/stabilization; Urethral and Vaginal prolapse repair; and<br>reconstruction of the pelvic floor. |
| Substantial<br>Equivalence: | The proposed device is substantially equivalent to the predicate<br>legally marketed devices indicated for use as Bone Anchor Systems<br>intended for soft tissue support. |
| Product Testing: ` | The proposed device has been tested and results compared to the predicate<br>devices. The results show that the proposed device is substantially<br>equivalent to the predicate devices in terms of the performance<br>characteristics that were tested. |

510(k) PreMarket Notification Bone Anchor System III 01/28/99
Confidential and Proprietary to Boston Scientific Corporation

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 1999

Ms. Christine E. Nichols Senior Regulatory Affairs Specialist Boston Scientific Corporation/Microvasive One Boston Scientific Place Natick, Massachusetts 01760-1537

K990295 Re: Bone Anchor System (BAS) III Trade Name: Regulatory Class: II Product Codes: MBI and HWC January 28, 1999 Dated: Received: January 29, 1999

Dear Ms. Nichols:

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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 regulations.

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Page 2 - Ms. Christine E. Nichols

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 [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,

Russell P. Page

/w 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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Section I-C. Indication For Use Statement

510(K) Number: k990295

Bone Anchor System III Device Name:

Indications for Use:

The proposed bone anchor system is intended for use in procedures that require placement of a bone anchor for the purpose of soft tissue reinforcement and support inclusive of, but not limited to, suspending sutures and/or placement of a sling for the treatment of urinary stress incontinence attributable to hypermobility and/or intrinsic sphincter deficiency such as: Pubourethral, Pubovaginal, and bladder neck support/stabilization; Urethral and Vaginal prolapse repair; and reconstruction of the pelvic floor.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Or

Over-The-Counter Use

(Optional Format 1-2-96)

Rumi Nazan li. cma

510(k) PreMarket Notification Bone Anchor System III 01/28/99 Confidential and Proprietary to Boston Scientific Corporation