(35 days)
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.
Bone anchor system
This document describes the acceptance criteria and the study for a Bone Anchor System III.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Characteristics | Substantially equivalent to predicate devices | Substantially equivalent to predicate devices |
Note: The document explicitly states that "The proposed device has been tested and results compared to the predicate devices. The results show that the proposed device is substantially equivalent to the predicate devices in terms of the performance characteristics that were tested." However, it does not provide specific quantitative acceptance criteria or detailed numerical performance results. The acceptance is based on demonstrating substantial equivalence to already marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). It only mentions "Product Testing" was conducted to compare the device to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study described is a comparison of performance characteristics to predicate devices, not a study involving expert assessment of a medical condition.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is based on product testing and comparison to predicate devices, not on expert adjudication of medical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focuses on the performance characteristics of the bone anchor system itself compared to predicate devices, not on the improvement of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the device described. The Bone Anchor System III is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance characteristics of the predicate devices. The study aims to demonstrate that the proposed device's performance characteristics are "substantially equivalent" to these established predicate devices. There is no mention of pathology, outcomes data, or expert consensus in relation to establishing ground truth for a medical condition.
8. The Sample Size for the Training Set
This information is not provided and is not applicable as the device is a physical bone anchor system, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the same reason as above.
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5/5/99
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Microvasive Urology
| 510(k) SUMMARY of Safety and EffectivenessSection V. | |
|---|---|
| Sponsor: | Boston Scientific/ MicrovasiveOne Scientific PlaceNatick, MA 01760-1537 |
| Contact Person: | Lorraine HanleyDivisional Manager, Regulatory Affairs |
| Submission Date: | January 28, 1999 |
| Common/Usual Name: | Bone anchor |
| Trade/Proprietary Name: | TBD |
| Device Classificationand Name: | Class II:CFR 888.3040; smooth or threaded metallic bone fixation fastener |
| Indications for Use: | The proposed bone anchor system is intended for use in procedures thatrequire placement of a bone anchor for the purpose of soft tissuereinforcement and support inclusive of, but not limited to, suspendingsutures and/or placement of a sling for the treatment of urinary stressincontinence attributable to hypermobility and/or intrinsic sphincterdeficiency such as: Pubourethral, Urethrovesical, Pubovaginal, and bladderneck support/stabilization; Urethral and Vaginal prolapse repair; andreconstruction of the pelvic floor. |
| SubstantialEquivalence: | The proposed device is substantially equivalent to the predicatelegally marketed devices indicated for use as Bone Anchor Systemsintended for soft tissue support. |
| Product Testing: ` | The proposed device has been tested and results compared to the predicatedevices. The results show that the proposed device is substantiallyequivalent to the predicate devices in terms of the performancecharacteristics 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 (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,
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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
N/A