(89 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 suture/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
Not Found
The provided text is related to a 510(k) premarket notification for a medical device called "Bone Anchor Systems" by Boston Scientific Corporation, approved by the FDA in 1997. It describes the device, its classification, and its substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.
The "Product Testing" section briefly states: "The proposed devices have been tested and compared to the predicate devices. The results indicate that the proposed devices are Substantially Equivalent to the predicate devices in terms of performance characteristics tested." This is a general statement required for 510(k) submissions, which focuses on demonstrating substantial equivalence rather than providing detailed performance metrics against specific acceptance criteria.
Therefore, I cannot fulfill your request for the specific information you asked for, as it is not present in the provided document.
Here's an explicit breakdown of why I cannot answer your specific questions:
- A table of acceptance criteria and the reported device performance: Not provided. The document only mentions "performance characteristics" and "substantially equivalent" without quantifiable criteria or results.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. This device is a physical bone anchor system, not an AI-assisted diagnostic tool, so an MRMC study with AI assistance would not be applicable or expected.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided and not applicable for this type of device.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
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JUN 25 1997
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510 (k) Summary Of Safety And Effectiveness
| Sponsor: | Boston Scientific Corporation |
|---|---|
| One Scientific Place | |
| Natick, MA 01760-1537 | |
| Contact Person: | Lorraine M. Hanley |
| Manager, Regulatory Affairs | |
| or | |
| Carol J. Holloway | |
| Regulatory Affairs Specialist | |
| Submission Date: | March 24, 1997 |
| Common/Usual Names: | Bone Anchor System |
| Trade/Proprietary Name: | TBD |
| Device Classificationand Name: | Boston Scientific Corporation believes the proposeddevice combines devices classified as Class II: |
| • CFR 888.3040; Smooth or threaded metallic bone fixationfastener; Procode: 87 HWC | |
| • CFR 878.5000; Nonabsorbable poly surgical suture;Procode: 79 GAW | |
| SubstantialEquivalence: | The proposed devices are Substantially Equivalent to thepredicate currently marketed devices indicated for use as a BoneAnchor System intended for soft tissue support. |
| Product Testing: | The proposed devices have been tested and compared to the predicatedevices. The results indicate that the proposed devices areSubstantially Equivalent to the predicate devices in terms ofperformance characteristics tested. |
- "
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol J. Holloway Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
JUN 2 5 1997
K971139 Re : Trade Name: Bone Anchor Systems Requlatory Class: II Product Codes: MBI and HWC Dated: March 24, 1997 Received: March 28, 1997
Dear Ms. Holloway:
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 of the Act. The general controls provisions 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug
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Page 2 - Ms. Carol J. Holloway
Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning.your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 qeneral 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,
Maus A Schroeder, MS, PT
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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Indications For Use
Page __ 1 __ of ___ l
510(k) Number (if known):
Device Name:
Bone Anchor Systems
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 suture/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
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| 4 км². Председанское седать продавические придементавия полициальность чельность чельность в | |
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or
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use - - -
Marie A. Schmoeker, MS, PT, fa, CMW
(Optional Format 1-2-96)
(Division Sign-Om)
Division of General Restorative Devices
510(k) Number K971139
N/A