(87 days)
The Straight-In Bone Screw Fixation System is intended for soft tissue fixation to the pubic bone by means of bone screws threaded with suture. It is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to the pubic bone is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency).
This 510(k) notification describes a bone screw and bone screw inserter intended for soft tissue fixation to the pubic bone by means of bone screws threaded with suture. The Straight-In Bone Screw Fixation System is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to the pubic bone is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency). The Straight-In Bone Screw Fixation System uses the identical bone screws and suture, but has a long, straight and narrow Inserter suitable for use in open and laparoscopic surgical procedures where soft tissue fixation to the pubic bone is needed.
This document is a 510(k) summary for a medical device called the "Straight-In Bone Screw Fixation System." It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with detailed acceptance criteria and validation data as might be expected for a novel AI/software medical device.
Therefore, many of the requested categories (e.g., acceptance criteria table, sample sizes, expert qualifications, MRMC study, ground truth details) are not applicable or cannot be extracted from this type of regulatory submission. The submission is for a physical medical device (bone screw and inserter), not an AI/software device.
Here's an analysis based on the provided text, indicating where information is present versus not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is for a physical medical device (bone screw and inserter), not an AI/software device that would typically have performance metrics like sensitivity, specificity, or AUC against acceptance criteria. The "performance testing" mentioned refers to mechanical and material equivalence rather than diagnostic or analytical performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission states "Performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance." This typically refers to benchtop mechanical testing rather than a clinical "test set" in the context of an AI/software device. No details on sample size, origin, or retrospective/prospective nature are provided for such testing in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth, experts, and their qualifications are not relevant for a physical medical device like a bone screw system in establishing substantial equivalence. This type of information is typically associated with validating diagnostic or prognostic AI/software.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As there is no "test set" or ground truth establishment in the context of an AI/software device validation, adjudication methods are not relevant here.
5. 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 Applicable. This is a physical medical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. See previous points; ground truth in this context is not relevant. The "ground truth" for demonstrating substantial equivalence for this device would be the established performance and material characteristics of the predicate devices.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is a physical medical device, not an AI/software product that undergoes machine learning.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this device.
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510(k) Summary of Safety and Effectiveness Influence, Inc.'s Straight-In Bone Screw Fixation System 922622 510(k) Number
This 510(k) notification is submitted by Influence, Inc., 601 Montgomery Street, Suite 845. San Francisco. California 94111. The contact person is Mark D. Kramer, Consultant to Influence, Inc.
This 510(k) notification describes a bone screw and bone screw inserter intended for soft tissue fixation to the pubic bone by means of bone screws threaded with suture. The Straight-In Bone Screw Fixation System is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to the pubic bone is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency).
The Straight-In Bone Screw Fixation System is substantially equivalent to Influence, Inc.'s In-Fast Bone Screw System cleared under K970292 and the Vesica Suture Anchor System cleared under K932925. The mechanical properties and device materials of the Straight-In and In-Fast systems are identical. In both devices, fixation of soft tissue to bone is accomplished by a sharp tipped small diameter bone screw threaded with polypropylene suture. The In-Fast system is inserted pervaginally through soft tissue and into the pubic bone, without drilling holes or performing soft tissue dissection. The Straight-In Bone Screw Fixation System uses the identical bone screws and suture, but has a long, straight and narrow Inserter suitable for use in open and laparoscopic surgical procedures where soft tissue fixation to the pubic bone is needed. Like the Vesica system, the Straight-In uses an abdominal access procedure for soft tissue fixation to the pubic bone.
Performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance.
Based on the information provided, the Straight-In Bone Screw Fixation System is substantially equivalent to the In-Fast and Vesica devices 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 consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top and bottom portions of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark D. Kramer Consultant to Influence, Inc. 12037 Winesap Terrace North Potomac, Maryland 20878-2331
OCT - 9 1997
K972622 Re: Straight-In Bone Screw Fixation System Trade Name: Requlatory Class: II Product Code: MBI Dated: July 14, 1997 Received: July 14, 1997
Dear Mr. Kramer:
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 reqistration, 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 Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 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 - Mr. Mark D. Kramer
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.qov/cdrh/dsmamain.html".
Sincerely yours,
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
| 510(k)-Number (if known): | K972622 |
|---|---|
| Device Name: | Straight-In Bone Screw System, consisting of the Straight-In Bone Screw Inserter and Straight-In Bone Screws |
| Indications for Use: | The Straight-In Bone Screw Fixation System is intended for soft tissue fixation to the pubic bone by means of bone screws threaded with suture. It is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to the pubic bone is needed (e.g., bladder neck suspension and urethral sling procedures for female stress 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 of General and Restorative Devices
| (Division Sign-off) | |
|---|---|
| --------------------- | -- |
| 510(k) Number | K972622 |
|---|---|
| --------------- | --------- |
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OR
Over the Counter Use__________________________________________________________________________________________________________________________________________________________
Prescription Use
X
(Per 21 CFR 801.109)
§ 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.