(74 days)
The Short Shaft Straight-In Bone Screw Fixation System is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region 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, sling procedure for male stress urinary incontinence resulting from prostatectomy).
This 510(k) notification describes a device intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. The Short Shaft Straight-In Bone Screw Fixation System is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region 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, sling procedure for male stress urinary incontinence resulting from prostatectomy). The design and materials of the Short Shaft Straight-In and Straight-In systems are identical. The only difference is that the Inserter of the Short Straight-In device is shorter to serve the needs of users who prefer the maneuverability of a shorter device in open surgical procedures.
The provided text describes a 510(k) submission for a medical device, the "Short Shaft Straight-In Bone Screw Fixation System." It details the device's intended use and claims substantial equivalence to a predicate device (Influence, Inc.'s Straight-In Bone Screw System, K972622).
However, the document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance metrics in the way typically associated with advanced AI/ML medical devices. This is because the submission is for a mechanical fixation system, not a software-driven diagnostic or treatment algorithm.
Therefore, many of the requested categories (expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Claim: Substantial Equivalence to Predicate Device (Straight-In Bone Screw System, K972622) | The Short Shaft Straight-In and Straight-In systems are identical in design and materials. The only difference is a shorter inserter for improved maneuverability in open surgical procedures. Information and performance testing (not detailed in this document) demonstrated equivalence to the predicate devices with respect to performance. |
| Intended Use: Soft tissue fixation to bones in the pelvic region. | The device is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension, urethral sling procedures). |
| Technological Characteristics: Identical to predicate device. | The design and materials of the Short Shaft Straight-In and Straight-In systems are identical. |
2. Sample size used for the test set and the data provenance
Not applicable. The submission is for a mechanical surgical device, not a data-driven diagnostic tool. Performance equivalence was likely assessed through bench testing and comparison of design specifications with the predicate device. No "test set" in the context of data points is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is not an AI/ML device, there is no mention of expert-established ground truth for a test set in this document.
4. Adjudication method for the test set
Not applicable. No "test set" in the context of data is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
Not applicable. MRMC studies are typically for diagnostic imaging software or similar devices involving human interpretation. This is a mechanical surgical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used
Not applicable. The "truth" here relates to the safety and effectiveness of the mechanical fixation system, assessed through engineering principles, material science, and comparison to a legally marketed predicate device, rather than a "ground truth" derived from expert labels or pathology.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is a mechanical device, not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of the Study Information Provided in the Document:
The document states: "Information and performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance."
- Study Type: This would have been an un-detailed equivalence study focused on showing that the new device (Short Shaft Straight-In Bone Screw Fixation System) performs comparably to the predicate device (Straight-In Bone Screw System, K972622).
- Nature of Study: Given the device type (mechanical bone screw), this likely involved:
- Mechanical bench testing: To compare properties like screw strength, pull-out force, material properties, and dimensional conformity.
- Design analysis: A review of the design and materials to confirm their identity or equivalence to the predicate.
- Clinical rationale: Justification for the shorter inserter not negatively impacting performance, potentially through physician feedback or direct observation during simulated use.
- Key Finding: The only stated difference between the new device and the predicate is the shorter inserter for improved maneuverability. The 510(k) summary asserts that this difference does not alter the fundamental technological characteristics or performance of the device in comparison to its predicate.
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AUG 3 1 1998
510(k) Summary of Safety and Effectiveness Influence, Inc.'s Short Shaft Straight-In Bone Screw Fixation System 510(k) Number K982155
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 bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. The Short Shaft Straight-In Bone Screw Fixation System is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region 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, sling procedure for male stress urinary incontinence resulting from prostatectomy).
The Short Shaft Straight-In Bone Screw Fixation System is substantially equivalent to Influence, Inc.'s Straight-In Bone Screw System cleared under K972622. The design and materials of the Short Shaft Straight-In and Straight-In systems are identical. The only difference is that the Inserter of the Short Straight-In device is shorter to serve the needs of users who prefer the maneuverability of a shorter device in open surgical procedures.
Information and performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance.
Based on the information provided, the Short Shaft Straight-In Bone Screw Fixation System is substantially equivalent to the Straight-In device with respect to intended use, technological characteristics, and performance.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three lines forming the body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 | 1998
Peter A. Bick, M.D. President and CEO Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105
K982155 Re: Short Shaft Straight-In Trade Name: Bone Screw Fixation System Regulatory Class: II Product Codes: MBI and HWC Dated: June 18, 1998 Received: June 18, 1998
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, Druq, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 - 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 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,
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): | K982155 |
|---|---|
| Device Name: | Short Shaft Straight-In Bone Screw System |
| Indications for Use: | The Short Shaft Straight-In Bone Screw Fixation System is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region 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, sling procedure for male stress urinary incontinence resulting from prostatectomy). |
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General and Restorative Devices
510(k) Number
X Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use_
ApcOeele
B
(Division Sign-Off) Division of General Re 510(k) Number
\\DC - 65853/3 - 0667455.01
§ 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.