(35 days)
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No
The summary describes a bone anchor system and its intended use for soft tissue reinforcement. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is described as a "bone anchor system" intended for "placement of a bone anchor for the purpose of soft tissue reinforcement and support" in various procedures to treat conditions like "urinary stress incontinence," "Urethral and Vaginal prolapse repair," and "reconstruction of the pelvic floor." These uses clearly indicate its role in treating or mitigating a disease, injury, or medical condition, thus qualifying it as a therapeutic device.
No
Explanation: The device is a bone anchor system intended for soft tissue reinforcement and support, not for diagnosing medical conditions.
No
The device description explicitly states "Bone anchor system," which is a hardware component used in surgical procedures. The intended use also describes the placement of a bone anchor, further indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to reinforce and support soft tissue in the pelvic floor for treating urinary stress incontinence and prolapse. This is a therapeutic and structural function within the body.
- Device Description: It's described as a "Bone anchor system," which is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / 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, Urethrovesical, Pubovaginal, and bladder neck support/stabilization; Urethral and Vaginal prolapse repair; and reconstruction of the pelvic floor.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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.
Microvasive Urology
| 510(k) SUMMARY of Safety and Effectiveness
| Section V. | |
|---|---|
| Sponsor: | Boston Scientific/ Microvasive |
| One Scientific Place | |
| Natick, MA 01760-1537 | |
| Contact Person: | Lorraine Hanley |
| Divisional Manager, Regulatory Affairs | |
| Submission Date: | January 28, 1999 |
| Common/Usual Name: | Bone anchor |
| Trade/Proprietary Name: | TBD |
| Device Classification | |
| and 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 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. | |
| Substantial | |
| Equivalence: | The proposed device is substantially equivalent to the predicate |
| legally marketed devices indicated for use as Bone Anchor Systems | |
| intended for soft tissue support. | |
| Product Testing: ` | 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. |
510(k) PreMarket Notification Bone Anchor System III 01/28/99
Confidential and Proprietary to Boston Scientific Corporation
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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.
2
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
3
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