(89 days)
Not Found
Not Found
No
The summary describes a mechanical bone anchor system and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
Explanation: The device is intended for soft tissue reinforcement and support for conditions like urinary stress incontinence, urethral and vaginal prolapse repair, and pelvic floor reconstruction, which are therapeutic interventions.
No
Explanation: The Intended Use describes the device as a bone anchor system for soft tissue reinforcement and support in surgical procedures, not for diagnosis.
No
The device is described as a "Bone Anchor System" intended for surgical procedures involving the placement of a bone anchor. This description strongly implies a physical, implantable device, not a software-only product. The lack of any mention of software in the provided text further supports this conclusion.
No, 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 body for treating conditions like urinary stress incontinence and pelvic organ prolapse. This is a therapeutic use, not a diagnostic one.
- Device Description (Not Found, but implied): While the description is missing, the intended use strongly suggests a physical implantable device, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory results.
IVDs are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support and repair within the body.
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 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
Product codes (comma separated list FDA assigned to the subject device)
87 HWC, 79 GAW, MBI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 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
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 Classification | |
| and Name: | Boston Scientific Corporation believes the proposed |
| device combines devices classified as Class II: | |
| • CFR 888.3040; Smooth or threaded metallic bone fixation | |
| fastener; Procode: 87 HWC | |
| • CFR 878.5000; Nonabsorbable poly surgical suture; | |
| Procode: 79 GAW | |
| Substantial | |
| Equivalence: | The proposed devices are Substantially Equivalent to the |
| predicate currently marketed devices indicated for use as a Bone | |
| Anchor System intended for soft tissue support. | |
| Product Testing: | 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. |
- "
ﺔ ﺑﻬﺎ ﺇﻟﻰ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
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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
3
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| 4 км². Председанское седать продавические придементавия полициальность чельность чельность в | |
|---|---|
| ---------------------------------------------------------------------------------------------- | -- |
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