(24 days)
Not Found
No
The summary describes a mechanical bone screw system for surgical fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
This device is used for soft tissue fixation via bone screws with attached sutures, which is a surgical procedure rather than a therapeutic treatment in the sense of delivering therapy.
No
The device is described as a system for soft tissue fixation using bone screws with attached suture, intended for surgical procedures like cystourethropexy and vaginal sling for urinary incontinence. Its purpose is to physically stabilize tissue, not to diagnose a condition.
No
The device description explicitly states it consists of a transvaginal inserter and bone screws with attached suture, which are physical hardware components.
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 procedure for soft tissue fixation to bone using screws and sutures. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device components (inserter, bone screws, suture) are all designed for surgical implantation and fixation within the body.
- 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 treatment.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is used in vivo for a surgical procedure.
N/A
Intended Use / Indications for Use
The In-Fast Bone Screw System is intended for soft tissue fixation to the publo bone by means of bone screws with attached suture. The In-Fast System is indicated for cystourethropexy and vaginal sling procedures for the cystouremropexy and vaginary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC, GAS
Device Description
The In-Fast Bone Screw System is intended for soft tissue fixation to the public bone by means of bone screws threaded with suture. It consists of a transvaginal inserter and bone screws with attached suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pubic bone
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 mechanical properties of the braided suture have been tested on the bench for compatibility with the In-Fast system. The suture complies with the USP Monograph for Non-Absorbable Sutures.
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.
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
JUL 1 3 2001
510(k) SUMMARY
Submitter's Name: American Medical Systems, Inc. Address: 10700 Bren Road West Minnetonka, MN 55343 Tel: 952-933-4666 Fax: 952-930-6157 Contact Person: Elsa A. Linke June 18, 2001 Date of Summary Preparation: Device Common Name: Bone Screw Inserter & Bone Screws Device Trade Name: In-Fast Bone Screw System Device Classification Name: Fastener, Fixation, Nondegradable, Soft Tissue Classification: Class II Product Code: MBI
Predicate Device:
In-Fast Bone Screw System K970292
Device Description
The In-Fast Bone Screw System is intended for soft tissue fixation to the public bone by means of bone screws threaded with suture. It consists of a transvaginal inserter and bone screws with attached suture.
Indications for Use
The In-Fast Bone Screw System is intended for soft tissue fixation to the public bone by means of bone screws with attached suture. The In-Fast System is indicated for cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Comparison to Predicate Device
The fundamental scientific technology of the device does not change with this modification. The only material change is the addition of braided suture to the device system.
[510(k) Summary continued]
1
Supporting Information
The mechanical properties of the braided suture have been tested on the bench for compatibility with the In-Fast system. The suture complies with the USP Monograph for Non-Absorbable Sutures.
Conclusion
The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance characteristics.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2001
Ms. Elsa A. Linke Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West Minnetonka, Minnesota 55343
Re: K011910
Device Name: In-Fast Bone Screw System Regulation Number: 21 CFR 888.3040 Regulatory Class: II Product Codes: HWC, MBI, GAS Dated: June 18, 2001 Received: June 19, 2001
Dear Ms. Linke:
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 legally marketed predicate 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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 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 - Ms. Elsa A. Linke
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 nredicate 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Mark N Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE ENCLOSURE
510(k) Number:
Koi 1916
Device Name:
In-Fast Bone Screw System
Indications for Use:
The In-Fast Bone Screw System is intended for soft tissue fixation to the publo bone by means of bone screws with attached suture. The In-Fast System is indicated for cystourethropexy and vaginal sling procedures for the cystouremropexy and vaginary 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 Sign-off) Division of General and Restorative Devices
510(k) Number __
Prescription Use X (Per 21 CFR801:109)
OR
Over the Counter Use_
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Mark N. Mulburn
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011916