(30 days)
Not Found
No
The description focuses on mechanical components (motorized inserter, bone screws, suture) and their intended surgical use for soft tissue fixation. There is no mention of AI, ML, image processing, or data-driven decision-making.
No
The device is used for soft tissue fixation to bones, which is a structural repair rather than a direct therapeutic intervention for disease treatment or prevention.
No
The device is described as a "Bone Screw System" intended for "soft tissue fixation to bones." Its purpose is to fix tissues, not to diagnose medical conditions or provide information about a patient's health status.
No
The device description explicitly states it consists of a "motorized inserter and bone screws with attached suture," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Straight-In Bone Screw System is a surgical device used for mechanical fixation of soft tissue to bone during surgical procedures. It involves physically implanting a screw and suture into the body.
- Intended Use: The intended use clearly describes a surgical procedure for fixing soft tissue to bone, not performing diagnostic tests on biological samples.
The device is a surgical implant/instrument, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Straight-In Bone Screw 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 or laparoscopic 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).
Product codes
MBI, HWC, GAT
Device Description
The Straight-In Bone Screw System consists of a motorized inserter and bone screws with attached suture. It 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 or laparoscopic surgical procedures where soft tissue fixation to bones in the pelvic region is needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic region (e.g., pubic, sacral, etc.)
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 Straight-In system. The suture complies with the USP Monograph for Non-Absorbable Sutures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
| Submitter's Name: | American Medical Systems, Inc. | MAR 1 3 2002 |
|---|---|---|
| Address: | 10700 Bren Road West | |
| Minnetonka, MN 55343 | ||
| Tel: | 952-933-4666 | |
| Fax: | 952-930-6157 | |
| Contact Person: | Elsa A. Linke | |
| Date of Summary Preparation: | February 8, 2002 | |
| Device Common Name: | Bone Screw Inserter & Bone Screws | |
| Device Trade Name: | Straight-In Bone Screw Fixation System | |
| Device Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue | |
| Classification: Class II | ||
| Product Code: MBI | ||
| Predicate Device: | Straight-In Bone Screw Fixation System | |
| K972622 |
Device Description
The Straight-In Bone Screw System consists of a motorized inserter and bone screws with attached suture. It 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 or laparoscopic surgical procedures where soft tissue fixation to bones in the pelvic region is needed.
Indications for Use
The Straight-In Bone Screw 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 or laparoscopic 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).
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.
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020446
[510(k) Summary continued]
Supporting Information
The mechanical properties of the braided suture have been tested on the bench for The monatibility with the Straight-In system. The suture complies with the USP Monograph for Non-Absorbable Sutures.
Conclusion
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The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance characteristics.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings. The design is simple and conveys a sense of official government affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2002
Elsa A. Linke Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West Minnetonka, Minnesota 55343
Re: K020446
Trade/Device Name: Straight-In Bone Screw Fixation System Regulation Number: 21 CFR §888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, GAT Dated: February 8, 2002 Received: February 11, 2002
Dear Ms. Linke:
We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve lowe and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may) annovisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Page 2 - Ms. Elsa Linke
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This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 McMillan
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: | K020446 |
|---|---|
| Device Name: | Straight-In Bone Screw Fixation System |
| Indications for Use: | The Straight-In Bone Screw 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 or laparoscopic 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). |
(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
(Per 21 CFR801.109)
OR
Over the Counter Use
for
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number_