(89 days)
No
The document describes a mechanical bone screw and inserter system and does not mention any AI or ML components.
Yes
The device is described as a bone screw and bone screw inserter intended for soft tissue fixation to the pubic bone for the treatment of stress type urinary incontinence. This direct application to treat a medical condition qualifies it as a therapeutic device.
No
The device is described as a bone screw and inserter for soft tissue fixation, intended for treatment of stress urinary incontinence. Its function is to fasten soft tissue to bone, which is a therapeutic rather than a diagnostic action.
No
The device description clearly outlines physical components (bone screw, bone screw inserter) and a surgical procedure, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue fixation to the pubic bone by means of bone screws with attached suture" for the treatment of stress urinary incontinence. This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details a bone screw and inserter used to physically anchor tissue to bone. This is a mechanical device used for surgical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant and instrument used directly on the patient's body.
N/A
Intended Use / Indications for Use
This 510(k) notification describes a bone screw and bone screw inserter intended for soft tissue fixation to the pubic bone by means of bone screws with attached suture. The In-Fast Bone Screw System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes
Not Found
Device Description
This 510(k) notification describes a bone screw and bone screw inserter intended for soft tissue fixation to the pubic bone by means of bone screws with attached suture. In both devices, fixation of soft tissue to bone is accomplished by a sharp tipped small diameter bone screw/anchor anchor threaded with polypropylene suture which is inserted pervaginally through soft tissue and into the pubic bone, without drilling holes or performing soft tissue dissection. The screw/anchor is loaded into an inserter which is positioned in the vagina. Pulling force is applied on the user handle to pass the screw/anchor's tip into the bone cortex. The inserter's safety lock is released and screw/anchor is inserted into the prescribed depth in the pubic bone. In the In-Fast system, the screw is threaded into the bone by the inserter's rotating shaft. In the UroTac system, the anchor is pushed into the bone by the spring-loaded inserter.
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)
Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k) cleared device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K962372, K932925, K920213, K953264
Reference Device(s)
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 of Safety and Effectiveness Influence, Inc.'s In-Fast Bone Screw System 510(k) Number K97-6292
APR
23
1997
This 510(k) notification is submitted by Influence, Inc., 601 Montgomery Street, Suite 845. San Francisco. California 94111. The contact person is Peter A. Bick, President & CEO.
This 510(k) notification describes a bone screw and bone screw inserter intended for soft tissue fixation to the pubic bone by means of bone screws with attached suture. The In-Fast Bone Screw System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The In-Fast Bone Anchor System is substantially equivalent to Influence. Inc.'s UroTac Bone Screw System cleared under K962372. The mechanical properties and technical procedure of the two systems are almost identical. In both devices, fixation of soft tissue to bone is accomplished by a sharp tipped small diameter bone screw/anchor anchor threaded with polypropylene suture which is inserted pervaginally through soft tissue and into the pubic bone, without drilling holes or performing soft tissue dissection. The screw/anchor is loaded into an inserter which is positioned in the vagina. Pulling force is applied on the user handle to pass the screw/anchor's tip into the bone cortex. The inserter's safety lock is released and screw/anchor is inserted into the prescribed depth in the pubic bone. In the In-Fast system, the screw is threaded into the bone by the inserter's rotating shaft. In the UroTac system, the anchor is pushed into the bone by the spring-loaded inserter. A cystourethropexy procedure is then performed which is identical for both the UroTac and In-Fast systems. Alternately, a transvaginal sling procedure may be performed using the In-Fast which is substantially equivalent to the in situ sling technique used in conjunction with the Vesica Suture Anchor System (K932925, Boston Scientific Corp., by its Microvasive division, the successor-in-interest to Vesica Medical, Inc., formerly Vesitec).
The Mitek GII Anchor (K920213), used in bladder neck suspensions, and the In-Fast bone screw have been proven to provide substantially equivalent fixation strength. The Ouestus "" Polyester Soft Tissue Anchor System (K953264 and K963200, Wright Medical Technologies, Inc.) is also used in bladder neck suspensions and closely resembles the screw used in the In-Fast system.
All materials used in the In-Fast Bone Screw System are either commonly used in medical applications or have been proven to be biocompatible through biocompatibility testing. Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k) cleared device.
Based on the information provided, the In-Fast Bone Screw System is substantially equivalent to the UroTac System with respect to intended use, technological characteristics, labeling, performance and surgical procedure. Also based on the
1
information provided, the In-Fast Bone Screw System is substantially equivalent to the Mitek GII Anchor with respect to intended use, technological characteristics and performance; the Vesica Suture Anchor System with respect to intended use, technological characteristics, performance and its use in the vaginal sling procedure; and the Questus™ Polyester Suture Soft Tissue Anchor with respect to intended use, technological characteristics and performance.