(76 days)
Innovasive 3.5mm ROC Suture Bone Fastener
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No
The device description and performance studies focus on mechanical properties and surgical instrumentation, with no mention of AI or ML.
Yes
The device is intended for bladder neck suspension to treat female urinary incontinence, which is a medical condition, making it a therapeutic device.
No
The device is a surgical implant (suture bone fastener) used for bladder neck suspension, not for diagnosing a condition.
No
The device description clearly outlines a physical implantable device made of acetal plastic, along with associated stainless steel instrumentation (drill, drill guide, awl) and a polysulfone deployment handle. There is no mention of software as a component of the device or its function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an implantable soft tissue fixation device used for bladder neck suspension and soft tissue to bone repair. It is surgically implanted into the body to provide structural support.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the patient. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the 3.5mm ROC XS Suture Bone Fastener is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 3.5mm ROC XS Suture Bone Fastener is intended for for use in bladder neck suspension for female urinary incontinence due to urethral hypermobility.
Product codes
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Device Description
The Innovasive Rotator Cuff Fastener is an implantable soft tissue fixation device complete with the instrumentation needed to effect soft tissue to bone repair. The devices consist of a three component system comprised entirely of acetal plastic. The Fastener is deployed through the use of a deployment handle made of molded polysulfone. The Fastener is deployed into the bone by causing a crown component to cam over a stationary anvil causing the fingers of the device to spread. The Fastener comes with various non-absorbable suture material.
In addition to the Fastener, a stainless steel drill, drill guide and awl are available to establish the proper hole for in the bone for the Fastener. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.
The Tastener will be available as a sterile, succe in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.
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
bladder neck
Indicated Patient Age Range
female
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)
- Bone model testing: Comparison of the ultimate holding strength and the strength with #2 suture in a bone model compared to the predicate device. The Innovasive 3.5mm ROC XS suture bone fastener holding strength was found to be equivalent to the strength of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Innovasive 3.5mm ROC Suture Bone Fastener
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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FEB 2 4 1997
1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229
Contact: Eric Bannon. Vice President of Quality Assurance and Regulatory Affairs Date Prepared: December 4, 1996
2. DEVICE:
Innovasive 3.5mm ROC XS Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices ROC Suture Bone Fastener
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the Innovasive Devices 3.5mm ROC XS Suture Bone Fastener was the Innovasive 3.5mm ROC Suture Bone Fastener
4. DEVICE DESCRIPTIONS:
The Innovasive Rotator Cuff Fastener is an implantable soft tissue fixation device complete with the instrumentation needed to effect soft tissue to bone repair. The devices consist of a three component system comprised entirely of acetal plastic. The Fastener is deployed through the use of a deployment handle made of molded polysulfone. The Fastener is deployed into the bone by causing a crown component to cam over a stationary anvil causing the fingers of the device to spread. The Fastener comes with various non-absorbable suture material.
In addition to the Fastener, a stainless steel drill, drill guide and awl are available to establish the proper hole for in the bone for the Fastener. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.
The Tastener will be available as a sterile, succe in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.
1
5. INTENDED USE:
The 3.5mm ROC XS Suture Bone Fastener is intended for for use in bladder neck suspension for female urinary incontinence due to urethral hypermobility.
6. COMPARISON OF CHARACTERISTICS:
The Innovasive Devices Rotator Cuff Fastener is comprised of acetal plastic. This device is used to secure suture in a predrilled hole in bone. It remains fixed in the bone through the spreading of the fingers of a crown component resulting in an inverted umbrella design.
The Innovasive Devices ROC Suture Bone Fastener is comprised of two polymer components, high density polyethylene and acetyl plastic. This device is used to secure suture in a predrilled hole in bone. It remains fixed in the bone through radial compression as the device is deployed. This remains true for all sizes of the device.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- Bone model testing: Comparison of the ultimate holding strength and the strength with #2 suture in a bone model compared to the predicate device. The Innovasive 3.5mm ROC XS suture bone fastener holding strength was found to be equivalent to the strength of the predicate device.