(67 days)
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No
The device description and performance studies focus on mechanical properties and surgical technique, with no mention of AI/ML components or data analysis.
Yes
The device is intended for bladder neck suspension to treat female urinary incontinence, which is a therapeutic purpose.
No
The device is described as an implantable soft tissue fixation device used for bladder neck suspension, indicating it is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines a physical implantable device (fastener) and associated surgical instrumentation made of various materials like polyethylene, acetyl, polysulfone, and stainless steel. It is not a software-only device.
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 for diagnosis, monitoring, or screening.
- Device Description: The ROC fastener is an implantable surgical device used to fix soft tissue to bone. It is used in the body during a surgical procedure, not to test specimens outside the body.
- Intended Use: The intended use is for bladder neck suspension for female urinary incontinence, which is a surgical procedure, not a diagnostic test.
The information provided clearly describes a surgical implant and associated instrumentation, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The ROC fastener is intended for bladder neck suspension for female urinary incontinence due to urethral hypermobility.
Product codes
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Device Description
The Innovasive ROC Suture Bone 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 high density polyethylene cartridge with an acetyl drive pin which is deployed into a pre-drilled hole in the bone. The Fastener is deployed through the use of a deployment handle made of molded polysulfone. The Fastener also has a stainless steel drive tool inside the cartridge which shears the implantable Fastener when deployed by the handle. The Fastener comes with various non-absorbable suture material.
In addition to the Fastener, a stainless steel drill guide is available to establish the proper hole for in the bone for the Fastener. A stainless steel and polysulfone extractor is included which can be used to remove the deployed Fastener should it be necessary. 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 Fastener will be available as a sterile, single use device. 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
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Indicated Patient Age Range
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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)
Cadaver study: Comparison of the ultimate holding strength in the bone indicated compared to the predicate device. The Innovasive Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device at a .01 significance level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Mitek GII Anchor
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.
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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.
0
NOV 1 1996
510(k) SUMMARY
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: August 25, 1996
2. DEVICE:
Innovasive 2.8mm and 3.5mm ROC 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 2.8mm and 3.5mm Roc Suture Bone Fastener was the Mitek GII Anchor, marketed by Mitek Surgical, Norwood, MA.
4. DEVICE DESCRIPTIONS:
The Innovasive ROC Suture Bone 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 high density polyethylene cartridge with an acetyl drive pin which is deployed into a pre-drilled hole in the bone. The Fastener is deployed through the use of a deployment handle made of molded polysulfone. The Fastener also has a stainless steel drive tool inside the cartridge which shears the implantable Fastener when deployed by the handle. The Fastener comes with various non-absorbable suture material.
In addition to the Fastener, a stainless steel drill guide is available to establish the proper hole for in the bone for the Fastener. A stainless steel and polysulfone extractor is included which can be used to remove the deployed Fastener should it be necessary. 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.
1
The Fastener will be available as a sterile, single use device. Both sutured and sutureless versions will be marketed.
5. INTENDED USE:
The ROC fastener is intended for bladder neck suspension for female urinary incontinence due to urethral hypermobility.
6. COMPARISON OF CHARACTERISTICS:
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.
The Mitek Mini Anchor is comprised of titanium with nitinol arcs. The arcs are imbedded in bone when placed in the predrilled hole. The intended use of the Mitek GII Anchor and the Innovasive ROC Fasteners are identical.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- l . Cadaver study: Comparison of the ultimate holding strength in the bone indicated compared to the predicate device. The Innovasive Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device at a .01 significance level.