(185 days)
Ethicon USB 4841-14-11
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No
The document describes a mechanical implant and associated tools for soft tissue fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an implantable soft tissue fixation device intended for the reattachment of ligaments, which qualifies it as a therapeutic device designed to treat or alleviate a medical condition.
No
The device is an implantable fastener used for reattachment of ligaments, not for diagnosing conditions.
No
The device description explicitly details physical components such as an implantable fastener, deployment handle, drive tool, drill guide, and extractor, all made of various materials like polyethylene, acetal, polysulfone, and stainless steel. This indicates it is a hardware medical device, not software-only.
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, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Innovasive Devices 1.9mm ROC Suture Bone Fastener is an implantable soft tissue fixation device. It is surgically placed in the body to reattach ligaments to bone.
- Intended Use: The intended use is for the reattachment of ligaments in the thumb and wrist. This is a surgical procedure performed directly on the patient's body, not on a specimen taken from the body.
The description clearly indicates a device used in vivo (within the living body) for structural support and repair, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Innovasive Devices 1.9mm ROC Suture Bone Fastener is intended for the reattachment of the ulnar collateral and lateral ligaments in the thumb and the scapholunate ligament in the wrist.
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 Fastener itself consists of a high density polyethylene cartridge with an acetal 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. The implantable Fastener when deployed by the handle 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 the Fastener in the bone. A stainless steel and polysulfone extractor is included which can be used to remove the deployed Fastener. 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 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
Thumb, wrist
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
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.
Key Metrics
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Predicate Device(s)
Ethicon USB 4841-14-11
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.
0
510(k) SUMMARY
I. SUBMITTER:
Innovasive Devices, Inc. 100B South St. Hopkinton, MA 01748 Telephone: 508-435-6000
MAR 2 1 1996
Contact: Eric Bannon, Director of Quality Assurance and Regulatory Affairs
Date Prepared: August 29, 1995 Date Prepared: August 29, 1995
2. DEVICE:
Innovasive 1.9mm ROC Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and
Taxle of the same accessories, accessories. Trade Name: Innovasive Devices ROC Suture Bone Fastener
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the Innovasive
Devices 1.9mm Roc Suture Bone Fastener was Ethioser USB 4841-14-11 and in the tale active Bone Fastener was Ethicon valence for the Inn.
Devices 1.9mm Roc Suture Bone Fastener was Ethicon USP #2/0 braided
Polyester suture with suture button polyester suture with suture button.
4. DEVICE DESCRIPTIONS:
The Innovasive ROC Suture Bone Fastener is an implantable soft tissue fixation
comin The instrumentation needed to offer to offer to for device of the instrumentation needed to effect soft tissue fixat
repaire complete with the instrumentation needed to effect soft tissue to bone repair instruments of a high density polyethyther soft tissue to bone in and tixation
drive pin which is deployed into a pre-drivene softridge with an acetal drive a mornees consist of a high density polyethylene cartise with onle
dever which is deployed into a pre-drilled hole in the bone. The Fastener is deployed through the use of a deployment handle made of mol and acent
The Fastener also has a stainless steel drive tool incided polysulfone.
The Fastener also has a stainles The implantable Fastener when stainless steel drive tool of the Pasceller is
the implantable Fastener when deployed by the handle polysufohe the implantable Fastener when deployed by the handle the cartridge which the implantable.
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 Features of establish the proper hole for in the bone for the Fastener. A stailable to
establish the proper hole for in the Fastener. A stainless steel and polysulfone extractor is included which can be used to remove the direct and r will as onlinetor is meluded which can be used to remove the deployed
be offered as reusable devices and can be autoclayor except the Fastener will be offered as reusable devices and can be autoclaved in the steples to be
be offered as reusable devices and can be autoclaved in the sterifization tray
provided for this pur provided for this purpose.
The Fastener will be available as a sterile. single use device in both an open and the and the with be wanable as a sterile. single use device in both an open a
rthroscopic version. Both sutured and sutureless versions will be marketed.
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11 11, 1995
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5. INTENDED USE:
The Innovasive Devices 1.9mm ROC Suture Bone Fastener is intended for the reattachment of the ulnar collateral and lateral ligaments in the thumb and the scapholunate ligament in the wrist.
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 Ethicon suture is comprised of braided polyester fibers and the suture button is comprised of molded polypropylene. The devices are used in conjunction with each other to reattach soft tissue to bone. The suture is passed through the bone and tissue and fixed with a suture button. This approximates the tissue to the bone to allow the final repair.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- 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.