(85 days)
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No
The device description details a mechanical implant and associated instruments for surgical repair, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device's intended use is to protect sutures during rotator cuff repair, and its description focuses on its mechanical function in securing sutures within bone tunnels, not on directly treating a disease or condition for therapeutic benefit.
No
The device is described as an implantable component (ROClet) and associated instruments used to protect a suture during transosseous bone tunneling in rotator cuff repair. Its function is to facilitate the surgical procedure and protect the suture post-procedure, not to diagnose or detect a medical condition.
No
The device description clearly outlines physical components: an implantable ROClet, an insertion instrument, and an awl. It describes their materials, dimensions, and how they are used in a surgical procedure. There is no mention of software as a component of this device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ROClet's Intended Use: The ROClet's intended use is to protect a suture during a surgical procedure (rotator cuff repair). It is an implantable device used directly within the body during surgery.
- Device Description: The description clearly outlines a physical implant and surgical instruments used to place it within bone. There is no mention of analyzing biological specimens.
The ROClet is a surgical implant and associated instruments, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The intended use of the ROClet is to protect the suture during its use in transosseous bone tunneling in the repair of rotator cuff tears of the shoulder.
Product codes
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Device Description
The ROClet product consists of the implantable ROClet, an insertion instrument and an awl. The ROClet will be offered as a sterile single use device. The insertion instrument and awl will be offered as a non-sterile reusable instrument.
The ROClet consists of a molded component 2.8mm in diameter and 6.4mm long with a flange at one end and barbs along its length. The flange is intended to rest of the humeral head bone surface. The barbs are used to keep the device in place only until the suture is tied during the repair procedure. The ROClet is fitted with a nylon suture threader assembly placed in the ID of the device and is used to pass the sutures used during the tunnel procedure down the center of the ROClet until it is eventually tied during the repair.
The ROClet and suture threader assembly will be in a holding cartridge when received by the surgeon. The device is loaded onto the insertion instrument and removed from the cartridge. The sutures exiting the bone tunnel already established to repair the rotator cuff is passed through the suture threader assembly. The suture threader assembly with the suture is then withdrawn from the back of the ROClet and discarded. This results in the suture exiting the bone tunnel now passing through the center of the ROClet device and exiting the back of the device at its flanged end. If needed, the awl can be used to size the bone tunnel. This ensures the device works with all methods used to create a bone tunnel.
The ROClet, still on the insertion tool is then manually pressed into the bone tunnel. The ribbed end of the ROClet, now in the tunnel, aids in keeping the device in place while the end of the suture exiting the device is tied off and the repair completed. The tied suture ensures the device remains in place in the bone tunnel hole until the bone to tissue interface heals. One ROClet is used for each bone tunnel.
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
transosseous bone tunneling in the repair of rotator cuff tears of the shoulder.
Indicated Patient Age Range
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Intended User / Care Setting
surgeon
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 strength of suture with and without the ROClet placed in the bone tunnel. In addition, the cyclic loading with the device was characterized.
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.
The predicate device used to determine substantial equivalence for the Innovasive Devices ROClet was the 2mm GORE-TEX soft tissue patch, produced by W.L. Gore, Flagstaff, AZ.
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.
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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: February 4, 1997
2. DEVICE:
Innovasive 2.8mm x 6.4mm ROClet Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices ROClet
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the Innovasive Devices ROClet was the 2mm GORE-TEX soft tissue patch, produced by W.L. Gore, Flagstaff, AZ.
4. DEVICE DESCRIPTIONS:
The ROClet product consists of the implantable ROClet, an insertion instrument and an awl. The ROClet will be offered as a sterile single use device. The insertion instrument and awl will be offered as a non-sterile reusable instrument.
The ROClet consists of a molded component 2.8mm in diameter and 6.4mm long with a flange at one end and barbs along its length. The flange is intended to rest of the humeral head bone surface. The barbs are used to keep the device in place only until the suture is tied during the repair procedure. The ROClet is fitted with a nylon suture threader assembly placed in the ID of the device and is used to pass the sutures used during the tunnel procedure down the center of the ROClet until it is eventually tied during the repair.
The ROClet and suture threader assembly will be in a holding cartridge when received by the surgeon. The device is loaded onto the insertion instrument and removed from the cartridge. The sutures exiting the bone tunnel already established to repair the rotator cuff is passed through the suture threader assembly. The suture threader assembly with the suture is then withdrawn from the back of the ROClet and discarded. This results in the suture exiting the bone tunnel now passing through the center of the ROClet device and exiting the back
1
of the device at its flanged end. If needed, the awl can be used to size the bone tunnel. This ensures the device works with all methods used to create a bone tunnel.
The ROClet, still on the insertion tool is then manually pressed into the bone tunnel. The ribbed end of the ROClet, now in the tunnel, aids in keeping the device in place while the end of the suture exiting the device is tied off and the repair completed. The tied suture ensures the device remains in place in the bone tunnel hole until the bone to tissue interface heals. One ROClet is used for each bone tunnel.
5. INTENDED USE:
The intended use of the ROClet is to protect the suture during its use in transosseous bone tunneling in the repair of rotator cuff tears of the shoulder.
6. COMPARISON OF CHARACTERISTICS:
The Innovasive Devices ROClet is comprised of acetal plastic. This device is used to protect suture when used to complete a repair of the rotator cuff through the use of transosseous bone tunnels. The ROClet is placed into the bone tunnel and the suture passed through its center. This protects the suture from damage from the surrounding hole and prevents migration of the suture through the bone. An inserter is used to place the device and an awl is used to ensure each bone tunnel is appropriately sized to receive the device.
The 2mm GORE-TEX soft tissue patch is a square of material constructed of Goretex which is used as a pladget. The material is used to augment the strength of the bone and surrounding tissue by more evenly distributing the load from the sutures over a wider area.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- Bone model testing: Comparison of the ultimate strength of suture with and without the ROClet placed in the bone tunnel. In addition, the cyclic loading with the device was characterized.