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K Number
K970089
Device Name
INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER
Manufacturer
INNOVASIVE DEVICES, INC.
Date Cleared
1997-03-25

(74 days)

Product Code
MBI
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 2.8mm and 3.5mm ROC LF Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications: SHOULDER 1. Repair of rotator cuff tears 2. capsular instability 3. slap lesion repair 4. acromio-clavicular separation 5. capsule shift/capsulolabral reconstruction 6. biceps tenodesis 7. deltoid repair KNEE 1. Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament, posterior oblique ligament, joint capsule closure. 2. Patellar ligament and tendon avulsion repairs. 3. Extra-capsular reconstruction, ITB tenodesis ANKLE 1. Lateral instability 2. Medial instability 3. Achilles tendon reconstruction and repair 4. Mid-foot reconstructions FOOT 1. Hallux valgus reconstruction BLADDER NECK SUSPENSION 1. Bladder neck suspension for female urinary incontinence due to urethral hypermobility.
Device Description
The ROC LF suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve, the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole. In addition to the Fastener, a stainless steel drill guide is available to establish the proper hole in the bone for the Fastener along with an obturator, deployment handle and hole finder. 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 in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.
More Information

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Not Found

No
The device description focuses on the mechanical components and function of a suture bone fastener and associated instruments. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.

Yes.
The device is intended for the reattachment of soft tissue to bone for various medical conditions, including rotator cuff tears, ligament repairs, and bladder neck suspension, which are therapeutic interventions.

No

This device is a surgical fastener used for reattaching soft tissue to bone, which is a therapeutic function, not a diagnostic one.

No

The device description clearly details physical components like a shear pin, expander, sleeve, drill guide, obturator, deployment handle, and hole finder, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes the device as being used for the reattachment of soft tissue to bone for various surgical procedures in the shoulder, knee, ankle, foot, and bladder neck. This is a direct surgical intervention on the patient's body.
  • Device Description: The device description details a mechanical implant (fastener) and associated surgical instruments used to physically secure tissue to bone.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.

N/A

Intended Use / Indications for Use

The 2.8mm and 3.5mm ROC LF Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:

SHOULDER

    1. Repair of rotator cuff tears
    1. capsular instability
    1. slap lesion repair
    1. acromio-clavicular separation
    1. capsule shift/capsulolabral reconstruction
    1. biceps tenodesis
    1. deltoid repair

KNEE

  1. Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament, posterior oblique ligament, joint capsule closure.

  2. Patellar ligament and tendon avulsion repairs.

  3. Extra-capsular reconstruction, ITB tenodesis

ANKLE

    1. Lateral instability
    1. Medial instability
    1. Achilles tendon reconstruction and repair
  1. Mid-foot reconstructions

FOOT

  1. Hallux valgus reconstruction

BLADDER NECK SUSPENSION

  1. Bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Product codes

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Device Description

The ROC LF suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve, the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole.

In addition to the Fastener, a stainless steel drill guide is available to establish the proper hole in the bone for the Fastener along with an obturator, deployment handle and hole finder. 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 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

Shoulder, Knee, Ankle, Foot, Bladder Neck

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

  1. Cadaver study: Comparison of the ultimate holding strength in the humeral head and gleniod compared to the predicate device. The Innovasive ROC LF Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.

  2. Bone model testing: Comparison of the ultimate holding strength in the bone model compared to the predicate device. The Innovasive ROC LF 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): 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.

Innovasive Devices ROC Suture Bone Fastener

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

MAR 2 5 1997

K970089

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: December 16, 1996

2. DEVICE:

Innovasive 2.8mm and 3.5mm ROC LF Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices ROC LF Suture Bone Fastener

3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for the Innovasive Devices 2.8mm and 3.5mm Roc LF Suture Bone Fastener was the Innovasive Devices ROC Suture Bone Fastener, marketed by Innovasive Devices, Marlborough, MA.

4. DEVICE DESCRIPTIONS:

The ROC LF suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve, the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole.

In addition to the Fastener, a stainless steel drill guide is available to establish the proper hole in the bone for the Fastener along with an obturator, deployment handle and hole finder. All of the instrumentation except the Fastener

1

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.

5. INTENDED USE:

The 2.8mm and 3.5mm ROC LF Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:

SHOULDER

    1. Repair of rotator cuff tears
    1. capsular instability
    1. slap lesion repair
    1. acromio-clavicular separation
    1. capsule shift/capsulolabral reconstruction
    1. biceps tenodesis
    1. deltoid repair

KNEE

  1. Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament, posterior oblique ligament, joint capsule closure.

  2. Patellar ligament and tendon avulsion repairs.

  3. Extra-capsular reconstruction, ITB tenodesis

ANKLE

    1. Lateral instability
    1. Medial instability
    1. Achilles tendon reconstruction and repair
  1. Mid-foot reconstructions

FOOT

  1. Hallux valgus reconstruction

BLADDER NECK SUSPENSION

  1. Bladder neck suspension for female urinary incontinence due to urethral hypermobility.

2

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 ROC LF device consists of similar materials as the ROC fastener. It uses an expander fitted on a shear pin which is drawn up into an expanable sleeve. The sleeve expands as the expander is drawn up into it. The shear pin then shears resulting in the device being fixed into the bone site.

7. PERFORMANCE DATA:

The following performance data was provided in support of the substantial equivalence determination:

  1. Cadaver study: Comparison of the ultimate holding strength in the humeral head and gleniod compared to the predicate device. The Innovasive ROC LF Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.

  2. Bone model testing: Comparison of the ultimate holding strength in the bone model compared to the predicate device. The Innovasive ROC LF Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.