The 2.8mm and 3.5mm ROC EZ 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 ELBOW 、バ - Tennis elbow repair 1. - Biceps tendon reattachment 2. - Medial and lateral repairs 3. BLADDER NECK SUSPENSION 1. Bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Device Description

The ROC EZ 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 and 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Innovasive ROC EZ Suture Bone Fastener, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the device is a medical implant and not an AI/software device, therefore, many of the requested fields are not applicable. I will provide information relevant to a medical device where possible.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Ultimate Holding Strength in Bone Model	Equivalent to the predicate device
Material Composition	High-density polyethylene and polysulfone
Mechanism of Fixation	Expander draws into sleeve, expanding it against bone, then shear pin shears.
Sterilization Status (Fastener)	Sterile, single-use
Sterilization Status (Instrumentation)	Reusable, autoclavable
Intended Use	Reattachment of soft tissue to bone (specific indications listed for shoulder, knee, ankle, foot, elbow, and bladder neck suspension)

2. Sample Size Used for the Test Set and Data Provenance

The provided text only refers to "Bone model testing" without specifying the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable for this type of device. The ground truth for device performance, in this case, is based on physical testing against defined material and mechanical properties, not expert interpretation of data.

4. Adjudication Method

Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or assessment, not physical device performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a physical implant, not an AI or software-assisted diagnostic tool that would involve human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

The ground truth for the "Bone model testing" would be the physical measurement of ultimate holding strength in a standardized bone model, as well as the material specifications of the device components.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned or implied for this type of physical device performance testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this context.

Study Description (Based on Provided Information)

The study was a bone model testing study comparing the modified Innovasive ROC EZ Suture Bone Fastener to its predicate device. The primary objective was to demonstrate equivalent ultimate holding strength between the two devices in a bone model.

Limitations of Information:

The provided 510(k) summary is very brief regarding the performance data. It states: "Bone model testing: Comparison of the ultimate holding strength in a bone model compared to the predicate device. The Innovasive ROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device."

This statement confirms that a study was conducted and met its (implied) acceptance criterion of equivalence, but it lacks critical details for a comprehensive report, such as:

Specifics of the bone model used (e.g., synthetic bone, cadaveric bone).
Number of samples tested for both the modified and predicate device.
Statistical methodology used to determine "equivalence."
Definition of "ultimate holding strength" and how it was measured.
Any predefined acceptance limits for equivalence.
Any other performance aspects tested (e.g., torque, deployment force, fatigue).

Summary

{0}------------------------------------------------

K971922 1 of 2

510(K) SUMMARY

AUG - 7 1997

1. SUBMITTER:

Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229

Contact: Stephen M. Page, Manager of Regulatory Affairs Date Prepared: May 21, 1997

2. DEVICE:

。「・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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

3. PREDICATE DEVICE:

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

4. DEVICE DESCRIPTION:

In addition to the Fastener, a stainless steel drill and 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.

5. INTENDED USE:

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

C.P.I.A.

{1}------------------------------------------------

K971922 2 af 2

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

Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament,

posterior oblique ligament, joint capsule closure.

Patellar ligament and tendon avulsion repairs.
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

ELBOW

、

バ

Tennis elbow repair 1.
Biceps tendon reattachment 2.
Medial and lateral repairs 3.

BLADDER NECK SUSPENSION

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

6. COMPARISON OF CHARACTERISTICS:

The existing Innovasive Devices ROC EZ Suture Bone Fastener is comprised of two polymer components, high density polyethylene and acetyl plastic. This device is used to secure a 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 modified ROC EZ device is comprised of high density polyethylene and polysulfone. As with the predicate device, the modified ROC EZ uses an expander fitted on a shear pin which is drawn up into an expandable 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. Bone model testing: Comparison of the ultimate holding strength in a bone model compared to the predicate device. The Innovasive ROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.
  Children Children Children Children Children Children Children Children Station Children Station Children Station Children Station Children Station Children Station Children

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

. -

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen M. Page 'Manager of Regulatory Affairs Innovasive Devices, Inc. 734 Forest Street Marlborough, Massachusetts 01752

Re : K971922 Innovasive 2.8mm and 3.5mm ROC™ EZ Suture Bone Fastener Requlatory Class: II Product Codes: MBI and HRX Dated: May 21, 1997 Received: May 23, 1997

Dear Mr. Page:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Image /page/2/Picture/8 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three heads, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the eagle in a circular fashion.

AUG - 7 1997

{3}------------------------------------------------

Page 2 - Mr. Stephen M. Page

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D. M.D.

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

SHOULDER

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

KNEE

Extra-capsular repairs reattachment of medial collateral ligament reattachment of lateral collateral ligament reattachment of posterior oblique ligament joint capsule closure patellar ligament and tendon avulsion repairs extra-capsular reconstruction ITB tenodesis.

ANKLE

Lateral and medial instability : achilles tendon reconstruction and repair mid-foot reconstructions.

FOOT

Hallux valgus reconstruction

ELBOW

Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs

BLADDER NECK SUSPENSION

Bladder neck suspension for temale urinary incontinence due to urethral hypermobility.

bcoello

Prescription Use
(Per 21 CFR 801.109)

Division Sign-Off
Division of General Restorative Devices
510(k) Number K971922

0094

Regulation Number and Section

§ 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.