EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM by DEPUY SPINE, INC.

The EAGLE Plus Micro Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Device Description

The EAGLE Plus Micro Anterior Cervical Plate System consists of a variety of plates and screws designed for use alone or adjacent to a previously implanted anterior cervical plate.

The EAGLE Plus Micro Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "EAGLE Plus Micro Anterior Cervical Plate System." This is a premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive de novo clinical trials with acceptance criteria for device performance in the same way a new drug or novel high-risk device might.

Based on the provided text, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the traditional sense for this 510(k) submission. The document states "Performance data were submitted to characterize the EAGLE Plus Micro Anterior Cervical Plate System." However, it does not provide a table of acceptance criteria (e.g., minimum tensile strength, fatigue life, etc.) or reported device performance against specific criteria in the way a clinical study would report efficacy or accuracy.

For medical implants like this, performance data typically refers to:

Mechanical Testing: Benchtop tests for strength, fatigue, torsional stability, pull-out strength of screws, etc., demonstrating that the device meets relevant ASTM or ISO standards for medical implants and is comparable to the predicate device.
Biocompatibility Testing: Ensuring the materials are safe for implantation.
Sterilization Validation: Demonstrating the device can be effectively sterilized.

The 510(k) process primarily uses these types of data to show substantial equivalence to a predicate device, meaning it performs as safely and effectively as a device already on the market. The text does not provide the specific numerical results of these tests or their acceptance thresholds.

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

This information is not provided in the given text. For mechanical testing, the "sample size" would refer to the number of devices or components tested. The data provenance would be the laboratory where the tests were conducted. Since this is a hardware device, there wouldn't typically be a "test set" of patient data for clinical performance in a 510(k) submission unless clinical studies were specifically required (which is rare for Class II devices demonstrating substantial equivalence).

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

This information is not applicable as this submission is for a physical medical implant, not a diagnostic or AI-driven device requiring expert-established ground truth from images or other patient data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as (3).

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

This information is not applicable. An MRMC study is relevant for diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images) where AI assistance might improve performance. This device is a surgical implant.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

This information is not applicable. For a surgical implant, the "ground truth" concept in the context of clinical efficacy would be observed patient outcomes, but these are not typically part of a 510(k) submission for substantial equivalence. Instead, the "truth" is that the device passes specific engineering and material standards and performs equivalently to a predicate device in benchtop testing.

8. Sample Size for the Training Set

This information is not applicable. This device is a physical implant, not an algorithm that requires a training set.

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

This information is not applicable for the same reasons as (8).

Summary of Device and 510(k) Approach based on provided text:

Device Name: EAGLE Plus Micro Anterior Cervical Plate System
Intended Use: Anterior cervical intervertebral body fixation following fusion, for stability.
Indications: Symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease, spinal stenosis, re-operation for failed fusion, or instability.
Levels: C2 to T1.
Materials: ASTM F-136 implant grade titanium alloy.
510(k) Strategy: The submission relies on demonstrating substantial equivalence to existing predicate devices (K070994 Eagle Plus Anterior Cervical Plate System and K914362 Acroplate Anterior Cervical Plate System).
"Study" type: "Performance data were submitted to characterize the EAGLE Plus Micro Anterior Cervical Plate System." This implies benchtop mechanical, material, and potentially biocompatibility testing to show that the new device performs comparably to the predicate devices and meets relevant industry standards for safety and effectiveness. The details of these tests, specific acceptance criteria, and observed performance values are not included in the provided 510(k) summary. The FDA's letter confirms a substantial equivalence determination based on these submissions.

Summary

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X. 510(k) Summary

SUBMITTER:	DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02780
CONTACT PERSON:	Frank S. Jurczak
DATE PREPARED:	January 24, 2008
CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis
PROPRIETARY NAME:	EAGLE Plus Micro Anterior Cervical Plate System
PREDICATE DEVICES:	K070994 Eagle Plus Anterior Cervical Plate System
	K914362 Acroplate Anterior Cervical Plate System(cleared as the Top Cervical Spine StabilizationSystem)
DEVICE DESCRIPTION:	The EAGLE Plus Micro Anterior Cervical PlateSystem consists of a variety of plates and screwsdesigned for use alone or adjacent to a previouslyimplanted anterior cervical plate.The EAGLE Plus Micro Anterior Cervical PlateSystem also contains Class 1 manual surgicalinstruments and cases that are considered exemptfrom premarket notification.
INTENDED USE:	The EAGLE Plus Micro Anterior Cervical PlateSystem is intended for anterior cervical intervertebralbody fixation. This system is indicated for patients inwhich stability is desired following anterior cervicalfusion for the indications listed below. The intendedlevels for treatment range from C2 to T1.Indications include symptomatic cervical spondylosis,trauma, fracture, post-traumatic kyphosis or lordosis,tumor, degenerative disc disease (defined asdiscogenic pain with degeneration of the discconfirmed by history and radiographic studies), spinalstenosis, re-operation for failed fusion, or instabilityfollowing surgery for the above indications.

DePuy Spine, Inc.
510(k)

APR - 2 2008

12080191
Page 1 of 2

Page 18

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K080191
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MATERIALS:

Manufactured from ASTM F-136 implant grade titanium alloy.

PERFORMANCE DATA:

Performance data were submitted to characterize the EAGLE Plus Micro Anterior Cervical Plate System.

DePuy Spine, Inc. 510(k)

Page 19

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Spine, Incorporated c/o Mr. Frank Jurczak Regulatory Affairs Associate 325 Paramount Drive Raynham, MA 02767

APR - 2 2008

Re: K080191 Trade/Device Name: Eagle Plus Micro Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 29, 2008 Received: March 3, 2008

Dear Mr. Jurczak:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Frank Jurczak

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mullen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K080191
page 1 of 1

IV. Indications for Use

K080191 510(k) Number (if known):

EAGLE Plus Micro Anterior Cervical Plate System Device Name:

Indications For Use:

Prescription Use: OR Over-The-Counter Use: _ (Per 21 CFR 801.109)

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.