The Endius Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and /or failed previous fusions.

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The Endius Cervical Plate System is a set of implants designed to be implanted via an anterior approach to the cervical spine. The system includes various plates and screws manufactured from Titanium. The material used in the manufacture of the components in the Endius Cervical System meets ASTM F136 for Ti 6A1-4VELI.

AI/ML Overview

The provided text describes a 510(k) summary for the Endius Cervical Plate System, focusing on its substantial equivalence to a predicate device rather than presenting a study with detailed performance metrics against specific acceptance criteria. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of features and adherence to recognized standards for mechanical testing.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define explicit performance acceptance criteria in terms of clinical outcomes or specific quantitative measures for the device's function in a biological system. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device and meeting a standard for biomechanical testing.

Acceptance Criteria (Inferred from Substantial Equivalence and ASTM Standard)	Reported Device Performance (Summary from Submission)
Product Components Match Predicate	Plates of various lengths, 4mm screws, 4.3mm revision screws. (Identical to predicate)
Indications for Use Match Predicate	Intended for anterior interbody screw fixation of cervical spine for temporary stabilization during fusion in patients with degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis, and/or failed previous fusions. (Identical to predicate)
Materials Match Predicate	Titanium (Meets ASTM F136 for Ti 6A1-4VELI). (Identical to predicate)
Product Labeling Matches Predicate	Instructions for use and box labeling including all necessary warning statements. (Identical to predicate)
Packaging/Sterilization Matches Predicate	Non-sterile, single use only. (Identical to predicate)
Biomechanical Performance Meets Standard	Meets ASTM F1717 (Standard Specification for Implantable Bar, Plate, and Screw Devices for Internal Fixation Applications).

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

The submission does not describe a test set in the context of clinical data or human subjects. The "testing" mentioned refers to biomechanical testing of the device itself.

Sample Size: Not applicable in terms of clinical subjects. For biomechanical testing (ASTM F1717), the standard defines the number of samples required for various tests; however, the specific number of test articles (plates, screws, constructs) used by Endius is not specified in this summary.
Data Provenance: Not applicable for clinical data. The biomechanical testing would have been conducted in a lab environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This was a 510(k) submission based on substantial equivalence and biomechanical testing, not a clinical study requiring expert consensus for ground truth on patient outcomes or diagnoses.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring adjudication.

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

Not applicable. This submission concerns a spinal implant, not an AI or imaging diagnostic device. No MRMC study was conducted or is relevant to this type of device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

The "ground truth" for this submission is established through:

Predicate Device Comparison: The legal marketing status and safety/effectiveness history of the Window Dynamic Plate System (another Endius product) serves as a "ground truth" for substantial equivalence.
ASTM F1717 Standard: Adherence to this recognized consensus standard for biomechanical testing of spinal implants (specifically "Implantable Bar, Plate, and Screw Devices for Internal Fixation Applications") provides the "ground truth" for the mechanical integrity and performance of the device under simulated physiological conditions.

8. Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The design and testing of the device are based on engineering principles, material science, and established biomechanical standards, not on learning from a data set.

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

Not applicable, as there was no training set.

Summary

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K014107 1/3

FEB 1 3 2002

Section 7 - 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted 7.1 in accordance with the requirements of SMDA 1990 and CFR 807.92 Statement

7.2	Endius, Inc.
Submitter	23 West Bacon Street
	Plainville, MA 02762

7.3	Gene DiPoto
Company	VP of Engineering
Contact	508-643-0983 ext. 104

7.4	Proprietary Name:	Endius Cervical Plate System
Device Name	Common Name:	Anterior Cervical Plating System
	Classification Name:	Spinal Intervertebral Body Fixation Orthosis.(KWQ)

7.5
Predicate	The Endius Cervical Plate System is substantially equivalent to the Window
Legally	Dynamic Plate System Plate System manufactured by Endius, Inc. (Plainville,
MarketedDevices	MA.)

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K014107 2/3

7.6 The Endius Cervical Plate System is a set of implants designed to be implanted Device via an anterior approach to the cervical spine. The system includes various Description plates and screws manufactured from Titanium. The material used in the manufacture of the components in the Endius Cervical System meets ASTM F136 for Ti 6A1-4VELI.

7.7 The Endius Cervical Plate System is intended for anterior interbody screw Device fixation of the cervical spine. The system is indicated for use in the Indications and temporary stabilization of the anterior spine during the development of Intended use cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and /or failed previous fusions.

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine

7.8 The Endius Cervical Plate System is substantially equivalent to the Window Substantial Cervical Spinal System. Equivalence Following is a table that describes the features of the new and the predicate systems that indicate substantial equivalence. Testing was also completed as per ASTM F1717 in order to demonstrate equivalence.

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3/3 K014107

Device Name	The Endius Cervical PlateSystem	Window Cervical System
ProductComponents	Plates of various lengths, 4mmscrews, 4.3mm revision screws	Identical components with identicalspecifications
Indications for Use	See above	Identical
Materials	Titanium	Titanium
Product Labeling	Instructions for use and boxlabeling including all of thenecessary warning statements	Instructions for use and box labelingincluding all of the necessarywarning statements
Packaging/Sterilization	Non-sterile, single use only	Non-sterile, single use only
BiomechanicalTesting	Meets ASTM F1717	Meets ASTM F1717

7.9 Table of Substantial Equivalence

Applicant Geen Diloh

Date 12/12/01

112

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three horizontal lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2002

Mr. Gene DiPoto Vice President of Engineering Endius Incorporated 23 West Bacon Street Plainville, Massachusetts 02762

K014107 Re:

Trade Name: Endius Cervical Plate System Regulation Number: 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: December 12, 2001 Received: December 13, 2001

Dear Mr. DiPoto:

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. Gene DiPoto

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K014107

Device Name: Endius Cervical Plate System

Indications for Use:

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurence of CDRH, Office of Device Evaluation (ODE)

(Posted July 1, 1998)

(Optional Format 3-10-98)

Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_KO14107

Regulation Number and Section

N/A