The EBI® XFIX® DFS® System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Device Description

The System consists of fixation components and implantable bone screws. The EBI® XFIX® DFS® System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue, and into the bone. The fixator frame of the EBI® XFIX® DFS® System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of modified self-drilling and blunt-tipped bone screws to the System. The components of the System may be manufactured from materials such as Aluminum, Stainless Steel, Cobalt Chrome, Carbon Fiber, and Titanium Alloy.

AI/ML Overview

This looks like a 510(k) summary for a medical device modification, not a study report that would include detailed acceptance criteria and performance data as requested. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through clinical studies in the way a new, innovative device might.

Therefore, many of the requested items (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of document because the submission is for a modification of an already cleared device and relies on showing it's as safe and effective as the predicate.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) summary. This document asserts substantial equivalence, meaning the modified device performs comparably to the predicate device, rather than fulfilling specific, novel performance criteria demonstrated through new testing. The "acceptance criteria" here are essentially "is substantially equivalent to the predicate device."

Acceptance Criteria	Reported Device Performance
Substantial equivalence to EBI® XFIX® DFS® System (K953406) in:	The modified EBI® XFIX® DFS® System is fabricated from the same materials.
- Materials	The modified EBI® XFIX® DFS® System has the same indications for use.
- Intended Use	The bone screw clamps are designed for attachment to bone screws, similar to the predicate.
- Function (specifically, bone screw clamps)	The additional component is provided non-sterile, like components of the predicate.
- Sterility (of additional component)	There are no significant differences in intended use, materials, and function.

2. Sample Size for the Test Set and Data Provenance

Not applicable. This is a 510(k) for a device modification (addition of modified self-drilling and blunt-tipped bone screws). No new clinical test set or data provenance is detailed, as the primary argument is substantial equivalence to a previously cleared device. New clinical data is typically not required for such modifications unless there are significant changes to the intended use or technology that raise new safety or effectiveness concerns.

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

Not applicable. No new test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This document does not describe any MRMC study. These types of studies are more common for diagnostic imaging AI devices, which is not what this device is.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done

Not applicable. This is a physical external fixation system, not an algorithm, so "standalone performance" in the AI sense does not apply.

7. Type of Ground Truth Used

Not applicable. As no new clinical study data is presented, no ground truth types are mentioned. The ground for approval here is the previously cleared predicate device.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or software device that utilizes a training set.

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

Not applicable. This is a physical medical device, not an AI or software device that utilizes a training set and ground truth.

Summary

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OCT 2 5 2002

Special 510(k) Device Modification: EBI® XFIX® DFS® Fixation System

KC23349
page 1 of 2

510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI® XFIX® DFS® System is provided as required per Section 513(1)(3) of the Federal Food. Drug and Cosmetic Act.

1. Sponsor: Contact Person: Frederic Testa, RAC EBI, L.P. Telephone: (973) 299-9300, ext.2208 100 Interpace Parkway Parsippany, NJ 07054
  Date Prepared: October 7, 2002

2. Proprietary Name:	EBI® XFIX® DFS® System
Common Name:	External Fixation Device
Classification Name:	Single Multiple Component Metallic Bone FixationAppliances and Accessories, 21 CFR 888.3030.

3. Predicate or Legally Marketed Device:

EBI® XFIX® DFS® System (K953406) .

4. Description of Device:

5. Intended Use:

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6. Materials:

The components of the System may be manufactured from materials such as Aluminum, Stainless Steel, Cobalt Chrome, Carbon Fiber, and Titanium Alloy.

7. Comparison of the technological characteristics of the device to predicate devices:

The modified EBI® XFIX® DFS® System is substantially equivalent to the following predicate device:

EBI® XFIX® DFS® System (K953406)

The modified EBI® XFIX® DFS® System is fabricated from . the same materials as the components of the currently marketed EBI® XFIX® DFS® Fixation System.
The modified EBI XFIX® DFS® System and the currently marketed EBI® . XFIX® DFS® System are both indicated for the treatment of bone conditions, including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
The bone screw clamps of the modified EBI® XFIX® DFS® System, like . the bone screw clamps currently marketed in the EBI® XFIX® DFS® System, are designed for attachment to the bone screws.
The additional component of the EBI® XFIX® DFS® System, like the ● components of the currently marketed EBI® XFIX® DFS® System, is provided non-sterile.
There are no significant differences between the modified EBI® XFIX® ● DFS® System and the currently marketed EBI® XFIX® DFS® System. It is substantially equivalent* to the predicate device with regard to intended use, materials, and function.

*Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977. FR 42520 (Docket No. 76N-0355.)]

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing people or families, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2 5 2002

EBI. L.P. Frederic Testa, RAC Regulatory Affairs Specialist 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K023399

Trade/Device Name: EBI® XFIX® DFS® System Regulation Number: 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: KTT Dated: October 8, 2002 Received: October 9, 2002

Dear Mr. Testa:

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. Frederic Testa

This Jetter 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" (21 CFR 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,

K-Mark A. Millbex

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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STATEMENT OF INDICATIONS FOR USE

Page

510(k) Number (if known): 112359 Device Name: EBI® XFIX® DFS® System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Mark A. Milliman

Division Sign. Of Divis : in rative and Neurological Devices

510(k) Number _K023399

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.