The EBI® XFIX® DFS® System is 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 external 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 carbon fiber material for the Central Body Component, Ankle Clamp, and T-Clamp.

AI/ML Overview

This document is a 510(k) summary for the modified EBI® XFIX® DFS® System, an external fixation device. It outlines the device's description, intended use, materials, and a comparison to a predicate device to establish substantial equivalence. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical or performance study for a diagnostic or AI-driven device would.

This 510(k) is for a modification to an existing, already cleared device (K953406). The modification involves adding carbon fiber material for certain components. The FDA’s review process for such modifications often focuses on showing that the new material does not significantly alter the device's safety or effectiveness compared to the predicate device, rather than requiring a new, comprehensive performance study with acceptance criteria and a detailed study design.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable or provided in this type of submission.

Here's a breakdown of the available information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not explicitly detailed in the way software or diagnostic device acceptance criteria would be presented. For this type of mechanical device modification, "acceptance" is primarily based on demonstrating substantial equivalence to a predicate device, meaning there are no significant differences in intended use, materials, and function that would raise new questions of safety or effectiveness.

Acceptance Criteria (Implied)	Reported Device Performance
Maintain intended use as predicate device	Intended use remains the same: "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."
Materials are substantially equivalent or safe for intended use	Components may be manufactured from materials such as aluminum, stainless steel, titanium alloy, and carbon fiber. (The modification adds carbon fiber, but this is presented as an equivalent material choice.)
Function is substantially equivalent to predicate device	"The bone screw clamps of the modified EBI XFIX DFS System, like the bone screw clamps currently marketed... are designed for attachment to the bone screws." There are "no significant differences... with regard to intended use, materials, and function."
Provided non-sterile, like predicate	"The additional component... is provided non-sterile."

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

Sample Size: Not applicable. There is no "test set" in the context of a clinical performance study as described for AI or diagnostic devices. The evaluation is based on material properties, design comparison, and functional assessment relative to the predicate.
Data Provenance: Not applicable.

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

Number of Experts: Not applicable.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable.

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

MRMC Study: No. This is not an MRMC study. It's a submission for a modification to a mechanical medical device, not a diagnostic imaging or AI-assisted system.

6. Standalone (Algorithm Only) Performance Study:

Standalone Study: No. This device does not involve an algorithm.

7. Type of Ground Truth Used:

Type of Ground Truth: Not applicable in the context of a "ground truth" for diagnostic accuracy. The "truth" in this submission relies on demonstrating that the modified device's materials and design result in equivalent performance and safety to the already-cleared predicate device. This would typically involve engineering analysis, material testing (not detailed in this summary), and a comparison against the predicate's established characteristics.

8. Sample Size for the Training Set:

Sample Size: Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

Ground Truth Establishment: Not applicable.

In summary:

This 510(k) submission (K031919) is for a modified external fixation device. The "study" proving the device meets acceptance criteria is primarily an engineering and regulatory comparison demonstrating substantial equivalence to a predicate device (K953406). The modification involves the addition of carbon fiber material for certain components. The acceptance criteria are implicitly met by showing that this material change does not alter the fundamental scientific technology, intended use, or safety/effectiveness of the device compared to the predicate. This is a common pathway for device modifications that do not introduce new risks or intended uses.

Summary

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Ko 3/1919

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510(k) Summary

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

1. Sponsor:	EBI, L.P.
	100 Interpace Parkway
	Parsippany, NJ 07054
Contact Person:	Peter Allan
Telephone:	(973) 299-9300, x3329
Date prepared:	June 20, 2003

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

3. Predicate or Legally Marketed Device:

EBI® XFIX® DFS® System EBI, L.P. (K953406) .

4. Description of the device:

5. Intended Use:

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K03/919
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6. Materials:

The components of the System may be manufactured from materials such as aluminum, stainless steel, titanium alloy, and carbon fiber.

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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that appears to be three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 4 2003

Mr. Peter Allan Regulatory Affairs Associate EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054

Re: K031919

Trade/Device Name: EBI® XFIX® DFS® System Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: KTT Dated: June 20, 2003 Received: June 23, 2003

Dear Mr. Allan:

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 (OS) 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. Peter Allan

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Mark n. Millerson

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

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Ko 31910 510(k) Number (if known): Device Name: EBI® XFIX® DFS® System

Indications For Use:

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.

Mark N. Melkerson

(Division Sign-Off) Dr. ision of General, Restorative and Neurological Devices

Kozigla 510(k) Number ________________________________________________________________________________________________________________________________________________________________

(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)

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.