EBI XFIX DFS OPTIROM ELBOW FIXATOR

• K Number: K992515
• Device Name: EBI XFIX DFS OPTIROM ELBOW FIXATOR
• Manufacturer: EBI, L.P.
• Date Cleared: 1999-08-17 ( 20 days)
• Product Code: KTT
• Regulation Number: 888.3030
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: K020403 , K021312

Intended Use

The EBI XFIX DFS® OptiROM™ Elbow Fixator external fixation device is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:
Fracture dislocation with ligamentos instability
Comminuted intra-articular fractures
Post traumatic reconstruction for joint stiffness

Device Description

The EBI XFIX DFS OptiROM Elbow Fixator has not changed the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX DFS OptiROM Elbow Fixator is utilized in the following manner: bone screws are inserted through the patient skin and soft tissue and into the bone. The fixator frame of the EBI XFIX DFS OptiROM Elbow Fixator is attached to the shanks of the bone screws.

AI/ML Overview

The provided 510(k) summary does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of medical devices like AI algorithms or diagnostic tools. This 510(k) is for a mechanical external fixation device, not a software or AI-driven diagnostic product.

Here's a breakdown of why this information is absent and what the document does provide:

• Type of Device: The EBI XFIX DFS® OptiROM™ Elbow Fixator is a mechanical external fixation device used for stabilizing bones in the upper extremity. Such devices are typically evaluated based on their mechanical properties (e.g., strength, durability, biocompatibility of materials), design similarity to predicate devices, and manufacturing processes, rather than diagnostic performance metrics like sensitivity, specificity, or AUC.
• 510(k) Process: For this type of device, the 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves comparing design, materials, intended use, and fundamental scientific technology. Clinical studies demonstrating diagnostic performance or reader improvement are generally not required for this type of submission unless there are significant technological differences or new safety/effectiveness concerns.

Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this specific submission.

What the document does indicate regarding "device performance" (in the context of substantial equivalence):

The document argues for substantial equivalence by stating:

• "The EBI XFIX DFS OptiROM™ Elbow Fixator is substantially equivalent to the following predicate EBI and competitive devices."
• "The components of the EBI XFIX DFS OptiROM Elbow Fixator are fabricated from the same types of materials as the components of the currently marketed EBI XFIX DFS Joint Fixator."
• "The bone screw clamps... are designed for attachment to the bone screws," similar to the predicate.
• "The Distractor... is designed to provide the surgeon the ability to compress or distract the bone of the patient for optimal treatment," similar to the predicate.
• "It is substantially equivalent to the predicate devices in regards to intended use, materials and function."

In essence, the "proof" that this device meets acceptance criteria is its demonstration of substantial equivalence in design, materials, and function to previously cleared devices. There is no mention of a formal study with statistical endpoints to demonstrate improvement in human performance or standalone diagnostic accuracy because the device's function does not involve diagnostic interpretation.

Summary

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K992515_{1of2}

510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI XFIX DFS® OptiROM™ Elbow Fixator is provided as required per Section 513(I)(3) of the Federal Food, Drug and Cosmetic Act.

1. Sponsor:	EBI, L.P.100 Interpace ParkwayParsippany, NJ 07054	Contact Person: Jonas WilfTelephone: [phone]
Date prepared: July 25, 1999
2. Proprietary Name:	EBI XFIX DFS® OptiROM™ ElbowFixator
Common Name:	External Fixation Device
Classification Names:	Single Multiple Component MetallicBone Fixation Appliances andAccessories, 21 CFR 888.3030.

3. Predicate or legally marketed devices that are substantially equivalent:

• EBI XFIX DFS Joint Fixator Electro-Biology, Inc. 트
• Description of the device: The EBI XFIX DFS OptiROM Elbow Fixator has not 4. changed the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX DFS OptiROM Elbow Fixator is utilized in the following manner: bone screws are inserted through the patient skin and soft tissue and into the bone. The fixator frame of the EBI XFIX DFS OptiROM Elbow Fixator is attached to the shanks of the bone screws.
• 5. Intended Use: The EBI XFIX DFS® OptiROM Elbow Fixator external fixation device is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:

Fracture dislocation with ligamentos instability Comminuted intra-articular fractures Post traumatic reconstruction for joint stiffness

• Materials: The components of the system may be manufactured from materials such as 6. Aluminum, Stainless Steel, Pyromet® 718, and Ti-6A1-4V ELI.

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K99 2515 20f2

• 7. Comparison of the technological characteristics of the device to predicate devices:
  • The EBI XFIX DFS OptiROM™ Elbow Fixator is substantially equivalent to the . following predicate EBI and competitive devices. The components of the EBI XFIX DFS OptiROM Elbow Fixator are fabricated from the same types of materials as the components of the currently marketed EBI XFIX DFS Joint Fixator.
  • The bone screw clamps of the EBI XFIX DFS OptiROM Elbow Fixator, like the . bone screw clamps currently marketed EBI XFIX DFS Joint Fixator, are designed for attachment to the bone screws.
  • . The Distractor of the EBI XFIX DFS OptiROM Elbow Fixator, like the currently marketed EBI XFIX DFS Joint Fixator, is designed to provide the surgeon the ability to compress or distract the bone of the patient for optimal treatment.

The EBI XFIX DFS OptiROM Elbow Fixator like the currently marketed EBI XFIX DFS Joint Fixator is provided non-sterile. There are no significant differences between the EBI XFIX DFS OptiROM Elbow Fixator and other currently marketed external fixation systems. It is substantially equivalent* to the predicate devices in regards 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 market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence intigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 17 1999

Mr. Jon Caparotta Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054-1079

Re: K992515

Trade Name: EBI XFIX DFS® OptiRom™ Elbow Fixator Regulatory Class: II Product Code: KTT Dated: July 25, 1999 Received: July 28, 1999

Dear Mr. Caparotta:

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 control provisions of the Act. The general control 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 Regulations, 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.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Mr. Jon Caparotta

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell J. Sayre
C. Lin McWhirter, Ph.D., M.D.

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

Enclosure

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Statement of Indications for Use:

The EBI XFIX DFS® OptiROM™ Elbow Fixator external fixation device is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:

• Fracture dislocation with ligamentos instability. 1.
• 2. Comminuted intra-articular fractures.
• 3. Post traumatic reconstruction for joint stiffness.

Russell S. Ayres Jr.

Prescription Use
(Per 21 CFR 801.109)

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.