EBI TROCHANTERIC NAIL SYSTEM by EBI, L.P.

The EB1® Trochanteric Nail is indicated for the treatment of fractures of the femur including: non-comminuted and comminuted midshaft fracture, subtrochanteric fracture, distal third fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures. The EBI Trochanteric Nail is also indicated for osteotomies, reconstructive procedures following tumor resection, revision procedures where other treatment or devices have failed, and arthrodesis.

Device Description

The EB10 Trochanteric Nail System is an interlocking intramedullary rod used in the fixation of fractures of the femur. The system consists of five basic components; trochanteric nails, lag screws, cortical screws, end caps, and set screws.

AI/ML Overview

The provided 510(k) summary for the EBI® Trochanteric Nail System (K050118) details a submission based on substantial equivalence to a predicate device, not a de novo clinical study with specific acceptance criteria for performance metrics like sensitivity or specificity. Therefore, many of the requested categories are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted from the provided text, and where the information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical strength equivalent to predicate	"mechanically as strong as the predicate device."
Substantially equivalent in:	"substantially equivalent* to the predicate device in regards to indications for use, location, design characteristics, material, mechanical strength, and sterility."
Safety and Effectiveness	"is as safe and effective and performs as well as the predicate device"

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

Not applicable. The submission is based on mechanical testing and comparison to a predicate device, not a human-data-based test set for device performance as would be seen in an AI/software device. There is no mention of a "test set" in the context of patient data.

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

Not applicable. As noted above, there is no human-data-based "test set" and thus no ground truth established by experts in this submission.

4. Adjudication Method for the Test Set

Not applicable. There is no human-data-based "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-powered devices to assess the impact on human reader performance, which doesn't apply to an intramedullary nail system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (intramedullary nail system), not an algorithm or software device.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established through mechanical testing standards and comparison to a legally marketed predicate device. The key "ground truth" is that its mechanical properties and functional characteristics are equivalent to the predicate device, which has already established its safety and effectiveness in the market.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm or software that requires a training set of data.

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

Not applicable. As above, there is no training set for this type of device.

Summary of the Study Proving Acceptance Criteria:

The study proving the EBI® Trochanteric Nail System meets its acceptance criteria is a non-clinical mechanical testing study (bench testing) paired with a comparative analysis of technological characteristics against a predicate device.

Study Design: The non-clinical testing involved mechanical load testing of the EBI® Trochanteric Nail System. This was supplemented by a detailed comparison of its design, materials, indications for use, and manufacturing processes with those of the Biomet Holland Femoral Nail System (K983641), which served as the predicate device.
Proof of Acceptance: The results of the mechanical tests demonstrated that the EBI® Trochanteric Nail System exhibits equivalent mechanical strength to the predicate device. Furthermore, the submission argues for substantial equivalence across various technological characteristics (indications for use, location, design, material, mechanical strength, and sterility). This combined evidence led to the conclusion that the device is "as safe and effective and performs as well as the predicate device."
Conclusion by FDA: The FDA's 510(k) clearance letter (K050118) confirms that they found the device "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market. This determination is based on the provided non-clinical testing and comparative analysis.

Summary

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K050118

FEB / 6 / JUS

510(k) Summary

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

1. Submitter:	EBI, L.P.100 Interpace ParkwayParsippany, NJ 07054	Contact Person:	Frederic TestaPhone: (973)299-9300, ext. 2208
Date prepared:	January 17, 2005
2. Proprietary Name:	EBI® Trochanteric Nail System
Common Name:	Internal Fixation Device
Classification Names:	Rod, Fixation, Intramedullary and Accessories,21 CFR 888.3020.

1. Predicate or legally marketed device that is substantially equivalent:
  Biomet Holland Femoral Nail System (K983641)
1. Description of the device: The EB10 Trochanteric Nail System is an interlocking intramedullary rod used in the fixation of fractures of the femur. The system consists of five basic components; trochanteric nails, lag screws, cortical screws, end caps, and set screws.
1. Intended Use: The EBI® Trochanteric Nail System is intended to be implanted into the long bones for alignment, stabilization, and fixation of fractures caused by trauma or disease, the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, and for athrodesis.

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1. Non-Clinical Testing: The results of the mechanical testing demonstrate that the EBI Trochanteric Nail System is mechanically as strong as the predicate device.
1. Comparison of the technological characteristics of the device to predicate

devices: There are no significant differences between the EBI® Trochanteric Nail System and other currently marketed internal fixation systems. It is substantially equivalent* to the predicate device in regards to indications for use, location, design characteristics, material, mechanical strength, and sterility.

1. Conclusion: Technological characteristics and mechanical testing have demonstrated that the EBI Trochanteric Nail System is as safe and effective and performs as well as the predicate device and is therefore substantially equivalent.
  * 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 intended to be 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 seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

9200 C
Rockyv

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050118

Trade/Device Name: EBI® Trochanteric Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: January 17, 2004 Received: January 18, 2004

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.

FEB 1 6 2005

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, RAC

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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

D Mark A. Milkerson

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 _ l __ of _______________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: EBI® Trochanteric Nail System

Indications For Use:

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark n Millen

(Division Sign-Off)

Division of General, Restorative
and Neurological Services

510(k) Number KCS 011

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.