Distal Humerus Plates are indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension. Olecranon Plates are indicated for intra-articular or extra-articular fractures of the proximal ulna, osteotomies, and nonunions. Longer plates may be used for proximal ulna fractures with diaphyseal extension.

Device Description

The VariAx™ Elbow System is intended for fracture fixation of long bones. The subject and predicate devices are made from Titanium alloy (Ti-6Al-4V) and Commercially pure titanium.

AI/ML Overview

This 510(k) summary describes a modification to the indications for use of the VariAx Elbow System, which is a bone plate and screw system. The submission does not involve a medical device that uses AI or machine learning, and therefore the concepts of acceptance criteria, device performance, ground truth, training sets, or expert adjudication as typically applied to AI/ML devices are not relevant here.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K073557) rather than providing performance data against specific acceptance criteria for a new or significantly modified device.

Here's a breakdown of why the requested information cannot be provided based on the given text:

A table of acceptance criteria and the reported device performance: Not applicable. This submission is for changing the indications for use of an existing device type, not for a device with a performance metric that would be assessed against specific acceptance criteria in the context of an AI/ML study. The device itself (bone plates and screws) is a mechanical fixation device, not a diagnostic or prognostic system with performance metrics like accuracy, sensitivity, or specificity.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of an AI/ML algorithm or a study designed to evaluate performance metrics. The substantial equivalence argument relies on the inherent properties of the device materials and design, not on clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There is no "ground truth" to establish for this type of submission, as it's not evaluating the output of an algorithm against a known correct answer.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or related adjudication process is described or relevant.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool. No human reader studies are mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established or used for this type of submission.
The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable. No ground truth for a training set.

Summary of the Study (Substantial Equivalence Justification):

The "study" in this context is a substantive equivalence justification, a regulatory pathway for medical devices that are similar to legally marketed predicate devices.

Acceptance Criteria (for regulatory clearance): The acceptance criterion for this submission is demonstrating that the modified VariAx Elbow System is substantially equivalent to its predicate device (K073527) for the new indications for use. This involves showing that the modifications do not raise new questions of safety and effectiveness.
Reported Device Performance (as presented):
- Intended Use: The revised intended use is for fracture fixation of long bones, specifically for "Distal Humerus Plates for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions" and "Olecranon Plates for intra-articular or extra-articular fractures of the proximal ulna, osteotomies, and nonunions."
- Basis for Equivalence:
  - No design changes: "No mechanical testing was needed to demonstrate substantial equivalence of the subject components since no design changes were made to the system."
  - Identical manufacturing methods, packaging, and sterilization.
  - Identical materials: Both predicate and subject devices are made from Titanium alloy (Ti-6Al-4V) and Commercially pure titanium.
  - Identical mechanical & functional properties: "The mechanical & functional properties of the subject VariAx Elbow System are identical to the predicate device VariAx Elbow System K073527."

In essence, the "study" proving the device meets the "acceptance criteria" (of substantial equivalence) is the assertion and demonstration that the physical device itself is unchanged from a previously cleared device, only its stated indications for use are being clarified and expanded. Therefore, the performance characteristics are assumed to be identical to the predicate device.

Summary

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5101056

a consumers and and the more of the resultance of the act and the comments of the comments

510(k) Summary of Safety and Effectiveness

MAY 1 3 2010

Proprietary Name:	VariAx Elbow System
Common Name:	Bone plates and screws
Classification Name and Reference:	Single/multiple component metallic bone fixationappliances and accessories21 CFR §888.3030
Regulatory Class:	Class II
Product Codes:	HRS: Plate, Fixation, Bone
For Information contact:	Melissa Matarese, Regulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5116 Fax: (201) 831-4116
Date Prepared:	April 13, 2010

Description:

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Howmedica Osteonics is extending the indications for use of the VariAx Elbow System to improve clarity for the end user.

Intended Use:

The VariAx™ Elbow System is intended for fracture fixation of long bones. The indications for use provided below are have been modified compared to the predicate VariAx Elbow System's indications (K073527).

Indications:

Howmedica Osteonics is changing the indications for use of the VariAx Elbow System from "distal humerus and proximal ulna" to "Distal Humerus Plates are indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

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Olecranon Plates are indicated for intra-articular or extra-articular fractures of the proximal ulna, osteotomies, and nonunions. Longer plates may be used for proximal ulna fractures with diaphyseal extension."

Substantial Equivalence:

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The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design. No mechanical testing was needed to demonstrate substantial equivalence of the subject components since no design changes were made to the system. In addition, the manufacturing methods, packaging, and sterilization of the predicate and subject components are identical.

The subject and predicate devices are made from Titanium alloy (Ti-6Al-4V) and Commercially pure titanium. The mechanical & functional properties of the subject VariAx Elbow System are identical to the predicate device VariAx Elbow System K073527.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Howmedica Osteonics Corp. % Ms. Melissa A. Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah. New Jersey 07430

MAY 1 3 2010

Re: K101056 Trade/Device Name: VariAx Elbow Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 13, 2010 Received: April 15, 2010

Dear Ms. Matarese:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Melissa A. Matarese

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

//www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely vours.

Sincerely yours,

Oharlew Prehr

Mark N. Mell Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): k10 i

Device Name: VariAx Elbow System

Indications for Use:

. .

Distal Humerus Plates are indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension. Olecranon Plates are indicated for intraarticular or extra-articular fractures of the proximal ulna, osteotomies, and nonumons. Longer plates may be used for proximal ulna fractures with diaphyseal extension.

Prescription Use X Over-The-Counter Use - AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anuta for mxn
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101056

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.