ORTHOHUB EXTERNAL FIXATOR SOFTWARE

K140550 · Orthohub, Inc. · OSN · Aug 25, 2014 · Orthopedic

Device Facts

• Record ID: K140550
• Device Name: ORTHOHUB EXTERNAL FIXATOR SOFTWARE
• Applicant: Orthohub, Inc.
• Product Code: OSN · Orthopedic
• Decision Date: Aug 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The OrthoHub External Fixator Software is used to assist the clinician in adjusting the Smith & Nephew Taylor Spatial Frame (TSF) External Fixator by creating a patient adjustment schedule. The OrthoHub software receives x-ray images of the deformity and installed fixator hardware and produces a prescription recommending adjustments to the fixator that define a correction path for the deformity. The software is used as an accessory to the commercially available hardware as detailed in the Instructions for Use, specifically, Smith and Nephew's Taylor Spatial Frame rings and struts.

Device Story

Software accessory for Smith & Nephew Taylor Spatial Frame (TSF) external fixator; used by clinicians to manage tibia deformity correction. Inputs: orthogonal x-ray images of patient deformity with installed fixator hardware. Operation: user creates colored graphical representation of bones/hardware, aligns graphics to x-rays, and defines correction rate. Software performs mathematical calculations to generate prescription of strut adjustments. Output: patient-specific strut adjustment schedule. Benefit: provides defined correction path for deformity treatment. Used in clinical setting.

Clinical Evidence

Bench testing only. Software verification and validation testing performed. Mechanical bench top side-by-side comparison testing conducted to confirm software produces appropriate adjustment recommendations based on x-ray inputs and user-defined parameters.

Technological Characteristics

Software application for Macintosh computer. Functions as accessory to Smith & Nephew TSF hardware. Uses image-based input (orthogonal x-rays) to calculate mechanical strut adjustments. Standalone software architecture.

Indications for Use

Indicated for patients requiring treatment of traumatic or reconstructive tibia deformities using Smith & Nephew Taylor Spatial Frame (TSF) rings and struts.

Regulatory Classification

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.

Predicate Devices

• Smith & Nephew, Inc. Spatialframe V4.1 Web-based Software (K110069)
• Smith & Nephew, Inc. Circular Fixation System (K093047)
• Smith & Nephew, Inc. Taylor Spatial Frame (K970748)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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

August 25, 2014

OrthoHub, Incorporated Ms. Peggy McLaughlin Regulatory Consultant 999 Menlo Oaks Drive Menlo Park, California 94025

Re: K140550

Trade/Device Name: OrthoHub External Fixator Software Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: OSN Dated: July 30, 2014 Received: August 1, 201

Dear Ms. McLaughlin:

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. 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

{1}------------------------------------------------

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

## Lori A. Wiggins -S

- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K140550

Device Name OrthoHub External Fixator Software

Indications for Use (Describe)

The OrthoHub External Fixator Software is used with Smith & Nephew Taylor Spatial Frame (TSF) rings and struts for the treatment of traumatic or reconstructive tibia deformities. It is used to generate a prescription of strut adjustments to provide to the patient.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of OrthoHub, Inc. Traditional 510(K) Submission Page 4

{3}------------------------------------------------

# OrthoHub, Inc.

### 5.0 510(k) Summary

Submitters Name and Address

OrthoHub, Inc. 999 Menlo Oaks Drive Menlo Park CA 94025

Contact Person Peggy McLaughlin Fax: [phone] Telephone: [phone] Email: [e-mail]

Date Prepared 30 July 2014

#### Medical Device

| Proprietary Name: | OrthoHub External Fixator Software |
|------------------------|---------------------------------------------------------------------------------------------|
| Common Name: | Orthopedic Software for Treatment |
| Classification Name: | Software for single/multiple component metallic bone<br>fixation appliances and accessories |
| Classification Number: | 21 CFR Sec. 888.3030 |
| Class: | II |
| Product Code: | OSN |

#### Predicate Devices

Smith & Nephew, Inc. Spatialframe V4.1 Web-based Software (K110069) Smith & Nephew, Inc. Circular Fixation System (K093047) Smith & Nephew, Inc. Taylor Spatial Frame (K970748) These devices have not been subject to a design-related recall.

No reference devices were used in this submission.

#### Indications For Use

The OrthoHub External Fixator Software is used with Smith & Nephew Taylor Spatial Frame (TSF) rings and struts for the treatment of traumatic or reconstructive tibia deformities. It is used to generate a prescription of strut adjustments to provide to the patient.

{4}------------------------------------------------

#### Device Description

The OrthoHub External Fixator Software is a software program used on a Macintosh Computer. The software is used to generate a prescription which details adjustments required for the treatment of traumatic or reconstructive tibia deformities when using the Smith and Nephew Taylor Spatial Frame External Fixator hardware. Users input orthogonal x-ray images of a patient's deformity taken after installation of the fixator hardware on the patient. The software creates a colored graphical representation of the bones and orthopedic fixator hardware shown in the x-rays, and the user adjusts this graphical representation so that it best matches the underlying x-rays. The user then defines a correction rate, and the software generates a prescription of strut adjustments to correct the deformity. This prescription is provided to the patient for strut adjustment during the prescription period.

#### Intended Use

The OrthoHub External Fixator Software is used to assist the clinician in adjusting the Smith & Nephew Taylor Spatial Frame (TSF) External Fixator by creating a patient adjustment schedule. The OrthoHub software receives x-ray images of the deformity and installed fixator hardware and produces a prescription recommending adjustments to the fixator that define a correction path for the deformity. The software is used as an accessory to the commercially available hardware as detailed in the Instructions for Use, specifically, Smith and Nephew's Taylor Spatial Frame rings and struts.

The intended use of the OrthoHub External Fixator Software is identical to the software component of the predicate devices.

#### Comparison of the technological characteristics with the predicate device

Both the OrthoHub Software and the predicates are software which, with the input of patient specific measurements or x-ray images, provides recommended adjustments to the external hardware to treat a patient's deformity. The software performs mathematical calculations to provide a prescription for strut adjustment after the Smith & Nephew hardware has been placed on the patient and while the patient is wearing the external hardware to correct a deformity of the tibia.

The following technological differences exist between the subject and predicate devices:

- . Use of a Macintosh computer (versus predicate's web-based software run in the cloud)
- . Use of x-ray images of patient (versus practitioner's input of measurements from the x-ray images)

{5}------------------------------------------------

#### Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Software Verification & Validation Testing

Mechanical Bench Top Side by Side Comparison Testing

Results of the testing confirmed that the software performs as intended. The software produced recommended adjustments as appropriate for the inputs (patient x-rays) and user entered information (fixator hardware, time for prescription/treatment). Results of performance testing through the bench testing and software verification and validation process demonstrate that the OrthoHub External Fixator Software functions as intended and is substantially equivalent to the predicate devices.

#### Conclusions

The OrthoHub External Fixator Software has the same intended use and indications and utilizes the same technology as the predicates. Performance testing and software verification and validation demonstrate that the OrthoHub External Fixator Software functions as intended. Thus, the OrthoHub External Fixator Software has been shown to be substantially equivalent to the predicate devices.