(174 days)
No reference devices were used in this submission.
No
The description focuses on user input of x-ray images and user adjustments to a graphical representation to generate a prescription based on a defined correction rate. There is no mention of the software learning from data or using algorithms typically associated with AI/ML for image analysis or prescription generation. The process described appears to be rule-based or algorithmic based on user input and defined parameters.
No.
The device is software that generates a prescription of strut adjustments for an external fixator; it does not directly treat or diagnose a disease or condition. It is an accessory to a therapeutic device (the external fixator).
No
This device assists clinicians in planning treatment by generating strut adjustment prescriptions based on x-ray images and user input. It does not diagnose medical conditions.
Yes
The device is explicitly described as "The OrthoHub External Fixator Software" and its function is solely to process input data (x-rays and user input) to generate a prescription for adjusting existing hardware. The description focuses entirely on the software's functionality and its use on a computer, without mentioning any accompanying hardware developed or included with the software itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The OrthoHub External Fixator Software processes x-ray images of a patient's tibia and external fixator hardware. It then generates a prescription for adjusting the external fixator struts.
- No Sample Analysis: The software does not analyze any biological samples from the patient. Its input is imaging data, not biological material.
- Purpose: Its purpose is to assist in the mechanical adjustment of an external medical device (the Taylor Spatial Frame) based on imaging, not to diagnose or monitor a condition through analysis of bodily fluids or tissues.
Therefore, the OrthoHub External Fixator Software falls under the category of a medical device software used for treatment planning and guidance, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
OSN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray images
Anatomical Site
tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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(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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
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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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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"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
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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: 941 827-8004 Telephone: 650 504-8501 Email: MPMAdvisors@gmail.com
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 |
| 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.
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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)
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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.