(60 days)
No
The description focuses on computational geometry and visualization for calculating strut lengths based on surgeon input, with no mention of AI/ML terms or learning from data.
No.
The Correx Software is a computational tool that helps surgeons determine external fixator element orientations and strut lengths, but it does not directly control hardware or perform treatment itself. The surgeon remains responsible for critical decisions regarding bone segment alignment and treatment execution.
No
Explanation: The device is described as software that assists in planning and calculating strut lengths for external fixation systems. Its purpose is to aid a surgeon in determining the necessary adjustments for bone segments, rather than to diagnose medical conditions or diseases. The surgeon ultimately determines the exact angulation and translation for treatment.
No
The device is described as a "component of multilateral external fixation system" and is intended for use with the "Dynex Ring Fixation System (K202054)". While the software provides computational and visualization tools, it is explicitly linked to and used in conjunction with a hardware external fixation system. The software's function is to assist the surgeon in determining strut lengths for the hardware system, not to operate as a standalone medical device.
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 Correx Software is a computational tool used in conjunction with an external fixation system. Its purpose is to help surgeons determine the necessary strut lengths and visualize bone segment positions for treating fractures and deformities. It does not analyze biological samples.
- Intended Use: The intended use clearly states its role in stabilizing fractures, performing arthrodesis, leg lengthening, and correcting bone deformities. These are all procedures related to musculoskeletal structure, not diagnostic testing of biological samples.
The software's function is to assist in the planning and implementation of a surgical procedure using an external fixation system, not to diagnose a condition based on in vitro analysis.
N/A
Intended Use / Indications for Use
The Correx Software is intended to be used as a component of multilateral external fixation system for the Vilex External Fixation System with the indications listed below:
- · Stabilization of Fractures & Osteotomy
- Rear and Mid-foot Arthrodesis
- · Adult and Pediatric Leg Lengthening
- · Correction of Bone Deformity in Upper & Lower Extremities
Product codes
KTT, JDW, OSN
Device Description
The Correx Software, intended for use with the Dynex Ring Fixation System (K202054), is an optional-use computational environment that can be used for determining the orientation of bone segments and external fixator elements attached to a bone to treat fractures and bone deformities.
The software includes user interface, processing, data storage, and display functions. The Correx Software can be used to visualize the position of a moving bone segment and to compute the strut lengths necessary to implement any desired translation or rotation. The Software program does not control the device. The Software program does not control any hardware (such as rings, struts, wires) directly. The goal of the Software program is to provide the Surgeon with a tool for determining the length of the six struts connecting the two circular rings. The Surgeon must decide where a bone segment should line up and the angulation and translation necessary for the treatment. The magnitude and direction of any rotation or translation is ultimately the responsibility of the Surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
A/P and M/L radiographs
Anatomical Site
Upper & Lower Extremities (inference based on "Correction of Bone Deformity in Upper & Lower Extremities")
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
Healthcare Professional
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 and validation testing was undertaken to ensure that the product requirements and specifications were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
October 12, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vilex LLC % Roshana Ahmed Sr. Regulatory Affairs Specialist TELOS Partners LLC 571 Christina Lake Drive Lakeland, Florida 33813
Re: K212552
Trade/Device Name: Correx Software Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, JDW, OSN Dated: August 13, 2021 Received: August 13, 2021
Dear Roshana Ahmed:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Correx Software
Indications for Use (Describe)
The Correx Software is intended to be used as a component of multilateral external fixation system for the Vilex External Fixation System with the indications listed below:
- · Stabilization of Fractures & Osteotomy
- Rear and Mid-foot Arthrodesis
- · Adult and Pediatric Leg Lengthening
- · Correction of Bone Deformity in Upper & Lower Extremities
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. Submitter
Vilex, LLC 111 Moffitt Street McMinnville, TN 37110
Contact Person: Brock Johnson, Vice President Phone: (435)-659-1880 Date Prepared: October 12, 2021
II. Device
| Device Proprietary Name: | Correx Software |
|---|---|
| Common or Usual Name: | Software for Diagnosis/Treatment |
| External Fixation System | |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances |
| and Accessories | |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | KTT/JDW/OSN |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- X-Fix Line Additions, K151881, Vilex in Tennessee, Incorporated ●
IV. Device Description
The Correx Software, intended for use with the Dynex Ring Fixation System (K202054), is an optional-use computational environment that can be used for determining the orientation of bone segments and external fixator elements attached to a bone to treat fractures and bone deformities.
The software includes user interface, processing, data storage, and display functions. The Correx Software can be used to visualize the position of a moving bone segment and to compute the strut lengths necessary to implement any desired translation or rotation. The Software program does not control the device. The Software program does not control any hardware (such as rings, struts, wires) directly. The goal of the Software program is to provide the Surgeon with a tool for determining the length of the six struts connecting the two circular
4
rings. The Surgeon must decide where a bone segment should line up and the angulation and translation necessary for the treatment. The magnitude and direction of any rotation or translation is ultimately the responsibility of the Surgeon.
V. Indications for Use
The Correx Software is intended to be used as a component of multilateral external fixation system for the Vilex External Fixation System with the indications listed below:
- Stabilization of Fractures & Osteotomy
- . Rear and Mid-foot Arthrodesis
- Adult and Pediatric Leg Lengthening .
- Correction of Bone Deformity in Upper & Lower Extremities .
VI. Comparison of Technological Characteristics
The subject and predicate device share the same intended use and technological characteristics.
A comparison of products technological characteristics is provided in the table below.
| Correx Software | P&C Software | |
|---|---|---|
| K151881 | ||
| Intended User | Healthcare Professional | Same |
| Software Use | Optional | Same |
| Principles of | ||
| Operation | The Software can be used to visualize the | |
| position of a moving bone segment and to | ||
| compute the strut lengths necessary to | ||
| implement any desired translation or | ||
| rotation. | Same | |
| Inputs | Surgeon Inputs based on X-Ray | |
| positioning | Same | |
| Image | ||
| Requirements | A/P and M/L radiographs after External | |
| Frame attached to bone segments | Same | |
| System Fields | ||
| (Data Inputs) | Ring Size, Struts, Preference Side, | |
| Deformity, Correction, Bone Alignment, | ||
| Separation Rate | Same | |
| Output | Daily schedule of strut lengths necessary | |
| to adjust the frame so that the bone | ||
| segments are aligned as desired and | ||
| translated to the desired position within a | ||
| minimum number of days | Same |
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VII. Performance Data
Software verification and validation testing was undertaken to ensure that the product requirements and specifications were met.
VIII. Conclusion
Based on the information provided above and within this submission, the Correx Software is substantially equivalent to the predicate device.
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