Deformity Analysis and Correction Software (DACS) and Instrumentation

K180539 · Arrowhead Medical Device Technologies, LLC · OSN · Aug 13, 2018 · Orthopedic

Device Facts

• Record ID: K180539
• Device Name: Deformity Analysis and Correction Software (DACS) and Instrumentation
• Applicant: Arrowhead Medical Device Technologies, LLC
• Product Code: OSN · Orthopedic
• Decision Date: Aug 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

The Deformity Analysis and Correction Software (DACS) and Instrumentation are intended to be used as components of the Smith & Nephew Taylor Spatial Frame external fixation system that is indicated for the following: post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

Device Story

DACS is an optional software tool for surgeons using the Smith & Nephew Taylor Spatial Frame (TSF). Inputs include surgeon-entered deformity measurements, mount parameters, frame components, and strut settings derived from orthogonal A/P and M/L radiographs. The software uses image recognition and graphical input to visualize bone position and calculate required strut lengths for translation/rotation. Output is a patient-specific prescription for frame adjustments. Used in clinical settings by physicians to guide external fixation treatment; benefits include precise, automated calculation of frame adjustments to correct complex orthopedic deformities and fractures.

Clinical Evidence

Bench testing only. No clinical data. Performance validated using CAD-generated image sets and Smith & Nephew Taylor Spatial Frame x-ray image sets. Testing compared known inputs (device types, strut settings) against software-calculated outputs to verify accuracy across diverse deformity variations and anatomical orientations.

Technological Characteristics

Software-based orthopedic planning tool. Includes Radiopaque Fiducial Markers for use with TSF external fixator. Features image recognition and graphical input for deformity analysis. Operates on standard clinical computing hardware. Software verification conducted per FDA 2005 guidance.

Indications for Use

Indicated for patients requiring external fixation for post-traumatic joint contracture, fractures, pseudoarthrosis of long bones, limb lengthening, bony/soft tissue deformity or defect correction, joint arthrodesis, or infected fractures/nonunions.

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

• Taylor Spatial Frame (TSF) (K110069, K093047, K970748)

Reference Devices

• TL-HEX Truelok Hexapod System (K141078, K152171)
• OrthoHub External Fixator Software (K140550)

Submission Summary (Full Text)

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August 13, 2018

Arrowhead Medical Device Technologies, LLC Thomas Twardzik VP - Marketing and Operations 328 Poplar View Lane East. Suite 2 Collierville, Tennessee 38017

#### Re: K180539

Trade/Device Name: Deformity Analysis and Correction Software (DACS) and Instrumentation Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: OSN, KTT Dated: July 5, 2018 Received: July 13, 2018

Dear Thomas Twardzik:

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/cdrl/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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jesse Muir -S 2018.08.13 18:43:19 -04'00' In lieu of. 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) K180539

#### Device Name

Deformity Analysis and Correction Software and Instrumentation

Indications for Use (Describe)

The Deformity Analysis and Correction Software (DACS) and Instrumentation are intended to be used as components of the Smith & Nephew Taylor Spatial Frame external fixation system that is indicated for the following: post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

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

| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--|-------------------------------------------------------------------|
| | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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K141078
K152171

K140550

Orthofix

OrthoHub

09/02/2014

09/28/2015

08/25/2014

# 510(k) Summary

| Sponsor: | Arrowhead Medical Device Technologies, LLC<br>328 Poplar View Lane East, Suite 2<br>Collierville, TN 38017 | | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------------------|----------------------------------------|
| Contact Person: | Thomas J. Twardzik<br>Vice President, Marketing and Operations<br>Office: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | | |
| Date of<br>Submission: | February 26, 2018 | | | |
| Proprietary Name: | Deformity Analysis and Correction Software (DACS) and<br>Instrumentation | | | |
| Common Name | Orthopaedic Software for Treatment and Instrumentation | | | |
| Regulatory Class | Class II | | | |
| Regulation | 21 CFR 888.3030 Single/multiple component metallic bone<br>fixation appliances and accessories | | | |
| Device Product<br>Code and Panel | OSN Software For Diagnosis/Treatment<br>KTT Appliance, Fixation, Nail/Blade/Plate Combination,<br>Multiple Component - Single/multiple component metallic<br>bone fixation appliances and accessories.<br>Orthopedic | | | |
| Predicate Devices | Device | Manufacturer | 510(k)<br>No. | Clearance<br>Date |
| | Taylor Spatial Frame<br>(TSF) | Smith & Nephew | K110069<br>K093047<br>K970748 | 02/08/2011<br>09/27/2010<br>05/09/1997 |

TL-HEX Truelok
Hexapod System

OrthoHub External

Fixator Software

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The Deformity Analysis and Correction Software (DACS) and Device Description Instrumentation is an optional software component and is used to assist the physician in calculating the lengths of the struts connecting the rings to manipulate the bone fragments. The software receives inputs from the physician and allows the physician to visualize the moving bone position. The program computes the strut lengths necessary to implement any desired translation and/or rotation required by the surgeon. The instrumentation includes Radiopaque Fiducial Markers which are attached to the Smith & Nephew Taylor Spatial Frame external fixator.

Intended Use The Deformity Analysis and Correction Software (DACS) and Instrumentation are intended to be used as component of the Smith & Nephew Taylor Spatial Frame (TSF) external fixation system that is indicated for the following: post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction: correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

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The Deformity Analysis and Correction Software (DACS) and Technological Characteristics Instrumentation are substantially equivalent to predicate devices in terms of intended use, product technical characteristics and performance characteristics. Software documentation was conducted according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Document issued on: May 11, 2005). The design characteristics of the subject system software do not raise any new types of questions of safety or effectiveness. Functional testing of the Deformity Analysis and Correction Software (DACS) and Instrumentation was conducted and summarized in Exhibit 36 Verification and Validation Documentation - SWVR-AMD-0101 Software Verification Report. Performance and accuracy testing were performed to test the ability of the Deformity Analysis and Correction Software (DACS) and Instrumentation to produce correct results under different variations of bone deformities, anatomical orientations, and device combinations. This testing protocol was executed against a variety of CAD-generated image sets and a Smith & Nephew Taylor Spatial Frame x-ray image set. The known inputs for each image (device types and strut settings) was compared to the results calculated by the Deformity Analysis and Correction Software (DACS) and Instrumentation. Testing with these image pairs demonstrated that the Deformity Analysis and Correction Software (DACS) and Instrumentation is capable of successfully correcting the variety of deformities it may encounter in the clinical setting. From the evidence submitted in this 510(k), the Deformity Analysis

and Correction Software (DACS) and Instrumentation demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicates.

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#### A review of the device intended use, product technical Substantial Equivalence and characteristics and performance characteristics confirmed that the Conclusions Deformity Analysis and Correction Software and Instrumentation is substantially equivalent to the predicate device. While the Deformity Analysis and Correction Software and Instrumentation is not identical to the predicate device software, comparisons of the subject and predicate device software confirmed that any differences between the subject device and predicate software do not render the device NSE as there is not a new intended use; and any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device. Therefore, it is concluded that the Deformity Analysis and Correction Software and Instrumentation is substantially equivalent to the Smith & Nephew Taylor Spatial Frame Software.

| Parameter | Deformity<br>Analysis and<br>Correction<br>Software and<br>Instrumentation | TSF System and<br>Software | TL-HEX Truelok<br>Hexapod System<br>and Software | OrthoHub<br>External<br>Fixator<br>Software |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Arrowhead<br>Medical Device<br>Technologies,<br>LLC | Smith & Nephew,<br>Inc.<br>Orthopaedic<br>Division | Orthofix | OrthoHub |
| 510(k)<br>Number(s) | K180539 | K110069,<br>K093047,<br>K970748 | K141078,<br>K152171 | K140550 |
| Regulation | CFR 888.3030 | CFR 888.3030 | CFR 888.3030 | CFR 888.3030 |
| Product Codes | KTT, OSN | KTT, OSN | KTT, OSN | OSN |
| Parameter | Deformity<br>Analysis and<br>Correction<br>Software and<br>Instrumentation | TSF System and<br>Software | TL-HEX Truelok<br>Hexapod System<br>and Software | OrthoHub<br>External<br>Fixator<br>Software |
| Intended Use | The Deformity Analysis<br>and Correction Software<br>( <i>DACS</i> ) and Radiopaque<br>Fiducial Markers are<br>intended to be used as<br>component of a spatial<br>frame external fixation<br>system that is indicated<br>for the following: post-<br>traumatic joint<br>contracture which has<br>resulted in loss of range<br>of motion; fractures and<br>disease which generally<br>may result in joint<br>contractures or loss of<br>range of motion and<br>fractures requiring<br>distraction; open and<br>closed fracture fixation;<br>pseudo-arthrosis of long<br>bones; limb lengthening<br>by epiphyseal or<br>metaphyseal distraction;<br>correction of bony or<br>soft tissue deformities;<br>correction of bony or<br>soft tissue defects; joint<br>arthrodesis; infected<br>fractures or nonunions. | The Smith & Nephew<br>Spatialframe.com<br>software is intended to<br>be used as a component<br>of multilateral external<br>fixation systems that are<br>indicated for the<br>following: post-<br>traumatic joint<br>contracture which has<br>resulted in loss of range<br>of motion; fractures and<br>disease which generally<br>may result in joint<br>contractures or loss of<br>range of motion and<br>fractures requiring<br>distraction; open and<br>closed fracture fixation;<br>pseudoarthrosis of long<br>bones; limb lengthening<br>by epiphyseal or<br>metaphyseal distraction;<br>correction of bony or<br>soft tissue deformities;<br>correction of bony or<br>soft tissue defects: joint<br>arthrodesis; infected<br>fractures or nonunions. | The TL-HEX System<br>is intended for limb<br>lengthening by<br>metaphyseal or<br>epiphyseal distractions,<br>fixation of open and<br>closed fractures,<br>treatment of nonunion<br>or pseudoarthrosis of<br>long bones and<br>correction of bony or<br>soft tissue defects or<br>deformities. Within<br>this range, indications<br>include:<br>• Post-<br>traumatic joint<br>contracture which has<br>resulted in loss of<br>range of motion •<br>Fractures and disease<br>which generally may<br>result in joint<br>contractures or loss of<br>range of motion and<br>fractures requiring<br>distraction • Open and<br>closed fracture fixation<br>• Pseudoarthrosis of<br>long bones • Limb<br>lengthening by<br>epiphyseal or<br>metaphyseal<br>distraction • Correction<br>of bony or soft tissue<br>deformities •<br>Correction of bony or<br>soft tissue defects •<br>Joint arthrodesis •<br>Infected fractures or<br>non-unions | The OrthoHub<br>External Fixator<br>Software is used<br>with Smith &<br>Nephew Taylor<br>Spatial Frame (TSF)<br>rings and struts for<br>the treatment of<br>traumatic or<br>reconstructive tibia<br>deformities. It is<br>used to generate a<br>prescription of strut<br>adjustments to<br>provide to the<br>patient. |
| Substantial Equivalence Comparison Table | | | | |
| Parameter | Deformity<br>Analysis and<br>Correction<br>Software and<br>Instrumentation | TSF System and<br>Software | TL-HEX Truelok<br>Hexapod System<br>and Software | OrthoHub<br>External<br>Fixator<br>Software |
| Software | | | | |
| Use | Optional | Optional | Optional | Optional |
| Inputs | Surgeon inputs based on<br>x-ray position | Surgeon inputs based on<br>x-ray position | Surgeon inputs based on<br>x-ray position | Surgeon inputs based on<br>x-ray position |
| Visualization | Visualize the moving<br>bone | Visualize the moving<br>bone | Visualize the moving<br>bone | Visualize the moving<br>bone |
| Image for<br>Input | Orthogonal A/P, M/L<br>radiograph after fixator<br>installed on patient | Orthogonal A/P, M/L<br>radiograph after fixator<br>installed on patient | Orthogonal A/P, M/L<br>radiograph after fixator<br>installed on patient | Orthogonal A/P,<br>M/L radiograph after<br>fixator installed on<br>patient |
| Data to Input | Deformity<br>Measurements<br>Mount Parameters<br>Frame Components<br>Strut Settings | Deformity<br>Measurements<br>Mount Parameters<br>Frame Components<br>Strut Settings | Deformity<br>Measurements<br>Mount Parameters<br>Frame Components<br>Strut Settings | Deformity<br>Measurements<br>Mount Parameters<br>Frame Components<br>Strut Settings |
| Means of<br>Measure and<br>Input | Software image<br>recognition and<br>hardware identification.<br>Graphical input.<br>Single item of manual<br>entry. | Manual measurement of<br>radiograph.<br>Manual entry. | Manual measurement<br>of radiograph.<br>Manual entry.<br>Limited graphical<br>input | Manual<br>measurement of<br>radiograph.<br>Limited graphical<br>input.<br>Manual entry. |
| Output | Patient prescription with<br>details for frame<br>adjustment. | Patient prescription with<br>details for frame<br>adjustment. | Patient prescription<br>with details for frame<br>adjustment. | Patient prescription<br>with details for<br>frame adjustment. |

#### Substantial Equivalence Comparison Table

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### Substantial Equivalence Comparison Table

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## Substantial Equivalence Comparison Table

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