(119 days)
No
The software is described as assisting the physician in calculating strut lengths and visualizing bone position based on physician input. It computes necessary strut lengths based on desired translation/rotation, which is a deterministic calculation, not indicative of AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
Yes
The device is described with intended uses such as "limb lengthening by epiphyseal or metaphyseal distraction," "correction of bony or soft tissue deformities," and "joint arthrodesis," all of which are considered therapeutic interventions for treating medical conditions.
No
The device is an external fixation system (SixFix™ Hexapod Fixator) and associated software (Deformity Analysis and Correction Software - DACS) used for correction of deformities, fracture fixation, and limb lengthening. While the software assists the physician in calculating strut lengths to manipulate bone fragments, its primary function is to aid in treatment plans and adjustments, not to diagnose a condition.
No
The device description clearly states that the SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) is a "multilateral circular external fixation system" that includes hardware components such as rings, footplates, arches, struts, threaded rods, and wires, in addition to the software. While the software is an optional component, the overall device is a system that includes both hardware and software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) is an external fixation system used for orthopedic procedures. It involves physically manipulating bone segments and correcting deformities.
- Intended Use: The intended uses listed are all related to surgical and orthopedic interventions on the body, not laboratory testing of samples.
- Device Description: The description details mechanical components (rings, struts, wires) and software for calculating adjustments, all of which are consistent with an external fixation device.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on bodily fluids, or providing diagnostic information based on such analysis.
Therefore, the SixFix™ Hexapod and DACS falls under the category of a surgical/orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) are intended to be used for posttraumatic 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 distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.
Product codes (comma separated list FDA assigned to the subject device)
KTT, HTY, OSN
Device Description
The SixFix™ Hexapod Fixator is a multilateral circular external fixation system. The system includes the following external fixator elements: rings, footplates, arches, struts, threaded rods, wires, external fixation accessories, and software. All of the elements are provided non-sterile and are for single use only.
The system is designed such that gradually adjusting the lengths of the struts in relation to one another alters the orientation of the rings and, consequently, the bone segments connected to the rings by half-pins and wires during the treatment period in order to achieve the patient's treatment goals.
The Deformity Analysis and Correction Software 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Static and dynamic mechanical testing were performed in support of the submission. The testing confirmed that the subject SixFix™ Hexapod Fixator is substantially equivalent to the predicate device.
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a Moderate Level of Concern. Documentation for Moderate Level of Concern was provided as follows.
- Device Hazard Analysis
- Software Requirements Specification
- Architectural Design Charts
- Software Design Specification Traceability Analysis
- Software Development Environment Description
- Software Verification Plan and Protocol
- Variety Testing Software Verification Protocol
- Cybersecurity Risk Analysis Report
- Off-the-Shelf Software Analysis
- Software Release Record
- Unresolved Anomaly Report
- Verification and Validation Documentation
From the evidence submitted in this 510(k) for the software, the Deformity Analysis and Correction Software (DACS) demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicates. The design characteristics of the subject system software do not raise any new types of questions of safety or effectiveness.
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.
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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July 5, 2022
Arrowhead DE, LLC Patrick Mullaney President/CEO 328 Poplar View Lane East, Suite 2 Collierville, Tennessee 38017
Re: K190069
Trade/Device Name: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, HTY, OSN
Dear Patrick Mullaney:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 14, 2019. Specifically, FDA is updating this SE Letter to address the inconsistent indications for use in the FDA Form 3881 as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ting Song, Ph.D., OHT6: Office of Orthopedic Devices, 301-796-7677, Ting.Song@fda.hhs.gov.
Sincerely,
Ting Song -S
Ting Song, Ph.D. 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
1
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May 14, 2019
Arrowhead DE, LLC Patrick Mullaney President/CEO 328 Poplar View Lane East, Suite 2 Collierville, Tennessee 38017
Re: K190069
Trade/Device Name: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: KTT, HTY, OSN Dated: April 17, 2019 Received: April 18, 2019
Dear Patrick Mullaney:
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/cfpm/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
2
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Digitally signed by Peter G. Peter G. Allen -S Date: 2019.05.14 Allen -S 10:08:37 -04'00'
FOR CAPT Raquel Peat, PhD, MPH, USPHS 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) K190069
Device Name
SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
Indications for Use (Describe)
The SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) are intended to be used for posttraumatic 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 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):
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary SixFix™ Hexapod Fixator and DACS K190069
l. Submitter:
Arrowhead Medical Device Technologies, LLC 328 Poplar View Lane East, Suite 2 Collierville, TN 38017
Contact Person: Thomas J. Twardzik Vice President, Marketing and Operations Office: (901) 853-4366 Fax: (206) 222-9173 Email: INFO@ArrowheadDevices.com
Date of Summary: May 7, 2019
II: Device
Proprietary Name: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
Common Name: Orthopaedic Software for Treatment and Instrumentation Regulatory Class: Class II
Regulation:
21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories
21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener Device Product Codes: KTT, HTY, and OSN Panel: Orthopedic
| III. Predicate Devices | |
|---|---|
| ------------------------ | -- |
| Device | Manufacturer | 510(k) No. | Clearance
Date |
|--------------------------------------------------------------------------------|--------------------------------------------------|------------|-------------------|
| Primary Predicate | | | |
| Taylor Spatial Frame | Smith & Nephew | K093047 | 09/27/2010 |
| | | K970748 | 05/09/1997 |
| Secondary Predicates | | | |
| Deformity Analysis and
Correction Software
(DASC) and
Instrumentation | Arrowhead Medical
Device
Technologies, LLC | K180539 | 08/13/2018 |
| Ilizarov External
Fixation Wires | Smith & Nephew | K870961 | 03/19/1987 |
| | | K962808 | 08/19/1996 |
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510(k) Summary SixFix™ Hexapod Fixator and DACS K190069
IV. Device Description
The SixFix™ Hexapod Fixator is a multilateral circular external fixation system. The system includes the following external fixator elements: rings, footplates, arches, struts, threaded rods, wires, external fixation accessories, and software. All of the elements are provided non-sterile and are for single use only.
The system is designed such that gradually adjusting the lengths of the struts in relation to one another alters the orientation of the rings and, consequently, the bone segments connected to the rings by half-pins and wires during the treatment period in order to achieve the patient's treatment goals.
The Deformity Analysis and Correction Software 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.
V. Intended Use
The SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) are intended to be used for 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.
VI. Comparison of Technological Characteristics with the Predicate Devices
The SixFix™ Hexapod Fixator is technologically substantially equivalent to predicate devices in terms of intended use, material, design, mechanical performance and safety. Testing and analyses confirmed that the Hexapod™ Fixator is substantially equivalent when compared to the predicate device. The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.
The subject device and predicate devices are optional software programs that are used with a spatial frame external fixation system. The functions performed by the SixFix™ DACS match the functions performed by the predicate DACS (K180539). Software validation confirmed that the DACS should perform as intended.
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510(k) Summary SixFix™ Hexapod Fixator and DACS K190069
VII. Performance Data
Static and dynamic mechanical testing were performed in support of the submission. The testing confirmed that the subject SixFix™ Hexapod Fixator is substantially equivalent to the predicate device.
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a Moderate Level of Concern. Documentation for Moderate Level of Concern was provided as follows.
- Device Hazard Analysis
- Software Requirements Specification ●
- Architectural Design Charts
- Software Design Specification Traceability Analysis
- Software Development Environment Description
- Software Verification Plan and Protocol
- Variety Testing Software Verification Protocol
- Cybersecurity Risk Analysis Report
- Off-the-Shelf Software Analysis
- Software Release Record
- Unresolved Anomaly Report
- Verification and Validation Documentation
From the evidence submitted in this 510(k) for the software, the Deformity Analysis and Correction Software (DACS) demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicates. The design characteristics of the subject system software do not raise any new types of questions of safety or effectiveness.
VIII. Conclusions
A review of the device indications, material composition, external element design, and technological characteristics confirmed that the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software are substantially equivalent to the predicate device. While the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software are not identical to the predicate device, comparisons of the subject and predicate device confirmed that any differences between the subject device and predicate 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 SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software is substantially equivalent to the predicate devices.