(89 days)
No
The description focuses on the software facilitating manual measurements and calculations based on user input on digitized X-rays, not on automated analysis or learning from data. There is no mention of AI, ML, or related concepts.
No.
The description explicitly states that "Spinalytics is an optional accessory to the KKT device and does not change the intended use of the device" and that it "facilitates the calculation of the treatment parameters". The KKT device is the therapeutic device, and Spinalytics is a software accessory that assists with calculation and communication of parameters for the therapeutic device, rather than being therapeutic itself.
Yes
The KKT device is used in the aid of managing chronic pain and involves the use of "diagnostic imaging that quantifies the misalignment of vertebrae." Spinalytics, an accessory to the KKT device, facilitates "measuring angles and distances of relevant skeletal structures in a patient, by providing the practitioner with an interface to mark the position of these structures directly on digitized X-Rays." This function in itself is a form of diagnosis, as it quantifies a condition (misalignment of vertebrae) in order to inform treatment.
No
The device description explicitly states that Spinalytics is an "optional software accessory to the KKT device" and that it "communicates directly with the KKT Device to seamlessly enter the treatment parameters into the device." It also mentions the software is installed on a computer that communicates with the KKT Device over a USB cable. This indicates the software is part of a larger system that includes hardware (the KKT Device and the computer), and is not a standalone software-only medical device.
Based on the provided information, the Spinalytics software application is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Spinalytics' function: Spinalytics processes digitized X-rays (imaging data) and helps calculate treatment parameters for a physical device (the KKT device) used to treat chronic pain. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's "in the aid of management of chronic pain due to non-congenital defects" and involves "diagnostic imaging" and "treatment." This aligns with a therapeutic or treatment planning device, not an IVD.
Therefore, Spinalytics falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the patient. The procedure involves the use of diagnostic imaging that quantifies the misalignment of vertebrae. The treatment is then administered using the KKT device to deliver impulses at a precise vector. Spinalytics is a software application which facilitates treatment using the KKT device.
Spinalytics provides an interface to manage the patient information stored in a central database. Spinalytics facilitates measuring angles and distances of relevant sketal structures in a patient, by providing the practitioner with an interface to mark the position of these structures directly on digitized X-Rays. Spinalytics then calculates standard treatment protocol parameters which can be sent directly to the KKT device. Spinalytics is an optional accessory to the KKT device and does not change the intended use of the device.
Product codes (comma separated list FDA assigned to the subject device)
LXM
Device Description
Spinalytics Application is an optional software accessory to the KKT device which facilitates the calculation of the treatment parameters, which were previously calculated manually. Qualified personnel may generate, review, verify, approve, print and export the treatment plan prior to patient treatment. Spinalytics Application also communicates directly with the KKT Device to seamlessly enter the treatment parameters into the device. The clinicians may still enter their own parameters in the Spinalytics Application which meet their own treatment and clinical protocols, if they choose.
The Spinalytics Application software is installed on a computer near the KKT Device. It can be installed on any commercial grade PC that meets the minimum hardware and operating system requirements. The computer and the KKT Device communicate over a USB cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digitized X-Rays, X-Rays
Anatomical Site
Spinal, vertebrae, cervical spine
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)
The device’s software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The device Hazard analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The Spinalytics device passed all testing and supports the claims of substantial equivalence and safe operation.
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The verification testing of the device's software was found to be acceptable and supports the claims of substantial equivalence.
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
N/A
0
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December 21, 2019
Optima Health Solutions International Corp. % Diane Sudduth Senior Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Bldg. 1, Suite 300 Austin, Texas 78746
Re: K192629
Trade/Device Name: Spinalytics Regulatory Class: Unclassified Product Code: LXM Dated: September 19, 2019 Received: September 23, 2019
Dear Diane Sudduth:
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
1
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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
For: Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine 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) K192629
Device Name Spinalytics
Indications for Use (Describe)
The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the patient. The procedure involves the use of diagnostic imaging that quantifies the misalignment of vertebrae. The treatment is then administered using the KKT device to deliver impulses at a precise vector. Spinalytics is a software application which facilitates treatment using the KKT device.
Spinalytics provides an interface to manage the patient information stored in a central database. Spinalytics facilitates measuring angles and distances of relevant sketal structures in a patient, by providing the practitioner with an interface to mark the position of these structures directly on digitized X-Rays. Spinalytics then calculates standard treatment protocol parameters which can be sent directly to the KKT device. Spinalytics is an optional accessory to the KKT device and does not change the intended use of the device.
| 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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Section 5 – 510(k) Summary
Spinalytics
1. Submission Sponsor
Optima Health Solutions International Corp.
Unit 303 - 828 W 8th Avenue
Vancouver, British Columbia
Canada, V5Z 1E2
Tel: (604) 266 5338
Fax: (604) 267 0911
Contact: Farhad Ghani
Title: Quality/Regulatory Affairs
Email: farhad@kktspinetreatment.com
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road, Bldg 1, Suite 300
Austin, TX 78746
Cell Phone: (561) 305.5075
Office Phone: (512) 327.9997
Fax: (512) 327-9998
Contact: Dr. Diane Sudduth, Senior Consultant, RA
Email: LST.AUS.ProjectManagement@ul.com
3. Date Prepared
12/21/19
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4. Device Identification
| Trade/Proprietary Name: | Spinalytics |
|---|---|
| Common/Usual Name: | Plunger-like Joint Manipulator |
| Classification Name: | N/A |
| Regulation Number: | N/A |
| Product Code: | LXM |
| Device Class: | Unclassified |
| Classification Panel: | Physical Medicine |
5. Legally Marketed Predicate Device(s)
KKT Device, Optima (K130666), primary predicate device
EOS Imaging, sterEOS Workstation, (K141137); reference device
6. Device Description
KKT Device (FDA Cleared Configuration)
The Khan Kinetic Treatment (KKT) device (manufactured by Optima Health Solutions, and cleared by K130666), is to be used in the aid of management of chronic pain due to non-congenital defects. The KKT device, in its cleared configuration, applies low-intensity mechanical impulses to the patient using parameters identified from the manual X-Ray analysis.
In its cleared configuration, the treatment parameters are determined by manually analyzing the patient's X-Rays and calculating the angles and distances of various skeletal landmarks of the cervical spine and skull. Once the practitioner determines the treatment parameters are programmed manually in the KKT Device through its LCD touch screen interface. The treatment is then administered using the KKT device to deliver precise impulses at a required vector configuration
KKT Device with Spinalytics Application Software Accessory
Spinalytics Application is an optional software accessory to the KKT device which facilitates the calculation of the treatment parameters, which were previously calculated manually. Qualified personnel may generate, review, verify, approve, print and export the treatment plan prior to patient treatment. Spinalytics Application also communicates directly with the KKT Device to seamlessly enter the treatment parameters into the device. The clinicians may still enter their own parameters in the Spinalytics Application which meet their own treatment and clinical protocols, if they choose.
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The Spinalytics Application software is installed on a computer near the KKT Device. It can be installed on any commercial grade PC that meets the minimum hardware and operating system requirements. The computer and the KKT Device communicate over a USB cable.
The Spinalytics Application software is installed on a computer near the KKT Device. It can be installed on any commercial grade PC that meets the minimum hardware and operating system requirements. The computer and the KKT Device communicate over a USB cable
7. Indication for Use Statement
The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that quantifies the misalignment of vertebrae. The treatment is then administered using the KKT device to deliver impulses at a precise vector.
Spinalytics is a software application which facilitates treatment using the KKT device. Spinalytics provides an interface to manage the patient information stored in a central database. Spinalytics facilitates measuring angles and distances of relevant skeletal structures in a patient, by providing the practitioner with an interface to mark the position of these structures directly on digitized X-Rays. Spinalytics then calculates standard treatment protocol parameters which can be sent directly to the KKT device. Spinalytics is an optional accessory to the KKT device and does not change the intended use of the device.
8. Substantial Equivalence Discussion
The following table compares Spinalytics to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing for the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities and differences to the primary predicate device (K130666).
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Table 5A – Comparison of Characteristics with Primary Predicate – KKT M2 Device
| Significant Difference | Spinalytics Application software | Primary Predicate KKT-M2 Device (K130666) | |
|---|---|---|---|
| Indications of Use | Similar |
The indications for use of the Spinalytics Application software is slightly different from K130666 as it is expanded to cover use of the optional software.
The software functions of the device do not raise any concerns because the information inputted by the physician is the same that would be typically calculated and maintained on paper records.
Also, software testing has been conducted to verify correct information for a specific patient/X-ray. | The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that quantifies the misalignment of vertebrae. The treatment is then administered using the KKT device to deliver impulses at a precise vector.
Spinalytics is a software application which facilitates treatment using the KKT device. Spinalytics provides an interface to manage the patient information stored in a central database. Spinalytics facilitates measuring angles and distances of relevant skeletal structures in a patient, by providing the practitioner with an interface to mark the position of these structures directly on digitized X-Rays. Spinalytics then calculates standard treatment protocol parameters which can be sent directly to the KKT device. Spinalytics is an optional accessory to the KKT device, and does not change the intended use of the device | The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration. |
| Discussion of Non-Clinical Tests | | Electrical safety, electromagnetic compatibility, environmental | Underwent and passed electrical safety, electromagnetic compatibility, environmental and |
| the
determination
of Substantial
Equivalence | testing is being leverage from
the cleared KKT-M2
(K130666). The Spinalytics
application software is
fulfilling the requirements of
the IEC 62304 standard
according to software
testing. | Classification according to IEC
60601-1. | |
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Discussion on similarities and differences
The current submission includes addition of the optional Spinalytics Application software to be used with the predicate device the Khan Kinetic Treatment (KKT-M2) device. This extension results in a new Indication for Use reflection for the addition of this analysis tool. The Spinalytics Application software does not introduce changes to the KKT device thus the components in this device are identical in the predicate device.
The purpose of the Spinalytics Application software is to measure angles and distances on multiple Xrays, and software validation testing has been conducted to verify data calculations.
The indications for use of the Spinalytics Application software is slightly different from K130666 as it is expanded to cover use of the optional software. The software functions of the device do not raise any concerns because the information inputted by the physician is the same that would be typically calculated and maintained on paper records. Also, software testing has been conducted to verify correct information for a specific patient/X-ray.
In the event of a software malfunction, there will be no effect on the KKT device.
Spinalytics and sterEOS software both provide tools for practitioners to analyze X-Rays to plan treatment protocols. The feature set of Spinalytics can be considered a subset of the feature set of sterEOS, as it provides an interface for a user to mark specific points on the image to measure different parameters. The sterEOS works with highly precise, spatially calibrated bi-planar X-Rays, which can only be produced by the EOS machine. Spinalytics calculates 3D measurements by having the user mark 3 different X-rays, which are taken from 3 orthogonal views (AP Open Mouth, LAT, Top).
The data calculated by Spinalytics software can be used by practitioners for analysis and to plan a protocol for treatment. The database can be accessible to a treatment device. For sterEOS, the measurements can also be used by practioner's for analysis and treatment planning, but it is not accessible to a treatment device.
9. Non-Clinical Performance Data
The device's software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for
8
each of the test plans to assure the device performs as intended. The device Hazard analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The Spinalytics device passed all testing and supports the claims of substantial equivalence and safe operation.
10. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The verification testing of the device's software was found to be acceptable and supports the claims of substantial equivalence.
11. Statement of Substantial Equivalence
The Spinalytics, as designed and implemented, is determined to be substantially equivalent to the referenced predicate device.