The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The KKT device is to be used as part of a series of steps in the total care of the patient. The device is to be used for the treatment of vertebral motor units which appear to be fixated. The procedure can involve xray analysis that quantifies the lateral and rotational misalignments between the vertebrae. The treatment is then administered using the KKT device to deliver precise impulses at a required vector configuration.

Device Description

The KKT device provides an integrated treatment system unlike manual manipulation of the upper cervical spine, applying significantly smaller forces than those applied manually. While other handheld devices have been used which employ similar treatment methods, the KKT device provides significant advancement and improvement in moments, the ANT repeatability. The device consists of a display and controller, a force application probe, and a multi-axis adjustable stand. The device is used to apply force, rotation, and vibration to a patient.

AI/ML Overview

The KKT (Khan Kinetic Treatment) Device is a manipulator device intended to aid in the management of chronic pain due to non-congenital defects, specifically for the treatment of fixated vertebral motor units. It aims to deliver precise impulses at a required vector configuration, with the goal of minimizing potential harm compared to manual adjustments. The submission highlights that the device provides significant advancements in positioning, accuracy, and repeatability compared to other handheld devices and manual manipulation.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Requirement	Method of Compliance	Reported Device Performance (Comment)
Electrical Safety	CSA 601.1 and UL 2601/60601-1, with CB Report done to IEC 60601.1	See the KKT Device Technical File
Electromagnetic Compatibility (EMC)	IEC 60601.1-2	See the KKT Device Technical File
KKT Device Verification Test Plan	Formal Design Verification Procedure	See the KKT Device Technical File

Note: The provided document states that the details for the reported device performance for these criteria are within the "KKT Device Technical File", which is not included in this extract. Therefore, specific numerical performance metrics are not available here. The document generally concludes the device is "safe and effective".

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly mention a specific "test set" in the context of clinical performance data involving human subjects or patient outcomes. The testing described focuses on engineering compliance (Electrical, EMC, Design Verification). Therefore, information regarding sample size, data provenance (country of origin, retrospective/prospective) for a clinical test set is not available in this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no clinical test set with human subjects or patient data is explicitly detailed, there is no information provided about the number of experts used to establish a ground truth or their qualifications. The submission indicates that the device can be used in conjunction with "x-ray analysis that quantifies the lateral and rotational misalignments between the vertebrae," implying that practitioners (likely chiropractors or medical professionals) would assess these misalignments. However, this is for clinical application, not for a ground truth establishment in a study described in this document.

4. Adjudication Method for the Test Set

As there is no described clinical test set with a need for ground truth establishment by multiple experts, there is no mention of an adjudication method (e.g., 2+1, 3+1, none).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned or summarized in the provided document. The submission focuses on device safety, electrical compliance, and substantial equivalence to a predicate device, rather than comparative clinical effectiveness with human readers.

6. Standalone (Algorithm only without human-in-the loop performance) Study

The KKT device is a physical manipulative device, not an algorithm or AI system in the sense of image analysis or diagnostic support. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned. The device's operation inherently involves human interaction for patient assessment and device application.

7. Type of Ground Truth Used

For the engineering tests (Electrical, EMC, Design Verification), the "ground truth" would be established by the specifications of the relevant standards (e.g., IEC 60601-1-2 for EMC). However, for clinical effectiveness, no specific ground truth (e.g., pathology, outcomes data) is mentioned in the context of a performance study in this document. The device's use is indicated based on "x-ray analysis that quantifies the lateral and rotational misalignments," implying a diagnostic assessment made by a clinician.

8. Sample Size for the Training Set

Since the KKT device is a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" in the traditional sense is not applicable. Therefore, no sample size for a training set is provided.

9. How the Ground Truth for the Training Set Was Established

As the concept of a training set does not apply to this device, there is no information on how its ground truth would be established.

Summary of Device Rationale and Approval:

The 510(k) submission for the Khan Kinetic Treatment Device (KKT-M1) primarily seeks to demonstrate substantial equivalence to an existing legally marketed predicate device, "The Atlas Orthogonal Percussion Instrument (K951217)." The basis for approval appears to be:

Similar Indications for Use: Both devices are pressure-applying devices for musculoskeletal manipulation.
Similar Technology/Operating Principles: The KKT device is described as operating on similar principles to other percussion devices but with advancements in "positioning, accuracy and repeatability" and "adjustable, modifiable forces."
Compliance with Recognized Standards: The device was tested for electrical safety (CSA 601.1, UL 2601/60601-1, IEC 60601.1) and EMC (IEC 60601.1-2, EN55022, EN61000).
Safety Features: The submission states that "numerous built-in mechanisms have been incorporated into the device to ensure safety" to minimize harm compared to manual adjustments.

The FDA's letter confirms that the device was found substantially equivalent to the predicate device, allowing it to be marketed. The information provided in this document focuses heavily on technical and regulatory compliance rather than extensive clinical performance data or AI model validation details.

Summary

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K060043

D. 1/4

510(k) SUMMARY

Khan Kinetic Treatment Device (KKT-M1)

Common Name: Manipulator Device Classification: Unclassified

Optima Health Solutions International, Inc. Unit 303, 828 West 8th Avenue Vancouver, British Colombia, Canada V5Z 1E2

Contact: Bram Ramjiawan Tel: 204-984-4623 Fax: 204-983-8835 Prepared: November 6, 2005

LEGALLY MARKETED PREDICATE DEVICES A.

The Khan Kinetic Treatment Device (KKT-M1) is equivalent to a similar pressure applying device - The Atlas Orthogonal Percussion Instrument.

Information on the Predicate Device

Name:	The Atlas Orthogonal Percussion Instrument
Classification Product Code:	LXM
510(k) Number:	K951217
Marketed by:	Sweat Chiropractic Clinic
Address:	3274 Buckeye Rd. N.E, Atlanta, GA 30341
FDA Establishment #:	1039671

Summary: The device is a pressure applying device that is a comparable to the KKT-M1 device.

B. DEVICE DESCRIPTION

Indication 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 total care of the patient. The device is to be used for the treatment of vertebral motor units which appear to be fixated. The procedure can involve xray analysis that quantifies the lateral and rotational misalignments between the vertebrae. The treatment is then administered using the KKT device to deliver precise impulses at a required vector configuration.

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The Device

Image /page/1/Picture/4 description: The image shows a piece of medical equipment. The equipment has a tall, rectangular base with a series of controls on the front. A horizontal arm extends from the top of the base, supporting a large, box-shaped component with a dark rectangular area on its side. A white piece of paper is placed on a surface near the base of the equipment.

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Image /page/2/Figure/2 description: This image shows a diagram of a Khan Kinetic Treatment Device. The device consists of a display and controller, a force application probe, and a multi-axis adjustable stand. The device is used to apply force, rotation, and vibration to a patient.

Similarities and Differences to Comparative Device

The KKT device is similar and comparable to pressure applying devices (reference CFR 21 Part 890, Sec. 890.5765) as well as percussion devices/percussors (reference CFR 21 Part 882, Sec. 882.1700). A comparable pressure applying device is the Atlas Orthogonal Percussion Instrument which is from Sweat Chiropractic Clinic. The Atlas Orthogonal Percussion Instrument is registered with the FDA under establishment license number 1039671 and is patented under US Patent No. 4,461,286 (issued to Sweat). Other devices patented that are similar or operate using the same principles include: US Patent No. 4,841,955 (issued to Evans), US Patent No. 4,549,535 (issued to Wing), US Patent No. 5,618,315 (issued to Elliott), and US Patent No. 6,602,211 (issued to Tucker).

The key difference between the KKT device and applying pressure via manual manipulation or via different impulse methods is that the KKT device provides an integrated treatment system that applies adjustable, modifiable forces in a more effective method and it provides significant advancement and improvement in positioning, accuracy and repeatability.

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ember 6, 2005 P. 4/4

C. TESTING

Requirement	Method of Compliance	Comment
Electrical	CSA 601.1 and UL2601/60601-1, with CBReport done to IEC60601.1	See the KKT Device Technical File
EMC	IEC 60601.1-2	See the KKT Device Technical File
KKT DeviceVerification Test Plan	Formal DesignVerification Procedure	See the KKT Device Technical File

D. STANDARDS

The KKT device was designed according to the medical device standards IEC60601-1, IEC60601-1-2 and the relevant EMC standards:

. EN55022
. EN61000

These standards, or variations thereof, are relevant to entry into other markets such as China, Canada, Australia and Japan.

The KKT device has received Health Canada approval for use, sale and marketing.

E. CONCLUSIONS

This submission for the Khan Kinetic Treatment device seeks to obtain approval for marketing in the US, a product that is intended to be used in chiropractic clinics. The device's intended use is for aid in management of chronic pain. More specifically, conditions of chronic pain is is is from structural anomalies such as misalignments and muscle imbalances. The device is safe and effective and is similar to the FDA approved predicate device (The Atlas Orthogonal Percussion Instrument (K951217)).

The current practices of performing manual spinal adjustments for the relief of pain have received negative attention due to the occurrence of injury. Unintended injury in these situations has occurred because of unregulated manual force generated by the individual clinicisn.

This device was developed to minimize (relative to the current practice of manual adjustments) potential harm by having a system that generates impulses as opposed to uncontinuits. mechanical force alone to stimulate areas of interest.

Numerous built-in mechanisms have been incorporated into the device to ensure safety.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2006

Optima Health Solutions International, Inc. c/o Dr. Bram Ramjiawan Industrial Technology Advisor IRAP West National Research Council Industrial Research Assistance Program 435 Ellice Avenue Winnipeg, Manitoba, Canada R3B 1Y6

Re: K060043

Trade/Device Name: Khan Kinetic Treatment Device (KKT-M1) Regulatory Class: Unclassified Product Code: LXM Dated: November 27, 2005 Received: January 26, 2006

Dear Dr. Ramjiawan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 – Dr. Bram Ramjiawan

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Helena Lemes

Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060043

Device Name:

Khan Kinetic Treatment (KKT) Device

Indications for Use:

The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The KN P device is to be asseries of steps in the total care of the patient. The device is to be rine device our of wood as a pebral motor units which appear to be fixated. The procedure can involve xray analysis that quantifies the lateral and rotational misalignments between the vertebrae. The treatment ray analysis that quantinos the factor and readiver precise impulses at a required vector configuration.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut Semen
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_ 06043

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

N/A