← Product Code LXM · K130666 # KHAN KINETIC TREATMENT (KKT-M2) (K130666) _Optima Health Solutions International Corporation · LXM · Jan 23, 2014 · PM · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K130666 ## Device Facts - **Applicant:** Optima Health Solutions International Corporation - **Product Code:** LXM - **Decision Date:** Jan 23, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** PM - **Attributes:** Therapeutic ## Intended Use The KKT-M2 device is to be used in the aid of management of chronic pain due to noncongenital 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. ## Device Story KKT-M2 is a manipulator device for chronic pain management in orthopedic clinics. It uses diagnostic imaging (X-rays) to identify vertebral misalignments. A physician operates the device to deliver controlled, low-intensity mechanical impulses to the atlas vertebra. The device consists of a treatment head on an electrically actuated stand; parameters (vector, amplitude, duration) are set via an LCD touchscreen or client application. The system uses a stepper motor and stylus to apply a specific pulse sequence: 16Hz constant frequency for 750ms, followed by a 50-80Hz frequency sweep, then a rotational twist, and a 750ms pause. A release mechanism with firmware interlock prevents excessive pressure. The output is a controlled vibration that gently urges skeletal realignment. Benefits include precise, repeatable force application compared to manual manipulation, potentially reducing pain associated with structural anomalies. ## Clinical Evidence Bench testing only. No clinical trials were conducted. Safety and performance were validated through compliance with IEC 60601-1 (Ed 3) and IEC 62366 (Ed 1). The manufacturer reports no adverse outcomes in over 10,000 treatments using the KKT system. ## Technological Characteristics Electrically actuated manipulator; 24VDC power supply. Stylus tip: Elastosil R401/60; Stylus body: Acrylic. Motion: Sinusoidal, 50-80Hz frequency sweep, 16Hz base frequency. Max force: 5 lbs. Connectivity: USB serial. Software: Firmware-controlled interlocks for pressure release. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62366. ## Predicate Devices - KKT-M1 ([K060043](/device/K060043.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION Suite 303 - 828 West 8th Avenue, Vancouver, BC, V5Z 1E2, Canada # Section 4 510(k) Summary JAN 2 3 2014 K130666 In accordance with 21 CFR 807.92: ### 1. Submitter's Information Khan Kinetic Treatment Device (KKT-M2) Optima Health Solutions International Corp. 303 - 828 West 8th Street Vancouver, British Columbia Canada, V5Z 1E2 Contact: Farhad Ghani Tel: (604) 266 5338 Fax: (604) 267 0911 ### 2. Name of the Device Khan Kinetic Treatment Device (KKT-M2) Common Name: Manipulator Device Device Classification Name: Manipulator, Plunger-Like Joint Classification (21CFR 890): Unclassified ### Legally Marketed Predicate Device: 3. The (KKT-M2) has the same intended use and indications for use as the previously cleared device (KKT-M1), as well as similar performance and principles of operation. The technological differences between the (KKT-M2) and predicate KKT-M1 device is primarily improvement in design and manufacturing of the device. The device and its components have been thoroughly tested for safety and effectiveness to ensure that no new issues of safety or effectiveness are raised from the design change. Information on the Predicate Device: Name: ........................................................................................................................................................................ Product Code: ................................................................................................................................................................ 510(k) Number: ............................................................................................................................................................... Marketed by: ................................... Optima Health Solutions International Corp. Address: ..................................................................................................................................................................... Vancouver, British Columbia Canada, V5Z 1E2 {1}------------------------------------------------ Suite 303 - 828 West 80 Avenue, Vancouver, BC, V5Z 1E2, Canada Establishment Registration No :: ' 10040107 ### Description of the Device: 4. The KKT device has been developed for the aid in management of chronic pain. More specifically, conditions of chronic pain arising from structural anomalies such as misalianments and muscle imbalances. Conditions of brain stem irritation as a result of musculoskeletal imbalances that may arise from impact. Typical conditions treated include: strains to soft tissue surrounding vertebral column, whiplash injuries to the head and neck, and biomechanical disrelationships of the axial skeleton. This device is not intended to be used in acute situations of pain management. #### 5. Statement of the Intended 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 procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT device to deliver precise impulses at a required vector configuration. #### Technical Description: છે. The KKT Device's mode of action consists of low-intensity mechanical impulses applied to the treatment site in a controlled and repeatable manner. The control of the direction (vector), amplitude and duration of the impulses allows for a known, finite, and predetermined amount of force and/or energy to be applied to the treatment site. This control is predetermined and then prescribed by a qualified medical practitioner where the treatment parameters to be correlated with (or derived from) data from X-rays, imaging systems, and physiological length, strength or distance measurements and used for the patient's treatment. The treatment protocol consists of a series of pulses applied to the atlas vertebra. Each pulse consists of a constant 16Hz frequency for approximately 750msec, a frequency sweep of 50 to 80 Hz in steps of 1 Hz for one full cycle each, followed by an extension while a twist is applied through the stepper motor, then a pause for approximately 750msec before the next pulse. The number of pulses can be set by the operator as can the amplitude of the stylus vertical motion and the amount and direction of the rotation. The device consists of a treatment head supported by an electrically actuated stand. Power is supplied through a grounded receptacle to an auto sensing 24VDC power supply. All actuators and controls are powered at 24VDC or lower. The vertical tower is positioned manually by sliding on the base plate and vertical and horizontal adjustment is controlled by redundant momentary switches located on either side of the horizontal arm. The position of the treatment head is set manually using the positioning display on the LCD screen mounted on the horizontal arm. Treatment parameters for duration and intensity are entered using the same screen or automatically through Client Application software. A release mechanism is incorporated into the treatment stylus to prevent excessive {2}------------------------------------------------ Suite 303 - 828 West 80 Avenue, Vancouver, BC, V5Z 1E2, Canada pressure being applied to the patient. This mechanism is interlocked through firmware to halt treatment and raise the treatment head when activated. #### 7. Comparison to Predicate The (KKT-M2) has the same intended use and indications for use as the previously cleared device (KKT-M1), as well as similar performance and principles of operation. The technological differences between the (KKT-M2) and predicate KKT-M1 device is primarily improvement in design and manufacturing of the device. The device, its components, and its operation have been thoroughly tested for safety and effectiveness to ensure of safety and effectiveness of the device. | Manufacturer | Optima Health Solutions | Optima Health Solutions | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | KKT-M1 | KKT-M2 | | 510(k) Number | K060043 | Pending | | Product Code | LXM | LXM | | Regulation
Number | Unclassified | Unclassified | | Regulation Name | Manipulator, plunger-like device | Same | | 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 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. | The KKT-M2 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. | | Intended Use/
Operation of
device | The KKT device is to be used in
the aid of management of
chronic pain due to non-
congenital defects. | Same | | Components
(System) | Touchscreen
Horizontal Arm
Vertical Tower
Base plate
Transducer head
Stylus | Same | | Software
Mechanical | Contains firmware | Same | | Diameter | 0.375 inches | 15 mm | | Stylus material | Carbon fiber | Acrylic | | Stylus tip | Delrin | Elastosil R401/60 | | Linear motion
Distance | 0.125 inches max. | Same | | | IMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION | | | Manufacturer | Optima Health Solutions | Optima Health Solutions | | Trade Name | KKT-M1 | KKT-M2 | | Motion | Sinusoidal | Same | | Frequency | 50 Hz to 100 Hz, 2 Hz increments (1 sweep =1 cycle) | 50-80Hz | | Force | 6 lbs (2.7 kg) max | 5lbs maximum | | Cycles | User controlled | User controlled | | Rotational motion | | | | Angle | +/- 30 deg max. | Same | | Direction | Clockwise, counterclockwise | Same | | Repetitions | Once per cycle | Same | | Limits | Electronic and mechanical stops | Same | | Positioning
Base & Stand Adjustments | | | | Stylus tip | | | | Vertical motion | 13 (+/-) inches
Electrically powered | Up to 3mm (1/8") during treatment. Maximum travel from lowest to highest points of the vertical leadscrew is 26cm. | | Horizontal
transverse
motion | 10 inches
Manual with friction lock
Perpendicular to patient | Distance unit can travel along base plate rail along the transverse patient plane is at least 50cm in each direction from center point. Manual operation with adjustable friction brake. | | Horizontal axial
motion | 10 inches
Manual with friction lock
Perpendicular to patient | Arm extends/retracts horizontally axially a total of 36cm. Motion is lead-screw driven, with braking mechanism incorporated into the lead screw controller. | | Horizontal
rotation | +/- 45 deg from normal, centered position, positive detent/lock at center | N/A | | Transducer head/armature adjustments | | | | Horizontal
motion | Horizontal motion | Same | | Angular motion | Angular motion | Same | | Interface | Interface | Same | | Transducer head | Transducer head | LCD touchscreen display | | Display | Display | Same | | Keypad | Keypad | Same | | Communications | Communications | USB serial | | Fuse (for 24 VDC
transducer
power) | 3 AG 4A, 250V | 1.6A 250VAC | | KKT Device System | | | | Mains power
supply | Mains power supply | Same | | Fuse, mains | Fuse, mains | Same | | Environment | 15C to 40C
10% - 90% RH | Same | | Storage | -20C to 50C
10% to 90% RH (non-
condensing) | -5C to 35C
10% to 90% RH, non-
condensing | | Weight | 150 lbs (66 kg) | 350 lbs | | Manufacturer | Optima Health Solutions | Optima Health Solutions | | Trade Name | KKT-M1 | KKT-M2 | | External switch
rating | 1 A @ 240 VAC/DC (resistive) | 6A @ 250VAC | | Accessories | | | | Standard | AC line cord
Foot switch | AC line cord
User Manual | | Optional | Start/stop switch
Motorized bed interface | Same | {3}------------------------------------------------ ### optima health solutions international corporation . . . . 4-4 . {4}------------------------------------------------ OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION ### 8. Standards and Testing The device has been successfully tested to the following standards by accredited testing laboratories for performance and safety testing. | # | Standard | Standard Title | Version | Date | Cert./ Report # | |---|---------------------|-----------------------------------------------------------|---------|-----------------|-----------------------------------------------------| | | IEC 60601-
1.1-2 | Medical electrical equipment - Part
1-2 | Ed 3 | Mar-30-
2007 | 27382 Rev1.4 | | 2 | IEC 60601-1 | Medical electrical equipment - Part | Ed 3 | Dec-2005 | CB Certification
US/3467/ITS
100290268BOX-001 | | ನ | IEC 62366 | Application of Usability Engineering
to Medical Device | Ed 1 | Oct-18-
2007 | 100290268BOX-002 | Additionally the KKT-M2 has been tested and approved for use sale and marketing into other markets including, Canada, CE, and China. ### 9. Conclusion This submission for the second generation of Khan Kinetic Treatment device (KKT-M2) seeks to obtain approval for marketing in the US, a product that is intended to be used in medical clinics, more specifically, orthopedic clinics. The device's intended use is for aid in management of chronic pain. More specifically, conditions of chronic pain arising from structural anomalies such as misalignments and imbalances of the soft tissues of the back and neck. The KKT-M2 has been tested for safety and effectiveness with improved features in comparison to the previously cleared device KKT-M1, and its predicates. In comparison to handheld devices or manual manipulation that deliver a single, relatively uncontrolled blow to the affected area, KKT-M2 delivers a highly controlled, low force, repetitive impulse to the treatment location, resulting in a controlled vibration, as is disclosed in the technical reports. This can be felt by the practitioner as impulse waves extending from the treatment location. As a result, KKT gently urges realignment of the skeletal system over one or more treatments. Standardized operating conditions: - Force is accurately adjustable and not more than 5 pounds, with suggested force of 10.3 N (2.3 pounds): - Stylus vertical displacement of up to 3mm (1/8") during treatment - - Wave form is sinusoidal; and - - Frequency is accurately adjustable and not more than 110 Hz, with suggested treatment being 16Hz + 50-80Hz for disc treatment. {5}------------------------------------------------ Suite 303 - 828 West 8" Avenue, Vancouver, BC, V5Z 1E2, Canada The results from the studies cited above support the efficacy of the treatment. Further, there have been no adverse outcomes reported in over 10,000 KKT treatments. {6}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### January 23, 2014 Optima Health Solutions International c/o Diane Sudduth, MS, MPH Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Re: K130666 Trade/Device Name: Khan Kinetic Treatment Device (KKT-M2) Regulatory Class: Unclassified Product Code: LXM Dated: November 1, 2013 Received: November 4, 2013 Dear Ms. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. {7}------------------------------------------------ ### Page 2 - Diane Sudduth, MS, MPH If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, ## Carlos L. Pena -S Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _ K130666 Device Name:__ Khan Kinetic Treatment Device (KKT-M2) Indications For Use: and the comments of The KKT-M2 device is to be used in the aid of management of chronic pain due to noncongenital 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. Prescription Use × (Part 21 CFR 801 Subpart D) and the country of the country of the country of 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 Center for Devices and Radiological Health (CDRH) Carlos L. Pena -S Page 1 of _ 1 --- **Source:** [https://fda.innolitics.com/device/K130666](https://fda.innolitics.com/device/K130666) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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