(56 days)
Not Found
No
The summary describes a device that delivers mechanical impulses based on diagnostic imaging, but there is no mention of AI or ML being used for image analysis, treatment planning, or impulse delivery control. The software is mentioned as "Moderate" level of concern, which is typical for many medical devices and doesn't necessarily indicate AI/ML.
Yes
The device is described as being used in the "aid of management of chronic pain" and for "treatment" by delivering "precise impulses" and "mechanical impulses" to the patient's tissues, which aligns with the definition of a therapeutic device.
No
The device description indicates it is used for "management of chronic pain" and "delivers precise impulses at a required vector configuration" as a treatment. While the procedure "involves the use of diagnostic imaging that qualifies the misalignment," the device itself is not performing the diagnostic imaging; it is used for treatment after the diagnostic process.
No
The device description explicitly states it converts electrical energy into mechanical energy and transmits it through a stylus tip, indicating a physical hardware component delivering therapy. The performance studies also include electrical safety and vibration frequency verification, which are relevant to hardware performance, not solely software.
Based on the provided information, the SONIK MONARK 100 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The SONIK MONARK 100 device is used to deliver mechanical impulses to the patient's intact skin. It does not analyze blood, urine, tissue, or any other bodily fluid or substance.
- The intended use is for the management of chronic pain. This is a therapeutic application, not a diagnostic one that involves analyzing a sample to determine a disease or condition.
- The device description focuses on the delivery of mechanical energy to the patient. This is a physical intervention, not a laboratory test.
While the device's use is aided by diagnostic imaging, the device itself is a therapeutic device that delivers treatment, not a device that performs a diagnostic test on a specimen.
N/A
Intended Use / Indications for Use
The SONIK MONARK 100 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 device to deliver precise impulses at a required vector configuration.
Product codes (comma separated list FDA assigned to the subject device)
LXM
Device Description
The SONIK MONARK 100 (SM-100) device is used for the management of chronic pain due to noncongenital defects. It operates through the delivery of low-frequency impulses onto intact skin. The device converts electrical energy into mechanical energy, which is then transmitted to the patient's tissues through the stylus tip. It employs a mode of action that involves the application of controlled and repeatable low-intensity mechanical impulses to the treatment site. The device can be used in a handheld manner or mounted to a movable arm on a cart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic imaging that qualifies the misalignment between vertebrae.
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)
Electrical Safety and Electromagnetic Compatibility (EMC):
The device has been successfully tested to the following standards by accredited testing laboratories for performance and safety testing:
- IEC 60601-1 Medical Electrical Equipment - Part 1 Ed 3 Jun-19-2023
- IEC 60601-1-2 Medical Electrical Equipment - Part 1-2 Ed 4.1 Sep-14-2023
Software Verification and Validation:
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "General Principles of Software Validation." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software may, prior to mitigation of hazards, result in a Minor injury to patient or user, but this would not present a hazardous situation with a probable risk of death or serious injury to the patient, user, or others in the environment of use.
Vibration Frequency Verification:
The study was conducted to verify the SONIK MONARK 100 accurately and reliably produces a sample of intended frequencies. For the intended frequencies that were tested, the frequencies produced by the device did not deviate from the target frequency by more than the acceptable margin of error (
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 15, 2024
Neuro Spinal Innovation Inc Madhava Tirukovela Quality and Procurement Specialist 77 City Centre Drive, Suite 501, East Tower Mississauga, ON L5B 1M5 Canada
Re: K234036
Trade/Device Name: SONIK MONARK 100 Regulatory Class: Unclassified Product Code: LXM Dated: December 20, 2023 Received: December 21, 2023
Dear Madhava Tirukovela:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Amber T. Ballard -S
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K234036
Device Name SONIK MONARK 100
Indications for Use (Describe)
The SONIK MONARK 100 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 device to deliver precise impulses at a required vector configuration.
| 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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4
510(k) Summary
SONIK MONARK 100
1. Submitter Information
Neuro Spinal Innovation Inc. 77 City Centre Drive, Suite 501 East Tower, Mississauga ON L5B 1M5 Canada
Contact: Madhava Tirukovela Tel: +1-323-412-5662 Email: regulatory@neuro-spinal.com Date Prepared: February 2, 2024
2. Device Identification
| Trade/Proprietary Name: | SONIK MONARK 100 |
|---|---|
| Common/Usual Name: | Manipulator Device |
| Classification Name: | Manipulator, Plunger-like Joint |
| Regulation Number: | 21 CFR 890 |
| Product Code: | LXM |
| Class: | Unclassified |
| Unclassified Reason: | Pre-Amendment |
| 510(k) #: | K234036 |
3. Legally Marketed Predicate Device(s)
| Device name: | KKT-M2 |
|---|---|
| 510(k) number: | K130666 |
| Manufacturer: | Optima Health Solutions International Corporation |
4. Indication for Use Statement
The SONIK MONARK 100 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 device to deliver precise impulses at a required vector configuration.
5
ട്. Device Description
The SONIK MONARK 100 (SM-100) device is used for the management of chronic pain due to noncongenital defects. It operates through the delivery of low-frequency impulses onto intact skin. The device converts electrical energy into mechanical energy, which is then transmitted to the patient's tissues through the stylus tip. It employs a mode of action that involves the application of controlled and repeatable low-intensity mechanical impulses to the treatment site. The device can be used in a handheld manner or mounted to a movable arm on a cart.
| Characteristic | Comparison | ||
|---|---|---|---|
| Manufacturer | Optima Health | ||
| Solutions International | |||
| Corporation | Neuro Spinal Innovation Inc. | N/A | |
| Trade Name | KKT-M2 | SONIK MONARK 100 | N/A |
| 510(k) Number | K130666 | K234036 | N/A |
| Product code | LXM | LXM | Same |
| Regulation | |||
| Number | Unclassified | Unclassified | Same |
| Regulation Name | Manipulator, plunger-like | ||
| device | 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 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. | The SONIK MONARK 100
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 device to deliver
precise impulses at a required
vector configuration. | Same |
| Intended Use/
Operation of
device | The KKT-M2 device is to be
used in the aid of
management of chronic | The SONIK MONARK 100
device is to be used in the aid
of management of chronic | Same |
| | | | |
| | pain due to non-congenital
defects. | pain due to non-congenital
defects. | |
| Components
(System) | Touchscreen
Horizontal Arm
Vertical Plate
Base Plate
Transducer Head
Stylus | Touch Screen
Treatment Head
Stylus | Different |
| Software | Contains Firmware | Contains Firmware | Same |
| Mechanical Characteristics | | | |
| Diameter | 15mm | 15mm | Same |
| Stylus material | Acrylic | Acrylic | Same |
| Stylus tip material | Elastosil R401/60 | Elastosil R401/60 | Same |
| Sterility | N/A | N/A | Same |
| Linear Motion of Stylus | | | |
| Distance | 0.125 inches max | 3.175 mm max (0.125 inches) | Same |
| Motion | Sinusoidal | Sinusoidal | Same |
| Frequency | 16-80Hz | 16-100Hz | Different |
| Force | 5lbs maximum | 17 N maximum (equivalent to
3.82 lbs) | Different |
| Cycles | User controlled | User controlled | Same |
| Rotational Motion of Stylus | | | |
| Angle | +/- 30deg max. | 0 deg | Different |
| Direction | Clockwise, Counter-
clockwise | Not Applicable; No Rotation | Different |
| Repetitions | Once per cycle | Not Applicable; No Rotation | Different |
| Limits | Electronic and mechanical
stop | Not Applicable; No Rotation | Different |
| Positioning Base and Stand Adjustments | | | |
| Stylus Tip | | | |
| Vertical motion | Up to 3mm (1/8") during
treatment.
Maximum travel from
lowest to highest points of
the vertical leadscrew is
26cm | Movement of 3 mm (1/8")
during treatment. | Different |
| Horizontal
transverse
motion | Distance unit can travel
along base plate rail along
the transverse patient
plane at least 50cm in each
direction from centre point.
Manual operation with
adjustable friction brake | Not Applicable | Different |
| | | | |
| Horizontal axial
motion | Arm extends/ retracts
horizontally axially a total
of 36cm. Motion is lead-screw driven, with braking
mechanism incorporated
into the lead screw
controller. | Not Applicable | Different |
| Treatment Head/Armature Adjustments | | | |
| Horizontal motion | Horizontal motion | Not Applicable | Different |
| Angular motion | Angular motion | Not Applicable | Different |
| Device System | | | |
| Interface
Transducer Head | Interface Transducer Head | Interface Transducer Head | Same |
| Display | LCD touchscreen display | LCD touch screen display | Same |
| Keypad | Keypad | Not Applicable | Different |
| Communications | USB serial | Bluetooth | Different |
| Mains Power
supply | Mains power supply | Mains power supply | Same |
| Fuse, mains | Fuse, mains | Fuse, mains | Same |
| Fuse (for 24VDC
transducer power) | 1.6A 250VAC | Slowblo 48VDC 2A | Different |
| Environment | +15°C to +40°C
10%-90% RH (non-
condensing) | +10°C to +35°C
30%-75% RH (non-condensing) | Different |
| Storage | -5°C to +35°C
10%-90% RH | -35°C to +55°C
10%-90% RH | Different |
| Weight | 350 lbs | Device: Approx. 1000g
Device + Accessories: Approx.
65kg | Different |
| Accessories | | | |
| Accessories
(optional) | Start/Stop
Motorized Bed Interface | Cart
Arm | Different |
Table 1 – Comparison of Characteristics of the SONIK MONARK 100 and the KKT-M2
6
7
7. Substantial Equivalence Discussion
The SONIK MONARK 100 and KKT-M2 have identical indications for use. The devices are identical with respect to their material, the type of energy used by the device, and type of energy that is delivered by the device to the patient. Both devices generate similar frequency ranges and are applied to patients in a similar manner. Although differences exist between the designs of the two devices, comparison of
8
the SONIK MONARK 100 with the predicate KKT-M2 device indicate that the technological characteristics of the SONIK MONARK 100 are substantially equivalent to those of the predicate device.
Design/technological differences between the two devices predominantly relate to device portability. The KKT-M2 device requires a base plate, vertical stand, and arm to position the treatment head, whereas the SONIK MONARK 100 features a smaller, lighter treatment head that can be operated as a handheld device. When in use, the arm accessory of the SONIK MONARK 100 is able to be manually adjusted, rather than requiring the use of an adjusting keypad. The SONIK MONARK 100 communicates with the connected computer wirelessly via Bluetooth, whereas the KKT-M2 device communicates with the connected computer via a USB cable. The SONIK MONARK 100 differs from the KKT-M2 in that it does not have a rotatory component in the stylus. Finally, the maximal force threshold for the SONIK MONARK 100 device was decreased from that of the KKT-M2. Since the force applied during treatment is slightly lower than the maximal force threshold of the KKT-M2 device, this will not impact the respective safety or efficacy of the SONIK MONARK 100 in comparison to the KKT-M2 device. Analysis of these differences indicates no substantial effect on the safety or effectiveness of the SONIK MONARK 100 in comparison to that of the KKT-M2. Overall, the SONIK MONARK 100 does not raise any questions of safety or effectiveness compared to the predicate device. Consequently, the devices can be considered to be substantially equivalent.
8. Performance Data
Electrical Safety and Electromagnetic Compatibility (EMC)
The device has been successfully tested to the following standards by accredited testing laboratories for performance and safety testing.
| # | Standard | Standard Title | Version | Date |
|---|---|---|---|---|
| 1 | IEC 60601-1 | Medical Electrical | ||
| Equipment - Part 1 | Ed 3 | Jun-19-2023 | ||
| 2 | IEC 60601-1-2 | Medical Electrical | ||
| Equipment - Part 1-2 | Ed 4.1 | Sep-14-2023 |
Software Verification and Validation
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "General Principles of Software Validation." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software may, prior to mitigation of hazards, result in a Minor injury to patient or user, but this would not present a hazardous situation with a probable risk of death or serious injury to the patient, user, or others in the environment of use.
Vibration Frequency Verification
9
The study was conducted to verify the SONIK MONARK 100 accurately and reliably produces a sample of intended frequencies. For the intended frequencies that were tested, the frequencies produced by the device did not deviate from the target frequency by more than the acceptable margin of error (