(56 days)
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.
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.
The FDA 510(k) summary for the SONIK MONARK 100 device does not contain a typical "acceptance criteria and reported device performance" table as one might find for an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC. Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (KKT-M2) by comparing technological characteristics and verifying specific engineering performance aspects.
The "study that proves the device meets the acceptance criteria" is primarily an engineering performance verification rather than a clinical trial with patient outcomes. The acceptance criteria are implicit in the comparison to the predicate device and the successful completion of specific technical tests.
Here's an analysis based on the provided text, addressing your points where information is available:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a direct table of acceptance criteria vs. performance results in the classical sense of diagnostic accuracy. Instead, the acceptance criteria are largely met by demonstrating substantial equivalence to the predicate and by verifying specific operational parameters.
Implicit Acceptance Criteria and Reported Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to KKT-M2 Predicate | "The SONIK MONARK 100 is substantially equivalent to the predicate KKT-M2 device in terms of its intended use, indications of use, operating principles, technological characteristics, and risk profile." |
| Electrical Safety (IEC 60601-1) | "The device has been successfully tested to... IEC 60601-1 Medical Electrical Equipment - Part 1" |
| Electromagnetic Compatibility (IEC 60601-1-2) | "The device has been successfully tested to... IEC 60601-1-2 Medical Electrical Equipment - Part 1-2" |
| Software Verification & Validation (FDA Guidance "General Principles of Software 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.'" (Assessed as "Moderate" level of concern) |
| Accurate and Reliable Vibration Frequency Production | "The frequencies produced by the device did not deviate from the target frequency by more than the acceptable margin of error (< 5 %). These findings support the conclusion that the SONIK MONARK 100 device accurately and reliably produces vibration frequencies as intended. This outcome confirms the device's precision achieves its target performance specifications." |
| Force Application (implicitly comparable to predicate) | Although the maximal force threshold for SONIK MONARK 100 (17 N) is different from the KKT-M2 (5 lbs ≈ 22.2 N), the submission states, "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." This implies the force is within a safe and effective range relative to the predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes engineering tests, not a clinical study on a patient sample.
- Sample Size: Not applicable in the sense of a patient cohort. The "vibration frequency verification" test would likely involve multiple measurements on the device itself.
- Data Provenance: The tests were conducted by "accredited testing laboratories" (Page 8), implying controlled laboratory environments. Country of origin for data is not specified beyond the manufacturer being in Canada. These are retrospective analyses of device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a physical therapy type device (manipulator device) and not one that produces diagnostic images requiring expert interpretation for ground truth. The ground truth for its performance is engineering specifications (e.g., target frequencies, force outputs).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human adjudication of clinical data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool. No MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm. Its "standalone performance" refers to its ability to meet engineering specifications (e.g., produce desired frequencies and forces) independently. The "Vibration Frequency Verification" is an example of such a standalone engineering performance test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating the device's performance is based on engineering specifications and established safety/EMC standards.
- For electrical safety and EMC, the ground truth is compliance with IEC 60601-1 and IEC 60601-1-2 standards.
- For software, the ground truth is compliance with FDA's "General Principles of Software Validation" guidance.
- For vibration frequency, the ground truth is the "target frequency" with an "acceptable margin of error (< 5 %)."
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI that requires training data in the typical sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this device.
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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"
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(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
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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) 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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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.
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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 HealthSolutions InternationalCorporation | 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 |
| RegulationNumber | Unclassified | Unclassified | Same |
| Regulation Name | Manipulator, plunger-likedevice | Manipulator, plunger-likedevice | Same |
| Indications ForUse | The KKT device is to beused in the aid ofmanagement of chronicpain due to non-congenitaldefects. The device can beused as part of a series ofsteps in the total care ofthe patient. The procedureinvolves the use ofdiagnostic imaging thatqualifies the misalignmentbetween vertebrae. Thetreatment is thenadministered using the KKT- M2 device to deliverprecise impulses at arequired vectorconfiguration. | The SONIK MONARK 100device is to be used in the aidof management of chronicpain due to non-congenitaldefects. The device can beused as part of a series of stepsin the total care of the patient.The procedure involves the useof diagnostic imaging thatqualifies the misalignmentbetween vertebrae. Thetreatment is then administeredusing the device to deliverprecise impulses at a requiredvector configuration. | Same |
| Intended Use/Operation ofdevice | The KKT-M2 device is to beused in the aid ofmanagement of chronic | The SONIK MONARK 100device is to be used in the aidof management of chronic | Same |
| pain due to non-congenitaldefects. | pain due to non-congenitaldefects. | ||
| Components(System) | TouchscreenHorizontal ArmVertical PlateBase PlateTransducer HeadStylus | Touch ScreenTreatment HeadStylus | 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 to3.82 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 mechanicalstop | Not Applicable; No Rotation | Different |
| Positioning Base and Stand Adjustments | |||
| Stylus Tip | |||
| Vertical motion | Up to 3mm (1/8") duringtreatment.Maximum travel fromlowest to highest points ofthe vertical leadscrew is26cm | Movement of 3 mm (1/8")during treatment. | Different |
| Horizontaltransversemotion | Distance unit can travelalong base plate rail alongthe transverse patientplane at least 50cm in eachdirection from centre point.Manual operation withadjustable friction brake | Not Applicable | Different |
| Horizontal axialmotion | Arm extends/ retractshorizontally axially a totalof 36cm. Motion is lead-screw driven, with brakingmechanism incorporatedinto the lead screwcontroller. | Not Applicable | Different |
| Treatment Head/Armature Adjustments | |||
| Horizontal motion | Horizontal motion | Not Applicable | Different |
| Angular motion | Angular motion | Not Applicable | Different |
| Device System | |||
| InterfaceTransducer 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 Powersupply | Mains power supply | Mains power supply | Same |
| Fuse, mains | Fuse, mains | Fuse, mains | Same |
| Fuse (for 24VDCtransducer power) | 1.6A 250VAC | Slowblo 48VDC 2A | Different |
| Environment | +15°C to +40°C10%-90% RH (non-condensing) | +10°C to +35°C30%-75% RH (non-condensing) | Different |
| Storage | -5°C to +35°C10%-90% RH | -35°C to +55°C10%-90% RH | Different |
| Weight | 350 lbs | Device: Approx. 1000gDevice + Accessories: Approx.65kg | Different |
| Accessories | |||
| Accessories(optional) | Start/StopMotorized Bed Interface | CartArm | Different |
Table 1 – Comparison of Characteristics of the SONIK MONARK 100 and the KKT-M2
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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
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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 ElectricalEquipment - Part 1 | Ed 3 | Jun-19-2023 |
| 2 | IEC 60601-1-2 | Medical ElectricalEquipment - 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
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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 (< 5 %).
These findings support the conclusion that the SONIK MONARK 100 device accurately and reliably produces vibration frequencies as intended. This outcome confirms the device's precision achieves its target performance specifications.
9. Discussion and Overall Conclusions
The SONIK MONARK 100 is substantially equivalent to the predicate KKT-M2 device in terms of its intended use, indications of use, operating principles, technological characteristics, and risk profile.
Both devices possess the same indications for use, operating principles, performance specifications, and safety features. Differences in the technological characteristics of the devices predominantly relate to portability. The technological characteristics of the SONIK MONARK 100, in comparison to those of the predicate device, do not raise any new questions of safety or effectiveness. In conclusion, the SONIK MONARK 100 device and the KKT-M2 device can be considered substantially equivalent devices.
N/A