(318 days)
Quantum Mitohormesis Medical Device is intended for:
- Stimulating healthy limb muscles to improve and facilitate muscle performance.
- Preventing or retardation of disuse atrophy of muscles.
Quantum Mitohormesis (QMT) is a medical device that uses unique pulsed electromagnetic fields for muscle therapy. Users (adults ≥ 22 years old) place one group of muscles in the lower limbs into the field applicator of QMT device, which for a defined duration generates specific electromagnetic fields that stimulates healthy muscles to improve and facilitate muscle performance, and prevents and retards muscle disuse atrophy.
QMT is applied directly to muscles (without direct contact) to stimulate muscle activity. In order to achieve optimized treatment outcome, QMT is applied to muscles on a weekly basis, once or twice a week, with each treatment application lasting a brief 10-minutes.
The device consists of the following high-level components:
- Base unit, which includes signal generator, power amplifier, and micro-controller unit.
- Field applicator, which includes electro-magnetic coils generating specific magnetic pulses.
- User Interface Panel, which allows users to operate the device and display necessary device information.
- Signal cord.
- Height and tilt adjustment knobs, which allow users to adjust the height and tilt of field applicator; and
The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria.
The document is a 510(k) premarket notification letter from the FDA to QuantumTX Pte. Ltd. regarding their Quantum Mitohormesis (QMT) device. It confirms the device's substantial equivalence to legally marketed predicate devices, allowing its marketing.
The document discusses:
- Regulatory information: Device classification, regulation numbers, and general controls.
- Device description: How the QMT device works (pulsed electromagnetic fields for muscle therapy) and its components.
- Intended Use/Indications for Use: Stimulating healthy limb muscles to improve and facilitate muscle performance, and preventing or retarding disuse atrophy of muscles.
- Comparison to Predicate Devices: A detailed table comparing the QMT device with two predicate devices (Storz Medical MAGNETOLITH Muscle Stimulator and Bemer Classic & Pro) across various parameters (device name, manufacturer, intended use, principle of action, technical specifications, etc.). This comparison aims to demonstrate substantial equivalence, not to prove performance against specific acceptance criteria.
- Summary of Non-Clinical Testing: States that the QMT device passed various non-clinical performance tests (biocompatibility, electrical safety, electromagnetic disturbance/immunity, and software verification/validation) in accordance with relevant ISO and IEC standards. These are safety and engineering compliance tests, not performance studies against specific clinical acceptance criteria for the intended use.
- Summary of Clinical Testing: Explicitly states, "There is no clinical data submitted with this submission."
Therefore, I cannot provide the requested information, particularly the table of acceptance criteria and reported device performance, the sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text. The submission relies solely on non-clinical testing and substantial equivalence to predicate devices, not on a clinical performance study.
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December 19, 2024
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QuantumTX Pte. Ltd. Ivan Goh CEO 378 Alexandra Road, Alexandra Hospital, Block 29, CIH Co-Working Space Level 1 Singapore, 159964 Singapore
Re: K240348
Trade/Device Name: Quantum Mitohormesis (QMT) (M2101) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, NGX Dated: November 21, 2024 Received: November 21, 2024
Dear Ivan Goh:
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/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.
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
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Sincerely,
Jitendra V. Virani -S
CDR Jitendra Virani Assistant 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
Submission Number (if known)
Device Name
Quantum Mitohormesis (QMT) (M2101)
Indications for Use (Describe)
Quantum Mitohormesis Medical Device is intended for:
- · Stimulating healthy limb muscles to improve and facilitate muscle performance.
- · Preventing or retardation of disuse atrophy of muscles.
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 of Safety and Effectiveness for Quantum Mitohormesis (QMT) is provided in accordance with 21 CFR 890 5850.
| Date: | 12 Jan, 2024 |
|---|---|
| Submitter (Owner): | QuantumTX Pte. Ltd.298 Tiong Bahru Rd.,Central Plaza, #20-06, Singapore168730ivangoh@quantumtx.com |
| 510(k) Contact Person: | Ivan Goh |
| Device Trade Name: | Quantum Mitohormesis (QMT) (M2101) |
| Regulation Number: | 21 CFR 890.5850 |
| Regulation Name: | Powered Muscle Stimulator |
| Classification Panel: | Physical Medicine |
| Device Class: | Class II |
| Product Code: | IPF, NGX |
| Primary Predicate Device: | Bemer Classic & Pro (K151834)Regulation number: 21 CFR 890.5850Regulation Name: Powered Muscle StimulatorDevice class: IIProduct code: NGXReview panel: Physical Medicine |
| Secondary Predicate Device: | Storz Medical MAGNETOLITH Muscle Stimulator (K203710)Regulation number: 21 CFR 890.5850Regulation Name: Powered Muscle StimulatorDevice class: IIProduct code: IPF, NGXReview panel: Physical Medicine |
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Indications for Use:
Quantum Mitohormesis Medical Device is intended for:
- Stimulating healthy muscles to improve and facilitate muscle performance. .
- Preventing or retardation of disuse atrophy of muscles. ●
Description of the Device:
Quantum Mitohormesis (QMT) is a medical device that uses unique pulsed electromagnetic fields for muscle therapy. Users (adults ≥ 22 years old) place one group of muscles in the lower limbs into the field applicator of QMT device, which for a defined duration generates specific electromagnetic fields that stimulates healthy muscles to improve and facilitate muscle performance, and prevents and retards muscle disuse atrophy.
QMT is applied directly to muscles (without direct contact) to stimulate muscle activity. In order to achieve optimized treatment outcome, QMT is applied to muscles on a weekly basis, once or twice a week, with each treatment application lasting a brief 10-minutes.
The device consists of the following high-level components:
- Base unit, which includes signal generator, power amplifier, and micro-controller unit. a)
- b) Field applicator, which includes electro-magnetic coils generating specific magnetic pulses.
- User Interface Panel, which allows users to operate the device and display necessary c) device information.
- d) Signal cord.
- Height and tilt adjustment knobs, which allow users to adjust the height and tilt of field e) applicator; and
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| Model Name | Model No. | Model Description |
|---|---|---|
| Quantum Mitohormesis(QMT) | M2101 | Quantum Mitohormesis (QMT) Model M2101, is a medical device that uses unique pulsed electromagnetic fields for muscle therapy. It is intended to stimulate healthy muscles to improve and facilitate muscle performance and prevent or retard disuse atrophy of muscles.The following components are included in the device packing: QMT Device (1), Power Cord (1), Instruction for Use (1). |
The model numbers included in the submission are indicated below:
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Quantum Mitohormesis (QMT) (M2101) 510(k) Summary Abbreviated 510(k): K240348
Comparison to Predicate Devices:
Two predicate devices are selected in this substantial equivalence discussion of Quantum Mitohormesis.
Predicate device 1: Storz Medical MAGNETOLITH Muscle Stimulator (K203710)
Predicate device 2: Bemer Classic & Pro (K151834)
| Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison |
|---|---|---|---|---|
| Device name | Quantum Mitohormesis | Storz Medical MAGNETOLITHMuscle Stimulator | Bemer Classic & Pro | |
| 510(k) number | Not registered | K203710 | K151834 | |
| Manufacturer | QuantumTX Pte. Ltd.298 Tiong Bahru Rd.,Central Plaza, #20-06,Singapore168730 | Biomed Research, Inc.3959 Van Dyke Road.,Suite 245,Lutz, Florida 33558, UnitedStates. | BEMER Int. AGAustrasse 15Triesen, 9495 Liechtenstein | |
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | Identical |
| Product code | IPF - Stimulator, Muscle,PoweredNGX - Stimulator, Muscle,Powered | IPF - Stimulator, Muscle,PoweredNGX - Stimulator, Muscle,Powered | NGX - Stimulator, Muscle,Powered | Identical |
| Product class | II | II | II | Identical |
| Intended use/indication | • Stimulating healthy limbmuscles to improve andfacilitate muscle performance. | • Relaxation of musclespasms | • To temporarily increase localblood circulation in healthy legmuscles | Identical |
| Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison |
| Device name | Quantum Mitohormesis | Storz Medical MAGNETOLITHMuscle Stimulator | Bemer Classic & Pro | |
| • Preventing or retardation ofdisuse atrophy of muscles. | • Prevention or retardation ofdisuse atrophy• Increasing local bloodcirculation• Muscle re-education• Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis• Maintaining or increasingrange of motion• To stimulate healthy musclesin order to improve andfacilitate muscleperformance | • To stimulate healthy muscles inorder to improve and facilitatemuscle performance | ||
| Principle of action | Non- invasive tissue stimulationvia magnetic field induction | Non- invasive tissue stimulationvia magnetic field induction | Non- invasive tissue stimulation viamagnetic field induction | Identical |
| Clinical use | Prescription use | Prescription use | Over the counter use | |
| Electrical protection | Class I, B | Class I, B | unknown | Identical |
| User interface | Buttons | Touch Screen | Touch Screen | Minor difference, no impacton safety and effectiveness. |
| Firmware controlled | Yes | Yes | Yes | Identical |
| Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison |
| Device name | Quantum Mitohormesis | Storz Medical MAGNETOLITHMuscle Stimulator | Bemer Classic & Pro | |
| Type of energy | Magnetic field | Magnetic field | Magnetic field | Identical |
| Number of outputs | 1 | 1 | 2 | Identical |
| Number of magneticcoils in theapplicator | 3 | 1 | unknown | Minor difference, no impacton safety and effectiveness. |
| Magnetic fieldintensity | Standard Mode amplitude: 1.0mT±10%Pro Mode amplitude: 1.3mT±10% | 0.4T ±20% at surface0.08T ±20% at center of coil | 35-100 µT | Minor difference, no impacton safety and effectiveness. |
| Pulse repetition rate | 3.3 kHz | 1-10 Hz | 10-30 Hz | 3.3 kHz electromagneticpulses are applied as 6 msbursts with a repetition rateof 50 Hz. Performancetesting show comparativesafety and effectivenessprofile. |
| Pulse duration | 150 µs | 125µs ± 20% | 10-33 μs | Minor difference, no impacton safety and effectiveness. |
| Therapy time | 10 minutes | 10-20 minutes | 20 minutes | Identical |
| Energy source | 100 - 240 VAC 50-60Hz | 100 - 240 VAC 50-60Hz | 100 - 240 VAC, 50/60 Hz | Identical |
| Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison |
| Device name | Quantum Mitohormesis | Storz Medical MAGNETOLITHMuscle Stimulator | Bemer Classic & Pro | |
| System dimensions(w×h×d) | 565 x 565 x 705mm | 454 x 187 x 460 mm | 320 x 320 x 70 mm | Difference in dimensiondoes not impact safety andeffectiveness. |
| Ambienttemperature | 5 – 35 °C | 10° – 30°C | 10° - 30°C | |
| Relative humidity | 15 - 90 % (non-condensing) | 5-55% | unknown | |
| Environmentalspecifications | For indoor use only | For indoor use only | For indoor use only | Identical |
| Biocompatibility | EN ISO 10993-1: 2018 BiologicalEvaluation of Medical DevicesPart 1: Evaluation and Testing | Not applicable | EN ISO 10993-1: 2009 BiologicalEvaluation of Medical Devices Part1: Evaluation and Testing | |
| Preclinical testing | IEC 60601-1:2020: MedicalElectrical Equipment - Part 1:General Requirements ForBasic Safety And EssentialPerformance IEC 60601-1-2:2014: MedicalElectrical Equipment - Part 1-2: General Requirements ForBasic Safety And EssentialPerformance - CollateralStandard: ElectromagneticDisturbances - RequirementsAnd Tests | IEC 60601-1:2012, (Ed. 3.1):Medical electrical equipment– Part 1: Generalrequirements for basic safetyand essential performance. IEC 60601-1-2: 2014 (4thEd.): Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagnetic | IEC/EN 60601-1:2007 MedicalElectrical Equipment, Part 1,General Requirements forSafety IEC 60601-1-2:2014 MedicalElectrical Equipment, Part 1-2,General Requirement forSafety, ElectromagneticCompatibility IEC/EN 60601-1-4:2001Medical Electrical Equipment,Part 1-4, Collateral Standard: | |
| Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison |
| Device name | Quantum Mitohormesis IEC TR 60601-4-2: 2016:Medical electrical equipment -Part 4-2: Guidance andinterpretation -Electromagnetic immunity:performance of medicalelectrical equipment andmedical electrical systems IEC 60601-1-6: 2020: Medicalelectrical equipment - Part 1-6: General requirements forbasic safety and essentialperformance - Collateralstandard: Usability IEC 62304: 2015: Medicaldevice software - Software lifecycle processes | Storz Medical MAGNETOLITHMuscle Stimulatorcompatibility – Requirementsand tests. IEC 60601-1-6: 2012 (3.1Ed.): Medical electricalequipment - Part 1-6:General requirements forbasic safety and essentialperformance – Collateralstandard: Usability. IEC 62304:2015: MedicalDevice Software - SoftwareLife Cycle Process. | Bemer Classic & Pro Programmable electricalmedical systems. IEC/EN 60601-1-6: 3rd MedicalElectrical Equipment, Part 1-6,Usability IEC/EN 60601-1-11: 2010Medical ElectricalEquipment, Part 1-11, Generalrequirements for basic safetyand essential performanceCollateral Standard:Requirements for medicalelectrical equipment andmedical electrical systems usedin the home healthcareenvironment IEC/EN 62366 Medicaldevices - Application of usabilityengineering to medical devices EN ISO 10993-1:2009Biological Evaluation of MedicalDevices Part 1: Evaluation andTesting (Overall plan andrequirements established | |
| Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison |
| Device name | Quantum Mitohormesis | Storz Medical MAGNETOLITHMuscle Stimulator | Bemer Classic & Pro | |
| internally, specific testsconducted by 3rd party, seeSection 16)• IEC/EN 62304 Software lifecycle processes |
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Summary of Non-Clinical Testing:
To demonstrate safety and effectiveness of Quantum Mitohormesis (QMT) and its substantial equivalence to the predicate devices, QuantumTX Pte. Ltd. completed a number of nonclinical performance tests. The QMT device meets all the requirements for overall design, labelling, biocompatibility, software testing, electromagnetic compatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.
The QMT device passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- Biocompatibility testing per ISO 10993-1: Passed
- Electrical safety testing per IEC 60601-1: Passed ●
- Electromagnetic Disturbance testing per IEC 60601-1-2: Passed ●
- . Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems testing per IEC TR 60601-4-2: Passed
- Software verification and validation testing per IEC 62304/FDA Guidance ●
Summary of Clinical Testing:
There is no clinical data submitted with this submission.
Conclusion:
Based on the results of risk assessments, biocompatibility evaluation, software, performance testing, electromagnetic compatibility and electrical safety testing, and compliance with recognized standards, it is determined that any differences between the Quantum Mitohormesis (QMT) device and the predicate devices do not raise new safety or effectiveness issues. Quantum Mitohormesis device is substantially equivalent to the predicate devices.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).