(318 days)
Not Found
No
The document describes a device using pulsed electromagnetic fields for muscle stimulation. There is no mention of AI, ML, image processing, or any data-driven decision-making or adaptation within the device description or performance studies. The device components are standard for this type of therapy.
Yes.
The device's intended use and mechanism of action, as described in the "Intended Use / Indications for Use" and "Device Description" sections, clearly indicate it is designed to treat or alleviate muscular conditions (stimulating muscle performance, preventing disuse atrophy) in patients, which is the definition of a therapeutic device.
No
The device description and intended use indicate that the device is for stimulating muscles and preventing atrophy, which are therapeutic functions, not diagnostic ones. There is no mention of the device being used to identify or characterize a disease or condition.
No
The device description explicitly lists hardware components such as a base unit, field applicator, user interface panel, signal cord, and adjustment knobs.
Based on the provided information, the Quantum Mitohormesis Medical Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to stimulate healthy limb muscles to improve performance and prevent/retard disuse atrophy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device uses pulsed electromagnetic fields applied directly to muscles. This is a physical therapy modality, not a method for analyzing biological samples (which is the core of IVD).
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts directly with the body.
- Predicate Devices: The predicate devices listed (Bemer Classic & Pro, Storz Medical MAGNETOLITH Muscle Stimulator) are also devices used for physical therapy and muscle stimulation, not IVD devices.
In summary, the Quantum Mitohormesis Medical Device is a therapeutic device for muscle stimulation, not a diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IPF, NGX
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs (muscles)
Indicated Patient Age Range
adults ≥ 22 years old
Intended User / Care Setting
Prescription Use
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)
Non-Clinical Performance Tests:
- 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: Passed
Clinical Testing:
There is no clinical data submitted with this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
December 19, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
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, Singapore168730 | |
| ivangoh@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 890.5850 | |
| Regulation Name: Powered Muscle Stimulator | |
| Device class: II | |
| Product code: NGX | |
| Review panel: Physical Medicine | |
| Secondary Predicate Device: | Storz Medical MAGNETOLITH Muscle Stimulator (K203710) |
| Regulation number: 21 CFR 890.5850 | |
| Regulation Name: Powered Muscle Stimulator | |
| Device class: II | |
| Product code: IPF, NGX | |
| Review 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 MAGNETOLITH | ||
| Muscle 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, United | ||||
| States. | BEMER Int. AG | |||
| Austrasse 15 | ||||
| Triesen, 9495 Liechtenstein | ||||
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | Identical |
| Product code | IPF - Stimulator, Muscle, | |||
| Powered | ||||
| NGX - Stimulator, Muscle, | ||||
| Powered | IPF - Stimulator, Muscle, | |||
| Powered | ||||
| NGX - Stimulator, Muscle, | ||||
| Powered | NGX - Stimulator, Muscle, | |||
| Powered | Identical | |||
| Product class | II | II | II | Identical |
| Intended use/ | ||||
| indication | • Stimulating healthy limb | |||
| muscles to improve and | ||||
| facilitate muscle performance. | • Relaxation of muscle | |||
| spasms | • To temporarily increase local | |||
| blood circulation in healthy leg | ||||
| muscles | Identical | |||
| Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison |
| Device name | Quantum Mitohormesis | Storz Medical MAGNETOLITH | ||
| Muscle Stimulator | Bemer Classic & Pro | |||
| • Preventing or retardation of | ||||
| disuse atrophy of muscles. | • Prevention or retardation of | |||
| disuse atrophy | ||||
| • Increasing local blood | ||||
| circulation | ||||
| • Muscle re-education | ||||
| • Immediate post-surgical | ||||
| stimulation of calf muscles to | ||||
| prevent venous thrombosis | ||||
| • Maintaining or increasing | ||||
| range of motion | ||||
| • To stimulate healthy muscles | ||||
| in order to improve and | ||||
| facilitate muscle | ||||
| performance | • To stimulate healthy muscles in | |||
| order to improve and facilitate | ||||
| muscle performance | ||||
| Principle of action | Non- invasive tissue stimulation | |||
| via magnetic field induction | Non- invasive tissue stimulation | |||
| via magnetic field induction | Non- invasive tissue stimulation via | |||
| magnetic 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 impact |
| on 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 MAGNETOLITH | ||
| Muscle Stimulator | Bemer Classic & Pro | |||
| Type of energy | Magnetic field | Magnetic field | Magnetic field | Identical |
| Number of outputs | 1 | 1 | 2 | Identical |
| Number of magnetic | ||||
| coils in the | ||||
| applicator | 3 | 1 | unknown | Minor difference, no impact |
| on safety and effectiveness. | ||||
| Magnetic field | ||||
| intensity | Standard Mode amplitude: 1.0mT | |||
| ±10% | ||||
| Pro Mode amplitude: 1.3mT | ||||
| ±10% | 0.4T ±20% at surface | |||
| 0.08T ±20% at center of coil | 35-100 µT | Minor difference, no impact | ||
| on safety and effectiveness. | ||||
| Pulse repetition rate | 3.3 kHz | 1-10 Hz | 10-30 Hz | 3.3 kHz electromagnetic |
| pulses are applied as 6 ms | ||||
| bursts with a repetition rate | ||||
| of 50 Hz. Performance | ||||
| testing show comparative | ||||
| safety and effectiveness | ||||
| profile. | ||||
| Pulse duration | 150 µs | 125µs ± 20% | 10-33 μs | Minor difference, no impact |
| on 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 MAGNETOLITH | ||
| Muscle 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 dimension |
| does not impact safety and | ||||
| effectiveness. | ||||
| Ambient | ||||
| temperature | 5 – 35 °C | 10° – 30°C | 10° - 30°C | |
| Relative humidity | 15 - 90 % (non-condensing) | 5-55% | unknown | |
| Environmental | ||||
| specifications | For indoor use only | For indoor use only | For indoor use only | Identical |
| Biocompatibility | EN ISO 10993-1: 2018 Biological | |||
| Evaluation of Medical Devices | ||||
| Part 1: Evaluation and Testing | Not applicable | EN ISO 10993-1: 2009 Biological | ||
| Evaluation of Medical Devices Part | ||||
| 1: Evaluation and Testing | ||||
| Preclinical testing | IEC 60601-1:2020: Medical | |||
| Electrical Equipment - Part 1: | ||||
| General Requirements For | ||||
| Basic Safety And Essential | ||||
| Performance IEC 60601-1-2:2014: Medical | ||||
| Electrical Equipment - Part 1- | ||||
| 2: General Requirements For | ||||
| Basic Safety And Essential | ||||
| Performance - Collateral | ||||
| Standard: Electromagnetic | ||||
| Disturbances - Requirements | ||||
| And Tests | IEC 60601-1:2012, (Ed. 3.1): | |||
| Medical electrical equipment | ||||
| – Part 1: General | ||||
| requirements for basic safety | ||||
| and essential performance. IEC 60601-1-2: 2014 (4th | ||||
| Ed.): Medical electrical | ||||
| equipment - Part 1-2: | ||||
| General requirements for | ||||
| basic safety and essential | ||||
| performance - Collateral | ||||
| standard: Electromagnetic | IEC/EN 60601-1:2007 Medical | |||
| Electrical Equipment, Part 1, | ||||
| General Requirements for | ||||
| Safety IEC 60601-1-2:2014 Medical | ||||
| Electrical Equipment, Part 1-2, | ||||
| General Requirement for | ||||
| Safety, Electromagnetic | ||||
| Compatibility IEC/EN 60601-1-4:2001 | ||||
| Medical 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 and | ||||
| interpretation - | ||||
| Electromagnetic immunity: | ||||
| performance of medical | ||||
| electrical equipment and | ||||
| medical electrical systems IEC 60601-1-6: 2020: Medical | ||||
| electrical equipment - Part 1- | ||||
| 6: General requirements for | ||||
| basic safety and essential | ||||
| performance - Collateral | ||||
| standard: Usability IEC 62304: 2015: Medical | ||||
| device software - Software life | ||||
| cycle processes | Storz Medical MAGNETOLITH | |||
| Muscle Stimulator | ||||
| compatibility – Requirements | ||||
| and tests. IEC 60601-1-6: 2012 (3.1 | ||||
| Ed.): Medical electrical | ||||
| equipment - Part 1-6: | ||||
| General requirements for | ||||
| basic safety and essential | ||||
| performance – Collateral | ||||
| standard: Usability. IEC 62304:2015: Medical | ||||
| Device Software - Software | ||||
| Life Cycle Process. | Bemer Classic & Pro Programmable electrical | |||
| medical systems. IEC/EN 60601-1-6: 3rd Medical | ||||
| Electrical Equipment, Part 1-6, | ||||
| Usability IEC/EN 60601-1-11: 2010 | ||||
| Medical Electrical | ||||
| Equipment, Part 1-11, General | ||||
| requirements for basic safety | ||||
| and essential performance | ||||
| Collateral Standard: | ||||
| Requirements for medical | ||||
| electrical equipment and | ||||
| medical electrical systems used | ||||
| in the home healthcare | ||||
| environment IEC/EN 62366 Medical | ||||
| devices - Application of usability | ||||
| engineering to medical devices EN ISO 10993-1:2009 | ||||
| Biological Evaluation of Medical | ||||
| Devices Part 1: Evaluation and | ||||
| Testing (Overall plan and | ||||
| requirements established | ||||
| Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison |
| Device name | Quantum Mitohormesis | Storz Medical MAGNETOLITH | ||
| Muscle Stimulator | Bemer Classic & Pro | |||
| internally, specific tests | ||||
| conducted by 3rd party, see | ||||
| Section 16) | ||||
| • IEC/EN 62304 Software life | ||||
| cycle 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.