(121 days)
Intended Use:
The PHYSIQ device is intended in EMS mode for:
Prevention or retardation of disuse atrophy Maintaining or increasing range of motion Muscle re-education Relaxation of muscle spasms Increasing local blood circulation Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
and in TENS mode for:
Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain
The PHYSIQ is a device provided with 4 handpieces by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.
The PhysiQ consists of :
- an AC/DC power supply unit,
- EMS/TENS driving electronic board
- CPU controller; ●
- user interface with LCD touch screen, . ●
- 4 EMS/TENS handpieces with interconnecting cables ●
EMS or TENS treatment is enabled at the same time on all 4 handpieces. The operator can choose how many handpieces to use and leave the unused ones in the proper holder.
Through the handpieces the electrical energy is delivered to the patient, which repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area.
During TENS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes which are in contact with the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.
During EMS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes in contact with the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms, prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.
Handpieces are directly applied on the area to be treated, such as-upper and lower back, abdomen, legs and arms.
The user interface allows to fully control the treatment parameters. The operator can manage Electro Muscle Stimulation (EMS) or Transcutaneous Electrical Nerve Stimulation (TENS) (OFF or ON from 1 to 50, with selection step of 1).
Treatment time can be changed regardless of the suggested one.
The provided text describes a 510(k) premarket notification for the PHYSIQ device, which is a powered muscle stimulator and transcutaneous electrical nerve stimulator. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on non-clinical performance data rather than extensive clinical studies with acceptance criteria based on patient outcomes.
Therefore, the acceptance criteria and study detailed below will focus on the non-clinical performance benchmarks used to establish substantial equivalence with the predicate device, rather than clinical performance metrics typically found in efficacy trials.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the PHYSIQ device are based on demonstrating similar performance characteristics to its predicate device, The InMode System with Tone Applicator (K192249), and compliance with relevant safety standards. The reported device performance aligns with these criteria.
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated by Equivalence to Predicate or Standard Compliance) | Reported Device Performance (PHYSIQ) |
|---|---|---|
| Indications for Use | Must have the same indications for use as the predicate device. | Same indications for use in both EMS and TENS modes for similar medical applications (Prevention or retardation of disuse atrophy, Maintaining or increasing range of motion, Muscle re-education, Relaxation of muscle spasms, Increasing local blood circulation, Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis; Symptomatic relief and management of chronic, intractable pain, Post-surgical acute pain, Post-traumatic acute pain). |
| Principle of Operation | Must operate on the same principle as the predicate device. | Uses electrical muscle stimulation (EMS) and transcutaneous electrical nerve stimulation (TENS) technologies. Mechanism of action is muscle contraction by electrical pulsing, same as predicate. |
| Device Design | Similar design components and functionality. | Consists of an AC/DC power supply, EMS/TENS driving electronic board, CPU controller, user interface with LCD touch screen, and 4 EMS/TENS handpieces. This is comparable to the predicate's console, controller, user interface, and Tone Applicator. |
| Basic Unit Characteristics | Similar electrical and physical specifications. | Console: Main Line Frequency (50-60Hz), Input Voltage (115-230VAC), Input Current (9A max), AC/DC isolation, Type BF Electrical Type, Patient Leakage Current (<100uA normal, <500uA fault), 2 output modes, 4 output channels, Synchronous operation, Regulated voltage on all channels with current limit, Software/Firmware/Microprocessor Control, Automatic Overload/No-Load Trip, Automatic Shut Off, Patient Override Control, Indicator Display, On/Off Status, No battery, Voltage levels display, Timer Range (0-60 min). |
| EMS Output Specifications | Similar output waveform, pulse shape, voltage, current, pulse width, frequency, and charge characteristics to ensure equivalent therapeutic effect. | Waveform: Symmetrical Biphasic Waveform. Pulse Shape: Rectangular. Max output voltage: 50V @ 500Ω, 50V @2kΩ, 50V@10kΩ. Max output current: 100mA @500 Ω, 25mA @2 kΩ, 5mA @10 kΩ. Pulse Width: 25 to 400 μs. Frequency: 3 to 200 Hz. Net Charge @ 500 ohms: 0μC. Max Phase Charge: 40 μC @ 500Ω. Max Current Density: 1.1 mA/cm2 @ 500Ω. Max Power Density: 6.4mW/cm2 @500Ω. Burst Mode: Yes (3-200 pulses/burst, 1 burst/sec, 0.2-60s burst duration). ON Time: 0.2-60s. OFF Time: 0.5-60s. Treatment Time: Up to 60 min. Output intensity levels: 1 to 50. |
| TENS Output Specifications | Similar output waveform, pulse shape, voltage, current, pulse width, frequency, and charge characteristics to ensure equivalent therapeutic effect. | Waveform: Symmetrical Biphasic Waveform. Pulse Shape: Rectangular. Max output voltage: 35V@500Ω, 35V@2kΩ, 35V@10kΩ. Max output current: 70mA@500 Ω, 17.5mA@2 kΩ, 3.5mA@10 kΩ. Pulse Width: 25 to 400 µs. Frequency: 3 to 200 Hz. Net Charge @ 500 ohms: 0μC. Max Phase Charge: 28 μC @ 500Ω. Max Current Density: 0.81 mA/cm2 @ 500Ω. Max Power Density: 3.6 mW/cm2 @ 500Ω. Burst Mode: Yes (3-200 pulses/burst, 1 burst/sec, 0.2-60s burst duration). ON Time: 0.2-60s. OFF Time: 0.5-60s. Treatment Time: Up to 60 min. Output intensity levels: 1 to 50. |
| Biocompatibility | Handpieces must be biocompatible (non-cytotoxic, non-irritant, non-sensitizing). | Cytotoxicity: Not Cytotoxic. In vivo skin irritation: Not irritant. Delayed Hypersensitivity: Not sensitizing. |
| Safety Standards Compliance | Must comply with recognized electrical safety and EMC standards. | Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, 21 CFR 898, 21 CFR 882.5890 (GZJ), and 21 CFR 890.5850 (IPF). |
2. Sample size used for the test set and the data provenance
The provided submission does not detail a clinical "test set" in the context of an AI/ML device. Instead, it refers to bench testing for the device's electrical, mechanical, and biological performance.
- Sample size for bench testing: Not explicitly quantified as a "sample size" in terms of subject count. The testing involved physical units of the PHYSIQ device.
- Data provenance: Not explicitly stated as "country of origin." The manufacturing company (DEKA M.E.L.A. srl) and submitter (El.En. S.p.A.) are based in Italy, suggesting the testing was likely conducted in or overseen by entities within Italy or the EU. The data is retrospective in the sense that it evaluates the manufactured device against pre-defined specifications and standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the submission describes a traditional medical device (electro-stimulator), not an AI/ML CADe/CADx device that would create "ground truth" labels from medical images or data. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards and specifications. Engineers and technicians with expertise in medical device testing, electrical safety, and biocompatibility would perform and interpret these tests.
4. Adjudication method for the test set
This is not applicable as there is no "test set" involving human interpretation or labeling that would require an adjudication method (like 2+1 or 3+1). The testing involved objective measurements and compliance assessments against predefined standards.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The PHYSIQ device is an electro-stimulator, not an AI-powered diagnostic tool, and the submission clarifies that "Clinical Performance Data: None" was provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. The PHYSIQ is a hardware device with embedded software/firmware for controlling its functions, but it's not described as an AI algorithm that performs an independent diagnostic or predictive task. Its "performance" is its ability to generate specific electrical outputs within defined parameters.
7. The type of ground truth used
For this device, the "ground truth" is established by engineering specifications, recognized national and international consensus standards, and documented biocompatibility assessments.
- Engineering Specifications: The design parameters for output voltage, current, pulse width, frequency, etc.
- Consensus Standards: Compliance with standards like AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, 21 CFR 898, 21 CFR 882.5890 (GZJ), and 21 CFR 890.5850 (IPF). These standards define acceptable safety and performance limits.
- Biocompatibility Assessments: Standardized biological tests (e.g., cytotoxicity, irritation, sensitization) that meet established criteria as "ground truth" for material biological safety.
8. The sample size for the training set
Not applicable. The PHYSIQ device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its functionality is based on direct electrical and mechanical engineering principles.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML training set, there is no corresponding ground truth establishment process for it.
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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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
November 25, 2020
El. En. Electronic Engineering SPA Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50041 Italy
Re: K202079
Trade/Device Name: Physiq Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: August 28, 2020 Received: August 31, 2020
Dear Paolo Peruzzi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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.
Vivek Pinto, PhD 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
510(k) Number (if known) K202079
Device Name PHYSIQ
Indications for Use (Describe) Intended Use:
The PHYSIQ device is intended in EMS mode for:
Prevention or retardation of disuse atrophy Maintaining or increasing range of motion Muscle re-education Relaxation of muscle spasms Increasing local blood circulation Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
and in TENS mode for:
Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain
| 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
Date: November 27, 2020 Submission number: K202079
Submitter:
El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy
Contact:
Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it
Date Summary Prepared:
November 10, 2020
Device Trade Name: PHYSIO
Manufacturer:
DEKA M.E.L.A. srl Via Baldanzese, 17 50041 Calenzano (FI), Italy
Common Name:
Electro Muscle Stimulator
Classification Name:
Powered Muscle Stimulator (IPF) Stimulator, nerve, transcutaneous, for pain relief (GZJ)
Classification Number:
21 CFR 890.5850 21 CFR 890.5890
Predicate Devices:
The InMode System with Tone Applicator (K192249)
Device Description:
The PHYSIQ is a device provided with 4 handpieces by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.
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The PhysiO consists of :
- an AC/DC power supply unit,
- EMS/TENS driving electronic board
- CPU controller; ●
- user interface with LCD touch screen, . ●
- 4 EMS/TENS handpieces with interconnecting cables ●
EMS or TENS treatment is enabled at the same time on all 4 handpieces. The operator can choose how many handpieces to use and leave the unused ones in the proper holder.
Through the handpieces the electrical energy is delivered to the patient, which repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area.
During TENS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes which are in contact with the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.
During EMS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes in contact with the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms, prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.
Handpieces are directly applied on the area to be treated, such as-upper and lower back, abdomen, legs and arms.
The user interface allows to fully control the treatment parameters. The operator can manage Electro Muscle Stimulation (EMS) or Transcutaneous Electrical Nerve Stimulation (TENS) (OFF or ON from 1 to 50, with selection step of 1).
Treatment time can be changed regardless of the suggested one.
Intended Use:
The PHYSIQ device is intended in EMS mode for:
- Prevention or retardation of disuse atrophy
- Maintaining or increasing range of motion ●
- . Muscle re-education
- . Relaxation of muscle spasms
- . Increasing local blood circulation
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
and in TENS mode for:
- Symptomatic relief and management of chronic, intractable pain ●
- Post-surgical acute pain ●
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- . Post-traumatic acute pain
Substantial equivalence discussion:
The PHYSIQ device is substantially equivalent to the InMode System with Tone Applicator (K192249)
| Device Trade Name | Subject DevicePHYSIQ | Predicate DeviceK192249The InModeSystem with ToneApplicator |
|---|---|---|
| Design | The PHYSIQSystem withconsists of AC/DCpower supplyunits, controllerand user interfaceincluding an LCDtouch screen. Thedelivery of theelectrical energy iscontrolled by aStart/Stop buttonpositioned on thefront panel.The Systemsupport thefollowingcomponents:• LCD displaytouch screen• Buzzer• 24V AC/DCpower supply• Controller• FansThe Systemoperates whileconnected to thehandpiece. | The InModeSystem with ToneApplicator consistsof an AC/DCpower supply unit,controller and userinterface includingan LCD touchscreen. Thedelivery of theelectrical energy iscontrolled by aStart/Stop buttonpositioned on thefront panel.The Systemsupport thefollowingcomponents:• LCD displaytouch screen• Audioloudspeaker• 48V AC/DCpower supply• Controller• FansThe Systemoperates whileconnected to theTone Applicator. |
| Mechanism of Action | Muscle contraction | Muscle contraction |
| Device Trade Name | Subject Device | Predicate DeviceK192249The InModeSystem with ToneApplicator |
| PHYSIQ | ||
| by electricalpulsing | by electricalpulsing | |
| Class, Product Code | Class II, IPF GZJ | Class II, IPF GZJ |
| RX/OTC | Rx only | Rx only |
| Basic Unit Characteristics | ||
| ComponentsConsole | The PHYSIQSystem consists ofthe followingcomponents:• Console (includingcontroller, powersupply units and allneeded electronicboards), and userinterface includingan LCD touchscreen.• Four Handpiecesconnected to theconsole via acable. | The InModeSystem consists ofthe followingcomponents:• Console,including a powersupply unit,controller and userinterface includingan LCD touchscreen.• Tone Applicatorconnected to theconsole via acable. |
| Dimensions | ||
| Console [W x H x D]Applicator [L x D] | 34cm x 67cm x90cmHandpiece9cm x 9cm | 35cm x 35cm x100cmTone Applicator12cm x 10cm |
| Weight: | ||
| ConsoleApplicator | 51.0 KgHandpiece: 0.5 Kg | 20.0 Kg [44 lbs.]Tone: 0.22 Kg [0.5lbs.] |
| PerformanceSpecifications:ComponentsConsole | Main LineFrequency(nominal)50-60Hz | Main LineFrequency(nominal)50-60Hz |
| Device Trade Name | Subject DevicePHYSIQ | Predicate DeviceK192249The InModeSystem with ToneApplicator |
| Input Voltage(nominal)115-230VACInput Current(rms)9A max | Input Voltage(nominal)100-240VACInput Current(rms)2A | |
| Method of line current isolation | AC/DC isolation | Indipendenttransformerisolated |
| Electrical Type | Type BF | Type BF |
| Patient Leakage Current - NormalCondition (μΑ) | <100uA patientleakage | <100uA patientleakage |
| Patient Leakage Current - SingleFault Condition (μΑ) | <500uA lineleakage | <300uA lineleakage |
| Number of output modes | 2 | 2 |
| Number of Output channels | 4 | 2 |
| Synchronous or alternating | Synchronous | Not PubliclyAvailable |
| Method of Channel Isolation | Through AC/DCand transformers | Throughtransformers andisolators |
| Regulated Current or RegulatedVoltage (output signals only) | Regulated voltageon all channelswith current limit | Regulated voltageon all channelswith current limit |
| Software/Firmware/MicroprocessorControl | Yes | Yes |
| Automatic Overload Trip | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes |
| Automatic Shut Off | Yes, On/off switch | Yes, On/off switch |
| Device Trade Name | Subject DevicePHYSIQ | Predicate DeviceK192249The InModeSystem with ToneApplicator |
| Patient Override Control | Yes | Yes |
| Indicator Display | Yes | Yes |
| On/Off Status | Yes | Yes |
| Battery | No battery | No battery |
| Voltage/Current level | Yes, voltage levels | Yes, voltage levels |
| Timer Range (minutes) | 0-60 minutes | 0-60 minutes |
| Compliance with 21 CFR 898 | YES | Not PubliclyAvailable |
| Compliance with 21 CFR 882.5890(GZJ) | Yes | Yes |
| Compliance with 21 CFR 890.5850(IPF) | Yes | Yes |
| Electrode area | 11 cm2 | 12 cm2 |
| Housing Material | Delrin | PC Makrolon 2458 |
| Output Specifications | ||
| EMS output mode | ||
| Waveform | SymmetricalBiphasicWaveform | SymmetricalBiphasicWaveform |
| Pulse Shape | Rectangular | Rectangular |
| Maximum output voltage(± 10%) | 50V @ 500Ω50V @2kΩ50V@10kΩ | 56V @ 500Ω56V @2kΩ56V @ 10kΩ |
| Device Trade Name | Subject DevicePHYSIQ | Predicate DeviceK192249The InModeSystem with ToneApplicator |
| Maximum outputcurrent (± 10%) | 100mA @500 Ω25mA @2 kΩ5mA @10 kΩ | 112mA @500 Ω28mA @2 kΩ5.6mA @10 kΩ |
| Pulse Width (μs) | 25 to 400 μs | 20 to 400 μs |
| Frequency (Hz) | 3 to 200 Hz | 3 to 200 Hz |
| Net Charge @ 500 ohms(µC/pulse)] | 0μC @ 500Ω | 0μC @ 500Ω |
| Maximum Phase Charge (µC) | 40 μC @ 500Ω | 44.8 μC @ 500Ω |
| Maximum Current Density(mA/cm2) | 1.1 mA/cm2 @500ΩSurface = 11cm² | 1 mA/cm2 @500ΩSurface = 12cm² |
| Maximum Power Density(mW/cm2)] | 6.4mW/cm2@500Ω | 55mW/cm2@500Ω |
| Burst Mode (i.e., pulse trains)a. Pulses per burstb. Bursts per secondc. Burst duration (seconds)d. Duty Cycle [Line (b) x Line (c)] | Yes:a. 3 - 200b. 1c. 0.2-60 sd. Time on / off | Yes:a. 3 - 200b. 1c. 1-60 sd. Time on / off |
| ON time | 0.2 - 60 s | 1 - 60 s |
| OFF time | 0.5 - 60 s | 1 - 60 s |
| Treatment Time (min) - | Up to 60 min | Up to 60 min |
| Output intensity levels | 1 to 50 | 1 to 50 |
| TENS output mode | ||
| Waveform | SymmetricalBiphasicWaveform | SymmetricalBiphasicWaveform |
| Pulse Shape | Rectangular | Rectangular |
| Maximum output voltage(± 10%) | 35V@500Ω35V@2kΩ | 36V @ 500Ω36V @2kΩ |
| Device Trade Name | Subject DevicePHYSIQ | Predicate DeviceK192249The InModeSystem with ToneApplicator |
| 35V@10kΩ | 36V@10kΩ | |
| Maximum outputcurrent (± 10%) | 70mA@500 Ω17.5mA@2 kΩ3.5mA@10 kΩ | 72mA@500Ω18mA@2 kΩ3.6mA@10 kΩ |
| Pulse Width (µs) | 25 to 400 µs | 20 to 400 µs |
| Frequency (Hz) | 3 to 200 Hz | 3 to 200 Hz |
| Net Charge @ 500 ohms(µC/pulse) | 0μC @ 500Ω | 0μC @ 500Ω |
| Maximum Phase Charge (µC) | 28 μC @ 500Ω | 28.8 µC @ 500Ω |
| Maximum Current Density(mA/cm2) | 0.81 mA/cm2@500ΩSurface = 11cm² | 0.65 mA/cm2@500ΩSurface = 12cm² |
| Maximum Power Density[mW/cm2] | 3.6 mW/cm2@ 500Ω | 22.7 mW/cm2@ 500Ω |
| Burst Mode (i.e., pulse trains)a. Pulses per burstb. Bursts per secondc. Burst duration (seconds)d. Duty Cycle [Line (b) x Line (c)] | Yes:a. 3 - 200b. 1c. 0.2-60 sd. Time on / off | Yes:a. 3 - 200b. 1c. 1-60 sd. Time on / off |
| ON time | 0.2 - 60 s | 1 - 60 s |
| OFF time | 0.5 – 60 s | 1 – 60 s |
| Treatment Time (min) - | Up to 60 min | Up to 60 min |
| Output intensity levels | 1 to 50 | 1 to 50 |
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The PHYSIQ device has the same indications for use as the above mentioned predicate device, with same principle of operation and similar performances.
Clinical Performance Data:
None
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Non-Clinical Performance Data:
Bench testing was conducted to demonstrate that the PHYSIQ performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements. The device was tested for validation of output waveform, basic unit characteristics, and output specifications.
The bench testing results demonstrated that the device performs as expected under anticipated conditions of use.
The biocompatibility of the PHYSIQ handpieces was justified using a biocompatibility assessment performed on representative test article.
The following biocompatibility tests were performed as part of the biocompatibility assessment:
Test Summary Conclusions
| Test | Test Summary | Conclusions |
|---|---|---|
| Cytotoxicity by elution test | Qualitative and quantitavieevalution showed no cytotoxiceffect | Not Cytotoxic |
| In vivo skin irritation test inalbino rabbit – single exposure | Animals exposed to the testarticle showed no local toxiceffects | Not irritant |
| Delayed Hypersensitivity Test(GPMT) | Animals exposed to the testarticle showed no sensitizingeffects | Not sensitizing |
In addition, the PHYSIQ has been tested and found in compliance with the following standards:
- AAMI/ANSI ES60601-1- Medical electrical equipment Part 1: General requirements for ● basic safety and essential performance.
- IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- . IEC 60601-2-10 - Medical electrical equipment - Part 2-10: Particular requirements for basic safety and essential performance of nerve and muscle stimulators.
- IEC 60601-1-6 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Usability.
Conclusion:
Based on the comparison to the predicate device and on the outcome of non-clinical performance tests carried out, demonstrating that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device, we can conclude that the PHYSIQ device is substantially equivalent to the predicate device.
§ 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).