(213 days)
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The Healy device is a single channel wearable electrotherapy device that is designed to alleviate temporary and chronic muscle and joint pain on multiple body locations. It delivers microcurrent therapy through the simple and convenient use of the dedicated iOS or Android App, or on product controls. Reusable, selfadhesive and contouring electrodes allow for discreet and convenient placement on multiple pain locations on the body. The system contains one unit, which is rechargeable and is attached to the electrode via cables. The electrode can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Healy system is completed through the available App or on product controls.
The provided text is a 510(k) summary for the Healy device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Omron Avail, Model PM601, K172079) rather than providing detailed acceptance criteria and a study proving the device meets those criteria.
However, based on the information provided, we can infer some details related to acceptance criteria and the underlying studies.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a specific table of acceptance criteria with corresponding performance metrics like a typical clinical trial report. Instead, it relies on demonstrating equivalence to a predicate device by comparing various technological characteristics and performance parameters. The "acceptance criteria" can be interpreted as demonstrating that the device's characteristics are either "No Difference", "Similar", or if different, that the differences "do not raise new questions of safety or effectiveness" when compared to the predicate device.
Here's an aggregated summary table based on the "Substantial Equivalence Comparison Table" and "Output Comparison" in the provided text. The "Acceptance Criteria" column reflects the implicit criteria used for substantial equivalence, i.e., that the device characteristics should be comparable to the predicate. The "Reported Device Performance" is the value for the Healy device. The "Outcome/Compliance" indicates whether the Healy device was found to be acceptable in comparison to the predicate.
| Characteristic | Acceptance Criteria (based on predicate) | Reported Device Performance (Healy) | Outcome/Compliance |
|---|---|---|---|
| General Characteristics | |||
| Regulation | 21 CFR§882.5890 | 21 CFR§882.5890 | No Difference |
| Usage | Over the Counter | Over the Counter | No Difference |
| Intended Use | Relief of pain associated with sore/aching muscles (back, arms, legs, shoulders, feet) from strain; symptomatic relief/management of chronic, intractable pain; relief of pain associated with arthritis. | Same as predicate | No Difference |
| Environment of Use | Clinics, hospital and home environments. | Clinics, hospital and home environments. | No Difference |
| Patient Population | All adults 18 years and older. | All adults 18 years and older. | No Difference |
| Contraindications | Cardiac pacemaker, implanted defibrillator, other implanted metallic/electronic device. | Same as predicate | No Difference |
| Sterility | External contacting device, nonsterile | External contacting device, nonsterile | No Difference |
| Power Source | Rechargeable Lithium Ion Battery | Rechargeable Lithium Ion Battery | No Difference |
| Method of Line Current Isolation | N/A (internal power source) | N/A (internal power source) | No Difference |
| Automatic No Load contact Trip | Yes | Yes | No Difference |
| Automatic Shut Off | Yes | Yes | No Difference |
| Compliance With Voluntary Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 | No Difference |
| Performance Characteristics (Microcurrent mode) | |||
| Waveform | Biphasic | Biphasic | No Difference |
| Shape | Rectangular | Rectangular | No Difference |
| Max Output Voltage (V) @ 500 Ohms | 0.025 (predicate) | 0.030 | Similar (slightly higher, but deemed acceptable for equivalence) |
| Max Output Voltage (V) @ 2k Ohms | 0.100 | 0.100 | No Difference |
| Max Output Voltage (V) @ 10k Ohms | 0.500 | 0.500 | No Difference |
| Maximum Output Current (mA) @ 500 Ohm | 0.050 | 0.050 | No Difference |
| Maximum Output Current (mA) @ 2kOhm | 0.050 | 0.050 | No Difference |
| Maximum Output Current (mA) @ 10kOhm | 0.050 | 0.050 | No Difference |
| Pulse Duration, Sec | 2.50 | 2.50 | No Difference |
| Frequency, Hz | 0.20 | 0.20 | No Difference |
| Maximum Phase Charge (uC) @ 500 Ohms | 125.0 | 125.0 | No Difference |
| Maximum Average Current, mA | 0.025 | 0.025 | No Difference |
| Maximum Current Density, mA/cm² @ 500 Ohms | 0.0008 (predicate) | 0.0010 | Similar (slightly higher, within IEC limit of 2mA/cm², deemed acceptable for equivalence) |
| Maximum Average Power [mW/cm²] @ 500Ohm | 0.00001398 (predicate) | 0.00002500 | Similar (slightly higher, deemed acceptable for equivalence) |
| Regulated Current or Voltage? | Current | Current (and Voltage) | Similar (Healy provides both current and voltage, enhancing safety, deemed acceptable) |
| Patient Leakage Current -normal Condition, uA | <10 | 0 | Similar (Healy somewhat lower, deemed acceptable for equivalence) |
| Patient Leakage Current - Fault Condition, uA | <50 | 0 | Similar (Healy somewhat lower, deemed acceptable for equivalence) |
| Average DC current through electrodes when device is on but no pulses are being applied (uA) | 0.0 | <1 | No Difference |
| Number of Output Modes | 1 Microcurrent mode (for comparison) | 1 Microcurrent mode | No Difference (Healy only compares to the predicate's microcurrent mode) |
| Automatic Overload Trip | No (predicate) | Yes | Similar (Healy adding an additional safety feature, deemed acceptable) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe any clinical study with a "test set" in the context of typical AI/software performance validation involving human data. The submission is a 510(k) for a TENS device, and the "performance data" section states, "All necessary non-clinical testing was conducted on the Healy device to confirm that the device performs as intended." This primarily refers to bench testing, electrical safety, EMC, and software validation.
Therefore, there is:
- No reported sample size for a test set.
- No clinical data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical "test set" based on human data or expert review was used for performance evaluation, no experts were needed to establish ground truth. The evaluation focused on engineering and software validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert-adjudicated test set was used.
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 is not an AI/imaging device. The Healy device is a transcutaneous electrical nerve stimulator, and the submission does not mention any AI component or human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is typically relevant for AI/software devices. The "standalone" performance here relates to the device's physical and electrical functioning. The document states that "non-clinical, bench testing included performance verification to confirm acceptable performance of device features and functions" and "It was functionally tested and found to be in compliance with the specification." This implies standalone testing of the device's electrical and software functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" was established by engineering specifications, international standards (IEC, EN), and regulatory guidance. For example:
- Electrical safety tests against IEC 60601 series standards.
- EMC tests against IEC 60601-1-2 and EN 301 489-1 & 17.
- Software validation against EN 62304, EN ISO 13485, EN ISO 14971, EN 62366 and FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices.
- Performance parameters (voltage, current, frequency, etc.) were compared against the predicate device's specifications and relevant safety limits (e.g., current density limit of 2mA/cm2 from IEC60601-2-10).
8. The sample size for the training set
Not applicable. The Healy device is a hardware medical device (TENS) with associated software for control. The provided documentation does not describe an AI/ML component that uses a "training set" in the typical sense for learning or pattern recognition.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML component is mentioned or relevant to this submission.
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Image /page/0/Picture/0 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2019
TimeWaver Production GmbH % Douglas Herrington Principal Consultant Herrington Consulting LLC 2885 Sanford Ave, SW #43083 Grandville, Michigan 49418
Re: K191075
Trade/Device Name: Healy Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NYN Dated: October 30, 2019 Received: November 12, 2019
Dear Douglas Herrington:
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.
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
{1}------------------------------------------------
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 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,
Pamela Scott 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
510(k) Number (if known) K191075
Device Name Healy
Indications for Use (Describe)
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K191075
General Information
Date: May 26, 2019
Applicant & Manufacturing Address:
TimeWaver Production GmbH Schloss Kränzlin, Darritzer Straße 6 Kränzlin, Germany 16818 Phone: +49-3391-40022-11 FAX: +49-3391-40022-99 Registration Number: 3009411292
Contact Name
Douglas Herrington Principal Consultant Herrington Consulting LLC 2885 Sanford Ave SW#43083 Grandville, MI 49418-1342 Telephone: 1.248.369.5564 Fax: 1.877.881.4412 E-mail: dgls herrington@yahoo.com
Regulatory Information
Device Name: Healy 510(K) Number: K191075 Classification: Class II Panel: Neurological Therapeutic Devices Product Code: NUH, NYN Regulation Number: 21 CFR 882.5890, Transcutaneous electrical nerve stimulator for pain relief
Indication for Use Statement
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities. And for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Environments of Use: Clinics, hospital and home environments.
Patient Population: All adults 18 years and older.
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510(k) Summary: K191075
Substantial Equivalence Summary
| Table 1: Substantial | |||
|---|---|---|---|
| Equivalence Comparison Table | Microcurrent | Microcurrent | Comparison |
| 510(k) Number | K191075 | K172079 | |
| Regulation | 21 CFR§882.5890 | 21 CFR§882.5890 | No Difference |
| Product Code | NUH, NYN | NUH | Similar, Healy adds product codeNYN, however Omron's IFU statesarthritis pain treatment but the 510kapproval is for only NUH. |
| Device Name | Healy | Avail, Model PM601 | |
| Manufacturer | TimeWaver Production GmbH | Omron Healthcare Inc | |
| Usage | Over the Counter | Over the Counter | No Difference |
| Intended Use | The Healy is intended for the reliefof pain associated with sore oraching muscles of the lower back,arms, legs, shoulders or feet due tostrain from exercise or normalhousehold work activities.For the symptomatic relief andmanagement of chronic, intractablepain and relief of pain associatedwith arthritis. | The Avail is intended for the reliefof pain associated with sore oraching muscles of the lower back,arms, legs, shoulders or feet due tostrain from exercise or normalhousehold work activities.When used for the symptomaticrelief and management of chronic,intractable pain and relief of painassociated with arthritis, use theTap, Shoulder, Arm or Leg modeof stimulation. | No Difference |
| Environment of Use | Environments of Use: Clinics,hospital and home environments. | Environments of Use: Clinics,hospital and home environments. | No Difference |
| Patient Population | Patient Population: All adults 18years and older. | Patient Population: All adults 18years and older. | No Difference |
| Contraindications/Warnings/Precautions | Contraindications: Do not use thisdevice if you have a cardiacpacemaker, implanted defibrillator,or other implanted metallic or | Contraindications: Do not use thisdevice if you have a cardiacpacemaker, implanted defibrillator,or other implanted metallic or | No Difference |
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510(k) Summary: TimeWaver Production GmbH
| electronic device. Such use could cause electric shock, burns, electrical interference, or death. Patient-contacting Pads are for single patient use | electronic device. Such use could cause electric shock, burns, electrical interference, or death. Patient-contacting Pads are for single patient use | No Difference | |
|---|---|---|---|
| Single Use | |||
| Sterility | External contacting device, nonsterile | External contacting device, nonsterile | No Difference |
| Over-the-Counter: (OTC) | Yes | Yes | No Difference |
| Power Source: Voltage | Rechargeable Lithium Ion Battery | Rechargeable Lithium Ion Battery | No Difference |
| Method of Line Current Isolation | N/A (internal power source) | N/A (internal power source) | No Difference |
| Patient Leakage Current | |||
| -normal Condition, uA | 0 | <10 | Similar with Healy having somewhat lower leakage current |
| - Fault Condition, uA | 0 | <50 | Similar with Healy having somewhat lower leakage current |
| Average DC Current Through electrodes when device is on but no pulses are being applied (uA) | <1 | 0.0 | No Difference |
| Number of Output Modes | 1 Microcurrent mode | 1 Microcurrent mode9 TENS modes | No Difference as Healy only compares to the Microcurrent mode. |
| Number of Output Channels | 1 | 1 | No Difference |
| Synchronous or Alternating | N/A | N/A | No Difference |
| Method of Channel Isolation | none | none | No Difference |
| Regulated Current or Regulated Voltage | both (Software control) | current | Similar with Healy providing both current and voltage regulation. |
| Software/Firmware/Microprocessor Control? | Microprocessor | Microprocessor | No Difference |
| Automatic Overload Trip | Yes | no | Similar with Healy adding an additional safety feature. |
| Automatic No Load contact Trip | Yes | yes | No Difference |
| Automatic Shut Off | Yes | yes | No Difference |
| User Override Control? | Yes, power On/Off button on the device and in the App software | Yes, power On/Off button on the device and in the App software | No Difference |
| Indicator Display |
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510(k) Summary: TimeWaver Production GmbH
| On/Off Status | Yes, on the App and LED indicatoron Main unit | Yes, on the App and LEDindicator on Main unit | No Difference |
|---|---|---|---|
| Low Battery? | Yes on app and LED indicator ondevice | YES, ON APP | No Difference |
| Voltage/Current | YES, ON APP | YES, ON APP | No Difference |
| Timer Range (minutes) | 1min - 180min | 5-60 minutes and30-180 minutes for Microcurrent | Similar with Heal having additionaltiming control of 1- 30 minutes |
| Compliance With Voluntarystandards? | IEC 60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11 | No Difference |
| Compliance with 21 CFR 898 | Yes | N/A no patient cable | Different with Healy complying with21 CFR 898. |
| Weight | device 34gelectrode 2g | Device: Approx. 42 gPad-L: Approx. 21 gPad-M: Approx. 17.5gCharger: Approx. 100g | Healy is lighter than the SE as thepads are smaller and no charger isprovided. |
| Dimensions (W x H x D). mm | device : 55 x 55 x 7pads: 32mm round x 5mm height | Device: Approx. 60 × 72 × 15.5Charger: Approx. 158 x 90 x 20.5Pad-L: Approx. 219 × 83.5 × 9.3Pad-M: Approx. 180 × 79.5 × 9.3 | Healy pads are smaller than thepredicate because they do not deliverTENS voltages/currents, and nocharger is provided. See the technicaldiscussion. |
| Operating Conditions | 5°C - 40°C15-93%RH700-1060hpa | 10 to 40 °C30 to 80 %RH700 to 1060 hPa (noncondensing) | Similar with Healy having slighthigher relative humidity |
| Charging Conditions | 5-40°C15-93% RH. | 5 to 35 °C30 to 80 %RH | Similar with Healy having slighthigher relative humidity |
| Storage Conditions | 5-40°C15-93% RH. | 0 to 40 °C30 to 80 % RH | Similar with Healy having slighthigher relative humidity and slightlylower temperature |
| Transporting Conditions | -20 to 60 °C15-93% RH | -20 to 60 °C10 to 90 % RH | Similar with Healy having slighthigher relative humidity and slightlylower temperature |
| Electrode Style | Reusable | Reusable | No Difference |
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| 510(k) Summary: TimeWaver Production GmbH | |||
|---|---|---|---|
| ------------------------------------------- | -- | -- | -- |
| Table 2: Output Comparison | |||
|---|---|---|---|
| Microcurrent mode | |||
| 510(k) Number | K191075 | K172079 | Comparison |
| Product Code | NUH, NYN | NUH | |
| Device Name | Healy | Avail, Model PM601 | |
| Manufacturer | TimeWaver Production GmbH | Omron Healthcare Inc | |
| Waveform | Biphasic | Biphasic | No Difference |
| Shape | Rectangular | Rectangular | No Difference |
| Max Output Voltage (V) | |||
| 500 Ohms | 0.030 | 0.025 | Similar with Healy havingslightly higher output current. |
| 2k Ohms | 0.100 | 0.100 | No Difference |
| 10k Ohms | 0.500 | 0.500 | No Difference |
| Maximum Output Current (mA) | |||
| 500Ohm | 0.050 | 0.050 | No Difference |
| 2kOhm | 0.050 | 0.050 | No Difference |
| 10kOhm | 0.050 | 0.050 | No Difference |
| Pulse Duration, Sec | 2.50 | 2.50 | No Difference |
| Frequency, Hz | 0.20 | 0.20 | No Difference |
| Net Charge (uC per charge) @ 500ohms | 0 | 0 | No Difference |
| Maximum Phase Charge (uC), 500Ohms | 125.0 | 125.0 | No Difference |
| Maximum Average Current, mA | 0.025 | 0.025 | No Difference |
| Maximum Current Density,mA/cm² | |||
| 500 Ohms | 0.0010 | 0.0008 | Similar with Healy havingslightly higher current density. |
| 2k Ohms | 0.001 | --- | Unknown as the predicate doesnot give a value |
| 10k Ohms | 0.001 | --- | Unknown as the predicate doesnot give a value |
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510(k) Summary: TimeWaver Production GmbH
| Maximum Average Power[mW/cm²] | |||
|---|---|---|---|
| 500Ohm | 0.00002500 | 0.00001398 | Similar with Healy havingslightly higher maximumaverage power. |
| 2kOhm | 0.0000100 | ---- | The predicate does not mentionthe value |
| 10kOhm | 0.0000500 | ---- | The predicate does not mentionthe value |
| Regulated Current or Voltage? | Current | Current | No Difference |
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510(k) Summary: K191075
Discussion of Healy and Avail similarities and differences
PREDICATE DEVICE(S) [807.92(a)(3)]
The Healy device is substantially equivalent to the primary predicate device, the Omron Avail Microcurrent mode (K172079) with regard to product labeling, intended use, anatomical sites, patient population, performance testing, technological and safety characteristics.
DEVICE DESCRIPTION [807.92(a)(4)]
The Healy device is a single channel wearable electrotherapy device that is designed to alleviate temporary and chronic muscle and joint pain on multiple body locations. It delivers microcurrent therapy through the simple and convenient use of the dedicated iOS or Android App, or on product controls. Reusable, selfadhesive and contouring electrodes allow for discreet and convenient placement on multiple pain locations on the body.
The system contains one unit, which is rechargeable and is attached to the electrode via cables. The electrode can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Healy system is completed through the available App or on product controls. The Healy will be packaged with an Instruction Manual and quick start guide that provides details on setting up the device for use, installing of the App, setting and controlling therapy modes, and troubleshooting. The system includes the unit, adhesive gel electrodes, USB charging cable, electrode connection cable, and storage case.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES, [807.92(a)(6)]
In regard to technological characteristics, the Healy device is similar to the predicate with only minor technological differences. Like the predicate Avail device is paired and controlled by a dedicated smartphone App and on product controls with treatment duration and intensity being controlled by the App or product controls. However, both proposed and predicate devices can be turned off by pressing the on/off button on the main unit or the App. The Healy device and the Avail both offer one microcurrent mode. The Healy and Avail both use biphasic rectangular waveform. Both products use microcurrent lowlevel electrical stimulation and share the same regulation number (21 CFR 882.5890) the same product codes of NUH and NYN. The Avail instruction booklet (pg 26 of the attached Avail IB) states. "Any of the modes can be used on body parts or pains described in this instruction manual of the device", which includes the microcurrent mode.
The microcurrent mode is considered a very low current TENS (rectangular biphasic waveform) delivered at a low frequency. A comparison of the Healy operating characteristics to the primary predicate is included in the 510k summary.
In general, the Healy output parameters fall within the range of output parameters for Avail. For example, the maximum current density (mA/cm2) range for Healy @ 500 ohms is 0.0010, while the Avail is 0.0008. This range is also well below the IEC60601-2-10:2012 (Clause 201.4.2) limit of less than 2mA/cm2. The maximum average power density (W/cm2) @500 ohms is 0.00002500 for Healy, whereas the Avail maximum average power density @500 ohms is 0.00001398.
The Healy and Avail differ in how the electrode pads are configured. The Avail has pads that do not use lead wires, where the Healy does use lead wires. Additionally, the Healy pads are 32mm round where the Avail is 180 x 80mm because Healy only delivers microcurrent stimulation whereas the Avail also delivers TENS voltages and currents. The Healy electrodes and cables comply with 21 CFR 898 so thev do not raise new questions of safety or effectiveness.
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The proposed device, predicate device and reference devices are all intended for use as transcutaneous electrical nerve stimulation in adult populations for use in clinic, hospital or home settings. TimeWaver has completed comprehensive design verification testing, electrical safety and electromagnetic compatibility testing, software verification and validation to ensure that the Healy device performs as intended. The Healy also passed all testing requirements for electrical safety and EMC, and the device electrode has been previously cleared by FDA. The minor differences in labeling and technological characteristics between the proposed device and the predicate device have been evaluated and determined to not raise different questions of safety or effectiveness. As such, the proposed Healy is substantially equivalent to the predicate device. A comparison table summarizing the specifications and features of the proposed Healy device and the predicate device is included in the 510k summary.
Performance Data [807.92(b)]
All necessary non-clinical testing was conducted on the Healy device to confirm that the device performs as intended.
Nonclinical Testing Summarv:
The nonclinical, bench testing included performance verification to confirm acceptable performance of device features and functions. Other nonclinical safety testing included:
- · Electrical safety and electromagnetic compatibility testing
- · Software verification and validation
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Healy meet the established specifications.
Performance Data: Electromagnetic Compatibility and Electrical Safety
The Healy device has been thoroughly tested against applicable EN and IEC standards by a third p arty and found to be in compliance with the applicable sections. It was functionally tested and found to be in compliance with the specification.
The applicable electrical and safety standards met are:
| IEC 60601-1: | Medical electrical equipment - Part 1: General requirements for basic safety andessential performance |
|---|---|
| IEC 60601-1-2: | Medical electrical equipment - Part 1-2: General requirements for basic safety andessential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests |
| IEC 60601-1-11: | Medical electrical equipment - Part 1-11: General requirements for basic safety andessential performance - Collateral Standard: Requirements for medical electricalequipment and medical electrical systems used in the home healthcare environment |
| IEC 60601-2-10: | Medical electrical equipment - Part 2-10: Particular requirements for the basic safetyand essential performance of nerve and muscle stimulators |
EN 301 489-1 &17: Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment
TCRL 2015-2: Bluetooth RF Compliance
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510(k) Summary: TimeWaver Production GmbH
Software Validation
The Healy device software was validated following FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices.
The applicable software validation standards met are: EN 62304 Medical device software - Software life cycle processes EN ISO 13485: 2012 Medical devices-Quality management systems-Requirements for regulatory purposes EN ISO 14971: 2012 Medical devices - Application of risk management to medical devices EN 62304: 2006 Medical device software - Software life cycle processes EN 62366: 2008 Medical devices - Application of usability engineering to medical devices
Biocompatibility Data
Biocompatibility testing is not required because the only patient contact surface is through the electrode which was previously cleared by FDA.
Non-Clinical Testing - Other
In addition to electrical safety testing and software validation, human factors analysis and testing was also conducted and no user issues were identified.
Conclusion
Based upon the intended use and technical information provided in this pre-market notification, the Healy device has been shown to be safe and effective and substantially equivalent to the currently marketed predicate device.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).