(88 days)
A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities., and
A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles.
The ENSO Model 2 should be applied to normal, healthy, dry and clean skin of adult patients.
The Hinge Health ENSO® Device System consists of the main ENSO Device, a disposable Gel Pad, and a charging cable with AC adapter for recharging. The ENSO App is used to access and control the device.
ENSO 2 is a wearable medical device that provides professional-grade transcutaneous electrical nerve stimulation (TENS) therapy along with an easy-to-use interface within a compact design. The device system consists of the main ENSO 2 Device, a disposable Gel Pad, and a charging cable with AC adapter for recharging the Device. ENSO 2 is controlled wirelessly using the Hinge Health app on a compatible Mobile Device.
The provided text describes a 510(k) premarket notification for the ENSO (Model 2) device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). The submission aims to demonstrate substantial equivalence to a predicate device (CUR Model 1, K160052) rather than proving the device meets specific acceptance criteria based on studies involving AI or human-in-the-loop performance.
Therefore, much of the requested information regarding AI model performance, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training/test set details is not applicable to this 510(k) summary. This document primarily focuses on demonstrating that the modified device (ENSO Model 2) is substantially equivalent to a previously cleared predicate device, meaning it is as safe and effective, and does not require extensive new clinical studies or elaborate AI performance evaluations.
Here's a breakdown of the available information based on your request:
1. Table of acceptance criteria and the reported device performance:
Since this is a 510(k) demonstrating substantial equivalence, the "acceptance criteria" are primarily a comparison to the predicate device, showing that the new device meets or exceeds the specifications of the predicate without introducing new safety or effectiveness concerns. There are no explicit "acceptance criteria" for AI performance listed in this document, as the device doesn't claim AI capabilities in the context of diagnostic or prescriptive functions commonly associated with AI/ML medical devices that would require such performance metrics.
The performance is reported through various comparison tables against the predicate device. The "acceptance" is that the parameters are "Identical," "Equivalent," or "Better" where applicable, and that modifications do not negatively impact safety or effectiveness.
| Attribute/Parameter | Subject Device (ENSO 2, K233784) | Predicate (CUR Model 1, K160052) | Reported Performance/Comment (Acceptance) |
|---|---|---|---|
| Intended Use & Indications for Use | Same as predicate (TENS for symptomatic pain relief, PMS for muscle performance) | Same as predicate | Identical (except for device name and model). This is a core "acceptance criterion" for substantial equivalence. |
| Primary Modifications | Improved battery shelf life, minor software updates (add functionality, change system requirements), add over-the-air (OTA) firmware update ability, extended gel pad expiration date (12mo to 18mo, then to 24mo), removal of "implanted metal devices" from contraindications warning. | Original specifications | These are the key changes. The "acceptance" is that these modifications do not adversely affect safety or effectiveness, which is supported by bench and non-clinical testing. |
| Design Comparison | Wearable medical device providing TENS therapy, identical anatomical sites, similar design, same type of mating components. | Similar wearable medical device | Identical (overall design philosophy and function), except for the addition of "Large" size gel pad and 1.6g heavier weight, ~1mm taller dimension, and polycarbonate/PET case (vs. polycarbonate plastic) for housing, noted as "Equivalent with more durability." These differences are considered acceptable as they do not change the fundamental scientific technology or safety/effectiveness. |
| Electrical Output Specifications | |||
| TENS Mode - Waveform | Biphasic, Rectangular (Mode A: Asymmetrical, Modes B/C: Symmetrical) | Biphasic, Rectangular (Mode A: Asymmetrical, Modes B/C: Symmetrical) | Identical across all modes for waveform, shape, maximum output voltage, maximum output current, pulse duration, frequency, net charge, maximum phase charge, maximum current density, maximum average current, and maximum average power density. |
| PMS Mode - Waveform | Biphasic, Symmetrical, Rectangular | Biphasic, Symmetrical, Rectangular | Identical for all specified parameters including waveform, shape, maximum output voltage, maximum output current, primary phase duration, pulse duration, frequency, net charge, maximum phase charge, maximum current density, maximum average current, and maximum average power density. |
| Safety/Compliance Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 60601-1-6, IEC 60601-1-11, IEC 60529, IEC 62133-2, IEC 62368, FCC §15.107, FCC §15.109, FCC §1.1310, RSS-102, IEC 62304, IEC 62366-1, ASTM D6862, ASTM D3330/D3331, ASTM F1980. | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10 | Compliance with these extensive standards (many of which are also specified for the predicate directly or implied by its clearance) is the basis of "acceptance" for safety and performance under these general controls. The document states they are "identical" or "equivalent" in compliance. |
| Shelf Life | 2-year gel pad expiration date | 1-year gel pad expiration date | Gel pad expiry extended "based on validation testing." This indicates successful testing to support the improved shelf life, which is a positive "performance" outcome. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it pertains to clinical studies often required for novel devices or significant changes. For a 510(k) relying on substantial equivalence and primarily bench/non-clinical testing for modifications, large clinical test sets are typically not needed. The document explicitly states: "Hinge Health determined that bench and non-clinical testing were sufficient to demonstrate that the ENSO Device System is as safe and effective as the predicate device."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable/provided. The ground truth in this context is the performance and safety characteristics of the predicate device, which have already been established through its prior clearance. The evaluation for ENSO (Model 2) focuses on demonstrating that its modifications do not alter this established safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable/provided. Adjudication methods are relevant for clinical studies, particularly when establishing ground truth from multiple expert readings or interpretations. This 510(k) does not present such a study.
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
This is not applicable/provided. An MRMC study or AI assistance effect size would be relevant for devices involving image interpretation or clinical decision support where AI assists human clinicians. This device is a TENS/PMS unit, and its modifications do not involve AI in this diagnostic or interpretive capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable/provided. The device does not present a standalone algorithm for diagnostic or clinical decision-making that would require such performance evaluation. The "software updates" mentioned are for functionality and system requirements, not for a clinical AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (CUR Model 1, K160052). The submission aims to demonstrate that the modified ENSO (Model 2) device is substantially equivalent to this predicate, meaning it performs as intended and is as safe and effective under its updated specifications and features. This is primarily established through bench testing and non-clinical data comparing the new device's specifications to the predicate's.
8. The sample size for the training set
This is not applicable/provided. There is no indication that a machine learning or AI model was "trained" in the typical sense for clinical interpretation or predictive tasks.
9. How the ground truth for the training set was established
This is not applicable/provided for the reason stated above.
In summary, this 510(k) submission focuses on demonstrating substantial equivalence of a modified electrical stimulation device to a predicate, primarily through extensive bench and non-clinical testing addressing the modified features and compliance with relevant medical device standards. It is not an AI/ML device submission that would require clinical validation studies with detailed information on AI model performance, test set characteristics, or ground truth establishment based on expert consensus or outcome data.
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February 23, 2024
Hinge Health, Inc. % Dawn Norman Regulatory Consultant EBG Advisors, Inc. 1227 25th Street, NW Suite 700 Washington, District of Columbia 20037
Re: K233784
Trade/Device Name: ENSO (Model 2) Regulation Number: 21 CFR 882.5890, 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 10, 2023 Received: November 27, 2023
Dear Dawn Norman:
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.
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,
Robert Kang -S
for Pamela Scott
Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation 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) K233784
Device Name ENSO (Model 2)
Indications for Use (Describe)
A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities., and
A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles.
The ENSO Model 2 should be applied to normal, healthy, dry and clean skin of adult patients.
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) | X |
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Traditional 510(k) Summary
| Manufacturer: | Hinge Health ™ Incorporated455 Market Street, Suite 700San Francisco, CA 94105USAPhone (855) 902-2777 |
|---|---|
| Contact Person: | Dawn N. Norman, MS |
- Partner MRC Global, LLC Phone (618) 604-3064 Email: Dawn.Norman@askmrcglobal.com
February 21, 2024 Date Prepared:
DEVICE INFORMATION
| Trade/Proprietary Name: | ENSO® Device System 510(k) |
|---|---|
| Common Name:Classification Names: | Transcutaneous Nerve StimulatorTranscutaneous Electrical Nerve Stimulator for Pain Relief, Powered Muscle Stimulator |
| 21 CFR 882.5890 and 21 CFR 890.5850Class IIDevice Product Codes: NUH, NGX |
PREDICATE DEVICE INFORMATION
| Predicate Device: | K160052 (CUR Model 1) |
|---|---|
| Trade/Proprietary Name: | CUR Model 1 |
| Common Name:Classification Names: | Transcutaneous Nerve StimulatorStimulator, Nerve, Transcutaneous, Over-The-Counter |
21 CFR 882.5890 and 21 CFR 890.5850 Class II Device Product Codes: NUH, NGX
ENSO® Device System 510(k)
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Product Description:
The Hinge Health ENSO® Device System consists of the main ENSO Device, a disposable Gel Pad, and a charging cable with AC adapter for recharging. The ENSO App is used to access and control the device.
The detailed device description and Engineering drawings for the ENSO® Device System can be found in Description Section of the eSTAR form.
The ENSO Device System that is the subject of this submission is a modification to the predicate Cur 1 Device System (K160052) that was cleared on May 20, 2016.
The subject of the present Traditional 510(k) submission is a modification of CUR Model 1. The device that is the subject of this 510(k) submission is identical to the predicate device (K160052) in terms of intended use, indications for use, charger function/materials. AC adaptor, gel pad tape, overall functionality. design, type of mating connections, biocompatibility and packaging. The subject device and the predicate share the same fundamental scientific technology and intended use.
Compared to the predicate device (K160052), the subject device uses several enhancements to improve device functionality and operation (see Performance Testing Section for details). The main changes are:
- ·Contraindications, remove implanted metal devices
- ·Extend gel pad expiration date period from 12mo to 18mo and then 18mo to 24mo
- ·Improve battery shelf life
- •Minor software updates to add functionality and change system requirements.
- ·Add over-the-air (OTA) firmware update ability
There are no changes to the product's intended use, indications for use, functionality, biocompatibility, and packaging.
The ENSO Device System that is the subject of this submission meets the specifications for electrical output for TENS and EMS Modes, and IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-1, ISO 10993-5 and -10.
Indications for Use (for this submission):
The Hinge Health ENSO Device System is intended to be used in the following: A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder,
ENSO® Device System 510(k)
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waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. , and
A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles.
The ENSO Device should be applied to normal, healthy, dry and clean skin of adult patients.
With the exception of the addition of Hinge Health's "ENSO" brand name, there are no changes to the indications for use or intended use from the previously cleared CUR Model 1 predicate (K160052). Form FDA 3881. Indications for Use. can be found in the 510(k) submission. The addition of the "ENSO" brand name to the Indications for Use statement is not considered a change because the product line has been branded "ENSO" since it was launched in the USA in 2017.
Performance Testing
No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the ENSO Device System was conducted in accordance with the various international standards listed below and in the Performance Testing - Bench Section of this 510(k) submission.
Performance testing of the subject device modification (ENSO 2) was conducted in accordance with the following standards and test methods as seen in Figure 5-1.
| Test Method | Standard(s) | |
|---|---|---|
| Safety | IEC 60601-1 | |
| IEC 60601-1-6 | ||
| IEC 60601-2-10 | ||
| IEC 60601-1-11 | ||
| IEC 60529 | ||
| IEC 62133-2 | ||
| IEC 62368 | ||
| EMC | IEC 60601-1-2 | |
| FCC §15.107 & ICES Issue 5, (Nov. 2014 Update),Conducted Emissions | ||
| FCC §15.109 & CAN/CSA-CISPR 22-10 Table 6 and ICES-003 Issue 5 (Nov. 2014 Update), Radiated Emissions | ||
| FCC § 1.1310, RF Exposure Evaluation | ||
| RSS-102, Issue 5:2015+A1:2021, RF Exposure Evaluation | ||
| SoftwareIEC 62304 |
Figure 5-1 Test Method and Standards
ENSO® Device System 510(k)
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| Test Method | Standard(s) |
|---|---|
| Usability | IEC 62366-1 |
| Biocompatibility | ISO 10993-1 |
| ISO 10993-5 | |
| ISO 10993-10 | |
| Packaging andShelf-life | ASTM D6862 |
| ASTM D3330/ASTM D3331ASTM F1980 |
Basis of Substantial Equivalence
The ENSO® Device System that is the subject of this submission has the following similarities to the predicate CUR Model 1 cleared under K160052:
- similar material ●
- same intended use ●
- same indications for use ●
- similar design ●
- similar sizes and dimensions .
- same type of mating components ●
- same biocompatibility .
- . same packaging methods
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Comparison Table - Indications for Use
Figure 5-2: Indications for Use Comparison Table
| ENSO® Device System | |||
|---|---|---|---|
| Attribute | Subject Device(ENSO 2, K233784) | Predicate(CUR Model 1, K160052) | Comments |
| Indications forUse | A transcutaneous electrical nerve stimulation (TENS) Modewhich is indicated for the symptomatic relief and management ofchronic intractable pain, and for temporary relief of painassociated with sore and aching muscles in the shoulder, waist,back, neck, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities.,andA powered muscle stimulation (PMS) mode which is indicated toimprove and facilitate muscle performance in healthy muscles.The ENSO® Model 2 should be applied to normal, healthy, dryand clean skin of adult patients. | A transcutaneous electrical nerve stimulation (TENS) Modewhich is indicated for the symptomatic relief and management ofchronic intractable pain, and for temporary relief of painassociated with sore and aching muscles in the shoulder, waist,back, neck, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities.,andA powered muscle stimulation (PMS) mode which is indicated toimprove and facilitate muscle performance in healthy muscles.The CUR Model 1 should be applied to normal, healthy, dry andclean skin of adult patients. | Identicalexcept fordevice nameand model |
| Class | II | II | Identical |
| Product Code | NUH; NGX | NUH; NGX | Identical |
| Regulation | 21 CFR 882.5890 and 21 CFR 890.5850 | 21 CFR 882.5890 and 21 CFR 890.5850 | Identical |
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Comparison Table – Contraindications
| ENSO® Device System | |||
|---|---|---|---|
| Attribute | Subject Device(ENSO 2, K233784) | Predicate(CUR Model 1, K160052) | Comments |
| Contraindications | Contraindication: Do not use this device if you have a cardiacpacemaker, implanted defibrillator, or other implantedelectronic device. Such use could cause electric shock,burns, electrical interference, or death.Warning: Do not apply stimulation over or near metallicimplants | Do not use this device if you have a cardiac pacemaker,implanted defibrillator, or other implanted metallic orelectronic device. Such use could cause electric shock,burns, electrical interference, or death. | Identical except "metallic"was removed and thewarning was added |
Figure 5-3: Contraindications Comparison Table
Comparison Table – Design Features
Figure 5-4: Design Feature Comparison Table
| ENSO® Device System | ||||
|---|---|---|---|---|
| Attribute | Subject Device(ENSO 2, K233784) | Predicate(CUR Model 1, K160052) | Comments | |
| Design Comparison | ENSO 2 is a wearable medical device thatprovides professional-grade transcutaneouselectrical nerve stimulation (TENS) therapyalong with an easy-to-use interface within acompact design. The device system consists ofthe main ENSO 2 Device, a disposable GelPad, and a charging cable with AC adapter forrecharging the Device. | CUR 1 is a wearable medical device that providesprofessional-grade transcutaneous electrical nervestimulation (TENS) therapy along with an easy-to-useinterface within a compact design. The device systemconsists of the main Cur 1 Device, a disposable Gel Pad,and a charging cable with AC adapter for recharging theDevice.Cur 1 is controlled wirelessly using the Cur Mobile app on a | Identical | |
| ENSO 2 is controlled wirelessly using the HingeHealth app on a compatible Mobile Device. | compatible Mobile Device. | |||
| Sizes | Disposable gel pad- LargeDisposable gel pad- Standard | Disposable gel pad | Identical | |
| ENSO® Device System | ||||
| Attribute | Subject Device(ENSO 2, K233784) | Predicate(CUR Model 1, K160052) | Comments | |
| Anatomical Sites | •shoulder•waist•back•neck•upper extremities (arm)•lower extremities (leg) | •shoulder•waist•back•neck•upper extremities (arm)•lower extremities (leg) | Identical | |
| Biocompatibility/ Material | Tested per ISO 10993-1ISO 10993-5 and -10 | Tested per ISO 10993-1ISO 10993-5 and -10 | Equivalentbiocompatibility resultsfor gel pad and tape | |
| Power Source(s) | Lithium-ion Polymer chemistry, and allowcharging at 4.20V | 3.7V Lithium-Polymer battery (rechargeable) | Equivalent or betterbattery life | |
| Method of Line CurrentIsolation | Physically isolated; device cannot connect toelectrodes and battery recharger concurrently | Physically isolated; device cannot connect to electrodes andbattery recharger concurrently | Identical | |
| Patient Leakage Current- Normal Condition (μΑ) | Battery powered(< 10 μΑ) | Battery powered(< 10 μΑ) | Identical | |
| Patient Leakage Current- Single Fault Condition (µA) | Battery powered(< 50 μΑ) | Battery powered(< 50 μΑ) | Identical | |
| Average DC current throughelectrodes when device is onbut no pulses are being applied(μΑ) | < 0.1μA | < 0.1μA | Identical | |
| Number of Output Modes | 3 TENS, 1 EMS | 3 TENS, 1 EMS | Identical | |
| Number of OutputChannels | 1 | 1 | Identical | |
| Method ofChannel Isolation | N/A | N/A | Identical | |
| Regulated Current orRegulated Voltage? | Yes | Yes | Identical | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Identical | |
| Automatic Overload Trip? | Yes | Yes | Identical | |
| ENSO® Device System | ||||
| Attribute | Subject Device(ENSO 2, K233784) | Predicate(CUR Model 1, K160052) | Comments | |
| Automatic No-Load Trip? | Yes | Yes | Identical | |
| Automatic Shut Off? | Yes | Yes | Identical | |
| User Override Control? | Yes | Yes | Identical | |
| IndicatorDisplay | On/Off Status?Low Battery?Voltage/CurrentLevel? | YesYesYes | YesYesYes | IdenticalIdenticalIdentical |
| Timer Range (minutes) | N/A | 60 minutes | No time range | |
| Compliance with Standards? | IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 10993-5 and -10 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 10993-5 and -10 | Identical | |
| Compliance with 21 CFR 898? | N/A | N/A | N/A | |
| Weight (g) | 13.1g | 11.5 g | 1.6g heavier | |
| Dimensions (mm) (W x H x D) | 38 x 38 x 11 | 38 x 38 x 10 | ~1mm taller (D) | |
| Housing Materials andConstruction | Polycarbonate/PET Case | Polycarbonate plastic | Equivalent with moredurability |
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Output Specifications Table for TENS Modes
Figure 5-5: Output Specification for TENS Mode Comparison Table
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| Output Specifications Table for TENS Modes | |||||||
|---|---|---|---|---|---|---|---|
| Subject Device | Predicate | Comments | |||||
| Parameter | (ENSO 2, K233784) | (CUR Model 1, K160052 | |||||
| Mode A(Default) | Mode B | Mode C | Mode A(Default) | Mode B | Mode C | ||
| Waveform (e.g., pulsed | Biphasic, | Biphasic, | Biphasic, | Biphasic, | Biphasic, | Biphasic, | Identical |
| monophasic, biphasic) | Asymmetrical | Symmetrical | Symmetrical | Asymmetrical | Symmetrical | Symmetrical | |
| Shape (e.g., rectangular, spike) | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Identical |
| 42.6V @ 500Ω | 43.2V @ 500Ω | 42.9V @ 500Ω | 42.6V @ 500Ω | 43.2V @ 500Ω | 42.9V @ 500Ω | Identical | |
| Maximum Output Voltage (volts)(10+/- %) | 85.2V @ 2kΩ | 85.4V @ 2kΩ | 86.0V @ 2kΩ | 85.2V @ 2kΩ | 85.4V @ 2kΩ | 86.0V @ 2kΩ | Identical |
| 87.0V @ 10kΩ | 85.4V @ 10kΩ | 87.8V @ 10kΩ | 87.0V @ 10kΩ | 85.4V @ 10kΩ | 87.8V @ 10kΩ | Identical | |
| 85.1 mA @500Ω | 86.3 mA @500Ω | 85.6 mA @500Ω | 85.1 mA @500Ω | 86.3 mA @ 500Ω | 85.6 mA @ 500Ω | Identical | |
| Maximum Output Current (mA)(10+/- %) | 43.1 mA @2kΩ | 43.2 mA @ 2kΩ | 43.5 mA @ 2kΩ | 43.1 mA @2kΩ | 43.2 mA @ 2kΩ | 43.5 mA @ 2kΩ | Identical |
| 8.8 mA @10kΩ | 8.8 mA @ 10kΩ | 8.8 mA @ 10kΩ | 8.8 mA @10kΩ | 8.8 mA @ 10kΩ | 8.8 mA @ 10kΩ | Identical | |
| Duration of primary (depolarizing)phase (usec) | 25.85 usec | 90.5 usec | 51.0 usec | 25.85 usec | 90.5 usec | 51.0 usec | Identical |
| Pulse Duration (both phases)(usec) | 91.7 usec | 221 usec | 142 usec | 91.7 usec | 221 usec | 142 usec | Identical |
| Frequency (Hz) | 40-160 Hz | 40-160 Hz | 120-160 Hz | 40-160 Hz | 40-160 Hz | 120-160 Hz | Identical |
| For multiphasic waveforms only: | N/A | N/A | N/A | N/A | N/A | N/A | Identical |
| Net Charge (microcoulombs (µC) | Nominally 0uC | Nominally 0uC | Nominally 0uC | Nominally 0uC | Nominally 0uC @ | Nominally 0uC @ | Identical |
| per pulse) (If zero, state how this | @ 500Ω, zero | @ 500Ω, zero | @ 500Ω, zero | @ 500Ω, zero | 500Ω, zero net | 500Ω, zero net | |
| was achieved) | net current | net current | net current | net current | current | current | |
| Maximum Phase Charge, (µC) | 7.16 uC @500Ω | 7.45 uC @ 500Ω | 4.14 uC @ 500Ω | 7.16 uC @500Ω | 7.45 uC @ 500Ω | 4.14 uC @ 500Ω | Identical |
| Maximum Current Density. | 0.009 mA/cm2 | 0.004 | 0.006 | 0.009 mA/cm2 | 0.004 | 0.006 | Identical |
| (mA/cm2, r.m.s.) | @500Ω | mA/cm2 @500Ω | mA/cm2 @500Ω | @500Ω | mA/cm2 @500Ω | mA/cm2 @500Ω | |
| Maximum Average Current(average absolute value), mA | 0.94 mA@500Ω | 1.85 mA@500Ω | 1.28 mA @500Ω | 0.94 mA@500Ω | 1.85 mA @500Ω | 1.28 mA @500Ω | Identical |
| Output Specifications Table for TENS Modes | |||||||
| Parameter | Subject Device(ENSO 2, K233784) | Predicate(CUR Model 1, K160052) | |||||
| Mode A(Default) | Mode B | Mode C | Mode A(Default) | Mode B | Mode C | Comments | |
| Maximum Average PowerDensity, (W/cm2), (using smallestconductive surface area) | 1.50 mW/cm2@500Ω | 3.05 mW/cm2@500Ω | 2.09 mW/cm2@500Ω | 1.50 mW/cm2@500Ω | 3.05 mW/cm2@500Ω | 2.09 mW/cm2@500Ω | Identical |
| Burst Mode(i.e., pulse trains): | N/A | N/A | N/A | N/A | N/A | N/A | Identical |
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Output Specifications Table for EMS Modes
Figure 5-6: Output Specifications for EMS Mode Comparison Table
| Output Specifications Table for EMS Modes | |||
|---|---|---|---|
| Parameter | Subject Device(ENSO 2, K233784) | Predicate(CUR Model 1, K160052) | Comments |
| Mode or Program Name | Measured(or Nominal as noted) | Measured(or Nominal as noted) | Identical |
| Waveform (e.g., pulsedmonophasic, biphasic) | Biphasic, Symmetrical | Biphasic, Symmetrical | Identical |
| Shape (e.g., rectangular, spike) | Rectangular | Rectangular | Identical |
| Maximum Output Voltage(volts) (10+/- %) | 38.4V @ 500Ω | 38.4V @ 500Ω | Identical |
| 85.0V @ 2kΩ | 85.0V @ 2kΩ | Identical | |
| 85.0V @ 10kΩ | 85.0V @ 10kΩ | Identical | |
| Maximum Output Current (mA)(10+/- %) | 76.7 mA @ 500Ω | 76.7 mA @ 500Ω | Identical |
| 43.0 mA @ 2kΩ | 43.0 mA @ 2kΩ | Identical |
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| Output Specifications Table for EMS Modes | |||
|---|---|---|---|
| Parameter | Subject Device(ENSO 2, K233784) | Predicate(CUR Model 1, K160052) | Comments |
| 8.1 mA @ 10Ω | 8.1 mA @ 10Ω | Identical | |
| Duration of primary(depolarizing) phase (usec) | 221.5 usec | 221.5 usec | Identical |
| Pulse Duration (both phases)(usec) | 483.8 usec | 483.8 usec | Identical |
| Frequency (Hz) | 2-15 Hz | 2-15 Hz | Identical |
| Formultiphasicwaveformsonly: | N/A | N/A | Identical |
| Net Charge (microcoulombs(µC) per pulse) (If zero, statehow this was achieved) | Nominally 0uC @ 500Ω, zero net current | Nominally 0uC @ 500Ω, zero net current | Identical |
| Maximum Phase Charge, (µC) | 16.21 uC @ 500Ω | 16.21 uC @ 500Ω | Identical |
| Maximum Current Density,(mA/cm2, r.m.s.) | 0.006 mA/cm2 @500Ω | 0.006 mA/cm2 @500Ω | Identical |
| Maximum Average Current(average absolute value), mA | 0.22 mA @500Ω | 0.22 mA @500Ω | Identical |
| Maximum Average PowerDensity, (W/cm2), (usingsmallest conductive surfacearea) | 0.315 mW/cm2 @500Ω | 0.315 mW/cm2 @500Ω | Identical |
| Burst Mode(i.e., pulsetrains): | N/A | N/A | Identical |
{15}------------------------------------------------
Sterility and Shelf Life Specifications Table
Figure 5-7: Sterility and Shelf Life Comparison Table
| Attribute | Subject Device | Predicate | Comments |
|---|---|---|---|
| Device Usage | Reusable | Reusable | Identical |
| Sterility | Provided non-sterile | Provided non-sterile | Identical |
| Expiration dating/Shelf life | 2-year gel pad expiration date | 1 year gel pad expiration date | Gel pad expiry extendedbased on validationtesting. See Sterilizationand Shelf-life Section. |
Clinical Testing
Hinge Health determined that bench and non-clinical testing were sufficient to demonstrate that the ENSO Device System is as safe and effective as the predicate device.
{16}------------------------------------------------
Conclusion:
The data and information provided in this submission support the conclusion that the ENSO Device System that is the subject of this 510(k) submission is substantially equivalent to its predicate device (K160052), and does not significantly affect the safety or effectiveness of the device. This modification is being proposed to improve device functionality, operation and is not at result of any clinical or performance factors.
§ 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).