ReliefBand 2.0 is indicated for use in the treatment of nausea, retching and vomiting due to motion sickness, chemotherapy and morning sickness associated with pregnancy. ReliefBand 2.0 is also indicated as an adjunct to antiemetics in reducing postoperative nausea.

Device Description

ReliefBand® 2.0 is a rechargeable, non-invasive digital therapeutic device that is worn on the wrist like a watch. It is a non-invasive device that is indicated for the over the counter use in the relief of mild to moderate nausea and vomiting associated with chemotherapy, motion sickness, mild to moderate nausea and vomiting associated with pregnancy, and as an adjunct to antiemetics in reducing mild to moderate postoperative nausea.

ReliefBand 2.0® includes a hypoallergenic band with two electrical contacts on the clasp end of the band. The two contacts must be placed firmly against the underside of the P6 location, approximately two fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles. The electrodes in the wristband provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist.

The ReliefBand® Device has a user display that incorporates a ten-segment linear LED that is used to display the intensity level. The patient can easily select the pulse amplitude of the electrical impulse and control the intensity of the stimulation via a pushbutton located on the edge of the device. Battery charge level is indicated by a separate four-segment circular LED. A fully charged battery will last for approximately 18 hours of continuous use at the mid-power level or below.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for the ReliefBand 2.0 device, a transcutaneous electrical nerve stimulator for pain relief, specifically for nausea, retching, and vomiting due to various conditions.

However, the document is a 510(k) summary (K182960), which primarily focuses on demonstrating substantial equivalence to a predicate device (ReliefBand 1.5) rather than providing detailed results from a clinical study proving its performance against pre-defined acceptance criteria.

Therefore, many of the requested details about acceptance criteria and a study proving device performance (especially those related to diagnostic performance, such as sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details) are not present in this document.

The document states:

"Substantial equivalence was determined on the basis that there have been no changes in the technology, mechanism of action or intended use."
"Device modifications include relocation of the electrodes from the back of the device face to the clasp end of the wrist band, changes in the size, shape and aesthetic appearance of the casing, a simpler and more streamlined user interface and a power source change from disposable to rechargeable batteries."
"These changes do not impact the safety of efficacy of the ReliefBand® 2.0 device."
"ReliefBand 2.0 was tested to the following standard: ISO 14971: Medical Devices Application of Risk Management to Medical Devices."

This indicates that the clearance was based on comparative analysis with the predicate device and engineering/safety testing (like risk management and adherence to ISO standards), not on a clinical trial with specific performance acceptance criteria for diagnostic accuracy or efficacy. The device is a direct treatment device, not an AI/diagnostic device, so many of the questions related to AI performance are not applicable.

Below is an attempt to address the questions based on the available information, noting where information is explicitly NOT provided.

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative clinical acceptance criteria or a reported performance based on those criteria for the ReliefBand 2.0's therapeutic effect in a clinical study. Instead, its "performance" is demonstrated by its substantial equivalence to the predicate device (ReliefBand 1.5) and compliance with relevant standards.

Acceptance Criteria (or Basis for Clearance)	Reported Device Performance (or Basis for Substantial Equivalence Determination)
Technological Characteristics: No changes that raise new questions about safety or effectiveness compared to predicate.	ReliefBand 2.0 is substantially equivalent to ReliefBand 1.5. Device modifications (electrode relocation, size/shape/aesthetic changes, simpler UI, rechargeable battery) "do not impact the safety of efficacy of the ReliefBand® 2.0 device."
Mechanism of Action: Same as predicate.	Identical mechanism of action (electrical stimulation of the median nerve on the ventral side of the patient's wrist).
Intended Use: Same as predicate.	Identical indications for use (treatment of nausea, retching, and vomiting due to motion sickness, chemotherapy, morning sickness associated with pregnancy, and as an adjunct to antiemetics in reducing postoperative nausea).
Safety: Device modifications maintain safety.	Electrode Material: Hypoallergenic surgical grade (316L) stainless steel contacts, previously cleared material, "Does not adversely impact safety and/or effectiveness."
Safety: Device modifications maintain safety.	Wrist Band Material: Latex-free, "Conforms to ISO 10993 standard." (Predicate contained latex).
Power/Battery: Meets standards and safe.	Rechargeable 40 mA Li-Ion Polymer: "Conforms to IEC 62133 standard."
Risk Management: Mitigate risks.	ISO 14971: Medical Devices Application of Risk Management to Medical Devices.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical study with a "test set" of patients for measuring efficacy of the ReliefBand 2.0. The device's approval is based on substantial equivalence to a predicate, not new clinical performance data from a specific test set.
Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. This device is a therapeutic device, not a diagnostic one that requires expert ground truth for image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

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-assisted diagnostic device, nor is it a multi-reader, multi-case study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a direct therapeutic device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. As a therapeutic device cleared via substantial equivalence, new clinical efficacy data with defined ground truth is not the primary basis for this 510(k) clearance.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would have a "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary of findings from the document:

The FDA 510(k) clearance for ReliefBand 2.0 (K182960) is based on demonstrating substantial equivalence to a previously cleared predicate device (ReliefBand 1.5). The document highlights that there have been no changes in technology, mechanism of action, or intended use that would raise new questions about safety or effectiveness. The modifications are primarily cosmetic, user interface improvements, and a change from disposable to rechargeable batteries. Compliance with ISO 14971 (Risk Management) and IEC 62133 (Battery safety), as well as the use of ISO 10993 compliant materials for the wristband, are mentioned as part of the safety assessment. There is no indication of a new clinical study involving a test set of patients or experts that would generate the type of performance data typically associated with diagnostic AI devices.

Summary

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June 21, 2019

ReliefBand Technologies LLC Barbara Whitman Vice President, Regulatory Affairs and Quality Assurance 220 Gibraltar Road, Suite 270 Horsham, Pennsylvania 19044

Re: K182960

Trade/Device Name: ReliefBand 2.0 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: May 22, 2019 Received: May 22, 2019

Dear Barbara Whitman:

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 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

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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 (QS) 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) K182960

Device Name ReliefBand 2.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 K182960 ReliefBand 2.0

Submitter Information

Applicant: Relief band® Technologies LLC 220 Gibralter Road, Suite 270 Horsham, PA 19044 Phone: 877-735-2263 Ext 122 Contact: Barbara Whitman Vice President of Regulatory Affairs and Quality Assurance Date Prepared: October 15, 2018

Device Classification

Trade name: ReliefBand® 2.0 Common Name: Nerve Stimulation Therapy Device Classification Name: Transcutaneous electrical nerve stimulator for pain relief (21 CFR 882.5890) Product Code: GZJ Device Classification: Class II Predicate Device: ReliefBand® 1.5, K173233

Description of the Device

Indications for Use

ReliefBand® 2.0 is indicated for use in the treatment of nausea, retching and vomiting due to motion sickness, chemotherapy and morning sickness associated with pregnancy. ReliefBand® 2.0 is also indicated as an adjunct to antiemetics in reducing postoperative nausea.

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Technical Characteristics

A comparison of the technological characteristics of the ReliefBand® 2.0 and the predicate device ReliefBand® 1.5 has been performed. The results of the comparison demonstrate that the ReliefBand® 2.0 device is substantially equivalent to the marketed predicate device. The differences between the ReliefBand® and the predicate device do not raise new questions about the safety or effectiveness of the device.

Basis for Determination of Substantial Equivalence

Substantial equivalence was determined on the basis that there have been no changes in the technology, mechanism of action or intended use. Device modifications include relocation of the electrodes from the back of the device face to the clasp end of the wrist band, changes in the size, shape and aesthetic appearance of the casing, a simpler and more streamlined user interface and a power source change from disposable to rechargeable batteries. There is a new user interface that provides 10 increments of intensity from 8 to 40 mA where there were previously 5 increments from 10 to 40 mA. These changes do not impact the safety of efficacy of the ReliefBand® 2.0 device.

Item	ReliefBand 1.5	ReliefBand 2.0	Comments
Indications forUse	Reliefband® is a digitaltherapeutic deviceindicated for use in thetreatment of nausea,retching and vomiting dueto motion sickness,morning sicknessassociated with pregnancy,and chemotherapy.Reliefband® is alsoindicated as an adjunct toantiemetic therapy inreducing post-operativenausea.	Reliefband® 2.0 isindicated for use in thetreatment of nausea,retching and vomitingdue to motionsickness,chemotherapy andmorning sicknessassociated withpregnancy.Reliefband® 2.0 isalso indicated as anadjunct to antiemeticsin reducing	Similar
Size	Teardrop shape, 3.81W x5.08L x 1.14 H cm	Rectangular shape,1.45 W x 2.35 L x 0.41H cm	Does not affectsafety andeffectiveness
Weight	Approximately 34 grams	Approximately 50grams	Does not affectsafety andeffectiveness
OperatingTemperature	10°C to 45°C (50°F to113°F) ±18% outputtolerance at operatingextremes	Same	Identical
User Controls	Push Button	Two Push Buttons:On/Off and IntensityDown/Up	Does not affectsafety andeffectiveness
OperatingModes	OFFON/Set intensity level	Same	Identical
InteractiveDisplay	Five flashing LED settingindicators (green), 2second flash period duringnormal operation. Oneflashing low battery LEDindicator (red), 4 secondflash period alternatingwith setting LED when inLow Battery operation	Blue LED logo pulsingmeans device isproviding therapy.Ten diagonal blueLED bars indicatetherapy power level.Four circular blueLED segments indicatebattery charge level.	Does not affectsafety andeffectiveness
Display FaceLocation	Ventral side	Dorsal side	Does not affectsafety andeffectiveness
OutputWaveform	Asymmetric biphasicpulses.Ramp up, constant andramp down phases.	Same	Identical
Peak pulseamplitude	Five discrete levelsbetween 10-40 mA(nominal), set by intensityselection; nominallyconstant current, +/-10%at nominal conditions	Ten discrete levelsbetween 8-40 mA(nominal), set byintensity selection;nominally constantcurrent, +/-10% atnominal conditions	Similar
Pulsefrequency	Fixed at 31 Hz (32millisecond period).	Same	Identical
Amplitudemodulationcycle	Single cycle	Same	Identical
MaximumChargeDelivered(500 Ω2 load)	Approximately 3.1microcoulombs (max. 3.56microcoulombs including15% output tolerance)	Same	Identical
Electrodes	Two gold-plated copper,nickel or zinc	Two hypoallergenicsurgical grade (316L)stainless steel contacts	Previously clearedmaterial. Does notadversely impactsafety and/oreffectiveness
Device StatusIndicators	Five separate greenflashing LEDs indicate 5intensity levels. Selectionof the intensity level isperformed via apushbutton located on theuser display. A sixthblinking LED is used todisplay the low batteryindicator.	Ten Intensity levelLEDS are arranged ina single line. Selectionof the intensity level isperformed via apushbutton on the edgeof the face. Batterycharge indicatorprovides 4 chargelevels and a red	Does not affectsafety andeffectiveness
Power	3V, CR2025 Lithium coincells only, replaceable.	Rechargeable 40 mALi-Ion Polymer (maxcapacity 50 mA)	Conforms to IEC62133 standard.
Regulation ofStimulusoutput withdecreasingbatteryvoltage	Regulation is ± 5% ofnominal output. Devicestops stimulation whenregulation cannot bemaintained (device turnsitself off).	Same	Identical
Battery life	150 hours continuous orintermittent use whentwo 3V CR2025 used.	Approximately threeyears or 500 chargecycle	Does not adverselyimpact safetyand/oreffectiveness
Low batterywarning	Low battery indicatorflashes whenapproximately 10% ofbattery life remains	When battery levelregisters 15% or less, asingle LED segmentwill switch from staticblue to flashing red	Does not adverselyimpact safetyand/oreffectiveness
Wrist band	Contains latex	Latex free	Conforms to ISO10993 standard

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Performance Specifications

The performance specifications for the ReliefBand® 2.0 device are substantially equivalent to the predicate device. ReliefBand 2.0 was tested to the following standard:

ISO 14971: Medical Devices Application of Risk Management to Medical Devices -

Conclusion:

A comparison of the technological characteristics of the ReliefBand® 2.0 and the predicate device ReliefBand® 1.5 was performed. The results of the comparison demonstrate that the ReliefBand® 2.0 device is substantially equivalent to the marketed predicate device.

Regulation Number and Section

§ 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).