Reliefband® is a digital therapeutic device indicated for use in the treatment of nausea, retching and vomiting due to motion sickness, morning sickness associated with pregnancy, and chemotherapy. Reliefband® is also indicated as an adjunct to antiemetic therapy in reducing postoperative nausea.

Device Description

The ReliefBand® 1.5 is a non-invasive device that is indicated for the counter use in the relief of mild to moderate nausea, retching 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. This device was originally marketed under its predicate name of Reliefband RB-EL (K020180) when owned by Woodside Biomedical, Inc. The devices are technologically identical. The same contract manufacturer has made this device for decades.

Exactly like its predicate, the Reliefband 1.5 is contained within a wristband, and provides relief of nausea, retching and vomiting through electrical stimulation of the nerves on the ventral side of the patient's wrist. The device can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists, 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 ReliefBand® 1.5 has a user display that incorporates five blinking LEDs which are used to identify the intensity level (5 discrete LEDs, one for each intensity level), so that the patient can easily select the desired stimulation. Selection of the intensity level is performed via a pushbutton located on the user display, which controls the peak pulse amplitude of the electrical impulse and thereby determines the intensity of the stimulation. A sixth blinking LED is used to display the low battery indicator.

AI/ML Overview

The provided document, a 510(k) Summary for the ReliefBand® 1.5 device (K173233), primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific performance acceptance criteria through clinical studies.

The core argument for the ReliefBand® 1.5's acceptance is that it is technologically identical to its predicate device, the Reliefband® RB-EL (K020180). Therefore, the performance and acceptance of the predicate device are directly applied to the new device.

Because the submission relies on substantial equivalence based on technological identity, a new study proving the device meets acceptance criteria similar to what would be done for a novel or significantly modified device is not described.

Here's an analysis of the provided information in the context of your questions:

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

Acceptance Criteria: The document does not explicitly state numerical "acceptance criteria" for performance that the new device had to meet through a new study. Instead, the acceptance criterion is substantial equivalence to the predicate devices. This means the device must perform as safely and effectively as the predicates.
Reported Device Performance: The "Performance Data" section (Section 3) states: "The performance data indicate that the Relief is substantially equivalent to the predicate devices cleared to market via 510(k) #s: K994387 and K020180." This is a declarative statement of equivalence, not a presentation of new performance data from a study of the ReliefBand® 1.5.
The "Technical Characteristics - Substantial Equivalency Table" provides a comparison of specifications between the subject device and the predicate devices (Section 2). This table effectively serves as the "performance data" demonstrating equivalence by showing identical or highly similar technical specifications. For example, Output Range, Waveform Characteristics, Maximum Charge Delivered, Voltage, and Channels are all essentially carried over from the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No new test set or clinical study for performance is described for the ReliefBand® 1.5. The basis for clearance is technological identity and substantial equivalence to existing devices. Therefore, these questions are not applicable to this 510(k) submission.

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)

Not applicable. As no new performance study was conducted or described in this 510(k) summary, there's no mention of experts establishing ground truth for a test set.

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

Not applicable. No new performance study described.

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 device is a transcutaneous electrical nerve stimulator, not an AI-assisted diagnostic tool.

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

Not applicable. This is a hardware device, not an algorithm.

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

Not applicable for new data. The "ground truth" for the ReliefBand® 1.5's effectiveness and safety is implicitly based on the historical performance and regulatory clearance of its technologically identical predicate devices.

8. The sample size for the training set

Not applicable. This isn't an AI/machine learning device. No training set is involved.

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

Not applicable.

In summary, the key takeaway from this 510(k) summary regarding "acceptance criteria" and "proof" is that:

Acceptance Criteria: Substantial equivalence based on technological identity to a legally marketed predicate device (Reliefband® RB-EL, K020180).
Proof: The "study" proving this device meets the acceptance criteria is a comparison of engineering specifications and design features that demonstrates the ReliefBand® 1.5 is the same device as the predicate, merely being re-marketed under new ownership/branding. No new clinical or performance studies were necessary or conducted for this specific submission because the device itself had not changed. The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." based on this argument.

Summary

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510(k) Summary K173233

Contact:	Barbara J. WhitmanRegulatory Affairs ConsultantReliefBand Technologies220 Gibraltar RoadSuite 270Horsham, PA 19044 USAPhone: 908-763-5225Email: whitmanregulatory@gmail.comWeb: www.reliefband.com
Date Prepared:	September 27, 2017
Trade name:	ReliefBand® Device
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
Manufacturer andDistributor:	ReliefBand Technologies220 Gibraltar RoadSuite 270Horsham, PA 19044 USA

Predicate Devices:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
(PRIMARY PREDICATE)ReliefBand® DeviceModels RB-DL, RB-EL,and RB-RL (OTC)	Woodside Biomedical,Inc.	K020180	March 21, 2002
ReliefBand® DeviceModels WB-2L, WB-6L,and WB-RL (Rx)	Woodside Biomedical,Inc.	K994387	March 16, 2000

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Description of the Subject Device

Indications For Use

Technical Characteristics

A comparison of the technological characteristics of the ReliefBand® 1.5 Device family and the predicate devices has been performed. The results of the comparison demonstrate that the ReliefBand® 1.5 is substantially equivalent to the marketed predicate devices. The differences between the ReliefBand® 1.5 and the predicate models are based solely on marketing changes and do not affect the safety or effectiveness of the device. The Reliefband® 1.5 is technologically identical to its previously cleared predicate device Reliefband® RB-EL. (Please see table below).

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Technical Characteristics - Substantial Equivalency Table

PerformanceCharacteristic	Rx Predicate Device (K994387)	OTC Predicate Device RB-xL (K020180)	K173233OTC ReliefBand® 1.5
Indications for Use	The ReliefBand NST Device is indicatedfor use in the treatmentof nausea and vomiting (NV) dueto chemotherapy, motion sickness, andpregnancy. The ReliefBand NST Device isindicated as an adjunct to antiemetics inreducing postoperative nausea (PON)	The ReliefBand Devices are indicated forover the counter use in the relief ofnausea and vomiting (NV) due to motionsickness and for relief of mild tomoderate nausea and vomitingassociated with pregnancy	Reliefband® is a digital therapeuticdevice indicated for use in the treatmentof nausea, retching and vomiting due tomotion sickness, morning sicknessassociated with pregnancy, andchemotherapy. Reliefband® is alsoindicated as an adjunct to antiemetictherapy in reducing postoperativenausea.
Size	Teardrop shape (approximately 1.5" by 2" by 0.45" thick enclosure)
Weight	Approximately 1.2 ounce (34 grams)
OperatingTemperature	10°C to 45°C (50°F to 113°F) (±18% output tolerance at operating extremes)
User Controls	Single push button (membrane keypad)
User Displays	Five flashing LED setting indicators (green), 2 second flash period during normal operation
	One flashing low battery LED indicator (red), 4 second flash period alternating with setting LED when in Low Battery operation
Operating Modes		OFF
PerformanceCharacteristic	Rx Predicate Device (K994387)	OTC Predicate Device RB-xL (K020180)	K173233OTC ReliefBand® 1.5
Output Range(Peak pulse current atnominal, 500 ohmload)	Five discrete levels between 10 mA (± 15%) – 40 mA (± 15%).
Output WaveformCharacteristics(At nominal, 500 Ohmload)	Asymmetric biphasic pulses.Ramp up, constant and ramp down phases.
Maximum ChargeDelivered(Setting 5, charge perpulse at nominal, 500ohm load)	Approximately 3.1 microcoulombs (max. 3.56 microcoulombs including 15% output tolerance)
Maximum OutputVoltage(open circuit, no load)	110 Volts
Output Channels	Two captive electrodes.
Regulation ofStimulus Output withDecreasing BatteryVoltage	Regulation is ± 5% of nominal output. Device stops stimulation when regulation cannot be maintained (device turns itself off).
Battery Life:(Setting 3 at nominal)	150 hours continuous or intermittent use when two 3V CR2025 used.Low battery indicator flashes when approximately 10% of battery life remains.

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Performance Data

The performance data indicate that the Relief anily is substantially equivalent to the predicate devices cleared to market via 510(k) #s: K994387 and K020180.

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Basis for Determination of Substantial Equivalence

Substantial equivalence was determined on the basis that there have been no changes in the mechanism of action, intended use and safety and effectiveness. The technology of the subject device has remained identical to that of its predicates and is therefore substantially equivalent to the predicate devices.

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November 30, 2017

ReliefBand Technologies % Barbara Whitman President Whitman Regulatory Consulting 616 Revere Court Flemington, New Jersey 08822

Re: K173233

Trade/Device Name: ReliefBand 1.5 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: September 27, 2017 Received: October 5, 2017

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Barbara Whitman

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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).