The ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are non-invasive nerve stimulation therapy devices, and are indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, pregnancy, and therapy related to acquired immune deficiency syndrome (AIDS). The devices are contained within a wristband, and provide relief of nausea and vomiting through electrical stimulation of the nerves in the patient's wrist.

The devices can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists. approximately 2 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® NST™ Device Models WB-2, WB-6, and WB-R have a single dial for setting the stimulation , and incorporate an LED which is used to display a normal operating condition (green color at a slow flash rate) and a low battery condition (red color at a faster flash rate).

All three models have a single operating mode, controlled by a single dial, which controls the peak pulse amplitude of the electrical impulse and thereby determines the intensity of the stimulation. The three models vary by (1) the number of intensity settings available to the user, (2) whether or not the device is reusable, and (3) the length of time that the batteries will last.

AI/ML Overview

The provided text describes a 510(k) submission for the ReliefBand® NST™ Device. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new, independent clinical studies to establish acceptance criteria and prove device performance against those criteria in the same way a PMA (Pre-Market Approval) would.

Based on the provided document:

A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner (e.g., a specific percentage reduction in nausea, or a specific statistical significance level). Instead, it states that the performance data "indicate that the ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are substantially equivalent to the ReliefBand® Devices distributed under K980333." This indicates that the acceptance criterion for this 510(k) was substantial equivalence to the predicate device (ReliefBand, Model SW-111, K980333). The reported device performance is that it meets this criterion of substantial equivalence.
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 provide details on a specific test set, its sample size, or data provenance. The 510(k) submission relies on demonstrating equivalence through technological characteristics and existing performance data (likely from the predicate device or a combination of bench testing and prior clinical understanding of similar devices), rather than new human clinical trials with defined test sets.
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 clinical study with a defined "test set" requiring expert ground truth establishment for a diagnostic or AI algorithm is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study with a defined "test set" requiring adjudication for a diagnostic or AI algorithm is described.
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. The device is a nerve stimulation therapy device, not an AI-based diagnostic tool requiring human reader comparison.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical device for nerve stimulation, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of a new clinical study. The "ground truth" for this 510(k) submission is the performance and safety profile of the predicate device, against which the new devices are deemed "substantially equivalent."
The sample size for the training set
Not applicable, as this is not an AI algorithm requiring a training set.
How the ground truth for the training set was established
Not applicable, as this is not an AI algorithm requiring a training set.

Summary of Acceptance Criteria and Device Performance (Based on 510(k) Framework):

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (ReliefBand, Model SW-111, K980333) in:	The performance data indicate that the ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are substantially equivalent to the predicate ReliefBand® Devices distributed under K980333. This equivalence is based on:
- Technological Characteristics	"A comparison of the technological characteristics of the ReliefBand® NST™ Device and the predicate device has been performed. The results of this comparison demonstrate that the ReliefBand® NST™ Device is equivalent to the marketed predicate device."
- Intended Use	The Indications for Use are identical: "treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, pregnancy, and therapy related to acquired immune deficiency syndrome (AIDS)." (Note: The final clearance letter from FDA omits "therapy related to acquired immune deficiency syndrome (AIDS)" in the Indications for Use, which is not reflected in the applicant's submission but is typically the cleared indication.)
- Safety and Effectiveness	Implied through the substantial equivalence determination, meaning the new devices present no new questions of safety or effectiveness compared to the predicate.

Study Details:

The document describes a 510(k) premarket notification rather than a clinical study designed to establish acceptance criteria and prove device performance through new data. The primary "study" is a comparison to a predicate device (ReliefBand, Model SW-111, K980333) to demonstrate substantial equivalence.

Sample Size and Data Provenance: Not explicitly detailed for a new clinical test set. The submission relies on existing data and comparisons to the predicate device's established performance.
Experts and Ground Truth: Not applicable for establishing new ground truth for a diagnostic test set in this context.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not applicable (device is a treatment, not an AI diagnostic).
Standalone Performance: The devices are standalone nerve stimulation devices; their performance is assessed in comparison to the predicate's known performance.
Type of Ground Truth: The "ground truth" in 510(k) is the established safety and effectiveness of the predicate device.
Training Set Sample Size and Ground Truth: Not applicable, as this is not an AI algorithm.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS Woodside Biomedical Inc. ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R

K982436

SUBMITTER INFORMATION

A.	Company Name:	Woodside Biomedical, Inc.
B.	Company Address:	1915 Aston Avenue, Suite 102Carlsbad, CA 92008
C.	Company Phone:	(760) 804-6900Company Fax: (760) 804-6925
D.	Contact Person:	Tom GreyVice-President of ProductDevelopmentWoodside Biomedical, Inc.
E.	Date Summary Prepared:	July 7, 1998

DEVICE IDENTIFICATION

A.	Generic Device Name:	Nerve Stimulation Therapy Device
B.	Trade/Proprietary Name:	ReliefBand® NST™ (Nerve StimulationTherapy) Device
C.	Classification:	Class II
D.	Product Code:	GZJ and BWK

IDENTIFICATION OF PREDICATE DEVICE

Device	Manufacturer	510(k) No.	Date Cleared
ReliefBand,Model SW-111	Woodside Biomedical, Inc.	K980333	February 18, 1998

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DEVICE DESCRIPTION

	WB-2(2-Day, Disposable)	WB-6(6-Day, Disposable)	WB-R(Reusable)
Identification ofdiscrete impulseintensity levels	Level 1	Level 1	Level 1
		Level 1.5	Level 1.5
	Level 2	Level 2	Level 2
		Level 2.5	Level 2.5
	Level 3	Level 3	Level 3

TABLE 1

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The user dial on the WB-2, WB-6, and WB-R devices identifies the intensity level, so the patient can select the desired stimulation easily. All models are powered by two 3V lithium batteries. The batteries in Models WB-2 and WB-6 are not user replaceable. The batteries in Model WB-R are user replaceable and are commercially available. Battery life for the three models is as follows:

Model WB-2: approximately 2 days (48 hours) on level 2; batteries not replaceable. ●
Model WB-6: approximately 6 days (144 hours) on level 2; batteries not replaceable. .
Model WB-R: approximately 6 days (144 hours) on level 2 before the batteries need . to be replaced.

SUBSTANTIAL EQUIVALENCE

The Woodside Biomedical, Inc. ReliefBand® NST™ devices, Models WB-2, WB-6, and WB-R devices are of comparable type and are substantially equivalent to the predicate ReliefBand®, Model SW-111 (K980333).

INDICATION FOR USE

The ReliefBand NST™ Device is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, pregnancy, and therapy related to acquired immune deficiency syndrome (AIDS).

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the ReliefBand® NST™ Device and the predicate device has been performed. The results of this comparison demonstrate that the ReliefBand® NST™ Device is equivalent to the marketed predicate device.

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PERFORMANCE DATA

The performance data indicate that the ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are substantially equivalent to the ReliefBand® Devices distributed under K980333.

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Image /page/4/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.

8 1998 OCT

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol L. Patterson Patterson Consulting Group Consultant for Woodside Biomedical, Inc. 18140 Smokesignal Drive San Diego, California 92127

Re: K982436 Trade Name: ReliefBand® NST™ Device Models WB-2, WB-6, WB-R Regulatory Class: II Product Codes: GZJ and BWK Dated: July 13, 1998 Received: July 14, 1998

Dear Ms. Patterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Carol L. Patterson

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and

Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number: K982436

Devicc Name:

ReliefBand® NST™ Device Models WB-2. WB-6, and WB-R

Indications For Use:

The ReliefBand® NST™ Device is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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Division of General Restorative Devices K982436
510(k) Number

Prescription Use (Pcr 21 CFR 801.109)

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Over The-Counter Use .........................................................................................................................................................

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).