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

Device Description

The ReliefBand® NST™ Device Models WB-2L, WB-6L, and WB-RL 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, and pregnancy. The ReliefBand ® NST™ Device is indicated as an adjunct to antiemetics in reducing postoperative nausea (PON). The devices are contained within a wristband, and provide relief of NV and PON 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 Model WB-xL family 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.

The ReliefBand™ NST™ device Model WB-xL family is powered by two commercially available 3V lithium batteries. These batteries are not user replaceable in the disposable 2 day (WB-2L) and 6 day (WB-6L) devices, but are user replaceable in the Reusable device (WB-RL). The battery life for the 2 day device is specified to be 50 hours when used at setting 3. The battery life for the 6 day and Reusable devices is specified to be 150 hours when used at setting 3.

AI/ML Overview

The acceptance criteria and study that proves the device meets the acceptance criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices (ReliefBand® NST™ Models WB-2, WB-6, and WB-R (K982436 and K983907))	The ReliefBand® NST™ Device Models WB-2L, WB-6L, and WB-RL are of comparable type and are substantially equivalent to the predicate ReliefBand® NST™ device and demonstrate equivalent technological characteristics. Performance data indicates substantial equivalence.
Intended Indications for Use	Indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy. Indicated as an adjunct to antiemetics in reducing postoperative nausea (PON).
Battery Life (Model WB-2L)	50 hours when used at setting 3
Battery Life (Model WB-6L and WB-RL)	150 hours when used at setting 3

2. Sample Sizes Used for the Test Set and Data Provenance

The provided document does not describe a new clinical study with a "test set" in the traditional sense for evaluating the ReliefBand™ NST™ Model WB-xL family. Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K982436 and K983907). This means the "provenance" of the data for this submission is historical, relying on the data that supported the clearance of the predicate devices.

Sample Size for Test Set: Not applicable, as no new clinical test set with human subjects is described for the WB-xL family. The submission refers to "performance data" but does not specify a distinct new study or sample size for this specific family of devices.
Data Provenance: The data provenance for demonstrating equivalence would stem from the studies and data submitted for the predicate devices (K982436 and K983907), which are not detailed in this document. The current submission is a retrospective comparison to existing cleared devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. As this submission relies on substantial equivalence to predicate devices, there's no mention of a new test set requiring expert ground truth establishment for this specific submission. The expertise would have been part of the original predicate device clearances.

4. Adjudication Method for the Test Set

Not applicable. No new test set or clinical study with human observations requiring adjudication is described for this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned or described in the provided document. The submission focuses on substantial equivalence based on technological characteristics and existing performance data from predicate devices, not on comparing human reader performance with or without AI assistance. The device in question is a nerve stimulation device, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The ReliefBand™ NST™ is a physical medical device for nerve stimulation, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant to this submission.

7. The Type of Ground Truth Used

The "ground truth" for this submission is effectively the established safety and effectiveness profile of the predicate devices (ReliefBand® NST™ Models WB-2, WB-6, and WB-R, cleared under K982436 and K983907). The argument is that the new devices are so similar in design and function that they inherently share the same "truth" of efficacy and safety as the predicates.

8. The Sample Size for the Training Set

Not applicable. The ReliefBand™ NST™ is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model.

Summary of the Study Proving Acceptance Criteria:

The document describes a 510(k) premarket notification for the ReliefBand™ NST™ Device Models WB-2L, WB-6L, and WB-RL. The acceptance criterion for these devices is substantial equivalence to legally marketed predicate devices: ReliefBand® NST™ Models WB-2, WB-6, and WB-R (cleared under K982436 and K983907).

The study proving this acceptance criterion is a comparison of technological characteristics and performance data between the new devices and the predicate devices. The submission asserts that the new models are "of comparable type" and have equivalent technological characteristics to the predicates. While the detailed performance data itself is not provided in this excerpt, the submission explicitly states that "The performance data indicate that the ReliefBand® NST™ Device Models WB-2L, WB-6L, and WB-RL are substantially equivalent to the ReliefBand® Devices distributed under K982436 and K983907." This statement, along with the detailed device description, forms the basis of their claim for substantial equivalence, which the FDA concurred with. The battery life specifications for the new models indicate that they meet pre-defined performance metrics, but these are part of the overall demonstration of equivalence, not a standalone clinical trial.

Summary

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MAR 1 6 2000

K99438 WOODSIDE BIOMEDICAL, INC.
ReliefBand™ NSTT™ Model WB-xL Family
Original Premarket 510(k) Notification

10F3

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

SUBMITTER INFORMATION

A	Company Name:	Woodside Biomedical, Inc.
B.	Company Address:	1915 Aston Avenue, Suite 102Carlsbad, CA 92008
C.	Company Phone:Company Fax:	(760) 804-6900(760) 804-6925
D.	Contact Person:	Tom GreyVice-President of ProductDevelopmentWoodside Biomedical, Inc.
E.	Date Summary Prepared:	December 19, 1999

DEVICE IDENTIFICATION

A.	Generic Device Name:	Nerve Stimulation Therapy Device
B.	Trade/Proprietary Name:	ReliefBand® NSTTM (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,	Woodside Biomedical, Inc.	K982436	October 8, 1998
Models WB-2,		K983907	December 9, 1999
WB-6, and WB-R

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WOODSIDE BIOMEDICAL, INC. RelietBand™ NST™ Model WB-xL Family Original Premarket 510{k) Notification

20F3

DEVICE DESCRIPTION

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WOODSIDE BIOMEDICAL, INC ReliefBand™ NSTTM Model WB-xL Family Original Premarket 510(k) Notification

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SUBSTANTIAL EQUIVALENCE

The Woodside Biomedical, Inc. ReliefBand® NST™ device Models WB-2L, WB-6L, and WB-RL are of comparable type and are substantially equivalent to the predicate ReliefBand® NST™ device Models WB-2, WB-6, and WB-R (K982436 and K983907).

INDICATION FOR USE

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.

PERFORMANCE DATA

The performance data indicate that the ReliefBand® NST™ Device Models WB-2L, WB-6L, and WB-RL are substantially equivalent to the ReliefBand® Devices distributed under K982436 and K983907.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on a circular seal. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 2000

Woodside Biomedical, Inc. Ms. Carol L. Patterson c/o Patterson Consulting Group 21911 Erie Lane Lake Forest, California 92630

Re: K994387

Trade Name: ReliefBand® NST™ Device Models WB-2L, WB-6L, WB-RL Regulatory Class: II Product Code: GZJ and BWK Dated: December 24, 1999 Received: December 28, 1999

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 control provisions of the Act. The general control 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.

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.

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Page 2 - Ms. Carol L. Patterson

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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

i. W. R.P. Ogden

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:	K994387 (To Be Assigned By FDA)
Device Name:	ReliefBand® NST™ Device Models WB-2L, WB-6L, andWB-RL
Indications For Use:	The ReliefBand® NST™ Device is indicated for use in thetreatment of nausea and vomiting (NV) due tochemotherapy, motion sickness, and pregnancy. TheReliefBand® NST™ Device is indicated as an adjunct toantiemetics in reducing postoperative nausea (PON).

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

NRO for cmo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K994387

× Prescription Use

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

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).