The ReliefBand® device is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.

Device Description

The ReliefBand® Device Models RB-DL, RB-EL, and RB-RL are non-invasive devices which are indicated for over the counter use in the relief of nausea and vomiting (NV) due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy. The devices are contained within a wristband, and provide relief 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® device Model RB-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® device Model RB-xL family is powered by two 3V lithium batteries. The batteries are not user replaceable in the disposable device model RB-DL, but are user replaceable in the reusable device models RB-EL and RB-RL. The battery life for all models is specified to be 150 hours when used at setting 3.

AI/ML Overview

Here's an analysis of the provided text regarding the ReliefBand® Device, specifically addressing the requested information:

The provided document (KO20180) is a 510(k) submission for the ReliefBand® Device Models RB-DL, RB-EL, and RB-RL. It aims to demonstrate substantial equivalence to previously cleared predicate devices. Crucially, this submission does not contain specific acceptance criteria, performance data, or detailed study results for the new devices. Instead, it relies on the previously cleared predicate devices for performance validation.

Therefore, many of the requested categories cannot be directly answered from the provided text.

Acceptance Criteria and Device Performance

Since the entire submission is based on demonstrating substantial equivalence to predicate devices, there are no specific acceptance criteria defined or reported for the new devices (RB-DL, RB-EL, RB-RL) in this document.

The document states:

"The performance data indicate that the ReliefBand® Device Models RB-DL, RB-EL, and RB-RL are substantially equivalent to the predicate ReliefBand® Devices distributed under K982967 and K994387."
"Woodside Biomedical, Inc. has demonstrated through its evaluation of the ReliefBand® Device Models RB-DL, RB-EL, and RB-RL that the devices are equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness."

This means the acceptance criteria and performance were implicitly met by demonstrating "substantial equivalence" to the predicate devices, which had previously undergone their own testing and established performance. The document doesn't provide what those criteria were for the predicate, nor how the new device's performance directly compared against them.

Detailed Breakdown of Study Information:

Due to the nature of this 510(k) submission (substantial equivalence to a predicate device rather than de novo clinical trials for the new models), much of the requested information regarding study details is not available in the provided text. The performance data section explicitly states that the performance data indicate substantial equivalence, but it does not provide the performance data itself for the new devices, nor the specifics of the studies that generated it. Instead, it refers back to the predicate devices' clearance numbers.

Here's what can be inferred or explicitly stated based on the document:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in this document for the new device models. The implied criterion is "substantial equivalence" to the predicate devices.
- Reported Device Performance: Not explicitly stated in this document for the new device models. The document only claims "substantial equivalence" to the predicate devices regarding performance.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the document. The document does not describe direct testing on the new models (RB-DL, RB-EL, RB-RL) that would involve a "test set" in the context of clinical performance. The focus is on demonstrating technological equivalence to previously cleared devices.
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/Not provided. As no new test set/clinical study is described for the performance of the new models, there's no mention of experts establishing ground truth within this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No new test set or adjudication process is described in this submission.
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 ReliefBand® is a transcutaneous nerve stimulator for nausea relief, not an AI-assisted diagnostic device. This type of study is irrelevant to this device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The ReliefBand® is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated for the new models. For the predicate devices, the "ground truth" for efficacy would likely have been patient-reported symptom relief (outcomes data) or a reduction in objectively measured nausea/vomiting episodes in clinical trials. However, this document does not detail those studies.
The sample size for the training set:
- Not applicable/Not provided. As this is not an AI/algorithm-based device, there is no "training set."
How the ground truth for the training set was established:
- Not applicable/Not provided. No training set is involved.

Summary

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KOZO190

510(k) SUMMARY MAR 2 1 2002 Woodside Biomedical Inc. ReliefBand® Device Models RB-DL, RB-EL, and RB-RL

SUBMITTER INFORMATION

A.	Company Name:	Woodside Biomedical, Inc.
B.	Company Address:	1915 Aston AvenueCarlsbad, 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:	January 16, 2002

DEVICE IDENTIFICATION

A.	Classification Name:	Transcutaneous Nerve Stimulator
B.	Trade/Proprietary Name:	ReliefBand® Device
C.	Classification:	Class II (21 CFR 882.5890)
D.	Product Code:	GZJ

IDENTIFICATION OF PREDICATE DEVICE

The Woodside Biomedical, Inc. ReliefBand® device Models RB-DL, RB-EL, and RB-RL are of comparable type and are substantially equivalent to the following predicate devices:

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Predicate Device	Manufacturer	510(k) No.	Date Cleared
ReliefBand® DeviceModels RB-2, RB-6,and RB-R (OTC)	Woodside Biomedical, Inc.	K982967	February 23, 1999
ReliefBand® DeviceModels WB-2L,WB-6L, and WB-RL(Rx)	Woodside Biomedical, Inc.	K994387	March 16, 2000

DEVICE DESCRIPTION

The ReliefBand® device Model RB-xL family is powered by two 3V lithium batteries. The batteries are not user replaceable in the disposable device model RB-DL, but are user

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replaceable in the reusable device models RB-EL and RB-RL. The battery life for all models is specified to be 150 hours when used at setting 3.

INDICATIONS FOR USE

The ReliefBand® Devices are indicated for over the counter use in the relief of nausea and vomiting (NV) due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the ReliefBand® Device and the predicate device has been performed. The results of this comparison demonstrate that the ReliefBand® Device is equivalent to the marketed predicate device. The differences between the ReliefBand® Device Models RB-DL, and RB-RL and RB-RL and the predicate models are insignificant and do not affect the safety or effectiveness of the device.

PERFORMANCE DATA

The performance data indicate that the ReliefBand® Device Models RB-DL, RB-EL, and RB-RL are substantially equivalent to the predicate ReliefBand® Devices distributed under K982967 and K994387.

CONCLUSIONS

Woodside Biomedical, Inc. has demonstrated through its evaluation of the ReliefBand® Device Models RB-DL, RB-EL, and RB-RL that the devices are equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2002

Woodside Biomedical,Inc. C/O Carol L. Patterson Patterson Consulting Group 21911 Erie Lane Lake Forest, California 92630

Re: K020180

Trade/Device Name: ReliefBand® Device Models RB-DL, RB-EL and RB-RL Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: January 17, 2002 Received: January 18, 2002

Dear Ms. Patterson:

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. Iisting 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 (PMA), 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 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); good manufacturing practice requirements as set

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Page 2 – Ms. Carol L. Patterson

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your your finding of substantial equivalence of your device to a legally premation fouried.com "Theesults 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 11 you desire specific acrise for for in vitro diagnostic devices), please contact the Office of additionally 21 Of IC For at 659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-6639 Compliance at (301) 594-4639. Also, please note the your do roos, pitted, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regaration on information on your responsibilities under the Act may be obtained from the Oinor gonetal intornational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Millison

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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OTC INDICATIONS FOR USE

510(k) Number:

KO20180 (To Be Assigned By FDA)

Device Name:

ReliefBand® Device Models RB-DL, RB-EL, and RB-RL

Indications For Use:

The ReliefBand® device is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ OR Over-The-Counter Use $\boxed{\checkmark}$

(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative
and Neurological Devices

Confidential K020180
510(k) Number __25 1-16-02

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).