RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R

K982436 · Woodside Biomedical, Inc. · GZJ · Oct 8, 1998 · Neurology

Device Facts

• Record ID: K982436
• Device Name: RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R
• Applicant: Woodside Biomedical, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Oct 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

ReliefBand® NST™ (Models WB-2, WB-6, WB-R) is a non-invasive nerve stimulation therapy device worn on the wrist. It delivers electrical stimulation to nerves located between the palmaris longus and flexor carpi radialis tendons. The device features a single dial for user-controlled peak pulse amplitude adjustment, allowing selection of stimulation intensity. An LED indicator displays operating status (green flash) and low battery (red flash). Powered by two 3V lithium batteries; WB-2 and WB-6 are disposable with non-replaceable batteries, while WB-R is reusable with replaceable batteries. Patients operate the device by selecting intensity levels to alleviate nausea and vomiting symptoms. The device provides a non-pharmacological treatment option for patients suffering from NV associated with chemotherapy, motion sickness, pregnancy, or AIDS therapy.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on performance data indicating equivalence to the predicate device (K980333).

Technological Characteristics

Non-invasive nerve stimulation device. Wrist-worn form factor. Powered by two 3V lithium batteries. Single-dial control for peak pulse amplitude adjustment. LED status indicator. Models vary by intensity settings (3 to 5 levels), reusability, and battery life. No specific materials or software algorithms described.

Indications for Use

Indicated for treatment of nausea and vomiting due to chemotherapy, motion sickness, pregnancy, and AIDS-related therapy. For use by patients experiencing these conditions.

Regulatory Classification

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.

Predicate Devices

• ReliefBand, Model SW-111 (K980333)

Submission Summary (Full Text)

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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 102<br>Carlsbad, CA 92008 |
| C. | Company Phone: | [phone]<br>Company Fax: [phone] |
| D. | Contact Person: | Tom Grey<br>Vice-President of Product<br>Development<br>Woodside 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 Stimulation<br>Therapy) Device |
| C. | Classification: | Class II |
| D. | Product Code: | GZJ and BWK |

### IDENTIFICATION OF PREDICATE DEVICE

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

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#### DEVICE DESCRIPTION

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. These features are summarized in Table 1:

| | WB-2<br>(2-Day, Disposable) | WB-6<br>(6-Day, Disposable) | WB-R<br>(Reusable) |
|-----------------------------------------------------------|-----------------------------|-----------------------------|--------------------|
| Identification of<br>discrete impulse<br>intensity 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

1. P

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)

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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 .........................................................................................................................................................