(79 days)
Not Found
No
The description focuses on electrical stimulation and user-controlled intensity levels, with no mention of AI or ML technologies.
Yes
The device is indicated for use in the treatment of nausea and vomiting, which are medical conditions, and provides relief through electrical stimulation, fitting the definition of a therapeutic device.
No
Explanation: The device is described as a "non-invasive nerve stimulation therapy device" used for the "treatment of nausea and vomiting." It applies electrical stimulation to nerves in the wrist to relieve symptoms, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components such as a wristband, LEDs, a pushbutton, and batteries, and describes the electrical stimulation mechanism.
Based on the provided text, the ReliefBand® NST™ Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves analyzing blood, urine, tissue, or other bodily fluids or samples to provide information about a person's health.
- The ReliefBand® NST™ Device is a non-invasive nerve stimulation therapy device. It works by applying electrical stimulation to the nerves in the wrist to treat nausea and vomiting. It does not involve the collection or analysis of any bodily specimens.
The description clearly states its mechanism of action is electrical stimulation applied externally to the wrist, which is a therapeutic intervention, not a diagnostic test performed on a sample.
N/A
Intended Use / 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. The ReliefBand® NST™ Device is indicated as an adjunct to antiemetics in reducing postoperative nausea (PON).
Product codes (comma separated list FDA assigned to the subject device)
GZJ, BNK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 102 |
| Carlsbad, CA 92008 | ||
| C. | Company Phone: | |
| Company Fax: | (760) 804-6900 | |
| (760) 804-6925 | ||
| D. | Contact Person: | Tom Grey |
| Vice-President of Product | ||
| Development | ||
| Woodside 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 Stimulation |
| Therapy) 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 |
1
WOODSIDE BIOMEDICAL, INC. RelietBand™ NST™ Model WB-xL Family Original Premarket 510{k) Notification
20F3
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.
2
WOODSIDE BIOMEDICAL, INC ReliefBand™ NSTTM Model WB-xL Family Original Premarket 510(k) Notification
3 of 5
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
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).
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.
3
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.
4
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
5
INDICATIONS FOR USE
| 510(k) Number: | K994387 (To Be Assigned By FDA) |
|---|---|
| Device Name: | ReliefBand® NST™ Device Models WB-2L, WB-6L, and |
| WB-RL | |
| 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. The | |
| ReliefBand® NST™ Device is indicated as an adjunct to | |
| antiemetics 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
OR
× Prescription Use
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)