(21 days)
Not Found
No
The device description details fixed operating modes and intensity levels selected by the user, with no mention of adaptive algorithms, learning, or data processing that would indicate AI/ML.
Yes
The device is indicated for use in the treatment of nausea and vomiting, which qualifies it as a therapeutic device.
No
The device is indicated for use in the treatment of nausea and vomiting, not for diagnosis.
No
The device description clearly states it is a "non-invasive nerve stimulation therapy device" contained within a "wristband" that provides "electrical stimulation." It also mentions being "powered by either three silver oxide batteries or three zinc-air batteries." These are all descriptions of hardware components, not software.
Based on the provided information, the ReliefBand is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The ReliefBand is a non-invasive device that provides electrical stimulation to the wrist. It does not analyze any biological samples.
- The intended use is for the treatment of nausea and vomiting. IVD devices are used for diagnosis, monitoring, or screening, not for direct treatment.
- The device description clearly states it's a "non-invasive nerve stimulation therapy device." This aligns with a therapeutic device, not a diagnostic one.
Therefore, the ReliefBand falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ReliefBand is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
73BWK, GZJ
Device Description
The ReliefBand® Model SW-111 is a non-invasive nerve stimulation therapy device, and is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy. The device is contained within a wristband, and provides relief of NV through electrical stimulation of the P6 acupuncture area on the patient's wrist.
This acustimulation wrist band can be worn on either hand on the ventral or palmar (i.e., inside) surface of the wrist, approximately 2-3 fingers breadth above the distal skin crease of the wrist joint between the tendons of the palmaris longus and flexor carpi radialis muscles.
There are three operating modes based on pulse amplitude modulation scheme:
- Mode A: 2 second burst, 6 seconds off. This is the first setting in the 3 mode sequence.
- Mode B: 4 second burst. continuous. This is the second setting in the 3 mode sequence.
- Mode C: 2 second burst, continuous. This is the third setting in the 3 mode sequence.
There are six intensity levels present for each of the three operating modes, and the intensity setting determines the strength of the stimulation. The user display on the wristband identifies both the operating mode and intensity level, so the patient can select the desired stimulation. The wristband is powered by either three silver oxide batteries (type 392/IEC SR41, 1.5 V), or three zinc-air batteries (type 312/IEC PR41, 1.4V), and should not be immersed in water.
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 meets the functional requirements and specifications of devices used for acustimulation of the P6 point.
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
K 980333
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 19: FEB 1 8 1998
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 19.1
| a. | Company Name: | Woodside Biomedical, Inc. |
|---|---|---|
| b. | Company Address: | 1132 San Marino Dr. |
| San Marcos, CA 92069 | ||
| c. | Company Phone: | (760) 761-0907 |
| Company Fax: | (760) 761-0535 | |
| d. | Contact Person: | Tom Grey |
| Vice-President of Product | ||
| Development | ||
| Woodside Biomedical, Inc. | ||
| e. | Date Summary Prepared: | January 26, 1998 |
19.2. DEVICE IDENTIFICATION
| a. | Trade/Proprietary Name: | ReliefBand |
|---|---|---|
| b. | Classification: | Class II |
- Product Code: 73BWK C.
IDENTIFICATION OF PREDICATE DEVICE 19.3
| Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| ReliefBand | Maven Laboratories | K961050 | August 1, 1997 |
1
19.4 DEVICE DESCRIPTION
The ReliefBand® Model SW-111 is a non-invasive nerve stimulation therapy device, and is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy. The device is contained within a wristband, and provides relief of NV through electrical stimulation of the P6 acupuncture area on the patient's wrist.
This acustimulation wrist band can be worn on either hand on the ventral or palmar (i.e., inside) surface of the wrist, approximately 2-3 fingers breadth above the distal skin crease of the wrist joint between the tendons of the palmaris longus and flexor carpi radialis muscles.
There are three operating modes based on pulse amplitude modulation scheme:
- 2 second burst, 6 seconds off. This is the first setting in the 3 mode Mode A: sequence.
- Mode B: 4 second burst. continuous. This is the second setting in the 3 mode sequence.
- 2 second burst, continuous. This is the third setting in the 3 mode Mode C: sequence.
There are six intensity levels present for each of the three operating modes, and the intensity setting determines the strength of the stimulation. The user display on the wristband identifies both the operating mode and intensity level, so the patient can select the desired stimulation. The wristband is powered by either three silver oxide batteries (type 392/IEC SR41, 1.5 V), or three zinc-air batteries (type 312/IEC PR41, 1.4V), and should not be immersed in water.
2
19:5 SUBSTANTIAL EQUIVALENCE
The Woodside Biomedical, Inc. ReliefBand is of comparable type and is equivalent to the predicate Maven ReliefBand (K961050).
INTENDED USE 19.6
The ReliefBand is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy.
19.7 TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the predicate and legally marketed devices has been performed. The results of this comparison demonstrate that the ReliefBand is equivalent to the marketed predicate device.
19.8 PERFORMANCE DATA
The performance data indicate that the ReliefBand meets the functional requirements and specifications of devices used for acustimulation of the P6 point.
19.9 510(K) CHECKLIST
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist has been provided in this submission.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract bird or wave-like form.
FEB 1 8 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol L. Patterson Consultant for Woodside Biomedical Inc. Patterson Consulting Group, Inc. 18140 Smokesignal Drive San Diego, California 92127
Re: K980333 ReliefBand® Trade Name: Regulatory Class: II Product Codes: GZJ and BWK Dated: January 27, 1998 January 28, 1998 Received:
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. ಗಿ 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.
4
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 requlation (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
5
INDICATIONS FOR USE
| 510(k) Number: | To Be Assigned By FDA |
|---|---|
| Device Name: | ReliefBand |
| Indications For Use: | The ReliefBand is indicated for use in the treatment of |
| nausea and vomiting (NV) due to chemotherapy, motion | |
| sickness, and pregnancy. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Adee
Division (Sign-Off)
Division of General Restorative Devices
510(k) Number L480333
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
JANUARY 26, 1998
. . .