RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL

• K Number: K020180
• Device Name: RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL
• Manufacturer: WOODSIDE BIOMEDICAL, INC.
• Date Cleared: 2002-03-21 ( 62 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K982967 , K994387

Intended 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.

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.

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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.

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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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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."

9. How the ground truth for the training set was established:

   • Not applicable/Not provided. No training set is involved.

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).