(79 days)
ReliefBand(R) is indicated for use in the treatment of nausea, vomiting associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy. ReliefBand is also indicated as an adjunct to antiemetics in reducing postoperative nausea. For over the counter use.
ReliefBand® models 1.5 and 2.0 are battery-powered non-invasive digital therapeutic devices that are worn on the wrist like a watch. They are indicated for the counter use in the relief of mild to moderate nausea and retching associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness associated with pregnancy as an adjunct to antiemetics in reducing mild to moderate postoperative nausea.
ReliefBand 1.5 and 2.0 include two electrical contacts on the back of the device (ReliefBand 1.5) or on the clasp (ReliefBand 2.0), which must be placed firmly against the underside of the wrist at the P6 location (approximately two fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles). The electrodes provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist.
The ReliefBand device has a user display that includes a five-level (ReliefBand 1.5) or 10-level (ReliefBand 2.0) LED that indicates the signal intensity. The patient can easily select the pulse amplitude of the electrical impulse and control the intensity of the stimulation via a pushbutton located on the face of the devices. A low battery indicator LED is also included on the face of the devices. ReliefBand 1.5 uses disposable batteries while ReliefBand 2.0 has a lithium-ion rechargeable battery. A fully charged battery will last for up to 18 hours of continuous use at the mid-power level or below.
This FDA 510(k) summary for ReliefBand 1.5 and ReliefBand 2.0 indicates that the devices are substantially equivalent to their predicate devices (ReliefBand 1.5 K173233 and ReliefBand 2.0 K182960). The submission does not include a study proving that the device meets specific acceptance criteria based on performance because the claim for substantial equivalence is based on the lack of changes to the device's technical characteristics and performance specifications.
Therefore, the requested information regarding acceptance criteria and the study proving the device meets them, including sample sizes, ground truth establishment, expert adjudication, or MRMC studies, is not available in the provided text.
The document explicitly states:
- "The subject and the predicate ReliefBand devices are identical. Only the wording in the indications for use has changed."
- "The are no changes in technical characteristic between the predicate and the subject devices."
- "The performance specifications for the applicant ReliefBand devices are identical, and thus substantially equivalent, to the predicate devices."
- "Substantial equivalence was determined on the basis that there have been no changes in the physical device, technology, mechanism of action or intended use. Device modifications include only the clarified intended use, which includes an additional anticipated source of nausea (physician-diagnosed migraine) that Reliefband is intended to treat. These changes do not impact the safety of efficacy of the ReliefBand 1.5 or ReliefBand 2.0 devices."
This means ReliefBand Technologies LLC is asserting that because the device itself (hardware, technology, mechanism of action, performance specifications) is unchanged from previously cleared devices, no new performance study is required to demonstrate its effectiveness against specific acceptance criteria for this 510(k) submission. The FDA concurred with this assessment for substantial equivalence.
In summary, based on the provided text, the device's substantial equivalence is established by its identity to predicate devices, not by a new clinical or performance study with defined acceptance criteria.
If such a study existed, it would likely have been part of the original 510(k) submissions for the predicate devices (K173233 and K182960).
§ 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).