(128 days)
Psi Bands are indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example:
- pregnancy (morning sickness)
- motion sickness
- anesthesia
- chemotherapy.
Psi Bands are intended for over-the-counter use.
Psi Bands, acupressure (pressure stimulation) wrist bands, consist of a plastic orb that applies pressure to the Nei-kuan (P6) acupressure point, the area that provides nausea relief. Psi Bands may be worn on both wrists at the same time and may be adjusted at two areas: 1) around the wrist like a watch, and 2) at the acupressure point by turning a plastic dial clock-wise. The plastic dial allows the user to apply different degrees of pressure at the acupressure point for maximum comfort and effectiveness. Select from one of three settings (mild nausea = low pressure; moderate nausea = medium pressure; troublesome nausea = high pressure). By turning the dial past the highest setting, the dial will automatically return to its neutral, or lowest, setting so that it cannot be overtightened.
Psi Bands are made from synthetic rubber, specifically medical grade Santoprene™ thermoplastic rubber and food grade ABS plastic which does not directly contact the patient after adjustment.
Components of the system include:
Strap and collar made of medical grade Santoprene™ thermoplastic rubber
Button is composed of three parts; the dial, the nut and the ring all made of food grade ABS plastic and which reside inside the button itself which is part of the Santoprene™strap
The Psi Bands 510(k) summary (K070766) indicates that no clinical tests were performed to establish the device's performance against acceptance criteria. Instead, the device's substantial equivalence to a predicate device (Acuband Acupressure Wrist Band Device, K053509) was determined through a comparison of their technical characteristics and non-clinical bench testing.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics. Instead, the focus is on demonstrating equivalence in technical characteristics and performance outputs with the predicate device.
| Feature | Acceptance Criteria (based on predicate device) | Reported Psi Band Performance |
|---|---|---|
| Intended Use | Relief of Nausea Caused by Morning Sickness (pregnancy), Motion Sickness, Anesthesia, and Chemotherapy | Relief of Nausea Caused by Morning Sickness (pregnancy), Motion Sickness, Anesthesia, and Chemotherapy |
| Length | 10.6 inches | 9.33 inches |
| Width | 0.8 inches | 0.6 inches |
| Wrist Circumference Limit | 8.5 inches | 8.25 inches |
| Band Composition | Nylon Hook and loop fabric (VelcroTM) strap, Acrylic Button and a Polypropylene buckle | SantopreneTM thermoplastic rubber and medical grade ABS plastic |
| Pressure Adjustment | Yes, Adjustable | Yes, Adjustable |
| Button Composition | Acrylic Plastic | ABS Plastic Covered by Medical Grade SantopreneTM Thermoplastic |
| Band Elasticity | Non-elastic | Non-elastic |
| Typical Button contact area | 0.12 square inches | 0.13 square inches |
| Button Dimensions (Diameter) | 0.55 inches | 0.40 inches |
| Minimum contact pressure | 0 pounds per square inch | 0 pounds per square inch |
| Typical contact pressure | 5-7 pounds per square inch | 5-7 pounds per square inch |
| Performance outputs (contact area and pressure exerted on P6 pressure point) | Equivalent to predicate device's outputs (established via bench testing) | Equivalent to predicate device's outputs (established via bench testing) |
Study Information:
The document explicitly states: "Not applicable. No clinical tests were performed." This means that many of the requested points related to clinical studies and test sets are not directly addressed in this 510(k) summary.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical tests were performed. Bench testing was performed to compare performance outputs, but details on sample size for this are not provided beyond the comparison of "performance outputs."
- 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, as no clinical tests were performed requiring direct expert-established ground truth for a test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical tests were performed.
- 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 device is not an AI-assisted diagnostic tool; it is a physical acupressure wrist band.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a physical product, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the purpose of substantial equivalence, the "ground truth" for the Psi Band was the established performance and characteristics of the predicate device. For the non-clinical comparison, the ground truth was derived from bench testing to measure physical properties like contact area and pressure.
- The sample size for the training set: Not applicable, as no clinical studies or machine learning algorithms were involved in this submission.
- How the ground truth for the training set was established: Not applicable, as no clinical studies or machine learning algorithms were involved.
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