(79 days)
Bonine Acupressure Bands are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
Bonine Acupressure Bands are acupressure devices made of comfortable fabric band straps with Velcro closures and a dome on the buckle. Bonine Acupressure Band's acupressure dome provides gentle pressure on the Nei-Kuan or P6 pressure point in the wrist. The amount of pressure applied is fully adjustable and allows the user to increase or decrease as needed. Bonine Acupressure Bands are provided for over-the-counter use to be worn directly as desired on the consumer's wrists.
This document pertains to the 510(k) premarket notification for the Bonine Acupressure Bands (K211823), intending to demonstrate its substantial equivalence to legally marketed predicate devices. It focuses on the device's ability to reduce symptoms of nausea by applying pressure to the Nei-Kuan (P6) acupressure point on the wrist.
Crucially, no clinical testing was conducted for this device. The demonstration of substantial equivalence relies primarily on:
- Comparison of Indications for Use: The Bonine Acupressure Bands share the same intended use (reduction of nausea symptoms) as the predicate devices (TumEase Acupressure Bracelets and Sea-Band).
- Comparison of Technological Features: The device operates on the same principle as the predicates, i.e., acupressure on the P6 point for nausea relief.
- Bench Performance Testing: The primary and only performance testing reported is non-clinical/bench testing to compare the contact pressure of the Bonine Acupressure Bands to the predicate device.
Given that no clinical study was performed, the typical elements of acceptance criteria and study design (such as sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable in this context. The acceptance criteria here are implicitly met by demonstrating comparable physical properties to the predicate.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical study was performed, the acceptance criteria are not in the format of clinical efficacy targets (e.g., sensitivity, specificity). Instead, the "acceptance criteria" revolve around demonstrating comparable physical characteristics to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Bonine Acupressure Bands) |
|---|---|
| Intended Use: Reduce symptoms of nausea (due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, Anesthesia). | Met: Same Indications for Use as predicate devices. |
| Technological Principle: Apply pressure to Nei-Kuan or P6 acupressure point on the wrist. | Met: Utilizes a dome on the buckle to apply pressure to the Nei-Kuan (P6) pressure point. |
| Contact Pressure: Comparable average contact pressure to the predicate device. | Met: Bench testing showed "comparable to the predicate device and was able to provide a similar average contact pressure." |
| Materials: Biocompatible and safe for skin contact. | Met: Described materials (nylon fabric, Velcro, polypropylene) are standard for such devices. |
| Over-The-Counter Use: Suitable for consumer use without prescription. | Met: Specified for Over-The-Counter Use, consistent with predicates. |
| Safety and Effectiveness: Does not raise new questions of safety or effectiveness compared to predicates based on technological differences. | Met: Stated that "any differences in the technological characteristics or materials do not raise any new questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. No clinical test set data was used.
- Data Provenance: Not applicable. The performance data is from non-clinical bench testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. No expert ground truth was established as no clinical data was analyzed.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done. This type of study evaluates human reader performance, which is not relevant for a device cleared based on substantial equivalence to physical properties and intended use.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This is a physical, non-electronic device; there is no "algorithm" to evaluate in standalone performance.
7. Type of Ground Truth Used:
- Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used. The basis for equivalence is the physical and functional similarity to predicate devices already cleared for the same indications.
8. Sample Size for the Training Set:
- Not applicable. This device does not involve a "training set" in the machine learning sense. Its design is based on the known, effective principles of acupressure and the established designs of predicate devices.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set ground truth was established.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" in this context is the non-clinical bench performance testing and the comparison of device characteristics (intended use, technological principle, materials, how supplied, application method, and dimensions) to the legally marketed predicate devices.
The key finding from the performance testing was that the Bonine Acupressure Bands were "comparable to the predicate device and was able to provide a similar average contact pressure in the pressure point bench testing." This demonstrates that the device physically functions similarly to the predicate in applying pressure.
The entire 510(k) submission, by definition, aims to prove "substantial equivalence" to existing legally marketed devices, rather than proving de novo clinical efficacy. The FDA's clearance (K211823) indicates their acceptance of this demonstration based on the provided non-clinical data and comparisons to predicate devices.
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