(89 days)
Pressure Right® is a drug-free, Single-Use, Pressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion.
The Pressure Right device is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point.
The Pressure Right device has a three-quarter wrist size design (5.50″ long X 1.0″ wide) with an affixed hard plastic button. Its pressure stimulation effect to the P6 acupressure point provides nausea and vomiting relief for surgical patients. Pressure Right device is intended for use by adults, 18 years and older and intended to be worn on each wrist. The Pressure Right device also comes with a P6 locator template to accurately determine an individual's P6 pressure point.
This document describes a 510(k) submission for the "Pressure Right® Acupressure, Pressure-Sensitive Wrist Strip" (K142471). The primary goal of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, particularly the Sea-Band® (K033268) for over-the-counter (OTC) use and an earlier version of the Pressure Right® (K110563) for prescription use.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly based on demonstrating performance equivalence to already cleared predicate devices, specifically regarding the pressure exerted and overall functionality. Since this is a 510(k) for an acupressure device, the primary performance measure highlighted is the typical contact pressure.
| Acceptance Criteria (Implied) | Reported Device Performance (Pressure Right®) |
|---|---|
| Equivalent typical contact pressure to predicate devices (5-7 lbs/sq. in) | 5-7 lbs/sq. in |
| Overall design and biocompatibility requirements met | Meets all requirements |
| Output meets design inputs and specifications | Passed testing |
2. Sample Size Used for the Test Set and Data Provenance
For the specific 510(k) submission K142471 describing the "Pressure Right® Acupressure, Pressure-Sensitive Wrist Strip," no clinical testing was performed. The non-clinical performance data relied on bench testing to evaluate the pressure equivalence between the Pressure Right device and the marketed predicate Sea-Band device. Therefore, there is no specified "test set" in terms of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective status for this submission.
The document states: "There was no new clinical testing required to support the medical device as bench testing was performed to evaluate the pressure equivalence of the Pressure Right acupressure device compared to the marketed predicate (Sea-Band) device."
However, it does mention that the predicate device, Pressure Right (K110563), was clinically tested, and that clinical data was included in its original submission (K110563). The details of the sample size and provenance for that predicate study are not provided in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable, as no clinical test set was used for this specific submission (K142471). Bench testing was conducted to assess physical attributes.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used for this specific submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A MRMC comparative effectiveness study was not conducted for this submission. The submission primarily relies on demonstrating substantial equivalence through non-clinical bench testing and comparison to predicate devices, including their existing clinical data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, in a sense. The "device" in question is a physical acupressure wrist strip. The performance evaluation was essentially a standalone assessment of its physical characteristics (primarily pressure output) compared to a predicate device, without a human-in-the-loop performance study for this specific submission.
7. The Type of Ground Truth Used
For this specific submission (K142471), the "ground truth" for the non-clinical bench testing was the measured typical contact pressure of the predicate Sea-Band device (5-7 lbs/sq. in). The new Pressure Right device was expected to demonstrate equivalent pressure.
For the predicate Pressure Right device (K110563), the document states it was "clinically tested" and had "proven safety and efficacy for the use of the device." This implies an existing body of clinical outcomes data (e.g., reduction in nausea symptoms) served as the ground truth for that prior submission, but the specifics are not detailed here.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device requiring a training set. The device is a physical acupressure wrist strip.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/algorithm-based device requiring a training set.
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