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510(k) Data Aggregation
(143 days)
The Bite Away is indicated for use to provide temporary relief of the pain and itching from insect stings and bites such as bees, wasps and mosquitoes by temporarily increasing localized blood flow.
The Riemser Pharma Bite Away device is a light weight, portable, hand held, battery powered, user-operated device that produces mild heat for direct contact with the affected areas of the skin. The heat is initiated by the user through the activation of the unit by depressing a non-locking button. The device is provided with two (2) side-by-side buttons. The user has the choice of a short 3 second heat treatment or a 6 second heat treatment depending on which button is depressed. The activation of the unit is signified with the illumination of an LED light and an audible chirp through the use of an electronic buzzer. An audible alarm is activated when there is a user error. The device is not connected to the user as the user is in complete control of the heat treatment and as such, self-delivers the heat treatment to themselves by contacting the device to their own anatomy / treatment site. The short duration of 3 and 6 seconds of heating the device's heated ceramic plate that contacts the patient further alleviates risk of overheating the skin as the device automatically stops heating the element after 3 or 6 seconds; limiting the maximum amount of heat to be delivered to the site.
The Riemser Pharma Bite Away device utilizes two AA batteries (1.5 volts each) that power a resistor that heats a 9mm ceramic disc to 51.5℃ +/- 1% when activated by the user through the use of one of the two electro-mechanical NOC (normal open contact) buttons (3 seconds or 6 seconds of heating). The device consists of a few major components: a hard plastic outer case, a printed circuit board, an activation button, AA batteries, and a heated ceramic plate that contacts the patient. The printed circuit board consists of the following components: electro-mechanical NOC buttons, microcontroller with programmed firmware, MOSFET transistor heating element, ceramic pad, resistors, coils, capacitor, thermistor temperature sensor and buzzer.
The Riemser Pharma Bite Away device is approximately 6 inches long and weighs approximately 25 grams. The Bite Away device is provided in 2 shapes, both of which are identical in every way except for the shape. One product is an elongated configuration called "Cobra" and the other configuration is an oblong configuration called "Mouse". Although these products have different shapes and names, the products are identical in every way to include raw materials, subcomponents, electronic circuits, electronic components, and imbedded software code, fabrication processes, etc., and only differs in the shape of the outer case (elongated Cobra model versus the oblong Mouse model).
This document describes the marketing authorization for the "Bite Away" device, a powered heating pad intended for temporary relief of pain and itching from insect stings and bites. The study provided focuses on clinical data to support the device's indications for use.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" is not explicitly defined as a numeric threshold in the document for the clinical study's primary endpoint. Rather, the study aims to demonstrate a statistically significant reduction in pain, itching (pruritus), and swelling as measured by a Visual Analog Scale (VAS) after using the Bite Away device. The reported performance shows significant improvement across these metrics.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Primary Endpoint: Statistically significant reduction in VAS scores for swelling, pain, and pruritus after treatment. | Swelling: Mean VAS score decreased from 4 (prior) to 2 (2-5 min post-treatment) and 1 (10 min post-treatment) (p < 0.0001). |
| Pain: Mean VAS score decreased from 6 (prior) to 2 (2 min post-treatment), 1 (5 min post-treatment), and 0 (10 min post-treatment) (p < 0.0001). | |
| Pruritus: Mean VAS score decreased from 5 (prior) to 2 (2 min post-treatment) and 0 (5 and 10 min post-treatment) (p < 0.0001). | |
| Safety: No mention of specific safety acceptance criteria, but generally implied to be safe for its intended use. | Not explicitly quantified in this section directly, but device safety is typically assessed through adverse event reporting which is not detailed here. The clinical study is a "single arm, open label" which might not be designed to extensively assess comparative safety but rather efficacy in a real-world setting. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: 146 subjects
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It is a prospective, single-arm, open-label clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The study utilized a Visual Analog Scale (VAS) for pain, swelling, and pruritus. This is a subjective patient-reported outcome. Therefore, there were no external "experts" used to establish a ground truth in the traditional sense (e.g., radiologist opinions). The "ground truth" was the subjects' own reported experience via the VAS scores.
4. Adjudication Method for the Test Set
Since the "ground truth" was based on patient-reported VAS scores, there was no adjudication method described for external review of these subjective reports.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. The device (Bite Away) is a direct treatment device, not an AI-powered diagnostic or assistive tool for human readers. The study evaluates the device's direct therapeutic effect on patients.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Bite Away" is a physical device, not an algorithm. Therefore, the concept of a "standalone" algorithmic performance study does not apply to this device. The clinical study evaluates the device's performance when used by a human (user-operated).
7. The Type of Ground Truth Used
The ground truth used was patient-reported outcomes (PROs) via a Visual Analog Scale (VAS) for pain, swelling, and pruritus.
8. The Sample Size for the Training Set
Not applicable. This device does not involve an AI algorithm that requires a training set. The clinical study evaluates the device's performance in a direct therapeutic context.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI algorithm being developed or evaluated, there is no training set or ground truth establishment for a training set.
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