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The bite away® neo is indicated for use to provide temporary relief of the pain and itching from insect stings and bites such as bees, wasps and mosquitoes.

The bite away® neo 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 5 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 5 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 5 seconds; limiting the maximum amount of heat to be delivered to the site.

The bite away® neo device utilizes two AA batteries (1.5 volts each) that power a resistor that heats a 7mm ceramic disc to approximately 50°C when activated by the user through the use of one of the two electro-mechanical NOC (normal open contact) buttons (3 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 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 bite away® neo device is approximately 7 inches long and weighs approximately 40 grams.

This document is a 510(k) Premarket Notification from MibeTec, GmbH to the FDA for their device, the bite away® neo. The device is a powered heating pad intended for the temporary relief of pain and itching from insect stings and bites.

Since this document is a 510(k) submission, the study performed is a non-clinical performance study to demonstrate substantial equivalence to a predicate device, not a comparative effectiveness study with human readers (MRMC study) or a standalone algorithm performance study. The core of this submission is comparison to a predicate device and demonstration that the new device is as safe and effective.

Here's an breakdown of the requested information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds for clinical efficacy in this document, as this is a 510(k) submission demonstrating substantial equivalence based primarily on non-clinical performance and design characteristics, rather than de novo clinical efficacy trials. The implicit acceptance criterion is that the device is as safe and effective as the predicate device and meets relevant safety and performance standards.

The document demonstrates this by:

• Identical Indications for Use: The bite away® neo and the predicate device (Riemser Bite Away, K160943) are indicated for the same purpose.
• Similar Design Principles: Both are user-operated, hand-held, battery-powered, reusable devices that deliver mild heat to the skin via a ceramic disc.
• Compliance with Safety Standards: The device underwent and passed electrical safety, EMC, software verification/validation, and usability testing according to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62366, IEC 60601-1-6) and FDA guidance for biocompatibility (ISO 10993-1).

Table of Acceptance Criteria (Implicit) and Reported Device Performance:

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "No clinical studies were performed to support safety or effectiveness of the subject device."

Therefore, there is no "test set" in the traditional sense of a clinical data set used to prove efficacy. The "testing" refers to non-clinical bench testing (biocompatibility, electrical safety, software validation, usability) against established standards. The data provenance is from laboratory testing and engineering analysis conducted by the manufacturer, MibeTec, GmbH (Germany), as part of their premarket notification submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. As no clinical studies were performed, there was no "ground truth" derived from expert consensus on medical images or patient outcomes. The "ground truth" for the non-clinical tests is adherence to engineering and safety standards, which are defined by international bodies and regulatory agencies like the FDA. The experts involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at the manufacturer and the testing laboratories.

4. Adjudication Method for the Test Set

N/A. There was no clinical test set requiring adjudication. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in clinical image interpretation studies or clinical trials, which were not conducted here.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical studies were performed to support safety or effectiveness of the subject device." Therefore, no MRMC study was conducted, and no effect size for human readers improving with or without AI assistance is provided. (Note: This device is a heating pad, not an AI-powered diagnostic tool, so an MRMC study would generally not be applicable in this context).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

N/A. This device is a powered heating pad, not an AI algorithm. There is no software or algorithm whose performance is being evaluated in a standalone manner. The software mentioned is for the device's internal control (e.g., heating duration, temperature regulation), verified as "moderate" level of concern.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established through:

• Engineering and Safety Standards: Compliance with international standards (IEC 60601 series, ISO 10993, IEC 62366).
• Predicate Device Equivalence: The legally marketed predicate device (K160943) serves as the primary benchmark for demonstrating safety and effectiveness. The premise of a 510(k) is that if the new device is substantially equivalent to a legally marketed predicate, it is considered safe and effective.

8. The Sample Size for the Training Set

N/A. As this is not an AI/machine learning device, there is no "training set" in the conventional sense. The device's design (e.g., microcontroller firmware) would be developed and refined through engineering iterations, but not trained on a distinct dataset like an AI model.

9. How the Ground Truth for the Training Set Was Established

N/A. See #8.

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