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.

Device Description

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.

AI/ML Overview

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:

Acceptance Criterion (Implicitly Met)	Reported Device Performance (vs. Predicate K160943)
Indications for Use Equivalence	Identical: Both devices are indicated for temporary relief of pain and itching from insect stings and bites (bees, wasps, mosquitoes). The difference in claim of "increasing localized blood flow" for the predicate is stated to not affect safety or efficacy.
Intended Use Equivalence	Identical: Delivery of mild heat to the skin/dermis.
Temperature Profile Equivalence	Similar Temperature Range: Subject device: 50 - 53°C (device surface); Predicate: 50 - 53°C (device surface). Max skin surface temp for subject: 48.6°C. Rationale: Identical temperature range, no additional risks.
Energy Transfer Mechanism Equivalence	Identical: Both use a heated ceramic disc.
Power Source Equivalence	Identical: Both use AA Batteries (3 volts DC).
Operator Control / Application Method Equivalence	Identical: Hand-held, user-operated, applied directly to the insect bite, user in complete control of heat treatment.
Biocompatibility	Compliant: Patient contact polymers and ceramics evaluated against ISO 10993-1, including Cytotoxicity, Sensitization, and Irritation.
Electrical Safety & Electromagnetic Compatibility (EMC)	Compliant: Tested against IEC 60601-1 (MOD), IEC 60601-1-2, and IEC 60601-1-11.
Software Verification and Validation	Compliant: Tested following FDA Guidance for "moderate" level of concern software; complies with IEC 62366 (implied).
Usability	Compliant: Tested against IEC 60601-1-6.
Risk Mitigation (Differences from Predicate)	Reduced Heating Time: Subject device has 3 and 5 seconds vs. predicate's 3 and 6 seconds. Rationale: "Greater safety with less heating time." Smaller Heated Area (7mm vs 9mm): Rationale: "Small disc size delivers heat to less surface area; reducing risk. User can apply to multiple areas for more surface area treatments." These differences are argued to enhance safety.
Material & Component Similarities	Hard plastic outer case, LED light, audible signal, microprocessor.
Regulatory Classification Equivalence	Identical: Powered Heating Pad, Class II, Product Code IRT, CFR Section 890.5740, OTC Use.

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.

Summary

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June 23, 2022

MibeTec. GmbH % Kenneth Kleinhenz Official Correspondent QSR Consulting 10807 Dakota Ranch Road Santee, California 92071

Re: K220514

Trade/Device Name: bite away® neo Regulation Number: 21 CFR 890.5740 Regulation Name: Powered heating pad Regulatory Class: Class II Product Code: IRT Dated: March 30, 2022 Received: April 1, 2022

Dear Kenneth Kleinhenz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220514

Device Name bite away® neo

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared: 21 June 2022

I. SUBMITTER

Manufacturer Name:

mibeTec, GmbH Munchener Strasse 15 Brehna, Germany D-17493 +49 34954 247 489 telephone

Mfg. Establishment Registration Number: 3015733772

Official Contact:

Kenneth K. Kleinhenz Regulatory Affairs Telephone (619) 244-9573 Kleinhenz64@gmail.com

II. DEVICE

Name of Device:	bite away® neo
Common or Usual Name:	Heating pad
Classification Name:	Powered Heating Pad (21 CFR 890.5740
Regulatory Class Name:	II
Product Code:	IRT
510(K) Identification:	K220514

PREDICATE DEVICE III.

Riemser Bite Away, K160943

DEVICE DESCRIPTION IV.

Design Characteristics

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Material Composition

The bite away® neo device housing is fabricated with biocompatible polymers and the heated disc is fabricated with a biocompatible ceramic material. The electronics are fabricated on a standard electrical circuit board with standard electronics (capacitors, resistor, microprocessors, etc.).

V. INDICATIONS FOR USE

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

INTENDED USE

Delivery of mild heat to the skin / dermis

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The bite away neo Device shares indications for use and design principles with the following predicate device: bite away (Riemser, K160943); a Class II medical device that was cleared for marketing in the United States under K160943.

Indications For Use

The bite away® neo Device and the bite away (Riemser, K160943) predicate device are substantially equivalent with respect to their indications for use as they are both indicated for the same intended use of temporary relief from the pain and itching resulting from insect stings and bites. Additionally, the bite away® neo and the bite away predicate device shares indications for use principles of being OTC (over the counter).

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Design and Materials

The design principles of the bite away® neo and the bite away predicate device (K160943) are substantially equivalent as they all share common design principals of being a useroperated, hand-held, light weight, battery powered, reusable devices that deliver mild heat to the skin/dermis as a means to transfer heat from the device to the user- directed anatomical location. All devices share the common design feature of user-applied heat therapy that is directed and controlled solely by the user. The bite away® neo and the bite away predicate device (K160943) share a common material and design principal of utilizing a ceramic disc to transfer the heat from the device to the skin. The bite away® neo and the bite away predicate device also share common design and material features of utilizing a light-weight polymer outer case to hold and contain the electronics and AA batteries that power the devices also share the common design feature of being form-fit packaged in a paperboard box. The bite away® neo and the bite away predicate device (K160943) share the design feature of being over-the-counter (OTC) devices under 21 CFR 890.5740. The delivery of heat to the insect bite is delivered and controlled by the user. Device weight does not play a role in the delivery of heat. A weight difference of 15 grams is virtually indistinguishable by the user. Therefore, differences in device weight do not affect safety or efficacy. Differences in contact time by 1 second (5 sec. versus 6 sec) do not affect safety or efficacy and only plays a role in greater safety as it creates a larger margin of safety against burns to the skin. The reduced heat contact time of 1 second does not affect efficacy given the fact that the user can reapply the heat with an additional heat treatment if necessary. The subject device and the predicate device have the same indications for use with respect to insect bites and only differ in the claimed mechanism of action (blood flow), which has no affect on safety or efficacy because the mechanisms of action does not affect the subjects use of the device.

	Subject Device	Predicate Device(K160943)	Rationale for no Effect onSafety and Efficacy
	bite away® neo	bite away
Manufacturer	mibeTec, GmbH	Riemser Pharma	Validated Process
Device Name	bite away® neo	bite away	Device name does not imply any claims.No additional risks
Intended Use	Delivery of mild heat to theskin/dermis	Delivery of mild heat to theskin/dermis	Identical. No additional risks
Indications forUse	The bite away® neo is indicatedfor use to provide temporaryrelief of the pain and itchingresulting from insect stings andbites such as bees, wasps andmosquitoes.	The bite away is indicated for use toprovide temporary relief of the painand itching resulting from insectstings and bites such as bees, waspsand mosquitoes by temporarilyincreasing localized bloodflow.	Indicated for same insect bites. Absenceof mechanism of action claims does notaffect safety or efficacy. No additionalrisks
Design	Hand held device that heats aceramic disc with a resistor totemperatures of 51.5°C	Hand held device that heats aceramic disc with a resistor totemperatures of 51.5°C	Identical Maximum No additionalrisks Temperature
	Subject Device	Predicate Device(K160943)	Rationale for no Effect onSafety and Efficacy
	bite away® neo	bite away
OperatorDirected/Applied to the Skin	Yes	Yes	Identical. Noadditional risks
Dry Weight	40 grams	25 grams	Weight does not play a role in thedelivery of heat. Insignificantdifference; essentially undetectable byuser
Weight withbatteries	86 grams	Not publicly available	Weight does not play a role in the deliveryof heat. Insignificant difference;essentially undetectable by user
Duration ofUse	3 and 5 seconds	3 and 6 seconds	Greater safety with less heating time
Dimension ofHeated Area onthe Device	7 mm	9 mm	Identical temperature range; noadditional risk. . Small disc sizedelivers heat to less surface area;reducing risk. User can apply tomultiple areas for more surface areatreatments.
TemperatureRange (devicesurface)	50 - 53°C	50 - 53°C	Identical temperature range. Noadditional risks
Temperaturemax at skinsurface	48.6°C	Not publicly available	Ceramic pad touching skin is identical.Min. and max. temperature output fromdevice deliver same heat to the skin.
Power Source	AA Batteries	AA Batteries	Identical. No additional risks
Voltage	3 volts DC	3 volts DC	Identical. No additional risks
Energy TransferSource	Heated ceramic disc	Heated ceramic disc	Identical. No additional risks
Hard PlasticOuterCase	Yes	Yes	Identical. No additional risks
LED Light	Yes	Yes	Identical. No additional risks
Audible Signal	Yes	Yes	Identical. No additional risks
Microprocessor	Yes	Yes	Identical. No additional risks
Placed Directlyon Insect Bitefor Treatments	Yes	Yes	Identical. No additional risks
ClassificationName	Powered Heating Pad	Powered Heating Pad	Identical. No additional risks
OTC Use	Yes	Yes	Identical. No additional risks
Product Class	2	2	Identical. No additional risks
Product Code	IRT	IRT	Identical. No additional risks
CFR Section	890.5740	890.5740	Identical. No additional risks
Intended Use	Delivery of mild heat to theskin/dermis	Delivery of mild heat to theskin/dermis	Identical. No additional risks

The bite away® neo device is substantially equivalent to the bite away predicate device (K160943) in the following respects:

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VII. PERFORMANCE DATA

Biocompatibility Testing

The patient contact polymers and ceramics were evaluated against the international standard ISO 10993-1 (Biological Evaluation of Medical Devices) and the FDA Guidance Document entitled, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process." The battery of testing included.

Cytotoxicity Sensitization Irritation

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the bite away neo® device, consistent with the appropriate sections of the following electrical standards: IEC 60601-1 (MOD), IEC 60601-1-2. and IEC 60601-1-11. The bite away neo® device complies with IEC 60601-1 (MOD) standard for safety, IEC 60601-1-2 standard for EMC compliance, and IEC 60601-1-11 standard for medical electrical equipment in a home healthcare environment.

Software Verification and Validation

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator. The bite away neo device complies with the applicable sections of IEC 62366.

Usability Studies

Usability testing was conducted on the bite away neo® device consistent with the appropriate sections of the following usability standards: IEC 60601-1-6. The bite away neo® device complies with the applicable sections of IEC 60601-1-6.

Clinical Studies

No clinical studies were performed to support safety or effectiveness of the subject device.

VIII. CONCLUSIONS

The nonclinical testing demonstrates that the subject device is as safe and effective, and performs as well as or better than the legally marketed predicate device.

Regulation Number and Section

§ 890.5740 Powered heating pad.

(a)
Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.