(121 days)
Not Found
No
The device description details a simple, user-operated heating device with a microcontroller and programmed firmware for basic timing and safety features. There is no mention of AI, ML, or any complex algorithms that would suggest learning or adaptive capabilities.
Yes.
The device provides temporary relief of pain and itching from insect stings and bites, which is a therapeutic function.
No
The device is indicated for providing temporary relief of pain and itching from insect stings and bites, which is a therapeutic function, not a diagnostic one. It does not identify, assess, or monitor any medical condition.
No
The device description clearly states it is a "light weight, portable, hand-held, battery powered, user- operated device" with physical components like a plastic case, buttons, batteries, and a heated ceramic plate. While it contains a microcontroller with programmed firmware, it is fundamentally a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the bite away® neo device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This includes tests for diagnosing diseases, monitoring treatments, and screening for conditions.
- bite away® neo Function: The bite away® neo device works by applying heat directly to the skin to provide temporary relief from pain and itching caused by insect bites and stings. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use clearly states it's for "temporary relief of the pain and itching from insect stings and bites." This is a therapeutic or symptomatic relief function, not a diagnostic one.
- Device Description: The description details a device that applies heat externally to the skin. There is no mention of collecting or analyzing biological specimens.
Therefore, the bite away® neo falls under the category of a medical device, but specifically a therapeutic or symptomatic relief device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
IRT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin / dermis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing: The patient contact polymers and ceramics were evaluated against the international standard ISO 10993-1 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.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
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
1
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
2
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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3
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
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.
4
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.
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 on
Safety 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 the
skin/dermis | Delivery of mild heat to the
skin/dermis | Identical. No additional risks |
| 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. | The bite away 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 by temporarily
increasing localized blood
flow. | Indicated for same insect bites. Absence
of mechanism of action claims does not
affect safety or efficacy. No additional
risks |
| Design | Hand held device that heats a
ceramic disc with a resistor to
temperatures of 51.5°C | Hand held device that heats a
ceramic disc with a resistor to
temperatures of 51.5°C | Identical Maximum No additional
risks Temperature |
| | Subject Device | Predicate Device
(K160943) | Rationale for no Effect on
Safety and Efficacy |
| | bite away® neo | bite away | |
| Operator
Directed/Appli
ed to the Skin | Yes | Yes | Identical. No
additional risks |
| Dry Weight | 40 grams | 25 grams | Weight does not play a role in the
delivery of heat. Insignificant
difference; essentially undetectable by
user |
| Weight with
batteries | 86 grams | Not publicly available | Weight does not play a role in the delivery
of heat. Insignificant difference;
essentially undetectable by user |
| Duration of
Use | 3 and 5 seconds | 3 and 6 seconds | Greater safety with less heating time |
| Dimension of
Heated Area on
the Device | 7 mm | 9 mm | Identical temperature range; no
additional risk. . Small disc size
delivers heat to less surface area;
reducing risk. User can apply to
multiple areas for more surface area
treatments. |
| Temperature
Range (device
surface) | 50 - 53°C | 50 - 53°C | Identical temperature range. No
additional risks |
| Temperature
max at skin
surface | 48.6°C | Not publicly available | Ceramic pad touching skin is identical.
Min. and max. temperature output from
device 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 Transfer
Source | Heated ceramic disc | Heated ceramic disc | Identical. No additional risks |
| Hard Plastic
Outer
Case | 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 Directly
on Insect Bite
for Treatments | Yes | Yes | Identical. No additional risks |
| Classification
Name | 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 the
skin/dermis | Delivery of mild heat to the
skin/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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7
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.