(143 days)
No
The device description details a simple, user-controlled heating element with a microcontroller for timing and safety features. There is no mention of adaptive learning, pattern recognition, or any other characteristic typically associated with AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for use to provide temporary relief of pain and itching from insect stings and bites, which aligns with the definition of a therapeutic device.
No
The device is indicated for temporary relief of pain and itching, not for diagnosing a condition.
No
The device description clearly states it is a hand-held, battery-powered device with physical components like a plastic case, circuit board, buttons, batteries, and a heated ceramic plate. While it contains embedded software (firmware), it is not solely software.
Based on the provided text, the Bite Away device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Bite Away's Function: The Bite Away device directly applies heat to the skin to provide temporary relief from pain and itching caused by insect bites and stings. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states "to provide temporary relief of the pain and itching from insect stings and bites... by temporarily increasing localized blood flow." This is a therapeutic or symptomatic relief function, not a diagnostic one.
- Device Description: The description details a device that generates heat for direct skin contact. There is no mention of collecting or analyzing biological samples.
Therefore, the Bite Away device falls under the category of a therapeutic or symptomatic relief device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
IRT
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected areas of the skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
User-operated, 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
The Riemser Pharma Bite Away device was evaluated in a prospective, single arm, open label clinical study for the temporary relief of the pain and itching from insect stings and bites such as bees, wasps and mosquitoes in 146 subjects. A total of 93 patients (64%) received a sting from a wasp, 33 patients (23%) receive a bite from a mosquito, and 8 patients (5%) received a sting from a bee. Among all patients, 108 subjects (74%) had swelling, 85 subjects (58%) had pain, 84 (57%) had erythema, 52 subjects (36%) had pruritus, and 2 had dyspnea. A visual analog scale (VAS) for pain and swelling was utilized to assess the effectiveness of the Bite Away device, with a score of 10 being the worst pain/swelling and zero (0) being no pain or swelling. The VAS score for swelling decreased with statistical significance after the use of the Bite Away device to treat the insect bite / sting. Bite Away treatment reduced swelling VAS scores from a mean of 4 prior to treatment, to a mean VAS score of 2 after 2-5 minutes post treatment and a VAS score of 1 after 10 minutes post treatment (p
§ 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2016
Riemser Pharma % Kenneth Kleinhenz Owner, Quality Systems Resources (qsr) 10807 Dakota Ranch Rd. Santee, California 92071
Re: K160943
Trade/Device Name: Bite Away Regulation Number: 21 CFR 890.5740 Regulation Name: Powered Heating Pad Regulatory Class: Class II Product Code: IRT Dated: July 25, 2016 Received: July 28, 2016
Dear Mr. 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. 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.
We note that your device exceeded the Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 CFR Part 890.9), and therefore required the submission and clearance of a premarket notification prior to commercial distribution in the United States.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
1
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 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Michael J.Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160943
Device Name Bite Away
Indications for Use (Describe)
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.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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DATE OF PREPARATION
August 25, 2016
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Riemser Pharma, GmbH An der Wiek 7 Greifswald – Insel Riems Germany, D-17493 +49 3033 842 70 telephone +49 3835 1767 78 fax
Official Contact:
Kenneth K. Kleinhenz Regulatory Affairs Telephone (858) 458-0900 Fax (858) 458-0994
DEVICE NAME
Classification Name:
Trade/Proprietary Name:
Infrared Lamp
Bite Away
ESTABLISHMENT REGISTRATION NUMBER 3007770022
DEVICE CLASSIFICATION AND PRODUCT CODE
As shown in 21CFR 890.5740 (powered heating pad), 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. These devices are classified as Class II. Powered heating pads have been assigned Product Code IRT.
INTENDED USE
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.
4
DEVICE DESCRIPTION
Design Characteristics
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).
Non-Clinical
Testing:
The Riemser Pharma Bite Away device demonstrated compliance with the appropriate sections of the following electrical standards: IEC 60601-1 (MOD), IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11 and IEC 62366. The patient contact polymers and ceramics were tested against the ISO 10993 standards (Biological Evaluation of Medical Devices) such as: ISO 10993-5 and ISO 10993-10.
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Clinical Testing
The Riemser Pharma Bite Away device was evaluated in a prospective, single arm, open label clinical study for the temporary relief of the pain and itching from insect stings and bites such as bees, wasps and mosquitoes in 146 subjects. A total of 93 patients (64%) received a sting from a wasp, 33 patients (23%) receive a bite from a mosquito, and 8 patients (5%) received a sting from a bee. Among all patients, 108 subjects (74%) had swelling, 85 subjects (58%) had pain, 84 (57%) had erythema, 52 subjects (36%) had pruritus, and 2 had dyspnea. A visual analog scale (VAS) for pain and swelling was utilized to assess the effectiveness of the Bite Away device, with a score of 10 being the worst pain/swelling and zero (0) being no pain or swelling. The VAS score for swelling decreased with statistical significance after the use of the Bite Away device to treat the insect bite / sting. Bite Away treatment reduced swelling VAS scores from a mean of 4 prior to treatment, to a mean VAS score of 2 after 2-5 minutes post treatment and a VAS score of 1 after 10 minutes post treatment (p