(1520 days)
Not Found
No
The device description and performance studies focus on a simple electrical stimulation mechanism and clinical trial results, with no mention of AI/ML terms or data processing that would suggest their use.
Yes
The device is intended to temporarily reduce itching caused by mosquito bites, which addresses a medical condition (itching) and provides therapy (reduction of symptoms).
No
The device is indicated for "temporarily reducing the itching caused by mosquito bites," which is a treatment or therapy, not a diagnostic purpose.
No
The device description explicitly states it is a "hand held device, consisting primarily of housing, a push button... a 'Piezo unit'... and electrical output terminals," indicating it is a physical hardware device, not software only.
Based on the provided information, the Zap-It! device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Zap-It! Function: The Zap-It! device works by delivering electrical current to the skin to reduce itching caused by mosquito bites. It interacts directly with the user's skin and does not analyze any biological samples taken from the body.
- Intended Use: The intended use is to temporarily reduce itching, which is a physical symptom, not to diagnose or detect a disease or condition based on biological samples.
Therefore, the Zap-It! falls under the category of a medical device that provides a therapeutic or symptomatic relief, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Zap-It! is indicated for temporarily reducing the itching caused by mosquito bites.
Product codes
OSG
Device Description
The Zap-It! is a hand held device, consisting primarily of housing, a push button (which the user depresses to excite the piezoelectric crystal), a "Piezo unit" (containing piezoelectric crystal) and electrical output terminals (placed flush to the user's skin) intended to deliver electrical current to the skin.
The user of the device places the end of the device containing the electrode output terminals (the end of the device opposite the push button) flush against the skin, at the site of the mosquito bite. The push button is manually depressed, which mechanically deforms the piezoelectric crystal, and electrical charge (high voltage, low amperage) travels via the electrode wires to the skin. Electrical charge may reach the skin via electrical conductive channel between the electrode terminals and skin, or electrical conductive channel through a small air gap to the skin (electrical spark). The deposition of the charge in the skin is intended to reduce the itch associated with the underlying mosquito bite.
The user may repeat activation of the device (a maximum of five activations per bite) until the mosquito bite itch has been satisfactorily reduced; however, the user is also instructed that repeated use at the same site increases the risk of mild cutaneous burns.
The device is designed for external, limited duration intact skin contact in an environment free from fluids and is provided non-sterile.
The device contains no software.
The Zap-It! Device is for over-the-counter (OTC) use. as described in the package insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin/Volar surface of the non-dominant forearm (for effectiveness study)
Indicated Patient Age Range
The safety and effectiveness has not been established in neonates, infants and children.
The data collected on adult population was extrapolated to justify the safe and effective use of the device on the adolescent population.
Intended User / Care Setting
Over-the-counter (OTC) use by consumers.
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
Human Performance Testing:
Sample size: 53 healthy subjects
Data source: Clinical trial conducted by the sponsor. Subjects were 18-65 years of age with a history of mosquito bite reaction but with no active skin lesions.
Annotation protocol: Subjects were randomized 1:1 to active treatment (n = 27) versus placebo (n = 26). Each subject received a single mosquito bite under controlled conditions on the volar surface of the non-dominant forearm. Subjects were then instructed to test the device according to package instructions. Itching was assessed using a visual analog scale (VAS) ranging from 0 (no itching) to 100 (severe itching). A mosquito bite was induced at t=0. A baseline assessment was made at t=5 minutes after the mosquito bite and prior to device use. Assessments of itching were made following device/sham use at 15, 25, 40 minutes and 1, 2, 3, 4, 6, and 24 hours after the mosquito bite. These were compared to the baseline assessment made 5 minutes after the mosquito bite and prior to device use. The key secondary outcome measure was an assessment of the length and width of edema (i.e., swelling of the erythematous area) associated with an individual mosquito bite.
Labeling Comprehension Study:
Sample size: 15 subjects
Data source: Study conducted by the sponsor. Subjects were instructed to read the device labeling.
Annotation protocol: Subjects completed a questionnaire with 24 questions after reading the labeling, intended to test their understanding of device use.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Characterization of Electrical Output (Oscilloscope Tracings):
Study type: Bench testing
Sample size: Not specified (device output characterization)
Key results: Device output, as characterized by oscilloscope tracings measured in open circuit, was 13 kV, 0.7 mA, and 20 µS pulse duration. Performed under loads of 500, 2000, and 10,000 ohms (simulating dry skin) and 50 ohms (simulating wet skin).
Performance Testing, Mechanical Failure (or Degradation):
Study type: Bench testing
Sample size: Not specified (device durability testing)
Key results: Evaluated ability to confer charge after 5000 device actuations. Device still conferred charge, but a 34% decrease in measured open circuit voltage was observed after 5000 actuations.
Biocompatibility Analysis:
Study type: Biocompatibility assessment
Sample size: Not applicable
Key results: Justification provided supporting biocompatibility of acrylonitrile butadiene styrene (ABS) for an externally-contacting device.
Human Performance Testing:
Study type: Clinical trial (randomized 1:1, active vs. placebo)
Sample size: 53 healthy subjects (n=27 active, n=26 placebo)
Key results:
Primary effectiveness outcome (responder analysis defined as proportion of subjects whose itching at t=15 minutes decreased 40% relative to baseline at t=5 minutes): 19 out of 27 test subjects met the success criterion, compared to 3 out of 26 placebo subjects. The difference in responder rates was statistically significant (p
§ 882.5894 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
(a)
Identification. A limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites is a device intended to alleviate skin reactions associated with insect bites via cutaneous, piezoelectric stimulation at the local site of the bite.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate testing to characterize the electrical output specifications of the device (
i.e., total charge delivered, maximum instantaneous output current, maximum instantaneous output voltage, pulse duration, charge density) must be conducted.(2) Mechanical bench testing must demonstrate that the device will withstand the labeled number duration of uses.
(3) All elements of the device that may contact the patient must be assessed to be biocompatible.
(4) Labeling must include:
(i) Validated instructions which addresses the following:
(A) Identification of areas of the body which are appropriate and not appropriate for contact with the device.
(B) Whether use of the device in conjunction with flammable materials (
e.g., insect repellent) is appropriate.(C) Use of the device on or near implanted devices.
(D) How to identify the correct type of skin condition.
(ii) Technical parameters of the device (maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration).
(iii) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device.
(iv) The anticipated number of device uses prior to failure.
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EVALUATION OF AUTOMATIC CLASS III DESIGNATION (DE NOVO) FOR ZAP-IT!
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites. A limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites is a device intended to alleviate skin reactions associated with insect bites via cutaneous, piezoelectric stimulation at the local site of the bite.
NEW REGULATION NUMBER: 21 CFR 882.5894
CLASSIFICATION: II (Exempt from premarket notification review, subject to the limitations in 21 CFR 882.9)
PRODUCT CODE: OSG
BACKGROUND
DEVICE NAME: Zap-It!
DE NOVO REQUEST: DEN100024
DATE OF DE NOVO REQUEST: September 8, 2010
REQUESTOR CONTACT: Ecobrands, Ltd. #2 - 36 Stratford Road London, W8 6QA, UK Phone: + 44-0-20-7460-8101 Fax: +44-0-20-7565-8779
REQUESTOR'S RECOMMENDED CLASSIFICATION: II
INDICATIONS FOR USE
Zap-It! is indicated for temporarily reducing the itching caused by mosquito bites.
Limitations
The Zap-It! device is available as an over-the-counter (OTC) device.
Please refer to the package insert for a complete list of Warnings and Precautions
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regarding the appropriate use of the Zap-It! device. The following statements are limitations of the device explicitly noted in the labeling:
Warnings
Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted electrical device. Such use could cause electric shock, burns, or electrical interference.
Do not use Zap-It! in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when you are using the product.
Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).
Do not use over viral lesions, as safety studies have not been performed to determine the effect of the Zap-It! on viral lesions; therefore, the effects are unknown.
Do not use on flammable materials. It may cause them to burn and burn your skin.
Zap-It! should not be used after applying insect repellent until it has fully dried to the touch, as repellant may be flammable and cause skin burns if ignited.
For external use only. Do not apply the Zap-It! inside the mouth or other body cavity as pain or injury may occur.
Do not apply the Zap-It directly to your eyes as this could cause damage to your evesight.
Do not use the Zap-It! in situations where electrical stimulation could put you at risk of injury, such as while driving a car or operating machinery.
Cutaneous burns are a danger when applying repeated electrical stimulus to the skin in rapid succession, and the repeated excessive use of the device on bites has not been studied.
Precautions
Do not use Zap-It! to remove the toxins or infection associated with mosquito bites. Zap-It! was only found in clinical studies to temporarily remove the itching. If you believe your mosquito bite is infected, seek medical attention.
Do not use in the bath or shower as water may cause the device to not properly function.
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The safety and effectiveness has not been established in neonates, infants and children.
Do not apply Zap-It! to your lips as this may cause pain.
Dispose of this device responsibly at the end of its useful life.
Discontinue use if irritation occurs.
Keep out of the reach of children.
Use caution if stimulation is applied over areas of skin that lack normal sensation.
The Zap-It! is a medical device. Do not let children play with Zap-It!.
CONDITIONS OF EXEMPTION
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites are appropriate for exemption from premarket notification, subject to the limitations of exemptions identified in 21 CFR 882.9, because the applicable special controls and general controls provide reasonable assurance of safety and effectiveness, if device manufacturers follow the special controls requirements. Examples of exceeding the limitations of exemption are where the output (absolute charge delivered or current) exceeds the specifications for this device, the indications is for something other than itching or the indications specify bites other than insect bites.
Exemption from the requirement of premarket notification for limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites does not mean that these devices would be exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's proposal to exempt these devices from the requirement of premarket notification [510(k)] is based, in part, on the assurance of safety and effectiveness provided by other regulatory controls, such as current good manufacturing practice requirements (21 CFR part 820) and the identified special controls.
DEVICE DESCRIPTION
The Zap-It! is a hand held device, consisting primarily of housing, a push button (which the user depresses to excite the piezoelectric crystal), a "Piezo unit" (containing piezoelectric crystal) and electrical output terminals (placed flush to the user's skin) intended to deliver electrical current to the skin. Please refer Figure 1 below for a graphical representation of the device:
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Image /page/3/Figure/0 description: This image shows a diagram of a device with several labeled parts. The device has a handle and a flat end designed to be placed on the skin surface. The diagram labels parts such as the "Push button", "Carrying lanyard loop", "Piezo unit", "Body", "Electrode wires", and "Electrode output terminals". The "Piezo length" is labeled as "1.1 ins" and the "Piezo width" is labeled as "0.2 ins".
Figure 1 - Graphical Representation of the Device
The user of the device places the end of the device containing the electrode output terminals (the end of the device opposite the push button) flush against the skin, at the site of the mosquito bite. The push button is manually depressed, which mechanically deforms the piezoelectric crystal, and electrical charge (high voltage, low amperage) travels via the electrode wires to the skin. Electrical charge may reach the skin via electrical conductive channel between the electrode terminals and skin, or electrical conductive channel through a small air gap to the skin (electrical spark). The deposition of the charge in the skin is intended to reduce the itch associated with the underlying mosquito bite.
The user may repeat activation of the device (a maximum of five activations per bite) until the mosquito bite itch has been satisfactorily reduced; however, the user is also instructed that repeated use at the same site increases the risk of mild cutaneous burns.
The device is designed for external, limited duration intact skin contact in an environment free from fluids and is provided non-sterile.
The device contains no software.
The Zap-It! Device is for over-the-counter (OTC) use. as described in the package insert.
SUMMARY OF PERFORMANCE TESTING
Characterization of Electrical Output (Oscilloscope Tracings)
To characterize device electrical output, oscilloscope tracings of the output were provided, under loads of 500, 2000, and 10,000 ohms to simulate the load presented by dry skin, while using a controlled and repeatable pressure to activate the piezoelectric element. Oscilloscope tracings were also provided under a load of 50 ohms to simulate the load presented by wet skin. The device output, as characterized by oscilloscope
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tracings measured in open circuit, was 13 kV, 0.7 mA, and 20 µS pulse duration.
Performance Testing, Mechanical Failure (or Degradation)
The sponsor provided testing which evaluated the ability of the device to confer charge after 5000 device actuations. This testing showed that the device still conferred charge, though after 5000 actuations, a 34% decrease in measured open circuit voltage was observed.
Biocompatibility Analysis
The patient-contacting material is a specific acrylonitrile butadiene styrene (ABS). Justification was provided supporting biocompatibility of this material for an externallycontacting device.
Human Performance Testing
The effect of the device on mosquito bite itch (device benefit) was evaluated in a clinical trial in which 53 healthy subjects 18-65 years of age with a history of mosquito bite reaction but with no active skin lesions were enrolled.
Study Design
Subjects were randomized 1:1 to active treatment (n = 27) versus placebo (n = 26). Each subject received a single mosquito bite under controlled conditions on the volar surface of the non-dominant forearm. Subjects were then instructed to test the device according to package instructions.
The sham (control) device was identical in appearance and function to the device, including the generation of an electrical discharge from piezoelectric crystals activated through mechanical stress. However, the sham device contained false electrical wires that did not transmit the electrical charge to the skin surface.
Itching was assessed using a visual analog scale (VAS) ranging from 0 (no itching) to 100 (severe itching). A mosquito bite was induced at t=0. A baseline assessment was made at t=5 minutes after the mosquito bite and prior to device use.
Assessments of itching were made following device/sham use at 15, 25, 40 minutes and 1, 2, 3, 4, 6, and 24 hours after the mosquito bite. These were compared to the baseline assessment made 5 minutes after the mosquito bite and prior to device use.
The primary effectiveness outcome was a responder analysis defined as the proportion of subjects whose itching at t=15 minutes decreased 40% relative to the baseline itching at t=5 minutes using the VAS in each study arm.
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The key secondary outcome measure was an assessment of the length and width of edema (i.e., swelling of the erythematous area) associated with an individual mosquito bite.
Results
Both the active (test) and placebo groups had similar baseline VAS scores for itching, with each group demonstrating a decreasing score over time. The primary endpoint was based on an individual success criterion of a 40% or greater relative decrease in Degree of Itching on the VAS from t=5 minutes to t=15 minutes. Out of 27 test subjects, 19 met the success criterion. Out of 26 placebo subjects, 3 met the success criteria. The difference in responder rates between the two study arms was statistically significant (p