(617 days)
Not Found
Not Found
No
The device description and performance study details describe a simple electromechanical device that delivers electrical current via a piezoelectric crystal. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The clinical study evaluates the device's physical effect, not the performance of an algorithm.
Yes
The device is intended for "temporarily reducing the swelling and itching caused by mosquito bites," which is a therapeutic purpose.
No
The device is intended to reduce swelling and itching, which is a therapeutic function, not a diagnostic one. It does not identify, detect, or monitor a medical condition.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to temporarily reduce swelling and itching caused by mosquito bites. This is a direct treatment/relief of a symptom on the body.
- Device Description: The device delivers electrical current to the skin. This is a physical interaction with the body.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
This device does not involve the examination of specimens taken from the body. It is a device that interacts directly with the skin to provide a therapeutic effect.
N/A
Intended Use / Indications for Use
Zanza-Click (or Disc-o-Click, or Mini-Click) is indicated for temporarily reducing the swelling and itching caused by mosquito bites.
Product codes
OSG
Device Description
The Zanza-Click (or Disc-o-Click, or Mini-Click) is a hand held device, consisting primarily of housing, a push button (which the user depresses to excite the piezoelectric crystal by means of a spring), 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 activates a spring to mechanically deform the piezoelectric crystal, and the 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 temporarily reduce the itch and swelling associated with the underlying mosquito bite.
The user may repeat activation of the device (a maximum of five activations per bite for children, and ten activations per bite for adults and adolescents) 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 for a single user in an environment free from fluids and is provided non-sterile.
The device contains no software.
The Zanza-Click (or Disc-o-Click, or Mini-Click) 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
Indicated Patient Age Range
Adults and adolescents. Safety and effectiveness has not been established in neonates, infants and children.
Intended User / Care Setting
Over-the-counter (OTC) 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
A prospective, double-blinded, placebo controlled clinical study which aimed to evaluate the safety (tolerance in the treated area and general tolerance) and the effectiveness (reduction/elimination of itching) of the Eco-Click device, manufactured by Tecnimed s.r.l., in healthy subjects aged 18-65 years was conducted. A total of 100 subjects were evaluated, half of which received the active device. The sham (control) device was designed to have the identical physical appearance and clicking sound as the active device. The sham device contained an active piezoelectric crystal, but the electric charge was diverted within the device instead of being delivered to the skin.
Subjects were asked to rate their level of itch on a scale of 0 (no itching) to 10 (severe itching). The investigator measured the length, width, and height, in mm, the erythema of the mosquito bite using a caliper or a small ruler. The total size of the erythema was calculated as L x W x H.
Assessments were made for both itching and swelling at 10 min, 20 min, 40 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, and 24 hours post bite. Subjects were allowed to leave the test site after 1 hour. Assessments at 2, 3, 4, and 6 hours post bite are not performed at the test site. The subjects were provided with case report forms to fill out and bring back to the site at the 24 hour follow-up.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Prospective, double-blinded, placebo controlled clinical study.
Sample Size: 100 subjects (50 active, 50 control).
Results:
| Outcome Measured | 10 minutes (after first application) Active Group | 10 minutes (after first application) Control (Sham) Group | 1 hour (after first application) Active Group | 1 hour (after first application) Control (Sham) Group | Fisher's exact p-value (device treatment group-the sham group) |
|---|---|---|---|---|---|
| 40% Itch reduction | 56% (28 of 50) | 34% (17 of 50) | 98% (49 of 50) | 94% (47 of 50) | p=0.62 |
| 10% Swelling reduction | 50% (25 of 50) | 28% (14 of 50) | 86% (43 of 50) | 48% (24 of 50) | 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.
0
EVALUATION OF AUTOMATIC CLASS III DESIGNATION (DE NOVO) FOR ZANZA-CLICK (OR DISC-O-CLICK, OR MINI-CLICK)
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: Zanza-Click (or Disc-o-Click, or Mini-Click)
SUBMISSION NUMBER: DEN130019
DATE OF DE NOVO REQUEST: February 14, 2013
| REQUESTOR CONTACT: | Tecnimed S.r.l.
12, P.le Cocchi
Vedano Olona, VA 21040 Italy
Phone: +39 0542 643496 |
| -------------------- | ---------------------------------------------------------------------------------------------- |
|---|
REQUESTOR'S RECOMMENDED CLASSIFICATION: II
INDICATIONS FOR USE
Zanza-Click (or Disc-o-Click, or Mini-Click) is indicated for temporarily reducing the swelling and itching caused by mosquito bites.
Limitations
The Zanza-Click (or Disc-o-Click, or Mini-Click) device is available as an over-thecounter (OTC) device.
1
Please refer to the package insert for a complete list of Warnings and Precautions regarding the appropriate use of the Zanza-Click (or Disc-o-Click, or Mini-Click) 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 electronic device. Such use could cause electric shock, burns, or electrical interference.
Do not use the device 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 use over open wounds or rashes, or over infected or pathological or abnormal skin conditions, on bleeding or secreting areas, or if you are sensitive to electric stimulus. Do not use over viral lesions, as safety studies have not been performed to determine the effect of the device on viral lesions; therefore, the effects are unknown.
The safety and effectiveness has not been established in neonates, infants and children.
Do not use if you have used an insect repellent and/or flammable substances containing alcohol (for example: perfume, cologne, deodorant, etc.), as this device can ignite flammable substances. Wait until insect repellent and/or substances containing alcohol have thoroughly dried before using this device.
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.
Do not use in or around sensitive areas such as the mouth, tongue, eves, ear canal, internal part of the wrist or palms, mucous membranes etc.
Do not use with wet hands and on wet skin. If water seeps into the device, wait for it to completely dry off.
Use the device on a single patient.
The device cannot be sterilized. In case of accidental contact with open wounds or blood, do not use and dispose it after disinfection.
The device was only found in clinical studies to temporarily remove the itching and swelling. If you believe your mosquito bite is infected, seek medical attention.
Do not use the device to remove toxins or infection associated with mosquito bites.
2
Precautions
Discontinue use if irritation occurs. If not used according to the Directions for Use, this product may cause sensitivity at the site of application.
Use caution if stimulation is applied over areas of skin that lack normal sensation.
Dry the area of the bite before apply the device, if necessary.
Keep out of the reach of children.
Zanza-Click (or Mini-Click, or Disc-o-Click) is a medical device. Do not use it as a toy! Do not let children play with Zanza-Click (or Mini-Click, or Disc-o-Click).
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 and swelling, 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 Zanza-Click (or Disc-o-Click, or Mini-Click) is a hand held device, consisting primarily of housing, a push button (which the user depresses to excite the piezoelectric crystal by means of a spring), 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 to Figures 1-3 below for a graphical representation of the devices:
3
Figure 1. Zanza-Click
Figure 2. Disc-o-Click Figure 3. Mini-Click
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 activates a spring to mechanically deform the piezoelectric crystal, and the 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 temporarily reduce the itch and swelling associated with the underlying mosquito bite.
The user may repeat activation of the device (a maximum of five activations per bite for children, and ten activations per bite for adults and adolescents) 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 for a single user in an environment free from fluids and is provided non-sterile.
The device contains no software.
The Zanza-Click (or Disc-o-Click, or Mini-Click) 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, 2,000, and 10,000 ohms to simulate the load presented by dry skin, while using a controlled and repeatable pressure to activate the piezoelectric element. The device output, as characterized by oscilloscope tracings measured with 10,000 ohm resistance, was 2.24 kV, and a current as high as 222.83mA.
4
Performance Testing, Mechanical Failure or Degradation
The device was tested to evaluate its ability to deliver at least 25,000 charges before it stops working. This testing showed that the device delivered at least 25,000 charges before it stops working.
The device is not provided sterile, which is acceptable for the Zanza-Click (or Disc-o-Click, or Mini-Click). The device is intended only for single patient use. It is intended only for external topical use and the labeling includes appropriate cleaning instructions for safe disposal of the device (in the event of inadvertent contact with an open wound/blood).
The sponsor stated a service life of 20,000 charges is to be expected based upon their testing and has identified such within the labeling.
Electromagnetic Compatibility and Electrical, Mechanical, and Thermal Safety
Electrical Safety testing was performed per IEC 60601-1:2006, and Electromagnetic Compatibility testing was performed per IEC 60601-1-2:2007.
Biocompatibility Analysis
The patient-contacting materials are a specific acrylonitrile butadiene styrene (ABS), styrene butadiene copolymer (SBC), and polypropylene. Justification was provided supporting biocompatibility of these materials for an externally-contacting, single user device.
Human Performance Testing
The effect of the device on mosquito bite itch and swelling (device benefit) was evaluated
Study Design
A prospective, double-blinded, placebo controlled clinical study which aimed to evaluate the safety (tolerance in the treated area and general tolerance) and the effectiveness (reduction/elimination of itching) of the Eco-Click device, manufactured by Tecnimed s.r.l., in healthy subjects aged 18-65 years was conducted. A total of 100 subjects were evaluated, half of which received the active device. The sham (control) device was designed to have the identical physical appearance and clicking sound as the active device. The sham device contained an active piezoelectric crystal, but the electric charge was diverted within the device instead of being delivered to the skin.
The effect of the blinding was examined after the study to assess whether patients could correctly identify the group (active or control) they were randomly assigned to.
5
Subjects were asked to rate their level of itch on a scale of 0 (no itching) to 10 (severe itching). The investigator measured the length, width, and height, in mm, the erythema of the mosquito bite using a caliper or a small ruler. The total size of the erythema was calculated as L x W x H.
Assessments were made for both itching and swelling at 10 min, 20 min, 40 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, and 24 hours post bite. Subjects were allowed to leave the test site after 1 hour. Assessments at 2, 3, 4, and 6 hours post bite are not performed at the test site. The subjects were provided with case report forms to fill out and bring back to the site at the 24 hour follow-up.
Results
| | 10 minutes
(after first application) | | 1 hour
(after first application) | | |
|---------------------------|-----------------------------------------|----------------------------|-------------------------------------|----------------------------|-------------------------------------------------------------------------------|
| Outcome
Measured | Active
Group | Control
(Sham)
Group | Active
Group | Control
(Sham)
Group | Fisher's
exact p-value
(device
treatment
group-the
sham group) |
| 40% Itch
reduction | 56%
(28 of 50) | 34%
(17 of 50) | 98%
(49 of 50) | 94%
(47 of 50) | p=0.62 |
| 10% Swelling
reduction | 50%
(25 of 50) | 28%
(14 of 50) | 86%
(43 of 50) | 48%
(24 of 50) | p