(617 days)
Zanza-Click (or Disc-o-Click, or Mini-Click) is indicated for temporarily reducing the swelling and itching caused by mosquito bites.
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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| No cutaneous burns from appropriate use. (Mitigated by: Characterization of Electrical Output, Labeling) | The device output was characterized and determined to be 2.24 kV and up to 222.83mA, with a duration of 30 microseconds. Labeling includes instructions to limit activation (max 10 clicks for adults, 5 for children) and warnings about repeated excessive use on the same site to avoid burns. |
| Biocompatible patient-contacting materials to prevent adverse skin reactions. (Mitigated by: Biocompatibility Assessment) | Patient-contacting materials (acrylonitrile butadiene styrene (ABS), styrene butadiene copolymer (SBC), and polypropylene) have provided justification supporting biocompatibility for external, single-user contact. |
| No damage to sensitive tissue (eyes, lips, mouth, open wounds). (Mitigated by: Labeling) | Labeling includes warnings against use in or around sensitive areas (mouth, tongue, eyes, ear canal, etc.), over open wounds or rashes, infected areas, or if sensitive to electric stimulus. Also advises caution on areas lacking normal sensation. |
| No infection from appropriate use. (Mitigated by: Labeling) | Labeling states the device cannot be sterilized, is for single patient use, and if accidental contact with open wounds/blood occurs, it should be disposed of after disinfection. |
| No burns/injuries from ignition of flammable substances. (Mitigated by: Labeling) | Labeling warns against use with insect repellent and/or flammable substances containing alcohol, and advises waiting until such substances have thoroughly dried. |
| No interference with implanted devices or other patient care devices. (Mitigated by: Labeling) | Labeling includes warnings against use if the user has a cardiac pacemaker, implanted defibrillator, or other implanted electronic device, and against use in the presence of electronic monitoring equipment. Electromagnetic Compatibility testing was performed per IEC 60601-1-2:2007. |
| Accurate targeting of the correct patient population and condition (temporary reduction of itching and swelling from mosquito bites). (Mitigated by: Labeling) | The Indications for Use specify the device is for "temporarily reducing the swelling and itching caused by mosquito bites." Labeling includes warnings that the device was only found to temporarily remove itching and swelling, and advises seeking medical attention for infected bites, and not to use it to remove toxins or infection. A labeling comprehension study indicated users understood cautionary language and instructions. |
| Effectiveness: | |
| Device must deliver at least 20,000 charges. (Mitigated by: Non-clinical (Bench) Testing, Labeling) | Mechanical degradation testing showed the device delivered at least 25,000 charges before failure. The labeling states, "Works for up to 20,000 clicks!" |
| Temporary reduction of itching and swelling caused by mosquito bites. (Mitigated by: Human Performance Testing) | At 1 hour (after first application): |
| 10% Swelling Reduction: Active Group: 86% (43 of 50) vs. Control (Sham) Group: 48% (24 of 50), with a Fisher's exact p-value |
§ 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.