(79 days)
The Aqua Spray is intended for use by Podiatric professionals as an accessory to a burr. The Aqua Spray provides an electric hand piece with an attachment that provides a fine mist of isopropyl alcohol and distilled water (50% concentration) to be dispensed over the burr. The purpose of this mist is to cool the burr and treatment area. In addition, the mist wets the treatment area, thus minimizing the amount of nail dust that becomes airborne during the nail debridement procedure.
The Aqua Spray is an electrically powered accessory to a burr. The Aqua Spray enables a burr to be attached to an electric hand piece capable of 30,000 rpm, in each direction. A small reservoir in which a 50% distilled water and isopropyl alcohol is placed is included in the unit. A small air pump sprays the water/alcohol liquid in a fine mist on the burr. The mist cools the area and prevents nail dust from the treatment area to become airborne.
This document is a 510(k) summary for a medical device (Aqua Spray). It explicitly states "Non-clinical tests: Not applicable" and "Clinical tests: Not applicable" and "Test summary: Not applicable".
Therefore, the study that proves the device meets acceptance criteria, and consequently, the acceptance criteria themselves, are not provided in the given text. This device was granted substantial equivalence ("K971941") without the need for clinical or non-clinical performance testing. The substantial equivalence was based on its similarity to a legally marketed predicate device (Podo Spray) in terms of intended use and technological characteristics.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.