(528 days)
The intended use of the Candela Dynamic Cooling Device is to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to reduce pain associated with laser treatment.
Candela's Dynamic Cooling Device consists of 1) a source of skin refrigerant fluid (CFC R-12), 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with an SPTL laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of CFC R-12 just prior to the delivery of a laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. Thermal injury to non-vascular structures is minimized and pain associated with the laser treatment is reduced.
The provided text is a 510(k) summary for the Candela Dynamic Cooling Device, submitted in 1996. It details the device's purpose and general information but does not contain the specific information required to answer your questions about acceptance criteria, study details, and performance metrics.
This document is focused on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway for approval, rather than demonstrating clinical or technical performance through detailed studies with specific metrics.
Therefore, I cannot populate the table or answer the specific questions because the foundational information is absent from the provided text. The document states:
- "Candela's Dynamic Cooling Device has undergone and passed testing during its development designed to assess the performance of components and finished devices, including dimensional testing, functional properties, function according to its intended use, ease of use and durability."
However, it does not provide the results of this testing, the acceptance criteria used, or any details about sample sizes, ground truth establishment, or expert involvement.
§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.