(178 days)
Agfa's Skintell is an Optical Coherence Tomography (OCT) system indicated for use in two-dimensional, cross-sectional, real-time imaging of external tissues of human body.
Agfa's Skintell is an optical coherence tomography imaging device (OCT) weighing approximately 105kg. It is used to create images of non-open wounded human skin and the corresponding close-to-surface tissue. Skintell offers users the following functions: volume and cross-sectional imaging, high resolution rendering of structures, geometrical length- measurements.
Here’s an analysis of the acceptance criteria and supporting study for the Agfa Skintell OCT system, based on the provided 510(k) summary:
The 510(k) summary for Agfa Skintell (K132800) is a substantial equivalence submission, meaning it aims to demonstrate that the new device is as safe and effective as a legally marketed predicate device (Michelson Diagnostics VivoSight Topical OCT System, K093520). Therefore, the "acceptance criteria" are primarily defined by the performance of the predicate device and relevant product safety/quality standards. The "study" largely consists of verification and validation testing, including comparative evaluations with the predicate and histological analysis.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a substantial equivalence submission relying heavily on a predicate device, the "acceptance criteria" are implicit in demonstrating performance that is equivalent or superior in key aspects, while adhering to relevant standards. The performance aspects are compared directly to the predicate.
| Acceptance Criteria (Implicit from Predicate & Standards) | Reported Device Performance (Agfa Skintell) |
|---|---|
| Functional Equivalence to Predicate K093520 | Provides volume and cross-sectional imaging, high resolution rendering of structures, geometrical length-measurements. |
| Optical Resolution (Predicate: |
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.