QRN · Radiation Therapy Marking Device

Radiology · 21 CFR 892.5785 · Class 2

Overview

Identification

A radiation therapy marking device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. The Comfort Marker 2.0 is an application system for placing reference marks on or in patient's skin to facilitate set-up for radiation therapy treatment, consisting of a battery-powered control unit with pen, a main-powered docking station, and a sterile, single-use safety needle.

Classification Rationale

Class II (special controls). The device is subject to the general controls of the FD&C Act and the identified special controls.

Special Controls

In combination with the general controls of the FD&C Act, the radiation therapy marking device is subject to the following special controls: - (1) Design verification and validation must include: - Documentation of performance data from studies that demonstrate: (i) - (A) The indicated colorant is compatible with the device and its method of delivery: - (B) The device can reproducibly deliver the indicated colorant with the specifications described; and - (C) The length of time that compatible colorants remain visible on the skin following device application. - (ii) Documentation of performance data from studies that demonstrate: - Accuracy and reproducibility of needle penetration depth; (A) - Device protection from cross-contamination, including fluid ingress (B) protection: - Adequacy of the cleaning and disinfection instructions to ensure that the (C) reusable components of the device can be cleaned and disinfected; and - (D) The sterility of all patient-contacting components (e.g., safety needle). - Documentation of performance data from studies that demonstrate electrical (iii) safety and electromagnetic compatibility (EMC) of all electrical components of the device. - Documentation of performance data from studies that demonstrate continued (iv) sterility, package integrity, and device functionality over the intended shelf life. - (v) Documentation of software verification, validation, and hazard analysis. - The labeling required under 21 CFR 801.109(c) must include: (2) - An explanation of the device and the mechanism of operation; (i) - Validated methods and instructions for reprocessing of any reusable components; (ii) - (iii) Disposal instructions: and - A shelf life for all sterile components. (iv)

Recent Cleared Devices (2 of 2)

Top Applicants

• Medical Precision BV — 2 clearances