(58 days)
The PrecisePLAN® Treatment Planning System is intended to be used for planning the dosimetry of treatments in radiation therapy. PrecisePLAN® provides 2 and 3 dimensional planning capabilities based upon user defined treatment plan parameters. As an option, the user may elect to use weight optimization functionality that suports Intensity Modulated Radiaton Therapy (IMRT). Using the IMRT functionality extends the 3-D conformal planning where geometric shaped apertures are created to cover target structure(s) and minimize exposure to surrounding organs at risk. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.
PrecisePLAN® 2.00 is an enhancement to the PrecisePLAN® 1.00, which has previously been cleared for commercial distribution (K002240 8/23/2000). This enhancement to PrecisePLAN® does not raise additional types of safety or effectiveness considerations.
The provided text is a Summary of Safety & Effectiveness for PrecisePLAN® 2.00, a treatment planning system for radiation therapy. It claims that PrecisePLAN® 2.00 is an enhancement to a previously cleared device (PrecisePLAN® 1.00) and does not introduce new safety or effectiveness concerns.
However, the document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide details on the performance of the device based on such a study. It primarily focuses on regulatory compliance, quality systems, and risk analysis related to the enhancement.
Therefore, I cannot provide the requested table and information based on the given text.
The document mainly discusses:
- Claim of substantial equivalence: PrecisePLAN® 2.00 is an enhancement to a previously cleared device (K002240) and does not raise additional safety or effectiveness considerations.
- Regulatory compliance: CE mark, ISO 9001, Medical Device Directive 93/42/EEC Annex II, 21 CFR 820.
- Risk analysis: Concluded that it does not introduce new hazards, and the level of concern is "Major" as per FDA guidance.
- Intended Use: Planning the dosimetry of treatments in radiation therapy, including 2D and 3D planning, and optional weight optimization functionality supporting Intensity Modulated Radiation Therapy (IMRT).
There is no data presented regarding specific performance metrics (e.g., accuracy, precision) of the device against predefined acceptance criteria.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.