(63 days)
INTERA I/T is a whole body 1.5T Magnetic Resonance Diagnostic Device being extended with optional hardware extensions to aid in the performance of interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging.
The INTERA I/T is based on the same platform as Philips INTERA 1.5T system (predicate device) with the same intended use but extended with additional hardware features. The optional hardware extensions are meant to aid in the performance of interventional procedures in the head, body and extremities, which may be assisted by existing MR techniques, such as real time imaging. The extension provides the facility to transfer the patient including the patient tabletop from a diagnostic imaging device of other modality (workspot), e.g. X-ray, to the MR system viceversa. These additional workspots are located outside the 0.5mT-fringe field of the MR system. The INTERA I/T will be offered in three optional versions: INTERA I/T Standard, INTERA I/T Neurosurgery, and INTERA I/T CV. The hardware extensions comprise of: Adaptation of the standard MR patient support system, Additional Patient Table (workspot outside the 0.5 mT fringefield), Interactive Display with a rail ceiling suspension, Interventional received RF-coils: Synergy Flex (circular) Large, Medium and Rectangular, and Interventional accessories: Head tilting device (Trendelenburg positioning possibility), straps and an add-on table top extension.
This document is a 510(k) summary for the Philips INTERA I/T Magnetic Resonance Diagnostic Device. It states that the INTERA I/T is substantially equivalent to a predicate device, the Philips INTERA 1.5T system (ref. K001796).
Based on the provided text, there is no specific study described that proves the device meets acceptance criteria. Instead, the document argues for substantial equivalence to a predicate device. This means the device's safety and effectiveness are asserted based on its similarities to an already legally marketed device, rather than through independent studies with predefined acceptance criteria.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Number of experts used to establish ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Summary of available information regarding acceptance criteria and proof of effectiveness:
The document explicitly states:
- Acceptance Criteria (Implied): Substantial Equivalence to the predicate device, Philips INTERA 1.5T (K001796). This implies that the device's performance, particularly regarding safety, should be identical or very similar to the predicate device.
- Study Proving Acceptance Criteria: The document does not describe a study in the traditional sense (e.g., a clinical trial or performance evaluation with specific metrics). Instead, it makes the following claims:
- "The safety parameters of the INTERA I/T remains the same as with its predicate device INTERA 1.5T (ref.K0001796)."
- "The safety and effectiveness of the INTERA I/T are the same with its predicate device the INTERA 1.5T (ref K001796.)."
- "It does not induce other safety issues and warnings than already valid for its predecessor and predicate device."
- "The INTERA I/T is substantially equivalent to the predicate device Philips INTERA 1.5T with FDA ref. K001796."
This approach of demonstrating substantial equivalence is common for 510(k) submissions, where a new device is compared to a legally marketed predicate device rather than undergoing extensive new clinical trials if its technological characteristics and intended use are similar. The submission relies on the established safety and effectiveness of the predicate device.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.