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510(k) Data Aggregation
(90 days)
The Picker International ASSET system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The ASSET APOLLO MR system includes the following enhancements: a water cooled gradient system, increased gradient performance, increased scan/reconstruction rates, and a user selectable bandwidth option.
This 510(k) submission (K971884) for the ASSET APOLLO Magnetic Resonance Imaging System focuses on demonstrating substantial equivalence to previously cleared predicate devices (ASSET K933835 and EDGE/VISTA K964626) rather than presenting a performance study with specific acceptance criteria and detailed statistical analysis as might be seen for a novel device or AI algorithm.
The core argument is that the ASSET APOLLO retains the same intended use and fundamentally similar technological characteristics to its predicates, with enhancements that do not raise new questions of safety or effectiveness. Therefore, there are no explicit acceptance criteria for device performance based on a new study outlined in this document, nor is there a study described that "proves the device meets the acceptance criteria" in the traditional sense of evaluating an algorithm's diagnostic accuracy.
The provided information primarily details the technical specifications of the ASSET APOLLO and compares them to the predicate devices to establish substantial equivalence.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported ASSET APOLLO Performance |
|---|---|---|
| Intended Use | Same as predicate ASSET system | Same as predicate ASSET system |
| Computer Subsystem | Equivalent to or improved over predicate K964626 | Same as K964626 |
| Image Storage (Short Term) | Equivalent to predicate ASSET (K933835) | Magnetic Disk |
| Image Storage (Archival) | Equivalent to predicate ASSET (K933835) | Optical Disk |
| Gradient Coils | Water-cooled self-shielded design, similar to K964626 | Water-cooled self-shielded |
| Max. Gradient Strength | Equal to or greater than predicate ASSET (10 mT/m) and within range of K964626 (16, 20, 27 mT/m) | 16 mT/m |
| Max. Slew Rate | Equal to or greater than predicate ASSET (18 mT/m/msec) and within range of K964626 (25, 40, 72 mT/m/msec) | 25 mT/m/msec |
| Gradient Amps | Equivalent to or improved over predicate ASSET and K964626 | 150 A RMS, 300 A peak, 400 V |
| DTR Spectrometer | Equivalent to predicate ASSET (K933835) | Same as K964626 |
| RF Amplifiers | Single frequency, 5.0 kW (improved over K933835's 2.5 kW) | Single frequency 5.0 kW |
| Body Coil | Equivalent to predicate ASSET (K933835) | Same as K933835 |
| Head Coil | Equivalent to predicate ASSET (K933835) | Same as K933835 |
| Optional Receive Only Coil Connection | Equivalent to predicate ASSET (K933835) | Same as K933835 |
| Transmit/Receive Box | Equivalent to predicate ASSET (K933835) | Same as K933835 |
| Magnet Subsystem | Equivalent to predicate ASSET (K933835) | Same as K933835 |
| Patient Handling | Equivalent to predicate ASSET (K933835) | Same as K933835 |
| Magnet Facade | Equivalent to predicate ASSET (K933835) | Same as K933835 |
| Power Distribution Subsystem | Equivalent to predicate ASSET (K933835) | Same as K933835 |
| Operating Software | Equivalent to predicate K964626 | Same as K964626 |
| Operational Features | Equivalent to predicate ASSET (K933835) | Same as K933835 |
| Standard Imaging Sequences | Equivalent to predicate ASSET, with addition of AcuScan package | Same standard imaging sequences with AcuScan |
| Acquisition and Reconstruction Techniques | Equivalent to predicate K964626 | Same as K964626 |
| Optional Receive Only Coils and Accessories | Equivalent to predicate ASSET (K933835) | Same as K933835 |
| Software Options | All options available on predicates; new options are incremental | Angiography, Cardiac Imaging, VFASE, GRaSE, EPI |
| Time Varying Magnetic Field (dB/dt) | Normal Operating Mode: ≤ 40 T/s (as K964626); First Controlled Operating Mode: ≤ 60 T/s (as K964626). Note: K933835 was ≤ 20 T/s, hence ASSET APOLLO is an improvement/equivalent to higher standard. | Same as K964626 (Normal: ≤40 T/s, First Controlled: 40 T/s |
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