(90 days)
The Medrad Contrast Holders are an accessory device intended to be used in conjunction with Medrad injectors. The device is designed to aid in the transfer of common contrast media or flushing agents such as saline to the syringe. Users of this device are to be medical professionals trained in CT, MR .Angiographic Procedures, and are expected to have a good understanding of the events leading up to and including the use of the device. The Medrad Contrast Holder replaces the need for a separate contrast holder or Medrad Contrast Holder and is designed specifically for use with Medrad injectors.
The Medrad Contrast Holder will be used in conjunction with 510 (k) approved Medrad Injector systems. The Contrast Holder mounts to either a Medrad injector pedestal or the Counterpoise System ( CS) by means of clamps that attach to the pedestal or CS.
The injector pedestal mounted Contrast Holder utilizes a two-section telescoping tube with a hand-turned knob to adjust the height. Two hooks are used to hang containers. One of the pedestal mounts uses two ring clamps to mount to the pedestal shaft. The other mounts to one of the pedestal legs and is supported by a clamp on the handle of the injector control unit.
The Contrast Holder for the CS uses a ring clamp to attach to the articulating counterbalance arm of the CS. A hook hangs vertically from the clamp.
An optional tray for holding accessories or bottles is available. The tray snaps into a clamp on the lower section of the telescoping tube and can be removed for cleaning.
This document describes a medical device, the Medrad Contrast Holder, and its performance testing. However, it does not describe acceptance criteria or a study that proves the device meets those criteria in the way typically associated with AI/ML-driven medical devices.
Instead, this document describes a traditional medical device (a physical holder for IV/Contrast containers) and its performance validation through a series of engineering and functional tests. Therefore, many of the requested fields are not applicable in this context.
Here's an analysis based on the provided text, highlighting where information is available or not applicable:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is safe and effective when used as intended | Meets all specifications and passed all tests. |
| Compatible with Medrad injector pedestals | Passed installation testing, compatible with Medrad injector pedestals. |
| Maintain a known weight of contrast containers | Passed support hook testing, indicated to maintain known weight. |
| Safely used in an MR environment | Made of aluminum pole and nonmagnetic stainless steel hooks/hardware; passed magnetic interference and magnetic attraction tests. |
| Functional (adjustable height, no collapse, etc.) | Passed functional evaluation including adjustable height, rate of collapse tests. |
| Durable and withstands life-cycle usage | Passed durability and life-cycle testing. |
| Withstands handling and shipping | Passed handling/tip testing and shipping and handling testing. |
| Chemically resistant | Passed chemical resistance testing. |
Explanation: The document lists various tests performed, implying that successfully passing these tests constitutes meeting the acceptance criteria for a safe and effective device. The "Reported Device Performance" is consistently stated as having "met all specifications and passed all tests performed."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. For a physical device, this would typically refer to the number of units tested. The document implies testing was done on at least one representative unit.
- Data Provenance: Not specified, but implied to be internal testing by Medrad, Inc. (Indianola, PA, USA). This would be prospective testing as it's part of the device development and clearance process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This device is hardware; its "ground truth" is established through engineering specifications, material properties, and functional performance tests conducted by engineers and technicians, not clinical experts for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for subjective assessments, often in diagnostic imaging. Here, tests are typically objective (e.g., measuring forces, observing physical behavior, material compatibility).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a hardware device, not an AI/ML diagnostic algorithm. MRMC studies are used for evaluating diagnostic performance with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications and Material Properties. The "ground truth" for this device's performance is its adherence to predefined engineering specifications (e.g., weight capacity, dimensions, material compatibility for MR environment, durability standards) and its functional operation as designed.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical device.
§ 880.6990 Infusion stand.
(a)
Identification. The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.