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.

Device Description

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.

AI/ML Overview

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.

Summary

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February 20, 1997

y 28, 1997

SUMMARY OF SAFETY AND EFFECTIVENESS Reference 807.92: Content and format of a 510(k) summary.

FEB 25 1997

K964782

Ms. Sandra A. Pavlovic 1) Medrad, Inc. One Medrad Drive Indianola, PA 15051 (412) 767-2400
November 22, 1996
Device Name: 2)
Trade/Proprietary Name: Common/Usual Name: Classification Name:

Medrad Contrast Holder Contrast Holder Unknown

Predicate Device Information: 3)

The Medrad Contrast Holder is compared to and is substantially equivalent to the EF Brewer IV Stand (K823270) as both devices are intended to hold IV/Contrast containers during examinations. Both the predicate device and the Medrad Contrast Holder have a hook assembly to hold the containers and are adjustable for height. The differences are that the Medrad Contrast holder is attached to the Injector mount and is made out of aluminum and stainless steel hardware that are compatible within an MR environment where as the EF Brewer IV Stand is free-standing and is made of chrome-plated steel.

Device Description: 4)

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.

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Image /page/1/Picture/1 description: The image shows the word "medrad" in a stylized font, with the text "QA-96-1054-A" below it. Above the word "medrad" is the text "P.9". Below the text is the date "February 20, 1997".

Device Description: (contd.) 4)

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.

Intended Use: ર)

Technological Characteristics: ୧)

There are no new technological characteristic differences between the Medrad Contrast Holder and the EF Brewer IV Stand. The most significant difference is that the Medrad Contrast Holder is made of an aluminum pole and nonmagnetic stainless steel hooks and hardware allowing the device to be used in an MR environment. The EF Brewer stand is made of chrome-plated steel.

Performance Data

The Medrad Contrast Holder was tested by performing a visual inspection of the system as a well as a functional evaluation that included adjustable height, magnetic interference, magnetic attraction, chemical resistance, rate of collapse, handling/tip testing, durability and life-cycle testing, support hook testing, installation testing and shipping and handling testing. These tests were performed while the Medrad Contrast Holder was attached to the injector pedestal and with the Contrast Holder both in the retracted and extended mode. The purpose of these tests was to ensure that 1) the device is safe and effective when used as intended, 2) that the contrast holder is compatible with the Medrad injector pedestals and could maintain a known weight of contrast containers and, 3) can be safely used in an MR environment. The Medrad Contrast Holder meets all specifications and passed all tests performed indicating that the device is safe and effective for ins intended use.

Regulation Number and Section

§ 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.