(90 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI/ML or data processing.
No
The device is an accessory (contrast holder) designed to aid in the transfer of contrast media or flushing agents to an injector, not directly to a patient for therapeutic purposes.
No
The device is an accessory (contrast holder) for Medrad injectors, designed to aid in the transfer of contrast media or flushing agents to the syringe, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like telescoping tubes, clamps, hooks, and an optional tray, indicating it is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, the Medrad Contrast Holders are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "aid in the transfer of common contrast media or flushing agents such as saline to the syringe." This describes a physical support and positioning device for substances that are introduced into the body for imaging purposes.
- Device Description: The description details a mechanical device that mounts to an injector system and holds containers. It does not involve any testing of samples outside the body.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device (height adjustment, magnetic compatibility, durability, etc.), not on the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Medrad Contrast Holders do not perform any such function. They are an accessory to a medical imaging procedure, not a diagnostic test itself.
N/A
Intended Use / Indications for Use
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.
Product codes
Unknown
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals trained in CT, MR .Angiographic Procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
-
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 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.
1
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)
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.
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.