(161 days)
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No
The device description focuses on the mechanical components of a syringe and its use with a powered injector for delivering contrast media. There is no mention of AI, ML, or any computational analysis of imaging data. The "computerized tomography" mentioned refers to the imaging modality, not a function of the syringe itself.
No
The device is used to deliver contrast media for diagnostic imaging (CT, MRI, angiography), not for treating a disease or condition.
No
The device is a component of a disposable syringe used to deliver contrast media for diagnostic imaging (CT, MRI, angiographic), but it does not perform the diagnostic function itself. It assists in the delivery of substances used to effect diagnostic imaging rather than being a diagnostic device.
No
The device description explicitly details physical components like a plastic barrel, plunger, synthetic rubber cover, and elastomeric seal, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for the intravascular delivery of contrast media and flushing solutions to assist in diagnostic imaging (CT, MRI, angiography). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a syringe assembly designed to contain and deliver fluids into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is designed to deliver substances into the body for imaging purposes.
N/A
Intended Use / Indications for Use
The intended use of the proposed device(s) duplicates the predicate device(s), in that, the proposed synthetic rubber cover , a component of the disposable syringe(s) device is used with a powered injector to assist the hospital clinician in the intravascular delivery of contrast media and flushing solutions at controlled flow rates and volumes, to effect computerized tomography, magnetic resonance, and angiographic diagnostic imaging.
Product codes
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Device Description
The Device is an assembly consisting of a plastic barrel, a plastic plunger, a Fluid is drawn into or expelled from the synthetic rubber cover, and an elastomeric seal. syringe by its piston which is powered and controlled by an automatic injector head. See drawing and labeling, Addendum 2.
The Device is designed to contain and hold contrast media and assist in delivery of same, to effect computerized tomography and magnetic resonance imaging, as well as, angiographic diagnostics.
The product is to be packaged in a white opaque vacuum formed plastic tray, heat sealed to a Tyvek lid. The entire package is compatible with an EtO Sterilization Cycle. See Addendum 3.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Intravascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital clinician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
See laboratory and design verification data, Addendum 5.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
See attached reference list, Addendum 1.
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).
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§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
APR 2 9 1997
510(k) SUMMARY 21 CFR 807.92
Date Prepared November 11, 1996
Submitter's Name
Medrad, Inc. One Medrad Drive Indianola, PA 15051
Mary Ann Greenawalt, J.D. Sr. Regulatory Affairs Associate (412) 767-2400 x 3111
Device Name
Classification Name: Common/Usual Name: Proprietary Name:
Injector & Syringe, Angiographic Disposable Syringe Medrad Disposable Syringe
Predicate Devices
See attached reference list, Addendum 1.
Device Description
The Device is an assembly consisting of a plastic barrel, a plastic plunger, a
Fluid is drawn into or expelled from the synthetic rubber cover, and an elastomeric seal. syringe by its piston which is powered and controlled by an automatic injector head. See drawing and labeling, Addendum 2.
The Device is designed to contain and hold contrast media and assist in delivery of same, to effect computerized tomography and magnetic resonance imaging, as well as, angiographic diagnostics.
The product is to be packaged in a white opaque vacuum formed plastic tray, heat sealed to a Tyvek lid. The entire package is compatible with an EtO Sterilization Cycle. See Addendum 3.
Intended Use
The intended use of the proposed device(s) duplicates the predicate
device(s), in that, the proposed synthetic rubber cover , a component of the disposable syringe(s) device is used with a powered injector to assist the hospital clinician in the intravascular delivery of contrast media and flushing solutions at controlled flow rates and volumes, to effect computerized tomography, magnetic resonance, and angiographic diagnostic imaging.
1
Technological Characteristics Comparisons/Distinctions:
See comparison chart, Addendum 4.
Performance Data:
:
See laboratory and design verification data, Addendum 5.
This substantially equivalent device excludes latex as an element of its formulation. However, there is no change in the function of the device(s), no changes in the safety or efficacy of the device(s), and the intended use remains the same.