(84 days)
Not Found
No
The device description details a purely mechanical fluid administration system with no mention of computational or algorithmic components.
No
The device is described as a contrast media administration set used to manage and deliver contrast agents, which are diagnostic tools rather than therapeutic agents. Its function is to facilitate the flow of contrast for imaging, not to treat a condition.
No
The device description indicates that the device is a fluid administration set used to manage contrast media. It does not mention any diagnostic functions, nor does it generate any diagnostic information. It is a tool for delivering substances to the patient, similar to an IV line.
No
The device description clearly describes physical components (spike assembly, Miser fluid administration set, burette chamber, stopcocks, shut-off disc, tubing, syringe) and their mechanical function in handling contrast media. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a system for managing and administering contrast media during a medical procedure. It describes the physical components and how they are used to control the flow of contrast. This is consistent with a device used in vivo (within the body) rather than in vitro (outside the body).
- No mention of analyzing biological specimens: The description focuses on handling contrast media, not on analyzing blood, urine, tissue, or other biological samples.
- Predicate Device: The predicate device is described as a "contrast savings delivery system," which further supports the idea that this device is for administering contrast, not for diagnostic testing of biological samples.
Therefore, the device described is a medical device used for administering contrast media, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The device consists of two parts; the spike assembly and the Miser™ fluid administration set. The spike assembly is inserted into a container of contrast media. The Miser is then attached to the spike assembly. The distal end (fixed male luer) of the Miser is attached to a manifold port (or stopcock with syringe). The stopcock on the spike assembly is opened to allow the contrast to flow into the Miser's burette chamber. The burette is filled to approximately the 10 ml level and then the contrast flow stopped by closing the stopcock on top of the burette. As contrast is withdrawn from the Miser, the level within the burette will remain at approximately the same level until the contrast in the container is depleted. The shut-off disc within the burette prevents air from entering the system when the contrast container becomes empty. The stopcock below the burette may be opened to allow the contrast contained within the proximal tubing to be aspirated.
The contrast manager is attached to a manifold port or a three way stopcock. A control syringe is connected to the manifold or stopcock on the opposite side from the indwelling catheter. Opening the port between the contrast manager and the syringe allows the syringe to aspirate contrast media. The port between the syringe and catheter is opened and the contrast can be injected into the catheter. This process can be repeated until the contrast is expended.
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
Not Found
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)
Not Found
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
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
MERIT MEDICAL
Date of Summary:
510(k) SUMMARY OF SAFETY and EFFECTIVENESS
May 8, 1996
AUG - I 1996
| Submitter's name: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095-2415
(801) 253-1600 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MERIT MEDICAL
SYSTEMS, INC. |
| Contact Person: | Dennis (Dan) Reigle |
| Name of device: | Contrast Management System |
| | 1600 WEST |
| Class: | Class II |
| | MERIT PARKWAY |
| Classification name: | Intravascular Administration Set |
| Predicate device: | The predicate device is the "contrast savings delivery
system" manufactured by North American Instrument
Company (NAMIC®) and reviewed by FDA under
premarket notification number K903493. |
| | SOUTH JORDAN,
UTAH 84095 |
DEVICE DESCRIPTION
The device consists of two parts; the spike assembly and the Miser™ fluid administration set. The spike assembly is inserted into a container of contrast media. The Miser is then attached to the spike assembly. The distal end (fixed male luer) of the Miser is attached to a manifold port (or stopcock with syringe). The stopcock on the spike assembly is opened to allow the contrast to flow into the Miser's burette chamber. The burette is filled to approximately the 10 ml level and then the contrast flow stopped by closing the stopcock on top of the burette. As contrast is withdrawn from the Miser, the level within the burette will remain at approximately the same level until the contrast in the container is depleted. The shut-off disc within the burette prevents air from entering the system when the contrast container becomes empty. The stopcock below the burette may be opened to allow the contrast contained within the proximal tubing to be aspirated.
The contrast manager is attached to a manifold port or a three way stopcock. A control syringe is connected to the manifold or stopcock on the opposite side from the indwelling catheter. Opening the port between the contrast manager and the syringe allows the syringe to aspirate contrast media. The port between the syringe and catheter is opened and the contrast can be injected into the catheter. This process can be repeated until the contrast is expended.
801-253-1600
FAX 801-253-1651
1
Image /page/1/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the words "MERIT MEDICAL" in a combination of solid black and outlined letters. The word "MERIT" is in solid black, while "MEDICAL" is outlined.
Safety Considerations
The components in the fluid administration set have been used for four years with various types of contrast media (ionic and non-ionic) without overt problems.
The redundant one way check valves were challenged to verify a high degree of reliability that retrograde flow is not possible through the one way valves thus preventing patient cross contamination.
An arbitrary six hour time limit was imposed by the predicate device manufacturer Systems, Inc. for the spike assembly to remain connected to the container of contrast. Merit agrees with this time limit and has indicated this limitation in the Instructions for Use. Merit used the six hour time limit as the exposure time for challenging the 1600 WEST one way check valves.
The protective dust cap (that is placed on the spike assembly between cases) is packaged in a separate pouch thereby preserving its sterility until needed.
Air filters are connected to all ports where air may be drawn into the system thereby preventing contamination from airborne contaminants. The air filter was challenged to verify its ability to effectively filter a test aerosol.
The Medical Device Reporting database was searched for MDRs from the two predicate device manufacturers for events relating to contrast infusion sets. Although there were no reports directly naming the predicate devices, there were several related reports. The events reported either air leaking into the infusion set or contrast leaking out. To prevent tubing set leaks, Merit has incorporated a final leak test for all (100%) tubing sets to verify set integrity. In addition, a cautionary statement is included in the labeling to verify connection integrity before use.
A study has shown radiological contrast agents to have anti-bactericidal or bacteristatic) activity.
MERIT MEDICAL
MERIT PARKWAY
South Jordan
Urah 84095
801-253-1600
iAx 801-253-1651