(20 days)
Not Found
No
The device description details a purely mechanical system for managing contrast media flow, with no mention of computational or data-driven components.
No
This device is for the vascular administration of contrast media and saline, which are diagnostic agents, not therapeutic agents used for treating a disease or condition.
No
The device is intended for the administration of contrast media, which is used to enhance imaging for diagnostic purposes, but the device itself does not perform any diagnostic function (e.g., image analysis, condition detection). It is a delivery system.
No
The device description clearly outlines physical components like spike assemblies, burette assemblies, tubing, valves, and stopcocks, indicating it is a hardware-based medical device.
Based on the provided information, the Miser Contrast Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the vascular administration of contrast media and saline." This describes a device used in vivo (within the body) for delivering substances, not for examining specimens in vitro (outside the body) to diagnose conditions.
- Device Description: The description details a system for managing and delivering fluids into the vascular system. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests on samples, or providing diagnostic information based on in vitro analysis.
Therefore, the Miser Contrast Management System is a medical device used for administering substances to a patient, not an IVD.
N/A
Intended Use / Indications for Use
The Miser Contrast Management System is intended for the vascular administration of contrast media and saline.
Product codes
FPA
Device Description
Merit Miser Contrast Management System consists of the Contrast Spike Assembly and Contrast Burette Assembly.
During use, the spike assembly is inserted into a container of contrast media. The proximal tubing of the burette assembly is attached to the spike assembly and the longer, distal burette tubing segment is attached to a manifold port (not provided).
The burette is filled to the approximate 20mL level by first pinching the 2 wings of the vent valve mechanism together while squeezing the burette chamber, thus forcing air from the burette chamber. The wings are then released, closing the vent. The residual vacuum in the burette draws contrast media through the 2 backflow valves into the chamber until the vacuum is neutralized. The fluid level will remain at this level until the vent valve is opened or the contrast media is depleted.
The shut off (orange ball) valve located at the bottom of the burette chamber minimizes the potential for air to enter the system when the contrast media container is depleted. The filtered stopcock located below the burette chamber may be used to allow the contrast solution remaining in the tubing to be aspirated for injection into the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General Hospital
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
Verification and Validation Studies, conducted to demonstrate control of risks identified in Mcrit's Miser Clinical Risk Assessment, demonstrate that the modified devices met all of their pre-determined acceptance criteria and acceptably control the identified risks.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Kanss76 (c.1.52)
Pa
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Merit Medical | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Miser Contrast Management System |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Systems. Inc. | Special 510(k) |
SECTION 5: 510(k) SUMMARY
DEC 2 3 2008
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
CONTACT: Stephanie Erskine, V.P. Regulatory Affairs 801. 208.4349; 801.253.6967 fax; scrskine@mcrit.com
DATE PREPARED: December 1, 2008
TRADE OR PROPRIETARY NAME: Miser Contrast Management System
CLASSIFICATION/ NAME: Class II, Intravascular Administration Set (880.5440), Product Code FPA; General Hospital
PREDICATE DEVICES: Miser Contrast Management System (K961794)
DEVICE DESCRIPTION:
Merit Miser Contrast Management System consists of the Contrast Spike Assembly and Contrast Burette Assembly.
During use, the spike assembly is inserted into a container of contrast media. The proximal tubing of the burette assembly is attached to the spike assembly and the longer, distal burette tubing segment is attached to a manifold port (not provided).
The burette is filled to the approximate 20mL level by first pinching the 2 wings of the vent valve mechanism together while squeezing the burette chamber, thus forcing air from the burette chamber. The wings are then released, closing the vent. The residual vacuum in the burette draws contrast media through the 2 backflow valves into the chamber until the vacuum is neutralized. The fluid level will remain at this level until the vent valve is opened or the contrast media is depleted.
The shut off (orange ball) valve located at the bottom of the burette chamber minimizes the potential for air to enter the system when the contrast media container is depleted. The filtered stopcock located below the burette chamber may be used to allow the contrast solution remaining in the tubing to be aspirated for injection into the patient.
INTENDED USE:
The Miser Contrast Management System is intended for the vascular administration of contrast media and saline.
1
| Merit Medical
Systems, Inc. | Miser Contrast Management System
Special 510(k) | |
| -------------------------------- | ---------------------------------------------------- | -- |
|---|
TECHNOLOGICAL COMPARISON:
The modified device has the identical intended use and employs the same fundamental technology as the predicate device. The burctte chamber material, burette venting mechanism, burette shutoff valve, and tubing formulation have been modified to address user preferences.
PERFORMANCE TESTING:
Verification and Validation Studies, conducted to demonstrate control of risks identified in Mcrit's Miser Clinical Risk Assessment, demonstrate that the modified devices met all of their pre-determined acceptance criteria and acceptably control the identified risks.
SUMMARY OF SUBSTANTIAL EQUIVALENCE:
Based on:
- Merit's conformance with Design Control requirements; .
- Analyses of Risks associated with the Modified Device; and �
- Results of Verification and Validation tests identified in the Clinical Risk Assessment . demonstrating that predetermined acceptance criteria have been met and risks adequately controlled,
Merit concludes that the modified devices are as safe and effective as, and perform as well as, or better than, the predicate devices.
2
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stephanie A. Erskine Vice President, Corporate Regulatory Affairs Merit Medical Systems. Incorporated 1600 West Merit Parkway South Jordan, Utah 84095
DEC 2 3 2008
Re: K083576
Trade/Device Name: Miser Contrast Management System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 2, 2008 Received: December 3, 2008
Dear Ms. Erskine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is an abstract symbol that resembles a stylized caduceus, with three curved lines representing the snakes and a central element representing the staff.
3
Page 2 - Ms. Erskine
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cure
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATIONS FOR USE
K Φ83576 510(k) Number (if known):
Device Name:
Indications for Use:
The Miser Contrast Management System is intended for the vascular administration of contrast media and saline.
Prescription Use _ X ____________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
ﻧﻴﻮﺯ
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anten Vorn
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _