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.

AI/ML Overview

I am sorry, but based on the provided text, I cannot extract the specific details you've requested about acceptance criteria and a study proving device performance as it does not contain that level of detail.

The document is a 510(k) summary for the "Miser Contrast Management System" and primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. While it mentions "Verification and Validation Studies, conducted to demonstrate control of risks identified in Merit's Miser Clinical Risk Assessment, demonstrate that the modified devices met all of their pre-determined acceptance criteria and acceptably control the identified risks," it does not provide the following information:

A table of acceptance criteria and the reported device performance: The document states that acceptance criteria were met but does not specify what those criteria were or the actual performance metrics.
Sample size used for the test set and the data provenance: No information on the sample size of the test set or the origin of the data is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the testing seems to be for device functionality rather than interpretation of diagnostic images.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document mentions "user preferences" for modifications, but not MRMC studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical device for administering contrast media, not an algorithm.
The type of ground truth used: Not applicable in the context of diagnostic interpretation. The "ground truth" here would pertain to functional performance standards which are not detailed.
The sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable.

The document is a high-level summary for regulatory filing and refers to underlying V&V studies, but the details of those studies (including specific acceptance criteria and performance data) are not included in this public summary.

Summary

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Kanss76 (c.1.52)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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.

INTENDED USE:

The Miser Contrast Management System is intended for the vascular administration of contrast media and saline.

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Merit MedicalSystems, Inc.	Miser Contrast Management SystemSpecial 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.

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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.

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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

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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: _ <483576

Regulation Number and Section

§ 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.