MISER CONTRAST MANAGEMENT SYSTEM

K083576 · Merit Medical Systems, Inc. · FPA · Dec 23, 2008 · General Hospital

Device Facts

• Record ID: K083576
• Device Name: MISER CONTRAST MANAGEMENT SYSTEM
• Applicant: Merit Medical Systems, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Dec 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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

Device Story

The Miser Contrast Management System is a fluid delivery accessory consisting of a contrast spike assembly and a burette assembly. It is used to facilitate the controlled administration of contrast media and saline during vascular procedures. The spike assembly connects to a contrast media container, while the burette assembly connects to a manifold port. Operation involves manual manipulation of a vent valve and burette chamber to create a vacuum, drawing contrast media into the chamber. A shut-off valve (orange ball) prevents air from entering the system when the media container is empty. A filtered stopcock allows for the aspiration of residual fluid. The device is intended for use by healthcare professionals in clinical settings to manage contrast delivery, minimizing air entry risks and optimizing fluid usage.

Clinical Evidence

Bench testing only. Verification and validation studies were conducted to demonstrate control of risks identified in the clinical risk assessment, confirming that the modified device met all pre-determined acceptance criteria.

Technological Characteristics

Intravascular administration set consisting of a contrast spike assembly and burette assembly. Features include a vent valve mechanism, a shut-off (orange ball) valve, and a filtered stopcock. Materials and tubing formulations were modified from the predicate to address user preferences. The device is a mechanical fluid management system; no electronic components, software, or energy sources are utilized.

Indications for Use

Indicated for the vascular administration of contrast media and saline in patients requiring such administration.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Miser Contrast Management System (K961794)

Submission Summary (Full Text)

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| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Merit Medical | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>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; [e-mail]

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.

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| Merit Medical<br>Systems, Inc. | Miser Contrast Management System<br>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.

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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.

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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 [phone]. 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 [phone] or [phone] 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