To inflate and deflate an angioplasty balloon or other interventional device and when equipped with a gauge, to monitor the pressure within the balloon.

Device Description

The Viceroy Inflation Device is a manually-controlled inflation device clinicians use to inflate and deflate an angioplasty balloon. The device is composed of a handle or know which the clinician manipulates to achieve the desired pressure. The bandle is connected to a threaded plunger which provides for incremental pressure regulation of the syringe barrel. A locking mechanism is incorporated to maintain a constant pressure without direct user effort. The syringe barrel allows for the storage of desired pressurization rates and its walls are transparent for syringe barrel content visualization. In most Viceroy configurations an analog gauge is available for neasuring barrel pressure and the gauged devices are connected to high pressure tubing which terminates in a rotating male lucr lock connector. The non-gauged devices also terminate in a rotating male luer lock connector.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Viceroy Inflation Device. It describes the device, its intended use, and states that non-clinical testing was performed to demonstrate substantial equivalence to predicate devices. However, the document does not describe a study that proves the device meets specific acceptance criteria in the manner requested.

Specifically, the document states:

"Merit has performed a series of comparative mechanical tests to support a substantially equivalent determination and to demonstrate the device's safe and effective performance when used as intended."
"The performance data indicate that the applicant and the predicate devices have substantially equivalent values. They also indicate that the design of the applicant device is sufficiently robust for its intended use."
"The Viceroy Inflation Device has met all acceptance criteria."

While these statements confirm that tests were done and criteria were met, the document does not provide the detailed information requested about those acceptance criteria, the specific test results, sample sizes, data provenance, expert involvement, or any information about multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot populate the table and answer the specific questions because the detailed information is not present in the provided text. The document focuses on regulatory approval based on demonstrating substantial equivalence, rather than a detailed breakdown of a specific clinical or performance study with published results.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3-9-2004

Kema Quality B.V. c/o Merit Medical Systems, Inc. Mr. J.A. van Vugt N.V. KEMA Utrechtseweg 310 NL-6812 AR Arnhem The Netherlands

K040138 Re:

Trade/Device Name: Viceroy Inflation Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: MAV Dated: January 21, 2004 Received: January 22, 2004

Dear Mr. Vugt:

This letter corrects our substantially equivalent letter of February 13, 2004 regarding the address change.

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 (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 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 - Mr. J.A. van Vugt

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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Merit Medical Systems, Inc. ViceroyTM Inflation Device PREMARKET NOTIFICATION [510(k)]

SECTION E

510(k) Summary

Submitter's Information:

Merit Medical Systems, Inc. 1600 W. Merit Parkway South Jordan, UT 84095 Phone - 801-253-1600 FAX - 801-253-6911 Primary Contact: John Nicholson Alternate Contact: Ms. Jerrie Hendrickson Preparation Date; December 17, 2003

Device Information Trade Name: Common Name: Classification Name: Classification Number:

Viceroy Inflation Device Inflation Device Angiographic Injector and Syringe 21CFR, Part 870.1650 - Class II

Predicate Device(s):

~ Boston Scientific's LeVeen™ Inflator Disposable Inflation Syringe

Guidant's Indeflator™ 20/30 Inflation Device
Wilson-Cook's Quantum™ Inflation Device

Device Description:

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K040138

Merit Medical Systems, Inc. Viceroy™ Inflation Device

PREMARKET NOTIFICATION [510(k)]

Intended Use:	The Viceroy Inflation Device is intended to inflate and deflate an angioplasty balloon or other interventional device and when equipped with a gauge, to monitor the pressure within the balloon.
Technological Characteristics:	Both the predicate and applicant devices achieve equivalent clinical functions by utilizing comparable device designs and biocompatible materials to inflate and deflate an angioplasty balloon or other interventional device and to monitor the pressure within the balloon.
Non-Clinical Testing:	Merit has performed a series of comparative mechanical tests to support a substantially equivalent determination and to demonstrate the device's safe and effective performance when used as intended.
	The performance data indicate that the applicant and the predicate devices have substantially equivalent values. They also indicate that the design of the applicant device is sufficiently robust for its intended use. There are no new safety and efficacy questions which arise when the applicant device is used as intended.
Conclusion:	The Viceroy Inflation Device has met all acceptance criteria. Based upon FDA's substantial equivalence criteria, the Viceroy Inflation Device has been demonstrated to be substantially equivalent to the cited predicate devices based on intended use, labeling, design, materials, pressurization ranges and comparative performance.

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Indications for Use

510(k) Number (if known): K040138

Device Name: Viceroy Inflation Device

Indications For Use: To inflate and deflate an angioplasty balloon or other interventional device and when equipped with a gauge, to monitor the pressure within the balloon.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dung R. Lochner

േത്രം വ Cardiova

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510(k) Number K040138

Regulation Number and Section

§ 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.