The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.

Device Description

The 30 ATM Monarch™ is a 20 ml single use balloon inflation and fluid dispensing syringe. This 30 ATM Monarch™ is a combination of a 20 ml syringe, microcomputer, back-lit LCD, threaded device with an integral pressure bar, a flexible high pressure extension tube and a plunger assembly with a lock and release button. The 30 ATM Monarch™ is capable of generating and monitoring pressures over a range of -1 to +30 atmospheres (-7 to + 441 PSI). The pressure is increased by turning the syringe plunger handle. The pressure increases by approximately 1 atmosphere with each 360° turn of the syringe plunger handle.

AI/ML Overview

The provided text is a 510(k) Safety and Effectiveness Summary for a medical device called the "30 ATM Monarch Syringe," a balloon inflation and fluid dispensing syringe. This document is from 2001 and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed studies with acceptance criteria, sample sizes, or ground truth validation as would be typical for more complex AI/software as a medical device (SaMD) clearances today.

Therefore, much of the requested information regarding acceptance criteria for device performance, expert-established ground truth, sample sizes for test and training sets, and MRMC studies is not present in the provided document, as it outlines a different type of regulatory submission from nearly two decades ago.

However, I can extract the information that is available and indicate when information is not provided.

Acceptance Criteria and Device Performance

The concept of specific "acceptance criteria" and "reported device performance" as might be seen for a software algorithm is not explicitly detailed in this 510(k) for a mechanical device. Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices (Monarch™ Inflation Syringe K943597 and Universal Fluid Dispensing Syringe K973230) by comparing materials, intended use, and operational capabilities. The key performance aspect mentioned is the ability to generate and maintain pressures.

Acceptance Criteria Category (Derived from Device Description)	Stated Performance / Capability of 30 ATM Monarch Syringe
Pressure Generation & Maintenance	Capable of generating and maintaining pressures over a range of -7 to +441 PSI (-1 to +30 atmospheres).
Volume Dispensing Capacity	20 ml (implied by "20 ml single use balloon inflation and fluid dispensing").
Inflation/Deflation Functionality	Used to inflate and deflate balloon angioplasty catheters.
Pressure Measurement Functionality	Used to measure the pressure within the balloon during the procedure.
Fluid Injection Functionality	Used to inject fluids into the body.
Fluid Pressure Monitoring Functionality	Used to monitor the pressure of that fluid.

Study Details (Information Not Fully Provided for AI/SaMD Context)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. This document does not describe a clinical study with a test set in the manner of an AI/SaMD product. The submission is based on demonstrating substantial equivalence through comparison with predicate devices and possibly bench testing, but details of such testing (sample sizes, data provenance) are not included in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not provided. This is a hardware device (syringe), not a diagnostic algorithm where expert-established ground truth is typically used for performance evaluation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This concept relates to the establishment of ground truth for diagnostic decisions, which is not relevant to this device's regulatory submission based on the provided text.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, not done. This is a medical device (syringe), not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided in this context. For a syringe, the "ground truth" would relate to its physical performance metrics (e.g., pressure accuracy, volume delivery accuracy, material integrity) measured through engineering tests, rather than clinical diagnostic ground truth. These test details are not in the summary.
The sample size for the training set:
- Not applicable/Not provided. This device does not have a "training set" in the context of an AI/machine learning algorithm.
How the ground truth for the training set was established:
- Not applicable/Not provided. See the previous point.

Summary of Non-Applicability/Missing Information:

The provided document is a 510(k) summary from 2001 for a mechanical medical device (a syringe). This type of submission primarily focuses on demonstrating "substantial equivalence" to legally marketed predicate devices in terms of intended use, technological characteristics, and safety/effectiveness. It does not contain the detailed study methodologies, sample sizes, ground truth establishment, or AI-specific performance metrics that are requested in the prompt, as these are more characteristic of regulatory submissions for advanced software or AI/Machine Learning as a Medical Device (SaMD) products, especially in recent years.

Summary

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SAFETY AND EFFECTIVENESS SUMMARY AUG 2 2 2001

This information of 510(k) safety and effectiveness information is being submitted in This micrination the requirements of 21 CFR 807.92.

Submitted by Name / Address:	Dennis (Dan) ReigleManager Regulatory AffairsMerit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4349 (direct)(801) 253-1684 (fax)
Contact Person:	Same as above
Date Summary Prepared:	July 24, 2001
Device Name:	30 ATM Monarch Syringe
Common Name:	Balloon Inflation Syringe
Trade Name:	Monarch™ Inflation SyringeUniversal Fluid Dispensing Syringe
Classification (if known):	Cardiovascular
Predicate Device(s):	Monarch™ Inflation Syringe (K943597)Universal Fluid Dispensing Syringe(K973230)

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SAFETY AND EFFECTIVENESS SUMMARY

Device Description:

The 30 ATM Monarch™ is a 20 ml single use balloon inflation and fluid dispensing I hic 50 ATM Monater - 18 a 20 million of 20 microcomputer, back-lit LCD, threaded device will an intogral problemense bar, a flexible high pressure extension tube and a punger assembly with locas recease our a career of the Monarch™ is capable of generating thice-way incoran pressures over a range of -- 1 to +30 atmospheres (-7 to + 441 PSI). The and montoning pressures over a lange withing the each 360° turn of the syringe plunger handle.

Intended Use:

The 30 ATM Monarch™ syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.

		Modified Device	Predicate Devices
		30 ATM Monarch(K011811)	25 ATM Monarch(K943597)	Universal FluidDispensing Syringe(K973230)
	Materials		Polycarbonate	Polycarbonate
●	Barrel	Same as Predicate Devices	Polycarbonate	Polycarbonate
●	Syringe Plunger	Same as Predicate Devices	ABS Plastic	ABS Plastic
●	Syringe Plunger Tip	Same as Predicate Devices	Natural Rubber	Natural Rubber
●	Tubing withRotating Adaptor	Same as Predicate Devices	Polyurethane tubing	Polyurethane tubing
			Polycarbonate adaptor	Polycarbonate adaptor
●	Pressure TransducerInterface	Same as Predicate Devices	Black Silicone Gel	Black Silicone Gel
●	Microprocessor	Same as Predicate Devices	NEC Electronics, Inc.µPD75328, 4bit CPU	NEC Electronics, Inc.µPD75328, 4bit CPU

Comparison of 30 ATM Monarch™ to Predicate Devices

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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 circle is a stylized symbol resembling an abstract caduceus, with three curved lines representing the staff and a serpent winding around it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2001

Mr. Dennis Reigle Manager, Regulatory Affairs Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095

K011811 Re:

Trade Name: Monarch™ Syringe Universal Fluid Dispensing Syringe Regulation Number: 870.1650 Regulatory Class: II (two) Product Code: 74 DXT and 74 MAV Dated: July 27, 2001 Received: July 30, 2001

Dear Mr. Reigle:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Dennis Reigle

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:_30 ATM Monarch Syringe

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Device*
510(k) Number K 171811

(Optional Format 3-10-98)

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.