The Acist™ CMS-2000 Angiographic Injection System with Contrast Management is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Device Description

The ACIST Medical Systems Angiographic Contrast Management System is an accessory to the ACIST Injection System. It is designed to allow the user to safely use contrast media for multiple procedures . It consists of a two-park kit—Parts A, a non-patient contact kit, and B, a patient contact kit. Part A is initially set up and filled with contrast media. Part B is then attached to Part A via a connector and the system is ready to initiate a procedure. " The Drish attached it Part R VILLE Collection of the procedure, Part B is disconnected and discarded. The syringe cap is placed on Part A to maintain sterility between procedures. The Angiographic Contrast Management System is provided sterile and is intended for single use only.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies:

This document is a 510(k) summary from 1998 for the "Angiographic Contrast Management System." It's important to note that the level of detail regarding comprehensive study design and statistical outcomes, especially for AI-specific criteria, was significantly different in 1998 compared to current FDA submissions. The device described here is a mechanical system, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML performance (like MRMC studies, standalone AI performance, training set details, and expert qualifications for ground truth in an imaging context) are not applicable or not provided in this type of submission.

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting established safety and performance standards for medical devices of this type. The provided document focuses on demonstrating that the device maintains sterility and structural integrity.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implied)	Reported Device Performance
Sterility Maintenance	The device must effectively maintain the sterility of the contrast media and syringe components, even with continued use across multiple procedures, preventing patient-contacting fluids from contaminating the main fluid supply. This aligns with the "safely use contrast media for multiple procedures" indication. (Implied from the device's design and comparison to predicates that also maintain sterility during multi-procedure use, as well as the 'Biological Challenge tests').	"Biological Challenge tests were conducted demonstrating the ability of the device to maintain the sterility of the contrast media and syringe, allowing continued used of those components." This directly addresses the sterility criterion.
Structural Integrity	The interconnect between Parts A and B of the two-part kit must be robust and secure to prevent leakage and ensure proper function during use. (Implied from the design and need for safe operation).	"Pressure testing verified the interconnect between Parts A and B." This confirms the structural integrity of the critical connection.
Packaging Integrity	The packaging must be validated to ensure the device remains sterile and intact until use. (General medical device requirement).	"Packaging validation testing verified the modified packaging configuration." This indicates that the packaging was tested and found acceptable.
Prevention of Retrograde	The device design must prevent the reflux or backward flow of patient-contacting fluids into the main contrast media supply. (Explicitly stated in technological characteristics).	"Like the predicate Merit and Namic products, the Angiographic Contrast Management System is designed with one-way check valves to prevent retrograde flow." While not a test result in the same way as the others, it outlines a design feature that inherently fulfills this criterion, which is typical for substantial equivalence if the predicate also uses such a design. The previous sterility testing would indirectly confirm the effectiveness of this design in preventing contamination from retrograde flow.

Study Details (Based on the provided K984231 information)

Given the nature of this 1998 mechanical device submission, many of the questions are geared towards AI/ML device studies and are not directly applicable.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. For "Biological Challenge tests," this would typically refer to the number of test articles (devices) and the number of cycles or procedures simulated. For "Pressure testing," it would be the number of test articles. For "Packaging validation," it would be the number of packages tested under various conditions.
- Data Provenance: Not specified, but generally, such tests would be conducted in a laboratory setting by the manufacturer or a contracted lab. It is inherently "prospective" in the sense that the testing is performed specifically to validate the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device does not involve image interpretation or diagnostic performance requiring expert "ground truth" in the way an AI/ML imaging device would. The "ground truth" for the tests (e.g., presence/absence of microbial growth, pressure integrity, package seal integrity) would be determined by standard laboratory methods and equipment, not by expert consensus on clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for establishing ground truth in subjective assessments, such as interpreting medical images. For objective laboratory tests like sterility or pressure testing, the results are typically quantitative or qualitative (pass/fail) based on predefined thresholds, not on a panel of adjudicators.
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, a MRMC study was not done. This device is a mechanical system for contrast delivery, not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done in the context of an AI algorithm. The device itself performs its function (delivering contrast, maintaining sterility) without an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Sterility Maintenance: The ground truth would be based on microbiological detection methods (e.g., culture-based tests for microbial growth) conforming to established standards for sterility testing.
- For Structural Integrity (Pressure Testing): The ground truth would be based on physical measurements of pressure and detection of failure (e.g., leakage, burst pressure) against engineering specifications.
- For Packaging Validation: The ground truth would be based on integrity tests (e.g., peel strength, visual inspection, dye penetration) and environmental conditioning results against established packaging standards.
The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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K984231

510(k) SUMMARY General Information

Date Prepared	November 23, 1998
Classification	Class II
Trade Name	Angiographic Contrast Management System
Common Name	Intravascular Fluid Delivery Set
Submitter	ACIST Medical System10250 Valley View RoadEden Prairie, MN 55344612-941-3507
Contact	Kate AndersonManager, QA/Regulatory
Predicate Devices	Acist Injection System (K963882)ACIST Medical Systems
	Merit Contrast Management System (K961794)Merit Medical Systems, Inc.
	NAMIC Contrast Saving Delivery System (K903493)North American Instrument Corporation, Angiographic SystemDivision

Device Description

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The Angiographic Contrast Management System is provided sterile and is intended for single use only.

Indication

The Acist™ Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. The Angiographic Contrast Management System allows the user to safely use contrast media for multiple procedures.

Technological Characteristics

The Angiographic Contrast Management System is designed to prevent patient contacting fluids from contaminating the fluid contained within the dual port syringe and contrast media container. Like the predicate Merit and Namic products, the Angiographic Contrast Management System is designed with one-way check valves to prevent retrograde flow.

As with the Namic product, Biological Challenge tests were conducted demonstrating the ability of the device to maintain the sterility of the contrast media and syringe, allowing continued used of those components. Pressure testing verified the interconnect between Parts A and B. Packaging validation testing verified the modified packaging configuration.

Summary

In summary, the above listed predicate devices and the ACIST Angiographic Contrast Management System are substantially equivalent based on design, performance characteristics, and indications for use.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 1 2000

Mr. Carl M. Beaurline Vice President Quality Assurance/Regulatory Affairs Acist Medical Systems, Inc. 7450 Flying Cloud Drive, Suite 150 Eden Prairie, MN 55344

K984231) and K991103 Re: (

R9042017 and RS-2000 Angiographic Injection System with Contrast Management Regulatory Class: Class II DXT Product Code: November 25, 1998 and March 26, 1999 Dated: November 25, 1998 and April 1, 1999 Received:

Dear Mr. Beaurline:

We have reviewed your Section 510(k) notifications of intent to market we nave reviewed your beceiver on the determined the device is the device fereienced above and his marketed predicate devices substantlainy equivatine co-regary many 28, 1976, the enactment Marketed in Incerdate Seathernments or to devices that have been date of the Medical Device famakers' of the Federal Food,
reclassified in accordance with the provisions of the dovice reclassified in accordance with eno pro therefore, market the device, Drug, and Cosmeric Acc (nec). Iou may and the Act. However, you Subject to the general some that the medical devices you use as are responsible to decembine ther been determined as substantially components in the neve casion ification process (Section 510 (k) of equivalence under the premained with market prior to May 28, 1976, the Please note: If you enactment date of the Medical Device Amendments. enactment auce or the components in bulk (i.e., unfinished) and further parchase your acterilize) you must submit a new 510(k) before process (e.g., Secrific) your kit/tray. The general controls Incruding these components in jequirements for annual registration, provisions of the nec incruas beganism
listing of devices, good manufacturing practice, and labeling, and frocing or as as as a so adulteration.

If your device is classified (see above) into either class II (Special II your device 15 crassized (bot class to the subject to such Controls) of Class III (Frenailer of the major regulations affecting your device additional concerner of Federal Regulations, Title 21, Parts 800 ound in the oly equivalent determination assumes compliance to 895. co 653. A Jubstanced in that is that is a requirements, as set with the Ourlows of System Regulation (QS) for Medical Devices:

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Page 2 - Mr. Carl M. Beaurline

General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notifications. 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 the 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" (21 CFR 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/dsma/dsmamain.html".

Sincerely yours,

Bunn E. Atuvenym

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

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PART A - INDICATIONS FOR USE FORM

Page of

K984231 510(k) Number:

Device Name:

Acist™ CMS-2000 Angiographic Injection System with Contrast Management

Indications for Use:

The Acist™ CMS-2000 Angiographic Injection System with Contrast Management is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Christopher M. Kure for Dillard.

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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.