This device is a modification to the Acist Angiographic Injector System. The modification is a means to use various types of radiographic contrast containers with the injector system. The present system is optimized for use with bottles of radiographic contrast. The modification is a hanger style holder and will work with the more recent types of radiographic contrast containers, such as bags, as well as bottles. The modification is designed to work with all types of radiographic contrast containers including bags and bottles of various sizes.

The ACIST is an angiographic injector system which supplies radiographic contrast material to a catheter at a clinician determined variable flow rate which can be remotely and continuously varied by the user. The system includes a motorized syringe pump which delivers radiographic contrast material to tubing which is connected to a angiographic catheter. The clinician controls the flow rate of radiographic contrast material from the pump to the catheter with a hand actuated proportional controller. By operating the hand control, the user can vary a command signal in order to adjust the flow rate of radiographic contrast material from the pump to the outlet during the operation of the pump. The remote hand control allows the clinician to interactively adjust flow rate (and thus volume of material delivered to the patient) while observing the angiographic procedure (for example on a fluoroscope monitor).

The system includes a remote hand controller which is responsive to the command signal from the clinician. Based upon that command signal, the controller controls flow rate of the radiographic contrast material from the pump to the outlet.

The system also includes a specifically designed disposable kit. The kit includes a syringe and valve assembly, injection manifold assembly, high pressure assembly, tubing assembly and associated caps and connectors. The kit is intended to provide all components necessary to perform an angiographic study.

The modification consists of:

a new holder for the contrast container. The new holder which . resembles a saline bag hanger and will accommodate various form factors of contrast media containers including bags and various sizes and shapes of bottles.
a new mechanical means to support the contrast empty sensor .
a new sensor to detect the presence/absence of contrast .
minor software changes to support the new sensor .

AI/ML Overview

Here's an analysis of the provided text regarding the ACIST Angiographic Injector System, structured to answer your questions about acceptance criteria and the supporting study:

The provided 510(k) summary focuses on a modification to an existing device, specifically a new contrast container holder (hanger style holder) and associated components. As such, the "study" described is primarily a series of verification and validation tests to ensure the modification functions correctly, doesn't introduce new hazards, and doesn't adversely affect the established performance of the original device. It is not a clinical "study" in the sense of a multi-reader, multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a list of tests conducted, but it does not explicitly state specific quantitative acceptance criteria or detailed numerical performance results for each test. Instead, it generally states that "All testing of the product yielded acceptable results."

Category of Test	Acceptance Criteria (Implicit from description)	Reported Device Performance
Functional Testing (Modification-Specific)	- Correct mechanical fit with various contrast containers (bags and bottles of various sizes/shapes).- Sensor correctly detects contrast present/not present.- System functions associated with changes (e.g., fill syringe) operate correctly.	"functioned correctly for all types of contrast containers", "sensor correctly detects contrast present/not present", "functions...function correctly"
Safety Testing (UL2601-1/IEC 601-1 selected portions)	- No sharp edges that could damage surgical gloves or harm users.- Passes 10-degree tip test (stability).- Meets mechanical strength requirements.- Meets rough handling (drop, roll) requirements.	"no sharp edges", "test according to the 10 degree tip test", "mechanical strength requirements", "rough handling (drop, roll) requirements" (all implicitly passed for "acceptable results")
Reliability/Life Testing	- Sensor door withstands specified number of cycles/duration.- Continues operation after rough handling.	"sensor door life test", "operation after rough handling" (all implicitly passed for "acceptable results")
Environmental Constraints Testing	- Operates correctly in the presence of dried contrast.- Operates correctly under various ambient light conditions.- Continues operation after rough handling.	"operation in the presence of dried contrast", "operation under various ambient light conditions", "operation after rough handling" (all implicitly passed for "acceptable results")
Regression Testing	- Performance of the overall system (not just the modification) has not been adversely affected.	"performance has not been affected" (implicitly passed for "acceptable results")
Software Testing	- Code review meets standards.- Changes to software function correctly.	"Code review of affected units", "Testing of the changes" (all implicitly passed for "acceptable results")

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify exact numerical sample sizes for the various tests. For example, it mentions "various types of radiographic contrast containers" without stating how many types or how many units of each were tested. Similarly, for reliability/life testing or rough handling, specific numbers of cycles or drops are not provided.
Data Provenance: The data is prospective as it describes testing specifically performed for this 510(k) submission. The document doesn't explicitly state the country of origin of the data, but given the submission is to the FDA in the US, it is reasonable to assume the testing was conducted either in the US or in a manner compliant with US regulatory requirements (though not explicitly stated).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to the verification and validation testing of a mechanical/software modification for an injector system. There isn't a "ground truth" to be established by experts in the same way there would be for an AI diagnostic device. The ground truth for functional tests would be whether the device physically performs as intended (e.g., container fits, sensor detects, software executes).

4. Adjudication Method for the Test Set

Not applicable for this type of device modification testing. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation tasks where there might be disagreement among human readers or between AI and human readers. For mechanical and software functional tests, the outcome is usually objectively pass/fail based on predetermined criteria.

5. 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. An MRMC study is not relevant here. This submission is for modifications to a mechanical and software system for injecting contrast, not for an AI diagnostic or interpretive tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable. The device is a mechanical injector system with integrated software; it's not a standalone algorithm that could perform without human interaction. The "software testing" mentioned refers to the functionality of the control software, not an interpretive algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is primarily engineering specifications and functional requirements. For example:

Mechanical fit: Verified by physically attempting to fit various containers. "Ground truth" is that the container should fit.
Sensor detection: Verified by observing the sensor's output when contrast is present/absent. "Ground truth" is the actual presence or absence of contrast.
Safety tests (UL/IEC): Verified against the specified limits and procedures in the relevant standards.
Software changes: Verified against the intended behavior defined in software requirements.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device that requires a training set. The software changes are deterministic programming logic, not a learned model.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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2/11/99

K984058

510(k) Summary

ACIST Angiographic Injector System

General Information

Classification	Class II
Trade Name	ACIST Angiographic Injector System
Submitter	Acist Medical Systems10250 Valley View DriveEden Prairie, MN 55344(612) 941-3507
Contact	Kate Anderson

Predicate Devices

Angiographic Injector System from Acist Medical. K963982

Manager, QA/regulatory

Device Description

Reason for Modification

The present Acist Angiographic Injector System holds contrast bottles by the neck of the bottle.

Since the design of the existing system, contrast manufacturers have started distributing contrast in bags.

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To accommodate all the presently known contrast containers, a new container holder was developed. The contrast holder resembles an IV style hanger.

Device Description of Acist Angiographic Injector System

Note: This is a description of the use of the system which is provided for background. This description does not specifically describe the modification which is the subject of this 510(k)

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Device Description of Contrast Hanger for the Acist Angiographic Injector System

The modification consists of:
a new holder for the contrast container. The new holder which . resembles a saline bag hanger and will accommodate various form factors of contrast media containers including bags and various sizes and shapes of bottles.
a new mechanical means to support the contrast empty sensor .
a new sensor to detect the presence/absence of contrast .
minor software changes to support the new sensor .

Intended Use

Note: There is no change to the indications for use.

The ACIST System from Invasatec is intended to be used for the controlled infusion of of radio-opaque contrast media for angiographic procedures.

Testing

Testing of the modification included:

functional testing that the change functions correctly for all . types of contrast containers. This included mechanical fit with the various contrast containers, that the sensor correctly detects contrast present/not present, and that the functions of the system associated with these changes (fill syringe with contrast) function correctly.
Testing to assure that the changes do not adversely affect the . safety of the product. Testing was done according to selected portions UL2601-1/IEC 601-1 General Requirements for Medical Electrical Equipment, including:
- test that there are no sharp edges which will damage . surgical gloves or user
- test according to the 10 degree tip test .
- mechanical strength requirements .
- rough handling (drop, roll) requirements .
Reliability/life testing of selected portions of the new design . including:
- . sensor door life test
- operation after rough handling (previously described) .
Functional testing with identified environmental constraints ●

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including:

operation in the presence of dried contrast .
operation under various ambient light conditions .
operation after rough handling (previously described) .
Regression testing of applicable portions of the system test to ● assure that performance has not been affected.
Software testing including: .
- Code review of affected units .
- Testing of the changes .

All testing of the product yielded acceptable results.

Summary of Substantial Equivalence

The ACIST Angiographic Injector System, with contrast hanger (proposed model number CL100H) is substantially equivalent to the ACIST Angiographic Injector System, Model CL100 basic overall design, methods of manufacturing, and materials used are substantially equivalent.

The clinical indications for use are identical to the predicate devices.

Acist Medical Systems believes the ACIST Angiographic Injector System, with contrast hanger is substantially equivalent to existing marketed devices.

Therefore, due to the similarity of design and construction, the test results and the identical indications for use to other angiographic injectors, Acist Medical Systems believes this product does not raise any new safety or effectiveness issues.

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Image /page/4/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The overall design is simple and professional, conveying the department's focus on health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 1999

Ms. Kate Anderson Acist Medical Systems 10250 Valley View Drive Eden Prairie, MN 55344

K984058 Re: Trade Name: ACIST Angiographic Injector Regulatory Class: II Product Code: IZQ Dated: October 30, 1998 Received: November 13, 1998

Dear Ms. Anderson:

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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements concerning action. 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 requlations.

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Page 2 - Ms. Kate Anderson

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 leqally 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 requlation (21 CFR Part 801 and additionally 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-Also, please note the regulation entitled, "Misbranding by 4639. 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

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Page 1 of 1

510(k) Number (if known): K984058

Device Name: ACIST Angiographic Injector System with
Contrast Hanger

Indications for Use:

The ACIST system 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 OF NEEDED)

Concurence of CDRH, Office of Device Evaulation (ODE)

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

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.