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 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.

AI/ML Overview

The provided document is a 510(k) summary for the ACIST Angiographic Injector System. It describes the device, its intended use, and tests conducted to demonstrate substantial equivalence to predicate devices. However, it does not detail specific acceptance criteria for performance metrics nor a comprehensive study design that would directly assess how the device meets such criteria in a robust, quantitative manner typically seen for AI/ML-based medical devices. The testing described is primarily focused on material biocompatibility, physical device integrity, and electrical safety, consistent with a traditional hardware medical device rather than an AI/ML algorithm.

Therefore, much of the requested information regarding acceptance criteria, study design for performance evaluation (especially for AI/ML aspects), sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document.

Here's an attempt to extract and interpret information related to your request based on the context of a 510(k) submission for a non-AI device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on testing)	Reported Device Performance
Biocompatibility	Compliance with USP Class VI and/or ISO 10993	"All materials are certified from the vendor as biocompatible based on compliance with USP Class VI and/or ISO 10993. All materials are biocompatible and are suitable for this application."
Physical Integrity	Dimensional inspection, bond strength, burst pressure, flow rate capability, performance under simulated conditions	"Physical testing of the system included: dimensional inspection, bond strength testing, burst pressure, flow rate capability, and performance under simulated conditions. All testing of the product yielded acceptable results."
Electrical Safety	Compliance with IEC 601-1	"Electrical safety testing was performed per IEC 601-1. All testing of the product yielded acceptable results."
Electromagnetic Compatibility (EMC)	Compliance with IEC 601-1-2	"electromagnetic compatibility testing per IEC 601-1-2. All testing of the product yielded acceptable results."

Note: The document states "All testing of the product yielded acceptable results" for various physical and electrical tests. It does not provide specific quantitative thresholds for "acceptable" or the measured performance values for these tests.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is for physical and electrical attributes of the device and its components, not for analytical or clinical performance based on patient data. Therefore, concepts like "test set," "data provenance," "country of origin," and "retrospective/prospective" do not apply in this context.

3. 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)

This information is not applicable and therefore not provided. The device is a mechanical injector, not an imaging analysis or diagnostic device that would require expert-established ground truth for its performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies or performance evaluations where there is a need to resolve discrepancies in expert interpretations or assessments, which is not relevant for the physical and electrical testing conducted for this device.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, nor is it applicable. This is not an AI-enabled device. The document states "The clinical indications for use are identical to the predicate devices" and "Invasatec believes this product does not raise any new safety or effectiveness issues," indicating a focus on substantial equivalence based on materials, design, and intended use to existing devices, rather than a novel performance claim requiring a comparative effectiveness study.

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

This is not applicable. The device is an angiographic injector system, not an algorithm. Its operation involves a "human-in-the-loop" interaction where the clinician controls the flow rate using a hand-actuated proportional controller. There is no "algorithm only" performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable. The testing performed (biocompatibility, physical integrity, electrical safety) does not rely on a "ground truth" derived from clinical data or expert interpretation in the way that an AI diagnostic device would. Instead, performance is measured against engineering specifications, material standards, and regulatory safety standards.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

This is not applicable. There is no "training set" or corresponding "ground truth" establishment process for this device.

Summary

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K963982

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Attachment G

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DEC - 5 1997

510(k) Summary

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510(k) Summary

ACIST Angiographic Injector System

General Information

Classification

Class II

ACIST Angiographic Injector System

Submitter

Trade Name

Invasatec Corporation 10180 Viking Drive Eden Prairie, MN 55344 (612) 941-3507

Contact

Doug Duchon Vice President

Predicate Devices

from Medrad, Inc. K822536. Mark V Mark V+ from Medrad, Inc.

Device Description

system includes a remote hand controller which is The 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.

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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.

Intended Use

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

Testing

The materials used in the construction of the ACIST disposable angiographic kit are well known materials widely used in the medical industry. All materials are certified from the vendor as biocompatible based on compliance with USP Class VI and/or ISO 10993. All materials are biocompatible and are suitable for this application.

Physical testing of the system included: dimensional inspection, bond strength testing, burst pressure, flow rate capability, and performance under simulated conditions. Electrical safety testing was performed per IEC 601-1 and electromagnetic compatibility testing per IEC 601-1-2. All testing of the product vielded acceptable results.

Summary of Substantial Equivalence

The ACIST System components are constructed of the same or substantially equivalent materials as the predicate products. The sizes and configurations available along with the packaging and sterilization methods are also equivalent.

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

due to the similarity of materials Therefore, to other angiographic injection systems, the test results and the identical indications for use to other angiographic injectors, Invasatec believes this product does not raise any new safety or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Rockville MD 20857

DEC - 5 1997

Mr. Doug Duchon V.P. Product Development Invasatec, Inc. 10180 Viking Lane Eden Prairie, Minnesota 55344

Re: K963982 Invasatec ACIST Angiographic Injector Regulatory Class: II (two) Product Code: DXT Dated: September 9, 1997 Received: September 10, 1997

Dear Mr. Duchon:

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 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 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 Please note: this response to your premarket the Federal Register. 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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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) 594-4648. 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

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Page_

510(k) Number (if known): K963982 Angiogr Device Name: Invosatec_ACIST Indications For Use: asatec The for the be int a que l (1 for procer (Division Sign-Off) Division of Cardiovascular, Ke and Neurological Devices 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (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.