(553 days)
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.
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.
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.
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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.
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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.
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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.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.