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510(k) Data Aggregation
(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.
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(429 days)
The ACIST System from Invasatec is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
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.
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.
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