(256 days)
The contrast delivery system Dual Shot Alpha 7 is an intravascular injection system intended for the administration of ionic and non-ionic contrast media and saline used in conjunction with computed X-ray tomography (CT).
The contrast delivery system ~ Dual Shot Alpha 7 is an angiographic injector that is used in conjunction with Computed Tomography, and is intended for use by doctors, radiology technologists and other licensed medical practitioners. This device is designed to be used in conjunction with various injection methods of contrast media and saline, and utilized with multi-slice CT scanners. The Dual Shot Alpha 7 has two driving mechanisms to deliver contrast media and/or saline, each side A and B respectively are capable of utilizing either a 100mL or 200mL size syringe. Syringes are connected to the patient via an intravascular catheter. The Dual Shot Alpha 7 consists following components; Injector Powerhead, Console, and optional Hand Switch.
The medical device, "Contrast Delivery System - Dual Shot Alpha 7" by Nemoto Kyorindo Co., Ltd., is an angiographic injector intended for the administration of ionic and non-ionic contrast media and saline in conjunction with computed X-ray tomography (CT).
Here's an analysis of its acceptance criteria and the study proving it meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Recognized Standards) | Reported Device Performance |
|---|---|
| Safety and Essential Performance | |
| EN 60601-1 (2006): Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance | The device has been tested in conformance with this standard. |
| Electromagnetic Compatibility (EMC) | |
| EN 60601-1-2 (2007): Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | The device has been tested in conformance with this standard. |
| Usability | |
| EN 60601-1-6 (2010): Medical electrical equipment Part 1-6: General requirements for safety and essential performance - Collateral standard. Usability | The device has been tested in conformance with this standard. |
| EN 62366:2008: Medical Devices - Application of usability engineering to medical devices | The device has been tested in conformance with this standard. |
| Software Life Cycle Processes | |
| EN 62304:2006: Medical Device Software - Software Life Cycle Processes | The device has been tested in conformance with this standard. |
| Information Supplied by Manufacturer (Labeling) | |
| EN 1041:2008: Information supplied by the manufacturer with medical devices | The device has been tested in conformance with this standard. |
| Quality Management Systems | |
| EN ISO13485:2012: Medical devices - Quality management systems - Requirements for regulatory purposes | The device has been tested in conformance with this standard. |
| Risk Management | |
| EN ISO14971:2012: Medical devices -- Application of risk management to medical devices | The device has been tested in conformance with this standard. |
| Biocompatibility | Not applicable, as the device does not include a sterile syringe and therefore does not have direct patient contact necessitating biocompatibility testing. |
Study Proving Device Meets Acceptance Criteria:
The provided document describes the "Special 510(k) SUMMARY" for the Dual Shot Alpha 7, which establishes substantial equivalence to a predicate device (Dual Shot Alpha K062168 and K071691). The study proving the device meets acceptance criteria is a compliance study with recognized international and European standards for medical devices, rather than a clinical effectiveness study.
The document states: "The contrast delivery system Dual Shot Alpha 7 has been tested in conformance with the following recognized standards, and is substantially equivalent to the predicate device Dual Shot Alpha." This implies that a series of tests and evaluations were conducted to demonstrate the device's adherence to the specified standards listed in the table above.
Key Information Requirements and Their Details:
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Sample size 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 summary. The "test set" here refers to the performance of the physical device against engineering and safety standards. Details on the specific number of devices tested, samples of injection cycles, or environmental testing conditions are not disclosed.
- The data provenance is not specified beyond the manufacturer being based in Saitama, Japan.
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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 type of information is not applicable to this submission. The "ground truth" in this context is the adherence to engineering specifications and safety standards, which would be verified by internal testing personnel, qualified engineers, and potentially third-party testing labs, not medical experts establishing diagnostic ground truth from images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable to this type of device and submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy, where multiple readers evaluate medical images against a consensus or pathological truth. This submission focuses on engineering and regulatory compliance.
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If a multi-reader multicase (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 comparative effectiveness study was not done. This device is a contrast delivery system (an angiographic injector), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a hardware system with embedded software, not a standalone algorithm for image analysis or diagnosis. Its performance is evaluated in terms of its mechanical, electrical, and software compliance, not "algorithm-only" performance as understood in AI/ML medical devices.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance directly relates to its adherence to the specified recognized standards (EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 62304, EN 62366, EN 1041, EN ISO13485, EN ISO14971). This "ground truth" is established through objective measurements, calibration, and engineering tests to verify parameters like flow rate accuracy, pressure limits, software functionality, electrical safety, usability engineering principles, and risk management processes. It is based on predefined technical specifications and regulatory requirements, not medical diagnostic outcomes.
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The sample size for the training set:
- This information is not provided and is not applicable in the context of this device. The phrase "training set" is typically used for machine learning models. The software in this device would have undergone traditional software development lifecycle verification and validation, not machine learning model training.
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How the ground truth for the training set was established:
- This information is not applicable as there is no "training set" in the machine learning sense for this device. The software development process would involve requirements definition, design specification, implementation, and rigorous testing against those specifications, which serve as the "ground truth" for software functionality.
§ 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.