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The Dual Shot – Contrast Delivery System 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).

DUAL SHOT - CONTRAST DELIVERY SYSTEM is an Angiographic injector that is used in conjunction with X-ray Computed tomography, and is intended for use by doctors, radiologic technologists and other licensed medical practitioners. This device is designed to correspond to the various injection methods of contrast media which were materialized with the appearance of multi-slice CT scanners. The DUAL SHOT has two driving parts to deliver contrast media and/or saline, one side is for 50mL, 100mL and 200mL, size syringes, and the other side for 50mL syringes capable for saline flush injection. Syringes are connected to the patient via an intravascular catheter. DUAL SHOT consists following components; Injector head, Console, Power Supply, Options (Hand Switch).

The Nemoto Kyorindo DUAL SHOT - CONTRAST DELIVERY SYSTEM is an intravascular injection system designed for administering ionic and non-ionic contrast media and saline during computed X-ray tomography (CT) procedures. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials or performance studies with specific statistical acceptance criteria for diagnostic accuracy.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "No performance standards have been established for Angiographic injectors under section 514 of the FD&C Act." Therefore, there isn't a table of specific performance acceptance criteria. Instead, the device's acceptability is based on conformance to recognized safety and quality standards and demonstrating substantial equivalence to a predicate device through feature comparison.

The "reported device performance" in this context refers to the device meeting general safety and electrical standards, and its functional specifications being comparable to the predicate.

• IEC60601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety
• IEC60601-1-1 (2000) Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
• IEC60601-1-2 (2001) Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
• IEC60601-1-4 (1996) Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
  | Quality Management System: | Conformance to ISO13485 (2003) Medical devices - Quality management systems - Requirements for regulatory purposes |
  | Risk Management: | Conformance to ISO14971 (2000) Medical devices - Application of risk management to medical devices |
  | Functional Equivalence to Predicate Device: | The device's features (Intended Use, Syringe System, Flow Rate, Pressure Limit, etc.) were compared to the Stellant CT Injector System (K023183 and K033881) and found to be "the same or substantially equivalent materials and technology." Specific differences and similarities are listed in the comparison table, but these are for demonstrating equivalence, not for meeting pre-defined performance thresholds. |
  | Biocompatibility: | Not applicable/not performed as the device does not include a sterile syringe. |

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

The document does not describe a clinical study with a "test set" in the context of diagnostic accuracy or a similar performance metric. The "testing" referred to is against electrical, safety, and quality standards in a laboratory setting. Therefore, information about test set sample size, data provenance, or retrospective/prospective nature is not provided because such a study was not conducted or required for this type of submission.

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

This information is also not applicable. As explained above, there isn't a "test set" for which ground truth would need to be established by experts for diagnostic or similar performance evaluation. The device's safety and functionality were assessed against engineering and electrical standards.

4. Adjudication Method for the Test Set:

Not applicable, as there was no test set requiring expert adjudication for performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The document does not mention any studies evaluating human reader performance with or without AI assistance, as the device is an Angiographic injector, not an AI-powered diagnostic algorithm.

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

No, a standalone algorithm performance study was not done. The device is a physical medical device (an injector), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The concept of "ground truth" as typically used in the context of diagnostic performance (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. The "truth" for this device's evaluation largely refers to conformance to the specified engineering, safety, and quality standards (e.g., did it meet the described voltage tolerances, did it operate within specified flow rates, etc.).

8. The Sample Size for the Training Set:

Not applicable. The DUAL SHOT - CONTRAST DELIVERY SYSTEM is a hardware device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this device.

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