(29 days)
100 mL/200 mL Syringe: The Disposable Syringe (Kit) (100 mL or 200 mL Syringe for the injection of contrast media orsaline for CT and MR imaging, for use on Nemoto injectors. 150 mL Syringe: The Disposable Syringe (Kit) (150 mL Syringe for the injection of contrast media or saline forangiography. for use on Nemoto injectors. J-Tube: J-Tube is to aid in transferring a media from its container (typically a vial or bottle) into the barrel of the Disposable Syringe (Kit). Extension Tubes: The Extension Tube is to provide a connection between the syringe barrel and the needle or catheter into the patient.
The "Disposable Syringe (Kit)" (Subject Device) is specifically designed for use with the Nemoto power injection systems marketed and sold in the USA using 510(k) references K133189, K071691, K173450, K092896, K091734. The Subject Device is a package provided to the end user that contains one or two plastic syringes, plastic tubing used for connecting syringe to needle or catheter (Extension Tubing) and a plastic J-shaped tube for transferring contrast media or physiological saline into the plastic syringe (J-Tube). The Subject Device, in accordance with the Indications for Use, may be used in conjunction with CT or MRI applications or in conjunction with angiographic applications. The key difference in the application as it relates to the Subject Device is the pressure required and the flow rates required for the Subject Device. The Subject Device when used for the CT and MRI applications must support a maximum pressure of 300PSI and a maximum flow rate of 10mL/second. The Subject Device when used for the angiographic applications must support a maximum pressure of 1200PSI and a maximum flow rate of 30ml/second. The maximum values related to the application are controlled by the Nemoto power injection system which are fully described in the aforementioned 510(k)s.
The provided text is a 510(k) summary for a medical device (Disposable Syringe (Kit)) and does not contain information about an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria and study details cannot be answered based on the provided input.
However, I can provide a summary of the non-clinical performance data presented for the Disposable Syringe (Kit), which demonstrates it meets its acceptance criteria based on established standards.
Non-Clinical Performance Data for Nemoto Disposable Syringe (Kit)
The Nemoto Disposable Syringe (Kit) underwent extensive non-clinical testing to demonstrate substantial equivalence to its predicate devices. The device passed numerous tests in accordance with internal requirements, national standards, and international standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test / Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity testing (ISO 10993-5) | Passed |
| Sensitization testing (ISO 10993-10) | Passed | |
| Irritation testing (ISO 10993-23) | Passed | |
| Acute systemic toxicity testing (ISO 10993-11) | Passed | |
| Hemolysis testing (ISO 10993-4, ASTM F 756) | Passed | |
| Pyrogenicity testing (ISO 10993-11, USP-NF 38 ) | Passed | |
| Sterility & Contamination | Particulate Contamination testing (USP ) | Passed |
| Endotoxin testing (USP-NF and ) | Passed | |
| Sterilization validation (demonstrates SAL of 10-6) | Passed | |
| Ethylene Oxide Sterilization Residuals (ISO 10993-7) | Passed | |
| Syringe Mechanical Performance | Lubricant testing (modified ISO 7886-1) | Passed |
| Tolerance on Graduated Capacity (ISO 7886-1) | Passed | |
| Scale testing (ISO 7886-1) | Passed | |
| Numbering of Scales testing (ISO 7886-1) | Passed | |
| Overall length of scale to nominal capacity line (ISO 7886-1) | Passed | |
| Position of Scale testing (ISO 7886-1) | Passed | |
| Barrel testing (ISO 7886-1) | Passed | |
| Plunger Stopper/Plunger Assembly testing (ISO 7886-1) | Passed | |
| Nozzle Lumen testing (ISO 7886-1) | Passed | |
| Dead Space testing (ISO 7886-1) | Passed | |
| Freedom from Air past Plunger Stopper (ISO 7886-1) | Passed | |
| Fit of Plunger Stopper/Plunger in Barrel (ISO 7886-1) | Passed | |
| Liquid Leakage past Plunger Stopper (in-house pressure) | Passed | |
| Chemical testing (ISO 7886-1, ISO 8536-9) | Passed | |
| Extension Tubes & Connectors | Transparency testing (ISO 8536-9) | Passed |
| Tensile Strength testing (ISO 8536-9) | Passed | |
| Leakage testing (ISO 8536-9) | Passed | |
| Injection Needle testing (ISO 8536-9) | Passed | |
| Connection force (in-house testing) | Passed | |
| Positive Pressure Liquid Leakage (ISO 80369-7) | Passed | |
| Sub-Atmospheric Pressure Air Leakage (ISO 80369-7) | Passed | |
| Stress Cracking testing (ISO 80369-7) | Passed | |
| Resistance to Separation from Axial Load (ISO 80369-7) | Passed | |
| Resistance to Separation from Unscrewing (ISO 80369-7) | Passed | |
| Resistance to Overriding testing (ISO 80369-7) | Passed | |
| Overall Device Performance | Compatibility (in-house testing) | Passed |
| Shelf Life Testing (supports 5 years) | Passed | |
| Transportation Testing (ASTM F88/88M, etc.) | Passed | |
| Usability Engineering (IEC 62366-1) | Evaluated |
2. Sample Size for Test Set and Data Provenance:
The document does not specify the sample sizes used for each non-clinical test. The tests are general performance and materials tests, not based on patient data.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. These are non-clinical engineering and laboratory tests, not clinical studies requiring expert ground truth for interpretation.
4. Adjudication Method:
Not applicable. This is not a clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is defined by the specific parameters and thresholds set by the relevant ISO standards (e.g., ISO 10993, ISO 7886-1, ISO 8536-9, ISO 80369-7) and internal requirements. These standards specify acceptable limits for various properties like cytotoxicity, leakage, tensile strength, and dimensions.
8. Sample Size for Training Set:
Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.
9. How Ground Truth for Training Set Was Established:
Not applicable.
§ 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.