(418 days)
Disposable High Pressure Injector Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.
The product has two types: one type is composed of one or several syringes and one or several accessories. The accessories include connecting tube and medicine aspirator (punctured medicine aspirator and tubular medicine aspirator); the other type is composed of individual accessory; the syringe is composed of barrel, plunger, piston or plunger cap. The connecting tube has one-way and multi-way. One-way connecting tube is composed of locking connector, tubing, female conical fitting, nozzle cap, protective cap or one-way valve; multi-way connecting tube is composed of multi-way connector, locking connector, tubing, female conical fitting, nozzle cap, protective cap, one-way valve or puncture.
Maximum rated pressure for the Disposable High Pressure Injector Syringe is either 300psi (2.07MPa) or 1200psi (8.3MPa). The rated pressure for each models are listed in the following Models and Combinations Table.
The aspirator has tubular medicine aspirator and punctured medicine aspirator. Punctured medicine aspirator has plastic pin.
Product packaging: Primary package is heat-sealed by Tyvek paper and PS blister.
The following configurations of various syringes and accessories are available than are in compatible with market available injectors from Medrad, Liebel-Flarsheim, Acist or Nemoto.
The provided document is a 510(k) summary for the Disposable High Pressure Injector Syringe, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed AI device performance study. Therefore, much of the requested information regarding AI device acceptance criteria, studies, and ground truth establishment is not present in this document.
However, I can extract the acceptance criteria and performance related to the non-clinical and clinical testing performed on the device itself.
Acceptance Criteria and Reported Device Performance (Non-AI device)
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Non-Clinical Testing | Maximum Rated Pressure Testing | Withstand pressures up to the stated maximum rated pressure (300psi or 1200psi depending on the model) without failure. | "The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies it met its own specified pressure ratings). |
| Connection Strength Test | Maintain secure connections between all components (syringes, connecting tubes, aspirators) under intended use conditions. | "The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies connections were secure). | |
| Compatibility Testing between the Injector and Syringes | Function correctly and safely when used with the specified US legally marketed angiographic injectors (Medrad, Liebel-Flarsheim, Acist, Nemoto models listed in the "Models and Combinations" table). | "The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies compatibility was demonstrated). | |
| Aged Verification | Maintain performance and integrity after simulated aging processes to ensure shelf-life stability. | "The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies shelf-life stability was demonstrated). | |
| Biocompatibility Tests (ISO 10993-1, -5, -10, -7) | Meet the biological safety requirements for medical devices in contact with the patient (e.g., non-cytotoxic, non-irritating, non-sensitizing, acceptable ethylene oxide residuals). | "The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies biocompatibility standards were met). | |
| Transportation Validation (ASTM D4169) | Withstand typical shipping conditions without damage or compromise to sterility/functionality. | "The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies shipping integrity was demonstrated). | |
| Clinical Testing | Appearance | Meet specified aesthetic requirements and be free from visible defects detrimental to function or safety. | "The Disposable High Pressure Injector Syringe was found to have a substantial equivalent profile that is similar to the predicate device." (Implies acceptable appearance). |
| Sliding Performance | Exhibit smooth and consistent plunger movement suitable for contrast media or saline injection. | "The Disposable High Pressure Injector Syringe was found to have a substantial equivalent profile that is similar to the predicate device." (Implies acceptable sliding performance). | |
| Sealing | Prevent leakage of fluid during injection. | "The Disposable High Pressure Injector Syringe was found to have a substantial equivalent profile that is similar to the predicate device." (Implies effective sealing). | |
| Fitting | Ensure proper and secure fit with compatible injector devices and accessories. | "The Disposable High Pressure Injector Syringe was found to have a substantial equivalent profile that is similar to the predicate device." (Implies proper fitting). |
Since this document is a 510(k) summary for a physical medical device (Disposable High Pressure Injector Syringe) and not an AI/ML software device, the following points address what is available in the document and explicitly state where information relevant to AI/ML software performance studies is not applicable or provided.
2. Sample size used for the test set and the data provenance:
For Non-Clinical Testing: The document states "Performance testing" for various physical and biological characteristics. However, specific sample sizes for each test (e.g., number of syringes tested for pressure, number of samples for biocompatibility) are not provided. The data provenance is implied to be from the manufacturer (Wuxi Yushou Medical Appliances Co., Ltd) and "external laboratory testing," likely conducted in China given the manufacturer's location. The testing is for the physical device itself, not an AI algorithm.
For Clinical Testing: The document mentions "The clinical testing is used to evaluate the performance of the high pressure syringe and injectors" and lists evaluation points like Appearance, Sliding Performance, Sealing, and Fitting. However, no sample size, patient count, or study design details for this "clinical testing" are provided. It's unclear if this refers to actual human clinical trials or observational use. Given the context of a 510(k) for a basic device, it's highly likely to be limited usability testing rather than a full-scale clinical trial with patient data.
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):
Not applicable. This is for a physical medical device, not an AI algorithm requiring expert-established ground truth from medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for a physical medical 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:
Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the physical device's performance, the "ground truth" is established through engineering and biological standards (e.g., pressure ratings, ISO 10993 for biocompatibility, ASTM D4169 for transportation). For the "clinical testing" aspects (Appearance, Sliding, Sealing, Fitting), the ground truth would be based on functional performance and visual inspection criteria, implicitly determined by the manufacturer's quality control and comparison to predicate devices, rather than medical ground truth.
8. The sample size for the training set:
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI device that requires a training set or its associated ground truth establishment.
§ 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.