(221 days)
ANT Angiographic Syringes are syringes for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.
The applicant device of ANT Angiographic Syringes are plastic, single-use, disposable syringes to be offered in 10 mL, 12 mL, 20mL, 60mL, 60ml, 65ml, 100ml, 115 ml, 125 mL, 130ml, 140ml and 200mL sizes. The syringes will be offered made of polypropylene or PET- both materials, of which, are available in current legally marketed products.
Variants: All variants include 7 series as followings: Series 1: Model 100101, Model 100103, Model 100103, Model 100202, Model 100202, Model 100203, Model 100204, Model 100301, Model 100302, Series 2: Model 200101, Model 200201, Model 200202, Model 200203, Model 200301, Series 3: Model 300101, Model 300102, Model 300202, Model 300301, Model 300302, Series 4: Model 400101, Series 5: Model 500101, Model 500102, Series 6: Model TR0012, Series 7: Model CS0010, Model CS0020,
All 8 series follow same design principle, same material, and same intended use. The only differences are volume and the connection (nozzle) to different angiography injector from different manufacturer. The connection differs to fit with US legally Market Angiographic Injectors from company Medrad. The connector difference is only to fit the injector and does not affect the performance of the syringes.
The provided document describes a 510(k) submission for ANT Angiographic Syringes. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria as might be seen for novel devices.
Therefore, the submission does not contain detailed information about acceptance criteria for a new device, a study proving the device meets these criteria, or specific performance metrics in the way a novel AI/ML device submission would. Instead, the "Effectiveness" section broadly states that "All the variant models of the applicant device are evaluated regarding the performance." without providing specific criteria or results.
The submission relies on demonstrating Substantial Equivalence to a predicate device (K051799 Disposable CT/MR Syringes for Nemoto Injectors) based on:
- Same classification
- Same intended use
- Same sterilizations
- Same performance (this is a general claim, not a specific metric)
- Same biocompatibility
- Same chemical specifications
- Similar physical and mechanical specifications (differences are stated as "too slight to influence the effectiveness and safety").
Because dedicated performance studies as would be conducted for a new device are not explicitly detailed with specific acceptance criteria and performance results, I cannot fill out the detailed table and answer all subsequent questions as requested. The available information primarily addresses the regulatory path of substantial equivalence for a medical syringe.
However, I can extract information related to the 'study' as presented within the context of a 510(k) for this type of device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Substantial Equivalence | Same classification, intended use, sterilizations, performance, biocompatibility, chemical specifications, and similar physical and mechanical specifications as predicate device. | "The Applicant device has the same classification intended use, sterilizations, performance, biocompatibility, chemical specifications and similar physical and mechanications with the predicate device. The only difference between applicant device and predicate device is some physical specifications variant which is too slight to influence the effectiveness and safety." |
| "The applicant device is Substantially Equivalent (SE) to the predicate device in terms of Effectiveness and Safety." | ||
| Effectiveness | Implied equivalence to predicate; safe and effective for intended use. | "All the variant models of the applicant device are evaluated regarding the performance." |
| "The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness." | ||
| Safety (Biocompatibility) | Compliance with ISO 10993 standards for relevant tests. | "The all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the possible skin-contact component material in the finished product meets the requirement of Biocompatibility." Tests included: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Systemic Toxicity (Acute), Haemo-compatibility. |
2. Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a "test set" in the context of a clinical study or performance study with quantified metrics. The evaluation relies on comparing specifications and materials to a predicate, and conducting biocompatibility tests.
- Data provenance: Not applicable in this context as it's a submission for equivalence, not a clinical trial. The biocompatibility tests would have been performed in a laboratory, likely in China (country of manufacturer: Shenzhen, China).
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 not a study requiring expert readers to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No observer-dependent adjudication was involved.
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:
- No MRMC study was done. This device is a syringe, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone performance study of an algorithm was done. This is a medical device (syringe), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The 'ground truth' in this submission is effectively established by:
- Predicate Device Equivalence: The specifications and performance of the legally marketed predicate device (K051799) serve as the benchmark.
- Established Standards: Compliance with international standards like ISO 10993 for biocompatibility.
- Material Science/Engineering: Performance "evaluation" of the syringe variants would involve engineering tests to ensure functionality (e.g., fluid delivery, structural integrity), rather than clinical 'ground truth' in the diagnostic sense.
8. The sample size for the training set:
- Not applicable. This is not a machine learning/AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning/AI device.
§ 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.