(153 days)
For use with the LF OptiStar Injector for injection of contrast media or saline.
The MR Syringe is a pack that includes two 60ml MR Syringes, a 96" coiled Y-Line, and two Lateral Flow Needle Spikes. The alternate configuration of the MR Syringe is a pack that includes one 60mL MR Syringe, a 60" Coiled Line, and one Lateral Flow Needle Spike. Each of the components to be used in the proposed device has been cleared for marketing under previous 510(k) submissions.
The MR Syringe Dual Pack is intended for use with the LF OptiStar Injector for injection of contrast media or saline. The device was deemed substantially equivalent to predicate devices based on non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Evaluation | Verification of visual acceptance (e.g., presence of all components). | Products inspected to verify visual acceptance. (Implied: Met acceptance criteria as no issues reported and substantial equivalence was determined). |
| Dimensional Evaluation | Verification of dimensional acceptance (e.g., ISO 594 luer compliance). | Products inspected to verify dimensional acceptance. (Implied: Met acceptance criteria as no issues reported and substantial equivalence was determined). |
| Functional Verification (Dynamic) | Appropriate function when injection was simulated at higher flow rates, challenging the injector's maximum pressure capability (150psi). | Syringe, spike, and Y-Line were tested using higher flow rates, ensuring appropriate function when injection was simulated at the maximum pressure capability of the injector (150psi). (Implied: Met acceptance criteria as no issues reported and substantial equivalence was determined, demonstrating the device can withstand the maximum pressure and flow conditions). |
| Functional Verification (Static) | Syringe held at the maximum capability of the injector for an extended period. | Static testing was conducted where the syringe was held at the maximum capability of the injector for an extended period of time. (Implied: Met acceptance criteria as no issues reported and substantial equivalence was determined, demonstrating the device's ability to maintain integrity under sustained pressure). |
| Age Verification | Expiration of 3 years based on packaging and components, leveraging previous 510(k) clearances. | The expiration of 3 years is leveraged under the 510k submissions and labeling of products as previously cleared and/or marketed based on the packaging and components used in the proposed device. (Implied: Met acceptance criteria, confirming the established shelf life). |
| Biocompatibility (Overall) | Meets requirements of ISO 10993 for an external communicating, indirect contact, less than 24-hour duration device. | The components of the kit met the requirements for such a device. Results: Cytotoxicity: Pass, Kligman Maximization Test: Pass, Intracutaneous Injection Test: Pass, Systemic Injection Test: Pass, Hemolysis: Pass, In Vitro Hemocompatibility Assay: Pass, Rabbit Pyrogen Test: Pass, Inactivated Partial Thromboplastin: Pass, Complement Activation Assay: Pass. (Met all specific biocompatibility acceptance criteria, indicating material safety for intended use). |
| Cytotoxicity | Pass | Pass (March 13, 2014) |
| Kligman Maximization Test | Pass | Pass (April 10, 2014) |
| Intracutaneous Injection Test | Pass | Pass (March 11, 2014) |
| Systemic Injection Test | Pass | Pass (March 10, 2014) |
| Hemolysis | Pass | Pass (March 11, 2014) |
| In Vitro Hemocompatibility Assay | Pass | Pass (April 10, 2014) |
| Rabbit Pyrogen Test | Pass | Pass (March 6, 2014) |
| Inactivated Partial Thromboplastin | Pass | Pass (March 6, 2014) |
| Complement Activation Assay | Pass | Pass (March 9, 2014) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes for each non-clinical test (visual, dimensional, functional, age verification, biocompatibility). It references "testing used to verify substantial equivalence" and "inspection of the product" for visual and dimensional. For functional tests, it mentions "the syringe, spike and Y-Line were tested." Biocompatibility tests were conducted on "the kit."
The data provenance is from non-clinical tests conducted by or for Coeur, Inc. The dates provided for the biocompatibility tests (e.g., March-April 2014) suggest these were prospective tests specifically performed for this 510(k) submission. There is no indication of country of origin for the data, but the submitter is based in Lebanon, TN, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study involved non-clinical performance and biocompatibility testing of a medical device, not a diagnostic or AI algorithm requiring expert ground truth establishment. The "ground truth" for these tests would be the established scientific and engineering standards (e.g., ISO 594, ISO 10993) and the objective measurements confirming compliance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the study did not involve human interpretation or adjudication processes typical of diagnostic studies. The results of the non-clinical tests are objective measurements against predefined acceptance criteria.
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:
This information is not applicable. The submission relates to a medical device (syringe kit) and does not involve an AI component or any human-in-the-loop performance evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The submission relates to a medical device and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests was established by predetermined objective standards and specifications. This includes:
- Engineering specifications and visual standards for visual and dimensional evaluations.
- Mechanical and fluid dynamics principles for functional verification (pressure, flow rate).
- Established industry standards such as ISO 594 for luer compliance and ISO 10993 for biocompatibility, specific parts of which define the acceptable limits and methodologies for tests like cytotoxicity, sensitization, systemic toxicity, and hemocompatibility.
8. The sample size for the training set:
This information is not applicable. This is a submission for a medical device (syringe kit) and does not involve an AI algorithm with a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for an AI algorithm.
§ 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.