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510(k) Data Aggregation
(132 days)
For use with the Medrad Spectris® Solaris™ MR Injection of contrast media or saline to the vascular system for diagnostic purposes.
The MR Syringes for Solaris Injectors (65mL and 115mL syringe) falls into the Cardiovascular Devices Category and are classified as Angiographic Syringes within the classification of Angiographic Injectors and Syringes. The syringe is intended for use with Medrad Spectris® Solaris™ MR Injection System to inject diagnostic fluids (such as contrast media and saline) into a patient. The MR Syringe Dual Pack for Solaris Injectors will be sold as a Dual Pack. The following configurations may be offered:
i. C853-2201 65mL and 115mL Syringe with 96" Coiled extension YLine and Fill SpikesLine, Prime Tube, and Fill Spikes
ii. C853-2202 65mL and 115mL Syringe with 96" Coiled extension Y-Line and Contrast and Saline Spikes
iii. C853-2203 65mL and 115mL Syringe with 96" Coiled extension Y
iv. C853-2204 65mL and 115mL Syringe with 96" Coiled extension YLine, Prime Tube, and Contrast and Saline SpikesLine and Fill Tube
v. C853-2205 ~ 65mL and 115mL Syringe with 96" Coiled Extension Y
vi. C853-2206 65mL and 115mL Syringe with 96" Coiled Extension Y~Line, Prime Tube, and Fill Tube
This document is a 510(k) summary for the MR Syringe Dual Pack for Solaris Injectors (K161471), a medical device. It does not describe an AI or algorithm-driven device, but rather a physical syringe product. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's the information extracted from the document that aligns with your request, with "NA" (Not Applicable) for categories that don't fit this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Visual Verification (Conformance to visual requirements) | Product inspected for conformance to visual requirements. (Implied: Passed) |
| Dimensional Evaluation | |
| - ISO 594-2:1998 Evaluation | Evaluation to applicable requirements of the ISO 594 standard. (Implied: Passed) |
| - Injector Fit (Medrad Spectris® Solaris™ MR Injection System) | Evaluation of fit and function. (Implied: Passed) |
| - Volume Accuracy | Evaluation of volume accuracy. (Implied: Passed) |
| Functional Verification | |
| - Pressure Testing (Syringe at 350psi for 10s) | Syringe held at 350psi for 10 seconds. (Implied: Passed without failure) |
| - Pressure Testing (Extension Line at 400psi for 2.5 min) | Extension Line held at 400psi for 2.5 minutes. (Implied: Passed without failure) |
| - Failure Testing (post-pressure) | Syringes and Extension Lines pressurized under increasing pressure until failure. (Implied: Demonstrated acceptable failure characteristics) |
| Age Verification (Based on packaging/component material) | Leveraged 1-year expiration from currently marketed devices using same materials. (Implied: 1-year shelf life accepted) |
| Biocompatibility | Made of same materials in fluid path as cleared devices (K971712 and K051799) with no added chemicals. (Implied: Biocompatible) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated as a number of devices. The document implies that "the product," "syringes and Extension Lines," and individual units were subjected to these tests without specifying the quantity.
- Data Provenance: Not specified, but this is a physical medical device. The testing would have been conducted by the manufacturer (Coeur, Inc.) in a lab setting. It is not patient or case data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- NA, as this is not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The ground truth for physical properties (e.g., pressure resistance, dimensions) is based on engineering specifications and international standards.
4. Adjudication Method for the Test Set
- NA, no adjudication method is mentioned as there are no expert readings or interpretations to adjudicate for this type of 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
- NA, this is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- NA, this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is based on engineering specifications, material properties, and established international standards (e.g., ISO 594-2:1998) for physical medical devices.
8. The sample size for the training set
- NA, this is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- NA, this is a physical medical device, not an AI algorithm.
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(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.
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