(81 days)
The Medrad Manual Syringe Loader is designed as an accessory to Medrad's line of angiographic injectors and syringes. It is intended to facilitate manual syringe contrast filling. It is not intended for patient use or use as a contrast injector.
The Medrad Manual Loader is designed as an accessory to Medrad's CT and MR angiographic injectors and syringes. The system offers a manual alternative to the electronic filling function of the injectors. Due to the different configurations of the syringes for the MR and CT injectors, two options of the Manual Loader will be available, each compatible with either CT syringes or MR Syringes.
The provided document is a 510(k) summary for the Medrad Manual Syringe Loader. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it conspicuously lacks detailed acceptance criteria and a study dedicated to proving the device meets those criteria, as typically seen in submissions for AI/software as a medical device (SaMD) or devices requiring rigorous performance validation.
This is due to the nature of the device: a manual syringe loader, which is a relatively simple accessory for existing angiographic injectors. Its primary function is to facilitate manual filling, not to perform a diagnostic or therapeutic function that would require extensive performance studies with clinical endpoints or AI metrics. The FDA's substantial equivalence determination for this type of device often relies on demonstrating that its design and intended use are similar to already legally marketed devices, and that it doesn't raise new questions of safety or effectiveness.
Therefore, many of the requested categories for AI/SaMD studies are not applicable to this 510(k) submission.
Here's an analysis based on the information available:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format typically used for performance studies of complex medical devices (e.g., sensitivity, specificity, accuracy thresholds). Instead, the "acceptance criteria" are implied by the comparison to predicate devices and the demonstration of substantial equivalence. The device's "performance" is implicitly considered acceptable if it functions as intended (manual filling of syringes) and shares similar characteristics with the predicate's filling function, without introducing new risks.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Syringe Filling Mechanism: The Medrad Manual Loader should perform the function of manually filling disposable contrast or saline syringes in a manner comparable to the filling function of existing Medrad angiographic injectors. | The Medrad Manual Loader is described as having the "same intended use as the syringe filling function of Medrad angiographic injectors." It "offers a manual alternative to the electronic filling function of the injectors." The comparison table highlights that it performs "Manual filling of disposable contrast or saline syringes." This suggests functional performance is considered equivalent for its manual function. |
| Material Compatibility: Compatible with existing Medrad CT and MR syringes. | "Due to the different configurations of the syringes for the MR and CT injectors, two options of the Manual Loader will be available, each compatible with either CT syringes or MR Syringes." This directly addresses compatibility. |
| Target User Group Appropriateness: Usable by medical imaging/hospital staff. | Stated target population is "Medical imaging/Hospital staff," which is identical to the predicate device's target population for the filling function. |
| Environmental Compatibility (Non-MR environment): Not intended for use within MRI scanning rooms. | "Not intended to be installed within the scanning rooms," distinguishing its use case from the MR-hardened predicate injectors themselves. This is a design specification rather than a performance metric, but it indicates appropriate functional design for its intended environment. |
| Safety: Does not introduce new safety concerns compared to predicate devices for the syringe filling function. | The 510(k) clearance implies that the FDA determined no new significant safety or effectiveness concerns were raised, thus finding it substantially equivalent. Specific safety tests or clinical performance data are not detailed in this summary, as is typical for low-risk, mechanically simple accessories. |
Study Details (as applicable)
Given the nature of the device, many of these detailed study aspects are not present in this 510(k) summary. The submission focuses on substantial equivalence to predicate devices, rather than a de novo performance study.
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Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. The document is a 510(k) summary for a manual accessory. There isn't a "test set" of data in the sense of clinical images or patient outcomes for performance evaluation. Instead, the "evaluation" is based on a comparison of device characteristics and intended use to predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses or measurements. This device does not generate diagnostic data or require expert interpretation for its function.
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Adjudication method for the test set:
- Not Applicable. No test set or expert adjudication is described for this type of device.
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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/SaMD device. It's a mechanical accessory.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-based device. It's a manual mechanical loader.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. See point 2. The "ground truth" for this device's approval lies in demonstrating that its manual filling function is within acceptable engineering and safety parameters and is substantially equivalent to aspects of already cleared devices.
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The sample size for the training set:
- Not Applicable. No "training set" is relevant for this manual mechanical device.
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How the ground truth for the training set was established:
- Not Applicable. No training set or ground truth in this context.
§ 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.