(36 days)
The MEDRAD® Mark 7 Arterion Injection System is indicated to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
Imaging System Interface (ISI)
The ISI option is indicated for the specific purpose of allowing a MEDRAD® Mark 7 Arterion Injection System to interface with an angiography imaging system.
The MEDRAD Mark 7 Arterion Iniector is a software-controlled medical device used to inject contrast agents from a 150 ml disposable syringe. Commonly referred to as an automated injection system, it is designed to allow a user to fill a disposable syringe and perform an injection with a user programmed volume and flow rate.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the MEDRAD Mark 7 Arterion Injection System:
It's important to note that this 510(k) submission is for an administrative update to include an Imaging System Interface (ISI) module in the Indications for Use. Therefore, the information related to comprehensive acceptance criteria and standalone performance studies for the core injection system itself is not present in this document, as it refers back to previous 510(k) clearances.
Acceptance Criteria and Reported Device Performance
Given that this 510(k) is an administrative update and points to a previously cleared predicate device (K132928) for performance, there are no new acceptance criteria or reported device performance metrics specifically established or tested for this submission. The document explicitly states:
"Verification testing was not necessary to demonstrate that the modified indication for use remains safe and effective. Performance testing performed with MEDRAD Mark 7 Arterion Injection System which was provided in previous 510(k)s remains applicable."
However, the comparison table (Table 1) provides the specifications of the device, which can be seen as the operational parameters that the device is designed to meet.
| Parameter | Predicate Device Specification (K132928) | Proposed Device Specification |
|---|---|---|
| Indications for Use | Injecting contrast medium and common flushing solutions into humans for angiographic studies. | Same, PLUS ISI option indicated for interfacing with an angiography imaging system. |
| Fill Volume | 1 – 150 ml in 1 ml increments | Same |
| Fill Speed (user) | 1 — 10 ml/sec | Same |
| Fill Speed (manual control by user) | 1 - 20 ml/sec | Same |
| Fixed Flow Rate | 0.1 to 45.0 ml/sec in 0.1 ml increments (Single and Phased protocols); 0.1 to 59.9 ml/min in 0.1 ml/min increments (ml/m protocol) | Same |
| Variable Flow Rate | 1.0 – 10.0 ml/sec in 0.1 ml/sec increments | Same |
| Flow Rate Rise Time | 0.0 to 9.9 seconds in 0.1sec increments | Same |
| Delay | 0.0 to 9.9 seconds in 0.1sec increments | Same |
| Pressure Limit (150 ml syringe) | 100-1200 psi or 689-8273 kPa in increments of 1 psi (kPa) | Same |
| Syringe Heat Maintainer | 35°C ± 5°C | Same |
| Protocol Memory | 40 protocols | Same |
| Injection History Memory | 50 injections | Same |
| Information Display | Color LCD | Same |
| Programming Keys | Software-generated via an LCD touch screen | Same |
| Touch Screen | Yes | Same |
| Multi-Phase | 4 phases per protocol | Same |
| Arming Modes | Single and Multi-arming modes | Same |
| Syringe System | Single (150 ml) syringe | Same |
| Manual Retract Control | Yes | Same |
| Check for Air Control | Yes | Same |
| Variable Flow Option | Yes | Same |
| Hand Switch (start switch) | Yes | Same |
| Foot Switch (start switch) | Yes | Same |
| Variable Flow Hand Controller | Yes | Same |
| Splash Guard | Yes | Same |
| Wiper Seal | Optional | Same |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable/Not provided in this document. This submission is an administrative update and did not involve new performance testing. It refers to previous 510(k)s for performance data.
- Data Provenance: Not applicable/Not provided in this document.
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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. This submission is for an administrative update and did not involve clinical or performance studies requiring expert-established ground truth.
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Adjudication method for the test set:
- Not applicable. No new test set was evaluated for this submission.
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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:
- No MRMC study was done or is relevant. This device is an angiographic injector, not an AI-assisted diagnostic or decision support system. The update is purely administrative to expand the indications for use of the ISI module.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done or is relevant for this submission. The device is a hardware/software system for injecting contrast media, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable to this administrative update. Performance data for the core device relies on engineering and functional testing, not diagnostic ground truth.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set in the conventional sense. The software in the injector is control software, not a learning algorithm.
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
Summary of Device and Submission Type:
This 510(k) (K193028) is a Special 510(k) Premarket Notification for an administrative update to the MEDRAD Mark 7 Arterion Injection System. The core device functions and performance are unchanged from its predicate (K132928). The modification solely adds the "Imaging System Interface (ISI) option" to the Indications for Use, allowing the injector to interface with angiography imaging systems. Because the changes are administrative and do not impact the fundamental scientific technology, principle of operation, or introduce new issues of safety and effectiveness, no new performance testing, clinical testing, or studies described in your prompt (e.g., MRMC, standalone algorithm performance, expert ground truth, training/test sets) were required for this specific submission. The FDA's clearance is based on the substantial equivalence to the predicate device, including its previously demonstrated performance.
§ 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.