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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.

Study Details

1. 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.

2. 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.

3. Adjudication method for the test set:

   • Not applicable. No new test set was evaluated for this submission.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.

The MEDRAD Mark 7 Arterion Injector 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.

For the Mark 7 Arterion Injector System, the MEDRAD VFlow Hand Controller is provided sterile for single patient use only. The hand controller provides the operator the ability to precisely control and instantaneously adjust variable flow rates of contrast during contrast injection and puffing operations.

When the injector is in the variable rate injection mode, the flow rate increases incrementally as the hand controller plunger is depressed, and decreases as the hand controller is released. In the fixed rate injection mode, the hand controller acts as a start switch, and release of the device ceases all flow. The VFlow Hand Controller requires the same amount of force to depress the plunger regardless of the set flow rate, volume, and pressure limit or the viscosity of the delivered contrast media. Additionally, the VFlow Hand Controller allows the clinician to step away from the radiation source during an injection.

The Twist & Go Syringe function is the same as the Mark 7 Arterion Syringe. The syringes are both supplied sterile and are designed to be loaded into the automated injector head from the front of the injector (front loading). The clear polycarbonate material used in both syringes improves visualization of residual air compared to opaque polypropylene. The Twist & Go Syringe enables single-handed attachment of the Twist & Go High Pressure Connector Tubing to the syringe.

Below is a summary of the acceptance criteria and study information for the MEDRAD Mark 7 Arterion Injection System, MEDRAD Mark 7 Arterion Syringe, and MEDRAD Twist & Go Syringe, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific numerical acceptance criteria for a new clinical performance study. The "Performance Data" section in the document broadly states that "Bench and laboratory testing were performed to support a determination of substantial equivalence to the predicate devices. Results from the testing provide assurance that the proposed devices conform to the requirements for their intended use."

The tables provided (Tables 1 and 2) compare the features and specifications of the proposed devices against their predicate devices. Since the changes are primarily the addition of a variable flow rate option and a new syringe configuration, the acceptance criteria are implicitly that the new features function as intended and that the core functionalities (shared with the predicate) remain equivalent.

For instance, for the "Variable Flow Rate" feature:

• Acceptance Criteria (Implicit): The variable flow rate should operate within the specified range of 1.0 - 10.0 ml/sec in 0.1 ml/sec increments.
• Reported Device Performance: The proposed device includes a "Variable: 1.0 - 10.0 ml/sec in 0.1 ml/sec increments". This indicates that it meets its own defined specification.

For the syringes:

• Acceptance Criteria (Implicit): The pressure rating should be 1200 psi.
• Reported Device Performance: The proposed MEDRAD Mark 7 Arterion Syringe and MEDRAD Twist & Go Syringe both have a "Pressure rating" of "1200 psi".

Below are the performance-related criteria explicitly mentioned in the comparison tables, and their reported performance, which demonstrates equivalence to the predicate or adherence to new specifications.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes "Bench and laboratory testing" and "System level testing with a MEDRAD automated injector (syringe)" but does not specify sample sizes for these tests. The provenance is internal laboratory testing ("Bench and laboratory testing"). It does not appear to be retrospective or prospective in the clinical sense, as it refers to device functionality testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided in the document. Given that the testing detailed is "Bench and laboratory testing" focused on physical and mechanical properties, as well as software functionality, it's unlikely that ground truth in the context of expert medical interpretation (e.g., radiologist consensus) was established for these tests. The term "ground truth" as typically used in medical device AI/ML contexts does not apply here.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided as the tests relate to engineering performance and functional compliance, not subjective interpretations requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not performed or reported. The submission describes a device for injecting contrast agents, not a diagnostic or AI-assisted interpretation tool that would typically involve human readers.

6. Standalone Performance Study:

A standalone performance study (algorithm only performance without human-in-the-loop) was not performed or reported. This device is an injector, not an AI algorithm. The performance testing evaluated the functionality of the device itself (injector and syringes) and its new variable flow rate software.

7. Type of Ground Truth Used:

The "ground truth" for the performance data in this submission would be defined by the engineering specifications and physical measurements from the bench and laboratory tests. For example, testing the pressure rating of the syringe against a known standard (1200 psi), or measuring flow rates and volumes to ensure they match programmed settings. This is distinct from ground truth based on pathology, expert consensus, or outcomes data, which are typically used for diagnostic or AI-powered devices.

8. Sample Size for the Training Set:

This information is not applicable and not provided. The device is an electro-mechanical angiographic injector system, not an AI/ML algorithm that requires a "training set" of data in the conventional sense. The "software-controlled" aspect implies programmed logic and control algorithms, not machine learning or AI models trained on data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided for the same reasons as #8.

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