(30 days)
The AVERT™ Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 300 or 370 mgI/mL.
The Osprey Medical AVERT™ Contrast Modulation System allows for the modulation of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT System consists of a reusable, non-sterile apparatus (contrast modulator), which a force to a disposable sterile modulation reservoir with a standard, off-the-shelf 4-way stopcock and extension line. The contrast modulator utilizes an internal mechanism to apply a force to the modulation reservoir; allowing for modulated diversion of manual contrast injections. The force can be easily and quickly adjusted by moving the location of the pin as identified on the outer housing of the system, thereby increasing or decreasing the amount of force applied to the modulation reservoir. The contrast modulator is attached to a wheeled stand and is positioned near the patient, outside of the sterile field.
The provided document describes the AVERT™ Contrast Modulation System, for which Osprey Medical, Inc. submitted a 510(k) premarket notification (K150485). The document indicates that this submission is for a minor modification to an already cleared predicate device (K140425).
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion / Test Performed | Reported Device Performance |
|---|---|---|
| Device Performance Testing | - Flow rate | "All testing passed and demonstrated product performance met all prior established acceptance criteria." (indicating acceptable flow rate, peak pressure reduction, contrast diversion, and flow rate adjustability) |
| - Peak pressure reduction | ||
| - Contrast diversion | ||
| - Flow rate adjustability | ||
| - Mechanical cycle testing (leveraged from predicate) | "All testing passed and demonstrated product performance met all prior established acceptance criteria." | |
| - Image analysis (leveraged from predicate) | "All testing passed and demonstrated product performance met all prior established acceptance criteria." | |
| - Compatibility to Osprey Medical Contrast Monitoring System (leveraged from predicate) | "All testing passed and demonstrated product performance met all prior established acceptance criteria." | |
| Sterilization Validation | - Sterilization conditions validated to achieve Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135-1:2007 (leveraged from predicate) | "All testing passed." |
| Simulated Use (Animal) & Post-market Design Validation | - Assessment of injection pressure (leveraged from predicate) | "Testing demonstrated no new or different question of safety or effectiveness were raised." (indicating acceptable injection pressure, contrast diversion, and image analysis results in animal models) |
| - Contrast diversion (leveraged from predicate) | ||
| - Image analysis (leveraged from predicate) | ||
| Shelf-Life & Distribution Testing | - Visual inspection, cycle testing, dye leak test, seal strength test, and functional testing per ASTM D4169 (leveraged from predicate) | "All testing passed and demonstrated product performance met all prior established acceptance criteria." |
| Biocompatibility Testing | - Cytotoxicity, sensitization, irritation (intracutaneous reactivity), systemic toxicity, hemocompatibility, genotoxicity, chemical characterization in accordance with ISO 10993-1:2009 (leveraged from predicate) | "All testing passed and meet prior established acceptance criteria." |
| Overall | Compliance with established performance criteria and performance as intended. | "All test results demonstrate that the materials, manufacturing processes and design of the Osprey Medical AVERT™ Contrast Modulation System meet the established performance criteria and will perform as intended." and "no new or different questions of safety or effectiveness are raised with the proposed modification." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each test set. However, it indicates that testing was performed and/or leveraged from the predicate (K140425). The tests are described as "Bench testing," "Simulated use (animal)," and "Shelf-life, distribution and shipping testing." There is no mention of human clinical test sets, as the submission explicitly states "No clinical testing was performed."
The data provenance is largely retrospective in the sense that much of the data was already generated and validated for the predicate device. For the specific modification (new spring component in model RMS-ISOV-300-C), new bench testing was performed. The origin of the simulated use (animal) data is not specified beyond "animal."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. Given that the testing primarily involved bench, animal, and physical performance tests, the "ground truth" would likely be objective measurements against predefined engineering and biological specifications, rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods are typically relevant for clinical studies involving subjective interpretations, which were not performed for this submission.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable. The AVERT™ Contrast Modulation System is an angiographic injector and syringe system, a medical device for controlled infusion of contrast media. It is not an AI-powered diagnostic or assistive tool for human readers, so MRMC studies and "AI assistance" effect sizes are irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The AVERT™ Contrast Modulation System is a hardware device that modulates contrast media during manual injections. It is not an algorithm or software that operates in a standalone capacity.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the various tests was based on:
- Established product specifications and performance requirements for bench testing (flow rate, pressure, diversion, adjustability).
- Validated standards for sterilization (ISO 11135-1:2007) and biocompatibility (ISO 10993-1:2009).
- Standardized testing methods for shelf-life and distribution (ASTM D4169).
- Assessment of safety and effectiveness in simulated use (animal) models against expected physiological responses.
In essence, the ground truth was primarily based on objective engineering and biological performance metrics and compliance with recognized standards, rather than clinical expert consensus, pathology, or outcomes data, as no clinical studies were performed.
8. The Sample Size for the Training Set
This question is not applicable. The AVERT™ Contrast Modulation System is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this type of device.
§ 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.