(235 days)
These devices are intended for balloon inflation/deflation and to measure the pressure within the balloon during angioplasty procedures.
The Breeze Digital Inflation Device, like its predicates, the Morse Balloon Inflation Device and the Merit Monarch Inflation Syringe is a Balloon Inflation Syringe. These devices are intended for balloon inflation/deflation and to measure the pressure within the balloon during angioplasty procedures.
A Balloon angioplasty catheter provides a fluid column which communicates pressure inside the balloon to the digital pressure gage. The gel acts as a vibratory membrane, allowing the signal to be passed to the sensor. The analog signal from the sensor is then displayed on the liquid crystal display of the gage. The manual timer operates independently of the above mentioned pressure gage. The timer is started and stopped by depressing the Start/Stop button and can be reset to 00m00s by depressing the Reset Button.
The Breeze Digital Inflation Device shares a common design with the Morse Balloon Inflation Device in that they both are comprised of a clear syringe barrel with an attached pressure gauge, a threaded plunger and a latching mechanism that operate in tandem to generate and control balloon inflation pressure. The Breeze Digital Inflation Device has in common with the Merit Monarch Inflation Syringe, a digital pressure gauge.
This 510(k) summary describes a medical device, the Breeze™ Digital Balloon Inflation Device, but it does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth, or expert involvement.
The document focuses on:
- Device Description: What the device is and its intended use (balloon inflation/deflation and pressure measurement during angioplasty).
- Comparison to Predicates: How it's similar to and different from previously cleared devices (Morse Balloon Inflation Device, Merit Monarch Inflation Syringe).
- Material Equivalence: Mentions biocompatibility testing on predicate devices and states the fluid path material is identical.
- Key Design Differences: Highlights changes like the latching mechanism, digital vs. analog gauge, O-ring vs. stopper, increased pressure rating, and increased syringe volume.
- Digital Gauge Specifics: Notes that the Breeze device's digital gauge uses non-software driven solid-state circuitry, unlike the Merit Monarch's software-driven microprocessor.
- Performance Testing (Limited): It mentions "non-clinical performance testing" for gauge pressure rating and accuracy, and states "The results of the tests do support the claimed pressure and accuracy."
Here's why I cannot fulfill your request based on the provided text:
- Acceptance Criteria Table: The document states the claimed pressure and accuracy (0-30 ATM ± 2% of full scale) and that the test results support this claim. However, it does not provide a table outlining the acceptance criteria (e.g., what would be considered unacceptable performance within that tolerance) and the "reported device performance" beyond a general statement of compliance.
- Study Details (Sample Size, Data Provenance, # Experts, Adjudication, MRMC, Standalone): This document is a 510(k) summary, which is a high-level overview. It does not include the detailed methodology of the performance testing. Therefore, it lacks:
- Sample size for the test set.
- Data provenance (country, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- Any mention of MRMC comparative effectiveness studies or their results.
- Clarification on whether the performance testing was "standalone" in the way you're asking (i.e., algorithm only without human-in-the-loop performance, though for a manual device, this specific question might not fully apply).
- Ground Truth, Training Set: These concepts are typically relevant for AI/ML devices or diagnostic accuracy studies. For a mechanical device like a balloon inflation device, "ground truth" often refers to a verified standard (e.g., a calibrated pressure transducer). While it states non-clinical performance testing was done, it does not specify the ground truth used (e.g., what type of calibrated reference device was used), nor does it mention any "training set," as this device does not appear to involve machine learning or AI.
In summary, the provided text is insufficient to answer your comprehensive questions about acceptance criteria and study details. It confirms performance testing was done for pressure accuracy, but without the granular details you're requesting.
§ 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.