(14 days)
The catheter is intended for use in obtaining venograms by occluding the coronary sinus.
The Balloon Catheter is a 6 F occluding catheter with a latex balloon. It is available in three lengths: 60 cm (Model 6746), 90 cm (Model 6714), and 110 cm (Model 6747). All models provide a balloon with an inflation capacity of 1 cc and accept a maximum guide wire diameter of .035 inches. The inflated balloon diameter is 10 mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Guidant Balloon Catheter (K021283).
1. Acceptance Criteria and Reported Device Performance
The provided text focuses on a labeling modification for an already marketed device, meaning the device's design, materials, manufacturing, etc., are unchanged. The core of the new submission is related to the expanded indication for use. Therefore, the "acceptance criteria" revolve around demonstrating the safety and effectiveness of the device for this new indication.
Given the information, the acceptance criteria are implicitly met by demonstrating that the device is "safe and effective for use in occluding the coronary sinus to obtain a venogram," and that this performance is "acceptable within the coronary vein." The comparison is primarily against a legally marketed predicate device (Arrow Balloon Wedge Pressure Catheter) and another substantially equivalent device (Cardima VUEPORT Guiding Catheter). Specific numerical performance metrics (e.g., success rates, complication rates) are not explicitly stated in the summary, which is common for 510(k) submissions where substantial equivalence is the goal rather than demonstrating superiority against a specific threshold.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device is safe and effective for occluding the coronary sinus to obtain a venogram (Human Clinical). | "The results demonstrated that the Balloon Catheter is safe and effective for use in occluding the coronary sinus to obtain a venogram." Additionally, "Animal GLP and human clinical data support the modified indication for use." |
| Device performance is acceptable within the coronary vein (Animal Study). | "The results of the in vivo animal evaluation showed that the performance of the Balloon Catheter is acceptable within the coronary vein." |
| Device is substantially equivalent to predicate devices for the modified indications. | "The Balloon Catheter with the modified indication is substantially equivalent to the currently marketed Arrow Balloon Wedge Pressure Catheter (pre-enactment device) with regard to indications for use..." and "The modified indication for use is also substantially equivalent to the currently marketed Cardima VUEPORT Guiding Catheter (K973298)." |
2. Sample Size Used for the Test Set and Data Provenance
- Human Clinical Study: While a "clinical investigation" was conducted, the sample size is not explicitly stated in the provided document.
- Animal Study (In Vivo Testing): The sample size is not explicitly stated in the provided document.
- Data Provenance:
- Human Clinical Study: The document states "Human Clinical Testing Data" was collected, implying a prospective human study, but country of origin is not specified.
- Animal Study: An "animal study was conducted," implying a prospective animal study. The document mentions "GLP" (Good Laboratory Practice), which indicates a controlled experimental setting, but country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that this is a 510(k) for a medical device (catheter) and not an AI/imaging device, the concept of "ground truth" established by human experts in the context of image interpretation or diagnostic performance doesn't directly apply in the same way.
- For the human clinical study, the "ground truth" would be the observed clinical outcomes and performance of the device (e.g., successful occlusion, successful venogram, absence of complications) as assessed by the clinicians performing the procedures. The number and qualifications of these clinicians are not specified in the summary.
- For the animal study, the "ground truth" would be the observed physiological responses and device performance in the animal model, assessed by the researchers/veterinarians conducting the study. Their number and qualifications are also not specified.
4. Adjudication Method for the Test Set
This is not applicable in the context of this type of medical device study. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in diagnostic studies, especially those involving image interpretation where expert disagreement might occur. For a catheter-based procedure, the assessment of safety and effectiveness would be based on direct observation and measurement during the procedure and follow-up.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
- This type of study is primarily relevant for diagnostic imaging devices or AI tools that assist human readers in interpretation. The Guidant Balloon Catheter is an interventional device.
- The study design focuses on demonstrating the device's own safety and effectiveness for a specific physiological task (occluding the coronary sinus) and its substantial equivalence to predicate devices, rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone study was not done.
- This concept is also not applicable here. The device is a physical catheter used by a clinician. Its function is inherently "human-in-the-loop," as a human operator manipulates it. There is no algorithm or AI component to be evaluated in a standalone manner.
7. Type of Ground Truth Used
- Clinical Outcomes/Performance Data:
- For the human clinical study, the ground truth was based on direct observation of the device's function in occluding the coronary sinus and enabling venogram creation, along with safety observations. This aligns closest with "outcomes data" or direct "performance data."
- For the animal study, the ground truth was based on the observed physiological performance of the catheter within the coronary vein, as assessed in the in vivo animal model.
8. Sample Size for the Training Set
- Not Applicable / Not Provided:
- This device is a physical medical instrument, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The device's design and manufacturing are based on established engineering principles and prior iterations/knowledge rather than iterative machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no "training set" for an AI algorithm, the concept of establishing ground truth for it does not apply. The device's design and performance benchmarks would have been established through traditional engineering, pre-clinical testing, and clinical experience with similar devices.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).