(94 days)
The Endosonics Automatic PBD is intended for use as a pull back accessory to the Endosonics Intravascular Ultrasound Imaging catheters. The Automatic Pull Back Device withdraws the imaging catheter from the vessel through the guide catheter.
The Automatic PBD is a battery powered device that is used in the catheterization laboratory during intravascular ultrasound assessment. The Automatic PBD has a nominal linear travel distance of approximately 12 cm and provides a uniform, slow pull back rate of the catheter's imaging element. The speed is selectable between 1 mm/sec or 0.5mm/sec. The Auto PBD has no direct or indirect patient contact. The device is constructed of materials common to the medical industry for both patient and non-patient contact devices and equipment
This 510(k) summary describes a basic accessory device, an "Automatic Pull Back Device," which is used in conjunction with an intravascular ultrasound imaging system. As such, the information typically associated with complex AI/ML device evaluations (like detailed performance studies, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable and therefore not provided in the document.
Here's an analysis based on the provided text, focusing on what can be extracted and explicitly stating what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain explicit "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI/ML device. For this hardware accessory, substantial equivalence is based on functional characteristics rather than diagnostic performance.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| 1. Intended Use Equivalence: No direct patient contact and functions as a pull-back accessory for IVUS catheters. | "The Automatic PBD is intended for use as a pull back accessory to the Endosonics Intravascular Ultrasound Imaging catheters. The Automatic Pull Back Device withdraws the imaging catheter from the vessel through the guide catheter." |
| "The Auto PBD has no direct or indirect patient contact." | |
| 2. Technological Characteristics Equivalence: Materials, design, specifications, and mode of operation comparable to predicates. | "The Automatic PBD and the predicate devices have substantially equivalent technological characteristics (materials, design, specifications, and mode of operation). These accessory devices have no patient contact. The devices are designed so catheters will attach to a movable carriage." |
| 3. Linear Travel Distance: Comparable to predicate devices (implied). | "The Automatic PBD has a nominal linear travel distance of approximately 12 cm." (No comparable metric provided for predicates, but implies meeting sufficient range). |
| 4. Selectable Pull-Back Rates: Uniform, slow pull-back with selectable speeds comparable to predicates. | "The speed is selectable between 1 mm/sec or 0.5mm/sec." |
| "The Automatic PBD incorporates pull-back rates comparable to predicate devices." | |
| 5. Safety: Constructed of common medical industry materials. | "The device is constructed of materials common to the medical industry for both patient and non-patient contact devices and equipment." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided in the document. The submission is for a hardware accessory, not a diagnostic device requiring a clinical test set with patient data for performance evaluation. The "study" described is a declaration of substantial equivalence based on a comparison of device characteristics to existing legally marketed predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. "Ground truth" in the context of expert review is relevant for diagnostic or AI/ML devices. For this mechanical accessory, there is no "ground truth" to be established by experts in the context of a clinical performance study.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations for diagnostic studies. This is not relevant for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided. MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, for diagnostic tasks. This device is a mechanical accessory and does not involve human reader interpretation or AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable and not provided. This device is a mechanical pull-back device, not an algorithm or AI system. Therefore, standalone algorithm performance is not a concept that applies here.
7. Type of Ground Truth Used
This information is not applicable and not provided. Again, "ground truth" in the context of pathology, outcomes data, or expert consensus is relevant for diagnostic performance validation, not for a simple mechanical accessory. The "truth" for this device lies in its functional specifications and comparison to predicate devices, not clinical outcomes it determines.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device does not involve machine learning or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As there is no training set, there is no ground truth to establish for it.
In summary: The provided 510(k) summary relates to a mechanical accessory and demonstrates substantial equivalence based on functional and technological characteristics compared to predicate devices. It does not involve AI/ML technology, and thus, the detailed performance study and validation criteria typically associated with such devices are completely absent and irrelevant to this submission. The "study" here is essentially a comparative analysis of specifications and intended use against existing market products.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.