(50 days)
SPAS is an adjunct device intended to be used to maneuver endo-vascular stent delivery systems and support their positioning in Percutaneous Coronary Interventions (PCI). SPAS is not intended for use in neurovascular interventional procedures
SPAS is a sterile disposable device, which serves as adjunct to compatible coronary stent delivery systems. It interfaces with the coronary stent delivery system and supports the positioning the coronary stent on the delivery system. SPAS is made of biocompatible polycarbonate with an inner polymer sleeve/hub, which interfaces with the distal outer diameter of the catheter of stent delivery systems. It does not interfere with proximal catheter handling until the stent target region is approximated. Then it is slid to the most proximal outer part of the patient's vascular access and fixated with its inner sleeve to the delivery catheter to allow its precise advancement and positioning in the target region.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal / Test) | Reported Device Performance (Result) |
|---|---|
| Non-Clinical Performance | |
| Biocompatibility | Complies with ISO 10993-1:2018 (Biological evaluation of medical devices). |
| Sterilization Effectiveness | Complies with ISO 11135-1:2014 (Sterilization of health care products - Ethylene oxide). Device is sterile with defined shelf life. |
| Packaging Integrity (Sterile Barrier) | Complies with ISO 11607-1:2019 (Packaging for terminally sterilized medical devices - Part 1). |
| Packaging Process Validation | Complies with ISO 11607-2:2019 (Packaging for terminally sterilized medical devices - Part 2). |
| Risk Management | Complies with ISO 14971:2019 (Medical devices - Application of risk management). |
| Torque Ability | Demonstrated by non-clinical verification testing. The device can fix/release the coronary stent delivery system and move it in both forward and backward directions via rotatory motions. (Compared to predicate: manually rotates devices between 3 and 5 times clockwise and counter-clockwise.) |
| Compatibility | Demonstrated by non-clinical verification testing (compatibility with compatible coronary stent delivery systems). |
| Usability (Non-clinical) | Demonstrated by non-clinical verification testing. |
| Clinical Performance | |
| Usability (Clinical) | Operators were satisfied with the SPAS device, as evaluated using a 7-point device usability questionnaire. |
| Safety / Adverse Events | No (device-related) adverse events were reported in a wide range of cardiac stenting procedures (standard to complex). |
| Effectiveness / Stent Positioning | The study's main objective was to evaluate the usability of the SPAS device in stent positioning. While "satisfaction" is reported, specific metrics for "effectiveness" in positioning are not explicitly detailed in the provided text beyond the general statement of usability. However, the absence of adverse events suggests it did not hinder the procedure. This is implied to be met through successful procedures and user satisfaction. |
| Substantial Equivalence | The SPAS is substantially equivalent to the predicate device (K141054) in terms of intended use, technological characteristics, and safety and effectiveness, supported by both non-clinical and clinical data, and meets specified consensus standards without raising new safety/effectiveness concerns. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 55 standard stenting procedures.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "multi-center usability study," implying data from multiple medical institutions. It was a usability evaluation with real device use, so it is a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Seven (7) cardiologists.
- Qualifications: "Cardiologists." No further specific details like years of experience or sub-specialization are provided.
4. Adjudication Method for the Test Set
- The text describes the usability evaluation using a "7-point device usability questionnaire" completed by the operators (cardiologists). It doesn't mention any independent adjudication of the clinical outcomes or the usability scores by external experts. The cardiologists themselves were the evaluators of usability and adverse events. Therefore, there was no external adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The study evaluated the usability of the SPAS device itself. It did not compare the effectiveness of human readers (cardiologists) with and without AI assistance (as SPAS is a mechanical device, not an AI-assisted diagnostic tool).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- N/A. The SPAS is described as a "sterile disposable device" that "serves as adjunct to compatible coronary stent delivery systems." It's a physical, mechanical assistance device, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" doesn't apply. The evaluation inherently involves a human operator (the cardiologist).
7. The Type of Ground Truth Used
- For the usability criteria, the "ground truth" was established by the subjective evaluation and feedback from the seven cardiologists through a 7-point usability questionnaire.
- For safety, the "ground truth" was the absence of reported device-related adverse events during the 55 procedures, which can be considered an outcome-based assessment of safety.
- For the non-clinical performance, the ground truth was compliance with recognized international and FDA-recognized consensus standards (e.g., ISO standards for biocompatibility, sterilization, packaging, risk management), and direct verification testing for torque ability and compatibility.
8. The Sample Size for the Training Set
- The provided text does not mention a training set as the device is a physical mechanical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
- As the device is a physical mechanical device and not a machine learning algorithm, there is no training set mentioned, and therefore no ground truth establishment for a training set. Performance was evaluated through non-clinical testing against standards and a clinical usability study.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.