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510(k) Data Aggregation
(27 days)
The Encore™ 26 Advantage Kit is a kit of sterile disposable devices intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.
- Encore™ 26 Inflation Device: Inflation Devices are indicated for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
- GateWay™ Plus Y-Adapter: Used for providing hemostasis around guidewires, balloon dilatation catheters, and other therapeutic devices.
- TD2® Torque Device: Used for guidewire manipulation.
- Insertion Tool: Used for percutaneous introduction and placement of guidewires in vascular procedures.
The Encore™ 26 Advantage Kit is a kit of sterile disposable devices intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.
The proposed Encore™ 26 Advantage Kit will include the following currently marketed devices: Boston Scientific (BSC) Encore Inflation Device (K955869); BSC GateWay™ PLUS Y-Adaptor (K951089); Navilyst Medical TD2 Torque Device (K922706); and NeedleTech Products, Inc. Guidewire Insertion Needle (K031173).
This is a 510(k) premarket notification for the Encore™ 26 Advantage Kit. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not involve a study of an AI/ML powered device. Therefore, many of the requested details about acceptance criteria, device performance, sample sizes for test and training sets, expert involvement, and comparative effectiveness studies are not applicable.
Here's an breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a device kit and not an AI/ML powered device with specific performance metrics like sensitivity or specificity, the "acceptance criteria" pertain to mechanical, biocompatibility, and sterility testing. The "reported device performance" indicates that these tests were performed and met the necessary standards for substantial equivalence.
| Acceptance Criteria Category | Specific Test | Reported Device Performance |
|---|---|---|
| Mechanical Bench Testing | I.D. (Guidewire Compatibility) | Performed, verifying performance and usability of the guidewire insertion tool remains substantially equivalent to the predicate. (Specific numerical results are not provided in this summary but implied to meet requirements). |
| Hub Tensile Strength | Performed, verifying performance and usability of the guidewire insertion tool remains substantially equivalent to the predicate. (Specific numerical results are not provided). | |
| Biocompatibility Testing | Cytotoxicity | Performed, verifying overall safety and efficacy. (Implied to meet ISO or FDA biocompatibility standards). |
| Sensitization | Performed, verifying overall safety and efficacy. | |
| Irritation Or Intracutaneous React | Performed, verifying overall safety and efficacy. | |
| Systemic Toxicity (Acute) | Performed, verifying overall safety and efficacy. | |
| Hemocompatibility | Performed, verifying overall safety and efficacy. | |
| Latex | Performed, verifying overall safety and efficacy. | |
| USP Physicochemical | Performed, verifying overall safety and efficacy. | |
| Sterility Testing | Performed, verifying overall safety and efficacy. (Implied to meet relevant sterilization standards). | |
| Packaging Testing | Performed, verifying overall safety and efficacy. (Implied to meet relevant packaging integrity standards). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this is a non-clinical, bench-testing focused submission. For mechanical and biocompatibility testing, sample sizes would typically be determined by statistical methods for device testing, but this information is not provided in the summary.
- Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Boston Scientific Corporation. This is not medical imaging data or patient data, so concepts like "country of origin" or "retrospective/prospective" in the typical sense do not apply.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- Not Applicable. This submission does not involve expert review/ground truth establishment for clinical data as there was no clinical study. The "ground truth" for mechanical and biocompatibility testing would be defined by established engineering and biological standards, not human expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
- Not Applicable. Since there's no diagnostic interpretation by experts, there's no adjudication method in the context of clinical or diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This was not an AI/ML powered device, and no clinical studies, including MRMC studies, were performed.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable. This is a medical device kit, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" is based on established engineering standards, biocompatibility standards (e.g., ISO standards), and sterility validation criteria for medical devices. The testing verifies that the device meets these pre-defined physical, chemical, and biological requirements.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of AI/ML for this device. The development process would involve iterative design and testing, but not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set.
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