(29 days)
The SpiderFX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.
The SpiderFX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpiderFX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a 190 cm or a convertible 320/190 cm PTFE-coated 0.014" stainless steel guidewire and a dual-ended SpiderFX Catheter for delivery and recovery.
Acceptance Criteria and Device Performance for SpiderFXTM Embolic Protection Device
This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantatitive acceptance criteria for the SpiderFX™ device. Instead, the study's goal was to demonstrate substantial equivalence to a predicate device. Therefore, the "acceptance criteria" can be inferred as achieving equivalence to the predicate device's performance in various tests.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Summary of Testing) |
|---|---|
| Equivalent in vitro bench performance | Test results verified that the SpiderFX Device is equivalent to the predicate device. |
| Equivalent package integrity | Test results verified that the SpiderFX Device is equivalent to the predicate device. |
| Equivalent in vivo animal study performance | Test results verified that the SpiderFX Device is equivalent to the predicate device. |
| Adequacy for intended use | Test results verified that the SpiderFX Device is adequate for its intended use. |
| Substantially equivalent to predicate device in intended use, materials, technological characteristics, and performance. | The SpiderFX™ Embolic Protection Device is substantially equivalent to the currently marketed SpideRX™ Embolic Protection Device (K062201) in intended use, materials, technological characteristics and performance. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not specify exact sample sizes for the "in vitro bench testing," "package integrity testing," or "in vivo animal studies." It only generally states that these tests were conducted.
- Data Provenance: The studies were non-clinical, involving in vitro bench testing and in vivo animal studies. The country of origin for the data is not specified, but the manufacturer is based in Plymouth, MN, USA. The data is implicitly prospective as it was generated to support the 510(k) submission.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: This information is not provided in the text.
- Qualifications of Experts: This information is not provided in the text.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. Since the studies were non-clinical bench and animal tests, the concept of expert adjudication as used in clinical imaging studies would not typically apply.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The device is a physical medical device (embolic protection device), not an AI algorithm for diagnostic imaging that typically involves MRMC studies to assess human reader improvement.
6. Standalone (Algorithm Only) Performance Study
This question is not applicable as the SpiderFX™ Embolic Protection Device is a physical medical device, not a standalone algorithm.
7. Type of Ground Truth Used
For the non-clinical studies:
- In vitro bench testing: The ground truth would be based on physical and engineering measurements against predefined specifications or comparative performance with the predicate device.
- In vivo animal studies: The ground truth would be established through direct observation, animal physiological measurements, and potentially necropsy results to evaluate the device's ability to contain and remove embolic material, as well as its safety.
8. Sample Size for the Training Set
This question is not applicable. The SpiderFX™ Embolic Protection Device is a physical medical device. It does not employ machine learning or AI that would require a "training set" in the conventional sense. The development of the device would involve engineering design, prototyping, and iterative testing, not data-driven training of an algorithm.
9. How Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons stated in point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).