(65 days)
The GORE® Flow Reversal System is intended to provide embolic protection during carotid artery angioplasty and stenting for the patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below:
- Adequate iliac/femoral access
- Common carotid artery diameters between 6 and 12 mm
- External carotid artery diameters less than 6 mm
The GORE® Flow Reversal System consists of three primary components:
- GORE® Balloon Sheath
- GORE® Balloon Wire
- GORE® External Filter
When assembled together, the GORE® Flow Reversal System reverses the flow of blood at the treatment site of the internal carotid artery (ICA), directing embolic particles away from the neurovascular circulation and removing them through an external filter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GORE® Flow Reversal System (K123156), based only on the information given:
1. Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the provided document does not explicitly state specific acceptance criteria in terms of numerical thresholds or performance targets. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
The reported device performance primarily revolves around qualitative assessments:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Tested in accordance with ISO 10993-1, results demonstrate substantial equivalence. |
| Sterilization | Tested, results demonstrate substantial equivalence. |
| Shelf Life | Tested, results demonstrate substantial equivalence. |
| Functional Performance | Tested, results demonstrate substantial equivalence. |
| Mechanical Performance | Tested, results demonstrate substantial equivalence. |
| Physical Performance | Tested, results demonstrate substantial equivalence. |
| Design Characteristics | Substantially equivalent to the predicate device. |
| Material Characteristics | Substantially equivalent to the predicate device. |
| Intended Use | Substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on a "test set" or any clinical study involving patient data (retrospective or prospective). The evaluations mentioned are described as "non-clinical evaluations."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not mentioned in the document, as no clinical test set requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set
This information is not mentioned in the document, as no clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned in the provided text. The evaluation is focused on demonstrating substantial equivalence through non-clinical testing, not on comparative effectiveness with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical medical device (catheter system) and not an algorithm or AI system.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to performance studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable to the "non-clinical evaluations" described. The "truth" in this context is based on engineering specifications, regulatory standards (e.g., ISO 10993-1), and comparison to the predicate device's established characteristics through physical and functional testing.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical device and not an AI system that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical medical device and not an AI system.
§ 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).