(80 days)
The Gandras catheter is designed to be used for delivering embolic materials and radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
The Gandras catheter is an angiographic intravascular catheter that has a working length of approximately 80cm, not including the tip length. The Gandras catheter is offered in three tip lengths-2cm (model 5580), 4cm (model 5581), or 6cm (model 5582). Each catheter assembly has a single lumen that is formed by a segment of nylon that extends distally from the hub, a segment of 40 durometer Pebax that extends distally from the nylon, and pellethane that forms the distal tip. Each catheter also has a Texin outer layer that overlays the nylon and pebax tubing in the mid-shaft. The distal 10-15cm of the catheter is hydrophilically coated to provide a lubricious outer surface. The catheter's radiopacity is provided by 40% bismuth subcarbonate loading in the nylon, 60% tungsten loading in the Pebax, and 65% tungsten loading in the pellethane tubing components. Each catheter has a press-fit luer hub and strain relief on the proximal end, and a peelable tip straightener. Each Gandras catheter is compatible with ≥5F introducer sheaths and
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary for the Gandras Intravascular Catheter (K073200) lists several bench tests conducted, but it does not explicitly define specific quantitative acceptance criteria or report detailed performance metrics against those criteria. The summary generally states that "The results of the tests confirmed the suitability of the device for its intended use."
Here's a table based on the provided information, noting the lack of specific criteria and data:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary Statement) |
|---|---|
| Hydrophilic coating lubricity | Confirmed suitability for intended use |
| Visual inspection | Confirmed suitability for intended use |
| Packaging stylet removal force | Confirmed suitability for intended use |
| Corrosion resistance | Confirmed suitability for intended use |
| Catheter Radiopacity | Confirmed suitability for intended use |
| Curve retention | Confirmed suitability for intended use |
| Guidewire passage | Confirmed suitability for intended use |
| Introducer sheath passage | Confirmed suitability for intended use |
| Tortuosity | Confirmed suitability for intended use |
| Embolic material passage | Confirmed suitability for intended use |
| Flow rate with contrast | Confirmed suitability for intended use |
| Dynamic pressure | Confirmed suitability for intended use |
| Liquid leak under pressure | Confirmed suitability for intended use |
| Static pressure | Confirmed suitability for intended use |
| Leak During Aspiration | Confirmed suitability for intended use |
| Kink resistance | Confirmed suitability for intended use |
| Hub bond strength | Confirmed suitability for intended use |
| Proximal to mid shaft strength | Confirmed suitability for intended use |
| Mid to distal shaft strength | Confirmed suitability for intended use |
| Tip straightener peel test | Confirmed suitability for intended use |
| Packaging-Product Visual Appearance | Confirmed suitability for intended use |
| Packaging-Label Legibility | Confirmed suitability for intended use |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the sample size for any of the bench tests mentioned. It only lists the tests performed.
- Data Provenance: The data provenance is bench testing, meaning it was conducted in a laboratory setting. There is no information regarding the country of origin, but as the submitter is based in Minneapolis, MN, USA, it's highly probable the testing was conducted within the United States. The testing is retrospective in the sense that it was completed before the 510(k) submission, confirming the device's design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not applicable to this submission. The "test set" for this device consisted of physical bench tests on the catheter itself, not interpretation of data by experts. The "ground truth" was established by engineering specifications and objective measurements against those specifications.
4. Adjudication Method for the Test Set:
- This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., image reading) where disagreement needs to be resolved. For bench tests, the outcome is generally determined by objective measurements and passing/failing predefined engineering criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical evaluations were not required for this device." This type of study would involve human readers and clinical cases, which were not part of this clearance process.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:
- No, an algorithm-only standalone study was not done. This device is a physical intravascular catheter, not an AI or software algorithm. Therefore, "standalone performance" in the context of AI is not relevant here.
7. The Type of Ground Truth Used:
- The ground truth for the bench tests would have been based on predetermined engineering specifications, industry standards, and material properties relevant to intravascular catheters. For example, "flow rate with contrast" would have a specified minimum flow rate, "kink resistance" would have a minimum force/angle, and "hub bond strength" would have a minimum pull force. These are objective engineering parameters, not expert consensus or outcomes data.
8. The Sample Size for the Training Set:
- This information is not applicable. "Training set" refers to data used to train an AI algorithm. As this device is a physical medical device and not an AI system, there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable. As per point 8, there is no "training set" for this device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).