(153 days)
The Enpath Deflectable Catheter is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.
The Enpath Deflectable Catheter is a guide catheter (delivery sheath) which has a distal tip that deflects to create a variable curve shape. The deflection is controlled through a handle mechanism with the ability to lock at any point along the catheter tip curve travel. The handle incorporates a luer fitting or a hemostasis valve. The deflectable catheter shaft is constructed of Pebax, lined with PTFE and filled with Barium Sulfate as a radiopacifier. The catheter hub is overmolded Nylon 12 (10% glass filled). The catheter hub houses a hemostasis valve which is molded silicone rubber. The deflectable catheter handle is made of machined ABS, and is cyanoacrylate bonded onto the deflectable shaft. The dilator tube is made of MDPE (high density/low density polyethylene blend) and has a hub made of HDPE resin overmolded onto the dilator tube. The dilator assembly is coated with silicone lubricant to reduce insertion force through the sheath hemostasis valve. The deflectable tip sheath size range is from 7 FR (ID) to 14 FR. The materials and construction are the same for all French sizes. The Deflectable Tip Sheath will be packaged and EtO sterilized for single use in a Tyvek pouch. The sterile kit packaging configuration will include the deflectable catheter and the dilator. The product may be provided as a bulk non-sterile device to OEM customers for further processing and packaging.
Here's a breakdown of the acceptance criteria and study information for the Enpath Deflectable Catheter, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The submission statement indicated that the device performs per specification requirements, however specifics criteria and performance metrics were not provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device Specifications | Performs per requirements (details not provided) |
| Functional Testing of Articulation | Performs per requirements (details not provided) |
| Deflection Radius | Performs per requirements (details not provided) |
| Deflection Force | Performs per requirements (details not provided) |
| Hemostasis of the Valve Portion | Performs per requirements (details not provided) |
| Deflection Cycle Testing | Performs per requirements (details not provided) |
| Consistent with FDA Guidance (3/19/1995) for Intravascular Catheters (as applicable) | Performs per requirements (details not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set or the data provenance (country of origin, retrospective/prospective). It refers generally to "performance testing" and "test results" without specific numbers of devices tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The ground truth for the performance testing appears to be based on engineering specifications and in-house testing rather than expert clinical assessment.
4. Adjudication Method for the Test Set
This information is not provided. It's likely that the testing involved objective measurements against established specifications rather than a consensus-based adjudication process typical for clinical or image-based studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not conducted or reported. This type of study typically involves human readers analyzing cases with and without AI assistance, and it's not applicable to a device like a catheter where the primary assessment is mechanical and functional performance.
6. Standalone (i.e., algorithm-only without human-in-the-loop performance) Study
Yes, in essence, the described "performance testing" is a standalone evaluation of the device's mechanical and functional properties without human intervention during the measurement process. The "algorithm" in this context refers to the device's design and manufacturing, and its performance was assessed independently of a human operator's influence on the test outcome (beyond initiating the test).
7. Type of Ground Truth Used
The ground truth used for the device's performance testing was based on engineering specifications and established functional requirements derived from the device's intended use and relevant FDA guidance.
8. Sample Size for the Training Set
This information is not applicable and is not provided. The Enpath Deflectable Catheter is a physical medical device, not an AI/software algorithm that requires a "training set" in the machine learning sense. The development and verification of such devices rely on engineering design, material science, and physical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, this is a physical device, not an AI/software algorithm, so there is no "training set" or "ground truth for the training set" in the context of machine learning. The design and manufacturing process would involve engineering principles, material selection, and iterative prototyping and testing to meet performance objectives.
§ 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).