(29 days)
The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray that is individually pouched in a Tyvek/Nylon corner peel pouch, heat-sealed one time, and the single sealed pouch is placed into a cardboard nest and top-loading box.
The subject 510(k) pertains to a design change to the Steerable Guide Catheter. The proposed change to the Steerable Guide Catheter consists of a design and processing modification to the internal feature of the tip ring component at the distal tip.
This document describes K172394, the Steerable Guide Catheter, which is a design modification to an existing device. The performance data section is brief, focusing on a single test.
Here’s a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile strength of the catheter tip (to demonstrate the subject device meets performance specifications and is substantially equivalent to the predicate) | "Tensile strength evaluation of the catheter tip was conducted on predicate (unmodified) and subject (modified tip) devices to demonstrate that the subject device meets performance specifications and is substantially equivalent to the predicate Steerable Guide Catheter." (No specific numerical values or success/failure metrics are provided for the acceptance criteria or reported performance.) |
| Manufacturing process consistency (to demonstrate consistent production of devices meeting performance specifications) | "Process validation was conducted to demonstrate that the manufacturing process consistently produces subject devices that meet performance specifications." (No specific metrics or details of the validation are provided.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the tensile strength evaluation or the process validation. It also does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The study involved physical testing of a medical device, not interpretation of data by human experts to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. The study involved physical testing of a medical device, not expert adjudication.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described is a physical performance test (tensile strength and process validation) of a medical device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is a physical catheter, not an algorithm or AI system. The performance testing was of the physical device itself.
7. The Type of Ground Truth Used
For the tensile strength evaluation, the "ground truth" would be the measured tensile strength values compared against predetermined engineering specifications (though these specifications are not explicitly stated in the provided text). For process validation, the "ground truth" would be consistent manufacturing output that meets specified performance metrics.
8. The Sample Size for the Training Set
This is not applicable, as there is no "training set" for physical device testing in the context of an algorithm or AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set."
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).