(19 days)
The Steerable Guide Catheter is used for introducing various 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 enclosed in a sealed Tyvek pouch and boxed in a cardboard shelf-carton.
This document is a 510(k) premarket notification for a medical device called the "Steerable Guide Catheter." It aims to demonstrate substantial equivalence to previously marketed predicate devices. The information provided heavily focuses on regulatory compliance and comparison to predicates rather than detailed performance study results of the new device against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria and study data are not explicitly stated in the provided text. The document asserts that the new device "meets the same performance specifications as the predicate device" due to "equivalent in fundamental scientific design," but it doesn't present the acceptance criteria or a dedicated study for the new device as an individual entity.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific performance acceptance criteria for the new Steerable Guide Catheter (K161985) are not explicitly defined, nor are detailed quantitative performance results reported. The document states that the new device "meets the same performance specifications as the predicate device." This implies an equivalence rather than a separate set of criteria and direct test results for K161985.
| Acceptance Criteria (Not explicitly stated for new device - inferred as "same as predicate") | Reported Device Performance (Not explicitly stated for new device - inferred as "meets predicate specifications") |
|---|---|
| Implied: Functional performance parameters consistent with predicate steerable guide catheters. | Implied: Device functions equivalently to predicate devices. |
| Implied: Material compatibility and durability consistent with predicate devices. | Implied: Materials and durability are comparable to predicate devices. |
| Implied: Dimensional and design specifications consistent with predicate devices. | Implied: Dimensions and design match or are within acceptable ranges of predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set or data provenance for a performance study of the new Steerable Guide Catheter (K161985). It makes a claim of equivalence to predicates without detailing newly generated test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The document does not describe a study involving expert assessment of generated data for the new device's performance.
4. Adjudication Method for the Test Set
Not applicable. The document does not describe a study that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done according to the provided text. The submission focuses on substantial equivalence to predicate devices, not on comparative effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical instrument (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
Not explicitly stated in the context of performance testing for the new device. The submission relies on "technological characteristics such as design, material, and indications for use" being substantially equivalent to predicates. The "ground truth" for the submission is the regulatory acceptance of the predicate devices based on their established performance and safety profiles.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no "training set" for a physical medical device.
§ 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).