(91 days)
Indicated use - Patients requiring suctioning of airway secretions
Hudson RCI intends to introduce a full range of suction catheters and configurations. In summary these are:
- Suction catheters only 1.
- Suction catheter with a protective sleeve only 2.
- Continuous ventilating suction catheter system with patient connector 3. and irrigation port
Each product incorporates the same suction catheter tubing and suction control valve. The differences are whether the device has -
- protective sleeve for catheter
- Incorporates a patient connector for direct attachment to the patient airway connector and ventilator circuit
- Patient connector is a "Tee" or an "Angled" configuration which may also incorporate a swivel feature
The provided document describes a medical device, the CATH-GUIDE suction catheter, and compares it to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria, device performance, a specific study proving acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop studies.
The document is a "Non-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS" from 1995, which is typical for a 510(k) submission to the FDA. This type of submission relies heavily on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed clinical study with quantitative performance metrics against predefined acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document, as it focuses on qualitative comparisons of features and intended use.
Here's what can be inferred or explicitly stated based on the provided text, along with what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantitative metrics. The "acceptance criteria" in this context are implicitly that the device's characteristics and performance are "substantially equivalent" to the predicate devices.
- Reported Device Performance: No quantitative performance metrics (e.g., suction pressure, flow rates, efficacy in clearing secretions) are reported. The performance is described qualitatively through features like "Allows ventilation during suctioning" or "Reduces patient oxygen desaturation," and these are compared to predicate devices.
Missing: Specific numeric or measurable acceptance criteria and corresponding reported performance data from a dedicated study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/not provided. This document describes the device and compares its features to predicates; it does not detail a study involving a "test set" of patients or data.
- Data Provenance: Not applicable. The "data" here is primarily a comparison of device specifications and intended use with existing marketed devices.
Missing: Information on a test set, its size, or provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not provided. There is no mention of a test set with ground truth established by experts.
Missing: Information on experts or ground truth establishment.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not provided. There is no test set or adjudication process described.
Missing: Information on an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
- MRMC Study: No. This document does not describe any MRMC study.
- Effect Size: Not applicable.
Missing: Information on an MRMC study or effect size.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- Standalone Performance: Not applicable. This is a physical medical device (suction catheter), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
Missing: This question is not relevant to the described device type.
7. The type of ground truth used.
- Type of Ground Truth: Not applicable/not provided. No ground truth is mentioned. The basis for evaluating the device is its comparison to predicate devices, focusing on design features, materials, intended use, and general performance claims (e.g., "Allows ventilation during suctioning").
Missing: Explicit ground truth definition.
8. The sample size for the training set.
- Training Set Sample Size: Not applicable/not provided. This document does not describe a machine learning algorithm or a training set.
Missing: Information on a training set.
9. How the ground truth for the training set was established.
- Ground Truth Establishment for Training Set: Not applicable/not provided. As there's no training set mentioned, this information is not relevant.
Missing: Information on ground truth establishment for a training set.
Conclusion from the document:
The document serves as a regulatory submission (likely 510(k)) to demonstrate that the CATH-GUIDE suction catheter is substantially equivalent to existing predicate devices. The "comparison to predicate devices" tables are the core of this demonstration. The conclusion explicitly states: "No differences which would affect the intended use, the application, the safety or the effectiveness... have been identified." This statement is the "proof" that the device meets regulatory requirements for market clearance based on substantial equivalence, rather than a proof against specific, quantitative acceptance criteria from a de novo study.
§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.