(80 days)
The Contami-Shield ™ Breathing Circuit Sleeve, indicated for use with mechanically-ventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone. For Single Patient Use.
The Contami-Shield Breathing Circuit Sleeve, indicated for use with mechanicallyventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone. The disclosed device is an external device, not in physical contact with the patient, intended for use with ventilators, anesthesia machines, and open flow systems where the external protection of the breathing circuit is desired. The disclosed device shall be slipped over the external surface of the breathing circuit prior to use. A filter or HME filter may be changed or removed from the breathing circuit, while the Contami-Shield is present and in use, if desired.
This document is a 510(k) summary for the RenMed Contami-Shield™ Breathing Circuit Sleeve. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, and expert qualifications are not present in this type of submission.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
This document does not present specific acceptance criteria in numerical or quantifiable terms for the RenMed Contami-Shield™ Breathing Circuit Sleeve, nor does it provide a study with "reported device performance" against such criteria. The submission is a comparison to a predicate device to demonstrate substantial equivalence, rather than a performance study with defined metrics.
The comparison table (on page 2) focuses on design and intended use similarities:
| Aspect | RenMed Contami-Guard | ARC Medical circuit-Guard |
|---|---|---|
| Intended to provide protection for the breathing circuit against gross exterior contamination. | YES | YES |
| To be used in conjunction with a bacterial/viral breathing filter to reduce internal and external contamination of the breathing circuit. | YES | YES |
| Single Patient Use. | YES | YES |
| Clear polyethylene/polypropylene sleeve. | YES | YES |
The "reported device performance" is essentially the statement: "None of the differences noted in the performance specifications for each device are significant when the Contami-Guard is used as intended." This is a qualitative statement of equivalence, not a quantitative performance metric.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) summary based on a comparison to a predicate device, not a clinical or performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts is described as this is not a study assessing diagnostic or predictive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool, so an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical breathing circuit sleeve, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is used as this is not a study requiring such data. The basis of the submission is a comparison of product features and intended use to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is a physical device, and the submission does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is relevant to this submission.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).