(52 days)
To reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.
The Circuit Guard is a thin-wall sleeve which when attached to a Filter / HME housing, is pulled over the breathing circuit wye and tubing to cover these items to reduce gross contamination of the circuit components. It is viewed to be similar the intended use of a sleeved suction catheter. This is a modification of our ARC Filter and ARC Filter / HME.
The provided document is a 510(k) summary for a medical device called "Circuit Guard." It describes a modification to an existing device and compares it to predicate devices to establish substantial equivalence.
Based on the information provided, here's a breakdown of the requested details:
Acceptance Criteria and Study to Prove Device Meets Criteria
The submission does not contain details about a study to prove the device meets specific performance acceptance criteria in the traditional sense of a clinical trial or performance validation study. Instead, this 510(k) notification focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" can be inferred from the attributes compared between the proposed device and the predicate devices, aiming to show that the Circuit Guard is equivalent in terms of use, design, and materials.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate Devices' Performance) | Reported Device Performance (ARC Circuit Guard) |
|---|---|---|
| Intended to reduce gross contamination on a surface | Yes (based on predicate Concord-Portex Steri-Cath) | Yes |
| Used with breathing circuits, ventilator circuits, resuscitators | Yes (based on predicate ARC Filter/HME) | Yes |
| Environment of use - Hospital, OR, anesthesia, ICU | Yes (based on both predicates) | Yes |
| Indicated for single use | Yes (based on both predicates) | Yes |
| Placed in the breathing circuit | Yes (based on both predicates) | Yes |
| Incorporates a thin-walled protective sleeve | Yes (based on predicate Concord-Portex Steri-Cath) | Yes |
| Performance Standards / Specifications | None applicable for proposed modification | Yes (meaning it adheres to this statement) |
| Materials - Sleeve - Polyethylene | Yes (based on predicate Concord-Portex Steri-Cath) | Yes |
Interpretation of "Acceptance Criteria": For a 510(k) submission like this, the "acceptance criteria" are not explicit numerical thresholds from a pre-defined performance study. Instead, they are met by demonstrating that the proposed device shares the same fundamental scientific technology, intended use, and similar design and materials as predicate devices. The "performance" of the Circuit Guard is "reported" as being "Yes" for all these attributes, indicating it meets the implicit equivalence criteria by sharing these characteristics with the predicates.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission does not describe a "test set" in the context of typical algorithm performance evaluation (e.g., a set of images or patient data used to evaluate AI accuracy). The evaluation is based on a comparison of device characteristics to predicate devices, not on a test of its effectiveness with a specific sample of users or operating conditions.
- Data Provenance: Not applicable. There is no "data" in the sense of patient data, images, or outcomes being evaluated. The comparison is based on the design, intended use, and materials of the device itself and its predicates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No ground truth was established by experts for a test set. The review process by the FDA involves regulatory experts, but that's different from experts establishing "ground truth" for a device's performance data.
4. Adjudication Method for the Test Set
- Not applicable. There was no test set requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This is a mechanical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a physical accessory, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable. The concept of "ground truth" as used in AI/performance evaluation (e.g., pathology, outcomes data) is not relevant here. The "truth" in this context is the documented characteristics and intended use of both the proposed device and its legally marketed predicate devices, which the FDA then reviews for substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth establishment for it.
In summary: The K982239 submission is a traditional 510(k) premarket notification for a physical medical device. It demonstrates substantial equivalence to predicate devices based on intended use, design, and materials, rather than through performance studies involving patient data, AI algorithms, or expert ground truth establishment for a test set. The "study" referenced is the submission itself, which details the comparison between the new device and existing ones.
§ 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).