(354 days)
The humidifier chambers for the SCT 3000 are indicated for use with the SCT 3000 unit and to hold water required to humidify the air being delivered to patients.
The humidifier chambers offered for use with the Marquest SCT 3000 and Fisher & Paykel MR700, MR720, and MR730
Here's an analysis of the provided text to extract information about the device's acceptance criteria and studies:
IPI Humidification Chamber for Fisher & Paykel and Marquest Humidifier Bases
1. Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) Premarket Notification summary) does not contain a specific table of acceptance criteria with numerical targets (e.g., specific thresholds for performance metrics) or directly reported quantitative device performance data from a pivotal study.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The primary "acceptance criterion" for this type of submission is the determination by the FDA that the new device is as safe and effective as a legally marketed predicate device.
The study proving this "meets acceptance criteria" is the comparison to predicate devices and the absence of new questions of safety or effectiveness. The device description highlights its intended use with specific predicate humidifier bases (Marquest SCT 3000 and Fisher & Paykel MR 700, MR720, and MR730). It's implied that if the device functions as intended with these established systems and doesn't introduce new risks, it meets the inherent "acceptance criteria" of being safe and effective within that context.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size or data provenance for a "test set" in the context of a performance study with human subjects or a large-scale data analysis. This is typical for a 510(k) submission where substantial equivalence is demonstrated primarily through engineering comparisons, material compatibility, and intended use matching, rather than a full clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. As noted, the submission primarily relies on substantial equivalence to predicate devices, not on a new, independent test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not provided as a formal test set requiring adjudication in the typical sense for clinical performance metrics is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The submission focuses on device equivalence, not on the improvement of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical product (humidification chamber), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context is the safety and effectiveness profile of the predicate devices (Marquest SCT 3000, HPD Medical devices, and Fisher & Paykel devices). The new device is deemed "substantially equivalent" if it operates under the same principles, uses similar materials, and achieves the same intended use without raising new safety or effectiveness concerns, thereby relying on the established "truth" of the predicate devices.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical medical product, not an algorithm or AI system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as above.
Summary of Study (Based on 510(k) Nature):
The "study" demonstrating the device meets the "acceptance criteria" (i.e., substantial equivalence) is the Premarket Verification Summary [510(k)] Section 5, which details the comparison of the IPI Humidification Chamber to its predicate devices. This involves demonstrating:
- Identical Intended Use: The IPI Humidification Chambers are intended for use with the specific predicate humidifier bases (Marquest SCT 3000 and Fisher & Paykel MR 700, MR720, MR730) for humidifying air delivered to patients.
- Similar Technological Characteristics: While not explicitly detailed in this summary, a 510(k) submission would typically present data on materials, design, and functional characteristics to show they are similar enough to existing devices as to not raise new questions of safety and effectiveness.
- Matching Classification: The device falls under the same classification (Class II, Respiratory Gas Humidifiers) and product code (73 BTT) as the predicate devices.
The FDA's review of this submission and subsequent clearance (K993282) signifies their agreement that the device is substantially equivalent to the predicates, effectively "proving" that it meets the regulatory "acceptance criteria" for market entry.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).