(14 days)
The intended use of the device is to enable qualified personnel to mix medical grade air and medical grade oxygen, at operator selected ratios, for delivery to patients through various types of respiratory care equipment.
The Sechrist Series 3500HL Air-Oxygen Mixer is a precision pressure regulation and proportioning device which is designed to mix medical air with medical oxygen, for delivery to patients through a variety of respiratory care equipment.
The mixer receives air and oxygen at a nominal 50 psi via Diameter Index Safety System (D.I.S.S.) inlet connections. The unit will operate satisfactorily with inlet pressures of 30 to 70 psi providing the pressures are within 20 psi of one another.
Two outlets for the mixed gas are provided. One is located on the side of the unit for the convenient connection of a flowmeter. The second outlet may be used to power other respiratory or cardiopulmonary care equipment requiring a controlled FI02.
The air-oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses. Flowmeters may also be purchased separately.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This 510(k) summary for the Sechrist Air-Oxygen Mixer does not describe traditional acceptance criteria in terms of quantitative performance metrics or a detailed study designed to prove the device meets those criteria.
Instead, the submission focuses on substantial equivalence to a previously cleared device (Sechrist Air-Oxygen Mixer K802226). The "performance standards" listed are quality assurance and regulatory compliance standards, not in-depth performance specifications of the device itself.
Therefore, many of the requested sections below will indicate "Not Applicable" or "Not Provided" due to the nature of this 510(k) submission, which relies on a comparison to a predicate device rather than a de novo performance study.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) relies on substantial equivalence to a predicate, specific quantitative acceptance criteria for this new device are not explicitly stated in the document as performance targets for a study. The document focuses on showing that the changes made do not affect the intended use or fundamental scientific technology, implying the performance remains equivalent to the predicate.
For the purpose of illustrating what would be considered "acceptance criteria" based on the device description, I've inferred potential operating parameters as "acceptance criteria" and noted how the device description states it meets them. However, these are descriptive operational characteristics, not formal performance study acceptance criteria.
| Acceptance Criteria (Inferred from Device Description) | Reported Device Performance (from Device Description) |
|---|---|
| Inlet Pressure Range | 30 to 70 psi |
| Inlet Pressure Differential | Within 20 psi of one another |
| Gas Mixing Capability | Mixes medical grade air and oxygen at operator-selected ratios |
| Output Connections | Two outlets for mixed gas provided |
| Compatibility with Respiratory Equipment | Deliverable to patients through various types of respiratory care equipment |
| Quality System Compliance | ISO 9001, ISO 13485, EN 46001, 21CFR820 (QS Regulation) |
Study Information
Since this is a substantial equivalence submission for minor modifications, a formal performance study as typically understood for a new device (especially one proving performance against specific acceptance criteria) was not conducted or detailed in this summary. The core "study" here is an analysis of the modifications to demonstrate they do not alter the fundamental safety and effectiveness or intended use compared to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided. No dedicated "test set" of patient data or device performance data for a new study is mentioned, as the submission focuses on changes to an already cleared device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable / Not Provided. No new "ground truth" establishment was required for this substantial equivalence submission concerning modifications. The device's safety and effectiveness were established by the predicate device's clearance.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided. No formal "test set" or adjudication process described as part of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not Applicable. This device is a breathing gas mixer, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a hardware device; the concept of a standalone algorithm performance does not apply.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Not Applicable / Not Provided explicitly. For a substantial equivalence claim, the "ground truth" effectively rests on the prior clearance of the predicate device (K802226), which implicitly established the safety and effectiveness of the device type. The current submission argues that the modifications do not negatively impact this established "truth."
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. No "training set" in the context of machine learning or complex algorithm development is relevant or mentioned for this device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided. As noted above, no training set or ground truth establishment for such a set is relevant to this device's submission.
Summary of the "Study" Proving Acceptance:
The "study" in this context is the analysis and comparison of the modified device against the predicate device (Sechrist Air-Oxygen Mixer K802226). The acceptance criteria for this type of submission are that the modifications:
- Do not affect the intended use.
- Do not alter the fundamental scientific technology of the device.
- Do not raise new questions of safety or effectiveness.
The conclusion stated in the 510(k) summary (Section 1) serves as the "proof":
"Modifications made to the cleared device include flowmeter options and corresponding labeling changes made to the User's Manual that were not contained in the original 510(k). These changes do not affect the intended use or alter the fundamental scientific technology of the device. Therefore, the modified device is substantially equivalent to the cleared device."
This statement confirms that the device meets the implicit "acceptance criteria" for a special 510(k) submission, meaning it maintains substantial equivalence to its predicate. The detailed technical documentation submitted to the FDA (which is not fully available in this summary) would have provided the evidence for this claim (e.g., engineering analysis, risk assessment, potentially limited verification testing of the new flowmeter components, though not detailed here).
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).