(35 days)
The FM-1 NO Blender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the FM-1 NO Blender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot be used. In this capacity, it can be used with a self-inflating manual resuscitator bag. This intended use includes applications within a medical facility. The FM-1 NO blender is not intended for use as a primary NO delivery system for long term use. (Note: These indications for use are unchanged form K003665.
The Fadasis Medical FM-1 NO Blender is substantially equivalent to the Fadasis FM-1 NO Blender, The 1 addis Incontaint I 1 1 rith 510(k) premarket notification number K003665. The purpose of this Which was clouded by I DA whan 2000 (EEK, rather than stainless steel, in the capillary tubes.
The new FM-1 NO blender is identical to the predicate FM-1 NO blender with the exception of the capillary tube material, which has been changed to PEEK from stainless steel.
The provided document describes a Special 510(k) submission for the Fadasis Medical FM-1 NO Blender, where the only change from the previously cleared device (K003665) is the material used for capillary tubes (from stainless steel to PEEK). Therefore, the study presented focuses on validating this material change.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance results for the FM-1 NO Blender. Instead, it states that "All testing indicated the FM-1 NO Blender met its design input specifications, design output specifications, hazard analysis and risk control requirements."
However, the validation and verification activities listed in text within the section titled "The Fadasis Medical FM-1 NO Blender was designed to comply with the limited applicable portions of the following:" implicitly define the performance areas checked.
| Performance Area Checked (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|
| Material Compatibility (PEEK capillary tubes) | validated via FTIR testing |
| FM-1 NO Blender 5-15 lpm Performance Characteristics | Met design input/output specifications |
| FM-1 NO Blender Validation with Self Inflating Manual Resuscitator Bags | Met design input/output specifications |
| FM-1 NO Blender Validation of the Concentration Profile When Used with Self Inflating Manual Resuscitator Bags | Met design input/output specifications |
| FM-1 NO Blender Regulator Check Function | Met design input/output specifications |
| FM-1 NO Blender 5-15 Ipm Failure Testing | Met design input/output specifications |
| FM-1 NO Blender Material Compatibility Information (general) | Met design input/output specifications |
| FM-1 NO Blender Drop Test | Met design input/output specifications |
| FM-1 NO Blender Packaging and Shipping Validation | Met design input/output specifications |
| Compliance with CGA 626: Medical NO Gas Connections | Device designed to comply |
| Compliance with IEC 601-1: Medical Electrical Equipment (general requirements) | Device designed to comply |
| Compliance with FDA Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer | Device designed to comply |
| Hazard Analysis and Risk Control Requirements | Met requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the individual tests (e.g., how many units were drop-tested, how many resuscitator bag validation cycles were performed). It refers to "All testing."
- Data Provenance: Not explicitly stated, but given it's an FDA submission, the tests were presumably performed at the manufacturer's facility in Middleton, WI, USA. The data would be prospective for the specific tests performed for this submission, validating the PEEK material. For the original K003665, the data would have been prospective for that submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device. The testing is for engineering performance, material compatibility, and functional validation of a medical device, not for interpretation of medical images or diagnoses. Ground truth is established by engineering specifications and objective measurements.
4. Adjudication Method for the Test Set
Not applicable. The testing involves engineering measurements and functional assessments rather than subjective interpretations requiring adjudication.
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 a nitric oxide blender, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a hardware medical device; it's not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device's performance validation is based on:
- Engineering Design Specifications: The device's intended operational parameters, flow rates, concentration ranges, safety limits, etc.
- Regulatory Standards: Compliance with CGA 626, IEC 601-1, and FDA Guidance Documents.
- Material Science Principles: For the FTIR testing of PEEK, the ground truth would be the known chemical and physical properties of PEEK for medical applications and its compatibility with the intended gases.
- Functional Requirements: The ability to perform its intended use (blending NO, oxygen, and nitrogen; operating with resuscitator bags; regulator function).
8. The Sample Size for the Training Set
Not applicable. This is a hardware device validation, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 868.5165 Nitric oxide administration apparatus.
(a)
Identification. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”