(212 days)
The Intersurgical Flo - Guard Breathing Filter is for use at machine end connections in home and hospital breathing system applications. It is designed to reduce bacterial/viral transmissions in order to protect the patient and respiratory equipment. The filter is single patient use for an adult target patient population, is intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.
The breathing filer is classified as "Breathing Circuit Bacterial Filters" according to 21 CFR 868.5260. They are all in Regulatory Class II and have a product code of CAH. The Flo-Guard breathing filter is designed to be placed at the machine end of a breathing system to protect the patient and machine against cross contamination while maintaining a low resistance across a wide range of flow rates. The gas flow path is simple, the pathway is through the 22F to the 22M connection on the inspiratory breath and should the filter be used on the expiratory side, from the 22M to the 22F on the expired breath. The Flo-Guard is a single use product. The low resistance makes it an ideal filter for use in both the hospital and the home where high flow rates may potentially be used; this includes CPAP, BIPAP and cough assist applications. The filter has been designed to protect between the machine and breathing circuit interfaces. The 1690030 is a Bacterial/viral filter capable of delivering low resistance values at high flows. It is designed to accompany BiPAP circuits and cough assist circuits for systems and is an expiratory silencer kit for neonatal ventilators also to be available as a stand alone low resistance product.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Intersurgical Flo-Guard Breathing Filter:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic Compared | Acceptance Criteria (Predicate Device) | Reported Device Performance (1690030 Flo-Guard Breathing Filter) |
|---|---|---|
| Product Labeling | 99.99% BFE & VFE | 99.99% BFE & 99.95% VFE |
| Intended Use | Reduce bacterial/viral transmissions | Reduce bacterial/viral transmissions |
| Target Population | All | All (Adult target patient population) |
| Environment of Use | Clinical | Clinical (Healthcare and home environments) |
| Maximum Duration of Use | (Not explicitly stated for predicate) | 24 hours |
| Physical Characteristics | Round/Cylindrical | Round/Cylindrical |
| Approximate Volume (ml) | 74 ml | 82 ml |
| Resistance (at 30 l/min) | 0.7 cm H2O | 0.4 cm H2O |
| Weight | 29 g | 28 g |
| Type of Filtration | Electrostatic | Electrostatic |
Note: The document establishes substantial equivalence by comparing the proposed device to a predicate device (Respironics Breathing Filter K973797). Therefore, the predicate device's specifications serve as the de facto "acceptance criteria" for the new device to demonstrate similar performance. The "Reported Device Performance" column shows how the new device compares.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for any specific "test set" in the traditional sense of a clinical or lab study involving a human population. Instead, the comparison is made on characteristics of the device filters themselves.
- Sample Size: Not specified in terms of number of devices tested for each characteristic. It refers to "the Flo-Guard" as a general type.
- Data Provenance: The testing for characteristics like resistance, filtration efficiency, and volume was conducted internally or at an external test house. The country of origin of the data is not specified, but the applicant company is based in Liverpool, NY, USA. The testing appears to be prospective in nature, performed specifically for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to this type of device submission. The "ground truth" for a breathing filter is not established by expert consensus on clinical findings or images. Instead, it's based on objective, measurable physical and functional characteristics of the device (e.g., bacterial filtration efficiency, resistance to flow).
- The document implies that established laboratory methods (e.g., "Henderson rig" for filtration efficiency) are used, which are standard, objective measurements rather than subjective expert interpretations.
4. Adjudication Method for the Test Set
- Not applicable. Since the "ground truth" is determined by objective physical and functional measurements, there is no need for expert adjudication. The tests produce quantitative results that are then compared against established standards or predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is typically performed for diagnostic devices where human readers interpret medical images or data, and AI assistance might improve their accuracy. This submission is for a medical device (breathing filter) with objective performance metrics, not an AI-based diagnostic tool. Therefore, human-in-the-loop performance with or without AI assistance is not relevant or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical breathing filter, not an algorithm or AI system. Its performance is inherent to the device itself, not an independent algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective physical and functional measurements using standardized laboratory test methods. These include:
- Bacterial Filtration Efficiency (BFE) and Viral Filtration Efficiency (VFE): Determined by specialized external testing (e.g., using a "Henderson rig").
- Resistance to Flow: Measured by applying rated flow and recording pressure increase.
- Approximate Volume: Calculated using internal pressure recordings and gas laws.
- Weight: Measured using a calibrated balance.
- Leakage: Tested by maintaining internal pressure and measuring air flow.
- Maximum Duration of Use: Verified through conditioning tests (e.g., 24 hours on a ventilator, 24 hours on moisture return rig).
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI algorithm or a machine learning model, so there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply here.
§ 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).