(412 days)
GGM Breathing Circuit Bacterial Filter contains two types of bacterial Filters, namely "Bacterial Filter" with only filtering function and "HME Filter" with heat and moisture exchanger function.
Intended patient population: VF-2160, VF-2160-1 and VH-3110 are intended for adult patients with the tidal volume between 250ml-1500ml; VH-3210 is intended for adult patients with the tidal volume between 250ml-1000ml.
Bacterial Filter (VF-2160, VF-2160-1) -
The Bacterial Filter is intended to reduce the transmission of bacteria and viruses to a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired gases is desired. The Bacterial Filter is single use device for use on a single patient for up to 24hrs. The Bacterial Filter is designed to be used in hospital environments by trained personnel.
HME Filter (VH-3110, VH-3210) -
HME (Heat and Moisture Exchange) Filter is intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation.
HME Filter is normally positioned at the patient end of the breathing system between the circuits Y-piece and the catheter mount or patient airway device. HME Filter is a single use device for use on a single patient for up to 24hrs. HME Filter is designed to be used in hospital environments by trained personnel.
GGM Breathing Circuit Bacterial Filter contains two types of bacterial filters, namely "Bacterial Filter" with only filtering function and "HME Filter" with heat and moisture exchanger function.
Bacterial Filter (models VF-2160, VF-2160-1):
Bacterial Filter is a single-used medical device, which is used for filtering the bacteria and virus in the respiratory gas to the patient during the respiratory therapy. VF-2160 and VF-2160-1 are all intended for adult patients with the tidal volume between 250ml-1500ml.
HME Filter (models VH-3110, VH-3210):
HME Filter is a kind of breathing circuit bacterial filter with the function of passive heat and moisture exchanger (artificial nose). It is a breathing circuit bacterial filter that contains electrostatic cotton for filtration and contains heat preserved and moisture absorbed paper roll for airway heat preservation and humidification. The Heat and Moisture Exchanger Filter (HMEF) should be installed on the patient's end based on the principle of passive humidification treatment. VH-3110 is intended for adult patients with the tidal volume between 250ml-1500ml, and VH-3210 is intended for adult patients with the tidal volume between 250ml-1000ml.
Here's a breakdown of the acceptance criteria and study information for the GGM Breathing Circuit Bacterial Filter, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document lists "Methodology only, no acceptance criteria" for some tests but then states "Meet the requirements of the clinical application" or "Meet the requirements of the standard" for their results. For such cases, I've used the general "Meets standards" or "Clinical application met" as the "Reported Performance" to reflect this. For metrics where specific criteria are given, those are included.
| Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Packaging for Terminally Sterilized Medical Devices | ||
| ISO 10993-7 (EO/ ECH/ EG residual test) | Non-Detected | PASS |
| ISO 11737-2 (Sterility test) | Negative | PASS |
| ASTM F1608 (Microbial Ranking Test) | LRV > 3.0 (99.9%) | PASS |
| ASTM F1929 (Dye Penetration Test) | No Penetration | PASS |
| ASTM F1140 (Burst and Creep Test) | Package successfully held for creep duration | PASS |
| ASTM F88 (Seal Peel Strength Test) | > 0.1 kg/cm | PASS |
| Shelf Life Test | ||
| ISO 9360-1 (Moisture Loss, Pressure Drop, Leakage, Compliance) | Methodology only, no acceptance criteria | Meet the requirements of the clinical application |
| ISO 5356-1 (Security of Engagement, Housing Burst Strength, Drop Test) | Does not fall off and crack | PASS |
| ASTM F2101 (Filtration Efficiency Test) | Methodology only, no acceptance criteria | Meet the requirements of the standard |
| Biocompatibility Test | ||
| ISO 10993-5 (In Vitro Cytotoxicity test) | Cell viability is greater than 70% | PASS |
| ISO 10993-10 (Skin Sensitization Study - Maximization Test) | Did not produce skin sensitization | PASS |
| ISO 10993-10 (White Rabbit Intracutaneous Reactivity Test) | Did not cause intracutaneous irritation | PASS |
| ISO 10993-11 (Acute Systemic Toxicity Study) | Did not cause systemic toxicity reaction or death | PASS |
| ISO 10993-11 (Repeat- Dose Subchronic Systemic Toxicity Study) | No significant adverse effects. | PASS |
| ISO 10993-3 (In Vitro Mammalian Cell Gene Mutation Test) | No genotoxic effects | PASS |
| ISO 10993-3 (Salmonella Reverse Mutation Test) | Did not cause mutagenic | PASS |
| ISO 10993-3 (Mice Erythrocyte Micronucleus Test) | Does not produce micronuclei | PASS |
| ISO 10993-6 (Muscle Implant Study) | Nonirritant (Score 70%, PM2.5 ≤ 12 µg/m3). |
8. The Sample Size for the Training Set
This question does not apply, as the device is a physical medical device and does not involve AI model training sets.
9. How the Ground Truth for the Training Set was Established
This question does not apply, as the device is a physical medical device and does not involve AI model training sets or associated ground truth establishment.
§ 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).