(319 days)
The Georgia BioMedical Filter Heater/Hydrator Insufflation Gas Conditioner is an accessory to an insufflator intended to heat, humidify and filter a gas stream used for inflation during laparoscopic surgery.
The Filter Heater/Hydrator Insufflation Gas Conditioner is a single use device which attaches to the outlet port of an insufflator and is designed to warm and humidify the gas stream prior to insufflation. The device consists of a universal gas connector, a control module which houses the control and safety circuits for the system and a disposable filter heater/humidifier (FHH) tubing set.
Gas from the insufflator is routed into the FHH tubing set via the control module. Within the filter heater/humidifier tubing set particles >0.3 um in size are filtered from the gas, the gas is heated to 35°C and the gas is hydrated to >80% relative humidity. The distal end of the filter heater/humidifier tubing set terminates in a Luer lock connection for attachment to a gas entrance port for the abdomen, pleural space, chest cavity, abdominal cavity or any other body cavity.
Here's a breakdown of the acceptance criteria and study information for the Georgia BioMedical, Inc. Filter Heater/Hydrator Insufflation Gas Conditioner, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Heating Time | Device reaches 35°C (body temperature) rapidly after activation. | Operates at 36°C within 100 seconds of activation. |
| Humidity (Flow Rate) | Maintains >80% relative humidity at varying flow rates. | >80% relative humidity maintained at flow rates up to 8 liters/minute. |
| Pressure Drop | Insignificant reduction in gas pressure. | Only a very slight reduction in gas pressure, which increases with flow rate; humidification of FHH cassette does not increase pressure drop. |
| Sustained Humidity | Capacity adequate to humidify 180 liters of gas over usage conditions. | Under worst-case conditions (high flow rate, under-humidification), results suggest adequate capacity with 8cc water charge and moderate flow rates. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" in terms of number of devices or experimental replicates for the performance tests. The descriptions are general (e.g., "Testing was performed").
- Test Set Sample Size: Not explicitly stated. The descriptions imply multiple measurements were taken for each test condition (e.g., "This procedure was repeated for flow rates of 3,5,6 and 8 liters/minute").
- Data Provenance: The studies were conducted by Georgia BioMedical, Inc. or their consultants for regulatory submission. The origin (e.g., country) is the USA, based on the submission to the FDA. The nature of the studies is prospective as they are performance tests conducted to demonstrate the device meets design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the described tests are laboratory performance evaluations of physical parameters (temperature, humidity, pressure), not diagnostic or interpretative tasks requiring human expert ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes laboratory performance testing of the device's physical functions (heating, humidification, pressure), not a study comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical accessory with no AI algorithms. The performance testing described is "standalone" in the sense that it measures the device's inherent physical performance, but it's not applicable to the context of "algorithm only" performance.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria was established by measurement against engineering specifications and industry standards/expectations for medical gas conditioning. For example:
- Temperature: Measured by a thermometer/sensor.
- Relative Humidity: Measured by a hygrometer/sensor.
- Gas Pressure: Measured by a pressure gauge/sensor.
These measurements were then compared against the target performance values (e.g., 35°C, >80% relative humidity, slight pressure reduction).
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical hardware product, not a software algorithm that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.