(22 days)
The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS can be used for spontaneous, manually assisted, automatic or pressure support ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.
The Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius Tiro can be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.
The Fabius GS and Fabius Tiro are continuous flow gas anesthesia systems.
The compact breathing system (COSY) used with the Fabius GS (K030624) and Fabius Tiro (K031400) anesthesia systems is being modified to incorporate a heater plate. The addition of a heater plate is a hardware change only. The basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies within the Fabius GS/Tiro remain unchanged.
The heater consists of a heater foil, metal plate and insulator plate that are mounted between the absorber canister and COSY block. The heater subassembly is connected via a power cable to a separate power supply mounted externally to a Fabius GS/Tiro Anesthesia System.
Like the heater plate utilized in the NM6400's (K033498) Divan ventilator, the heater incorporated into the COSY is intended to warm the breathing system to minimize moisture accumulation in the breathing system components, especially during cases utilizing low flow anesthesia and/or during cases of low ambient environmental temperatures. It is not intended to control or maintain a set temperature of the patient breathing gas or to humidify the gas. Once activated, the heating plate in the COSY, like the NM6400, heats up to a constant temperature. This heat is then transferred, through conduction, to the components of the breathing system above it. In the NM6400, the heater plate is activated when the NM6400 System Power switch is turned to the "On" position and is de-activated when the NM6400 is switched to "Standby." With the COSY, heater activation is independent of the Fabius GS/Tiro. To activate the heater, the user is required to switch the heater power supply to the "On" position. To deactivate, the user is required to switch the power supply to the "Off" position.
This document describes the Fabius GS and Fabius Tiro Anesthesia Systems with a modification: the addition of a heater plate to the compact breathing system (COSY). The acceptance criteria and supporting study details are based on the provided text, which is a 510(k) premarket notification summary.
It's important to note that this document is a 510(k) summary for a hardware modification to an existing medical device, not a new, AI-powered diagnostic device. Therefore, many of the typical elements expected for AI/ML device studies (e.g., sample size for AI, ground truth establishment, MRMC studies) are not applicable here. The evaluation focuses on the safety and effectiveness of the hardware change relative to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format with specific performance metrics such as accuracy, sensitivity, or specificity, as would be common for diagnostic AI algorithms. Instead, the "acceptance criteria" are implied by the scope of the premarket notification: to demonstrate that the modified device remains substantially equivalent to legally marketed predicate devices and that the hardware change does not introduce new safety or effectiveness concerns.
The performance is implicitly demonstrated by the comparison to predicate devices and the completion of standard engineering verification and validation.
| Feature/Criterion | Reported Device Performance |
|---|---|
| Safety and Effectiveness (General) | The device with the heater plate modification is deemed substantially equivalent to predicate devices (K030624, K031400, K033498), implying it meets the same safety and effectiveness standards. The addition of the heater plate is a hardware change only. The basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies remain unchanged. |
| Heater Function (Minimize moisture accumulation) | The heater is "intended to warm the breathing system to minimize moisture accumulation... especially during cases utilizing low flow anesthesia and/or during cases of low ambient environmental temperatures." This function is analogous to the heater plate in the predicate NM6400's Divan ventilator. When activated, it heats up to a constant temperature, transferring heat through conduction to the breathing system components above it. No quantitative performance data related to moisture reduction is provided, but functional equivalence to the predicate is asserted. |
| Heater Intended Use (Not for gas temperature/humidity) | The heater is explicitly not intended to control or maintain a set temperature of the patient breathing gas or to humidify the gas. This clarifies its functional scope and prevents misinterpretation of its capabilities. |
| Activation/Deactivation Mechanism | For the COSY, heater activation is independent of the main Fabius GS/Tiro unit. The user is required to switch a separate power supply to "On" to activate and "Off" to deactivate. This is different from the NM6400, where activation is tied to the system power switch. This difference is noted but not presented as a non-conformance. |
| Verification/Validation Testing | "Qualification of the modified compact breathing system included hazard analysis, system level qualification, and verification/validation tests." This confirms that standard engineering and regulatory processes were followed to ensure the safety and functionality of the modified device. No specific results or metrics from these tests are detailed in the provided summary. |
Study Details:
The supporting "study" is a collection of engineering tests and regulatory analyses performed to ensure the modified device (Fabius GS/Tiro with heater plate) remains safe and effective and continues to be substantially equivalent to its predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This concept doesn't directly apply in the context of this 510(k) for a hardware modification. There isn't a "test set" of patient data in the way an AI/ML diagnostic algorithm would have. Instead, the "testing" involves internal engineering verification and validation of the physical device, including hazard analysis and system-level qualification. The sample size for these engineering tests would likely refer to the number of units tested, the number of test cycles, or the specific operating conditions evaluated, which are not detailed in this summary.
- Data Provenance: Not applicable in the context of patient data for an algorithm. The "data" comes from internal engineering and manufacturing records, hazard analyses, and performance testing of the device hardware.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. There is no "ground truth" established by experts for a test set of data in this context. The evaluation is of hardware performance and substantial equivalence to predicate devices, not of diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method (like 2+1, 3+1 consensus) would be used for this type of hardware modification submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images). This submission is for a hardware modification to an anesthesia machine and does not involve human readers analyzing medical cases with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This device is a piece of hardware, an anesthesia machine, which inherently requires human operation and interaction for its intended use. There is no standalone "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
Not applicable in the typical sense of diagnostic algorithms (e.g., pathology, outcomes data). The "ground truth" for this submission revolves around:
- Engineering specifications and design requirements.
- Performance against established safety standards.
- Functional equivalence compared to predicate devices (e.g., the NM6400's heater plate).
- Results from internal verification and validation testing, which confirm the device meets its design intent.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML algorithm involved, and therefore no "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).