(325 days)
The A9800 Anesthesia Workstation provides general inhalation anesthesia and ventilatory support for adolescents to adults in an operating room environment. The device is indicated for volume or pressure control ventilation.
The A9800 Anesthesia Workstation provides accurate, pneumatically driven and electronically controlled ventilation. The A9800 includes modes that provide patient-appropriate defaults and ranges. The A9800 was rigorously tested to harmonized standards, which included a full human factors study with physicians. Like the predicate device (K123125) A9800 provides complete anesthesia ventilation capabilities that include traditional and "intensive care type" ventilation modes. Low-flow anesthesia delivery creates savings by lower facility gas usage. The integrated electronic flow meter provides accurate monitoring and intuitive operation. The A9800 bellows contains breathing gasses to be delivered to the patient as does the predicate device. Likewise, for patient safety both the predicate and the A9800 maintain positive pressure in the breathing system so any leakage that occurs is outward. PEEP (Positive End Expiratory Pressure) in A9800 is electronically regulated for patient safety and is substantially equivalent to the predicate device. Both the A9800 and the predicate device offer an ACGO (alternate common gas outlet) to provide fresh gas to non-rebreathing adapters. The A9800 and the predicate device (K123125) include the following ventilation modes: Volume Mode, Pressure Control Mode, Pressure Support Mode with Apnea Backup, Synchronized Intermittent Mandatory Ventilation Mode (SIMV), and Pressure Controlled Ventilation with Volume Guarantee (PCV-VG). The predicate offers SIMV-PCV-VG, which is not offered on the A9800. The A9800 method of control, of the maximum applied breathing pressure, during manual ventilation (by using a single turn APL valve along with a manual breathing bag) is equivalent to the predicate device. Both the predicate device (K123125) and the A9800 have an accessory gas analyzer that can monitor FiO2 and patient respiratory gas for CO2, N2O, and five types of anesthetic agents. A9800 and the predicate also have an Anesthetic Gas Scavenging System (AGSS) for the safe and effective removal of waste gas. Both the predicate device (K123125) and the A9800 utilize a large 15 inch touch screen monitor with a navigator wheel that provides a simple intuitive interface for user control. The screen can be tilted upward and downward according to the doctor's needs and position. The parameter areas on the main screen are shown in different colors for ease of identification. The waveforms and alarm records are clearly shown for easy review by the clinician. Like the predicate device (K123125) the A9800 displays patient data with waveforms and spirometry loops. A reference loop can be stored to best understand changes in patient response to therapy. Both the A9800 and its predicate device (K123125) contain electronic flow meters for Oz, Air, and NzO, which are designed especially for low flow applications. Electronic fresh gas flow displays are used in addition to traditional mechanical flow controllers for enhanced patient safety. Data communications export is supported to connect to the Hospital IT systems and support electronic medical records (EMR).
The Oricare™ A9800 Anesthesia Workstation is indicated to provide general inhalation anesthesia and ventilatory support for adolescents to adults in an operating room environment, specifically for volume or pressure control ventilation.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document uses a "Substantial Equivalence" comparison against predicate devices rather than specific quantitative acceptance criteria with reported device performance values. The acceptance criterion is generally being substantially equivalent to the predicate devices for each specified item.
| Item of Comparison | Predicate Device Performance (GE Avance, Mindray A5, Draeger Apollo) | Oricare A9800 Reported Performance | Acceptance Criteria Met? (Substantial Equivalence) | Notes |
|---|---|---|---|---|
| Intended Use | General inhalation anesthesia and ventilatory support for various patient ranges (neonatal, pediatric, adult) | General inhalation anesthesia and ventilatory support for adolescents to adults | Yes | Slight difference in target population (adolescents to adults vs. including neonatal/pediatric) but deemed substantially equivalent. |
| Target Population | Neonatal, pediatric, adult (GE, Draeger); Pediatric, Adult (Mindray) | Adolescent to Adult | Yes | Considered "No Difference - SE". |
| Ventilation Modes | Volume Control, Pressure Control, PCV-VG (except Draeger), SIMV-VCV/PCV (except Draeger), SIMV-PCV-VG (GE, Mindray), Pressure Support, Apnea Backup | Volume Control, Pressure Control, PCV-VG, SIMV-VCV/PCV, Pressure Support, Apnea Backup | Yes | SIMV-PCV-VG is not offered on A9800, but deemed "no patient safety risk by not offering this mode." Oricare A9800 has better resolution for incremental settings of Tidal Volume (300-1000 mL range). |
| Tidal Volume Range (VT) | 0-1500 mL (Mindray), 20-1500 mL (GE), 20-1400 mL (Draeger) | 20 to 1500 mL | Yes | |
| O2 Flow Accuracy | ±5% or ±20 mL/min (GE), ±10% or 120 mL/min (Mindray, Draeger) | ±10% or 120 mL/min | Yes | Within the range of predicate devices. |
| Auxiliary Oxygen System | O2 only (No Blender) | Blender (O2/Air) | Yes | Highlighted as a "SAFETY FEATURE" with additional capability to lower O2 concentration below 100% to prevent surgical fires, aligning with FDA, ASA, and APSF initiatives. No patient risk. |
| Safety Standards Compliance (e.g., IEC 60601-1) | Tested | Passed | Yes | Device underwent rigorous testing to harmonized standards. |
| Human Factors | Tested | Tested | Yes | Included a full human factors study with physicians. |
| Electrical Safety | ISO 60601-1 | ISO 60601-1 | Yes | |
| Mechanical Safety | ISO 60601-1 | ISO 60601-1 | Yes | |
| Physical Specifications (Height, Width, Depth, Weight) | Varied between predicates | Varied, but deemed equivalent | Yes | Small differences in physical dimensions and weight were individually assessed and found to be "Substantially Equivalent," not introducing new safety concerns. |
| Operating Temperature | 50-100°F (GE), 50-104°F (Mindray), 59-104°F (Draeger) | 50-104°F | Yes | Within the range of predicate devices. |
| Operating Humidity | Less than 95% RH (GE), 15-90% Non-condensating (Mindray, Draeger) | 15-90% Non-condensating | Yes | Within the range of predicate devices. |
| N2O shut off with loss of O2 pressure | Yes | Yes | Yes | |
| Hypoxic Guard | Yes | Yes | Yes | |
| AGSS Type | Adjustable Flow | Adjustable Flow | Yes |
2. Sample size used for the test set and the data provenance:
The document describes extensive non-clinical testing for safety and performance (harmonized standards adherence, bench tests, and simulated use validation). However, these are not described as using a "test set" in the context of clinical or diagnostic performance with a specific sample size of patients or data points.
- Test set: Not explicitly defined in terms of patient data or clinical cases. The "tests" refer to engineering and safety verifications.
- Data provenance: Not applicable in the context of clinical data. The tests performed are laboratory and engineering tests conducted by 3rd party testing labs (TUV, National Testing and Inspection Center) and internally by Oricare.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not explicitly stated for specific ground truth establishment.
- Qualifications of experts: The device underwent a "full human factors study with physicians." This indicates involvement of qualified medical professionals in evaluating usability and safety from a human interaction perspective, but not for establishing "ground truth" for a diagnostic or prognostic test.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable. The studies described are non-clinical engineering and safety validations, not studies requiring expert adjudication of clinical outcomes or images.
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:
- MRMC study: No, this device is an anesthesia workstation, not a diagnostic AI device requiring MRMC studies to assess AI assistance.
- Effect size of human readers improve with AI: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance: Not applicable. The device is a medical apparatus (anesthesia workstation) and its performance is evaluated through engineering standards, bench testing, and usability, not as a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of ground truth: The "ground truth" for this device's performance is established by adherence to recognized national and international safety and performance standards (e.g., IEC 60601-1, ISO 80601-2-13), as well as internal engineering and simulated use testing against design specifications. For biological safety, specific tests like cytotoxicity, systemic toxicity, and sensitization tests define the "ground truth" of biocompatibility.
8. The sample size for the training set:
- Training set sample size: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Ground truth for training set: Not applicable.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its "acceptance criteria" (which in this context is primarily substantial equivalence to predicate devices and adherence to safety/performance standards) consists of comprehensive non-clinical testing. This includes:
- Adherence to Harmonized Standards: The A9800 passed safety tests for compliance with various IEC and ISO standards related to medical electrical equipment, electromagnetic compatibility, alarm systems, and usability engineering (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62366, ISO 80601-2-13, IEC 60601-1-6). These tests were conducted by 3rd party testing labs (TUV, National Testing and Inspection Center).
- Bench Tests: A wide array of specific bench tests were performed, including:
- Waveform analysis comparing A9800 to the GE Avance predicate.
- Simulated Use Validation.
- Phasein standard requirements report.
- ISTA shipping test report.
- Gas Analyzer test report.
- Multiple hardware unit test reports (BDU/PSU, SBU, KBD, EFM).
- Integration test and prototype machine verification.
- Blender test report.
- Breathing system manual/auto switch life cycle test.
- Breathing system test to ISO 8835-2.
- ACGO Switch life cycle test.
- Hardware system Verification and Validation Report.
- Breathing system Hi temperature steaming test and heating test.
- Battery charge & discharge test.
- AGSS Test to ISO 8835-3-2007.
- Biological Safety Assessment (NAMSA reports): This included cytotoxicity, systemic toxicity in mice, and intracutaneous and sensitization tests in rabbits and guinea pigs.
- Sterilization and Disinfection Validation: Steam sterilization cycle validation and high-level disinfection validation reports were provided (LSO Autoclave, Nelson Lab Disinfectant).
- Human Factors Study: A "full human factors study with physicians" was conducted.
The conclusion drawn from these non-clinical tests is that the A9800 Anesthesia Workstation is substantially equivalent to the listed predicate devices (K123125, K123211, and K042607) and introduces no new issues of safety or effectiveness. No clinical trials were required for this device type.
§ 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).