(342 days)
The Anodyne TM CC Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
The HEYER America® Anodyne™ CC Anesthesia System is a standalone anesthesia device. The device is a reusable, non-sterile, life-supporting anesthesia machine for prescription use in hospitals, clinics and surgery centers. The device is software driven. Adequate software testing with respect to the new IEC 601-1-4 has been conducted on the device. The device is electrically operated.
The provided text describes the Heyer America® Anodyne™ CC Anesthesia System and its comparison to predicate devices for 510(k) clearance. However, it does not contain a study specifically designed to establish acceptance criteria or prove device performance through clinical trials with human subjects, statistical analysis, or defined ground truth establishment methods.
Instead, the document focuses on a performance comparison with predicate devices based on technical specifications and functional capabilities. The core argument for safety and effectiveness relies on substantial equivalence to existing, legally marketed anesthesia systems.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study (e.g., target sensitivity/specificity). Instead, it presents a comparison of the Anodyne™ CC's technical specifications and performance parameters against two predicate devices (Narkomed® 2C and Modulus® II Plus). The implied "acceptance criterion" is that the Anodyne™ CC's performance should be comparable to or within the established ranges of these predicate devices.
| Parameter | Anodyne™ CC Reported Performance | Predicate Device 1 (Narkomed® 2C) Performance | Predicate Device 2 (Modulus® II Plus) Performance |
|---|---|---|---|
| Ventilator Performance | |||
| Tidal volume range (Total) | 50 - 1,400 ml | 50 - 1,500 ml | 50 - 1,500 ml |
| Tidal volume range (Pediatric) | 50 - 400 ml | 50 - 300 ml | 50 - 300 ml |
| Tidal volume range (Adult) | 300 - 1,400 ml | 300 - 1,500 ml | 300 - 1,500 ml |
| Frequency range (Total) | 2 - 99 BPM | 1 - 99 BPM | 2 - 100 BPM |
| Frequency range (Pediatric) | 20 - 99 BPM | 1 - 99 BPM | 2 - 100 BPM |
| Frequency range (Adult) | 2 - 30 BPM | 1 - 99 BPM | 2 - 100 BPM |
| I:E Ratio range | 1:3, 1:2, 1:1.5, 1:1, 2:1, 3:1 | 1:4.5, 1:4, 1:3.5, 1:3, 1:2.5, 1:2, 1:1.5, 1:1 | dependent variable |
| Insp. Flow Range | dependent variable | 10 - 33 l/min | 10 - 100 l/min |
| Insp. Pause | 20%, 30% | - | 25% |
| Sigh | 1 of 100, 1.5 * Vt | - | - |
| Pressure limit range | 10 - 100 cmH2O | 15 - 120 cmH2O | 20 - 100 cmH2O |
| Airway Pressure Monitor | |||
| Pressure range | -10 - 100 cmH2O | -10 - 70 cmH2O | -20 - 120 cmH2O |
| High Alarm limits | 10 - 100 cmH2O | 10 - 70 cmH2O | 20 - 100 cmH2O |
| Sustain Alarm limits | 2 - 30 cmH2O | 10 - 30 cmH2O | 10 - 30 cmH2O |
| Spirometer / Volume Monitor | |||
| Tidal volume range | 20 - 9,999 ml | 70 - 9,999 ml | 0 - 9,999 ml |
| Breath rate range | 0 - 99 BPM | 3 - 50 BPM | 0 - 99 BPM |
| Minute Volume range | 0.1 - 999.9 l/min | 0 - 999.9 l/min | 0 - 999.9 l/min |
| Tidal v. Low Alarm limits | 20 - 1,400 ml | 70 - 1,500 ml | - |
| Minute v. Low Alarm limits | 0.5 - 5 L/min | 0.5 - 10 L/min | 0 - 9.9 L/min |
| Low rate Alarm limits | 2 - 30 BPM | - | - |
| High rate Alarm limits | 10 - 99 BPM | - | - |
| Oxygen Monitor Performance | |||
| Concentration range | 0 - 100 Vol% | 0 - 100 Vol% | 0 - 105 Vol% |
| Response time T90 | 15 sec | 20 sec | 15 sec |
| Sensor Life | 12 months | 12 months | 12 months |
| Low Fio2 Alarm limits | 18 - 99 Vol% | 18 - 99 Vol% | 18 - 99 Vol% |
| High Fio2 Alarm limits | 30 - 99 Vol% | 18 - 99 Vol% | 18 - 99 Vol% |
| Gas Management Performance | |||
| Pipeline operating range | 45 - 55 psig | 50 - 55 psig | 50 psig |
| O2 supply failure alarm starts at | 27 psig | 27 psig | 27 psig |
| N2O shut off at | 24 psig | 20 psig | 20 psig |
| O2 flush | 50 ± 10 lpm | 55 ± 10 lpm | 60 ± 15 lpm |
| Minimum O2 flow | 250 ± 50 ml/min | 250 ± 50 ml/min | 200 ml/min |
| Hypoxic guard | 25 Vol% O2 | 25 Vol% O2 | 25 Vol% O2 |
| Rebreathing Circuit | |||
| APL range | 2 - 50 cm H2O | 2 - 100 cm H2O | 1 - 75 cm H2O |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The document describes a comparison based on product specifications and predicate device performance, not a clinical trial with a defined test set of patients or data points. The "performance comparison" tables list operational ranges and features, implying engineering validation against design specifications rather than a test on a specific dataset.
- Data Provenance: Not applicable in the context of a "test set." The comparison references the specifications of the Anodyne™ CC and two predicate devices (OHMEDA® Modulus® II Plus and North American Dräger® Narkomed® 2C). The document also mentions that the Anodyne™ CC is based on products legally marketed in Europe (HEYER Anesthesia DOGMA® and ACCESS®), implying their successful use in Europe contributes to the provenance of the underlying technology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No "ground truth" for a test set was established by experts in the context of a clinical study or evaluation of diagnostic accuracy.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There was no clinical test set requiring adjudication.
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, an MRMC comparative effectiveness study was not done. The device is an anesthesia system, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable as the device is an anesthesia machine. While it contains software and electronic controls, its performance is assessed as a complete system, and it is intended for use by medical professionals (human-in-the-loop). The document states, "Adequate software testing with respect to the new IEC 601-1-4 has been conducted on the device." This implies engineering and software validation, but not a "standalone performance" study in the AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable. The comparisons are based on the published technical specifications, operational envelopes, and functional descriptions of the devices. For example, "Tidal volume range 50 - 1,400 ml" would be validated against calibrated measuring equipment consistent with engineering and manufacturing standards, not medical ground truth like pathology. The "Clinical discussion" refers to the long-standing safe and effective use of similar devices in Europe as a basis for substantial equivalence, which could be considered a form of "outcomes data" at a high level, but not a formal ground truth for a specific test set.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document is for a 510(k) premarket notification for an anesthesia system, not an AI/machine learning device that would require training sets. The "software-driven" nature only indicates it has controlling software, not learning algorithms.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
§ 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).