Search Results
Found 1 results
510(k) Data Aggregation
(255 days)
The A7 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 A7 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric (including neonate, infant, child and adolescent) populations.
The A7 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A7 incorporates 02, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane).
This document refers to the Mindray A7 Anesthesia System (K171292). It outlines its indications for use, device description, and a comparison to a predicate device (K151954), along with reference devices, to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information based on the provided text:
Summary of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Mindray A7 Anesthesia System are implicitly derived from its comparison to a predicate device (also an A7 Anesthesia System, K151954) and several reference devices. The core principle is "substantial equivalence," meaning the new device performs at least as well as, or comparably to, the established devices.
The table below summarizes the key technical characteristics and their reported performance/specifications for both the subject device and its direct predicate. Since the document states "The functional and system level testing showed that the device continues to meet specifications and the performance of the device is equivalent to the predicate," the performance of the subject device is presented as matching the predicate.
| Characteristic | Acceptance Criteria (from Predicate/Reference) | Reported Device Performance (Subject Device) |
|---|---|---|
| Vaporizers | Two or Three, variable bypass | Two or Three, variable bypass |
| Agent Support | Sevoflurane, Isoflurane, Desflurane, Halothane, Enflurane | Sevoflurane, Isoflurane, Desflurane, Halothane, Enflurane |
| Automatic Ventilator | Yes | Yes |
| Bellows | Yes | Yes |
| Bellows Volume | 1500mL | 1500mL |
| Ventilation Modes | VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, PS (and additional modes from reference: SIMV-VG, CPAP/PS, APRV) | VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, PS (and additional modes: SIMV-VG, CPAP/PS, APRV) |
| Tidal Volume Range | 20 to 1500 ml | 20 to 1500 ml |
| Rate (bpm) | 4 to 100 bpm | 4 to 100 bpm |
| I:E Ratio | 4:1 to 1:8 with 0.5 increment | 4:1 to 1:8 with 0.5 increment |
| Inspiratory Pause | Off, 5 to 60% of insp. Period | Off, 5 to 60% of insp. Period |
| Air Flow Range | 0 to 15 L/min | 0 to 15 L/min |
| N2O Flow Range | 0 to 12 L/min | 0 to 12 L/min |
| O2 Flow Range | 0 to 15 L/min | 0 to 15 L/min |
| Individual Gas Flow Accuracy | ±50 ml/min or ±5% of setting value, whichever is greater | ±50 ml/min or ±5% of setting value, whichever is greater |
| Pressure Limit | 0 to 100cm H₂O | 0 to 100cm H₂O |
| PEEP | Off, 3 to 30, 1 cm H₂O increment | Off, 3 to 30, 1 cm H₂O increment |
| System Checks | Auto at start | Auto at start |
| Airway Pressure Measured at | Inspiratory | Inspiratory |
| High/Low Airway Pressure Alarm | Yes | Yes |
| Pressure Limiting Alarm | Yes | Yes |
| Sub Atmospheric Pressure Alarm | Yes | Yes |
| Continuous Press Alarm | Yes | Yes |
| Apnea >2 Minute Alarm | Yes | Yes |
| Apnea Alarm | Yes | Yes |
| High/Low Minute Volume Alarm | Yes | Yes |
| High/Low O₂ Concentration Alarm | Yes | Yes |
| Heated Breathing Circuit | Yes | Yes |
| Spirometry | Pressure-Volume and Flow-Volume loops | Pressure-Volume and Flow-Volume loops |
| AG Module Sampling Rate | Adult/pediatric: 120, 150, 200mL/min; Neonate: 70, 90, 120mL/min | Adult/pediatric: 120, 150, 200mL/min; Neonate: 70, 90, 120mL/min |
| AG Module Sampling Delay Time | <4 seconds | <4 seconds |
| AG Module Refresh Rate | 1 second | 1 second |
| AG Module Warm-up Time | 45 seconds to warm-up status, 10 minutes to ready-to-measure status | 45 seconds to warm-up status, 10 minutes to ready-to-measure status |
| AG Module Accuracy CO₂ | 0-1%: +/-.1%, 1-5%: +/-.2%, 5-7%: +/-.3%, 7-10%: +/-.5% | 0-1%: +/-.1%, 1-5%: +/-.2%, 5-7%: +/-.3%, 7-10%: +/-.5% |
| AG Module Accuracy N₂O | 0-20%: +/-2%, 20-100%: +/-3% | 0-20%: +/-2%, 20-100%: +/-3% |
| AG Module Accuracy Desflurane | 0-1%: +/-.15%, 1-5%: +/-.2%, 5-10%: +/-.4%, 10-15%: +/-.6%, 15-18%: +/-1% | 0-1%: +/-.15%, 1-5%: +/-.2%, 5-10%: +/-.4%, 10-15%: +/-.6%, 15-18%: +/-1% |
| AG Module Accuracy Sevoflurane | 0-1%: +/-.15%, 1-5%: +/-.2%, 5-8%: +/-.4% | 0-1%: +/-.15%, 1-5%: +/-.2%, 5-8%: +/-.4% |
| AG Module Accuracy Enflurane/Isoflurane/Halothane | 0-1%: +/-.15%, 1-5%: +/-.2% | 0-1%: +/-.15%, 1-5%: +/-.2% |
| AG Module Accuracy O2 | 0-25%: +/-1%, 25-80%: +/-2%, 80-100%: +/-3% | 0-25%: +/-1%, 25-80%: +/-2%, 80-100%: +/-3% |
| AG Module Accuracy awRR | 2-60rpm: +/-1rpm | 2-60rpm: +/-1rpm |
| AG Module Measurement Rise Time | CO2: <250ms, N2O: <250ms, O2: ≤500ms, Hal/Iso/Sev/Des: ≤300ms, Enf: <350ms | CO2: <250ms, N2O: <250ms, O2: ≤500ms, Hal/Iso/Sev/Des: ≤300ms, Enf: <350ms |
| Measurement Range CO2 | 0 to 30% | 0 to 30% |
| Measurement Range N2O | 0 to 100% | 0 to 100% |
| Measurement Range Des | 0 to 30% | 0 to 30% |
| Measurement Range Sev | 0 to 30% | 0 to 30% |
| Measurement Range Enf/Iso/Hal | 0 to 30% | 0 to 30% |
| Measurement Range O2 | 0 to 100% | 0 to 100% |
1. A table of acceptance criteria and the reported device performance
See the table above. The "Acceptance Criteria" column is derived from the predicate and reference devices' specifications, which the new device is stated to meet or be equivalent to.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Nonclinical testing and Performance" which includes:
- Software (Unit testing, Integration testing, System testing)
- Performance (AG Module, Fresh Flow Optimizer, Sample Gas Return and CO2-absorbent, Suction, Heating Module, Power Supply, Thermal, Cleaning and Disinfection, Waveform Comparison)
- Biocompatibility (Volatile Organic Compounds, Particulate Testing, Cytotoxicity, Sensitization, Irritation / intracutaneous reactivity, Extractables and leachables (E&L) testing, Inorganic gases (03, 02, CO2, NO2) testing)
- Human Factors Validation Testing
- Testing as per consensus standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-2, ISO 80601-2-13, ISO 80601-2-55, ASTM F1101-90, ISO 10079-3, AIM 7351731)
However, the specific sample sizes for these tests are NOT provided in this document. The document states it is for a "Nonclinical testing" demonstrating "functional and system level testing." This typically implies laboratory testing of the device itself or its components under controlled conditions, rather than testing with human subjects or patient data. Therefore, data provenance such as country of origin of patient data or retrospective/prospective nature is not applicable here, as it's not a clinical study involving patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The testing described is primarily non-clinical, focusing on engineering and performance specifications against standards and predicate devices. Expert-adjudicated ground truth is not typically relevant for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to the non-clinical, performance-based testing described.
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
No MRMC study was conducted or reported. This device is an anesthesia system, not an AI-powered diagnostic or assistive tool that would involve human "readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an "algorithm only" performance. The device itself performs measurements and control functions. The "Performance" section lists various modules (e.g., AG Module, Fresh Flow Optimizer) that have been tested. This implies standalone performance testing of these components and the integrated system. However, the document does not provide details on specific statistical metrics that would typically characterize "standalone" performance for an AI algorithm (e.g., sensitivity, specificity, AUC). Instead, it focuses on meeting physical and measurement specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" would be established by:
- Industry consensus standards: Such as AAMI / ANSI ES60601-1, IEC 60601-1-2, ISO 80601-2-13, ISO 80601-2-55, ASTM F1101-90, ISO 10079-3, AIM 7351731.
- Engineering specifications and measurements: For example, the accuracy of gas module measurements (CO₂, N₂O, O₂, anesthetic agents), flow ranges, pressure limits, and alarm thresholds are compared against predefined engineering targets.
- Predicate device performance: The performance of the predicate A7 Anesthesia System (K151954) serves as a benchmark for determining substantial equivalence.
8. The sample size for the training set
This information is not applicable and not provided. This device is not described as involving machine learning or AI models that require a "training set." The testing focuses on the physical and software performance of an anesthesia system.
9. How the ground truth for the training set was established
This information is not applicable and not provided as there is no mention of a training set or machine learning components.
Ask a specific question about this device
Page 1 of 1