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510(k) Data Aggregation
(255 days)
A7 Anesthesia System
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 |
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(104 days)
A7 Anesthesia System
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 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 O2, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane). The A7 consists of a main unit (includes an anesthetic ventilator and flow meter monitor assembly) and a detachable breathing system.
This document is a 510(k) premarket notification for the Mindray A7 Anesthesia System and primarily focuses on establishing substantial equivalence to a predicate device (K142552). It does not contain specific acceptance criteria for a study demonstrating performance, nor does it detail a standalone study or an MRMC comparative effectiveness study for a new AI feature.
The submission revolves around a modification to an existing A7 Anesthesia System (K142552) to include a "Fresh Gas Flow Optimizer feature." The key point is that "This feature does not change the fresh gas flow setting nor does it supply an alarm if the user does not follow the recommended fresh gas flow setting." This implies the feature is advisory and doesn't directly control the device's critical functions in a way that would necessitate extensive clinical performance studies for efficacy or safety.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present because the submission's purpose is to demonstrate equivalence of a modified, non-critical feature, rather than proving the performance of a new diagnostic or AI system.
However, based on the provided text, I can extract information related to general performance testing and the comparison between the subject device and its predicate.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "acceptance criteria" table with specific thresholds for a novel diagnostic or AI performance. Instead, it presents a technical comparison table between the subject A7 Anesthesia System and its predicate (K142552), demonstrating that their technical characteristics are largely identical or equivalent. The "performance data" section mentions compliance with various standards, which serve as the implicit acceptance criteria for the device's safety and fundamental operational performance.
| Technical Characteristic | Subject Device (A7 Anesthesia System) | Predicate Device (A7 Anesthesia System K142552) | Acceptance Criteria / Observation (from document) |
|---|---|---|---|
| Fresh Gas Flow Optimizer feature | Included (displays recommended value, does not change setting or alarm) | Not provided | The new feature is advisory and does not change established safety or effectiveness. The implicit acceptance is that this addition does not negatively impact existing device performance or safety. |
| Vaporizers | Two or Three, variable bypass | Two, variable bypass | Identical in function, subject device offers more options. |
| Agent Monitoring (Sevoflurane, etc.) | Yes (identical accuracy specified below) | Yes (identical accuracy specified below) | Accuracy specifications are considered the "acceptance criteria" for these aspects, and they are identical between devices. |
| Ventilation Modes | VCV, PCV, PCV–VG, SIMV-VC, SIMV–PC, PS | VCV, PCV, PCV–VG, SIMV-VC, SIMV–PC, PS | Identical. |
| Tidal Volume Range | 20 - 1500 ml | 20 - 1500 ml | Identical. |
| Rate, bpm | 4-100 bpm | 4-100 bpm | Identical. |
| Inspiratory Flow, L/min | 110 L/min + fresh gas flow | 110 L/min + fresh gas flow | Identical. |
| I:E Ratio | 4:1 to 1:8 with 0.5 increment | 4:1 to 1:8 with 0.5 increment | Identical. |
| Inspiratory Pause | Off, 5 - 60% of insp. Period | Off, 5 - 60% of insp. Period | Identical. |
| Individual Gas Flow Accuracy | ±50 ml/min or ±5% of setting value, whichever is greater | ±120 ml/min or ±10% of setting value, whichever is greater | Subject device has improved accuracy. This is presented as an equivalent or superior performance, meeting or exceeding predicate's performance. |
| Pressure Limit, cm H2O | 0 - 100 | 0 - 100 | Identical. |
| PEEP, cm H2O | Off, 3-30, 1 cmH2O increment | Off, 3-30, 1 cmH2O increment | Identical. |
| System Checks | Auto at start | Auto at start | Identical. |
| Alarm Systems (High/Low Airway, etc.) | Yes (all listed alarms operate identically) | Yes (all listed alarms operate identically) | Identical alarm functionalities are considered acceptable. |
| O2 Sensor Type | Paramagnetic | Paramagnetic or Galvanic | Paramagnetic is utilized for integrated gas module in both, subject device standardizes to paramagnetic. Considered acceptable. |
| Anesthetic Gas Module Accuracy (CO2, N2O, Desflurane, Sevoflurane, Enflurane/Isoflurane/Halothane, O2, awRR) | All stated accuracies are identical to predicate. See document for specific ranges and +/- values. | All stated accuracies are identical to predicate. See document for specific ranges and +/- values. | The stated accuracy values are the "acceptance criteria" for these measurement capabilities, and the subject device meets them identically to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This document refers to the validation of a physical medical device and its embedded software, not a diagnostic algorithm or AI system. The testing is based on engineering verification and validation against specified standards and product specifications.
- Data Provenance: Not applicable. The "study" here is a technical validation against engineering specifications and industry standards, not a clinical data collection study for a diagnostic algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. This relates to the device's engineering performance and compliance with standards, not expert-adjudicated ground truth from clinical images or data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This concept applies to expert review of clinical cases rather than engineering testing. Performance data refers to objective measurements against specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The new feature ("Fresh Gas Flow Optimizer") is described as providing a "recommended value" to assist clinicians but "does not change the fresh gas flow setting nor does it supply an alarm if the user does not follow the recommended fresh gas flow setting." This indicates it's an informational, non-critical, non-diagnostic feature that wouldn't typically warrant an MRMC study for improved reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No, a standalone study for an AI algorithm's performance was not explicitly done or reported in this document in the typical sense. The "Fresh Gas Flow Optimizer" is an embedded software feature, and its performance would have been verified as part of the overall software validation (mentioned in section 4: "Software – The A7 Anesthesia System software has been fully verified and validated..."). However, there are no specific performance metrics like sensitivity/specificity for a standalone algorithm presented.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For the device's overall performance, the "ground truth" consists of established engineering specifications, performance tolerances (e.g., accuracy for gas measurements), and compliance requirements of recognized medical device standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-2-13, ISO 80601-2-55, IEC 62304).
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. The device's software is "verified and validated" but not described as a machine learning or AI model trained on a dataset. The "Fresh Gas Flow Optimizer" likely uses predefined algorithms and parameters based on physiology and anesthesia principles, rather than learning from a "training set."
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable, as there is no mention of a machine learning "training set" or corresponding ground truth in the context of this 510(k) submission. For the device itself, as stated in point 7, the "ground truth" is defined by engineering specifications and industry standards.
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(135 days)
A7 Anesthesia System
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 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). The A7 consists of a main unit (includes an anesthetic ventilator and flow meter monitor assembly) and a detachable breathing system.
The provided document is a 510(k) premarket notification for a medical device, the A7 Anesthesia System. It aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria through a clinical study involving experts and ground truth as might be expected for an AI/ML device.
Therefore, much of the requested information (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size, and how training set ground truth was established) is not applicable or available in this type of document, as it describes a traditional medical device and its performance is validated through engineering and safety standards, not AI-centric clinical studies.
However, I can extract information related to "acceptance criteria" in the context of this device's regulatory pathway, and the "study" (testing) that proves it meets these criteria, which are primarily engineering standards and performance specifications.
Here's the breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
For an anesthesia system, "acceptance criteria" are typically defined by recognized consensus standards for safety and performance, and the "reported device performance" demonstrates adherence to these standards and documented specifications. The document provides a detailed comparison to a predicate device, which implicitly defines performance targets.
| Performance Characteristic (Acceptance Criteria Implicitly by Predicate) | A7 Anesthesia Delivery System (Reported Performance) | Predicate Device (A5 Anesthesia Delivery System, K123211) |
|---|---|---|
| General | ||
| Vaporizers | Two, variable bypass | Two, variable bypass |
| Agents Supported | Sevoflurane, Isoflurane, Desflurane, Halothane, Enflurane | Sevoflurane, Isoflurane, Desflurane, Halothane, Enflurane |
| Automatic Ventilator | Yes | Yes |
| Bellows Volume | 1500mL | 1500mL |
| Ventilation Modes | ||
| VCV | Yes | Yes |
| PCV | Yes | Yes |
| PCV – VG | Yes | Yes |
| SIMV - VC | Yes | Yes |
| SIMV - PC | Yes | Yes |
| PS | Yes | Yes |
| Specifications | ||
| Tidal Volume Range | 20 - 1500 ml | 20 - 1500 ml |
| Rate | 4-100 bpm | 4-100 bpm |
| Inspiratory Flow | 110 L/min + fresh gas flow | 110 L/min + fresh gas flow |
| 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 - 60% of insp. Period | Off, 5 - 60% of insp. Period |
| Air Flow Range (Fresh Gas) | 0~15 L/min | 0~15 L/min |
| N₂O Flow Range (Fresh Gas) | 0~12 L/min | 0~12 L/min |
| O₂ Flow Range (Fresh Gas) | 0~15 L/min | 0~15 L/min |
| Individual Gas Flow Accuracy | ±50 ml/min or ±5% of setting value, whichever is greater | ±120 ml/min or ±10% of setting value, whichever is greater (A7 shows improved accuracy) |
| Pressure Limit | 0 - 100 cm H2O | 0 - 100 cm H2O |
| PEEP | Off, 3-30, 1 cmH2O increment | Off, 3-30, 1 cmH2O increment |
| System Checks | Auto at start | Auto at start |
| Airway Pressure Measured At | Inspiratory | Inspiratory |
| Alarms (High/Low Airway Pressure, Pressure Limiting, Sub Atmospheric, Continuous Press, Apnea >2 Minute, Apnea, High/Low Minute Volume, High/Low O2 Concentration) | All "Yes" (present) | All "Yes" (present) |
| Type of O2 Sensor | Paramagnetic | Paramagnetic or Galvanic (A7 is more specific) |
| Heated Breathing Circuit | Yes | Yes |
| Spirometry (Pressure-Volume & Flow-Volume loops) | Yes | Yes |
| Anesthetic Gas Module Sampling Rate | P/N 9200-10-10530 water trap: 120, 150, 200mL/min; P/N 9200-10-10574 water trap: 70, 90, 120mL/min | P/N 9200-10-10530 water trap: 120, 150, 200mL/min; P/N 9200-10-10574 water trap: 70, 90, 120mL/min |
| Anesthetic Gas Module Sampling Delay Time | 10%: unspecified | 0-1%: +/-.1%; 1-5%: +/-.2%; 5-7%: +/-.3%; 7-10%: +/-.5%; >10%: unspecified |
| Anesthetic Gas Module Accuracy N2O | 0-20%: +/-2%; 20-100%: +/-3% | 0-20%: +/-2%; 20-100%: +/-3% |
| Anesthetic Gas Module Accuracy Desflurane | 0-1%: +/-.15%; 1-5%: +/-.2%; 5-10%: +/-.4%; 10-15%: +/-.6%; 15-18%: +/-1%; >18%: unspecified | 0-1%: +/-.15%; 1-5%: +/-.2%; 5-10%: +/-.4%; 10-15%: +/-.6%; 15-18%: +/-1%; >18%: unspecified |
| Anesthetic Gas Module Accuracy Sevoflurane | 0-1%: +/-.15%; 1-5%: +/-.2%; 5-8%: +/-.4%; >8%: unspecified | 0-1%: +/-.15%; 1-5%: +/-.2%; 5-8%: +/-.4%; >8%: unspecified |
| Anesthetic Gas Module Accuracy Enf/Iso/Hal | 0-1%: +/-.15%; 1-5%: +/-.2%; >5%: unspecified | 0-1%: +/-.15%; 1-5%: +/-.2%; >5%: unspecified |
| Anesthetic Gas Module Accuracy O2 | 0-25%: +/-1%; 25-80%: +/-2%; 80-100%: +/-3% | 0-25%: +/-1%; 25-80%: +/-2%; 80-100%: +/-3% |
| Anesthetic Gas Module Accuracy awRR | 2-60rpm: +/-1rpm; >60rpm: unspecified | 2-60rpm: +/-1rpm; >60rpm: unspecified |
| Anesthetic Gas Module Measurement Rise Time (CO2, N2O, O2, Hal/Iso/Sev/Des, Enf) | 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, N2O, Des, Sev, Enf/Iso/Hal, O2) | CO2: 0-30%; N2O: 0-100%; Des: 0-30%; Sev: 0-30%; Enf/Iso/Hal: 0-30%; O2: 0-100% | CO2: 0-30%; N2O: 0-100%; Des: 0-30%; Sev: 0-30%; Enf/Iso/Hal: 0-30%; O2: 0-100% |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. For this type of device, "testing" refers to verification and validation against engineering specifications and standards, often conducted in a laboratory or simulated environment, not a clinical "test set" in the sense of patient data.
- Data Provenance: Not applicable. The testing described is functional and safety testing to standards, not based on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in the context of device performance is established by metrology, engineering specifications, and adherence to recognized standards, not by expert consensus on patient data.
4. Adjudication method for the test set
- Not applicable. There is no "adjudication method" in the sense of reconciling disagreements among experts for a clinical dataset. Device performance is objectively measured against predefined engineering and safety criteria.
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
- Not applicable. This device is an anesthesia system, not an AI/ML-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a traditional medical apparatus, not an algorithm, and is designed for human operation within a clinical workflow.
7. The type of ground truth used
- Engineering specifications and recognized consensus standards. The device's "performance data" describes compliance with several IEC, ISO, ASTM, and CGA standards (e.g., IEC 60601 series for safety and essential performance, ISO 14971 for risk management, ISO 5356-1 for connectors, ISO 21647 for respiratory gas monitors, ASTM F1101-90 for ventilators, etc.). Biocompatibility testing (ISO 10993 series) also constitutes a "ground truth" for material safety.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML system that requires a "training set" of data.
9. How the ground truth for the training set was established
- Not applicable. As it's not an AI/ML system, there is no training set or ground truth established for one.
Summary of Acceptance Criteria and Proving Compliance for this Device:
The "acceptance criteria" for the A7 Anesthesia System are primarily defined by:
- Safety and Performance Standards: The device must meet the requirements of a comprehensive list of international and national standards (e.g., IEC 60601 series, ISO 10993 series, ISO 14971, ASTM F1101, etc.).
- Functional Specifications: The device must perform according to its design specifications (e.g., flow ranges, accuracy of gas monitoring, alarm functionalities, ventilation modes, etc.) as demonstrated through comparison with a legally marketed predicate device (the A5 Anesthesia System).
- Biocompatibility: Materials in patient or gas path contact must comply with ISO 10993 requirements.
- Software Validation: The software must be fully verified and validated in accordance with FDA guidance.
The "study that proves the device meets the acceptance criteria" consists of:
- Biocompatibility Testing: Conducted per ISO 10993-1, 5, 10, and 18 for cytotoxicity, irritation, sensitization, and volatile organic compound testing.
- Software Verification and Validation: Documentation provided to FDA in accordance with relevant guidance.
- Performance Testing: Demonstrated compliance with its product specifications and intended use by adhering to the listed standards (e.g., IEC 60601-1, IEC 60601-2-13, ISO 21647, etc.). This involves engineering tests, measurements, and simulations to confirm that the device's functional characteristics match its design and meet the safety and performance requirements set by the standards and predicate device's established performance.
- Substantial Equivalence Comparison: A detailed technical comparison to the predicate A5 Anesthesia Delivery System (K123211) showing that any differences do not raise new questions of safety or effectiveness. The comparison table explicitly lists how the A7's performance metrics align with or, in some cases (like individual gas flow accuracy), improve upon the predicate's. New features (Fresh Gas Control System, Negative Pressure Suction Device, Agent Consumption Calculation, Auxiliary Common Gas Outlet, Sample Gas Return, Quick Release APL Valve, Auxiliary Work Surface) were also subjected to performance testing to ensure safety and effectiveness.
In essence, for this type of traditional medical device, "acceptance criteria fulfillment" is a demonstration of engineering rigor, adherence to recognized safety and performance standards, and functional equivalence (or justifiable differences) to a predicate device, rather than a clinical trial with patient data interpreted by experts.
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