(104 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 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2015
Shenzhen Mindray Bio-Medical Electronics Co. LTD Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan 518057. P.R China
Re: K151954
Trade/Device Name: A7 Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: Class II Product Code: BSZ, CCK, CBS, CBR, NHO, CBQ,NHQ,NHP, CCL, KDP Dated: September 23, 2015 Received: September 24, 2015
Dear Mr. Bai,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director. Division of Anesthesiology, Respiratory General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151954
Device Name A7 Anesthesia System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the A7 Anesthesia System is provided below.
| Device Common Name: | Gas-Machine, Anesthesia |
|---|---|
| Device Proprietary Name: | A7 Anesthesia System |
| Submitter: | SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680 |
| Contact: | Yanhong BaiManager Regulatory AffairsSHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, Nanshan518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com |
| Date Prepared: | July 15, 2015 |
| Panel: | Anesthesiology |
| Classification Regulationand Product Code: | Primary:868.5160- BSZ Anesthesia Gas Machine Class IISecondary:868.1400 - CCK - Carbon Dioxide Gas Analyzer868.1500 – NHO/CBQ/NHQ/NHP - Enflurane gas analyzer868.1620 - CBS - Halothane Gas Analyzer868.1700 - CBR - Nitrous Oxide Gas Analyzer868.1720 - CCL- Oxygen Gas Analyzer880.6740 - KDP- Vacuum Regulator |
Predicate Devices:
K142552 - A7 Anesthesia System, ShenZhen Mindray Bio-Medical Electronics CO., LTD. K042607 - Primus US, Draeger Medical Inc.
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Indication for Use:
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.
Device Description:
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.
Performance Data:
Software – The A7 Anesthesia System software has been fully verified and validated and documentation in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: May 11, 2005" has been provided in this submission.
Performance Testing - The A7 Anesthesia system has been tested to comply with its product specifications and intended use. The following standards were adhered to for performance testing submitted in this 510(k):
- ANSI/AAMI ES60601-1:2005/(R) 2012 and C1:2009/(R) 2012 and, A2:2010/(R) ● 2012 Medical electrical equipment - Part 1: General Requirements for basic safety and essential performance
- IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements . for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-2-13:Edition 3.1 2009-08 Medical electrical equipment Part 2-13: ● Particular requirements for the safety and essential performance of anesthetic systems
- ISO 80601-2-55:2011 Medical electrical equipment Part 2-55: Particular ● requirements for the basic safety and essential performance of respiratory gas monitors
- IEC 62304: 2006 Medical device software Software life cycle processes ●
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Substantial Equivalence:
The A7 that is the subject of this 510(k) submission has been modified from the A7 that was cleared in K142552 to include the Fresh Gas Flow Optimizer feature. The Fresh Gas Flow Optimizer displays a recommended value for fresh gas to assist the clinician in determining a value that will meet the needs of the patient. The predicate device as cleared by FDA did not provide this feature. 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.
A technical comparison of the subject device to the primary predicate device as cleared in K142552 is provided in the table below.
| TechnicalCharacteristics | Subject DeviceA7 Anesthesia SystemShenZhen Mindray Bio-MedicalElectronics CO., LTD.(Subject Device) | Predicate DeviceA7 Anesthesia SystemShenZhen Mindray Bio-MedicalElectronics CO., LTD.(K142552) | |
|---|---|---|---|
| Vaporizers | Two or Three, variable bypass | Two, variable bypass | |
| Agent - Sevoflurane | Yes | Yes | |
| Agent - Isoflurane | Yes | Yes | |
| Agent - Desflurane | Yes | Yes | |
| Agent - Halothane | Yes | Yes | |
| Agent - Enflurane | Yes | Yes | |
| Automatic Ventilator | Yes | Yes | |
| Bellows | 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 | |
| Tidal Volume | Yes | Yes | |
| Specifications | |||
| Range, ml | 20 - 1500 | 20 - 1500 | |
| Minute Volume | Yes | Yes | |
| Rate, bpm | 4-100 bpm | 4-100 bpm | |
| Inspiratory Flow, L/min | 110 L/min + fresh gas flow | 110 L/min + fresh gas flow | |
| TechnicalCharacteristics | Subject DeviceA7 Anesthesia System | Predicate DeviceA7 Anesthesia System | |
| ShenZhen Mindray Bio-MedicalElectronics CO., LTD.(Subject Device) | ShenZhen Mindray Bio-MedicalElectronics CO., LTD.(K142552) | ||
| 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 | 0~15 L/min | 0~15 L/min | |
| Fresh Gas | N2O Flow Range | 0~12 L/min | 0~12 L/min |
| O2 Flow Range | 0~15 L/min | 0~15 L/min | |
| Individual GasFlow Accuracy | $±50$ ml/min or $±5%$ of setting value,whichever is greater | $±120$ ml/min or $±10%$ of settingvalue, whichever is greater | |
| Pressure Limit, cm H2O | 0 - 100 | 0 - 100 | |
| PEEP, cm H2O | 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 | |
| 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 ConcentrationAlarm | Yes | Yes | |
| Type of O2 Sensor | Paramagnetic | Paramagnetic or Galvanic (TheParamagnetic sensor is utilizedwhen using the integrated gasmodule. The Galvanic sensor isutilized when the gas module isnot connected.) | |
| Heated Breathing Circuit | Yes | Yes | |
| Spirometry: Pressure-Volume andFlow Volume loops | Yes | Yes | |
| Subject DeviceA7 Anesthesia System | Predicate DeviceA7 Anesthesia System | ||
| TechnicalCharacteristics | ShenZhen Mindray Bio-MedicalElectronics CO., LTD.(Subject Device) | ShenZhen Mindray Bio-MedicalElectronics CO., LTD.(K142552) | |
| Anesthetic Gas Module SamplingRate | P/N 9200-10-10530 water trap: 120,150, 200mL/minP/N 9200-10-10574 water trap: 70,90, 120mL/min | P/N 9200-10-10530 water trap:120, 150, 200mL/minP/N 9200-10-10574 water trap:70, 90, 120mL/min | |
| Anesthetic Gas Module SamplingDelay Time: | <4 seconds | <4 seconds | |
| Anesthetic Gas Module RefreshRate: | 1 second | 1 second | |
| Anesthetic Gas Module Warm-upTime: | 45 seconds to warm-up status 10minutes to ready-to-measure status | 45 seconds to warm-up status10 minutes to ready-to-measurestatus | |
| Anesthetic Gas ModuleAccuracy CO2: | 0-1%: +/-.1%1-5%: +/-.2%5-7%: +/-.3%7-10%: +/-.5%>10%: unspecified | 0-1%: +/-.1%1-5%: +/-.2%5-7%: +/-.3%7-10%: +/-.5%>10%: unspecified | |
| Anesthetic Gas ModuleAccuracy N2O: | 0-20%: +/-2%20-100%: +/-3% | 0-20%: +/-2%20-100%: +/-3% | |
| Anesthetic Gas ModuleAccuracy 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 ModuleAccuracy Sevflurane: | 0-1%: +/-.15%1-5%: +/-.2%5-8%: +/-.4%>8%: unspecified | 0-1%: +/-.15%1-5%: +/-.2%5-8%: +/-.4%>8%: unspecified | |
| Anesthetic Gas ModuleAccuracy Enflurane/Isoflurane/Halothane: | 0-1%: +/-.15%1-5%: +/-.2%>5%: unspecified | 0-1%: +/-.15%1-5%: +/-.2%>5%: unspecified | |
| Anesthetic Gas ModuleAccuracy O2: | 0-25%: +/-1%25-80%: +/-2%80-100%: +/-3% | 0-25%: +/-1%25-80%: +/-2%80-100%: +/-3% | |
| Anesthetic Gas ModuleAccuracy awRR: | 2-60rpm: +/-1rpm>60rpm: unspecified | 2-60rpm: +/-1rpm>60rpm: unspecified | |
| TechnicalCharacteristics | Subject DeviceA7 Anesthesia SystemShenZhen Mindray Bio-MedicalElectronics CO., LTD.(Subject Device) | Predicate DeviceA7 Anesthesia SystemShenZhen Mindray Bio-MedicalElectronics CO., LTD.(K142552) | |
| Anesthetic Gas ModuleMeasurement Rise Time: | CO2: ≤250msN2O: ≤250msO2: ≤500msHal/Iso/Sev/Des: ≤300msEnf: ≤350ms | CO2: ≤250msN2O: ≤250msO2: ≤500msHal/Iso/Sev/Des: ≤300msEnf: ≤350ms | |
| Measurement Range CO2 | 0-30% | 0-30% | |
| Measurement Range N2O | 0-100% | 0-100% | |
| Measurement Range Des | 0-30% | 0-30% | |
| Measurement Range Sev | 0-30% | 0-30% | |
| Measurement Range Enf/Iso/Hal | 0-30% | 0-30% | |
| Measurement Range O2 | 0-100% | 0-100% |
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Substantial Equivalence Conclusion
The subject A7 Anesthesia System and the primary predicate are both gas anesthesia machines used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. These systems may be used in adult and pediatric populations. Both of the devices are prescription use, and are not suitable for use in an MRI environment.
Based on the technical comparison, the identical indications for use and the complete system level testing, the modifications to the A7 Anesthesia System do not raise different questions of safety and effectiveness and can be found substantially equivalent to the predicate device cleared in K142552.
§ 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).