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 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.

AI/ML Overview

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	<4 seconds	<4 seconds
Anesthetic Gas Module Refresh Rate	1 second	1 second
Anesthetic Gas 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
Anesthetic Gas Module Accuracy 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 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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 23, 2015

Shenzhen Mindray Bio-Medical Electronics Co., Ltd Tang Hao Product Approval Engineer, Technical Regulation Department Mindrav Building. Keii 12th Road South High-tech Industrial Park, Nanshan Shenzhen, Guandong 518057 CHINA

Re: K142552

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 Dated: December 19, 2014 Received: December 22, 2014

Dear Mr. Hao,

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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Page 2 - Tang Hao

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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Keith Director Division of Anesthesiology, General Hospital, Respiratory, 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) K142552

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K142552

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:	January 23, 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:

K123211 - A5 Anesthesia Delivery System, Mindray DS USA, Inc. K042607 - Primus US, Draeger Medical Inc. K110213 - GE Datex-Ohmeda Aisys, Datex-Ohmeda Inc.

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K123125 - Avance CS2, GE

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.

De vice De scription:

Performance Data:

Biocompatibility - Each patient contacting material and gas path material has been tested to comply with the following applicable requirements per ISO 10993-1:

Cytotoxicity: ISO10993-5:2009 Biological evaluation of medical devices -. Part 5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Irritation: ISO10993-10:2010 Biological evaluation of medical devices Part 10: Tests . for irritation and skin sensitization
Sensitization: ISO10993-10:2010 Biological evaluation of medical devices Part 10: ● Tests for irritation and skin sensitization
Volatile Organic Compound Testing: ISO10993-18:2005 Biologica1 evaluation of . medical devices -- Part 18: Chemical characterization of materials

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:

IEC 60601-1:1988+A1:1991+A2:1995: Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-1:2000 General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
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 60601-1-4:2000 Medical electrical equipment Part 1-4: General requirements ● for safety - Collateral standard: Programmable electrical medical systems

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. IEC 60601-1-8:2003 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-2-13:2009 Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anesthetic systems
IEC 62304: 2006 Medical device software Software life cycle processes ●
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ISO 14971:2007 Medical devices Application of risk management to medical ● devices
ISO 15223-1:2012 Medical devices Symbols to be used with medical devices labels, ● labeling, and information to be supplied - Part 1: General requirements
ISO 5356-1:2004 Anesthetic and respiratory equipment Conical connectors Part 1: ● Cones and sockets
ISO 21647:2004 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
ASTM F1101-90:2003 Standard Specification for Ventilators Intended for Use ● During Anesthesia
CGA V-1:2005 Standard for Compressed Gas Cylinder Valves Outlet and Inlet . Connections
CGA V-5:2008 Diameter-Index Safety System (Noninterchangeable Low Pressure ● Connections for Medical Gas Applications)

Substantial Equivalence :

The subject device has the exact same indication statement as the primary predicate device. the A5 as cleared in K123211. 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.

A technical comparison of the subject device to the primary predicate device, the A5 as cleared in K123211 is provided in the table below.

TechnicalCharacteristics	A7 Anesthesia Delivery SystemShenzhen Mindray Bio-MedicalElectronics Co., Ltd	A5 Anesthesia Delivery SystemMindray DS USA, Inc.K123211
Vaporizers	Two, variable bypass	Two, variable bypass
Agent - Sevoflurane	Yes	Yes
Agent - Isoflurane	Yes	Yes
	TechnicalCharacteristics	A7 Anesthesia Delivery SystemShenzhen Mindray Bio-MedicalElectronics Co., Ltd	A5 Anesthesia Delivery SystemMindray DS USA, Inc.K123211
	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
	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
FreshGas	Air Flow Range	0~15 L/min	0~15 L/min
	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 H20	Off, 3-30, 1 cmH2O increment	Off, 3-30, 1 cmH2O increment
	System Checks	Auto at start	Auto at start
	Airway PressureMeasured at	Inspiratory	Inspiratory
	High/Low Airway	Yes	Yes
TechnicalCharacteristics	A7 Anesthesia Delivery SystemShenzhen Mindray Bio-MedicalElectronics Co., Ltd	A5 Anesthesia Delivery SystemMindray DS USA, Inc.K123211
Pressure Alarm	Yes	Yes
Pressure Limiting Alarm	Yes	Yes
Sub Atmospheric PressureAlarm	Yes	Yes
Continuous Press Alarm	Yes	Yes
Apnea >2 Minute Alarm	Yes	Yes
Apnea Alarm	Yes	Yes
High/Low Minute VolumeAlarm	Yes	Yes
High/Low O2Concentration Alarm	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 and Flow-Volumeloops	Yes	Yes
Anesthetic Gas ModuleSampling Rate	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 ModuleSampling Delay Time:	<4 seconds	<4 seconds
Anesthetic Gas ModuleRefresh Rate:	1 second	1 second
Anesthetic Gas ModuleWarm-up Time:	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
TechnicalCharacteristics	A7 Anesthesia Delivery SystemShenzhen Mindray Bio-MedicalElectronics Co., Ltd	A5 Anesthesia Delivery SystemMindray DS USA, Inc.K123211
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 ModuleAccuracyEnflurane/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
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 RangeEnf/Iso/Hal	0-30%	0-30%
Measurement Range O2	0-100%	0-100%

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K142552

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K142552

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A7 Anesthesia System

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A7 Anesthesia System

Substantial Equivalence Conclusion

There are seven new features that have been added to the A7 when compared to the A5 as follows:

1. Fresh Gas Control System
1. Negative Pressure Suction Device
1. Agent Consumption Calculation
Auxiliary Common Gas Outlet 4.
Sample Gas Return 5.
Quick Release APL Valve 6.
1. Auxiliary Work Surface

A detailed comparison of these 7 new features is provided in the submission and performance testing was completed to establish that the new features do not raise new issues of safety and effectiveness.

The A7 Anesthesia System has the same intended use as the predicate device, to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A7 is a line extension of the FDA-cleared A5 Anesthesia System (the primary predicate device), and has the identical indications for use as the A5. The differences in the technological characteristics of these features when compared to the predicate device do not raise new types of safety and effectiveness questions. Therefore the A7 can be found substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).