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.

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).

AI/ML Overview

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.

Summary

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January 12, 2018

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park. Shenzhen, 518057 China

Re: K171292

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, NHO, CBS, CBQ, CBR, CCL, NHQ, NHP, KDP Dated: December 8, 2017 Received: December 11, 2017

Dear Yanhong 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/SafetyReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Tara A. Ryan -S
DN: c=US, o=U.S. Government, ou=HHS,
Tara A. Ryan -s ou=FDA, ou People, cn=Tara A. Ryan-5,
0.9.2342.19200300.100.1.1=1300030749
Date: 2018.01.12 11:26:05-05'00'

for Tina Kiang, Ph.D. Acting 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) K171292

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.

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:	December 6th, 2017
Panel:	Anesthesiology
Classification Regulation and Product Code:
Primary:
868.5160- BSZ Anesthesia Gas Machine Class II
Secondary:
868.1400 – CCK - Carbon Dioxide Gas Analyzer
868.1500 – NHO/CBQ/NHQ/NHP - Enflurane gas analyzer
868.1620 - CBS - Halothane Gas Analyzer
868.1700 – CBR - Nitrous Oxide Gas Analyzer
868.1720 – CCL- Oxygen Gas Analyzer
880.6740 – KDP- Vacuum Regulator

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510(k) number	Trade or proprietor or modelname	Manufacturer
K151954	A7 Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Predicate Device:

Reference Devices:

510(k) number	Trade or proprietor or modelname	Manufacturer
K123211	A5 Anesthesia Delivery System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K083050	Evita XL Ventilator	Dräger Medical AG & Co. KG
K110213	GE Datex-OhmedaAisys	Datex-Ohmeda Inc.
K132530	GE Datex-OhmedaAisys CS2	Datex-Ohmeda Inc.

Indications 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.

Device Description:

Nonclinical testing and Performance:

The following areas have been tested:

. Software
- o Unit testing
- Integration testing o
- o System testing
Performance ●
- o AG Module
- Fresh Flow Optimizer O
- Sample Gas Return and CO2-absorbent O

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Suction o
Heating Module O
Power Supply O
Thermal O
Cleaning and Disinfection o
Waveform Comparison o
Biocompatibility ●
- Volatile Organic Compounds o
- Particulate Testing O
- Cytotoxicity O
- Sensitization O
- Irritation / intracutaneous reactivity O
- Extractables and leachables (E&L) testing O
- Inorganic gases (03, 02, CO2, NO2) testing O
Human Factors Validation Testing ●
. Testing as per consensus standards:
- o AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, ,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 Edition 3: 2007 Medical electrical equipment Part 1-2: General o requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment Part 2- O 13: Particular requirements for basic safety and essential performance of an anesthetic workstation
- ISO 80601-2-55 First edition 2011-12-15 Medical electrical equipment -Part 2-55: o Particular requirements for the basic safety and essential performance of respiratory gas monitors
- ASTM F1101-90 (Reapproved 2003) Standard Specification for Ventilators O Intended for Use During Anesthesia
- ISO 10079-3:2014 Medical suction equipment Part 3:Suction equipment o powered from a vacuum or positive pressure gas source
- AIM 7351731 medical electrical equipment and system electromagnetic O immunity test for exposure to radio frequency identification readers - an aim standard. (General II (ES/EMC))

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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.

Substantial Equivalence:

Comparison of Indications:

Both the predicate device and the subject A7 Anesthesia System are gas anesthesia machine used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The indications for use of the subject device (A7 Anesthesia System) have been modified to add the definition of the pediatric population subgroup. All of the pediatric population subgroup was cleared in the predicate device A7 Anesthesia System (K151954). In conclusion, the minor changes to the indications for use do not change the intended use of the A7 Anesthesia System.

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Comparison of Technological Characteristics:

The table below compares the key technological feature of the subject device to the predicate device (A7 Anesthesia System (K151954)).

Device Comparison Table

	TechnicalCharacteristics	Subject DeviceA7 Anesthesia System(subject device)	Predicate DeviceA7 Anesthesia System(K151954)
	Vaporizers	Two or Three, variable bypass	Two or three, 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
Specifications
	Tidal Volume	Yes	Yes
	Range, ml	20 to 1500	20 to 1500
	Minute Volume	Yes	Yes
	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
Fresh Gas	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
TechnicalCharacteristics	Subject DeviceA7 Anesthesia System(subject device)	Predicate DeviceA7 Anesthesia System(K151954)
Individual Gas FlowAccuracy	±50 ml/min or ±5% of settingvalue, whichever is greater	±50 ml/min or ±5% of settingvalue, whichever is greater
Pressure Limit, cm H₂O	0 to 100cm H₂O	0 to 100cm H₂O
PEEP, cm H₂O	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 andFlow-Volume loops	Yes	Yes
Anesthetic Gas Module Sampling Rate	Adult/pediatric: 120, 150,200mL/minNeonate: 70, 90, 120mL/min	High volume: 120, 150,200mL/minLow volume: 70, 90, 120mL/min
Anesthetic Gas Module SamplingDelay Time:	<4 seconds	<4 seconds
Anesthetic Gas Module Refresh Rate:	1 second	1 second
Anesthetic Gas Module Warm-upTime:	45 seconds to warm-up status10 minutes to ready-to-measurestatus	45 seconds to warm-up status10 minutes to ready-to-measurestatus
Anesthetic Gas Module AccuracyCO₂:	0 to 1%: +/-.1%1 to 5%: +/-.2%5 to 7%: +/-.3%7 to10%: +/-.5%>10%: unspecified	0 to 1%: +/-.1%1 to 5%: +/-.2%5 to 7%: +/-.3%7 to10%: +/-.5%>10%: unspecified
Anesthetic Gas Module AccuracyN₂O:	0 to 20%: +/-2%20 to 100%: +/-3%	0 to 20%: +/-2%20 to 100%: +/-3%
TechnicalCharacteristics	Subject DeviceA7 Anesthesia System(subject device)	Predicate DeviceA7 Anesthesia System(K151954)
Anesthetic Gas Module AccuracyDesflurane:	0 to 1%: +/-.15%1 to 5%: +/-.2%5 to 10%: +/-.4%10 to 15%: +/-.6%15 to 18%: +/-1%>18%: unspecified	0 to 1%: +/-.15%1 to 5%: +/-.2%5 to 10%: +/-.4%10 to 15%: +/-.6%15 to 18%: +/-1%>18%: unspecified
Anesthetic Gas Module AccuracySevoflurane:	0 to 1%: +/-.15%1 to 5%: +/-.2%5 to 8%: +/-.4%>8%: unspecified	0 to 1%: +/-.15%1 to 5%: +/-.2%5 to 8%: +/-.4%>8%: unspecified
Anesthetic Gas Module AccuracyEnflurane/Isoflurane/Halothane:	0 to 1%: +/-.15%1 to 5%: +/-.2%>5%: unspecified	0 to 1%: +/-.15%1 to 5%: +/-.2%>5%: unspecified
Anesthetic Gas Module Accuracy O2:	0 to 25%: +/-1%25 to 80%: +/-2%80 to 100%: +/-3%	0 to 25%: +/-1%25 to 80%: +/-2%80 to 100%: +/-3%
Anesthetic Gas Module AccuracyawRR:	2 to 60rpm: +/-1rpm>60rpm: unspecified	2 to 60rpm: +/-1rpm>60rpm: unspecified
Anesthetic Gas ModuleMeasurementRise Time:	CO2: <250msN2O: <250msO2: ≤500msHal/Iso/Sev/Des: ≤300msEnf: <350ms	CO2: <250msN2O: <250msO2: ≤500msHal/Iso/Sev/Des: ≤300msEnf: <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%

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There are some differences between the subject A7 Anesthesia System and the predicate device A7 Anesthesia System (K151954). Per the FDA Guidance, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued July 28, 2014, the following devices are provided to support substantial equivalence.

Differences	Reference Device
Add Three VentilationModes	SIMV-VG	Evita XL Ventilator (K083050)
	CPAP/PS	Aisys anesthesia system (K110213)
	APRV	Evita XL Ventilator (K083050)
Lung Recruitment Ventilation Function		GE Datex-Ohmeda Aisys CS2Anesthesia System (K132530)
Added O2 Sensor		A5 Anesthesia Delivery System(K123211)
Redesign the Existing Ventilator Control Board UsingDSP Hardware Platform		A7 Anesthesia System (K151954)
Change about the Anesthetic Gas Module andAccessories		A7 Anesthesia System (K151954)
Get Data from Anesthetic Gas Module plugged intothe Passport 12M/17M patient monitor (K170876) tosupport optimizer function and agent usage calculationfunction		A7 Anesthesia System (K151954)
Increase the Maximum Inspiratory Flow		Evita XL Ventilator (K083050)
Change the Material of the Airway Pressure GaugeHousing		A7 Anesthesia System (K151954)

Substantial Equivalence Conclusion:

Based on the detailed comparison of specifications for each of the modifications to the previously cleared A7 Anesthesia System (K151954) and cited reference devices, the performance testing results and conformance with applicable standards show that the A7 Anesthesia System 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).