A5 Anesthesia System

K171311 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · BSZ · Jan 12, 2018 · Anesthesiology

Device Facts

• Record ID: K171311
• Device Name: A5 Anesthesia System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: BSZ · Anesthesiology
• Decision Date: Jan 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The A5 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 A5 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 Story

A5 Anesthesia System is a continuous flow inhalation gas anesthesia system; delivers anesthetic vapor; provides automatic and manual ventilation modes. Inputs: O2, N2O, air, anesthetic agents (Desflurane, Isoflurane, Enflurane, Sevoflurane, Halothane). System monitors gas concentrations (O2, CO2, N2O, agents) and airway pressure. Used in health care facilities by licensed clinicians. Features include Fresh Flow Optimizer, agent usage calculation, and multiple ventilation modes (VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, PS, SIMV-VG, CPAP/PS, APRV, Lung Recruitment). Output: visual display of waveforms, gas data, and ventilation parameters. Clinicians use output to adjust anesthesia delivery and ventilation settings, supporting patient stability during surgical procedures.

Clinical Evidence

Bench testing only. Testing included software unit/integration/system testing, performance verification, power supply, thermal, cleaning/disinfection, biocompatibility (cytotoxicity, sensitization, irritation), and human factors validation. Conformance to standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 80601-2-13, ISO 80601-2-55, ASTM F1101-90) was demonstrated.

Technological Characteristics

Continuous flow inhalation gas anesthesia system. Materials: biocompatible components. Sensing: Paramagnetic or Galvanic fuel cell O2 sensors, gas sampling module. Energy: electrical power. Connectivity: integrated gas module, data interface with patient monitors. Software: DSP-based ventilator control. Sterilization: cleaning/disinfection protocols. Standards: AAMI/ANSI ES60601-1, ISO 80601-2-13, ISO 80601-2-55.

Indications for Use

Indicated for adult and pediatric (including neonate, infant, child, adolescent) patients requiring general inhalation anesthesia and ventilation maintenance in a health care facility.

Regulatory Classification

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. 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).

Predicate Devices

• A5 Anesthesia Delivery System (K123211)

Reference Devices

• A7 Anesthesia System (K151954)
• Evita XL Ventilator (K083050)
• GE Datex-Ohmeda Aisys (K110213)
• GE Datex-OhmedaAisys CS2 (K132530)
• Passport 12M/17M patient monitor (K170876)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 12, 2018

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

Re: K171311

Trade/Device Name: A5 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, CBQ, NHQ, NHP, CBS, CBR, CCL 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.

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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 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.

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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Tara A. Ryan -
S
Digitally signed by Tara A. Ryan -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Tara A. Ryan -S,
0.9.2342.19200300.100.1.1=1300030749
Date: 2018.01.12 09:06:21-05'00'

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) K171311

Device Name A5 Anesthesia System

Indications for Use (Describe)

The A5 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 A5 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 A5 Anesthesia System is provided below.

| Device Common Name: | Gas-Machine, Anesthesia |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | A5 Anesthesia System |
| Submitter: | SHENZHEN MINDRAY BIO-MEDICAL<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>Shenzhen 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone] |
| Contact: | Yanhong Bai<br>Manager Regulatory Affairs<br>SHENZHEN MINDRAY BIO-MEDICAL<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>518057, P.R. China<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | December 6th, 2017 |
| Panel: | Anesthesiology |
| Classification Regulation and Product Code: | Primary:<br>868.5160- BSZ Anesthesia Gas Machine Class II<br>Secondary:<br>868.1400 - CCK - Carbon Dioxide Gas Analyzer<br>868.1500 – NHO/CBQ/NHQ/NHP - Enflurane gas analyzer<br>868.1620 – CBS - Halothane Gas Analyzer<br>868.1700 - CBR - Nitrous Oxide Gas Analyzer<br>868.1720 - CCI - Oxygen Gas Analyzer |

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| 510(k) number | Trade or proprietor or model<br>name | Manufacturer |
|---------------|--------------------------------------|--------------------------------------------------------|
| K123211 | A5 Anesthesia Delivery System | Shenzhen Mindray Bio-<br>Medical Electronics Co., Ltd. |

#### Predicate Device:

### Reference Devices:

| 510(k) number | Trade or proprietor or model<br>name | Manufacturer |
|---------------|--------------------------------------|--------------------------------------------------------|
| K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-<br>Medical Electronics Co., Ltd. |
| K083050 | Evita XL Ventilator | Dräger Medical AG & Co. KG |
| K110213 | GE Datex-Ohmeda Aisys | Datex-Ohmeda Inc. |
| K132530 | GE Datex-OhmedaAisys CS2 | Datex-Ohmeda Inc. |

## Indication for Use:

The A5 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 A5 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 A5 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A5 incorporates 02, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane).

## Nonclinical testing and Performance:

The following areas have been tested:

- Software .
- o Unit testing
- Integration testing O
- System testing o
- Performance ●

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- Power Supply o
- Thermal O
- Cleaning and Disinfection O
- Fresh Flow Optimizer O
- o AG Module
- Heating Module O
- o Waveform Comparison
- Biocompatibility ●
- Volatile Organic Compounds O
- Particulate Testing O
- o Cytotoxicity
- 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:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, ,C1:2009/(R)2012 and O 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
- 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 A5 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 (A5 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 A5 Anesthesia Delivery System (K123211). In conclusion, the minor changes to the indications for use do not change the intended use of the A5 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 (A5 Anesthesia Delivery System (K123211)).

## Device Comparison Table

| | Technical<br>Characteristics | Subject Device<br>A5 Anesthesia System | Predicate Device<br>A5 Anesthesia Delivery System<br>(K123211) |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| | 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 |
| Fresh Gas | 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 |
| Technical<br>Characteristics | Subject Device<br>A5 Anesthesia System | Predicate Device<br>A5 Anesthesia Delivery System<br>(K123211) | |
| Individual Gas Flow<br>Accuracy | ±50 ml/min or ±5% of setting<br>value, whichever is greater | ±50 ml/min or ±5% of setting<br>value, whichever is greater | |
| Pressure Limit, cm H2O | 0 to 100 cm H2O | 0 to 100 cm 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 | |
| Type of O2 Sensor | Paramagnetic or<br>Galvanic fuel cell | Paramagnetic or<br>Galvanic fuel cell | |
| Heated Breathing Circuit | Yes | Yes | |
| Spirometry: Pressure-Volume and<br>Flow-Volume loops | Yes | Yes | |
| Anesthetic Gas Module Sampling Rate | Adult/pediatric: 120, 150, 200<br>mL/min<br>Neonate: 70, 90, 120 mL/min | High volume: 120, 150, 200<br>mL/min<br>Low volume: 70, 90, 120 mL/min | |
| Anesthetic Gas Module Sampling<br>Delay Time: | <4 seconds | <4 seconds | |
| Anesthetic Gas Module Refresh Rate: | 1 second | 1 second | |
| Anesthetic Gas Module Warm-up<br>Time: | 45 seconds to warm-up status<br>10 minutes to ready-to-measure<br>status | 45 seconds to warm-up status<br>10 minutes to ready-to-measure<br>status | |
| Anesthetic Gas Module Accuracy<br>CO2: | 0 to 1%: +/-.1%<br>1 to 5%: +/-.2%<br>5 to 7%: +/-.3%<br>7 to10%: +/-.5%<br>>10%: unspecified | 0 to 1%: +/-.1%<br>1 to 5%: +/-.2%<br>5 to 7%: +/-.3%<br>7 to10%: +/-.5%<br>>10%: unspecified | |
| Technical<br>Characteristics | Subject Device<br>A5 Anesthesia System | Predicate Device<br>A5 Anesthesia Delivery System<br>(K123211) | |
| Anesthetic Gas Module Accuracy<br>N2O: | 0 to 20%: +/-2%<br>20 to 100%: +/-3% | 0 to 20%: +/-2%<br>20 to 100%: +/-3% | |
| Anesthetic Gas Module Accuracy<br>Desflurane: | 0 to 1%: +/-.15%<br>1 to 5%: +/-.2%<br>5 to 10%: +/-.4%<br>10 to 15%: +/-.6%<br>15 to 18%: +/-1%<br>>18%: unspecified | 0 to 1%: +/-.15%<br>1 to 5%: +/-.2%<br>5 to 10%: +/-.4%<br>10 to 15%: +/-.6%<br>15 to 18%: +/-1%<br>>18%: unspecified | |
| Anesthetic Gas Module Accuracy<br>Sevoflurane: | 0 to 1%: +/-.15%<br>1 to 5%: +/-.2%<br>5 to 8%: +/-.4%<br>>8%: unspecified | 0 to 1%: +/-.15%<br>1 to 5%: +/-.2%<br>5 to 8%: +/-.4%<br>>8%: unspecified | |
| Anesthetic Gas Module Accuracy<br>Enflurane/Isoflurane/<br>Halothane: | 0 to 1%: +/-.15%<br>1 to 5%: +/-.2%<br>>5%: unspecified | 0 to 1%: +/-.15%<br>1 to 5%: +/-.2%<br>>5%: unspecified | |
| Anesthetic Gas Module Accuracy O2: | 0 to 25%: +/-1%<br>25 to 80%: +/-2%<br>80 to 100%: +/-3% | 0 to 25%: +/-1%<br>25 to 80%: +/-2%<br>80 to 100%: +/-3% | |
| Anesthetic Gas Module Accuracy<br>awRR: | 2 to 60rpm: +/-1rpm<br>>60rpm: unspecified | 2 to 60rpm: +/-1rpm<br>>60rpm: unspecified | |
| Anesthetic Gas Module<br>Measurement<br>Rise Time: | CO2: ≤250ms<br>N2O: ≤250ms<br>O2: ≤500ms<br>Hal/Iso/Sev/Des: ≤300ms<br>Enf: ≤350ms | CO2: ≤250ms<br>N2O: ≤250ms<br>O2: ≤500ms<br>Hal/Iso/Sev/Des: ≤300ms<br>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% | |

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There are some differences between the subject A5 Anesthesia System and the predicate device A5 Anesthesia Delivery System (K123211). 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.

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| | | | | Differences from Predicate Device A5 (K123211) |
|--|--|--|--|------------------------------------------------|
|--|--|--|--|------------------------------------------------|

| Differences | Reference Device |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Add Three Ventilation<br>Modes<br>SIMV-VG | Evita XL Ventilator (K083050) |
| CPAP/PS | Aisys anesthesia system<br>(K110213) |
| APRV | Evita XL Ventilator (K083050) |
| Lung Recruitment Ventilation Function | GE Datex-Ohmeda Aisys CS2<br>Anesthesia System (K132530) |
| Optimizer Function and Agent Usage Calculation Function | A7 Anesthesia System (K151954) |
| Redesign the Existing Ventilator Control Board Using DSP<br>Hardware Platform | A5 Anesthesia Delivery System<br>(K123211) |
| Change about the Anesthetic Gas Module and Accessories | A5 Anesthesia Delivery System<br>(K123211) |
| Get Data from Anesthetic Gas Module plugged into the<br>Passport 12M/17M patient monitor (K170876) to support<br>optimizer function and agent usage calculation function | A7 Anesthesia System (K151954) |
| Increase the Maximum Inspiratory Flow | Evita XL Ventilator (K083050) |
| Change the Material of the Airway Pressure Gauge<br>Housing | A7 Anesthesia System (K151954) |

### Substantial Equivalence Conclusion

Based on the detailed comparison of specifications for each of the modifications to the previously cleared A5 Anesthesia Delivery System (K123211) and cited reference devices, the performance testing results and conformance with applicable standards show that the A5 Anesthesia System can be found substantially equivalent to the predicate device.