A7 Anesthesia System
Device Facts
| Record ID | K151954 |
|---|---|
| Device Name | A7 Anesthesia System |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product Code | BSZ · Anesthesiology |
| Decision Date | Oct 27, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5160 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
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. 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 Story
Continuous flow inhalation gas anesthesia system; delivers anesthetic vapor; provides automatic and manual ventilation modes. Incorporates O2, CO2, N2O, and anesthetic agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane, Halothane). Main unit includes anesthetic ventilator and flow meter monitor assembly; detachable breathing system. Features 'Fresh Gas Flow Optimizer' to display recommended fresh gas values to assist clinicians. Used in health care facilities by licensed clinicians. Output displayed on monitor for clinician review to guide anesthetic delivery and ventilation management. Benefits include optimized gas usage and patient ventilation support.
Clinical Evidence
Bench testing only. Compliance with ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-13, ISO 80601-2-55, and IEC 62304. Software verified and validated per FDA guidance.
Technological Characteristics
Continuous flow gas anesthesia system. Includes anesthetic ventilator, flow meter monitor, and detachable breathing circuit. Sensors: Paramagnetic O2 sensor, CO2/agent gas module. Connectivity: Integrated gas monitoring. Software: IEC 62304 compliant. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-13, ISO 80601-2-55.
Indications for Use
Indicated for adult and pediatric patients requiring general inhalation anesthesia and ventilation maintenance within 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
Submission Summary (Full Text)
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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):
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☐</span> 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-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: +86 755 81885635<br>Fax: +86 755 26582680 |
| 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: +86 755 81885635<br>Fax: +86 755 26582680<br>E-mail: baiyanhong@mindray.com |
| Date Prepared: | July 15, 2015 |
| Panel: | Anesthesiology |
| Classification Regulation<br>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 - CCL- Oxygen Gas Analyzer<br>880.6740 - 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.
| Technical<br>Characteristics | Subject Device<br>A7 Anesthesia System<br>ShenZhen Mindray Bio-Medical<br>Electronics CO., LTD.<br>(Subject Device) | Predicate Device<br>A7 Anesthesia System<br>ShenZhen Mindray Bio-Medical<br>Electronics CO., LTD.<br>(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 | |
| | Technical<br>Characteristics | Subject Device<br>A7 Anesthesia System | Predicate Device<br>A7 Anesthesia System |
| | | ShenZhen Mindray Bio-Medical<br>Electronics CO., LTD.<br>(Subject Device) | ShenZhen Mindray Bio-Medical<br>Electronics CO., LTD.<br>(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 Gas<br>Flow Accuracy | $±50$ ml/min or $±5%$ of setting value,<br>whichever is greater | $±120$ ml/min or $±10%$ of setting<br>value, 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 Concentration<br>Alarm | Yes | Yes |
| | Type of O2 Sensor | Paramagnetic | Paramagnetic or Galvanic (The<br>Paramagnetic sensor is utilized<br>when using the integrated gas<br>module. The Galvanic sensor is<br>utilized when the gas module is<br>not connected.) |
| | Heated Breathing Circuit | Yes | Yes |
| | Spirometry: Pressure-Volume and<br>Flow Volume loops | Yes | Yes |
| | Subject Device<br>A7 Anesthesia System | Predicate Device<br>A7 Anesthesia System | |
| Technical<br>Characteristics | ShenZhen Mindray Bio-Medical<br>Electronics CO., LTD.<br>(Subject Device) | ShenZhen Mindray Bio-Medical<br>Electronics CO., LTD.<br>(K142552) | |
| Anesthetic Gas Module Sampling<br>Rate | P/N 9200-10-10530 water trap: 120,<br>150, 200mL/min<br>P/N 9200-10-10574 water trap: 70,<br>90, 120mL/min | P/N 9200-10-10530 water trap:<br>120, 150, 200mL/min<br>P/N 9200-10-10574 water trap:<br>70, 90, 120mL/min | |
| Anesthetic Gas Module Sampling<br>Delay Time: | <4 seconds | <4 seconds | |
| Anesthetic Gas Module Refresh<br>Rate: | 1 second | 1 second | |
| Anesthetic Gas Module Warm-up<br>Time: | 45 seconds to warm-up status 10<br>minutes to ready-to-measure status | 45 seconds to warm-up status<br>10 minutes to ready-to-measure<br>status | |
| Anesthetic Gas Module<br>Accuracy CO2: | 0-1%: +/-.1%<br>1-5%: +/-.2%<br>5-7%: +/-.3%<br>7-10%: +/-.5%<br>>10%: unspecified | 0-1%: +/-.1%<br>1-5%: +/-.2%<br>5-7%: +/-.3%<br>7-10%: +/-.5%<br>>10%: unspecified | |
| Anesthetic Gas Module<br>Accuracy N2O: | 0-20%: +/-2%<br>20-100%: +/-3% | 0-20%: +/-2%<br>20-100%: +/-3% | |
| Anesthetic Gas Module<br>Accuracy Desflurane: | 0-1%: +/-.15%<br>1-5%: +/-.2%<br>5-10%: +/-.4%<br>10-15%: +/-.6%<br>15-18%: +/-1%<br>>18%: unspecified | 0-1%: +/-.15%<br>1-5%: +/-.2%<br>5-10%: +/-.4%<br>10-15%: +/-.6%<br>15-18%: +/-1%<br>>18%: unspecified | |
| Anesthetic Gas Module<br>Accuracy Sevflurane: | 0-1%: +/-.15%<br>1-5%: +/-.2%<br>5-8%: +/-.4%<br>>8%: unspecified | 0-1%: +/-.15%<br>1-5%: +/-.2%<br>5-8%: +/-.4%<br>>8%: unspecified | |
| Anesthetic Gas Module<br>Accuracy Enflurane/Isoflurane/<br>Halothane: | 0-1%: +/-.15%<br>1-5%: +/-.2%<br>>5%: unspecified | 0-1%: +/-.15%<br>1-5%: +/-.2%<br>>5%: unspecified | |
| Anesthetic Gas Module<br>Accuracy O2: | 0-25%: +/-1%<br>25-80%: +/-2%<br>80-100%: +/-3% | 0-25%: +/-1%<br>25-80%: +/-2%<br>80-100%: +/-3% | |
| Anesthetic Gas Module<br>Accuracy awRR: | 2-60rpm: +/-1rpm<br>>60rpm: unspecified | 2-60rpm: +/-1rpm<br>>60rpm: unspecified | |
| Technical<br>Characteristics | Subject Device<br>A7 Anesthesia System<br>ShenZhen Mindray Bio-Medical<br>Electronics CO., LTD.<br>(Subject Device) | Predicate Device<br>A7 Anesthesia System<br>ShenZhen Mindray Bio-Medical<br>Electronics CO., LTD.<br>(K142552) | |
| Anesthetic Gas Module<br>Measurement 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 | 0-30% | 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.
