A5 Anesthesia System (A5); A7 Anesthesia System (A7)
Device Facts
| Record ID | K253330 |
|---|---|
| Device Name | A5 Anesthesia System (A5); A7 Anesthesia System (A7) |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product Code | BSZ · Anesthesiology |
| Decision Date | Jun 25, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5160 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The A5, 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 A5, A7 Anesthesia System is intended for use by licensed clinicians in the administration of general anesthesia, for patients requiring anesthesia within a health care facility, and can be used in adult, pediatric and neonate populations. High Flow Nasal Cannula (HFNC) is indicated for delivery of nasal high flow oxygen to spontaneously breathing adult patients. It can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms. It is not intended for apneic ventilation. HFNC is indicated for use in adults only.
Device Story
Continuous flow inhalation anesthesia system; delivers anesthetic vapor; provides automatic/manual ventilation. Inputs: O2, CO2, N2O, anesthetic agents; patient physiological signals (EEG, nerve stimulation). Transforms inputs via integrated gas monitoring and ventilator control; provides real-time monitoring of gas concentrations, airway pressure, and respiratory mechanics. Used in operating rooms by licensed clinicians. Output: Anesthetic gas delivery; ventilation support; monitoring data (gas, EEG, NMT). Healthcare providers use output to adjust anesthesia depth and ventilation parameters; supports clinical decision-making during surgery. Benefits: Precise anesthetic delivery; patient ventilation maintenance; integrated monitoring of patient status.
Clinical Evidence
Bench testing only. No clinical data provided. Performance established through functional and system-level testing, software verification/validation, and compliance with consensus standards (ISO 10993, ISO 18562, IEC 60601 series, ISO 80601 series).
Technological Characteristics
Continuous flow anesthesia workstation. Materials: Breathing gas pathways compliant with ISO 18562. Sensing: O2, CO2, N2O, anesthetic agents, EEG, NMT. Connectivity: RJ45 network port. Sterilization: Compatible with standard clinical cleaning/disinfection. Software: Embedded control system for ventilation and gas monitoring. Standards: IEC 60601-1, ISO 80601-2-13, ISO 80601-2-55.
Indications for Use
Indicated for general inhalation anesthesia and ventilation maintenance in adult, pediatric, and neonate populations within healthcare facilities. HFNC indicated for nasal high-flow oxygen delivery to spontaneously breathing adults for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation; not for apneic ventilation.
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
- A8 Anesthesia System (K201957)
Reference Devices
- BeneVision N Series Patient Monitors (K192972)
- Maquet Servo-U Ventilator (K201874)
- SV600 Ventilator (K220107)
- Atlan Anesthesia machine (K230931)
- Hamilton-C2 Ventilator (K121225)
- A5 Anesthesia System (K171311)
- BIS™ Advance Monitoring System (K230693)
Submission Summary (Full Text)
{0}
**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 25, 2026
Shenzhen Mindray Bio-Medical Electronics Co., LTD.
Li Lei
Manager Regulatory Affairs
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
Shenzhen, Guangdong 518057
China
Re: K253330
Trade/Device Name: A5 Anesthesia System (A5); A7 Anesthesia System (A7)
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, KOI, OLW, OLT, OMC, ORT
Dated: May 22, 2026
Received: May 22, 2026
Dear Li Lei:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled 'Deciding When to Submit a 510(k) for a Change to an Existing Device'
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
www.fda.gov
{1}
K253330 - Li Lei
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
{2}
K253330 - Li Lei
Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn
Assistant Director
DHT1C: Division of Anesthesia,
Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253330 | ? |
| Please provide the device trade name(s). | | ? |
| A5 Anesthesia System (A5); A7 Anesthesia System (A7) | | |
| Please provide your Indications for Use below. | | ? |
| The 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 Anesthesia System is intended for use by licensed clinicians in the administration of general anesthesia, for patients requiring anesthesia within a health care facility, and can be used in adult, pediatric and neonate populations. High Flow Nasal Cannula (HFNC) is indicated for delivery of nasal high flow oxygen to spontaneously breathing adult patients. It can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms. It is not intended for apneic ventilation. HFNC is indicated for use in adults only. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
A5 Anesthesia System
Page 13 of 102
{4}
510(k) Summary
Page 1 of 11
## 1. SUBMITTER
Applicant: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen 518057, P.R. China
Tel: +86 755 81888998
Fax: +86 755 26582680
Contact: Contact Person: Lei Li
Title: Manager Regulatory Affairs
Phone: +86 755 81885953
Fax: +86 755 26582680
E-mail: lilei.js@mindray.com
Date Prepared: May 22, 2026
## 2. DEVICE
Device Trade Name: A5, A7 Anesthesia System
Device Common Name: Gas-Machine, Anesthesia
Classification Name: 868.5160, Class II, Gas-Machine, Anesthesia
Regulatory Class: Class II
Primary Product Code: BSZ
**Table 1: Secondary Product Codes**
| Regulation Number/Class | Product Code | Regulation description | Device Common Name |
| --- | --- | --- | --- |
| 868.1400, II | CCK | Carbon Dioxide Gas Analyzer | Carbon Dioxide Gas Analyzer |
| 868.1500, II | NHO/CBQ/ NHQ/NHP | Enflurane gas analyzer | Enflurane gas analyzer |
| 868.1620, II | CBS | Halothane Gas Analyzer | Halothane Gas Analyzer |
| 868.1700, II | CBR | Nitrous Oxide Gas Analyzer | Nitrous Oxide Gas Analyzer |
| 868.1720, II | CCL | Oxygen Gas Analyzer | Oxygen Gas Analyzer |
| 868.2775, II | KOI | Electrical peripheral nerve stimulator | Stimulator, nerve, peripheral, electric |
| 882.1400, II | OLW | Electroencephalograph. | Index-generating electroencephalograph software |
1
{5}
510(k) Summary
Page 2 of 11
| Regulation Number/Class | Product Code | Regulation description | Device Common Name |
| --- | --- | --- | --- |
| 882.1400, II | OLT | Electroencephalograph | Non-normalizing quantitative electroencephalograph software |
| 882.1400, II | OMC | Electroencephalograph | Reduced- montage standard electroencephalograph |
| 882.1400, II | ORT | Electroencephalograph | Burst suppression detection software for electroencephalograph |
### 3. PREDICATE DEVICE
Primary predicate:
- K201957 – A8 Anesthesia System, ShenZhen Mindray Bio-Medical Electronics Co., Ltd.
### 4. REFERENCE DEVICES
- K192972 - BeneVision N Series Patient Monitors, ShenZhen Mindray Bio-Medical Electronics Co., LTD.
- K201874 - Maquet Servo-U Ventilator, Maquet Critical Care AB
- K220107 - SV600 Ventilator, ShenZhen Mindray Bio-Medical Electronics Co., Ltd.
- K230931 - Atlan Anesthesia machine, Drägerwerk AG & Co. KGaA
- K121225 - Hamilton-C2 Ventilator, HAMILTON MEDICAL AG
- K171311 - A5 Anesthesia System, ShenZhen Mindray Bio-Medical Electronics Co., Ltd.
- K230693 - BIS™ Advance Monitoring System, Covidien LLC.
### 5. DEVICE DESCRIPTION
The A5, 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 A5, A7 Anesthesia System incorporates O₂, CO₂, N₂O and Agent concentration monitoring (Desflurane, Isoflurane, Halothane, Enflurane and Sevoflurane). The A5, A7 Anesthesia System of this 510(k) is a modified version of the previously cleared A8 Anesthesia System (K201957).
### 6. INTENDED USE/INDICATIONS FOR USE
The A5, 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.
2
{6}
510(k) Summary
Page 3 of 11
The A5, A7 Anesthesia System is intended for use by licensed clinicians in the administration of general anesthesia, for patients requiring anesthesia within a health care facility, and can be used in adult, pediatric and neonate populations.
High Flow Nasal Cannula (HFNC) is indicated for delivery of nasal high flow oxygen to spontaneously breathing adult patients. It can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms. It is not intended for apneic ventilation. HFNC is indicated for use in adults only.
## 7. SUBSTANTIAL EQUIVALENCE
### Comparison of Indications
The primary predicate A8 Anesthesia System (K201957) and the subject device A5, A7 Anesthesia System Indications for Use are the same. As the definition of pediatric population subgroups includes the neonate population according to Table 1 of the FDA Guidance, *“Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices” issued May 14, 2004*, all the populations of the subject device A5, A7 Anesthesia System were cleared in the primary predicate A8 Anesthesia System (K201957).
### Comparison of Technological Characteristics
Table 2 compares the key technological features of the subject devices to the primary predicate device (A8 Anesthesia System (K201957)) and reference device.
**Table 2: Technological Characteristics Comparison**
| Technical Characteristics | Subject device A5 Anesthesia System | Subject device A7 Anesthesia System | Primary predicate A8 Anesthesia System | Reference Device(s) |
| --- | --- | --- | --- | --- |
| | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (K201957) | |
| *Anesthetic ventilator* | | | | |
| Working Mode | Standby mode | Standby mode | - | - |
| | Manual Ventilation mode | Manual Ventilation mode | - | - |
| | Automatic Ventilator mode | Automatic Ventilator mode | - | - |
| | Lung Recruitment Ventilation | Lung Recruitment Ventilation | - | - |
| | Cardiac Bypass mode | Cardiac Bypass mode | - | - |
| | ACGO mode | ACGO mode | - | - |
| | Flow Pause | Flow Pause | - | - |
| | Monitor mode | Monitor mode | - | - |
| Automatic | VCV | VCV | - | - |
3
{7}
510(k) Summary
Page 4 of 11
| Technical Characteristics | Subject device A5 Anesthesia System | Subject device A7 Anesthesia System | Primary predicate A8 Anesthesia System | Reference Device(s) |
| --- | --- | --- | --- | --- |
| | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (K201957) | |
| Ventilation mode | PCV | | PCV | - |
| | PCV-VG | | PCV-VG | - |
| | SIMV-VC | | SIMV-VC | - |
| | SIMV-PC | | SIMV-PC | - |
| | SIMV-VG | | SIMV-VG | - |
| | PS | | PS | - |
| | CPAP/PS | | CPAP/PS | - |
| | APRV | | APRV | - |
| | AMV | | - | SV600 Ventilator (K220107) |
| Anesthetic Ventilator setting parameter | Tidal Volume, Inspiratory Pressure, Support Pressure, Apnea Pressure, Plimit, PEEP, Tslope, RR, Min RR, I:E ,Apnea I:E ,Apnea Tinsp, Tinsp, Tpause, Trig Window, F-Trig, P-Trig, Exp%, Phigh, Plow, Thigh, Tlow, MV% | | Tidal Volume, Inspiratory Pressure, Support Pressure, Apnea Pressure, Plimit, PEEP, Tslope, RR, Min RR, I:E, Apnea I:E, Apnea Tinsp, Tinsp,Tpause, Trig Window, F-Trig, P-Trig, Exp%, Phigh, Plow , Thigh, Tlow , | - |
| Anesthetic Ventilator monitoring parameter | Tidal Volume, Minute Volume (MV, MVmand , MVspon), Airway pressure, PEEP, Respiratory Rate (RR, RRmand, RRspon), I:E, Resistance (Raw) , Compliance (Compl) , Minute Volume leakage (MVLeak) , Inspiratory-Expiratory Tidal volume difference ΔVt, Drive pressure range, Time Constant (TC) | | Tidal Volume, Minute Volume, Airway pressure, PEEP, Respiratory Rate, I:E, Resistance (Raw) , Compliance (Compl) , Minute Volume leakage (MVLeak) | - |
| | Elastance (E) | | - | Servo-U (K201874) |
| | Mechanical Power, Work of breathing (WOBtot, WOBvent, WOBpat) | | - | SV600 Ventilator (K220107) |
| Gas Advanced Monitoring Values | AA Uptake, O2 Uptake, MVxCO2 | | - | Altan (K230931) |
| Inspiration hold | Yes | | - | SV600 Ventilator (K220107) |
| Expiration hold | Yes | | - | |
| IntelliCycle | Yes | | - | SV600 Ventilator (K220107) |
| Spirometry loop | Flow-Volume, Pressure-Volume and Pressure-Flow | | Flow-Volume, Pressure-Volume and Pressure-Flow | - |
4
{8}
510(k) Summary
Page 5 of 11
| Technical Characteristics | Subject device A5 Anesthesia System | Subject device A7 Anesthesia System | Primary predicate A8 Anesthesia System | Reference Device(s) |
| --- | --- | --- | --- | --- |
| | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (K201957) | |
| Maximum Inspiratory flow | 180L/min | | 180L/min | - |
| Lung Recruitment Ventilation | Multi-step Recruitment and One-step Recruitment | | Multi-step Recruitment and One-step Recruitment | - |
| Basic Alarm | High/Low Minute Volume Alarm High/Low Tidal Volume Alarm High/Low RR Alarm High/Low Airway Pressure Alarm Pressure Limiting Alarm Sub Atmospheric Pressure Alarm Continuous Airway Pressure Alarm Apnea Alarm Apnea >2 Minute Alarm Apnea CO2 Alarm High/Low FiO2 Alarm | | High/Low Minute Volume Alarm High/Low Tidal Volume Alarm High/Low RR Alarm High/Low Airway Pressure Alarm Pressure Limiting Alarm Sub Atmospheric Pressure Alarm Continuous Airway Pressure Alarm Apnea Alarm Apnea >2 Minute Alarm Apnea CO2 Alarm High/Low FiO2 Alarm | - |
| **Gas supply** | | | | |
| Pipeline supply | 280 to 600kPa (40 to 87PSI) for O_{2}, N_{2}O, Air; | | 280 to 600kPa (40 to 87PSI) for O_{2}, N_{2}O, Air; | - |
| Backup Cylinder supply | 6.9 to 20.0MPa (1000 to 2900PSI) for O_{2}, Air 4.2 to 6.0MPa (600 to 870PSI) for N_{2}O | | 6.9 to 20.0MPa (1000 to 2900PSI) for O_{2}, Air 4.2 to 6.0MPa (600 to 870PSI) for N_{2}O | - |
| **Fresh Gas** | | | | |
| Electronic Flowmeter | - | **Direct Flow Control Mode:** O_{2} flow range: 0, 0.2 to 15L/min N_{2}O flow range: 0 to 12L/min Air flow range: 0 to 15L/min O_{2} concentration range in the O_{2}/N_{2}O mixed gas: ≥25% | **Direct Flow Control Mode:** O_{2} flow range: 0, 0.2 to 15.0L/min N_{2}O flow range: 0 to 12L/min Air flow range: 0 to 15L/min O_{2} concentration range in the O_{2}/N_{2}O mixed gas: ≥25% | - |
5
{9}
510(k) Summary
Page 6 of 11
| Technical Characteristics | Subject device A5 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Subject device A7 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Primary predicate A8 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (K201957) | Reference Device(s) |
| --- | --- | --- | --- | --- |
| | - | **Total Flow Control Mode:** Total flow range: 0, 0.2 to 20L/min O_{2} concentration range: 21% to 100% (Balance gas is Air) 26% to 100 (Balance gas is N_{2}O) | **Total Flow Control Mode:** Total flow range: 0, 0.2 to 20.0L/min O_{2} concentration range: 21% to 100% (Balance gas is Air) 26% to 100% (Balance gas is N_{2}O) | - |
| Backup Flowmeter | - | Yes | Yes | - |
| Flowmeter | O_{2} flow range: 0 to 15.0L/min N_{2}O flow range: 0 to 12.0L/min Air flow range: 0 to 15.0L/min O_{2} concentration range in the O_{2}/N_{2}O mixed gas: ≥25% | - | O_{2} flow range: 0, 0.2 to 15.0L/min N_{2}O flow range: 0 to 12L/min Air flow range: 0 to 15L/min O_{2} concentration range in the O_{2}/N_{2}O mixed gas: ≥25% | - |
| Optimal Flow Indicator (Optimizer) | Yes | Yes | - |
| Oxygen flush | Yes | Yes | - |
| **Auxiliary Gas** |
| Auxiliary Flowmeter | Flow range: 0 to 15L/min O_{2}% range: 21% to 100% | Flow range: 0 to 15L/min O_{2}% range: 21% to 100% | - |
| HFNC | Flow range: 2 to 60L/min O_{2}% range: 21% to 100% | Flow range: 2 to 60L/min O_{2}% range: 21% to 100% | - |
| **Anesthetic Breathing System** |
| CO_{2} absorbent volume | 1500mL±100mL | 1500mL±100mL | - |
| CO_{2} absorber | Loose fill or Pre-pak canisters | Loose fill or Pre-pak canisters | - |
| APL Valve | Adjustable range: Approximately 0 (SP) to 70cmH_{2}O | Adjustable range: Approximately 0 (SP) to 70cmH_{2}O | - |
| APL Valve Quick Release | Yes | Yes | - |
6
{10}
510(k) Summary
Page 7 of 11
| Technical Characteristics | Subject device A5 Anesthesia System | Subject device A7 Anesthesia System | Primary predicate A8 Anesthesia System | Reference Device(s) |
| --- | --- | --- | --- | --- |
| | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (K201957) | |
| Airway pressure gauge range | -20 to 100cmH_{2}O | | -20 to 100cmH_{2}O | - |
| Breathing system safety pressure | 110±10cmH_{2}O | | 110±10cmH_{2}O | - |
| Sample Gas Return | Yes | | Yes | - |
| Heated Breathing Circuit | Yes | | Yes | - |
| **AGSS** | | | | |
| Active Low-flow AGSS | Yes | | Yes | - |
| Extract flow range of Active Low-flow AGSS | 25 to 50L/min | | 25 to 50L/min | - |
| Passive AGSS | Yes | | Yes | - |
| **Anesthetic Gas Module (AGM)** | | | | |
| Sample flowrate | Neonate water trap: 100, 110, 120ml/min (Optional) Adult/pediatric water trap: 150, 180, 200ml/min (Optional) | | Neonate water trap: 100, 110, 120ml/min (Optional) Adult/pediatric water trap: 150, 180, 200ml/min (Optional) | - |
| Measurement range | CO_{2}: 0.0% to 30% O_{2}: 0% to 100% N_{2}O: 0% to 100% HAL: 0.0% to 30% ISO: 0.0% to 30% ENF: 0.0% to 30% SEV: 0.0% to 30% DES: 0.0% to 30% RR: 2 to 100bpm | | CO_{2}: 0% to 30% O_{2}: 0% to 100% N_{2}O: 0% to 100% HAL: 0% to 30% ISO: 0% to 30% ENF: 0% to 30% SEV: 0% to 30% DES: 0% to 30% RR: 2 to 100bpm | - |
| **Oxygen Cell** | | | | |
| Measurement range | 18% to 100% | | 18% to 100% | - |
| **BIS Module** | | | | |
| Measured parameters | EEG BIS, BIS L, BIS R: 0 to 100 | | - | BeneVision N Series Patient Monitors |
7
{11}
510(k) Summary
Page 8 of 11
| Technical Characteristics | Subject device A5 Anesthesia System | Subject device A7 Anesthesia System | Primary predicate A8 Anesthesia System | Reference Device(s) |
| --- | --- | --- | --- | --- |
| | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (K201957) | |
| Calculated parameters | SQI, SQI L, SQI R: 0% to 100% EMG, EMG L, EMG R: 0dB to 100dB SR, SR L, SR R: 0% to 100% SEF, SEF L, SEF R: 0.5Hz to 30.0 Hz TP, TP L, TP R: 40dB to 100dB BC, BC L, BC R: 0 to 30 sBIS L, sBIS R: 0 to 10.0 sEMG L, sEMG R: 0 to 10.0 ASYM: 0% to 100% | | - | (K192972) |
| **NMT Module** | | | | |
| TOF (Train Of Four) mode | TOF-Ratio (Response percentage): 5% to 160% TOF-Count (Number of responses): 0 to 4 TOF-T1% (Response to the first stimulus as percentage of the reference value): 0% to 200% | | - | BeneVision N Series Patient Monitors (K192972) |
| ST (Single Twitch) mode | ST-Ratio (Response percentage): 0% to 200% | | - | |
| DBS (Double-Burst Stimulation) 3.2/3.3 mode | DBS-Ratio (Response percentage): 5% to 160% DBS-Count (Number of responses): 0 to 2 | | - | |
| PTC (Post-Tetanic Count) mode | PTC-Count (Number of responses): 0 to 20 | | - | |
| **Agent usage calculation** | | | | |
| Agent usage calculation | Agent usage speed range: Isoflurane: 0 to 250mL/h Sevoflurane: 0 to 450mL/h Desflurane: 0 to 900mL/h Agent total usage range: 0 to 3000mL | | Agent usage speed range: Isoflurane and Halothane: 0 to 250mL/h Sevoflurane: 0 to 450mL/h Desflurane: 0 to 900mL/h Agent total usage range: 0 to 3000mL | - |
| **Others** | | | | |
| Folding Auxiliary Worktable | Yes | | Yes | - |
| Top shelf | Yes | | Yes | - |
| Mounting Bracket | Yes | | Yes | - |
8
{12}
510(k) Summary
Page 9 of 11
| Technical Characteristics | Subject device A5 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Subject device A7 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Primary predicate A8 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (K201957) | Reference Device(s) |
| --- | --- | --- | --- | --- |
| Through RJ45 network port to send data to other device | Yes | Yes | - |
In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.
## 8. PERFORMANCE DATA
To establish the substantial equivalence of the A5, A7 Anesthesia System, Mindray conducted functional and system level testing on the subject device. The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. The functional and system level testing showed that the devices continue to meet specifications, and the performance of the device is equivalent to the predicate.
Mindray has conducted testing to ensure the subject device meets relevant consensus standards.
### Biocompatibility Testing
The A5, A7 Anesthesia System was assessed for conformity with the relevant requirements of the following standards and found to comply:
- ISO 10993-1:2018, Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process
- ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation
- ISO 10993-18:2020, Amd 2022, Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)]
- ISO 18562-1:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- ISO 18562-2:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
9
{13}
510(k) Summary
Page 10 of 11
- ISO 18562-3:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
- ISO 18562-4:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
## Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance "Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff". Verification of the A5, A7 Anesthesia System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.
## Electromagnetic Compatibility and Electrical Safety
The A5, A7 Anesthesia System were assessed for conformity with the relevant requirements of the following standards and found to comply:
- IEC 60601-1:2020, Ed. 3.2, CONSOLIDATED VERSION, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) [Including Amendment 2 (2021)]
- IEC 60601-1-2:2020 Ed. 4.1 CONSOLIDATED VERSION, Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral Standard: Electromagnetic disturbances – Requirements and tests
- ISO 80601-2-13:2011, Ed. 1, Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
- ISO 80601-2-55:2018, Ed. 2, Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- IEC TR 60601-4-2:2016, Ed. 1, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
## Bench Testing
To establish the substantial equivalence of the A5, A7 Anesthesia System, Mindray conducted functional and system level testing on the device. The results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device.
In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
10
{14}
510(k) Summary
Page 11 of 11
- • IEC 60601-1-6 :2020, Ed. 3.2, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- • IEC 60601-1-8:2020 Ed. 2.2, 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
- • ISO 80601-2-13:2011, Ed. 1, Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
- • ISO 80601-2-55:2018, Ed. 2, Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- • ISO 5356-1:2015, Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
- • IEC 60601-2-10:2016, Ed. 2.1, Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- • IEC 80601-2-26:2019, Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
## 9. CONCLUSION
Based on the detailed comparison of specifications for each of the characteristics to the predicate devices, the performance testing and conformance with applicable standards, the A5, A7 Anesthesia System can be found substantially equivalent to the predicate devices.
11
