(255 days)
The A8, A9 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 A8, A9 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.
The A8, A9 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A8, A9 Anesthesia System incorporates O2, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Halothane, and Sevoflurane). The A8, A9 Anesthesia System is a modified version the previously cleared Mindray A7 Anesthesia System cleared in K171292.
The provided text describes the 510(k) premarket notification for the Mindray A8, A9 Anesthesia System, focusing on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria based on studies involving human readers or AI performance metrics.
Therefore, most of the information requested in your prompt (acceptance criteria table with performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, and ground truth establishment for training set) is not available in this document.
The document details engineering tests and conformance to standards, which are different from clinical performance studies for AI/radiology devices.
Here's a breakdown of what is available and what is not:
Information Found in the Document:
- Device Name: A8, A9 Anesthesia System
- Predicate Devices: K171292 (A7 Anesthesia System), K192972 (BeneVision N Series Patient Monitors). Reference devices also listed.
- Technological Differences from Predicate:
- Change the Vaporizer Type and the addition of Electronic Vaporizers (A9)
- Change certain parameters of the ventilator modes
- Addition of the High Flow Nasal Cannula Oxygen (HFNC)
- Change the Anesthetic Gas Module and Accessories
- Addition of the Sealed Lead Acid Battery
- Performance Data (Type of Studies Conducted):
- Functional and System Level Testing (bench testing) to validate performance and ensure specifications are met.
- Biocompatibility Testing (conformance to ISO standards: 10993-1, -5, -10, -18, 18562-1, -2, -3)
- Software Verification and Validation Testing (following FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices")
- Electromagnetic Compatibility and Electrical Safety (conformance to IEC and ANSI/AAMI standards: ES60601-1, IEC 60601-1-6, -1-8, ISO 80601-2-13, -2-55, IEC 60601-1-2)
- Bench Testing (conformance to ASTM and ISO standards: F1101-90, IEC 60601-1-6, -1-8, ISO 5360, 10079-3, 80601-2-13, -2-55)
Information NOT Found in the Document (and why):
This document is for an Anesthesia System, which is a hardware medical device with integrated software for control and monitoring. It is not an AI-driven image analysis or diagnostic device that would typically involve acceptance criteria related to human reader performance, expert ground truth, or MRMC studies. The "performance data" section focuses on testing the device's functional specifications, safety, and compliance with general medical device standards.
- A table of acceptance criteria and the reported device performance: Not provided in the format of performance metrics against specific acceptance thresholds for diagnostic accuracy, sensitivity, specificity, etc. The document generally states that "the devices continue to meet specifications and the performance of the device is equivalent to the predicate" based on functional and system-level testing, and compliance with standards. Key technical characteristics are compared in a large table, but this is a comparison to the predicate, not a list of acceptance criteria with measured performance against them.
- Sample sized used for the test set and the data provenance: Not applicable in the context of this type of device submission. The "test set" here refers to the actual physical devices undergoing bench and functional testing, not a dataset of patient images or clinical cases.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be engineering specifications and validated measurement techniques, not expert clinical interpretation.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating diagnostic performance, typically for imaging devices or AI algorithms assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an anesthesia system, not a standalone AI algorithm for diagnosis.
- The type of ground truth used: For this device, ground truth is established by engineering design specifications, international and national consensus standards (e.g., ISO, IEC, ASTM), and validated measurement instruments.
- The sample size for the training set: Not applicable for this type of device. There is no "training set" in the machine learning sense described. Software validation ensures the embedded software performs as designed and specified for controlling the anesthesia system.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a regulatory submission for an anesthesia system, which relies on demonstrating safety and efficacy through engineering testing and adherence to established performance standards for medical devices, rather than AI model validation studies common for diagnostic algorithms.
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March 26, 2021
Shenzhen Mindray Bio-Medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China
Re: K201957
Trade/Device Name: A8, A9 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, NHP, CBS, CBR, CCL, KDP, NHQ Dated: February 24, 2021 Received: February 25, 2021
Dear Yanhong Bai:
We have reviewed vour 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. 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 located 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201957
Device Name A8, A9 Anesthesia System
Indications for Use (Describe)
The A8, A9 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 A8, A9 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mindray A8, A9 Anesthesia System is provided below.
1. SUBMITTER
| Applicant: | SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680 |
|---|---|
| Contact: | Contact Person: Yanhong BaiTitle: Manager Regulatory AffairsPhone: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com |
| Date Prepared: | March 25, 2021 |
2. DEVICE
| Device Trade Name: | A8, A9 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 | |||
|---|---|---|---|
| RegulationNumber/Class | ProductCode | 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 |
Table 1· Product Code
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| RegulationNumber/Class | ProductCode | Regulation description | Device Common Name |
|---|---|---|---|
| 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 |
| 880.6740, II | KDP | Vacuum | Vacuum |
3. PREDICATE DEVICES
Primary predicate:
- K171292 A7 Anesthesia System, ShenZhen Mindray Bio-Medical Electronics Co., Ltd. .
Secondary predicate:
- . K192972 - BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1), ShenZhen Mindray Bio-Medical Electronics Co., LTD. (Supports Anesthetic gas module and accessories)
4. REFERENCE DEVICES
Per the FDA Guidance, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued July 28, 2104, the following reference devices are provided to support substantial equivalence:
- K160665 - Flow-i Anesthesia System C20, Flow-i Anesthesia System C30, Flow-i Anesthesia System C40, Maquet Critical Care AB (Supports electronic vaporizers, sealed lead acid battery, electronic flowmeter total flow range)
- . K151570 - Carestation 620/650/650C. Datex-Ohmeda, Inc. (Supports apnea pressure and trig window, sealed lead acid battery, APL Valve Adjustable Range)
- K083050 Evita XL Ventilator, Drager Medical AG & Co. KG (Supports tidal volume, ● Inspiratory pressure, support pressure, Plimit, PEEP, Phigh, Plow, RR, PEEP on Exit)
- K180295- HAMILTON-G5, HAMILTON MEDICAL AG (Supports HFNC) ●
5. DEVICE DESCRIPTION
The A8, A9 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A8, A9 Anesthesia System incorporates O2, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Halothane, and Sevoflurane). The A8, A9 Anesthesia System is a modified version the previously cleared Mindray A7 Anesthesia System cleared in K171292.
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6. INTENDED USE/INDICATIONS FOR USE
The A8, A9 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 A8, A9 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
Comparing with the primary predicate A7 Anesthesia System (K171292), the indications for use for the subject device A8, A9 Anesthesia System includes the indications for use for the A7 and additionally adds the indications for use for HFNC in adult patients. 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 A8, A9 Anesthesia System were cleared in the primary predicate A7 Anesthesia System (K171292).
The BeneVision N Series Patient Monitor modules (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1), ShenZhen Mindray Bio-Medical Electronics Co., LTD cleared under K192972 are incorporated into this workstation with no changes to the modules. This predicate serves as a reference device for the Anesthetic Gas Module. A more detailed comparison of the features is included in the sections below.
The indications for the BeneVision N Series Patient Monitors modules are the same since the modules are incorporated with no changes in indications into the anesthesia workstation.
As a conclusion, the indications for use of the subject device A8, A9 Anesthesia System is the same as the primary predicate A7 Anesthesia System as cleared in K171292 and the BeneVision N Series Patient Monitors cleared in K192972.
Comparison of Technological Characteristics
The table below compares the key technological feature of the subject devices to the primary predicate device (A7 Anesthesia System (K151954)). The features in gray are features which are different between the predicate devices and the subject devices.
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| TechnicalCharacteristics | Subject deviceA8 Anesthesia SystemShenzhen MindrayBio-MedicalElectronics Co., Ltd.(Subject device) | Subject deviceA9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.(Subject device) | Primary predicateA7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co.,Ltd.(K171292) |
|---|---|---|---|
| Connection Type | Double, Selectatec®,with interlockingfunction | Double, Insertion typeconnection, with interlockingfunction | Two or three, Selectatec®,with interlocking function |
| - | Working with an electronic basedinjector | - | |
| ElectronicVaporizer | - | Applicable anesthetic agent:IsofluraneSevofluraneDesflurane | - |
| - | Filling method:Isoflurane (Safety filling adapter)Sevoflurane(Safety fillingadapter)Sevoflurane (Quik-fil)Desflurane (Saf-T-Fill) | - | |
| - | Setting range:Isoflurane: 0.0% to 5.0%Sevoflurane: 0.0% to 8.0%Desflurane: 0.0% to 18.0% | - | |
| - | Accuracy: ±15% of the settingvalue or ±5% of the maximumsetting value, whichever isgreater | - | |
| Anesthetic agent -Sevoflurane | - | Yes | Yes |
| Anesthetic agent -Isoflurane | Yes | Yes | |
| Anesthetic agent -Desflurane | Yes | Yes | |
| Anesthetic agent -Halothane | Yes | - | Yes |
| Working Mode | - | - | - |
| Standby mode | - | Yes | Yes |
| Manual Ventilationmode | - | Yes | Yes |
| AutomaticVentilator mode | - | Yes | Yes |
| TechnicalCharacteristics | Subject deviceA8 Anesthesia SystemShenzhen MindrayBio-MedicalElectronics Co., Ltd.(Subject device) | Subject deviceA9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.(Subject device) | Primary predicateA7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co.,Ltd.(K171292) |
| Lung RecruitmentVentilation | Yes | Yes | Yes |
| Cardiac Bypassmode | Yes | Yes | Yes |
| ACGO mode | Yes | Yes | Yes |
| Flow Pause | Yes | Yes | Yes |
| Monitor mode | Yes | Yes | Yes |
| Automatic Ventilation mode | |||
| VCV | Yes | Yes | Yes |
| PCV | Yes | Yes | Yes |
| PCV-VG | Yes | Yes | Yes |
| SIMV-VC | Yes | Yes | Yes |
| SIMV-PC | Yes | Yes | Yes |
| SIMV-VG | Yes | Yes | Yes |
| PS | Yes | Yes | Yes |
| CPAP/PS | Yes | Yes | Yes |
| APRV | Yes | Yes | Yes |
| Specifications - Anesthetic Ventilator setting parameter | |||
| Tidal Volumerange | 10 to 2000mL (VCV, SIMV-VC)5 to 2000mL (PCV-VG, SIMV-VG) | 20 to 1500mL | |
| InspiratoryPressure range | 5 to 90cmH2O | 5 to 70cmH2O | |
| Support Pressurerange | 0, 3 to 60cmH2O | OFF, 3 to 50cmH2O | |
| Apnea Pressurerange | 3 to 60cmH2O | 3 to 50cmH2O | |
| Plimit range | 5 to 100cmH2O | 10 to 100cmH2O | |
| PEEP range | 0 to 50cmH2O | OFF, 3 to 30cmH2O | |
| Tslope range | 0.0 to 2.0s | 0.0 to 2.0s | |
| RR range | 4 to 100bpm | 4 to 100bpm | |
| TechnicalCharacteristics | Subject deviceA8 Anesthesia SystemShenzhen MindrayBio-MedicalElectronics Co., Ltd.(Subject device) | Subject deviceA9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.(Subject device) | Primary predicateA7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co.,Ltd.(K171292) |
| Min RR range | 2 to 60bpm | 2 to 60bpm | 2 to 60bpm |
| I:E range | 4:1 to 1:8 | 4:1 to 1:8 | 4:1 to 1:8 |
| Apnea I:E range | 4:1 to 1:8 | 4:1 to 1:8 | 4:1 to 1:8 |
| Apnea Tinsp range | 0.2 to 10s | 0.2 to 10s | 0.2 to 10s |
| Tinsp range | 0.2 to 10s | 0.2 to 10s | 0.2 to 10s |
| Tpause range | OFF, 5% to 60% of Tinsp | OFF, 5% to 60% of Tinsp | OFF, 5% to 60% of Tinsp |
| Trig Window range | 5% to 80% of Texp | 5% to 80% of Texp | 25% of Texp |
| F-Trig range | 0.2 to 15L/min | 0.2 to 15L/min | 0.2 to 15L/min |
| P-Trig range | -20 to -1cmH2O | -20 to -1cmH2O | - |
| Exp% range | 5% to 80% | 5% to 80% | 25% |
| Phigh range | 3 to 90cmH2O | 3 to 90cmH2O | 3 to 70cmH2O |
| Plow range | 0 to 50cmH2O | 0 to 50cmH2O | OFF, 3 to 30cmH2O |
| Thigh range | 0.2 to 10s | 0.2 to 10s | 0.2 to 10s |
| Tlow range | 0.2 to 10s | 0.2 to 10s | 0.2 to 10s |
| MaximumInspiratory flow | 180L/min | 180L/min | 180L/min |
| Specifications - Anesthetic Ventilator monitoring parameter | |||
| Tidal Volumerange | 0 to 3000mL | 0 to 3000mL | 0 to 3000mL |
| Minute Volumerange | 0 to 100L/min | 0 to 100L/min | 0 to 100L/min |
| Airway pressure(PEAK, PLAT,MEAN) range | -20 to 120cmH2O | -20 to 120cmH2O | -20 to 120cmH2O |
| PEEP range | 0 to 70cmH2O | 0 to 70cmH2O | 0 to 70cmH2O |
| RR range | 0 to 150bpm | 0 to 150bpm | 0 to 120bpm |
| Spirometry loop | Flow-Volume, Pressure-Volume and Pressure-Flow | Flow-Volume, Pressure-Volume and Pressure-Flow | Flow-Volume, Pressure-Volume and Pressure-Flow |
| Type | Multi-step Recruitment and One-step Recruitment | Multi-step Recruitment and One-step Recruitment | Preset Procedure and PressureAdjust |
| Step range | OFF, 1 to 7 | OFF, 1 to 7 | OFF, 1 to 7 |
| Breaths | 3 to 10 | 3 to 10 | 3 to 10 |
| TechnicalCharacteristics | Subject deviceA8 Anesthesia SystemShenzhen MindrayBio-MedicalElectronics Co., Ltd.(Subject device) | Subject deviceA9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.(Subject device) | Primary predicateA7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co.,Ltd.(K171292) |
| Pressure Hold | 20 to 60cmH2O | 20 to 60cmH2O | 20 to 60cmH2O |
| Hold Time | 10 to 40s | 10 to 40s | 10 to 40s |
| PEEP on Exit | 0 to 50cmH2O | 0 to 50cmH2O | OFF, 3 to 30cmH2O |
| Specifications - Alarm | |||
| High/Low MinuteVolume Alarm | Yes | Yes | Yes |
| High/Low TidalVolume Alarm | Yes | Yes | Yes |
| High/Low RRAlarm | Yes | Yes | Yes |
| High/Low AirwayPressure Alarm | Yes | Yes | Yes |
| Pressure LimitingAlarm | Yes | Yes | Yes |
| Sub AtmosphericPressure Alarm | Yes | Yes | Yes |
| Continuous AirwayPressure Alarm | Yes | Yes | Yes |
| Apnea Alarm | Yes | Yes | Yes |
| Apnea >2 MinuteAlarm | Yes | Yes | Yes |
| Apnea CO2 Alarm | Yes | Yes | Yes |
| High/Low FiO2Alarm | Yes | Yes | Yes |
| Pipeline supply | 280 to 600kPa (40 to 87PSI) for O2, N2O, Air | 280 to 600kPa (40 to 87PSI) for O2, N2O, Air | 280 to 600kPa (40 to 87PSI)for O2, N2O, Air |
| Connector type | DISS | DISS | DISS |
| Pressuremonitoring range | 0 to 1000kPa (0 to 140PSI) for O2, N2O, Air | 0 to 1000kPa (0 to 140PSI) for O2, N2O, Air | 0 to 1000kPa (0 to 140PSI) forO2, N2O, Air |
| Pressuremonitoringaccuracy | ±(4% of the full scale reading+8% of the actual reading) | ±(4% of the full scale reading+8% of the actual reading) | ±(4% of the full scalereading+8% of the actualreading) |
| Backup Cylindersupply | 6.9 to 20.0MPa (1000 to 2900PSI) for O2, Air4.2 to 6.0MPa (600 to 870PSI) for N2O | 6.9 to 20.0MPa (1000 to 2900PSI) for O2, Air4.2 to 6.0MPa (600 to 870PSI) for N2O | 6.9 to 15.5MPa (1000 to2250PSI) for O2, Air4.2 to 6MPa (600 to 870PSI)for N2O |
| TechnicalCharacteristics | Subject deviceA8 Anesthesia SystemShenzhen MindrayBio-MedicalElectronics Co., Ltd.(Subject device) | Subject deviceA9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.(Subject device) | Primary predicateA7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co.,Ltd.(K171292) |
| Connector type | Pin-index of E cylinder | Pin-index of E cylinder | Pin-index of E cylinder |
| Pressuremonitoring range | 0 to 25MPa (0 to 3500PSI) for O2, Air0 to 10MPa (0 to 1400PSI) for N2O | 0 to 25MPa (0 to 3500PSI) for O2, Air0 to 10MPa (0 to 1400PSI) for N2O | 0 to 25MPa (0 to 3500PSI) forO2, Air0 to 10MPa (0 to 1400PSI) forN2O |
| Pressuremonitoringaccuracy | ±(4% of the full scale reading+8% of the actual reading) | ±(4% of the full scale reading+8% of the actual reading) | ±(4% of the full scalereading+8% of the actualreading) |
| Specifications – Fresh Gas | |||
| ElectronicFlowmeter - DirectFlow ControlMode | O2 flow range: 0, 0.2 to 15.0L/minN2O flow range: 0 to 12L/minAir flow range: 0 to 15L/minO2 flow accuracy: ±50ml/min or ±5% of the setting value,whichever is greaterBalance gas (Air/N2O) flow accuracy: ±50ml/min or ±5% ofthe setting value, whichever is greater | O2 flow range: 0 to 15L/minN2O flow range: 0 to 12L/minAir flow range: 0 to 15L/minO2 flow accuracy: ±50ml/min or ±5% of setting value,whichever is greaterBalance gas (Air/N2O) flow accuracy: ±50ml/min or ±5% ofthe setting value, whichever is greater | O2 flow range: 0 to 15L/minN2O flow range: 0 to 12L/minAir flow range: 0 to 15L/minO2 flow accuracy: ±50ml/minor ±5% of setting value,whichever is greaterBalance gas (Air/N2O) flowaccuracy: ±50ml/min or ±5%of setting value, whichever isgreater |
| ElectronicFlowmeter - TotalFlow ControlMode | Total Flow Control Mode:Total flow range: 0, 0.2 to 20.0L/minTotal flow accuracy: ±100ml/min or ±5% of the settingvalue, whichever is greaterO2 concentration range:21% to 100% (Balance gas is Air)26% to 100% (Balance gas is N2O)O2 concentration accuracy:Volume fraction of ±5% (Flow <1L/min)±5% of the setting value (Flow ≥1L/min) | Total Flow Control Mode:Total flow range: 0, 0.2 to 20.0L/minTotal flow accuracy: ±100ml/min or ±5% of the settingvalue, whichever is greaterO2 concentration range:21% to 100% (Balance gas is Air)26% to 100% (Balance gas is N2O)O2 concentration accuracy:Volume fraction of ±5% (Flow <1L/min)±5% of the setting value (Flow ≥1L/min) | Total Flow Control Mode:Total flow range: 0, 0.2 to18L/minTotal flow accuracy:±100ml/min or ±5% of settingvalue, whichever is greaterO2 concentration range:21% to 100% (The balance gasis Air)26% to 100% (The balance gasis N20)O2 concentration accuracy:±5% V/V for flows <1L/min±5% of setting for flows≥1L/min |
| Optimal FlowIndicator(Optimizer) | Optimum fresh gas flow: Green; Insufficient fresh gas flow:Red; Excessive fresh gas flow: Yellow | Optimum fresh gas flow: Green; Insufficient fresh gas flow:Red; Excessive fresh gas flow: Yellow | Optimum fresh gas flow:Green; Insufficient fresh gasflow: Red; Excessive fresh gasflow: Yellow |
| TechnicalCharacteristics | Subject deviceA8 Anesthesia SystemShenzhen MindrayBio-MedicalElectronics Co., Ltd. | Subject deviceA9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. | Primary predicateA7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co.,Ltd. |
| (Subject device) | (Subject device) | (K171292) | |
| Backup Flowmeter | O2 flow range: 1.0 to 15L/minAir flow range: 0 to 15L/minAccuracy: ±10% of the indicated value (Under the conditionof 20°C and 101.3kPa, for flow between 10% and 100% offull scale) | O2 flow range: 1.0 to 15L/minAir flow range: 0 to 15L/minAccuracy: ±10% of the indicated value (Under the conditionof 20°C and 101.3kPa, for flow between 10% and 100% offull scale) | O2 flow range: 1.0 to 15L/minAir flow range: 0 to 15L/minAccuracy:±10%oftheindicatedvalue (Undertheconditionof 20 °Cand101.3kPa, for flow between10% and 100% of full scale) |
| Oxygen flush flowrange | 35 to 50L/min | 35 to 50L/min | |
| AuxiliaryFlowmeter | Flow range: 0 to 15L/minO2% range: 21% to 100% | Flow range: 0 to 15L/minO2% range: 21% to 100% | |
| HFNC | Flow range: 2 to 60L/minO2% range: 21% to 100% | ||
| Specifications - Anesthetic Breathing System | |||
| CO2 absorbentvolume | 1500mL±100mL | 1500mL±100mL | |
| CO2 absorber | Loose fill or Pre-pak canisters | Loose fill or Pre-pak canisters | |
| APL Valve | Adjustable range: Approximately 0 (SP) to 70cmH2O | Adjustable range:Approximately 0 (SP) to75cmH2O | |
| Airway pressuregauge range | Range: -20 to 100cmH2OAccuracy: ±(2% of the full scale reading+4% of the actual reading) | Range: -20 to 100cmH2OAccuracy: ±(2% of the fullscale reading+4% of thereading) | |
| Breathing systemsafety pressure | 110±10cmH2O | 110±10cmH2O | |
| Sample Gas Return | Yes | Yes | |
| Heated BreathingCircuit | Yes | Yes | |
| APL Valve QuickRelease | Yes | Yes | |
| Specifications - AGSS | |||
| Flow sensor | Inspiration/Expiration flow sensor component | Inspiration/Expiration flow sensor component | Inspiration/Expiration flowsensor assembly |
| Active Low-flowAGSS | Yes | Yes | Yes |
| TechnicalCharacteristics | Subject deviceA8 Anesthesia SystemShenzhen MindrayBio-MedicalElectronics Co., Ltd.(Subject device) | Subject deviceA9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.(Subject device) | Primary predicateA7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co.,Ltd.(K171292) |
| Extract flow rangeof Active Low-flow AGSS | 25 to 50L/min | 25 to 50L/min | |
| Passive AGSS | Yes | Yes | |
| Anesthetic GasModule (AGM) | 2-slot Anesthetic Gas Module with Oxygen | 2-slot Anesthetic Gas Modulewith Oxygen | |
| Water trap | DRYLINE II Water trap, Adult/pediatric | DRYLINE II Water trap, Adult/pediatricDRYLINE II Water trap, Neonate | DRYLINE II Water trap,Adult/pediatricDRYLINE II Water trap,Neonate |
| Sampling Line | DRYLINE Gas Sampling Line, Neonate 2.5 mDRYLINE Gas Sampling Line, Adult/pediatric 2.5 m | DRYLINE Gas Sampling Line, Neonate 2.5 m | DRYLINE Gas SamplingLine, Neonate 2.5 mDRYLINE Gas SamplingLine, Adult/pediatric 2.5 m |
| Airway adapter | Airway adapter (straight)Airway adapter (elbow) | Airway adapter (straight)Airway adapter (elbow) | Airway adapter (straight)Airway adapter (elbow) |
| Type of O2 Sensor | Paramagnetic | Paramagnetic | |
| Warm-up time | 45s to warm-up status10min to ready-to-measure status | 45s to warm-up status10min to ready-to-measurestatus | |
| Sample flowrate | Neonate water trap: 100, 110, 120ml/min (Optional)Adult/pediatric water trap: 150, 180, 200ml/min (Optional) | Neonate water trap: 70, 90,120ml/min (Optional)Adult/pediatric water trap:120, 150, 200ml/min(Optional) | |
| Measurement range | CO2: 0.0% to 30%O2: 0% to 100%N2O: 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 | CO2: 0.0% to 30%O2: 0% to 100%N2O: 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 | CO2: 0% to 30%O2: 0% to 100%N2O: 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 |
| TechnicalCharacteristics | Subject deviceA8 Anesthesia SystemShenzhen MindrayBio-MedicalElectronics Co., Ltd.(Subject device) | Subject deviceA9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.(Subject device) | Primary predicateA7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co.,Ltd.(K171292) |
| CO2 accuracy | 0% to 1%: ±0.1%1% to 5%: ±0.2%5% to 7%: ±0.3%7% to 10%: ±0.5%>10%: Unspecified | 0% to 1%: ±0.1%1% to 5%: ±0.2%5% to 7%: ±0.3%7% to 10%: ±0.5%>10%: Unspecified | 0% to 1%: ±0.1%1% to 5%: ±0.2%5% to 7%: ±0.3%7% to 10%: ±0.5%>10%: Unspecified |
| O2 accuracy | 0% to 25%: ±1%25% to 80%: ±2%80% to 100%: ±3% | 0% to 25%: ±1%25% to 80%: ±2%80% to 100%: ±3% | 0% to 25%: ±1%25% to 80%: ±2%80% to 100%: ±3% |
| N2O accuracy | 0% to 20%: ±2%20% to 100%: ±3% | 0% to 20%: ±2%20% to 100%: ±3% | 0% to 20%: ±2%20% to 100%: ±3% |
| HAL, ENF, ISOaccuracy | 0% to 1%: ±0.15%1% to 5%: ±0.2%>5%: Unspecified | 0% to 1%: ±0.15%1% to 5%: ±0.2%>5%: Unspecified | 0% to 1%: ±0.15%1% to 5%: ±0.2%>5%: Unspecified |
| SEV accuracy | 0% to 1%: ±0.15%1% to 5%: ±0.2%5% to 8%: ±0.4%>8%: Unspecified | 0% to 1%: ±0.15%1% to 5%: ±0.2%5% to 8%: ±0.4%>8%: Unspecified | 0% to 1%: ±0.15%1% to 5%: ±0.2%5% to 8%: ±0.4%>8%: Unspecified |
| DES accuracy | 0% to 1%: ±0.15%1% to 5%: ±0.2%5% to 10%: ±0.4%10% to 15%: ±0.6%15% to 18%: ±1%>18%: Unspecified | 0% to 1%: ±0.15%1% to 5%: ±0.2%5% to 10%: ±0.4%10% to 15%: ±0.6%15% to 18%: ±1%>18%: Unspecified | 0% to 1%: ±0.15%1% to 5%: ±0.2%5% to 10%: ±0.4%10% to 15%: ±0.6%15% to 18%: ±1%>18%: Unspecified |
| RR accuracy | 2 to 60bpm: ±1bpm61 to 100bpm: ±2bpm | 2 to 60bpm: ±1bpm61 to 100bpm: ±2bpm | 2 to 60bpm: ±1bpm61 to 100bpm: ±2bpm |
| Specifications - Oxygen Cell | |||
| Oxygen Cell | Galvanic Fuel cell | Galvanic Fuel cell | |
| Measurement range | 18% to 100% | 18% to 100% | |
| Measurementaccuracy | ±(volume percent of 2.5%+2.5% of gas level) | ±(volumefractionof2.5%+2.5% gas level) | |
| Specifications - Negative Pressure Suction Device | |||
| ContinuousNegative PressureSuction | Yes | Yes | Yes |
| TechnicalCharacteristics | Subject deviceA8 Anesthesia SystemShenzhen MindrayBio-MedicalElectronics Co., Ltd.(Subject device) | Subject deviceA9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.(Subject device) | Primary predicateA7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co.,Ltd.(K171292) |
| Performancecategory | Pharyngeal Suction | Pharyngeal Suction | |
| Maximum vacuum | 69 to 72kPa (517.5 to 540mmHg) with external vacuumapplied of 72kPa (540mmHg) and 40L/min free flow | 69 to 72kPa (517.5 to540mmHg) with externalvacuum applied of 72kPa(540mmHg) and 40L/min freeflow | |
| Maximum flow | 39 to 40L/min with external vacuum applied of 72kPa(540mmHg) and 40L/min free flow | 39 to 40L/min with externalvacuum applied of 72kPa(540mmHg) and 40L/min freeflow | |
| Minimum flow | 20L/min | 20L/min | |
| Vacuum gaugeaccuracy | ±5% of full scale | ±5% of full scale | |
| Specifications - Agent usage calculation | |||
| Anestheticagents(AA) | IsofluraneSevofluraneDesfluraneHalothane | IsofluraneSevofluraneDesflurane | IsofluraneSevofluraneDesfluraneHalothaneEnflurane |
| Agent usage speedrange | IsofluraneandHalothane: 0 to250mL/hSevoflurane: 0 to450mL/hDesflurane: 0 to900mL/h | Isoflurane: 0 to 250mL/hSevoflurane: 0 to 450mL/hDesflurane: 0 to 900mL/h | Enflurane,Isoflurane andHalothane: 0 to 250mL/hSevoflurane: 0 to 450mL/hDesflurane: 0 to 900mL/h |
| Agent usage speedaccuracy | ±2mL/h or ±15% of the actual reading, whichever isgreater | ±2mL/h or ±25% of thedisplayed value, whichever isgreater | |
| Agent total usagerange | 0 to 3000mL | 0 to 3000mL | |
| Specifications - Data from the patient monitor to support the optimizer and the agent usage calculation functions | |||
| Agent total usageaccuracy | ±2mL or ±15% of the actual reading, whichever isgreater | ±2mL or ±25% of thedisplayed value, whichever isgreater | |
| TechnicalCharacteristics | Subject deviceA8 Anesthesia System | Subject deviceA9 Anesthesia System | Primary predicateA7 Anesthesia System |
| Shenzhen MindrayBio-MedicalElectronics Co., Ltd.(Subject device) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd.(Subject device) | Shenzhen Mindray Bio-Medical Electronics Co.,Ltd.(K171292) | |
| Receive data fromthe patient monitorto support theoptimizer functionand the agent usagecalculationfunction | Receive data from the Anesthetic Gas Module plugged intothe Passport 12M/17M patient monitor (K190011) to supportthe optimizer function and the agent usage calculationfunction | Receive data from the Anesthetic Gas Module plugged intothe Passport 12M/17M patient monitor (K190011) to supportthe optimizer function and the agent usage calculationfunction | Receive data from theAnesthetic Gas Moduleplugged into thePassport12M/17Mpatient monitor(K190011) to supporttheoptimizer function andthe agentusagecalculationfunction |
| Specifications - Internal Battery | |||
| Battery | Sealed lead acid battery | Li-Ion (sealed) battery | |
| Capacity | One or two batteries16Ah×1 pcs16Ah×2 pcs (Optional) | Two batteries16Ah×2 pcs | Two batteries4.5Ah×2 pcs |
| Operating time(Typical) | ≥90min (1 pcs)≥180min (2 pcs) | ≥90min | ≥90min |
| Operating time(Maximum) | ≥50min (1 pcs)≥100min (2 pcs) | ≥50min | ≥60min |
| Specifications - Other | |||
| AuxiliaryWorktable | Available | Available | Available |
| Top shelf | Available | Available | Available |
| Monitor bracket | Available | Available | Available |
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In conclusion, there are five technological differences between the subject device (A8, A9 Anesthesia System) and the primary predicate A7 Anesthesia System (K171292):
- Change the Vaporizer Type and the addition of Electronic Vaporizers (A9)
- Change certain parameters of the ventilator modes ●
- Addition of the High Flow Nasal Cannula Oxygen (HFNC)
- Change the Anesthetic Gas Module and Accessories .
- Addition of the Sealed Lead Acid Battery
The differences in technological characteristics do not raise new questions of safety and effectiveness.
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8. PERFORMANCE DATA
To establish the substantial equivalence of the A8, A9 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 A8, A9 Anesthesia System were 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 cvtotoxicitv
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation ● and skin sensitization
- ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical ● characterization of medical device materials within a risk management process
- ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare . applications - Part 2: Tests for emissions of particulate matter
- . ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification of the A8, A9 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 A8, A9 Anesthesia System were assessed for conformity with the relevant requirements of the following standards and found to comply:
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- ANSI/AAMI 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 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-8 Edition 2.1 2012-11 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 First edition 2011-08-11 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [including: Amendment 1 2015-03-01 and Amendment 2 2018-07]
- ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Bench Testing
To establish the substantial equivalence of the A8, A9 Anesthesia System. Mindray conducted functional and system level testing to validate the performance of the devices. 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.
- ASTM F1101-90 (Reapproved 2003) Standard Specification for Ventilators Intended for ● Use During Anesthesia
- IEC 60601-1-6 Edition 3.1 2013-10 General requirements for basic safety and essential ● performance - Collateral standard: Usability
- IEC 60601-1-8:2012 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 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers Agent-specific filling . systems
- ISO 10079-3 Third edition 2014-05-01 Medical suction equipment Part 3: Suction ● equipment powered from a vacuum or positive pressure gas source
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- . ISO 80601-2-13:2011/ Amd.1:2015/Amd.2:2018 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
- ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment Part 2-55: Particular ● requirements for the basic safety and essential performance of respiratory gas monitors
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 A8, A9 Anesthesia System can be found substantially equivalent to the predicate devices.
§ 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).