(255 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional anesthesia system components and functionalities.
Yes.
This device is designed to administer general inhalation anesthetic and maintain a patient's ventilation, and also includes High Flow Nasal Cannula for oxygen delivery, all of which are interventions aimed at treating or alleviating medical conditions or symptoms.
No
Explanation: The device is described as an "anesthesia system" that administers anesthetic and maintains ventilation. While it incorporates monitoring of physiological parameters like O2, CO2, N2O, and anesthetic agent concentrations, its primary stated purpose is therapeutic (administering anesthesia and maintaining ventilation), not diagnostic. The monitoring features are for guiding and ensuring the correct administration of anesthesia, not for diagnosing a patient's condition.
No
The device description clearly states it is a "continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation," indicating it is a hardware device with integrated software.
Based on the provided text, the A8, A9 Anesthesia System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is to administer anesthetic gases and maintain patient ventilation. This is a direct interaction with the patient's respiratory system and circulatory system (via gas exchange), not the examination of specimens derived from the human body.
- Device Description: The description focuses on the delivery of gases, ventilation modes, and monitoring of gas concentrations within the system and the patient's breathing circuit. While it monitors O2, CO2, N2O, and anesthetic agent concentrations, this monitoring is for controlling the delivery of these substances to the patient, not for diagnosing a condition based on the analysis of a biological sample.
- Lack of IVD Characteristics: The text does not mention any analysis of biological specimens (blood, urine, tissue, etc.) or the use of reagents, calibrators, or controls typically associated with IVD devices.
Therefore, the A8, A9 Anesthesia System falls under the category of a therapeutic and monitoring device used directly on the patient, not an IVD device used to examine specimens from the patient.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
BSZ, CCK, NHO, CBQ, NHP, CBS, CBR, CCL, KDP, NHQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonate populations. High Flow Nasal Cannula (HFNC) is indicated for use in adults only.
Intended User / Care Setting
licensed clinicians within a health care facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K160665, K151570, K083050, K180295
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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
1
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
2
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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3
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-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: Yanhong Bai
Title: Manager Regulatory Affairs
Phone: +86 755 81885635
Fax: +86 755 26582680
E-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 | |||
|---|---|---|---|
| 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/CB | ||
| Q/NHQ/ | |||
| NHP | Enflurane gas analyzer | Enflurane gas analyzer |
Table 1· Product Code
4
| Regulation
Number/Class | Product
Code | 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.
5
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.
6
| Technical
Characteristics | Subject device
A8 Anesthesia System
Shenzhen Mindray
Bio-Medical
Electronics Co., Ltd.
(Subject device) | Subject device
A9 Anesthesia System
Shenzhen Mindray Bio-
Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
A7 Anesthesia System
Shenzhen Mindray Bio-
Medical Electronics Co.,
Ltd.
(K171292) |
|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connection Type | Double, Selectatec®,
with interlocking
function | Double, Insertion type
connection, with interlocking
function | Two or three, Selectatec®,
with interlocking function |
| | - | Working with an electronic based
injector | - |
| Electronic
Vaporizer | - | Applicable anesthetic agent:
Isoflurane
Sevoflurane
Desflurane | - |
| | - | Filling method:
Isoflurane (Safety filling adapter)
Sevoflurane
(Safety filling
adapter)
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 setting
value or ±5% of the maximum
setting value, whichever is
greater | - |
| 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 Ventilation
mode | - | Yes | Yes |
| Automatic
Ventilator mode | - | Yes | Yes |
| Technical
Characteristics | Subject device
A8 Anesthesia System
Shenzhen Mindray
Bio-Medical
Electronics Co., Ltd.
(Subject device) | Subject device
A9 Anesthesia System
Shenzhen Mindray Bio-
Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
A7 Anesthesia System
Shenzhen Mindray Bio-
Medical Electronics Co.,
Ltd.
(K171292) |
| Lung Recruitment
Ventilation | Yes | Yes | Yes |
| Cardiac Bypass
mode | 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 Volume
range | 10 to 2000mL (VCV, SIMV-VC)
5 to 2000mL (PCV-VG, SIMV-VG) | | 20 to 1500mL |
| Inspiratory
Pressure range | 5 to 90cmH2O | | 5 to 70cmH2O |
| Support Pressure
range | 0, 3 to 60cmH2O | | OFF, 3 to 50cmH2O |
| Apnea Pressure
range | 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 |
| Technical
Characteristics | Subject device
A8 Anesthesia System
Shenzhen Mindray
Bio-Medical
Electronics Co., Ltd.
(Subject device) | Subject device
A9 Anesthesia System
Shenzhen Mindray Bio-
Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
A7 Anesthesia System
Shenzhen 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 |
| Maximum
Inspiratory flow | 180L/min | 180L/min | 180L/min |
| Specifications - Anesthetic Ventilator monitoring parameter | | | |
| Tidal Volume
range | 0 to 3000mL | 0 to 3000mL | 0 to 3000mL |
| Minute Volume
range | 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 Pressure
Adjust |
| Step range | OFF, 1 to 7 | OFF, 1 to 7 | OFF, 1 to 7 |
| Breaths | 3 to 10 | 3 to 10 | 3 to 10 |
| Technical
Characteristics | Subject device
A8 Anesthesia System
Shenzhen Mindray
Bio-Medical
Electronics Co., Ltd.
(Subject device) | Subject device
A9 Anesthesia System
Shenzhen Mindray Bio-
Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
A7 Anesthesia System
Shenzhen 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 Minute
Volume Alarm | Yes | Yes | Yes |
| High/Low Tidal
Volume Alarm | Yes | Yes | Yes |
| High/Low RR
Alarm | Yes | Yes | Yes |
| High/Low Airway
Pressure Alarm | Yes | Yes | Yes |
| Pressure Limiting
Alarm | Yes | Yes | Yes |
| Sub Atmospheric
Pressure Alarm | Yes | Yes | Yes |
| Continuous Airway
Pressure Alarm | Yes | Yes | Yes |
| Apnea Alarm | Yes | Yes | Yes |
| Apnea >2 Minute
Alarm | Yes | Yes | Yes |
| Apnea CO2 Alarm | Yes | Yes | Yes |
| High/Low FiO2
Alarm | 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 |
| Pressure
monitoring 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) for
O2, N2O, Air |
| Pressure
monitoring
accuracy | ±(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 scale
reading+8% of the actual
reading) |
| Backup Cylinder
supply | 6.9 to 20.0MPa (1000 to 2900PSI) for O2, Air
4.2 to 6.0MPa (600 to 870PSI) for N2O | 6.9 to 20.0MPa (1000 to 2900PSI) for O2, Air
4.2 to 6.0MPa (600 to 870PSI) for N2O | 6.9 to 15.5MPa (1000 to
2250PSI) for O2, Air
4.2 to 6MPa (600 to 870PSI)
for N2O |
| Technical
Characteristics | Subject device
A8 Anesthesia System
Shenzhen Mindray
Bio-Medical
Electronics Co., Ltd.
(Subject device) | Subject device
A9 Anesthesia System
Shenzhen Mindray Bio-
Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
A7 Anesthesia System
Shenzhen Mindray Bio-
Medical Electronics Co.,
Ltd.
(K171292) |
| Connector type | Pin-index of E cylinder | Pin-index of E cylinder | Pin-index of E cylinder |
| Pressure
monitoring range | 0 to 25MPa (0 to 3500PSI) for O2, Air
0 to 10MPa (0 to 1400PSI) for N2O | 0 to 25MPa (0 to 3500PSI) for O2, Air
0 to 10MPa (0 to 1400PSI) for N2O | 0 to 25MPa (0 to 3500PSI) for
O2, Air
0 to 10MPa (0 to 1400PSI) for
N2O |
| Pressure
monitoring
accuracy | ±(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 scale
reading+8% of the actual
reading) |
| Specifications – Fresh Gas | | | |
| Electronic
Flowmeter - Direct
Flow Control
Mode | O2 flow range: 0, 0.2 to 15.0L/min
N2O flow range: 0 to 12L/min
Air flow range: 0 to 15L/min
O2 flow accuracy: ±50ml/min or ±5% of the setting value,
whichever is greater
Balance gas (Air/N2O) flow accuracy: ±50ml/min or ±5% of
the setting value, whichever is greater | O2 flow range: 0 to 15L/min
N2O flow range: 0 to 12L/min
Air flow range: 0 to 15L/min
O2 flow accuracy: ±50ml/min or ±5% of setting value,
whichever is greater
Balance gas (Air/N2O) flow accuracy: ±50ml/min or ±5% of
the setting value, whichever is greater | O2 flow range: 0 to 15L/min
N2O flow range: 0 to 12L/min
Air flow range: 0 to 15L/min
O2 flow accuracy: ±50ml/min
or ±5% of setting value,
whichever is greater
Balance gas (Air/N2O) flow
accuracy: ±50ml/min or ±5%
of setting value, whichever is
greater |
| Electronic
Flowmeter - Total
Flow Control
Mode | Total Flow Control Mode:
Total flow range: 0, 0.2 to 20.0L/min
Total flow accuracy: ±100ml/min or ±5% of the setting
value, whichever is greater
O2 concentration range:
21% to 100% (Balance gas is Air)
26% to 100% (Balance gas is N2O)
O2 concentration accuracy:
Volume fraction of ±5% (Flow 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, ISO
accuracy | 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: ±1bpm
61 to 100bpm: ±2bpm | 2 to 60bpm: ±1bpm
61 to 100bpm: ±2bpm | 2 to 60bpm: ±1bpm
61 to 100bpm: ±2bpm |
| Specifications - Oxygen Cell | | | |
| Oxygen Cell | Galvanic Fuel cell | | Galvanic Fuel cell |
| Measurement range | 18% to 100% | | 18% to 100% |
| Measurement
accuracy | ±(volume percent of 2.5%+2.5% of gas level) | | ±(volume
fraction
of
2.5%+2.5% gas level) |
| Specifications - Negative Pressure Suction Device | | | |
| Continuous
Negative Pressure
Suction | Yes | Yes | Yes |
| Technical
Characteristics | Subject device
A8 Anesthesia System
Shenzhen Mindray
Bio-Medical
Electronics Co., Ltd.
(Subject device) | Subject device
A9 Anesthesia System
Shenzhen Mindray Bio-
Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
A7 Anesthesia System
Shenzhen Mindray Bio-
Medical Electronics Co.,
Ltd.
(K171292) |
| Performance
category | Pharyngeal Suction | | Pharyngeal Suction |
| Maximum vacuum | 69 to 72kPa (517.5 to 540mmHg) with external vacuum
applied of 72kPa (540mmHg) and 40L/min free flow | | 69 to 72kPa (517.5 to
540mmHg) with external
vacuum applied of 72kPa
(540mmHg) and 40L/min free
flow |
| Maximum flow | 39 to 40L/min with external vacuum applied of 72kPa
(540mmHg) and 40L/min free flow | | 39 to 40L/min with external
vacuum applied of 72kPa
(540mmHg) and 40L/min free
flow |
| Minimum flow | 20L/min | | 20L/min |
| Vacuum gauge
accuracy | ±5% of full scale | | ±5% of full scale |
| Specifications - Agent usage calculation | | | |
| Anesthetic
agents(AA) | Isoflurane
Sevoflurane
Desflurane
Halothane | Isoflurane
Sevoflurane
Desflurane | Isoflurane
Sevoflurane
Desflurane
Halothane
Enflurane |
| Agent usage speed
range | Isoflurane
and
Halothane: 0 to
250mL/h
Sevoflurane: 0 to
450mL/h
Desflurane: 0 to
900mL/h | Isoflurane: 0 to 250mL/h
Sevoflurane: 0 to 450mL/h
Desflurane: 0 to 900mL/h | Enflurane,
Isoflurane and
Halothane: 0 to 250mL/h
Sevoflurane: 0 to 450mL/h
Desflurane: 0 to 900mL/h |
| Agent usage speed
accuracy | ±2mL/h or ±15% of the actual reading, whichever is
greater | | ±2mL/h or ±25% of the
displayed value, whichever is
greater |
| Agent total usage
range | 0 to 3000mL | | 0 to 3000mL |
| Specifications - Data from the patient monitor to support the optimizer and the agent usage calculation functions | | | |
| Agent total usage
accuracy | ±2mL or ±15% of the actual reading, whichever is
greater | ±2mL or ±25% of the
displayed value, whichever is
greater | |
| Technical
Characteristics | Subject device
A8 Anesthesia System | Subject device
A9 Anesthesia System | Primary predicate
A7 Anesthesia System |
| | 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.
(K171292) |
| Receive data from
the patient monitor
to support the
optimizer function
and the agent usage
calculation
function | Receive data from the Anesthetic Gas Module plugged into
the Passport 12M/17M patient monitor (K190011) to support
the optimizer function and the agent usage calculation
function | Receive data from the Anesthetic Gas Module plugged into
the Passport 12M/17M patient monitor (K190011) to support
the optimizer function and the agent usage calculation
function | Receive data from the
Anesthetic Gas Module
plugged into the
Passport
12M/17M
patient monitor
(K190011) to support
the
optimizer function and
the agent
usage
calculation
function |
| Specifications - Internal Battery | | | |
| Battery | Sealed lead acid battery | | Li-Ion (sealed) battery |
| Capacity | One or two batteries
16Ah×1 pcs
16Ah×2 pcs (Optional) | Two batteries
16Ah×2 pcs | Two batteries
4.5Ah×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 | | | |
| Auxiliary
Worktable | Available | Available | Available |
| Top shelf | Available | Available | Available |
| Monitor bracket | Available | Available | Available |
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8
9
10
11
12
13
14
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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:
17
- 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.