A8, A9 Anesthesia System

K201957 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · BSZ · Mar 26, 2021 · Anesthesiology

Device Facts

• Record ID: K201957
• Device Name: A8, A9 Anesthesia System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: BSZ · Anesthesiology
• Decision Date: Mar 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

A8/A9 Anesthesia System: continuous flow inhalation gas anesthesia workstation; delivers anesthetic vapor; provides automatic/manual ventilation. Inputs: O2, CO2, N2O, anesthetic agents (Desflurane, Isoflurane, Halothane, Sevoflurane); patient physiological data via integrated Anesthetic Gas Module (AGM) and patient monitor. Operation: clinician-controlled via interface; electronic flowmeters; electronic vaporizer (A9); automatic ventilation modes (VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, SIMV-VG, PS, CPAP/PS, APRV). Outputs: anesthetic gas delivery, ventilation support, monitoring data (gas concentrations, airway pressure, flow, volume). Used in operating rooms by licensed clinicians. Benefits: precise anesthetic delivery, respiratory support, and integrated monitoring for patient safety during surgery.

Clinical Evidence

Bench testing only. No clinical data presented. Functional and system-level testing validated performance against specifications and consensus standards (ISO 10993, ISO 18562, ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-13, ISO 80601-2-55, ASTM F1101-90).

Technological Characteristics

Anesthesia workstation; gas delivery via electronic flowmeters; electronic vaporizer (A9); sealed lead acid battery; integrated AGM; HFNC capability. Materials comply with ISO 10993 and ISO 18562. Connectivity: integrated with patient monitor (Passport 12M/17M). Standards: ISO 80601-2-13 (anesthetic workstation), ISO 80601-2-55 (gas monitors), IEC 60601-1-8 (alarms).

Indications for Use

Indicated for administration of general inhalation anesthesia and maintenance of ventilation in adult, pediatric, and neonate patients in healthcare facilities. HFNC indicated for delivery of nasal high flow oxygen to spontaneously breathing adult patients 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

• A7 Anesthesia System (K171292)
• BeneVision N Series Patient Monitors (K192972)

Reference Devices

• Flow-i Anesthesia System C20/C30/C40 (K160665)
• Carestation 620/650/650C (K151570)
• Evita XL Ventilator (K083050)
• HAMILTON-G5 (K180295)
• Passport 12M/17M patient monitor (K190011)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>Shenzhen 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone] |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact Person: Yanhong Bai<br>Title: Manager Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| 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<br>Number/Class | Product<br>Code | Regulation description | Device Common Name |
| 868.1400, II | CCK | Carbon Dioxide Gas Analyzer | Carbon Dioxide Gas Analyzer |
| 868.1500, II | NHO/CB<br>Q/NHQ/<br>NHP | Enflurane gas analyzer | Enflurane gas analyzer |

#### Table 1· Product Code

{4}------------------------------------------------

| Regulation<br>Number/Class | Product<br>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<br>Characteristics | Subject device<br>A8 Anesthesia System<br>Shenzhen Mindray<br>Bio-Medical<br>Electronics Co., Ltd.<br>(Subject device) | Subject device<br>A9 Anesthesia System<br>Shenzhen Mindray Bio-<br>Medical Electronics Co., Ltd.<br>(Subject device) | Primary predicate<br>A7 Anesthesia System<br>Shenzhen Mindray Bio-<br>Medical Electronics Co.,<br>Ltd.<br>(K171292) |
|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connection Type | Double, Selectatec®,<br>with interlocking<br>function | Double, Insertion type<br>connection, with interlocking<br>function | Two or three, Selectatec®,<br>with interlocking function |
| | - | Working with an electronic based<br>injector | - |
| Electronic<br>Vaporizer | - | Applicable anesthetic agent:<br>Isoflurane<br>Sevoflurane<br>Desflurane | - |
| | - | Filling method:<br>Isoflurane (Safety filling adapter)<br>Sevoflurane<br>(Safety filling<br>adapter)<br>Sevoflurane (Quik-fil)<br>Desflurane (Saf-T-Fill) | - |
| | - | Setting range:<br>Isoflurane: 0.0% to 5.0%<br>Sevoflurane: 0.0% to 8.0%<br>Desflurane: 0.0% to 18.0% | - |
| | - | Accuracy: ±15% of the setting<br>value or ±5% of the maximum<br>setting value, whichever is<br>greater | - |
| Anesthetic agent -<br>Sevoflurane | - | Yes | Yes |
| Anesthetic agent -<br>Isoflurane | Yes | | Yes |
| Anesthetic agent -<br>Desflurane | Yes | | Yes |
| Anesthetic agent -<br>Halothane | Yes | - | Yes |
| <b>Working Mode</b> | - | - | - |
| Standby mode | - | Yes | Yes |
| Manual Ventilation<br>mode | - | Yes | Yes |
| Automatic<br>Ventilator mode | - | Yes | Yes |
| Technical<br>Characteristics | Subject device<br>A8 Anesthesia System<br>Shenzhen Mindray<br>Bio-Medical<br>Electronics Co., Ltd.<br>(Subject device) | Subject device<br>A9 Anesthesia System<br>Shenzhen Mindray Bio-<br>Medical Electronics Co., Ltd.<br>(Subject device) | Primary predicate<br>A7 Anesthesia System<br>Shenzhen Mindray Bio-<br>Medical Electronics Co.,<br>Ltd.<br>(K171292) |
| Lung Recruitment<br>Ventilation | Yes | Yes | Yes |
| Cardiac Bypass<br>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<br>range | 10 to 2000mL (VCV, SIMV-VC)<br>5 to 2000mL (PCV-VG, SIMV-VG) | | 20 to 1500mL |
| Inspiratory<br>Pressure range | 5 to 90cmH2O | | 5 to 70cmH2O |
| Support Pressure<br>range | 0, 3 to 60cmH2O | | OFF, 3 to 50cmH2O |
| Apnea Pressure<br>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<br>Characteristics | Subject device<br>A8 Anesthesia System<br>Shenzhen Mindray<br>Bio-Medical<br>Electronics Co., Ltd.<br>(Subject device) | Subject device<br>A9 Anesthesia System<br>Shenzhen Mindray Bio-<br>Medical Electronics Co., Ltd.<br>(Subject device) | Primary predicate<br>A7 Anesthesia System<br>Shenzhen Mindray Bio-<br>Medical Electronics Co.,<br>Ltd.<br>(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…