(255 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard anesthesia system functionalities and monitoring.
Yes
The device is used to administer anesthesia and maintain ventilation, which are direct interventions for medical conditions or procedures, aligning with the definition of a therapeutic device.
No
Explanation: The A5 Anesthesia System is described as a device used to administer anesthetic and maintain patient ventilation. While it incorporates monitoring of various gas concentrations (O2, CO2, N2O, and Agent), this monitoring is for the purpose of controlling and delivering anesthesia, not primarily for diagnosing a medical condition. Its intended use explicitly states "administer to a patient... a general inhalation anesthetic and to maintain a patient's ventilation," which are therapeutic and supportive functions, not diagnostic.
No
The device description clearly states it is a "continuous flow inhalation gas anesthesia system" and mentions hardware components like gas monitoring and ventilation modes. The performance studies also include testing of hardware aspects like power supply, thermal, and heating modules, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation." This describes a device used on a patient for treatment and life support, not a device used to examine specimens from a patient to provide diagnostic information.
- Device Description: The description focuses on the delivery of anesthetic gases and ventilation, along with monitoring of gases within the system and the patient's breathing circuit. It does not mention analyzing biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: The description and performance studies do not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens.
- Providing diagnostic information about a patient's health status.
- Use of reagents or assays.
The A5 Anesthesia System is a medical device used for anesthesia delivery and ventilation, which are therapeutic and life-support functions performed directly on the patient.
N/A
Intended Use / Indications for Use
The A5 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
The A5 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric (including neonate, infant, child and adolescent) populations.
Product codes
BSZ, CCK, NHO, CBQ, NHQ, NHP, CBS, CBR, CCI
Device Description
The A5 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A5 incorporates 02, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane).
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 and pediatric (including neonate, infant, child and adolescent) populations.
Intended User / Care Setting
licensed clinicians, for patients requiring anesthesia 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)
Nonclinical testing and Performance:
The following areas have been tested:
- Software .
- o Unit testing
- Integration testing O
- System testing o
- Performance ●
- Power Supply O
- Thermal O
- Cleaning and Disinfection O
- Fresh Flow Optimizer O
- o AG Module
- Heating Module O
- o Waveform Comparison
- Biocompatibility ●
- Volatile Organic Compounds O
- Particulate Testing O
- o Cytotoxicity
- Sensitization O
- Irritation / intracutaneous reactivity O
- Extractables and leachables (E&L) testing o
- Inorganic gases (03, 02, CO2, NO2) testing O
- Human Factors Validation Testing ●
- Testing as per consensus standards:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, ,C1:2009/(R)2012 and O A2:2010/(R)2012 Medical electrical equipment - Part 1: General Requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 3: 2007 Medical electrical equipment Part 1-2: General o requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment Part 2- O 13: Particular requirements for basic safety and essential performance of an anesthetic workstation
- ISO 80601-2-55 First edition 2011-12-15 Medical electrical equipment -Part 2-55: o Particular requirements for the basic safety and essential performance of respiratory gas monitors
- ASTM F1101-90 (Reapproved 2003) Standard Specification for Ventilators O Intended for Use During Anesthesia
- AIM 7351731 medical electrical equipment and system electromagnetic O immunity test for exposure to radio frequency identification readers - an aim standard. (General II (ES/EMC))
The functional and system level testing showed that the device continues to meet specifications and the performance of the device is equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K151954, K083050, K110213, K132530
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 12, 2018
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Builday, Keji 12th Road South, Hi-tech Industrial Park, Shenzhen, 518057 China
Re: K171311
Trade/Device Name: A5 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, NHQ, NHP, CBS, CBR, CCL Dated: December 8, 2017 Received: December 11, 2017
Dear Yanhong Bai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tara A. Ryan -
S
Digitally signed by Tara A. Ryan -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Tara A. Ryan -S,
0.9.2342.19200300.100.1.1=1300030749
Date: 2018.01.12 09:06:21-05'00'
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171311
Device Name A5 Anesthesia System
Indications for Use (Describe)
The A5 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
The A5 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric (including neonate, infant, child and adolescent) populations.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the A5 Anesthesia System is provided below.
| Device Common Name: | Gas-Machine, Anesthesia |
|---|---|
| Device Proprietary Name: | A5 Anesthesia System |
| Submitter: | 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 81885635 | |
| Fax: +86 755 26582680 | |
| Contact: | Yanhong Bai |
| Manager Regulatory Affairs | |
| SHENZHEN MINDRAY BIO-MEDICAL | |
| ELECTRONICS CO., LTD. | |
| Mindray Building, Keji 12th Road South | |
| High-tech Industrial Park, Nanshan | |
| 518057, P.R. China | |
| Tel: +86 755 81885635 | |
| Fax: +86 755 26582680 | |
| E-mail: baiyanhong@mindray.com | |
| Date Prepared: | December 6th, 2017 |
| Panel: | Anesthesiology |
| Classification Regulation and Product Code: | Primary: |
| 868.5160- BSZ Anesthesia Gas Machine Class II | |
| Secondary: | |
| 868.1400 - CCK - Carbon Dioxide Gas Analyzer | |
| 868.1500 – NHO/CBQ/NHQ/NHP - Enflurane gas analyzer | |
| 868.1620 – CBS - Halothane Gas Analyzer | |
| 868.1700 - CBR - Nitrous Oxide Gas Analyzer | |
| 868.1720 - CCI - Oxygen Gas Analyzer |
4
| 510(k) number | Trade or proprietor or model
name | Manufacturer |
|---------------|--------------------------------------|--------------------------------------------------------|
| K123211 | A5 Anesthesia Delivery System | Shenzhen Mindray Bio-
Medical Electronics Co., Ltd. |
Predicate Device:
Reference Devices:
| 510(k) number | Trade or proprietor or model
name | Manufacturer |
|---------------|--------------------------------------|--------------------------------------------------------|
| K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-
Medical Electronics Co., Ltd. |
| K083050 | Evita XL Ventilator | Dräger Medical AG & Co. KG |
| K110213 | GE Datex-Ohmeda Aisys | Datex-Ohmeda Inc. |
| K132530 | GE Datex-OhmedaAisys CS2 | Datex-Ohmeda Inc. |
Indication for Use:
The A5 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
The A5 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric (including neonate, infant, child and adolescent) populations.
Device Description:
The A5 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A5 incorporates 02, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane).
Nonclinical testing and Performance:
The following areas have been tested:
- Software .
- o Unit testing
- Integration testing O
- System testing o
- Performance ●
5
- Power Supply o
- Thermal O
- Cleaning and Disinfection O
- Fresh Flow Optimizer O
- o AG Module
- Heating Module O
- o Waveform Comparison
- Biocompatibility ●
- Volatile Organic Compounds O
- Particulate Testing O
- o Cytotoxicity
- Sensitization O
- Irritation / intracutaneous reactivity O
- Extractables and leachables (E&L) testing o
- Inorganic gases (03, 02, CO2, NO2) testing O
- Human Factors Validation Testing ●
- Testing as per consensus standards:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, ,C1:2009/(R)2012 and O A2:2010/(R)2012 Medical electrical equipment - Part 1: General Requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 3: 2007 Medical electrical equipment Part 1-2: General o requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment Part 2- O 13: Particular requirements for basic safety and essential performance of an anesthetic workstation
- ISO 80601-2-55 First edition 2011-12-15 Medical electrical equipment -Part 2-55: o Particular requirements for the basic safety and essential performance of respiratory gas monitors
- ASTM F1101-90 (Reapproved 2003) Standard Specification for Ventilators O Intended for Use During Anesthesia
- AIM 7351731 medical electrical equipment and system electromagnetic O immunity test for exposure to radio frequency identification readers - an aim standard. (General II (ES/EMC))
6
The functional and system level testing showed that the device continues to meet specifications and the performance of the device is equivalent to the predicate.
Substantial Equivalence:
Comparison of Indications
Both the predicate device and the subject A5 Anesthesia System are gas anesthesia machine used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The indications for use of the subject device (A5 Anesthesia System) have been modified to add the definition of the pediatric population subgroup. All of the pediatric population subgroup was cleared in the predicate device A5 Anesthesia Delivery System (K123211). In conclusion, the minor changes to the indications for use do not change the intended use of the A5 Anesthesia System.
7
Comparison of Technological Characteristics:
The table below compares the key technological feature of the subject device to the predicate device (A5 Anesthesia Delivery System (K123211)).
Device Comparison Table
| | Technical
Characteristics | Subject Device
A5 Anesthesia System | Predicate Device
A5 Anesthesia Delivery System
(K123211) |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| | Vaporizers | Two or Three, variable bypass | Two or three, variable bypass |
| | Agent - Sevoflurane | Yes | Yes |
| | Agent - Isoflurane | Yes | Yes |
| | Agent - Desflurane | Yes | Yes |
| | Agent - Halothane | Yes | Yes |
| | Agent - Enflurane | Yes | Yes |
| | Automatic Ventilator | Yes | Yes |
| | Bellows | Yes | Yes |
| | Bellows Volume | 1500mL | 1500mL |
| Ventilation Modes | VCV | Yes | Yes |
| | PCV | Yes | Yes |
| | PCV-VG | Yes | Yes |
| | SIMV-VC | Yes | Yes |
| | SIMV-PC | Yes | Yes |
| | PS | Yes | Yes |
| Specifications | Tidal Volume | Yes | Yes |
| | Range, ml | 20 to 1500 | 20 to 1500 |
| | Minute Volume | Yes | Yes |
| | Rate, bpm | 4 to 100 bpm | 4 to 100 bpm |
| | I:E Ratio | 4:1 to 1:8 with 0.5 increment | 4:1 to 1:8 with 0.5 increment |
| | Inspiratory Pause | Off, 5 to 60% of insp. Period | Off, 5 to 60% of insp. Period |
| Fresh Gas | Air Flow Range | 0 to 15 L/min | 0 to 15 L/min |
| | N2O Flow Range | 0 to 12 L/min | 0 to 12 L/min |
| | O2 Flow Range | 0 to 15 L/min | 0 to 15 L/min |
| Technical
Characteristics | Subject Device
A5 Anesthesia System | Predicate Device
A5 Anesthesia Delivery System
(K123211) | |
| Individual Gas Flow
Accuracy | ±50 ml/min or ±5% of setting
value, whichever is greater | ±50 ml/min or ±5% of setting
value, whichever is greater | |
| Pressure Limit, cm H2O | 0 to 100 cm H2O | 0 to 100 cm H2O | |
| PEEP, cm H2O | Off, 3 to 30, 1 cm H2O increment | Off, 3 to 30, 1 cm H2O increment | |
| System Checks | Auto at start | Auto at start | |
| Airway Pressure Measured at | Inspiratory | Inspiratory | |
| High/Low Airway Pressure Alarm | Yes | Yes | |
| Pressure Limiting Alarm | Yes | Yes | |
| Sub Atmospheric Pressure Alarm | Yes | Yes | |
| Continuous Press Alarm | Yes | Yes | |
| Apnea >2 Minute Alarm | Yes | Yes | |
| Apnea Alarm | Yes | Yes | |
| High/Low Minute Volume Alarm | Yes | Yes | |
| High/Low O2 Concentration Alarm | Yes | Yes | |
| Type of O2 Sensor | Paramagnetic or
Galvanic fuel cell | Paramagnetic or
Galvanic fuel cell | |
| Heated Breathing Circuit | Yes | Yes | |
| Spirometry: Pressure-Volume and
Flow-Volume loops | Yes | Yes | |
| Anesthetic Gas Module Sampling Rate | Adult/pediatric: 120, 150, 200
mL/min
Neonate: 70, 90, 120 mL/min | High volume: 120, 150, 200
mL/min
Low volume: 70, 90, 120 mL/min | |
| Anesthetic Gas Module Sampling
Delay Time: | 10%: unspecified | 0 to 1%: +/-.1%
1 to 5%: +/-.2%
5 to 7%: +/-.3%
7 to10%: +/-.5%
10%: unspecified | |
| Technical
Characteristics | Subject Device
A5 Anesthesia System | Predicate Device
A5 Anesthesia Delivery System
(K123211) | |
| Anesthetic Gas Module Accuracy
N2O: | 0 to 20%: +/-2%
20 to 100%: +/-3% | 0 to 20%: +/-2%
20 to 100%: +/-3% | |
| Anesthetic Gas Module Accuracy
Desflurane: | 0 to 1%: +/-.15%
1 to 5%: +/-.2%
5 to 10%: +/-.4%
10 to 15%: +/-.6%
15 to 18%: +/-1%
18%: unspecified | 0 to 1%: +/-.15%
1 to 5%: +/-.2%
5 to 10%: +/-.4%
10 to 15%: +/-.6%
15 to 18%: +/-1%
18%: unspecified | |
| Anesthetic Gas Module Accuracy
Sevoflurane: | 0 to 1%: +/-.15%
1 to 5%: +/-.2%
5 to 8%: +/-.4%
8%: unspecified | 0 to 1%: +/-.15%
1 to 5%: +/-.2%
5 to 8%: +/-.4%
8%: unspecified | |
| Anesthetic Gas Module Accuracy
Enflurane/Isoflurane/
Halothane: | 0 to 1%: +/-.15%
1 to 5%: +/-.2%
5%: unspecified | 0 to 1%: +/-.15%
1 to 5%: +/-.2%
5%: unspecified | |
| Anesthetic Gas Module Accuracy O2: | 0 to 25%: +/-1%
25 to 80%: +/-2%
80 to 100%: +/-3% | 0 to 25%: +/-1%
25 to 80%: +/-2%
80 to 100%: +/-3% | |
| Anesthetic Gas Module Accuracy
awRR: | 2 to 60rpm: +/-1rpm
60rpm: unspecified | 2 to 60rpm: +/-1rpm
60rpm: unspecified | |
| Anesthetic Gas Module
Measurement
Rise Time: | CO2: ≤250ms
N2O: ≤250ms
O2: ≤500ms
Hal/Iso/Sev/Des: ≤300ms
Enf: ≤350ms | CO2: ≤250ms
N2O: ≤250ms
O2: ≤500ms
Hal/Iso/Sev/Des: ≤300ms
Enf: ≤350ms | |
| Measurement Range CO2 | 0 to 30% | 0 to 30% | |
| Measurement Range N2O | 0 to 100% | 0 to 100% | |
| Measurement Range Des | 0 to 30% | 0 to 30% | |
| Measurement Range Sev | 0 to 30% | 0 to 30% | |
| Measurement Range Enf/Iso/Hal | 0 to 30% | 0 to 30% | |
| Measurement Range O2 | 0 to 100% | 0 to 100% | |
8
9
There are some differences between the subject A5 Anesthesia System and the predicate device A5 Anesthesia Delivery System (K123211). Per the FDA Guidance, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued July 28, 2014, the following devices are provided to support substantial equivalence.
10
| Differences from Predicate Device A5 (K123211) | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------ |
| Differences | Reference Device |
|---|---|
| Add Three Ventilation | |
| Modes | |
| SIMV-VG | Evita XL Ventilator (K083050) |
| CPAP/PS | Aisys anesthesia system |
| (K110213) | |
| APRV | Evita XL Ventilator (K083050) |
| Lung Recruitment Ventilation Function | GE Datex-Ohmeda Aisys CS2 |
| Anesthesia System (K132530) | |
| Optimizer Function and Agent Usage Calculation Function | A7 Anesthesia System (K151954) |
| Redesign the Existing Ventilator Control Board Using DSP | |
| Hardware Platform | A5 Anesthesia Delivery System |
| (K123211) | |
| Change about the Anesthetic Gas Module and Accessories | A5 Anesthesia Delivery System |
| (K123211) | |
| Get Data from Anesthetic Gas Module plugged into the | |
| Passport 12M/17M patient monitor (K170876) to support | |
| optimizer function and agent usage calculation function | A7 Anesthesia System (K151954) |
| Increase the Maximum Inspiratory Flow | Evita XL Ventilator (K083050) |
| Change the Material of the Airway Pressure Gauge | |
| Housing | A7 Anesthesia System (K151954) |
Substantial Equivalence Conclusion
Based on the detailed comparison of specifications for each of the modifications to the previously cleared A5 Anesthesia Delivery System (K123211) and cited reference devices, the performance testing results and conformance with applicable standards show that the A5 Anesthesia System can be found substantially equivalent to the predicate device.