(255 days)
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.
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).
This document is a 510(k) summary for the A5 Anesthesia System. It describes the device, its intended use, and compares it to a predicate device and several reference devices to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it lists various "Nonclinical testing and Performance" areas that were tested and states that "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."
However, the "Device Comparison Table" on pages 7 and 8 provides a comparison of technical characteristics between the subject device (A5 Anesthesia System) and the predicate device (A5 Anesthesia Delivery System (K123211)). This table implies that the performance of the subject device in these listed characteristics meets or is equivalent to the predicate device, which can be interpreted as the acceptance criteria being parity with the predicate.
Here's an attempt to construct a table based on the provided information, interpreting the predicate device's specifications as the acceptance criteria for the subject device:
| Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (Subject Device A5 Anesthesia System) |
|---|---|
| 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, PCV, PCV-VG, SIMV-VC, SIMV-PC, PS | VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, PS (Subject device also adds SIMV-VG, CPAP/PS, APRV) |
| Tidal Volume Range: 20 to 1500 ml | 20 to 1500 ml |
| Minute Volume Rate: 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 |
| 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 |
| 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: 0 to 100 cm H2O | 0 to 100 cm H2O |
| PEEP: 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 | 120, 150, 200 mL/min |
| Anesthetic Gas Module Sampling Rate (Neonate): 70, 90, 120 mL/min | 70, 90, 120 mL/min |
| Anesthetic Gas Module Sampling Delay Time: <4 seconds | <4 seconds |
| Anesthetic Gas Module Refresh Rate: 1 second | 1 second |
| Anesthetic Gas Module Warm-up Time: 45 seconds to warm-up status, 10 minutes to ready-to-measure status | 45 seconds to warm-up status, 10 minutes to ready-to-measure status |
| Anesthetic Gas Module Accuracy CO2: 0 to 1%: +/-.1%, 1 to 5%: +/-.2%, 5 to 7%: +/-.3%, 7 to 10%: +/-.5%, >10%: unspecified | 0 to 1%: +/-.1%, 1 to 5%: +/-.2%, 5 to 7%: +/-.3%, 7 to 10%: +/-.5%, >10%: unspecified |
| 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 | ≤250ms |
| Anesthetic Gas Module Measurement Rise Time N2O: ≤250ms | ≤250ms |
| Anesthetic Gas Module Measurement Rise Time O2: ≤500ms | ≤500ms |
| Anesthetic Gas Module Measurement Rise Time Hal/Iso/Sev/Des: ≤300ms | ≤300ms |
| Anesthetic Gas Module Measurement Rise Time Enf: ≤350ms | ≤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% |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Nonclinical testing and Performance" areas like:
- Software (Unit testing, Integration testing, System testing)
- Performance
- Power Supply
- Thermal
- Cleaning and Disinfection
- Fresh Flow Optimizer
- AG Module
- Heating Module
- Waveform Comparison
- Biocompatibility (Volatile Organic Compounds, Particulate Testing, Cytotoxicity, Sensitization, Irritation / intracutaneous reactivity, Extractables and leachables (E&L) testing, Inorganic gases testing)
- Human Factors Validation Testing
- Testing as per consensus standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 80601-2-13, ISO 80601-2-55, ASTM F1101-90, AIM 7351731)
However, the document does not specify:
- The sample size used for any of these tests.
- The data provenance (e.g., country of origin, retrospective or prospective nature of the data if any clinical data was implied).
The testing appears to be mostly focused on hardware and software functionality, performance, and safety against specified standards, rather than clinical trial data involving patient samples or expert interpretations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The testing described is primarily non-clinical (engineering, software, biocompatibility, standards compliance). There is no mention of "ground truth" being established by experts in the context of clinical interpretation, as might be found in studies for diagnostic AI devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Given the nature of the tests (non-clinical performance, safety, and standards compliance), an adjudication method as typically used for clinical endpoints or image interpretation is not applicable or described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for AI-powered diagnostic or decision support tools that assist human readers, which is not the primary function of this anesthesia system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an "Anesthesia System" which delivers anesthetic vapor and provides ventilation. It includes an "Anesthetic Gas Module" for monitoring, but it is not an "algorithm only" device operating without human-in-the-loop. Its performance, as described by the parameters in the comparison table, would be standalone in terms of its ability to measure and deliver gases accurately, but it functions as part of a system used by clinicians. There is no mention of a standalone algorithm's performance in isolation from the hardware components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (software, performance, electrical safety, biocompatibility, etc.), the "ground truth" would be defined by engineering specifications, international consensus standards, and predicate device performance. For example, the accuracy of gas measurement (e.g., CO2 accuracy 0 to 1%: +/-.1%) would be tested against calibrated references, where the reference measurement itself serves as the ground truth. There is no mention of clinical ground truth types like pathology or outcomes data.
8. The sample size for the training set
This information is not applicable and not provided. The A5 Anesthesia System is a traditional medical device (hardware and software for life support functions and monitoring), not an AI/Machine Learning model that requires a "training set" in the computational sense. The software testing mentioned (Unit, Integration, System) refers to traditional software development and verification, not machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as point 8.
{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) |
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}------------------------------------------------
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-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680 |
| Contact: | Yanhong BaiManager Regulatory AffairsSHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, Nanshan518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com |
| Date Prepared: | December 6th, 2017 |
| Panel: | Anesthesiology |
| Classification Regulation and Product Code: | Primary:868.5160- BSZ Anesthesia Gas Machine Class IISecondary:868.1400 - CCK - Carbon Dioxide Gas Analyzer868.1500 – NHO/CBQ/NHQ/NHP - Enflurane gas analyzer868.1620 – CBS - Halothane Gas Analyzer868.1700 - CBR - Nitrous Oxide Gas Analyzer868.1720 - CCI - Oxygen Gas Analyzer |
{4}------------------------------------------------
| 510(k) number | Trade or proprietor or modelname | Manufacturer |
|---|---|---|
| K123211 | A5 Anesthesia Delivery System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Predicate Device:
Reference Devices:
| 510(k) number | Trade or proprietor or modelname | 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
| TechnicalCharacteristics | Subject DeviceA5 Anesthesia System | Predicate DeviceA5 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 | |
| TechnicalCharacteristics | Subject DeviceA5 Anesthesia System | Predicate DeviceA5 Anesthesia Delivery System(K123211) | |
| Individual Gas FlowAccuracy | ±50 ml/min or ±5% of settingvalue, whichever is greater | ±50 ml/min or ±5% of settingvalue, 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 orGalvanic fuel cell | Paramagnetic orGalvanic fuel cell | |
| Heated Breathing Circuit | Yes | Yes | |
| Spirometry: Pressure-Volume andFlow-Volume loops | Yes | Yes | |
| Anesthetic Gas Module Sampling Rate | Adult/pediatric: 120, 150, 200mL/minNeonate: 70, 90, 120 mL/min | High volume: 120, 150, 200mL/minLow volume: 70, 90, 120 mL/min | |
| Anesthetic Gas Module SamplingDelay Time: | <4 seconds | <4 seconds | |
| Anesthetic Gas Module Refresh Rate: | 1 second | 1 second | |
| Anesthetic Gas Module Warm-upTime: | 45 seconds to warm-up status10 minutes to ready-to-measurestatus | 45 seconds to warm-up status10 minutes to ready-to-measurestatus | |
| Anesthetic Gas Module AccuracyCO2: | 0 to 1%: +/-.1%1 to 5%: +/-.2%5 to 7%: +/-.3%7 to10%: +/-.5%>10%: unspecified | 0 to 1%: +/-.1%1 to 5%: +/-.2%5 to 7%: +/-.3%7 to10%: +/-.5%>10%: unspecified | |
| TechnicalCharacteristics | Subject DeviceA5 Anesthesia System | Predicate DeviceA5 Anesthesia Delivery System(K123211) | |
| Anesthetic Gas Module AccuracyN2O: | 0 to 20%: +/-2%20 to 100%: +/-3% | 0 to 20%: +/-2%20 to 100%: +/-3% | |
| Anesthetic Gas Module AccuracyDesflurane: | 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 AccuracySevoflurane: | 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 AccuracyEnflurane/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 AccuracyawRR: | 2 to 60rpm: +/-1rpm>60rpm: unspecified | 2 to 60rpm: +/-1rpm>60rpm: unspecified | |
| Anesthetic Gas ModuleMeasurementRise Time: | CO2: ≤250msN2O: ≤250msO2: ≤500msHal/Iso/Sev/Des: ≤300msEnf: ≤350ms | CO2: ≤250msN2O: ≤250msO2: ≤500msHal/Iso/Sev/Des: ≤300msEnf: ≤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 VentilationModesSIMV-VG | Evita XL Ventilator (K083050) |
| CPAP/PS | Aisys anesthesia system(K110213) |
| APRV | Evita XL Ventilator (K083050) |
| Lung Recruitment Ventilation Function | GE Datex-Ohmeda Aisys CS2Anesthesia System (K132530) |
| Optimizer Function and Agent Usage Calculation Function | A7 Anesthesia System (K151954) |
| Redesign the Existing Ventilator Control Board Using DSPHardware 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 thePassport 12M/17M patient monitor (K170876) to supportoptimizer 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 GaugeHousing | 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.
§ 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).