(135 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard anesthesia system components and functionalities.
Yes
The device is described as an "Anesthesia System" used to "administer to a patient... a general inhalation anesthetic and to maintain a patient's ventilation," which are therapeutic actions.
No
The device is used to administer anesthesia and maintain ventilation. While it monitors certain concentrations (O2, CO2, N2O, and anesthetic agents), this monitoring is part of the administration and maintenance function, not for diagnosing a patient's medical condition or disease.
No
The device description clearly states it is a "continuous flow inhalation gas anesthesia system" that includes a "main unit (includes an anesthetic ventilator and flow meter monitor assembly) and a detachable breathing system." This indicates significant hardware components beyond just 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... 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 details a system for delivering anesthetic gases and providing ventilation. It mentions monitoring of gases within the system and patient circuit, not analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The A7 Anesthesia System does not fit this description.
N/A
Intended Use / Indications for Use
The A7 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 A7 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.
Product codes (comma separated list FDA assigned to the subject device)
BSZ, CCK, NHO, CBQ, NHQ, NHP, CBR, CCL, KDP
Device Description
The A7 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A7 incorporates 02, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane). The A7 consists of a main unit (includes an anesthetic ventilator and flow meter monitor assembly) and a detachable breathing system.
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 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)
Performance Data: Biocompatibility - Each patient contacting material and gas path material has been tested to comply with the following applicable requirements per ISO 10993-1:
- Cytotoxicity: ISO10993-5:2009 Biological evaluation of medical devices -. Part 5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Irritation: ISO10993-10:2010 Biological evaluation of medical devices Part 10: Tests . for irritation and skin sensitization
- Sensitization: ISO10993-10:2010 Biological evaluation of medical devices Part 10: ● Tests for irritation and skin sensitization
- Volatile Organic Compound Testing: ISO10993-18:2005 Biologica1 evaluation of . medical devices -- Part 18: Chemical characterization of materials
Software - The A7 Anesthesia System software has been fully verified and validated and documentation in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: May 11, 2005" has been provided in this submission.
Performance Testing - The A7 Anesthesia system has been tested to comply with its product specifications and intended use. The following standards were adhered to for performance testing: - IEC 60601-1:1988+A1:1991+A2:1995: Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-1:2000 General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
- IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements ● for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-4:2000 Medical electrical equipment Part 1-4: General requirements ● for safety - Collateral standard: Programmable electrical medical systems
- . IEC 60601-1-8:2003 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-2-13:2009 Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anesthetic systems
- IEC 62304: 2006 Medical device software Software life cycle processes ●
- IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
- ISO 14971:2007 Medical devices Application of risk management to medical ● devices
- ISO 15223-1:2012 Medical devices Symbols to be used with medical devices labels, ● labeling, and information to be supplied - Part 1: General requirements
- ISO 5356-1:2004 Anesthetic and respiratory equipment Conical connectors Part 1: ● Cones and sockets
- ISO 21647:2004 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
- ASTM F1101-90:2003 Standard Specification for Ventilators Intended for Use ● During Anesthesia
- CGA V-1:2005 Standard for Compressed Gas Cylinder Valves Outlet and Inlet . Connections
- CGA V-5:2008 Diameter-Index Safety System (Noninterchangeable Low Pressure ● Connections for Medical Gas Applications)
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.
K123211, K042607, K110213, K123125
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. The logo is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Shenzhen Mindray Bio-Medical Electronics Co., Ltd Tang Hao Product Approval Engineer, Technical Regulation Department Mindrav Building. Keii 12th Road South High-tech Industrial Park, Nanshan Shenzhen, Guandong 518057 CHINA
Re: K142552
Trade/Device Name: A7 Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine For Anesthesia Or Analgesia Regulatory Class: Class II Product Code: BSZ Dated: December 19, 2014 Received: December 22, 2014
Dear Mr. Hao,
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
Page 2 - Tang Hao
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 (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith 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) K142552
Device Name A7 Anesthesia System
Indications for Use (Describe)
The A7 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 A7 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 A7 Anesthesia System is provided below.
| Device Common Name: | Gas-Machine, Anesthesia |
|---|---|
| Device Proprietary Name: | A7 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: | January 23, 2015 |
| 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 - CCL- Oxygen Gas Analyzer | |
| 880.6740 - KDP- Vacuum Regulator | |
| Predicate Devices: |
K123211 - A5 Anesthesia Delivery System, Mindray DS USA, Inc. K042607 - Primus US, Draeger Medical Inc. K110213 - GE Datex-Ohmeda Aisys, Datex-Ohmeda Inc.
4
K123125 - Avance CS2, GE
Indication for Use:
The A7 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 A7 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.
De vice De scription:
The A7 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A7 incorporates 02, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane). The A7 consists of a main unit (includes an anesthetic ventilator and flow meter monitor assembly) and a detachable breathing system.
Performance Data:
Biocompatibility - Each patient contacting material and gas path material has been tested to comply with the following applicable requirements per ISO 10993-1:
- Cytotoxicity: ISO10993-5:2009 Biological evaluation of medical devices -. Part 5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Irritation: ISO10993-10:2010 Biological evaluation of medical devices Part 10: Tests . for irritation and skin sensitization
- Sensitization: ISO10993-10:2010 Biological evaluation of medical devices Part 10: ● Tests for irritation and skin sensitization
- Volatile Organic Compound Testing: ISO10993-18:2005 Biologica1 evaluation of . medical devices -- Part 18: Chemical characterization of materials
Software - The A7 Anesthesia System software has been fully verified and validated and documentation in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: May 11, 2005" has been provided in this submission.
Performance Testing - The A7 Anesthesia system has been tested to comply with its product specifications and intended use. The following standards were adhered to for performance testing:
- IEC 60601-1:1988+A1:1991+A2:1995: Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-1:2000 General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
- IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements ● for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-4:2000 Medical electrical equipment Part 1-4: General requirements ● for safety - Collateral standard: Programmable electrical medical systems
5
- . IEC 60601-1-8:2003 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-2-13:2009 Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anesthetic systems
- IEC 62304: 2006 Medical device software Software life cycle processes ●
- IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
- ISO 14971:2007 Medical devices Application of risk management to medical ● devices
- ISO 15223-1:2012 Medical devices Symbols to be used with medical devices labels, ● labeling, and information to be supplied - Part 1: General requirements
- ISO 5356-1:2004 Anesthetic and respiratory equipment Conical connectors Part 1: ● Cones and sockets
- ISO 21647:2004 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
- ASTM F1101-90:2003 Standard Specification for Ventilators Intended for Use ● During Anesthesia
- CGA V-1:2005 Standard for Compressed Gas Cylinder Valves Outlet and Inlet . Connections
- CGA V-5:2008 Diameter-Index Safety System (Noninterchangeable Low Pressure ● Connections for Medical Gas Applications)
Substantial Equivalence :
The subject device has the exact same indication statement as the primary predicate device. the A5 as cleared in K123211. The subject A7 Anesthesia System and the primary predicate are both gas anesthesia machines used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. These systems may be used in adult and pediatric populations. Both of the devices are prescription use, and are not suitable for use in an MRI environment.
A technical comparison of the subject device to the primary predicate device, the A5 as cleared in K123211 is provided in the table below.
| Technical
Characteristics | A7 Anesthesia Delivery System
Shenzhen Mindray Bio-Medical
Electronics Co., Ltd | A5 Anesthesia Delivery System
Mindray DS USA, Inc.
K123211 | |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Vaporizers | Two, variable bypass | Two, variable bypass | |
| Agent - Sevoflurane | Yes | Yes | |
| Agent - Isoflurane | Yes | Yes | |
| | Technical
Characteristics | A7 Anesthesia Delivery System
Shenzhen Mindray Bio-Medical
Electronics Co., Ltd | A5 Anesthesia Delivery System
Mindray DS USA, Inc.
K123211 |
| | 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 |
| | Tidal Volume | Yes | Yes |
| Specifications | | | |
| | Range, ml | 20 - 1500 | 20 - 1500 |
| | Minute Volume | Yes | Yes |
| | Rate, bpm | 4-100 bpm | 4-100 bpm |
| | Inspiratory Flow, L/min | 110 L/min + fresh gas flow | 110 L/min + fresh gas flow |
| | 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 - 60% of insp. Period | Off, 5 - 60% of insp. Period |
| Fresh
Gas | Air Flow Range | 015 L/min | 015 L/min |
| | N₂O Flow Range | 012 L/min | 012 L/min |
| | O₂ Flow Range | 015 L/min | 015 L/min |
| | Individual Gas
Flow Accuracy | ±50 ml/min or ±5% of setting value,
whichever is greater | ±120 ml/min or ±10% of setting
value, whichever is greater |
| | Pressure Limit, cm H2O | 0 - 100 | 0 - 100 |
| | PEEP, cm H20 | Off, 3-30, 1 cmH2O increment | Off, 3-30, 1 cmH2O increment |
| | System Checks | Auto at start | Auto at start |
| | Airway Pressure
Measured at | Inspiratory | Inspiratory |
| | High/Low Airway | Yes | Yes |
| Technical
Characteristics | A7 Anesthesia Delivery System
Shenzhen Mindray Bio-Medical
Electronics Co., Ltd | A5 Anesthesia Delivery System
Mindray DS USA, Inc.
K123211 | |
| 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 | Paramagnetic or Galvanic (The
Paramagnetic sensor is utilized
when using the integrated gas
module. The Galvanic sensor is
utilized when the gas module is
not connected.) | |
| Heated Breathing Circuit | Yes | Yes | |
| Spirometry: Pressure-
Volume and Flow-Volume
loops | Yes | Yes | |
| Anesthetic Gas Module
Sampling Rate | P/N 9200-10-10530 water trap: 120,
150, 200mL/min
P/N 9200-10-10574 water trap: 70,
90, 120mL/min | P/N 9200-10-10530 water trap:
120, 150, 200mL/min
P/N 9200-10-10574 water trap:
70, 90, 120mL/min | |
| Anesthetic Gas Module
Sampling Delay Time: | 10%: unspecified | 0-1%: +/-.1%
1-5%: +/-.2%
5-7%: +/-.3%
7-10%: +/-.5%
10%: unspecified | |
| Technical
Characteristics | A7 Anesthesia Delivery System
Shenzhen Mindray Bio-Medical
Electronics Co., Ltd | A5 Anesthesia Delivery System
Mindray DS USA, Inc.
K123211 | |
| Anesthetic Gas Module
Accuracy N2O: | 0-20%: +/-2%
20-100%: +/-3% | 0-20%: +/-2%
20-100%: +/-3% | |
| Anesthetic Gas Module
Accuracy Desflurane: | 0-1%: +/-.15%
1-5%: +/-.2%
5-10%: +/-.4%
10-15%: +/-.6%
15-18%: +/-1%
18%: unspecified | 0-1%: +/-.15%
1-5%: +/-.2%
5-10%: +/-.4%
10-15%: +/-.6%
15-18%: +/-1%
18%: unspecified | |
| Anesthetic Gas Module
Accuracy Sevflurane: | 0-1%: +/-.15%
1-5%: +/-.2%
5-8%: +/-.4%
8%: unspecified | 0-1%: +/-.15%
1-5%: +/-.2%
5-8%: +/-.4%
8%: unspecified | |
| Anesthetic Gas Module
Accuracy
Enflurane/Isoflurane/
Halothane: | 0-1%: +/-.15%
1-5%: +/-.2%
5%: unspecified | 0-1%: +/-.15%
1-5%: +/-.2%
5%: unspecified | |
| Anesthetic Gas Module
Accuracy O2: | 0-25%: +/-1%
25-80%: +/-2%
80-100%: +/-3% | 0-25%: +/-1%
25-80%: +/-2%
80-100%: +/-3% | |
| Anesthetic Gas Module
Accuracy awRR: | 2-60rpm: +/-1rpm
60rpm: unspecified | 2-60rpm: +/-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 | 0-30% | 0-30% | |
| Measurement Range N2O | 0-100% | 0-100% | |
| Measurement Range Des | 0-30% | 0-30% | |
| Measurement Range Sev | 0-30% | 0-30% | |
| Measurement Range
Enf/Iso/Hal | 0-30% | 0-30% | |
| Measurement Range O2 | 0-100% | 0-100% | |
6
7
8
A7 Anesthesia System
9
A7 Anesthesia System
Substantial Equivalence Conclusion
There are seven new features that have been added to the A7 when compared to the A5 as follows:
-
- Fresh Gas Control System
-
- Negative Pressure Suction Device
-
- Agent Consumption Calculation
- Auxiliary Common Gas Outlet 4.
- Sample Gas Return 5.
- Quick Release APL Valve 6.
-
- Auxiliary Work Surface
A detailed comparison of these 7 new features is provided in the submission and performance testing was completed to establish that the new features do not raise new issues of safety and effectiveness.
The A7 Anesthesia System has the same intended use as the predicate device, to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A7 is a line extension of the FDA-cleared A5 Anesthesia System (the primary predicate device), and has the identical indications for use as the A5. The differences in the technological characteristics of these features when compared to the predicate device do not raise new types of safety and effectiveness questions. Therefore the A7 can be found substantially equivalent to the predicate device.