(125 days)
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
No.
The device is used for administering anesthesia and maintaining ventilation, which are medical treatments, but it is not described as directly treating a disease or condition itself.
No
The device administers anesthetic and maintains ventilation, and is not described as diagnosing any conditions or diseases.
No
The device description explicitly states it is an "Anesthesia Delivery System" used to "administer" anesthetic and "maintain a patient's ventilation," which are functions requiring hardware components beyond software. The performance studies also mention compliance with safety, performance, and electromagnetic compatibility standards, and software verification and validation, which are typical for hardware-inclusive medical devices.
Based on the provided information, the A5 Anesthesia Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is used to administer anesthetic and maintain ventilation to a patient. This is a direct interaction with the patient's body for therapeutic and life-support purposes.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The A5 does not perform this function.
- Device Description: The description reinforces the direct patient interaction for administering anesthetic and ventilation.
Therefore, the A5 Anesthesia Delivery System falls under the category of a therapeutic or life-support medical device, not an IVD.
N/A
Intended Use / Indications for Use
The A5 Anesthesia Delivery 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 populations.
Product codes
BSZ, CCK, NHO, CBQ, NHQ, NHP, CBS, CBR, CCL
Device Description
The A5 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
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, 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)
The A5 has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards.
A risk analysis has been developed to identify potential hazards and documents the mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements.
The A5 has been evaluated by end-users and found to meets performed within its intended use and met their specific needs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K123211
510(k) Summary A5 Anesthesia Delivery System
FEB 1 4 2013
This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.
Date:
November 9, 2012
Submitter:
Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 Contact: Russell Olsen Vice President, Quality and Regulatory Affairs Telephone: 201-995-8391 Facsimile: 201-995-8605
Device Trade Name:
A5 Anesthesia Delivery System
Common Name:
Gas Machine, Anesthesia Delivery
Device Classification:
Primary: §868.5160- BSZ Gas Machine, Anesthesia
$868.1400 - CCK - Carbon Dioxide Gas Analyzer
Secondary:
$868.1500 - NHO/CBQ/NHQ/NHP - Enflurane gas analyzer $868.1620 - CBS - Halothane Gas Analyzer 8868.1700 - CBR - Nitrous Oxide Gas Analyzer $868.1720 - CCL- Oxygen Gas Analyzer
Predicate Devices:
AS3700 Anesthesia Delivery System / Mindray DS USA, Inc. - K102471 Beneview T-Series Patient Monitor / Shenzhen Mindray Biomedical Electronics C., Ltd. - K092449
Device description:
The A5 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
Section 5 - 510(k) Summary Page 1 of 3
1
Indications for Use:
The A5 Anesthesia Delivery 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 AS 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.
Technological Comparison to Predicate Devices:
The A5 is equivalent to the predicate AS3700 (K102471) device respecting indications for use basic operation and performance specifications and energy supply. Both devices are used to administer a general inhalation anesthetic and to maintain a patient's ventilation and intended for use in adult and pediatric populations.
The A5 and the predicate AS3700 support manual and automatic ventilation modes. Automatic ventilation modes include VCV, PCV, PCV- VG, SIMV-PC, SIMV-PC, SIMV- PC and PS.
The A5 has been updated to incorporate respiratory gas monitoring for measuring a patient's anesthetic and respiratory gases. The anesthetic gas monitoring module utilized by the A5 is equivalent to the module utilized in the predicate Beneview T-Series Patient Monitor (K092449). Gases measured include CO2, Desflurane, Isoflurane. Sevoflurane Halothane and Enflurane.
The A5 also incorporates material color changes and nonsignificant component changes relative to the AS3700.
Summary of Performance Testing:
The A5 has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards.
A risk analysis has been developed to identify potential hazards and documents the mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements.
The A5 has been evaluated by end-users and found to meets performed within its intended use and met their specific needs.
Section 5 - 510(k) Summary Page 2 of 3
2
The A5 has been tested and found to be in compliance with the following safety, performance and electromagnetic compatibility standards:
- IEC 60601-1:1988+A1:1991+A2:1995 .
- IEC 60601-1-2:2007 .
- IEC 60601-1-4:2000 .
- IEC 60601-1-8:2006 .
- IEC 60601-2-13:2003 ●
- IEC 62304: 2006 ●
- IEC 62366:2007 .
- ISO10993-1: 2009 .
- ISO 14971:2007 .
- ISO 15223-1:2012 .
- ISO 5356-1:2004 .
- ISO 21647:2004 .
- CGA V-1:2005 .
- CGA V-5:2008 .
- ASTM F1101-90:2003 .
- ISO10993-5:2009 .
- ISO10993-10:2002 +A1:2006
Conclusion:
Based on similarities in intended use and technological characteristics, results of performance and validation/verification testing, the A5 Anesthesia Delivery System is considered substantially equivalent to the predicate devices.
Section 5 - 510(k) Summary Page 3 of 3
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2013
Mr. Russell Olsen Vice President, Quality and Regulatory Affairs Mindray DS USA, Incorporated 800 MacArthur Boulevard MAHWAH NJ 07430
Re: K123211
Trade/Device Name: A5 Anesthesia Delivery System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ, CCK, NHO, CBQ, NHQ, NHP, CBS, CBR, CCL Dated: January 9, 2013 Received: January 15, 2013
Dear Mr. Olsen:
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.
4
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Image /page/4/Picture/7 description: The image shows the name "Kwame O. Ulmer" in a bold, sans-serif font. The letters "Kwame" and "Ulmer" are clear and easily readable. The "O." is stylized with a decorative pattern in the background, making it slightly less distinct than the rest of the name.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital,
Respiratory. Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K |25211
Device Name: A5 Anesthesia Delivery System
Indications For Use:
The A5 Anesthesia Delivery 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 populations.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Albert E. Moya for LS
Division Slan-Islon of Anesthestology, General Hospital Infection Control, Denta
510(k) Number;
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