(182 days)
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No
The document describes a standard anesthesia workstation with various monitoring and ventilation functionalities. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies summary.
Yes
The device is used for anesthesia, which is a medical treatment. It helps in administering anesthetic agents and provides ventilation during surgical or diagnostic interventions.
No
Explanation: The device is described as an "anesthesia workstation" and "continuous flow gas anesthesia system" intended for "anesthetizing" and "patient ventilation". While it includes monitoring systems for ventilation and gas concentrations, its primary function is to deliver anesthesia and ventilate patients during interventions, not to diagnose medical conditions.
No
The device description clearly outlines numerous hardware components including a blower-based ventilator, control display with touchscreen, gas mixer, breathing system, monitoring systems, and more. This is a physical anesthesia workstation with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for delivering anesthesia and providing ventilation to patients during surgical or diagnostic interventions. This is a direct interaction with the patient's respiratory system and the administration of gases and anesthetic agents.
- Device Description: The device components and functionality are focused on gas delivery, ventilation, monitoring of patient's respiratory parameters (flow, pressure, gas concentrations), and anesthetic agent delivery. These are all related to patient care and intervention, not the analysis of biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The monitoring is of the patient's physiological response to the anesthesia and ventilation.
In summary, the Perseus A500 is an anesthesia workstation, which is a medical device used for patient treatment and support, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The anesthesia workstation Perseus is intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
Perseus is equipped with airway monitoring, gas measurement and device monitoring, O2 insufflation, and an anesthetic gas receiving system.
Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents.
Ventilation is accomplished on the patient through a laryngeal mask, a mask, or an endotracheal tube.
The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow).
A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional).
Perseus A500 is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.
Product codes (comma separated list FDA assigned to the subject device)
BSZ
Device Description
The Perseus A500 is a continuous flow gas anesthesia system that delivers anesthetic vapour, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas, and agent identification.
The main functionality of the anesthesia system comprises
- gas delivery for mixing oxygen and carrier gases, -
- anesthetic agent delivery (via vaporizers such as Dräger Vapor 3000),
- anesthesia ventilator (blower based), -
- anesthesia breathing system ABS, -
- airway monitoring (flow, pressure, gas concentrations) .
The Perseus A500 consists of the following main components:
- M3 Blower based Anesthesia Ventilator, electrical driven, supporting the Ventilation . modes
- o Man/Spont
- o Volume Controlled
- Pressure Controlled o
- Embedded control display with touch screen technology and rotary/confirm knob for selecting and confirming parameters.
- . Gas Mixer
- . Heated integrated Anaesthesia Breathing System ABS
- Patient Gas Monitoring with agent mixture detection and Oxygen monitoring .
- Integrated Anesthesia Gas Scavenging System -
- Auxiliary Oxygen Therapy w/ flow indicator -
- Oxygen cylinder support (reserve gas inlet) -
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
adults, children, and neonates
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The software has been verified and validated according to the specification and test requirements, and documented as described in the FDA Guidance for the Content of Premarket Submissions for Software. The development of Perseus A500 was in accordance with these procedures and passed all verification activities. The risk management file identifies potential hazards and documents the result of the risk analysis including mitigation of hazards. Usability features have been evaluated by end-users and found that the Perseus A500 is safe and effective for use by the intended users, intended use, and use environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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).
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§ 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).
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K13896
JUN 2 0 2014
Traditional 510(k) Perseus A500
Date: 16. December 2013
Dräger
Premarket Notification 510(k) summary As required per 807.92
General Company Information
| Submitters Name and Address: | Dräger Medical GmbH |
|---|---|
| Moislinger Allee 53-55, | |
| D-23542 Luebeck, Germany |
Contact Person:
Mr. Ulrich Schroeder Moislinger Allee 53-55, D-23542 Luebeck, Germany Phone : 49 (451) 882-3648 Fax :49 (451) 882-3018 Email: Ulich.Schroeder@draeger.com
Alternate:
Mrs. Beth Zis Draeger Medical Systems, Inc., 6 Tech Dr, Andover, MA 01810 Phone +1 (978) 3798255 Fax: +1 (978) 3798335 Email: beth.zis@draeger.com
1
:
Image /page/1/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" has an umlaut, which is two dots above the letter. The word is black and the background is white.
Device Name
| Common Name: | Gas-machine, anesthesia |
|---|---|
| Legally Marketed Device | |
| Identification: | Perseus A500 |
| Regulation Number | 868.5160 |
| Regulation Description | Gas machine for anesthesia |
| Regulation Medical Specialty | Anesthesiology |
| Product Code | BSZ |
| Class | 2 |
2
Image /page/2/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in Dräger has an umlaut, which is a diacritical mark consisting of two dots placed over the letter. The word is in black and is set against a white background. A horizontal line is present at the bottom of the image.
Device description:
The Perseus A500 is a continuous flow gas anesthesia system that delivers anesthetic vapour, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas, and agent identification.
Image /page/2/Picture/4 description: The image shows a Dräger Perseus A500 anesthesia machine. The machine has a monitor at the top, a work surface in the middle, and a base with wheels. The monitor displays various waveforms and numerical data. The work surface has several knobs and dials. The base has a footrest and a storage compartment.
The main functionality of the anesthesia system comprises
- gas delivery for mixing oxygen and carrier gases, -
- anesthetic agent delivery (via vaporizers such as Dräger Vapor 3000),
- anesthesia ventilator (blower based), -
- anesthesia breathing system ABS, -
- airway monitoring (flow, pressure, gas concentrations) .
3
The Perseus A500 consists of the following main components:
- M3 Blower based Anesthesia Ventilator, electrical driven, supporting the Ventilation . modes
- o Man/Spont
- o Volume Controlled
- Pressure Controlled o
- Embedded control display with touch screen technology and rotary/confirm knob for selecting and confirming parameters.
- . Gas Mixer
- . Heated integrated Anaesthesia Breathing System ABS
- Patient Gas Monitoring with agent mixture detection and Oxygen monitoring .
- Integrated Anesthesia Gas Scavenging System -
- Auxiliary Oxygen Therapy w/ flow indicator -
- Oxygen cylinder support (reserve gas inlet) -
Image /page/3/Figure/14 description: This image shows a labeled diagram of an anesthesia machine. The diagram labels the control display, APL vent, vapor bar, table with electronics, blower and patient gas monitoring, auxiliary mains outlets, mixer status display, on/off switch, optional gas cylinders, optional drawer element, and batteries with optional separation. The diagram provides a comprehensive overview of the machine's components and their functions.
4
Image /page/4/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is in black and is set against a white background. The two dots above the "a" are also black. A black line is present below the word.
Indications / Intended Use:
The anesthesia workstation Perseus is intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
Perseus is equipped with airway monitoring, gas measurement and device monitoring, O2 insufflation, and an anesthetic gas receiving system.
Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents.
Ventilation is accomplished on the patient through a laryngeal mask, a mask, or an endotracheal tube.
The integrated breathing system can be used with partial rebreathing (low-flow or minimumflow).
A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional).
Perseus A500 is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.
Substantial Equivalence:
The Perseus A500 is substantial equivalent to the following predicate devices:
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K042607 | Primus US | Draeger Medical GmbH |
| K983635 | JULIAN ANESTHESIA | |
| WORKSTATION, MODEL # JULIAN | Draeger Medical GmbH | |
| K093633 | Infinity Acute Care System Workstation | |
| Critical Care | Draeger Medical GmbH |
The devices are substantial equivalent the following characteristics:
General performance including operation concept
The Perseus is equivalent to the predicate devices by a uniform use concept, user interface and integrated display. The general performance is equivalent to the predicate devices and typical for anesthesia devices available on the market. The gas mixing concept is equivalent to the Primus US (K042607) for the product variant with the mechanically controlled mixer and equivalent to the Julian (K983635) for the product variant with the electronically controlled mixer.
5
Image /page/5/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is black and the background is white. The two dots above the "a" are also black and bold. The word is slightly distorted, as if it were printed on a slightly uneven surface.
Ventilation parameters, gas delivery, ventilation monitoring
The ventilation parameters Pressure Support, Pressure Control, Press. Ctrl. APRV (Airway Pressure Release Ventilation), Volume Control and Vol. Ctrl. AutoFlow are equivalent to the predicate devices Primus US (K042607) and the Infinity Acute Care System Workstation Critical Care (K093633) for Airway Pressure Release Ventilation.
The monitoring principals and parameters like Pressure waveform display, Volume measurement, Anesthetic gas measurement CO2 and O2 measurement are equivalent to the predicate devices.
Indications:
The side by side comparison of the indications between the Perseus A500 and the predicate devices showed that labelling and indications are substantial equivalent.
6
Dräger
Performance and testing:
Dräger installed and maintains an internal Quality Management (QM) System. The QM System describes the procedures for development related to medical devices and requires a particular development process with all related activities including risk management, verification, validation and documentation. This procedure is in accordance with the design controls as defined in the current "Good Manufacturing Practice" published by FDA.
Design controls procedures are implemented and maintained at Dräger. All product developments and changes to Dräger products follow this internal procedure laid down in internal standard operating procedures DMS IN4000 "Develop Product" and DMTN LM2310 "Execute Product Design Changes" respectively. The software has been verified and validated according to the specification and test requirements, and documented as described in the FDA Guidance for the Content of Premarket Submissions for Software.
The development of Perseus A500 was in accordance with these procedures and passed all verification activities. The risk management file identifies potential hazards and documents the result of the risk analysis including mitigation of hazards. Usability features have been evaluated by end-users and found that the Perseus A500 is safe and effective for use by the intended users, intended use, and use environment.
Utilized Standards:
The Perseus A500 has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards:
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Including: National Deviations as per UL 60601.1
IEC 60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety: Collateral standard: Programmable electrical medical systems
IEC 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-2-13 Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems (Recognition Number 1-61)
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 8835-2 Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems
ISO 8835-3 Inhalational anaesthesia systems - Part 3: Transfer and receiving systems
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Image /page/7/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in Dräger has an umlaut, which is a diacritical mark consisting of two dots placed over the letter. The text is black and the background is white. The image appears to be a logo or brand name.
of active anaesthetic gas scavenging systems
ISO 8835-5 Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators
ISO 21647 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (Recognition Number 1-65)
Biocompatibility was verified according to the requirements Memorandum - #G95-1 (and tested based on the requirements of IEC 60601-1 (Clause 48) and the applicable ISO 10993 standards)
Hygienic evaluation as defined in ISO 17664.
ISO 15001 Oxygen Compatibility
Conclusion:
Based on similarities in the indications and technological characteristics the Perseus A500 is considered substantially equivalent to the predicate devices. The results of performance and validation/verification testing show, that the use of the device is safe and effective.
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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2014
Dräger Medical GmbH Mr. Ulrich Schroeder Moislinger Allee 53-55 D-23542 Luebeck, Germany
Re: K133886
Trade/Device Name: Gas-machine, anesthesia Regulation Number: 21 CFR 868.5160 Regulation Name: Gas-machine for anesthesia Regulatory Class: II Product Code: BSZ Dated: May 12, 2014 Received: May 12, 2014
Dear Mr. Schroeder:
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.
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Page 2 - Mr. Schroeder
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
The anesthesia workstation Perseus A500 is intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing.
Perseus A500 is equipped with airway monitoring, gas measurement and device monitoring. O2 insufflation, and an anesthetic gas receiving system.
Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents.
Ventilation is accomplished on the patient through a laryngeal mask, a mask, or an endotracheal tube.
The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow).
A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional).
Perseus A500 is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Neha Gu |
|---|
| 2014.06.2011 |
510(k) Perseus A500