PERSEUS A500

K133886 · Draeger Medical GmbH · BSZ · Jun 20, 2014 · Anesthesiology

Device Facts

• Record ID: K133886
• Device Name: PERSEUS A500
• Applicant: Draeger Medical GmbH
• Product Code: BSZ · Anesthesiology
• Decision Date: Jun 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

Perseus A500 is a continuous flow anesthesia workstation for clinical use by anesthesia professionals. It integrates a blower-based ventilator, gas mixer, and heated breathing system. Inputs include medical gases (O2, Air, N2O) and volatile anesthetic agents. The system provides automatic/manual ventilation modes (Volume/Pressure Controlled, APRV, Pressure Support) and monitors airway parameters (flow, pressure, gas concentrations). Output is displayed on an integrated touchscreen for clinician decision-making regarding patient ventilation and anesthesia depth. Benefits include precise gas delivery, integrated monitoring, and support for low-flow/minimum-flow rebreathing, facilitating safe patient management during surgery.

Clinical Evidence

Bench testing only. Verification and validation activities were performed in accordance with internal Quality Management Systems and FDA-recognized standards (IEC 60601 series, ISO 8835 series, ISO 21647, ISO 15001). Usability features were evaluated by end-users. No clinical trial data was required for this submission.

Technological Characteristics

Continuous flow anesthesia system. Components: M3 blower-based ventilator, gas mixer, heated anesthesia breathing system (ABS), patient gas monitor. Connectivity: Integrated touchscreen display with rotary/confirm knob. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-8, IEC 60601-2-13, ISO 8835-2/3/5, ISO 21647, ISO 15001. Biocompatibility per ISO 10993. Software: Programmable electrical medical system.

Indications for Use

Indicated for anesthesia delivery and ventilation in adults, children, and neonates during surgical or diagnostic interventions. Supports automatic/manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing via laryngeal mask, mask, or endotracheal tube.

Regulatory Classification

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. 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).

Predicate Devices

• Primus US (K042607)
• JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN (K983635)
• Infinity Acute Care System Workstation Critical Care (K093633)

Submission Summary (Full Text)

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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 : [phone] Fax :[phone] Email: [e-mail]

Alternate:

Mrs. Beth Zis Draeger Medical Systems, Inc., 6 Tech Dr, Andover, MA 01810 Phone [phone] Fax: [phone] Email: [e-mail]

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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<br>Identification: | Perseus A500 |
| Regulation Number | 868.5160 |
| Regulation Description | Gas machine for anesthesia |
| Regulation Medical Specialty | Anesthesiology |
| Product Code | BSZ |
| Class | 2 |

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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) .

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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.

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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<br>WORKSTATION, MODEL # JULIAN | Draeger Medical GmbH |
| K093633 | Infinity Acute Care System Workstation<br>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.

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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.

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**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 [phone] or [phone] 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 [phone] or [phone] 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

K133886

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