PRIMUS US

K042607 · Draeger Medical, Inc. · BSZ · Nov 26, 2004 · Anesthesiology

Device Facts

• Record ID: K042607
• Device Name: PRIMUS US
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Nov 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Primus Us is an inhalation anesthesia machine for use in operating, induction and recovery rooms. It can be used with rebreathing systems, semi closed to virtually closed systems with low flow and minimal flow techniques, and non-rebreathing systems. It may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.

Device Story

Primus US is a continuous flow anesthesia workstation for operating, induction, and recovery rooms. It delivers anesthetic vapor and provides manual or automatic ventilation using an electronically controlled, electrically driven piston ventilator with fresh gas decoupling. Inputs include O2, N2O, and Air from pipelines or cylinders; anesthetic agents via mounted vaporizers. System monitors O2, CO2, breathing pressure, respiratory volume, and anesthetic agent concentration using thermo anemometry flow sensors and integrated gas monitoring. Operated by physicians/clinicians via color screen, rotary knob, and keys. Features include battery backup, automatic preuse checkout, and ORC to prevent hypoxic mixtures. Output data (numerics, graphics, alarms) informs clinical decisions regarding patient ventilation and anesthesia depth. Benefits include precise gas delivery, integrated monitoring, and automated safety features like leak detection and valve monitoring.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, system-level qualification, and risk analysis to verify performance against predicate devices.

Technological Characteristics

Continuous flow anesthesia system; electronically controlled, electrically driven piston ventilator; thermo anemometry flow sensors; color screen UI; battery backup; integrated breathing system with APL valve; Selectatec/Auto Exclusion vaporizer mounts. Connectivity includes pipeline/cylinder gas inputs. Sterilization/cleaning via standard hospital protocols for anesthesia equipment.

Indications for Use

Indicated for continuous flow anesthesia delivery and ventilation (manual or automatic) in patients requiring anesthesia. Monitors O2, CO2, breathing pressure, respiratory volume, and anesthetic agent concentration. Prescription use only.

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

• Fabius GS Anesthesia Workstation (K041622)
• Julian Anesthesia Workstation (K983635)
• Narkomed 6400 w/IPM Anesthesia Workstation (K033498)
• Divan Ventilator (K980208)
• Vamos w/ Return Sample Gas (K040847)

Reference Devices

• Scio patient gas monitor (K031340)
• Evita 4

Submission Summary (Full Text)

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NOV 26 2004

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A Drager and Siemens Company

K042607

# Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

| Proprietary Name: | Primus US |
|------------------------------------------------------|----------------------------------------------------------------------------|
| Common Name: | Gas Machine-Anesthesia |
| Classification Name: | Gas Machine -Anesthesia |
| Product Codes: | 73 BSZ |
| Device Class: | Class II |
| Manufacturer: | Draeger Medical AG & Co KGaA<br>53/55 Moislinger Allee<br>Luebeck, Germany |
| Establishment Registration Number: 9611500 | |
| Devices to which substantial equivalence is claimed: | |
| Fabius GS Anesthesia Workstation (Fabius GS) | K041622 |
| Julian Anesthesia Workstation (Julian) | K983635 |
| Narkomed 6400 w/IPM Anesthesia Workstation (NM6400) | K033498 |
| Divan Ventilator | K980208 |
| Vamos w/ Return Sample Gas (Vamos w/ RGS) | K040847 |

#### Device Description:

The Primus US, is a continuous flow gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas, and agent identification.

### Indications for Use:

The Primus Us is indicated as a continuous flow anesthesia system. The Primus US may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic

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vapor, and monitoring of; oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.

# Intended Use:

The Primus Us is an inhalation anesthesia machine for use in operating, induction and recovery rooms. It can be used with rebreathing systems, semi closed to virtually closed systems with low flow and minimal flow techniques, and non-rebreathing systems.

It may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.

## Substantial Equivalence:

Like the Fabius GS, the Primus US provides integrated electronic monitoring for inspired O2, breathing pressure, respiratory volume. The Primus US also provides integrated patient gas monitoring like the Julian. The Primus US uses the same Gas measurement technology as the Scio patient gas monitor (K031340).

Like the NM6400, Primus US has a color screen display with a combination of a rotary knob, hard keys, and soft keys for the user interface. Information presented on the screen includes machine status, numerics, alarms, graphics, and prompt fields, ventilation, gas measurement and monitoring parameters.

Like the Fabius GS the Primus US has a battery back up system which is automatically enabled in the event of an AC power failure.

Electronic flow sensor technology is used by the Fabius GS and the Primus US for the virtual and total flow meters. Control of the flow meters is via corresponding color coded mechanical flow control knobs. Both devices are available with an auxiliary 02 flow meter and O2 flush valve.

The oxygen ratio controller (ORC) of the Primus US and Fabius GS are identical in the way they control the percentage of O2 to N2O to prevent a hypoxic mixture, and cut off the flow of N2O in case of an O2 supply failure.

Like the Fabius GS, the ventilator of Primus US is an electronically controlled, electrically driven piston ventilator with fresh gas decoupling. The ventilators are volume or pressure controlled preset, time cycled, pressure limited, with electronic timing, pneumatic circuitry, and controls for frequency, inspiratory to expiratory ratio (inspiratory time), inspiratory flow rate, tidal volume and inspiratory pressure limit.

Both have an integrated breathing system consisting of inspiratory and expiratory valves with patient hose connectors, pneumatic connectors, rotary style APL valve, breathing bag, and a standard 1.5 liter absorber, or the Drägersorb CLIC disposable absorber.

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Respiratory volume is derived via thermo anemometry flow sensors in both systems. A difference is that the Primus US uses flow sensors in the inspiratory and expiratory limbs, while the Fabius GS provides a flow sensor only in the expiratory limb. By adding the inspiratory flow sensor, leaks within the system can be measured, the functionality of the inspiratory valve can be monitored, and a better trigger performance for triggered patient ventilation modes is achieved.

Ventilation modes available in both the Primus US and the Fabius GS are: Manual/Spontaneous, Volume-Controlled, Pressure-Controlled, Pressure Support, and Pressure Support with Apnea ventilation. Like the Fabius GS the Primus US ventilator is piston driven.

Like the NM6400 the Primus US also offers synchronized intermittent mandatory ventilation (SIMV). Like the Evita 4, Primus US provides an optional synchronized volume controlled ventilation with pressure support mode, synchronized pressure controlled ventilation, and pressure support.

The ventilation parameters of the Fabius GS and Primus US are user adjustable via keys and an incremental encoder/confirmation knob.

The heated breathing circuit in Primus US and the Divan ventilator used in the NM6400, operate on the same principle to warm the gas in the patient breathing circuit.

Both the Fabius GS and Primus US can deliver up to three gases and one agent at a time, and use pipeline connections and back up gas cylinders for O2, N2O and Air.

The Primus Us is designed to interface with the same Anesthesia Gas Scavenger as the Fabius GS, or the passive scavenger system available for use Julian. An optional suction system is also provided.

Prior to use, the user is prompted to run a preuse checkout procedure. Like the NM6400, the checkout is run automatically by the machine, and prompts the user for interactions as necessary.

Electrical power is supplied to the ventilators via the anesthesia system's power supply.

Like the Fabius GS, Primus US can accommodate up to three vaporizers for use with either the Dräger Vapor® Selectatec ™ interlock systems or the Dräger Auto Exclusion 3 Vaporizer Mount. The Dräger Auto Exclusion 2 Vaporizer Mount may also be used on Primus US.

Qualification of Primus US included a risk analysis, system level qualification, and verification/validation testing.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird with stylized feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2004

Mr. James J. Brennan Director, Regulatory Affairs Draeger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K042607

Trade/Device Name: Primus US Anesthesia Workstation Regulation Number: 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: September 23, 2004 Received: September 24, 2004

Dear Mr. Brennan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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. Brennan

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Carl

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Primus US Anesthesia Workstation

Indications For Use:

The Primus US is indicated as a continuous flow anesthesia system. The Primus US may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of; oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.

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)

Aay Svelson

(Division Side-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K042667

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