JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN

K983635 · Draeger Medical, Inc. · BSZ · Jan 11, 1999 · Anesthesiology

Device Facts

• Record ID: K983635
• Device Name: JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Jan 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Julian may be used for spontaneous, manually assisted, or automatic ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The Julian can monitor oxygen, breathing pressure, respiratory volume, CO2, N2O, and anesthetic agent identification and concentration.

Device Story

Julian is a continuous flow anesthesia workstation; provides ventilation (spontaneous, manual, automatic) and delivers anesthetic gases/vapors. Inputs include medical gases and anesthetic agents; monitors oxygen, breathing pressure, respiratory volume, CO2, N2O, and anesthetic agent concentration/identification. Operates via bellows-based breathing system; utilizes thermo anemometry for volume measurement. Used in clinical settings by physicians/anesthesia providers. Output displayed on integrated monitor; assists clinicians in managing patient ventilation and anesthesia depth during procedures. Benefits include integrated monitoring and gas delivery control.

Clinical Evidence

Bench testing only. Qualification included hazard analysis, functional testing, communication testing, environmental testing, and electromagnetic compatibility testing. No clinical data provided.

Technological Characteristics

Continuous flow anesthesia system. Uses thermo anemometry for respiratory volume measurement. Incorporates bellows-based breathing system. Features RS-232 and RS-422 serial communication ports. Supports up to two vaporizers with an identical exclusion system to the NM6000 to prevent simultaneous use. Integrated monitoring for O2, pressure, volume, CO2, N2O, and anesthetic agents.

Indications for Use

Indicated for use as a continuous flow anesthesia system for spontaneous, manually assisted, or automatic ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. Federal law restricts this device to sale by or on the order of a physician.

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

• Narkomed 6000 Anesthesia System (K980553)
• Divan (K980280)
• Evita 2 Dura (K970165)
• Combination Oximeter/Carbon Dioxide Gas Analyzer (K964239)

Submission Summary (Full Text)

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# JAN 1 1 1999

### Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

Julian Anesthesia Workstation Proprietary Name:

Gas-Machine, Anesthesia 73BSZ Classification Name:

Device Class: Class II

Manufacturer: Dräger Medizientechnik GmbH 53/55 Moislinger Allee Lübeck, Germany 23558

Establishment Registration Number: 9611500

Devices to which substantial equivalence is claimed:

| Narkomed 6000 Anesthesia System | K980553 |
|--------------------------------------------------|---------|
| Divan | K980280 |
| Evita 2 Dura | K970165 |
| Combination Oximeter/Carbon Dioxide Gas Analyzer | K964239 |

#### Device Description:

The Julian is a continuous flow gas anesthesia system.

#### Intended Use:

The Julian may be used for spontaneous, manually assisted, or automatic ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The Julian can monitor oxygen, breathing pressure, respiratory volume, CO2, N2O, and anesthetic agent identification and concentration.

#### Substantial Equivalence:

Like the NM6000 the Julian is an anesthesia system with integrated monitors providing measurement and display of inspired oxygen, breathing pressure, respiratory volume, CO2, N2O, anesthetic agent concentration, and agent identification. The NM6000 does not offer pulse oximetry, the Julian pulse oximetry module is also used in the Combination Oximeter/Carbon Dioxide Gas Analyzer.

Both the Julian and the Evita 2 Dura use thermo anemometry to measure respiratory volume.

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The theory of operation of the Julian gas delivery system from pipeline to the ventilator function is similar to the Evita 2 Dura.

The Julian can simultaneously deliver up to two gases and one agent, while the NM6000 can simultaneously deliver up to three gases and one anesthetic agent.

Both the Julian and the NM6000 use a compact breathing system. The Julian's system uses a bellows in place of the piston assembly in the NM6000.

Both the NM6000 and the Julian incorporate RS-232 and RS-422 serial communication ports.

Both the Julian and the NM6000 can accommodate up to two vaporizers. The NM6000 also provides a bracket for storage of a third vaporizer on the back of the machine.

The exclusion system of the Julian is identical to the NM6000. Both systems prevent more than one vaporizer from being used at one time.

Qualification of the Julian included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing.

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Image /page/2/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 1999

Ms. Gale E. Winarsky North American Drager 3135 Quarry Road Telford, PA 18969

K983635 Re: Julian Anesthesia Workstation Requlatory Class: II (two) Product Code: 73 BSZ Dated: October 15, 1998 Received: October 15, 1998

Dear Ms. Winarsky:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Gale E. Winarsky

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1983635 510(k) Number (if known):

Device Name: Julian Anesthesia Workstation

Indications for Use:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR Over-The-Counter Use
Mark Kramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 493636 510(k) Number.

(Optional Format 1-2-96)