DRAGER-VAPOR 2000

K971923 · Draeger Medical, Inc. · CAD · Sep 16, 1997 · Anesthesiology

Device Facts

• Record ID: K971923
• Device Name: DRAGER-VAPOR 2000
• Applicant: Draeger Medical, Inc.
• Product Code: CAD · Anesthesiology
• Decision Date: Sep 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vapor 2000 is intended for vaporization and delivery of a controlled amount of liquid anesthetic agent. The Vapor 2000 is designed and labeled accordingly for use with Enflurane, Isoflurane, Halothane, and Sevoflurane,

Device Story

Dräger-Vapor 2000 is a concentration-calibrated, non-heated vaporizer for liquid anesthetic agents (Enflurane, Isoflurane, Halothane, Sevoflurane). Device integrates into anesthesia delivery systems to enrich fresh gas flow with controlled vapor concentrations. Features include vaporizing chamber bypass, multiple filling system options (funnel, key-index, Quik-Fill), and a transport mode to prevent spillage/leakage and isolate the vaporizing chamber. Operated by clinicians in clinical settings. Output is a controlled concentration of anesthetic vapor, enabling precise anesthesia delivery to patients. Larger reservoir capacity compared to predecessor.

Clinical Evidence

Bench testing only. Compliance with ASTM Standard F 1161-88 demonstrated. Testing evaluated concentration output stability under varying conditions: temperature, gas flow, duration of use, tilting, and back pressure.

Technological Characteristics

Non-heated, concentration-calibrated vaporizer. Mechanical design with vaporizing chamber bypass. Filling systems: funnel, key-index, or Quik-Fill. Includes transport mode for chamber isolation. Complies with ASTM F 1161-88. No electronic or software components described.

Indications for Use

Indicated for use as a non-heated calibrated vaporizer to enrich fresh gas flow in an anesthesia delivery system with controlled anesthetic vapor. Intended for use with Enflurane, Isoflurane, Halothane, or Sevoflurane. Not for use with desflurane or within an anesthetic breathing system. Prescription use only.

Regulatory Classification

Identification

An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

Predicate Devices

• Dräger-Vapor® 19.1 (K940255)

Submission Summary (Full Text)

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K71923

# SEP 1 6 1997

# Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

Proprietary Name: Dräger-Vapor® 2000

Classification Name: Vaporizer, Anesthesia, Non-heated

Device Class: Class II

- Initial Distributor: North American Dräger 3135 Quarry Road Telford, Pennsylvania 18969
Establishment Registration Number: 2517967

- Manufacturer: Drägerwerk AG Lübeck, Germany
Establishment Registration Number: 2517967

Device to which substantial equivalence is claimed: Dräger-Vapor® 19.1 K940255

### Device Description:

The Dräger-Vapor 2000 (Vapor 2000) is a concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents.

## Intended Use:

The Vapor 2000 is intended for vaporization and delivery of a controlled amount of liquid anesthetic agent. The Vapor 2000 is designed and labeled accordingly for use with Enflurane, Isoflurane, Halothane, and Sevoflurane,

### Substantial Equivalence:

The Vapor 2000 is substantially equivalent to the Dräger-Vapor 19.1 (Vapor 19.1). Both are concentration calibrated, non-heated vaporizers for vaporizing liquid anestheiic agents with a vaporizing chamber bypass. Both the Vapor 2000 and Vapor 19.1 are available with attached funnel or key-index filling systems. The Vapor 2000 will also be available with the Quik-Fill™ filling system.

The Vapor 2000 differs slightly from the Vapor 19.1 in that the Vapor 2000 has a transport mode which secures the vaporizer from spillage of liquid agent, leakage of anesthetic vapor, and closes off the vaporizing chamber isolating liquid agent or vapors from the rest of the vaporizer.

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The Vapor 2000 has a larger reservoir than the Vapor 19.1.

The Vapor 2000 and the Vapor 19.1 have the same intended use and principal of operation and are substantially equivalent.

Qualification of the Vapor 2000 included testing to demonstrate compliance with ASTM Standard F 1161-88, and the effect of temperature, gas flow, duration of use, tilting, and back pressure on concentration output.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP 1 6 1997

Mr. James J. Brennan North American Drager 3135 Quarry Road 18869 Telford, Pennsylvania

к971923 Re: Dräger-Vapor® 2000 Regulatory Class: II (two) Product Code: 73 CAD August 5, 1997 Dated: Received: August 5, 1997

Dear Mr. Brennan:

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 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 Requlation (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 regulation may result in regulatory 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 - Mr. James J. Brennan

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 requlation (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 [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours
Thomas J. Callahan

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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Page 1

510(k) Number (if known): K971923

Device Name: Drager-Vapor& 2000

Indications for Use:

The Dräger-Vapor 2000 (Vapor 2000) is a non-heated calibrated vaporizer designed to enrich the fresh gas flow of an ancsthesia delivery system with a controlled amount of anesthetic vapor. Separate models of the single-agent vaporizer are intended for use with one of the following agents: isoflurane, halothane, cofluranc, or sevofiuranc. The vaporizer is not intended for use with desflurane, or for use within an anesthetic breathing system. Federal law restricts this device to sale by or on the order of a physician.

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Concurrence of CDRII, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

. Bazant

OR

Over-The-Counter Use_

Afl. A. Ciall.

(Optional Format 1-2-96)

(Division Sign-Off) (Division Sign-Oit)
Division of Cardiovascular, Respiratory, Division of Occal Devices

510(k) Number _