D-VAPOR

K042276 · Draeger Medical, Inc. · CAD · Sep 23, 2004 · Anesthesiology

Device Facts

• Record ID: K042276
• Device Name: D-VAPOR
• Applicant: Draeger Medical, Inc.
• Product Code: CAD · Anesthesiology
• Decision Date: Sep 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of anesthetic vapor. The D-Vapor is intended for use with Desflurane. It is not intended for use with Enflurane, Halothane, Isoflurane, or Sevoflurane or for use in a breathing circuit. Federal law restricts this device to sale by or on the order of a physician.

Device Story

D-Vapor is an electronic calibrated vaporizer for Desflurane delivery; integrates into anesthesia delivery system fresh-gas line. Device enriches fresh gas flow with controlled anesthetic vapor concentrations (2-18 vol.%). Features front display panel for status monitoring (operational, output, agent level, warm-up, battery) and audible alarms. Includes sight glass for agent level monitoring and keyed filling system (Saf-T-Fill) to prevent agent mismatch. Supports various mounting configurations (quick connect, Selectatec, block connector, conical fittings) and includes a transport mode for movement with agent. Operated by clinicians in clinical settings; provides visual/audible feedback to assist in anesthesia management. Benefits include precise agent delivery and improved workflow via transportability and standardized connectivity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic calibrated vaporizer; Desflurane-specific. Features front-panel status display, audible alarms, sight glass for agent level, and keyed filling system. Supports multiple mounting interfaces (Selectatec, block connector, conical fittings). Includes transport mode. Powered device with battery status monitoring. Not MRI compatible.

Indications for Use

Indicated for use with Desflurane anesthetic agent in the fresh-gas line of an anesthesia delivery system. Contraindicated for use with Enflurane, Halothane, Isoflurane, or Sevoflurane, use in a breathing circuit, or use in an MRI environment.

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

• Vapor 2000 (K971923)
• Tec 6 Plus (K000275)

Submission Summary (Full Text)

{0}------------------------------------------------

K642276

## SEP 2 3 2004

A Dräger and Siemens Company

# Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

D-Vapor Proprietary Name:

Common Name: Anesthesia Vaporizer

Classification Name: Anesthetic Vaporizer

73 CAD Product Codes:

Device Class: Class II

Draeger Medical AG & Co KGaA Manufacturer: 53/55 Moislinger Allee Luebeck, Germany

Establishment Registration Number: 9611500

Devices to which substantial equivalence is claimed: K971923 Vapor 2000 Tec 6 Plus K000275

### Device Description:

The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of Desflurane anesthetic vapor in concentrations of 2 to 18 vol.%.

### Indications for Use:

The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of anesthetic vapor. The D-Vapor is intended for use with Desflurane. It is not intended for use with Enflurane, Halothane, Isoflurane, or Sevoflurane or for use in a breathing circuit. Federal law restricts this device to sale by or on the order of a physician.

#### Intended Use:

The D-Vapor is intended to be used with Desflurane anesthetic agent, and inserted in the fresh-gas line of an anesthesia delivery system. It is not intended for use with Enflurane, Halothane, Isoflurane, or Sevoflurane, or in a breathing system.

Draeger Medical, Inc.
3135 Quarry Road
Telford, PA 18969
Tel: [phone], ext. 2363
Toll-free: 800-4DRAGER (437-2437)
Fax: [phone]
E-mail: [e-mail]

http://www.draeger-medical.com

{1}------------------------------------------------

#### Substantial Equivalence:

Like the Tec 6 Plus, the D-Vapor is an electronic vaporizer which delivers desflurane anesthetic agent. The D-Vapor can be adjusted from 2- 18 Vol.%, while the Tec 6 Plus adjustment is 1-18 Vol.%. Both the D-Vapor and the Tec 6 Plus have front display panels which provide the user with a visual indication of the status of the vaporizer for the following

categories: Operational, No Output, Low Agent Level, Warm Up, and Battery Status. Both systems also provide audible alarms, and the ability to silence alarms. Like the Vapor 2000, the D-Vapor provides a sight glass on the front of the device to visually indicate the level of agent in the vaporizer both for filling the vaporizer and monitoring remaining agent within the vaporizer.

The D-Vapor can be used with quick connect systems identical to the Vapor 2000 plug in adapter system, or identical to the Tec 6 plug in system for Selectatec® plug in connectors. It can be permanently installed using a block connector with o-rings and screws like the Tec 6 Plus, or used with conical fittings like the Vapor 2000.

The D-Vapor and the Tec 6 Plus have keyed filling systems to only allow the use of Desflurane bottles with the Saf-T-Fill™ system when adding Desflurane agent to the vaporizers.

The D-Vapor and the Vapor 2000 have a transport mode allowing the vaporizer to be removed from the delivery system and moved with agent in the vaporizer.

Both the D-Vapor and the Tec 6 Plus are contraindicated for use in an MRI environment.

Draeger Medical, Inc.
3135 Quarry Road
Telford, PA 18969
Tel: [phone], ext. 2363
Toll-free: 800-4DRAGER (437-2437)
Fax: [phone]
E-mail: [e-mail]

http://www.draeger-medical.com

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, with three stylized wing-like shapes above a wavy line.

SEP 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Gale E. Winarsky Regulatory Affairs Project Manager Dräegar Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K042276

Trade/Device Name: D-Vapor Regulation Number: 21 CFR 868.5880 Regulation Name: Anesthetic Vaporizer Regulatory Class: II Product Code: CAD Dated: August 20, 2004 Received: August 23, 2004

Dear Ms. Winarsky:

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 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.

{3}------------------------------------------------

Page 2 - Ms. Winarsky

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,

Susan Ropp

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

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): _ ko42276

Device Name: ___D-Vapor

Indications for Use:

The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of The D- Vapor is an electronic a controlled amount of anesthetic vapor. The D-Vapor an anosthoon a with Desflurane. It is not intended for use with Enflurane, Halothane, Is intended for abo will and or for use in a breathing circuit. 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 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CQRH, Office of Device Evaluation (ODE)

Susan Dunno

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

1042220 510(k) Number ..

Page 1 of 1