GAV - GENERAL ANAESTHETIC VAPORIZER

K051666 · General Anaesthetic Services Limited · CAD · Aug 23, 2005 · Anesthesiology

Device Facts

• Record ID: K051666
• Device Name: GAV - GENERAL ANAESTHETIC VAPORIZER
• Applicant: General Anaesthetic Services Limited
• Product Code: CAD · Anesthesiology
• Decision Date: Aug 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5880
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

General anesthesia may be produced using techniques of inhalation anesthesia and in such cases the use of an anesthetic vaporizer such as the GAV will be indicated. The GAV General Anesthetic Vaporizer is a concentration-calibrated device intended to deliver specific anesthetic agents into the fresh gas supply of an anesthesia workstation or anesthesia gas machine. The volatile agents intended to be used with this device are: Isoflurane, Sevoflurane and Halothane. US Federal law restricts this device for sale by or on the order of a licensed physician

Device Story

GAV is a mechanical, agent-specific, concentration-calibrated anesthetic vaporizer. It connects to anesthesia machine breathing circuits via the Selectatec system. Operation involves variable bypass flow-over technology with automatic flow compensation to maintain constant output concentration across varying temperatures and flow rates. Device features include a single direct-reading control dial, integral interlock, keyed filler, and liquid level indicator. Used by physicians in clinical environments to induce and maintain inhalation anesthesia. Benefits include precise delivery of volatile anesthetic agents to the patient breathing circuit.

Clinical Evidence

Bench testing only. No clinical data provided. Performance equivalence established through comparative technical specifications, design analysis, and verification of output concentration stability under varying flow and temperature conditions.

Technological Characteristics

Mechanical, agent-specific, variable bypass, flow-over vaporizer. Materials: brass, copper, aluminum, bronze, stainless steel, glass, cotton, metal foil, thermoplastics, PTFE. Features: Selectatec-compatible, integral interlock, keyed filler, liquid level indicator, direct-reading control dial calibrated in % V/V. No software or electronic components.

Indications for Use

Indicated for patients requiring inhalation anesthesia via delivery of Isoflurane, Sevoflurane, or Halothane. Intended for use by licensed physicians in clinical settings.

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

• Tec 5 Continuous Flow Vaporizer (K892057)

Submission Summary (Full Text)

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KOSIolde

AUG 2 3 2005

# 510(k) Summary

### Submitter

General Anaesthetic Services Limited Worth Valley House Ingrow Bridge Business Park Halifax Road Keighley West Yorkshire BD21 5EF UK 044 (0)1535 609615 Tel:

044 (0) 1535 691033 Fax:

| Contact: | Andrew J W Wall, Quality Manager | |
|-------------------|----------------------------------|--------|
| Summary Prepared: | 18 April 2005 | Rev. 0 |
| Summary Amended: | 12 July 2005 | Rev. 1 |

# Name of Device

| Trade Name: | GAV - General Anaesthetic Vaporizer |
|----------------------|-------------------------------------|
| Common Name: | Vaporizer |
| Classification Name: | Vaporizer, Anesthesia, Non-Heated |
| Product Code: | CAD |
| Regulation Number: | 21 CFR 868.5880 |

### Legally Marketed Device on which equivalence is claimed

| Trade Name: | Tec 5 Continuous Flow Vaporizer |
|----------------------|-----------------------------------|
| Common Name: | Vaporizer |
| Classification Name: | Vaporizer, Anesthesia, Non-Heated |
| Product Code: | CAD |
| Regulation Number: | 21 CFR 868.5880 |
| 510(k) Number: | K892057 |

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### Description of the Device

The GAV – General Anaesthetic Vaporizer is designed for use in continuous flow techniques of THE GAV – General Anacotherio Tuponized to Goughed with an output which remains largely general anesthesia. It has a finely graduation that occipis and temperatures. Safety features such as unteriged Over a wide range of ther see incorporated together with many convenience features intenoun, Nor-oplir and Reyou Fillor are meet persition. GAV vaporizers are agent specific and are clearly labelled and colour coded for additional safety.

### Intended Use

Indications For Use:

General anesthesia may be produced using techniques of inhalation anesthesia and in such cases the use of an anesthetic vaporizer such as the GAV will be indicated.

### Non-Clinical Performance Data

The pre-market notification references non-clinical tests the results of which are detailed in Section 4.

### Summary of Comparisons - GAV v Tec 5

#### Clinical:

#### Used for the same clinical purpose (to induce and/or maintain required depths of inhalation anaesthesia in patients)

Used at the same site in the body (connected to the patient breathing circuit via the Selectatec system and the common gas outlet of the anaesthetic machine)

Used on similar patient populations (Ages, anatomy, physiology etc.)

Has similar relevant performance according to expected clinical effect for the specified intended use (output matches the set concentration and remains constant over a number of changing/changeable variables)

#### Technical:

GAV used under similar conditions of use (used in appropriate clinical environments)

Has similar specifications and properties (Accuracy, temperature range, flow range, pressures and output matches the set concentration and remains constant over a number of changing/changeable variables)

#### Is of similar design

(Mechanical with single, direct-reading control dial which is calibrated in volumes percent (% V/V), compatible with Selectatec system, integral interlock, keyed filler, liquid level indicator.

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## Has similar principles of operation

Has Similar principles over with wicks. For use outside the (Vanable bypass, frow Over thin minnensation by automatic flow variation. Agent specific)

# Manufactured from similar materials

Manufactured from Similar mater, aluminium, bronze, stainless (Specified grades of brace, copper), Glass, cotton, metal foil. Steel, themnoplastics, FT E and rabs and wax. Electroplating and anodizing.)

#### Biological:

(Connected to the patient breathing circuit via the Selectatec system and the (Oonnoolou to the pof the anaesthetic machine)

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular, with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of several curved lines that suggest the wings and body of a bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2005

General Anaesthetic Services, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K051666

Trade/Device Name: GAV - General Anaesthetic Vaporizer Regulation Number: 21 CFR 868.5880 Regulation Name: Anaesthetic Vaporizer Regulatory Class: II Product Code: CAD Dated: August 11, 2005 Received: August 15, 2005

Dear Mr. Job:

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.

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Page 2 - Mr. Job

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/industry/support/index.html.

Sincerely yours,

Suser Runner

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

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# Indications for Use

Not yet known 510(k) Number (if known):

GAV - General Anaesthetic Vaporizer Device Name:

Indications For Use:

The GAV General Anesthetic Vaporizer is a concentration-calibrated device intended to deliver specific anesthetic agents into the fresh gas supply of an anesthesia workstation or anesthesia gas machine. The volatile agents intended to be used with this device are: Isoflurane, Sevoflurane and Halothane.

US Federal law restricts this device for sale by or on the order of a licensed physician

Prescription Use Applicable (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use Not Applicable (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)

Cura Sulton

**510(k) Number:**

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