PASSIVE WASTE GAS SCAVENGER, MODEL 14600

K080039 · G. Dundas Co.,Inc. · CBN · Apr 14, 2008 · Anesthesiology

Device Facts

• Record ID: K080039
• Device Name: PASSIVE WASTE GAS SCAVENGER, MODEL 14600
• Applicant: G. Dundas Co.,Inc.
• Product Code: CBN · Anesthesiology
• Decision Date: Apr 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5430
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Passive Waste Gas Scavenger is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children. The Passive Waste Gas Scavenger is designed for use with non-recirculating waste gas disposal systems and is intended for prescription use only.

Device Story

Passive Waste Gas Scavenger connects to anesthesia machine ventilation system via horizontal hose terminal; transfers waste gases to non-recirculating exhaust system using ventilator outlet pressure. Device incorporates pressure relief valves to manage excess positive/negative pressure; prevents pressure exceeding 3.0 cm H2O under normal flow (75 L/min). Positive pressure relief limits inlet pressure to ≤ 9 cm H2O during blockages; negative pressure relief prevents inlet pressure falling below -2.5 mm H2O if exhaust becomes active. Reusable device; no patient contact. Used in clinical settings where general anesthesia is administered.

Clinical Evidence

Bench testing only. Performance testing compared subject device to predicates, confirming similar pressure relief functionality and flow characteristics under normal and fault conditions.

Technological Characteristics

Reusable passive gas scavenging apparatus. Materials include hose terminals (30mm/27mm/19mm). Operates via ventilator-supplied pressure. Incorporates positive and negative pressure relief valves. Complies with ASTM 1343-02 for scavenging systems. No electrical energy source; purely mechanical operation.

Indications for Use

Indicated for scavenging waste anesthetic gases from anesthesia machines during general anesthesia for adult and pediatric patients. Prescription use only.

Regulatory Classification

Identification

A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.

Predicate Devices

• Ohio Waste Gas Scavenging Interface (K842003)
• NAD Scavenging Relief Valve (K790333)

Submission Summary (Full Text)

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L080039
APR 14 2008

#### 510(k) Summary:

The Passive Waste Gas Scavenger is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children. The device meets the criteria for an active waste gas scavenger in the event the environment changes during use and negative pressure enters the evacuation system.

#### Submitter:

G. Dundas Company, Inc. 24301 Roberts Drive Black Diamond, WA 98010 253-631-8008 (phone) 360-886-1350 (fax)

# Contact:

Mario Sorci

#### Date:

2 January, 2008

#### Device Name:

Passive Waste Gas Scavenger

# Classification Name:

Apparatus, Gas Scavenging

#### Product Code:

CBN

#### Regulation Number:

868.5430

### Predicate Devices:

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# K842003

Ohio Waste Gas Scavenging Interface Applicant: Ohio Medical Products

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:

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# K790333

NAD Scavenging Relief Valve Applicant: Drager Medical, Inc.

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:

:

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#### Device Description:

The Passive Waste Gas Scavenger is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children. The Passive Waste Gas Scavenger is designed for use with non-recirculating waste gas disposal systems and is intended for prescription use only. This scavenging approach relies on the pressure of the waste gas to transfer the gas from the scavenger to the exhaust system.

The scavenger body incorporates one 30mm/27mm/19mm horizontal hose terminal to connect the scavenger to the anesthesia machine. The vertically oriented 30mm/19mm hose terminal is intended to connect the scavenger to the exhaust system.

The G. Dundas Passive Scavenger incorporates the same safety systems as predicate devices, providing relief of excess positive pressure and excess negative pressure to the patient through the use of pressure relief valves, in compliance with ASTM 1343-02 -Anesthetic Equipment -- Scavenging Systems for Anesthetic Gases. Although there is no standard for passive waste gas scavenging systems, the G. Dundas Passive Scavenger is designed to fail safe under active waste disposal conditions.

The G. Dundas Passive Scavenger and the predicate devices were tested and found to have similar performance. Testing procedures and data can be found in Section 7 of this application.

#### 3.a. Regulation CBN, Product Code 868.5430

3.b. Principle of Operation: The 14600 Passive Waste Gas Scavenger is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesía. It is designed for use with non-recirculating waste gas disposal systems. This scavenging approach relies on the pressure of the waste gas to transfer the scavenger to the exhaust system. The 14600 is not designed for patient contact and is a reusable device.

The inlet port is attached to the ventilation system of the anesthesia machine. During operation, waste gases from the patient are transfer into the scavenger by the outlet pressure supplied by the ventilator. The gases will then travel through the scavenger into a non-recirculating exhaust system. Under normal operating conditions (75 L/min flow through the inlet), the pressure shall not exceed 3.0 cm H2O.

The 14600 is designed with fault tolerances to handle changes in conditions of both the ventilator and the exhaust system. If pressure increases due to exit port occlusion or a blockage in the exhaust system, the positive pressure relief valve will open, limiting the inlet pressure to less than or equal to 9 cm H₂O. If conditions allow the exhaust system to become an active take away system, the negative relief valve will open, not allowing the inlet pressure to go below -2.5 mm H2O.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 4 2008

Mr. Mario Sorci G. Dundas Company, Incorporated 24301 Roberts Drive Black Diamond, Washington 98010

Rc: K080039

Trade/Device Name: Passive Waste Gas Scavenger Regulation Number: 21 CFR 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: II Product Code: CBN Dated: January 3, 2008 Received: March 31, 2008

Dear Mr. Sorci:

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. Sorci

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,

Sutie y. Michaud

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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# Statement of Indication for Use:

510(k) Number:

Device Name: Passive Waste Gas Scavenger

The Passive Waste Gas Scavenger is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children. The Passive Waste Gas Scavenger is designed for use with non-recirculating waste gas disposal systems and is intended for prescription use only.

Prescription Use (Per 21 CFR 801.109) And/Or

Over the Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suette Y. Mcheim Dms

24

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

510(k) Number.