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 Description

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.

AI/ML Overview

The provided text describes a medical device, the "Passive Waste Gas Scavenger," and its 510(k) submission to the FDA. It does not contain information about a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/ML device evaluations (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth dataset).

Instead, the document focuses on the device's design specifications and functional performance in relation to safety standards for medical gas scavenging systems. The "acceptance criteria" here are defined by the device's operational parameters and compliance with an existing ASTM standard, rather than statistical performance against a diagnostic endpoint.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission. I will extract the relevant information and indicate where categories are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Design/Functional Specification)	Reported Device Performance (Operational Parameter)
Inlet pressure during normal operation (75 L/min flow)	Shall not exceed 3.0 cm H$_{2}$O
Positive pressure relief valve activation	Limits inlet pressure to $\leq$ 9 cm H$_{2}$O
Negative pressure relief valve activation	Prevents inlet pressure from going below -2.5 mm H$_{2}$O
Compliance with ASTM 1343-02	Device incorporates safety systems providing relief of excess positive and negative pressure to the patient, similar to predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not applicable. The "testing" referred to appears to be engineering and functional validation, not a clinical study on a patient sample. The device's performance is described in terms of its operational parameters under specific flow and pressure conditions.
Data Provenance: Not applicable. The testing is likely internal engineering validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth for this type of device is based on established engineering principles and medical device safety standards (e.g., ASTM 1343-02), rather than expert clinical consensus on diagnostic outcomes.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Not applicable. There's no indication of a ground truth adjudication process in the clinical sense. Performance is assessed against predefined physical parameters.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a mechanical medical device, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: Engineering specifications and established medical device safety standards (specifically ASTM 1343-02 for "Anesthetic Equipment -- Scavenging Systems for Anesthetic Gases"). The performance is measured against these defined physical and safety thresholds.

8. The sample size for the training set

Not applicable. This is a mechanical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of the "Study" mentioned:

The document states, "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." This indicates that the "study" was a performance validation by comparing its functional operation to its predicate devices and against the safety requirements outlined in ASTM 1343-02. The described "performance" relates to maintaining specific pressure thresholds within the scavenging system under normal and fault conditions (e.g., positive and negative pressure relief valve activation). The provided data points (3.0 cm H₂O max inlet pressure, $\leq$ 9 cm H₂O positive relief, $\geq$ -2.5 mm H₂O negative relief) are the direct results of this functional testing.

Summary

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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

. .

K790333

NAD Scavenging Relief Valve Applicant: Drager Medical, Inc.

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Device Description:

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

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

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

510(k) Number.

Regulation Number and Section

§ 868.5430 Gas-scavenging apparatus.

(a)
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.(b)
Classification. Class II (performance standards).