(98 days)
Not Found
No
The device description focuses on mechanical components and pressure-based operation, with no mention of AI or ML.
No
The device is described as a 'Passive Waste Gas Scavenger' intended to scavenge waste anesthetic gases from anesthesia machines, not to provide therapeutic treatment to a patient. Its purpose is to handle by-products of anesthesia, not directly treat a medical condition.
No
The device is a passive waste gas scavenger, designed to manage waste anesthetic gases. Its function is to scavenge gases, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly details physical components like "scavenger body," "hose terminal," and "pressure relief valves," indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "scavenge waste anesthetic gases from anesthesia machines." This is a function related to managing the environment and safety during a medical procedure, not analyzing a biological sample from the human body.
- Device Description: The description details a physical device with hose terminals and pressure relief valves designed to connect to anesthesia machines and exhaust systems. It focuses on the mechanical function of gas removal.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment based on sample analysis.
- Reagents, calibrators, or controls typically associated with IVD tests.
The device is clearly designed to manage waste gases generated during anesthesia, which is an environmental and safety function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for 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 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CBN
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.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 anesthesia. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and children
Intended User / Care Setting
prescription use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
1
K842003
Ohio Waste Gas Scavenging Interface Applicant: Ohio Medical Products
.
.
.
.
.
.
.
:
. .
K790333
NAD Scavenging Relief Valve Applicant: Drager Medical, Inc.
.
:
:
2
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.
3
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.
4
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
5
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.