(10 days)
The DGSS™ 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 DGSSTM is a single unit, designed to replace a traditional anesthetic gas scavenging (interface) assembly, located between the exhaust outlet of an anesthesia machine and the waste anesthetic gas disposal (WAGD) suction line in an operating room. Like prior technology, it provides a safe interface between anesthesia delivery systems and hospital-provided WAGD suction lines, The DGSS™ 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 DGSS™ 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 "pop-off" relief valves, in compliance with ASTM 1343-02 - Anesthetic Equipment - Scavenging Systems for Anesthetic Gases. Although the indications and intended use are identical with predicate devices, the DGSS™ replaces the manually-adjusted needle valve with an automatic mechanism regulating the flow in the WAGD suction line. This valve is controlled by a pressuresensing switch which closes the valve when negative pressure is sensed in the manifold. This serves to reduce the needless entrainment of room air into the WAGD system of the healthcare facility. This sensor-valve arrangement operates within the inlet pressure range of -0.5 to 3.5 cm H2O, as specified by ASTM 1343-02 The valve-sensor mechanism is electrically powered with low-voltage direct current to prevent any hazard of electrical or fire injury in compliance with IEC 60601-1. The valve is normally open, so that a failure of electrical power results in the unit reverting to function identically to the predicate device. Other failure modes operate identically with the predicate device. Although the electrical portion of the device section presents no hazard of spark or fire, additional protection is provided by physically separating the electrical system from the waste gas pathway. This isolates the electrical subsystem from exposure to any oxygen-enriched waste anesthetic gas. Although technologically more advanced and efficient than the predicate device, the DGSS™ presents no additional issues of safety or efficacy due to its design. Any failure of the new design feature converts the device to one identical to predicate technology. Due to this design, the DGSS™ is substantially equivalent to the predicate device.
The provided text is a 510(k) summary for a medical device called the Dynamic Gas Scavenging System (DGSSTM). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The text focuses on demonstrating that the DGSSTM is substantially equivalent to a previously cleared predicate device (Ohio Waste Gas Scavenging Reservoir, K842003) by highlighting its similar indications for use and safety systems, while noting an improvement in efficiency through an automatic flow regulation mechanism. The key argument for substantial equivalence is that any failure of the new design feature causes the device to revert to the exact function of the predicate device.
Therefore, I cannot provide the requested table and study details based on this input. The information provided is primarily for regulatory clearance based on substantial equivalence, not a performance study against specific acceptance criteria.
{0}------------------------------------------------
KO
510(k) summary
Dynamic Gas Scavenging System (DGSSTM)
Submitter:
DEC = 1 2006
Anesthetic Gas Reclamation, LLC 700 Two American Center 3102 West End Avenue Nashville TN 37203-1304 615-336-0963 (voice)
Contact:
James M Berry, MD
Date:
October 9, 2006
Device Name:
Dynamic Gas Scavenging System (DGSSTM) An interface valve for scavenging waste anesthetic gases
Classification Name:
Apparatus, Gas Scavenging
Product Code:
CBN
Regulation Number:
868.5430
Predicate Device:
K842003 - Ohio Waste Gas Scavenging Reservoir
{1}------------------------------------------------
Device Description:
The DGSSTM is a single unit, designed to replace a traditional anesthetic gas scavenging (interface) assembly, located between the exhaust outlet of an anesthesia machine and the waste anesthetic gas disposal (WAGD) suction line in an operating room. Like prior technology, it provides a safe interface between anesthesia delivery systems and hospital-provided WAGD suction lines,
The DGSS™ 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 DGSS™ 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 "pop-off" relief valves, in compliance with ASTM 1343-02 - Anesthetic Equipment - Scavenging Systems for Anesthetic Gases.
Although the indications and intended use are identical with predicate devices, the DGSS™ replaces the manually-adjusted needle valve with an automatic mechanism regulating the flow in the WAGD suction line. This valve is controlled by a pressuresensing switch which closes the valve when negative pressure is sensed in the manifold. This serves to reduce the needless entrainment of room air into the WAGD system of the healthcare facility. This sensor-valve arrangement operates within the inlet pressure range of -0.5 to 3.5 cm H2O, as specified by ASTM 1343-02
The valve-sensor mechanism is electrically powered with low-voltage direct current to prevent any hazard of electrical or fire injury in compliance with IEC 60601-1. The valve is normally open, so that a failure of electrical power results in the unit reverting to function identically to the predicate device. Other failure modes operate identically with the predicate device.
Although the electrical portion of the device section presents no hazard of spark or fire, additional protection is provided by physically separating the electrical system from the waste gas pathway. This isolates the electrical subsystem from exposure to any oxygen-enriched waste anesthetic gas.
Although technologically more advanced and efficient than the predicate device, the DGSS™ presents no additional issues of safety or efficacy due to its design. Any failure of the new design feature converts the device to one identical to predicate technology. Due to this design, the DGSS™ is substantially equivalent to the predicate device.
Additional detailed information is attached as a section entitled "Specifications."
{2}------------------------------------------------
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Anesthetic Gas Reclamation, LLC C/O Mr. Robert Mosenkis Responsible Third Party Official Citech 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
OEC = 1 2006
Re: K063519
Trade/Device Name: Dynamic Gas Scavenging System (DGSSTM) Regulation Number: 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: II Product Code: CBN Dated: November 20, 2006 Received: November 21, 2006
Dear Mr. Mosenkis:
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 -Mr. Mosenkis
Please be advised that FDA's issuance of a substantial equivalence determination docs 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) 276-0120. 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,
Susan Rumoe
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:
Device Name: Dynamic Gas Scavenging System (DGSS™)
Indications for Use:
The DGSS™ 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.
X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
llen
Sign-Om
Flan of Anesthesiology, General Hospital,
........on Control, Dental Devices
8
§ 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).