(128 days)
Not Found
No
The device description focuses on mechanical components and pressure measurement for gas scavenging, with no mention of AI or ML.
No.
The device is used to remove expired and excess gases, not to deliver therapeutic treatment to the patient. It's a component of a sedation system but doesn't directly provide therapy.
No.
The device is designed for the delivery and removal of gases during nitrous oxide/oxygen sedation procedures, and it measures pressure to ensure proper scavenging, not to diagnose a medical condition.
No
The device description clearly outlines physical components like a scavenging hub, nasal hood, exhaust tubing, connectors, and a vacuum gauge, indicating it is a hardware device with a pressure measurement function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a scavenging circuit used in nitrous oxide/oxygen sedation systems. Its primary function is to deliver gases to a patient and remove expired and excess gases from the treatment location. It measures pressure to help ensure proper scavenging flow.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the human body. It interacts directly with the patient's respiratory system and the surrounding environment to manage gases.
Therefore, this device falls under the category of a medical device used for gas delivery and scavenging during a medical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
To be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases, for the removal from the treatment location of gases expired by the patient, and removal from the treatment location any excess gases delivered to a patient.
Product codes (comma separated list FDA assigned to the subject device)
CBN
Device Description
The RFS Vacuum Gauge Scavenging Circuit is designed for the removal of patient expired and excess gases during nitrous oxide / oxygen sedation procedures. For proper operation, the scavenging circuit must be cor.nected to a vacuum pump capable of providing at least 45 LPM of souverging on an operating vacuum pressure of 8 in Hg. The vacuum pump should vent exhaust gases to the outside of the building, away from fresh air intakes, windows, or walkways.
The scavenging circuit consists of the scavenging hub, which connects to a nasal hood, exhaust tubing and connectors; and the RFS Vacuum Gauge. The nasal hood fits over the patient's nasal cavity, which serves to deliver medical gases to the patient and which allows removal of expired, excess, and unused medical gases from the nasal hood and surrounding areas.
This device measures pressure. This will result in the NIOSH recommended 45 LPM decemmes correct vacually provided the mask is correctly attached, and there are no kinks or obstructions in the flow path.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's nasal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental analgesic/nitrous oxide sedation procedures
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)
Not Found
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
510(k) Number: K033503
Date: MARCH 12 2004
510(k) Summary
Introduction
This summary is intended to comply with requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510(k) Applicant
Accutron, Inc. 1733 W. Parkside Lane Phoenix, AZ 85027
510(k) Correspondent
Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors 13605 West 7th Ave., Golden, CO USA Tel: 303-234-9412 / Fax: 303-234-9413
Date Prepared
March 11, 2004
Trade Name of Device
RFS Vacuum Gauge Scavenging Circuit
Common Name of Device
Scavenging Circuit
Classification Name
Apparatus, Gas-Scavenging
510(k) Classification
868.5430 Class II Product Code: CBN
Device Description
The RFS Vacuum Gauge Scavenging Circuit is designed for the removal of patient expired and excess gases during nitrous oxide / oxygen sedation procedures. For proper operation, the scavenging circuit must be cor.nected to a vacuum pump capable of providing at least 45 LPM of souverging on an operating vacuum pressure of 8 in Hg. The vacuum pump should vent exhaust gases to the outside of the building, away from fresh air intakes, windows, or walkways.
The scavenging circuit consists of the scavenging hub, which connects to a nasal hood, exhaust tubing and connectors; and the RFS Vacuum Gauge. The nasal hood fits over the patient's nasal cavity, which serves to deliver medical gases to the patient and which allows removal of expired, excess, and unused medical gases from the nasal hood and surrounding areas.
1
510(k) Number: K033503
Date: MARCH IZ 2064
This device measures pressure, not flow. Setting the float ball at the yellow indicator level This device measures pressure. This will result in the NIOSH recommended 45 LPM decemmes correct vacually provided the mask is correctly attached, and there are no kinks or obstructions in the flow path.
Model Variations
There are two model variations: Detachable Remote Mount and Chair Mount. While the physical arrangement of exhaust tubing and appearance varies, the operating principles are the same for both model variations.
Intended Use
To be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of To be assul in mall as crimases, for the removal from the treatment location of gases expired by the batient, and removal from the treatment location any excess gases delivered to a patient.
Predicate Devices
K965239 PIP Low Profile Scavenging System (Models 260, 260U)
Risk Management
This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the cevice. Health hazard risk reduction has been accomplished by rigorous application of a risk management program.
The user must be qualified in dental analgesic/nitrous oxide sedation procedures, and must be familiar with all labeling and instructions for use associated with the device. The company believes many device health hazards are due to user error, or failure to follow instructions for use.
Accutron believes that the RFS Vacuum Gauge Scavenging Circuit is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings, positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2004
Accutron, Incorporated C/O Mr. Robert Clark Medical Device Regulatory Advisors 13605 West 7th Avenue Golden, Colorado 80401-4604
Re: K033503
Trade/Device Name: RFS Vacuum Gauge Scavenging Circuit Regulation Number: 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: II Product Code: CBN Dated: February 11, 2004 Received: February 12, 2004
Dear Mr. Clark:
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 mendments, 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 the rederal 1 000, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of an annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mry, it may of subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be round sh further announcements concerning your device in the Federal Register.
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 mean that 1177 mas made a autes and regulations administered by other Federal agencies. of the Act of all , I out all the Act's requirements, including, but not limited to: registration
3
Page 2 - Mr. Robert Clark
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 er result in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bectronic 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 (301) 594-4646. 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/dsma/dsmamain.html.
Sincerely yours,
Ouls
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
K033503 510(k) Number (if known):
RFS Vacuum Gauge Scavenging Circuit Device Name:
Indications for Use:
To be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases, for the removal from the treatment location of gases expired by the patient, and removal from the treatment location any excess gases delivered to a patient.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
ion of Anesthesiology, General Hospital, Infection Control Dental D
510(k) Number: K033503