(128 days)
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.
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 connected to a vacuum pump capable of providing at least 45 LPM of scavenging 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, not flow. Setting the float ball at the yellow indicator level This device measures pressure. This will result in the NIOSH recommended 45 LPM provided the mask is correctly attached, and there are no kinks or obstructions in the flow path.
The provided text describes a 510(k) summary for the "RFS Vacuum Gauge Scavenging Circuit." This document is a premarket notification for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics in the way a clinical trial report would for an AI/ML device.
Therefore, much of the requested information (acceptance criteria table, sample size, expert qualifications, adjudication, MRMC study, standalone performance, training set details) is not applicable or not provided in this type of regulatory submission for a physical scavenging circuit.
However, based on the provided text, we can infer some aspects related to the device's intended performance and its substantiation.
Here's an analysis based on the provided text:
Acceptance Criteria and Study Details
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Description) |
|---|---|
| Removal of expired/excess gases: Must effectively scavenge patient-expired and excess nitrous oxide/oxygen gases during sedation. | Designed for removal of patient expired and excess gases. Scavenging circuit connects to nasal hood to deliver gases and allow removal. |
| Achieve recommended scavenging flow: Must be capable of ensuring the NIOSH recommended 45 LPM scavenging. | "Setting the float ball at the yellow indicator level... will result in the NIOSH recommended 45 LPM provided the mask is correctly attached, and there are no kinks or obstructions in the flow path." Monitors pressure to infer flow. |
| Compatibility with vacuum pump: Requires connection to a vacuum pump providing at least 45 LPM at 8 in Hg. | Device description states: "scavenging circuit must be connected to a vacuum pump capable of providing at least 45 LPM of souverging on an operating vacuum pressure of 8 in Hg." |
| Safety: Device must be safe and effective when used as instructed. | "This device has been designed to either completely eliminate or mitigate known health hazards... rigorous application of a risk management program." "Accutron believes that the RFS Vacuum Gauge Scavenging Circuit is safe and effective when used as instructed." |
| Substantial Equivalence: To predicate device. | Determined "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This document does not describe a test set or data provenance in the context of validating a diagnostic or AI device's performance through data analysis. It's a submission for a physical device, and performance is likely demonstrated through engineering verification and validation testing, not a clinical data-driven "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. Ground truth establishment by experts is not described for this type of device. Performance is assessed against engineering specifications and regulatory standards.
4. Adjudication method for the test set
- Not Applicable / Not Provided. Adjudication methods are not described for this type of device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a physical medical device (scavenging circuit), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
- Engineering Specifications and Industry Standards: The "ground truth" for this device would be its ability to meet established engineering performance specifications (e.g., vacuum pressure, flow rates, sealing capabilities) and adherence to industry standards, such as the NIOSH recommended 45 LPM scavenging. This is determined through physical testing and measurement, not typically against expert consensus, pathology, or outcomes data in the way an AI diagnostic device would.
8. The sample size for the training set
- Not Applicable / Not Provided. This is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no training set, this question is not relevant.
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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.
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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.
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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
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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
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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
§ 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).