RFS VACUUM GAUGE SCAVENGING CIRCUIT

K033503 · Accutron, Inc. · CBN · Mar 12, 2004 · Anesthesiology

Device Facts

• Record ID: K033503
• Device Name: RFS VACUUM GAUGE SCAVENGING CIRCUIT
• Applicant: Accutron, Inc.
• Product Code: CBN · Anesthesiology
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5430
• Device Class: Class 2

Intended 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.

Device Story

The RFS Vacuum Gauge Scavenging Circuit is a gas-scavenging apparatus used in dental clinics during nitrous oxide/oxygen sedation. It connects to a nasal hood and a vacuum pump (minimum 45 LPM capacity at 8 in Hg) to remove patient-expired and excess medical gases from the treatment area. The system includes a scavenging hub, exhaust tubing, and a vacuum gauge. The gauge measures vacuum pressure to ensure proper flow; users adjust the system to a yellow indicator level to achieve the recommended 45 LPM scavenging rate. The device is available in detachable remote mount and chair mount configurations. By effectively removing waste gases, the device helps maintain air quality in the clinical environment, protecting both the patient and the healthcare provider from exposure to excess nitrous oxide.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Gas-scavenging apparatus; consists of scavenging hub, nasal hood, exhaust tubing, and vacuum pressure gauge. Operates via connection to an external vacuum pump (min 45 LPM at 8 in Hg). Available in detachable remote mount or chair mount configurations. Non-electronic, mechanical pressure monitoring.

Indications for Use

Indicated for use in nitrous oxide/oxygen sedation systems for patients undergoing dental analgesic/nitrous oxide sedation procedures. Requires a clinician qualified in dental analgesic/nitrous oxide sedation procedures.

Regulatory Classification

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.

Predicate Devices

• PIP Low Profile Scavenging System (Models 260, 260U) (K965239)

Submission Summary (Full Text)

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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: [phone] / Fax: [phone]

## 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 [phone]. 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 [phone] or [phone] 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