GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076

K992421 · Accutron, Inc. · BSZ · Oct 27, 1999 · Anesthesiology

Device Facts

• Record ID: K992421
• Device Name: GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
• Applicant: Accutron, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Oct 27, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5160
• Device Class: Class 2

Intended Use

Accessory device for use with nitrous oxide / oxygen sedation systems to monitor the medical gas system for a low oxygen pressure condition (less than 40 ps), and activate an audio alarm when this condition exists.

Device Story

Guardian™ Low Pressure Alarm (Model 34076) functions as an accessory to nitrous oxide/oxygen sedation systems. Input: medical gas pressure via DISS fittings. Operation: internal pressure switch monitors oxygen line pressure; circuit board triggers audible alarms for low tank pressure or low battery voltage. Output: audible alerts. Used in dental clinics by qualified dental professionals. Device ensures patient safety by alerting clinicians to potential hypoxia risks during sedation. Mitigation of hazards achieved through design, alarm systems, and user training.

Clinical Evidence

Bench testing only. The device was designed and tested to meet the American Dental Association (ADA) Acceptance Guidelines for Nitrous Oxide-Oxygen Conscious Sedation Systems. No clinical data provided.

Technological Characteristics

Components: circuit board, battery holder, pressure switch, manifold, DISS medical gas fittings, protective cover. Energy source: battery. Connectivity: standalone. Standards: ADA Acceptance Guidelines for Nitrous Oxide-Oxygen Conscious Sedation Systems. Operation: threshold-based pressure monitoring.

Indications for Use

Indicated for use as an accessory to nitrous oxide/oxygen sedation systems to monitor for low oxygen pressure (<40 psi) in patients undergoing dental analgesia procedures. User must be a qualified dental professional trained in sedation systems.

Regulatory Classification

Identification

A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

Submission Summary (Full Text)

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## Comparison to Predicate Device

The modified design will differ from the predicate device in that it will only monitor low oxygen pressure, will be used with portable gas supply systems, and will include the pressure switch within the device.

#### Device Description and Intended Use

The Guardian™ Low Pressure Monitor Model 34076 will consist of the following major sub-components:

- . Circuit board with battery holder and battery
- . Pressure switch
- � Manifold and medical gas fittings (DISS)
- . Protective cover

The intended major functional characteristics of the device are:

- . Audibly indicate proper initialization upon insertion of the battery (i.e. power up)
- � Audibly indicate low tank pressure
- . Audibly indicate low remaining battery life, as determined by battery voltage

## Applicable Standards and Non-Clinical Testing

The system is designed and tested to meet the requirements of the American Dental Association (ADA) Acceptance Guidelines for Nitrous Oxide-Oxygen Conscious Sedation Systems.

## Potential Adverse Health Effects

The modified design does not degrade the safety of the device. The Guardian™ Low Pressure Alarm model 34076 has been designed to either completely eliminate or mitigate all known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program. One or more of the following means (in order of preference) was used to implement mitigation of health hazards identified by the risk management program:

- 】. Design modifications.
- 2. Detection of hazard conditions and alerting of the user through alarms and visual indications.
- 3. Identification of any potentially undetectable health hazard conditions in the instruction manual and other device labeling.

The user must be qualified in dental analgesia procedures, trained in the use of the system, and must be familiar with all labeling and instructions for use associated with the equipment. The user of the device is advised to thoroughly understand the use of the equipment, and familiarize themselves with the location and function of all relevant controls and alarms prior to using the equipment.

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Accutron, Inc. believes that the Guardian™ Low Pressure Alarm is safe and effective when used as instructed by knowledgeable and trained personnel, and performs as well as or better than the legally marketed predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 1999

Ms. Dottie Knechtel Accutron, Inc. 2020 W. Melinda Lane Phoenix, AZ 85027

Re: K992421 Guardian™ Low Pressure Alarm Accessory Requlatory Class: II (two) Product Code: 73 ELI Dated: September 27, 1999 October 5, 1999 Received:

Dear Ms. Knechtel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements this concerning your device in the Federal Register. Please note: response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Ms. Dottie Knechtel

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device equivalence or your device and thus, permits 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Jeannetta Whitehouse for.

Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number:

Sam Houston

K99242

Device Name: Guardian Low Pressure Alarm

Indications for Use:

Accessory device for use with nitrous oxide / oxygen sedation systems to monitor the medical gas system for a low oxygen pressure condition (less than 40 ps), and activate an audio alarm when this condition exists.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

to Aulei Assher

Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use