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 Description

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

AI/ML Overview

This document describes a medical device, the Guardian™ Low Pressure Monitor Model 34076, designed to monitor low oxygen pressure in nitrous oxide/oxygen sedation systems. The provided text outlines the device's characteristics, intended use, and a regulatory submission (510(k)) to the FDA. However, it does not contain a detailed study demonstrating specific acceptance criteria with reported device performance metrics in the format requested.

The document primarily focuses on regulatory approval (510(k) clearance based on substantial equivalence to a predicate device) rather than a specific performance study with quantitative results against acceptance criteria.

Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC study, standalone performance, ground truth details, training set size, etc.) cannot be addressed from the provided text.

Here's an attempt to extract what is available and highlight what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated)	Reported Device Performance
Audibly indicate proper initialization upon battery insertion	Not explicitly reported with quantitative data in the provided text.
Audibly indicate low tank pressure (less than 40 psi)	Not explicitly reported with quantitative data in the provided text.
Audibly indicate low remaining battery life	Not explicitly reported with quantitative data in the provided text.
Meet ADA Acceptance Guidelines for Nitrous Oxide-Oxygen Conscious Sedation Systems	The system is designed and tested to meet these requirements, but specific performance data or a report detailing how it met them is not provided.

Missing Information: The provided text states the intended functional characteristics, which serve as de-facto acceptance criteria. However, it does not provide quantitative results or specific performance metrics demonstrating that the device actually meets these criteria. It only states that the system is "designed and tested to meet the requirements."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text. The text refers to "Non-Clinical Testing" and "rigorous application of a risk management program," but no details on the origin of data (e.g., country, retrospective/prospective) are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified in the provided text. There is no mention of an expert panel or ground truth establishment relevant to a test set's performance.

4. Adjudication method for the test set

Not specified in the provided text.

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

Not applicable. This device is a low-pressure monitor, not an AI-assisted diagnostic tool for which MRMC studies comparing human readers with and without AI assistance would be conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not explicitly described as a formal validation study. The device itself is a standalone alarm system. Its performance evaluation would naturally be "standalone" in the sense that the alarm mechanism operates independently of human interpretation of a reading. However, the text does not detail a study specifically validating the "algorithm only" performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not specified. For a device like this, the "ground truth" would likely be derived from calibrated pressure gauges and simulated low-pressure conditions. However, the document does not detail how this ground truth was established or used in testing.

8. The sample size for the training set

Not applicable/Not specified. This device does not appear to involve machine learning or AI that would require a "training set" in the conventional sense. Its function is based on a physical pressure switch and circuit logic.

9. How the ground truth for the training set was established

Not applicable/Not specified. As there's no mention of a training set, the establishment of ground truth for such a set is not detailed.

Summary of what can be inferred from the provided text:

The device, a low-pressure monitor, has defined functional requirements (audible alarms for power-up, low pressure < 40 psi, and low battery). These serve as the implicit acceptance criteria.
The device is "designed and tested to meet the requirements" of ADA Acceptance Guidelines.
A 510(k) submission (K992421) was made and cleared by the FDA, indicating substantial equivalence to legally marketed predicate devices. This regulatory pathway means a detailed performance study with quantitative metrics against acceptance criteria might not have been required to the same extent as for a novel device, as the focus is on equivalence.
The safety has been assessed through a risk management program, leading to design modifications, alarms, and labeling information to mitigate hazards.

What is explicitly missing from the provided text concerning a performance study:

Quantitative data or specific test results showing the device meets its functional requirements.
Details on the methodology, sample sizes, and ground truth establishment for any performance testing.
Any information related to multi-reader studies or AI algorithms.

Summary

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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.
1. Detection of hazard conditions and alerting of the user through alarms and visual indications.
1. 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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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "U.S. Department of Health & Human Services - USA" in a circular arrangement. The overall design is simple and conveys the department's focus on health and human welfare.

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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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:

(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)

Over-The-Counter Use

Regulation Number and Section

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)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.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. 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).(2)
Classification. Class II (performance standards).