(98 days)
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Not Found
No
The device description focuses on simple pressure and voltage thresholds triggering audio alarms, with no mention of AI/ML terms or complex data processing.
No
The device monitors nitrous oxide/oxygen sedation systems for low oxygen pressure and activates an alarm; it does not directly treat or diagnose a medical condition.
No
The device monitors low oxygen pressure and battery life, and activates alarms based on these conditions. It does not diagnose medical conditions in patients.
No
The device description explicitly lists hardware components such as a circuit board, battery holder, battery, pressure switch, manifold, medical gas fittings, and a protective cover.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the pressure of medical gases (nitrous oxide/oxygen) in a sedation system and activate an alarm based on that physical parameter (pressure). It does not involve testing or examining specimens taken from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
- Device Description: The components and functional characteristics described relate to pressure sensing, electrical circuitry, and audible alarms. These are typical of monitoring devices for physical parameters, not IVDs.
- Lack of IVD Characteristics: There is no mention of reagents, assays, specimen handling, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
73 ELI
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
0
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.
-
- Detection of hazard conditions and alerting of the user through alarms and visual indications.
-
- 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.
1
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.
2
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.
3
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
4
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