(12 days)
Not Found
No
The device description focuses on converting air pressure to electrical signals and does not mention any AI/ML components or algorithms.
No.
The device is intended for use in sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder; it does not treat or cure any condition.
Yes
The device is intended for use in sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder, which is a diagnostic purpose.
No
The device description clearly details a physical device with a plastic enclosure, battery power, electrical outputs, and a disposable nasal cannula. It converts air pressure to voltage, indicating hardware components are essential to its function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of the Pressure Transducer Airflow Sensor is to detect respiratory airflow directly from the patient using a nasal cannula. It does not analyze biological samples like blood, urine, or tissue.
- The device measures a physiological parameter (airflow pressure) directly from the patient. IVDs typically measure analytes or characteristics within a biological sample.
The device is a physiological sensor used for monitoring during sleep studies, not for analyzing biological specimens in vitro.
N/A
Intended Use / Indications for Use
The Pressure Transducer Airflow Sensor is intended for use in sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder. It is battery-powered, using a single patient use, disposable nasal cannula with a .2 micron hydrophobic filter that attaches to the patient and connects into the input of the Pressure Transducer Airflow Sensor. The cannula cannot be adequately cleaned for re-use. The outputs of the device provide low-level electrical signals for input to a physiological recorder (EEG, etc.),
The Pressure Transducer Airflow Sensor is indicated for use during sleep disorder studies to detect respiratory airflow onto a physiological recorder. It is a battery -powered device, with a disposable nasal cannula that attaches to the patient and connects into the input of the Pressure Transducer Airflow Sensor device. The outputs of the device provide low-level voltage signals that are intended to be input to a physiological recorder.
Product codes
73 MNR
Device Description
The Pressure Transducer Airlow Sensor is a small interface device which converts low levels of air pressure to corresponding low levels of voltage which can be recorded on any physiological recorder intended to record low-level electrical signals. There is one pressure, and one set of electrical outputs representing the electrical equivalent of the pressure. These electrical outputs are: the active or positive output and the reference or negative output. This device uses a disposable nasal cannula that attaches to the patient and connects to the pressure input This device uses a disposable hadd ballinals connect to the corresponding AC-coupled inputs of the system's labeled INT O' : The electined outpote connels of an electrode jack box. The output jack on patient of the storing the modular 4-pin jack. Electrical connections are made with 1.5mm "safety" connectors.
The device consists of a two-part plastic enclosure measuring approximately 7cm(W) x 12.5cm(L) x 2.5cm(H). The material is Oycolac ABS GSM, color light gray. It is battery-powered with one standard 9V alkaline cell. The estimated battery life is 320 hours (40 - eight hour uses), with an on-off switch provided to conserve battery life when not in use. The switch will also indicate a "battery test" that lights an LED indicating at least 8 hours of battery life remaining. Batteries can be replaced by removing the battery cover, removing the battery and inserting a new one in the orientation shown in the battery compartment of the unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The Pressure Transducer Airflow Sensor can be used to monitor the respiration for patients who are candidates for a Sleep Diagnostic evaluation. It can be used for pediatic patients - 2 years and above, and adult patients, to and including geriatic patients. The device is not intended for pediatric and infants below 2 years of age for the purpose of respiration or SIDS monitoring.
It can be used for pediatric patients - 2 years and above, and adult patients, to and including geriatric patients. The device is not intended for pediatic and infants below 2 years of age for the purpose of respiration or SIDS monitoring.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Laboratory testing has been performed using this device in place of the predicate device for respiratory airflow monitoring. These tests conclude that the electrical signals recorded using the Pressure Transducer Airflow Sensor provide equivalent informational content to the signals recorded using the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
JUL 1 3 1998
Image /page/0/Picture/4 description: The image shows a logo for "PRO-TECH" with the tagline "Committed to Excellence" underneath. A curved line is above the company name. The text is in a bold, sans-serif font, and the overall design is simple and professional.
Image /page/0/Picture/5 description: The image shows a circular logo with the text "ISO 9001 CERTIFIED" at the top and "FM 39012" at the bottom. The central part of the logo contains a symbol resembling a heart or shield, and the text "REGISTERED FIRM" is arranged around the circle. The logo appears to be a certification mark, possibly indicating compliance with ISO 9001 standards.
K9822293
SUMMARY AND CERTIFICATION
510(K) SUMMARY
SAFETY AND EFFECTIVENESS SUMMARY
Safety and Effectiveness information concerning this Airflow Sensor is summarized below.
Because this is not a CLASS III device, the special certification defined for this section is not required.
- Pro-Tech Services, Inc. PREPARED BY: 12826 NE 178th Street Suite A Woodinville, WA 98072
TELEPHONE: (425) 481-5452
CONTACT PERSON: Anthony Zaragoza
DATE ON WHICH THE SUMMARY WAS PREPARED: July 9, 1998
NAME OF DEVICE: Pressure Transducer Airflow Sensor
COMMON NAME: Airflow Sensor
Breathing Frequency Monitor (per CFR 868.1860) CLASSIFICATION NAME:
PREDICATE DEVICE: Cannula-Style Thermocouple Airflow Sensor, Pro-Tech Services, Inc. 510(k) #K813396
DESCRIPTION OF THE DEVICE:
The Pressure Transducer Airlow Sensor is a small interface device which converts low levels of air pressure to corresponding low levels of voltage which can be recorded on any physiological recorder intended to record low-level electrical signals. There is one pressure, and one set of electrical outputs representing the electrical equivalent of the pressure. These electrical outputs are: the active or positive output and the reference or negative output.
1
This device uses a disposable nasal cannula that attaches to the patient and connects to the pressure input This device uses a disposable hadd ballinals connect to the corresponding AC-coupled inputs of the system's labeled INT O' : The electined outpote connels of an electrode jack box. The output jack on patient of the storing the modular 4-pin jack. Electrical connections are made with 1.5mm "safety" connectors.
The device consists of a two-part plastic enclosure measuring approximately 7cm(W) x 12.5cm(L) x 2.5cm(H). The material is Oycolac ABS GSM, color light gray. It is battery-powered with one standard 9V alkaline cell. The estimated battery life is 320 hours (40 - eight hour uses), with an on-off switch provided to conserve battery life when not in use. The switch will also indicate a "battery test" that lights an LED indicating at least 8 hours of battery life remaining. Batteries can be replaced by removing the battery cover, removing the battery and inserting a new one in the orientation shown in the battery compartment of the unit.
INTENDED USE:
The Pressure Transducer Airflow Sensor is intended for use in sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder. It is battery-powered, using a single patient use, disposable nasal cannula with a .2 micron hydrophobic filter that attaches to the patient and connects into the input of the Pressure Transducer Airflow Sensor. The cannula cannot be adequately cleaned for re-use. The outputs of the device provide low-level electrical signals for input to a physiological recorder (EEG, etc.),
PATIENT POPULATION:
The Pressure Transducer Airflow Sensor can be used to monitor the respiration for patients who are candidates for a Sleep Diagnostic evaluation. It can be used for pediatic patients - 2 years and above, and adult patients, to and including geriatic patients. The device is not intended for pediatric and infants below 2 years of age for the purpose of respiration or SIDS monitoring.
SAFETY AND EFFECTIVENESS:
The maximum voltage within the Pressure Transducer Airllow Sensor is 9 Volts DC, based on the use of one 9-Volt battery. There is no direct electrical connection to the airflow pressure input uses an approved nasal cannula made of non-conducting plastic. The maximum output voltage is in two ranges: ±2.5mV and ±2.5V depending on the users' need. Due to these low-voltages, there is no danger to the patient or provider of serious injury due to electrical shock.
Laboratory testing has been performed using this device in place of the predicate device for respiratory airflow monitoring. These tests conclude that the electrical signals recorded using the Pressure Transducer Airflow Sensor provide equivalent informational content to the signals recorded using the predicate device. In some instances, the specifications for the Pressure Transducer Airflow Sensor exceed those of the predicate device. These areas are clarified in more detail in the following section.
2
1
The following comparison is provided as a summary of technological characteristics relative to the predicate The following comparison is provided as a summary of technological consort for the production
device. This is to demonstrate that the Pressue Transduce Airflor Series of Sec device. This is to demonstrate that the Pressure Transducer Rinow Och and Collection of Collectiveness.
from the predicate device that would adversely affect product safety
| COMPARISON PARAMETER | SIMILARITY OR DIFFERENCE |
|---|---|
| INTENDED USE | NO DIFFERENCE |
| POPULATION | NO SIGNIFICANT DIFFERENCE |
| POWER SOURCE | THE DEVICE USES A 9-VOLT BATTERY. THE PREDICATE DEVICE |
| IS SELF-GENERATING | |
| NUMBER OF CHANNELS | THE DEVICE PROVIDES ONE INPUT CHANNEL, THE PREDICATE |
| DEVICE PROVIDES UP TO THREE. | |
| METHOD OF CONNECTION TO PATIENT | THE DEVICE USES A PLASTIC TUBING AND CANNULA SET FOR |
| PATIENT CONNECTION. THERE ARE NO WIRES OR OTHER | |
| METAL PARTS CONNECTED TO THE PATIENT. THE PREDICATE | |
| DEVICE SENSOR ASSEMBLY ALSO ATTACHES TO THE PATIENT IN | |
| A MANNER SIMILAR TO A CANNULA. | |
| SAFETY CHARACTERISTICS | BOTH DEVICES PROVIDE FOR PATIENT ISOLATION BECAUSE |
| THERE IS NO DIRECT CONNECTION OF WIRES TO THE PATIENT IN | |
| EITHER CASE. THE PREDICATE DEVICE USES AN INSULATED | |
| THERMOCOUPLE ASSEMBLY, THE SUBJECT DEVICE USES | |
| PLASTIC TUBING. BOTH DEVICES CONNECT TO A | |
| PHYSIOLOGICAL RECORDER. | |
| RE-USE RESTRICTIONS | CLEANING AND DISINFECTING PROCEDURES ARE REQUIRED FOR |
| RE-USE OF THE THERMOCOUPLE PREDICATE DEVICE. THE | |
| SUBJECT DEVICE IS FOR SINGLE PATIENT USE ONLY. | |
| SENSOR TECHNOLOGY | THE SUBJECT DEVICE USES A SOLID-STATE PRESSURE |
| TRANSDUCER THAT CONVERTS SMALL CHANGES IN AIR | |
| PRESSURE INTO SMALL VOLTAGE CHANGES. THE PREDICATE | |
| DEVICE USES AN ELECTRICAL THERMOCOUPLE THAT CONVERTS | |
| TEMPERATURE CHANGES CAUSED BY THE AIRFLOW INTO SMALL | |
| VOLTAGE CHANGES. |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jul 1 3 1998
Mr. Anthony Zaragoza Pro-Tech Services, Inc. P.O. Box 2165 12826 NE 178th Street, Suite A Woodinville, WA 98072
Re: K982293 Pressure Transducer Airflow Sensor Requlatory Class: II (two) Product Code: 73 MNR Dated: June 26, 1998 Received: July 1, 1998
Dear Mr. Zaragoza:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this 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.
4
Page 2 - Mr. Anthony Zaragoza
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 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 requlation (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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
Page 1 of 1
K982293 510(k) Number (if known)
Device Name: PRESSURE TRANSDUCER AIRFLOW SENSOR
Indications for Use:
The Pressure Transducer Airflow Sensor is indicated for use during sleep disorder studies to detect respiratory airflow onto a physiological recorder. It is a battery -powered device, with a disposable nasal cannula that attaches to the patient and connects into the input of the Pressure Transducer Airflow Sensor device. The outputs of the device provide low-level voltage signals that are intended to be input to a physiological recorder.
It can be used for pediatric patients - 2 years and above, and adult patients, to and including geriatric patients. The device is not intended for pediatic and infants below 2 years of age for the purpose of respiration or SIDS monitoring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number __
Marla Kramer
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)