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.),

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. The electrical outputs 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.

AI/ML Overview

The provided text describes a medical device, the "Pressure Transducer Airflow Sensor," and its premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a formal study with detailed acceptance criteria and performance metrics in the way a clinical trial might.

The "Safety and Effectiveness Summary" and "Comparison Parameter" table serve as the primary source for understanding device performance and its comparison to the predicate device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device and meeting general safety requirements. The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it compares characteristics and states that the new device provides "equivalent informational content" to the predicate.

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence: Provide equivalent informational content for respiratory airflow monitoring compared to the predicate device.	"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."
Intended Use Equivalence: Same indications for use.	INTENDED USE: "NO DIFFERENCE" (compared to predicate device). Intended for use in sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder.
Patient Population Equivalence: Same target patient demographic.	POPULATION: "NO SIGNIFICANT DIFFERENCE" (compared to predicate device). For pediatric patients (2 years and above) and adult patients, including geriatric patients. Not for pediatric and infants below 2 years of age.
Safety: No increased risk of serious injury due to electrical shock.	"The maximum voltage within the Pressure Transducer Airflow Sensor is 9 Volts DC, based on the use of one 9-Volt battery. There is no direct electrical connection to the patient. 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."SAFETY CHARACTERISTICS: "BOTH DEVICES PROVIDE FOR PATIENT ISOLATION BECAUSE THERE IS NO DIRECT CONNECTION OF WIRES TO THE PATIENT IN EITHER CASE."
Biocompatibility: Safe patient contact materials (cannula).	Disposable nasal cannula made of non-conducting plastic. Cannula cannot be adequately cleaned for re-use.
Power Source: Device functions with its specified power source.	POWER SOURCE: "THE DEVICE USES A 9-VOLT BATTERY." (Difference from predicate which is self-generating, but not identified as negatively impacting safety/effectiveness). Estimated battery life is 320 hours (40 - eight-hour uses), with a battery test indicator.
Connection Method to Patient: Secure and safe connection.	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."
Differences from Predicate (No adverse effect on safety/effectiveness): Any technological differences do not negatively impact safety or effectiveness.	The document explicitly states: "This is to demonstrate that the Pressure Transducer Airflow Sensor has no new or modified technological characteristics from the predicate device that would adversely affect product safety and effectiveness." (Differences noted in power source, number of channels, re-use restrictions, and sensor technology are presented as not adversely affecting safety/effectiveness).

Study Details

The provided text describes a substantial equivalence determination through a 510(k) premarket notification process, not a traditional clinical trial or performance study against predefined numerical acceptance criteria. The "study" referenced is "Laboratory testing."

Sample size used for the test set and the data provenance:
- The document states "Laboratory testing has been performed." It does not specify a sample size (e.g., number of patients, number of tests, or duration of tests).
- The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective). It is implied to be laboratory data generated for the purpose of the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth in the context of the "laboratory testing." The assessment is based on comparing the electrical signals generated by the new device to those from the predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no indication of an adjudication process for a test set as this was not a clinical study involving interpretation by experts.
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:
- No, an MRMC study was not done. This device is an airflow sensor, not an AI-powered diagnostic tool requiring human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a standalone device in the sense that its performance (generating electrical signals) is evaluated independently, but it is not an algorithm. Its output (electrical signals) is intended for human interpretation via a physiological recorder. The "laboratory testing" involved assessing the device's ability to produce signals "equivalent informational content" to the predicate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" implicitly used for the laboratory testing appears to be the performance and output of the legally marketed predicate device. The new device's electrical signals were compared to the signals recorded using the predicate device to determine "equivalent informational content."
The sample size for the training set:
- Not applicable. This is a hardware medical device, not a machine learning model, so there is no concept of a "training set" in this context.
How the ground truth for the training set was established:
- Not applicable. As above, no training set for a machine learning model is involved.

Summary

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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:

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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:

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.

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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 DEVICEIS SELF-GENERATING
NUMBER OF CHANNELS	THE DEVICE PROVIDES ONE INPUT CHANNEL, THE PREDICATEDEVICE PROVIDES UP TO THREE.
METHOD OF CONNECTION TO PATIENT	THE DEVICE USES A PLASTIC TUBING AND CANNULA SET FORPATIENT CONNECTION. THERE ARE NO WIRES OR OTHERMETAL PARTS CONNECTED TO THE PATIENT. THE PREDICATEDEVICE SENSOR ASSEMBLY ALSO ATTACHES TO THE PATIENT INA MANNER SIMILAR TO A CANNULA.
SAFETY CHARACTERISTICS	BOTH DEVICES PROVIDE FOR PATIENT ISOLATION BECAUSETHERE IS NO DIRECT CONNECTION OF WIRES TO THE PATIENT INEITHER CASE. THE PREDICATE DEVICE USES AN INSULATEDTHERMOCOUPLE ASSEMBLY, THE SUBJECT DEVICE USESPLASTIC TUBING. BOTH DEVICES CONNECT TO APHYSIOLOGICAL RECORDER.
RE-USE RESTRICTIONS	CLEANING AND DISINFECTING PROCEDURES ARE REQUIRED FORRE-USE OF THE THERMOCOUPLE PREDICATE DEVICE. THESUBJECT DEVICE IS FOR SINGLE PATIENT USE ONLY.
SENSOR TECHNOLOGY	THE SUBJECT DEVICE USES A SOLID-STATE PRESSURETRANSDUCER THAT CONVERTS SMALL CHANGES IN AIRPRESSURE INTO SMALL VOLTAGE CHANGES. THE PREDICATEDEVICE USES AN ELECTRICAL THERMOCOUPLE THAT CONVERTSTEMPERATURE CHANGES CAUSED BY THE AIRFLOW INTO SMALLVOLTAGE CHANGES.

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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.

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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

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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)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).