The Bio-logic Airflow Pressure Transducer 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-use, disposable nasal cannula which attaches to the patient and plugs into the Airflow Pressure Transducer device. 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 (such as the Bio-logic Sleepscan product),

The Bio-logic Airflow Pressure Transducer is indicated for use during sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder. It is a battery-powered device, with a disposable nasal cannula which attaches to the patient and plugs into the Airflow Pressure Transducer device. The outputs of the device provide low-level voltage signals which are intended to be input to a physiological recorder (such as the Bio-logic Sleepscan product).

Device Description

The Bio-logic Airflow Pressure Transducer 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 pneumatic input for air pressure, and one set of electrical outputs representing the electrical equivalent of the pressure. These electrical outputs are: ACT (the active or positive output), REF (the reference or negative output), and COM (the electrical common). Within the device itself, the REF and COM are connected together. However, three leads are brought out for connection to a physiological recorder (such as the Bio-logic Sleepscan product), so the ACT and REF can be inputs to a differential amplifier, and COM can be connected to the system common.

For the airflow pressure input, this device uses a disposable nasal cannula which attaches to the patient and connects to the pressure input labeled "NASAL CANNULA". The electrical outputs connect to the corresponding AC-coupled inputs of the system's patient connection module. For the Bio-logic Sleepscan system, the connection is made to one of the bipolar input channels on the electrode jack box labeled INI(A) & IN2(R), for ACT and REF respectively. The COM is connected to the common jack on the headbox. The jacks on both the interface device and the electrode jack box are 1.5mm "safety" jacks, and the electrical connections are made with a reusable wire set with "safety" plugs on both ends.

This device consists of a two-part plastic enclosure measuring approximately 105 x 58 x 18.5 cm. The material is a composite of ABS and PMMA, color off-white. It is battery powered with two standard 1.5v AAA cells. The estimated battery life is 100 hours, and an on-off switch is provided for conserving battery life when the unit is not in use. Batteries can be replaced by removing two screws on the battery compartment of the unit.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, the performance is demonstrated through a comparison to a predicate device, focusing on equivalence and general specifications. The "acceptance criteria" here are implied by achieving similar or exceeding performance compared to the predicate.

Parameter for Comparison	Bio-logic Airflow Pressure Transducer Performance	Implied Acceptance Criteria (relative to Predicate Device)
Intended Use	No differences noted.	Equivalent to predicate device.
Population	No differences noted.	Equivalent to predicate device.
Safety Characteristics	Provides patient isolation through plastic tubing and approved safety jacks. Maximum voltage: 3V DC. Maximum output voltage: +/- 150 mV; signal range for normal breathing: +/- 1 mV. No direct electrical connection to patient.	Equivalent or superior patient isolation and electrical safety compared to predicate.
Informational Content of Electrical Signals	Equivalent informational content to signals recorded using the predicate device. In some instances, specifications exceed those of the predicate.	Equivalent or superior informational content compared to predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "Laboratory testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention using experts to establish ground truth or their qualifications for any test set. The comparison is based on device-to-device performance in a laboratory setting.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for a test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or described in the document. The study focused on device-to-device equivalence rather than human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

A standalone study was conducted, focusing on the device's performance in generating electrical signals. The "algorithm" in this context refers to the device's internal mechanism for converting air pressure to voltage. The study concluded that the "electrical signals recorded using the Bio-logic Airflow Pressure Transducer provide equivalent informational content to the signals recorded using the predicate device."

7. Type of Ground Truth Used

The "ground truth" for the device's performance was established by comparison to a predicate device's output for respiratory airflow monitoring. The predicate device's output served as the benchmark for "equivalent informational content."

8. Sample Size for the Training Set

The document does not mention a "training set" or its sample size. This device is a hardware sensor, not an AI/machine learning algorithm that typically requires training data.

9. How the Ground Truth for the Training Set Was Established

As this is a hardware device and not an AI/machine learning algorithm, the concept of a "training set" and establishing its ground truth as typically understood for AI systems does not apply. The device's functionality is based on its physical design and engineering principles rather than learned data.

Summary

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OCT 1 4 1997

One Bio-logic Plaza Mundelein, Illinois 60060-3700 1-800-323-8326 Fax: 847-949-8615

SECTION 2: SUMMARY AND CERTIFICATION

510(K) SUMMARY

SAFETY AND EFFECTIVENESS SUMMARY

Safety and effectiveness information concerning this Airflow Sensor device is summarized below.

Because this is not a CLASS III device, the special certification defined for this section is not required.

Bio-logic Systems Corp PREPARED BY: One Bio-logic Plaza Mundelein, IL 60060

(847)-949-5200 TELEPHONE:

CONTACT PERSON: Norman E. Brunner
DATE ON WHICH THE SUMMARY WAS PREPARED: April 23, 1997

NAME OF DEVICE: Bio-logic SLEEPSCAN Airflow Pressure Transducer.

COMMON NAME: Respiration Monitor.

CLASSIFICATION NAME: Breathing Frequency Monitor (per CFR 868.1860)

PREDICATE DEVICE: Cannula-Style Thermocouple Airflow Sensor, Pro-Tech, Inc., 510(k) #K913396.

DESCRIPTION OF THE DEVICE:

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INTENDED USE:

PATIENT POPULATION:

The Bio-logic Airflow Pressure Transducer can be used to monitor respiration for any patient who is a candidate for Sleep Diagnostic evaluation. This will typically be an adult population, but it can be used for patients of all ages.

SAFETY AND EFFECTIVENESS:

The maximum voltage within the Bio-logic Airflow Pressure Transducer is 3 volts DC, based on the use of two 1.5 volt AAA batteries connected in series. There is no direct electrical connection to the patient, since the airflow pressure input uses an approved nasal cannula made of non-conducting plastic. The maximum output voltage is +/- 150 mV, with an output signal range corresponding to normal breathing of +/- 1 mV Therefore, there is no danger to the patient 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 Bio-logic Airflow Pressure Transducer provide equivalent informational content to the signals recorded using the predicate device. In some instances, the specifications for the Airflow Pressure Transducer 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 device. This is to demonstrate that the Bio-logic Airflow Pressure Transducer has no significant differences from the predicate device which would adversely affect product safety and effectiveness.

Parameter for Comparison	Similarity or Difference
Intended Use	No differences.
Population	No differences.
Power Source	This device uses 2 AAA batteries. The predicatedevice does not require batteries.
Number of Channels	This device provides one input channel; the predicatedevice provides two.
Method of Connection to Patient	This device uses a plastic tubing and cannulaset for patient connection. There are no wires orother metal parts connected to the patient. Thepredicate device sensor assembly also attaches to thepatient in a 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 uses plastictubing. Both devices connect to the Sleepscan patientconnection module using approved safety jacks.
Re-use Restrictions	Cleaning and disinfecting procedures are required forreuse of the thermocouple predicate device. Thesubject device is for single-use only.
Sensor Technology	The subject device uses a solid-state pressuretransducer which converts small changes in airpressure into small voltage changes. The predicatedevice uses an electrical thermocouple which convertstemperature changes caused by the airflow into smallvoltage changes.

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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three parallel lines curving upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1997

Mr. Norman E. Brunner Bio-Logic Systems Corporation One Bio-logic Plaza Mundelein, Illinois 60060-3700

Re: K971501 Bio-logic Airflow Pressure Transducer Regulatory Class: II (two) Product Code: 73 MNR Dated: July 17, 1997 Received: July 18, 1997

Dear Mr. Brunner:

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 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 to 895. A substantially equivalent determination assumes compliance 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. 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. Norman E. Brunner

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 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/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Not Assigned

Device Name: BIO-LOGIC AIRFLOW PRESSURE TRANSDUCER FOR SLEEPSCAN PRODUCT

Indications For Use:

It can be used for patients of all ages, from newborn infants through adults, to and including geriatric patients.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Pury

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K971501

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).