The Salter Labs Oral/Nasal Thermal Airflow Sensor is used as a cannula accessory with existing recording devices and data acquisition systems in a sleep laboratory setting to support the diagnostic recording of nasal and/or oral airflow. The subject device itself performs no diagnostic functions, and only supports the diagnostic recording of airflow for use as an accessory component to a polysomnography recorder. The target population is adult and pediatric patients during a sleep study in a sleep laboratory.

Device Description

The modified device has a minor construction change from that of the predicate device where a series of connected thermocouples replace a series / parallel connection of thermistors. Both elements are placed at the bridge of the nose to measure the same temperature changes during breathing from each nare and from the mouth. The lower cost thermocouples provide a lowcost single-use replacement for the more expensive thermistor device already cleared.

AI/ML Overview

This document describes a Special 510(k) for a modified device, the Salter Labs Thermocouple (PneumoTherm), which replaces a thermistor-based thermal airflow sensor. The submission focuses on demonstrating substantial equivalence to the predicate device (K080922 Salter Labs Thermal Airflow Sensor) due to a minor construction change.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal acceptance criteria in terms of numerical thresholds for performance metrics. Instead, the acceptance criterion appears to be qualitative: demonstrating that the modified device is "sensitive enough to provide an adequate signal" and is "sensitive and timely enough to record a substantial signal" compared to other physiological respiratory events, and that it "performs as well or better as the predicate."

Since there are no numerical acceptance criteria, a direct comparison table is not possible in the traditional sense. However, based on the provided text, the performance can be summarized as:

Acceptance Criterion (Implicit)	Reported Device Performance
Provides an adequate signal on the Test Fixture (Polysomnograph system).	Met: The clinical testing showed the Thermocouple device was "sensitive enough to provide an an adequate signal on the Test Fixture (which includes a Polysomnograph system)".
Sensitive and timely enough to record a substantial signal compared to other physiological respiratory events.	Met: The device was shown to be "sensitive and timely enough to record a substantial signal compared to that of other physiological respiratory events."
No additional adverse effects or complications compared to the predicate device.	Met: "Clinically, the device adds no additional adverse effects or complications as did the predicate device, primarily because their structure is similar and both fit in properly designed cannulas."
Performs as well or better than the predicate device in providing a "safe and effective signal."	Met: The submission concludes, "the Thermocouple device provides a safe and effective signal. Safe, effective, and performs as well or better as the predicate." (Note: This is a direct statement from the summary of conclusions, indicating the assessment was positive, not a direct quantitative comparison unless implied by the prior points).
Functional equivalence to the predicate device (detects changes in temperature corresponding to inhalation/exhalation).	Met: "The thermocouple device functions in the same manner as does the predicate device and that is it detects changes in temperature, corresponding to an exhalation and inhalation of the patient." The technological characteristics also confirm both are "Thermal responsive device," although the specific mechanism differs (Thermocouple vs. Thermistor).
Intended use as a cannula accessory for recording nasal/oral airflow in sleep studies for adult and pediatric patients.	Met: The intended use statement for the modified device is identical to that implied for the predicate (as an accessory for polysomnography in sleep labs for adult and pediatric patients to record airflow). The comparison chart explicitly states "Patients used on: Adult and Pediatric Currently" for the modified device and "Adult, Pediatric and Neonatal" for the predicate. However, the Indications for Use for the modified device excludes neonatal.

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

Sample Size: The document does not specify the sample size for the clinical testing. It simply refers to "Clinical Testing."
Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the FDA (USA), it's highly probable the testing occurred in the USA or a region with similar clinical practices. The study is described as "Clinical Testing," implying it was prospective in nature, as it was conducted to demonstrate the functionality of the new device for this premarket notification.

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

The document does not provide any information regarding the number of experts or their qualifications used to establish ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. It simply states "Clinical Testing was simply down to show that the Thermocouple device was not only sensitive enough to provide an adequate signal... but that it was sensitive and timely enough to record a substantial signal compared to that of other physiological respiratory events." This suggests observation and comparison rather than a formal adjudication process for interpreting complex results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. The study's purpose was to demonstrate the function and safety of the device compared to a predicate, not to assess reader performance or the improvement with AI assistance (as this is not an AI device).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This is not an AI/algorithm-based device. It is a physical sensor (thermocouple). Therefore, the concept of a standalone algorithm performance study is not applicable. The "device function" section describes its direct physical detection capabilities.

7. The Type of Ground Truth Used

The ground truth can be inferred as physiological respiratory events observed and recorded by a Polysomnograph system. The document states clinical testing aimed to show the device's signal was "substantial compared to that of other physiological respiratory events." This implies that the standard polysomnography system provides the reference for what constitutes a "substantial signal" for breathing.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

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

Not applicable. As there is no training set for this type of device.

Summary

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NOV 24 2009

SALTER LABS

Special 510K. Summary

6092685

alter Labs

100 W. Sycamore Rd
Arvin, CA 93203
Phone: 661-854-3166
Fax: 661=855-2511
Contact Person: Terry Newton

August 21, 2009

Name of device: Thermocouple Trade name: PneumoTherm Common name: Thermal Airflow Sensor Classification name: Monitor, Breathing Frequency (21 CFR 868 2375) Product Code: BZQ

Equivalent Device: K080922 Salter Labs Thermal Airflow Sensor

Description of device as found in the labeling .
The modified device has a minor construction change from that of the predicate device where a series of connected thermocouples replace a series / parallel connection of thermistors. Both elements are placed at the bridge of the nose to measure the same temperature changes during breathing from each nare and from the mouth. The lower cost thermocouples provide a lowcost single-use replacement for the more expensive thermistor device already cleared.

Device function

The the mocouple device functions in the same manner as does the predicate device and that is it detects changes in temperature, corresponding to an exhalation and inhalation of the patient. The goal here is to determine rate of respiration for sleep lab studies.

Scientific concept . The scientific concept governing the Thermocouple is called the "Seebeck Effect".
Physical & Performance characteristics (device design, material used, .
properties)

Physically, both devices are small enough to be placed directly in the path of the air stream of the nares and mouth.

100 W. SYCAMORE ROAD * ARVIN, CALIFORNIA 93203-2300 FAX: +1 661-855-2511 PHONE: +1 661-854-3166

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From a performance standpoint, where the Thermistor required an interface box to energize the changed resistance to provide a signal, the Thermocouple self-generates a microvolt signal by having dissimilar materials.

· Intended Use:

The Salter Labs Oral/Nasali Thermal Airflow Sensor is used as a cannula ' accessory with existing recording devices and data acquisition systems in a sleep laboratory setting to support the diagnostic recording of nasal and/or oraliairflow. The subject device itself performs no diagnostic functions, and only supports the diagnostic recording of airflow for use as an accessory component to a polysomnography recorder. The target population is adult and pediatric patients during a sleep study in a sleep laboratory.

Technological Characteristics compared to predicate device The predicate device is a "thermal resistive element" and the Thermocouple. is a "Thermal Electric device". Both devices can be said to be a "Thermal responsive device", wherein "RTD" would fall into this category.

Feature	Modified Device	Predicate Device
ThermalResponsive	Thermocouple	Thermistor
Target Holderused on	Same	Salter Cannula Adult andPediatric Series
Patients used on	Adult and PediatricCurrently	Adult, Pediatric andNeonatal
Length of use	Disposable	Reusable
Need for aninterface box	Not Needed	Needed
Skin Contact	Intended use is to fit indesign Cannula	Intended use is to fit indesign Cannula

Comparison Chart

Brief description of clinical test and how results support SE Clinical Testing was simply down to show that the Thermocouple device was not only sensitive enough to provide an adequate signal on the Test Fixture (which includes a Polysomnograph system) but that it was sensitive and timely enough to record a substantial signal compared to that of other physiological respiratory events.
Clinically, the device adds no additional adverse effects or complications as did the predicate device, primarily because their structure is similar and both fit in properly designed cannulas.

100 W. SYCAMORE ROAD * ARVIN, CALIFORNIA 93203-2300 PHONE: +1 661-854-3166 FAX: +1 661-855-2511

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Summary for conclusions drawn from tests that demonstrate the device is
safe effective and performs as well or better as the predicate.

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100 W. SYGAMORE ROAD * ARVIN, CALIFORNIA 93203-2300 FAX: +1 661-855-2511 PHONE: +1 661-854-3166

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings.

Public Health Service

NUV % 4 2005

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Terry Newton Manager of Regulatory Affairs/Quality Assurance Salter Labs 100 West Sycamore Road Arvin, California 93203-2300

Re: K092685

Trade/Device Name: Thermal Airflow System (PneumoTherm, 5800 Series) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Codc: BZO Dated: October 20, 2009 Received: October 30, 2009

Dear Ms. Newton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Ms. Newton

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K 092685

Device Name: Thermal Airflow: System (PrieumoTherm: 5800 Series)

Indications for Use:

Prescription Use Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheiss

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page I of 1.

510(k) Number: K092685

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).