(83 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a simple sensor technology change without any mention of data processing or algorithmic analysis.
No
The device is described as an accessory that supports diagnostic recording of airflow and performs no diagnostic functions itself, indicating it is not a therapeutic device.
No
The text explicitly states, "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."
No
The device is a physical sensor (thermocouples) and a cannula accessory, not a software-only device.
Based on the provided text, the Salter Labs Oral/Nasal Thermal Airflow Sensor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is an "accessory" to existing recording devices and data acquisition systems in a sleep laboratory. Its purpose is to "support the diagnostic recording of nasal and/or oral airflow."
- Diagnostic Function: The text explicitly states, "The subject device itself performs no diagnostic functions." It only provides data (airflow temperature changes) to a separate diagnostic recording system.
- Nature of Measurement: It measures temperature changes related to breathing, which is a physiological process occurring in vivo (within the body), not in vitro (outside the body, typically on biological samples).
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
BZQ
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.
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 goal here is to determine rate of respiration for sleep lab studies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nares and mouth (at the bridge of the nose)
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Sleep laboratory setting
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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
1
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 |
|---|---|---|
| Thermal | ||
| Responsive | Thermocouple | Thermistor |
| Target Holder | ||
| used on | Same | Salter Cannula Adult and |
| Pediatric Series | ||
| Patients used on | Adult and Pediatric | |
| Currently | Adult, Pediatric and | |
| Neonatal | ||
| Length of use | Disposable | Reusable |
| Need for an | ||
| interface box | Not Needed | Needed |
| Skin Contact | Intended use is to fit in | |
| design Cannula | Intended use is to fit in | |
| design 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
2
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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. · · Summarylo: ondepentomis as wellor better as the provides a safe and-sifective
signal. Sale, Ghounve, and performo couple device provides a safe and effective
100 W. SYGAMORE ROAD * ARVIN, CALIFORNIA 93203-2300 FAX: +1 661-855-2511 PHONE: +1 661-854-3166
3
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.
4
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
5
Indications for Use
510(k) Number (if known) K 092685
Device Name: Thermal Airflow: System (PrieumoTherm: 5800 Series)
Indications for Use:
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.
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