(115 days)
Not Found
No
The device description focuses on a thermistor-based sensor and signal conditioning unit, with no mention of AI or ML algorithms for data processing or analysis.
No
The device is described as an accessory component that supports the diagnostic recording of airflow, but it performs no diagnostic functions itself and is not used for treatment.
No
The document 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 description explicitly details physical components like a thermistor, cannula, heat shrink tubing, battery source, and a signal conditioning unit, indicating it is a hardware device with electrical components.
Based on the provided information, the Salter Labs Oral/Nasal Thermal Airflow Sensor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Salter Labs sensor measures airflow from the patient's nose and mouth. It does not analyze samples taken from the body.
- Intended Use: The intended use is to support the diagnostic recording of airflow as an accessory to a polysomnography recorder in a sleep laboratory. It explicitly states that the device itself performs no diagnostic functions.
Therefore, the device falls outside the scope of an In Vitro Diagnostic. It is a medical device used for physiological monitoring.
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 ariflow 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 (comma separated list FDA assigned to the subject device)
BZQ
Device Description
The Salter Labs Thermal Airflow Sensor is composed of a Thermistor as the element which changes resistance as aiflow from the patient is delivered across the element of the themistor. The thermistor elements are located directly underneath the nares and in the airflow of the mouth. In both cases the element is kept from touching the skin in the patient in order to be the most effective change in temperature.
The thermistor will be mounted in the Cannula to position the thermistor properly under the nares and in the airflow path of the mouth. The thermistor will be covered with a heat shrink tubing to protect it from moisture from the patient.
The thermistor will require a battery source in order to derive a current flow through the circuit. This battery source will be located in a small container called a signal-conditioning unit. This unit has circuitry that will remove noise, display a smooth signal and is an added feature test for wire continuity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, oral
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
page 1 of 2
6.0 510(k) Summary
JUL 2 5 2008
Salter Labs Oral/Nasal Thermal Airflow Sensor
510(k) Summary
| Official Contact | Duane Kazal
Director Regulatory Affairs and Quality Assurance
Salter Labs
100 W. Sycamore Road
Arvin, California 93203 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Classification Reference | 21 CFR 868.2375 Breathing Frequency Monitor |
| Product Code | BZQ |
| Proprietary Name | Oral/Nasal Thermal Airflow Sensor |
| Common Name or Usual Name | Airflow Sensor |
| Predicate Device | Braebon Medical Corp. Airflow Sensor (K981445) |
| Reason for Submission | Initial Introduction into Interstate Commerce |
Substantial Equivalence
The Salter Labs Oral/Nasal Thermal Airflow Sensor is substantially equivalent to the Braebon Medical Corp. Airflow Sensor for the following reasons:
- Same intended use. .
- . Same operating principle.
- Same technology. �
- Similar manufacturing processes. ●
- Equivalent performance in all operating ranges. .
Description of the Device
The Salter Labs Thermal Airflow Sensor is composed of a Thermistor as the element which changes resistance as aiflow from the patient is delivered across the element of the themistor. The thermistor elements are located directly underneath the nares and in the airflow of the mouth. In both cases the element is kept from touching the skin in the patient in order to be the most effective change in temperature.
1
The thermistor will be mounted in the Cannula to position the thermistor properly under the nares and in the airflow path of the mouth. The thermistor will be covered with a heat shrink tubing to protect it from moisture from the patient.
The thermistor will require a battery source in order to derive a current flow through the circuit. This battery source will be located in a small container called a signalconditioning unit. This unit has circuitry that will remove noise, display a smooth signal and is an added feature test for wire continuity.
Intended Use
The Salter Labs 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 patient during a sleep study in a sleep laboratory.
2
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Duane Kazal Director of Regulatory Affairs and Quality Assurance Salter Labs 100 West Sycamore Road Arvin, California 93203-2300
JUL 2 5 2008
Re: K080922
Trade/Device Name: Salter Labs Oral/ Nasal Thermal Airflow Sensor Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: BZQ Dated: July 17, 2008 Received: July 21, 2008
Dear Mr. Kazal:
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 such 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.
3
Page 2 - Mr. Kazal
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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
J.K. Samuels Ferdin. Y for A
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (K080922)
Device Name: Salter Labs Oral/ Nasal Thermal Airflow Sensor
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 ariflow 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 XX (Part 21CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KAmuls-Reddy / for mH.
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080922