(115 days)
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.
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 signalconditioning unit. This unit has circuitry that will remove noise, display a smooth signal and is an added feature test for wire continuity.
This 510(k) summary for the Salter Labs Oral/Nasal Thermal Airflow Sensor (K080922) does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets them. This document is a summary for regulatory clearance based on substantial equivalence to a predicate device, not a detailed technical report of a performance study with specific acceptance criteria.
However, based on the provided text, I can infer some information and highlight what is missing.
Here's a breakdown of the available and missing information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|
| Same intended use as predicate device | The device has the same intended use as the Braebon Medical Corp. Airflow Sensor (K981445). |
| Same operating principle as predicate device | The device operates on the same principle as the predicate device (thermistor element changes resistance as airflow is delivered). |
| Same technology as predicate device | The device uses the same technology as the predicate device. |
| Similar manufacturing processes to predicate device | The device uses similar manufacturing processes as the predicate device. |
| Equivalent performance in all operating ranges (to predicate device) | The device has equivalent performance in all operating ranges to the predicate device. |
- Missing: Specific quantitative acceptance criteria (e.g., accuracy, precision, response time, specified drift, signal-to-noise ratio) are not provided. The document relies on qualitative equivalence to a predicate device. If a performance study was conducted, the detailed results against specific metrics are not included in this summary.
2. Sample size used for the test set and the data provenance
- Missing: This information is not provided in the 510(k) summary. Given that this is a substantial equivalence submission, it's possible no direct clinical or bench testing beyond what's needed to simply demonstrate equivalence to the predicate (which might not involve a "test set" in the sense of a standalone performance study) was required or reported in this summary. If any testing was done, the sample size and data provenance are not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Missing: Not applicable as a formal "ground truth" establishment for a test set in a human-in-the-loop diagnostic performance study is not described. The device is an accessory for diagnostic recording, not a diagnostic device itself.
4. Adjudication method for the test set
- Missing: Not applicable for the reasons stated above.
5. 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
- Missing: Not applicable. This device is a thermal airflow sensor, not an AI-powered diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Missing: The document 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." This implies it provides raw data rather than performing an "algorithm-only" interpretation or diagnosis. No standalone performance data is presented in this document. The "equivalent performance in all operating ranges" likely refers to bench testing or basic functional comparison against the predicate, not a clinical standalone study.
7. The type of ground truth used
- Missing: Not explicitly stated as a formal "ground truth" was likely not established for a clinical diagnostic performance study of the sensor itself. For a device like this, "ground truth" for proving performance would typically involve a reference standard for airflow measurement (e.g., spirometry, pneumotachograph) or comparison against the established performance of the predicate device under controlled conditions. This detail is not in the summary.
8. The sample size for the training set
- Missing: Not applicable. This is a hardware sensor, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Missing: Not applicable for the same reason as above.
Summary of Study (Based on the 510(k) Summary):
The document does not describe a particular "study" that proves the device meets specific acceptance criteria in the way one might expect for a diagnostic device. Instead, it relies on a "Substantial Equivalence" claim.
The implicit "study" is a comparison to a predicate device (Braebon Medical Corp. Airflow Sensor K981445). The "proof" is the assertion from Salter Labs that their device is substantially equivalent based on:
- Same intended use.
- Same operating principle (thermistor changes resistance with airflow).
- Same technology.
- Similar manufacturing processes.
- Equivalent performance in all operating ranges.
The 510(k) process for this type of accessory device often involves demonstrating that the new device functions reliably and similarly to a legally marketed predicate, rather than conducting extensive de novo clinical or performance trials with strict, quantitative, pre-defined acceptance criteria published in the summary. The "equivalent performance in all operating ranges" statement without specific data means that the FDA reviewed internal company data (not provided in this summary) and agreed that the new device performs at a similar level to the predicate, making it substantially equivalent.
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6.0 510(k) Summary
JUL 2 5 2008
Salter Labs Oral/Nasal Thermal Airflow Sensor
510(k) Summary
| Official Contact | Duane KazalDirector Regulatory Affairs and Quality AssuranceSalter Labs100 W. Sycamore RoadArvin, 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.
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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.
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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.
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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
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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
§ 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).