(281 days)
Not Found
No
The device description focuses on physical transducers (piezo-electric and thermistor) and passive electronic circuitry to convert physical signals into electrical signals for existing polysomnography equipment. There is no mention of AI or ML algorithms for signal processing, analysis, or interpretation.
No
The device is described as an accessory for polysomnography equipment used to detect and amplify breathing signals and snoring; it does not mention treating or alleviating any medical conditions.
Yes
The device is intended for use with polysomnography equipment during sleep disorder studies for the purpose of detecting and amplifying breathing signals and detection of snoring, which are diagnostic indicators for sleep disorders.
No
The device description clearly details physical components like transducers, cannulas, thermistors, and a signal-conditioning unit with a battery source, indicating it is a hardware device with associated software/circuitry for signal processing.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The description clearly states that this device is used to detect and amplify breathing signals and snoring of a sleeping patient through a nasal cannula. It measures physical parameters (airflow and pressure changes) directly from the patient's respiratory system.
- The device description focuses on the physical sensing of airflow and pressure. It describes how the device converts these physical changes into electrical signals for measurement by polysomnography equipment. There is no mention of analyzing biological samples.
- The intended use is for sleep disorder studies. This involves monitoring physiological signals during sleep, not analyzing biological samples for diagnostic purposes in the traditional sense of an IVD.
Therefore, this device falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BiNAPS Nasal Airflow Pressure and Snore Transducer (using the pressure transducer) is an accessory intended for use with polysomnography equipment during sleep disorder studies for the purpose of detecting and amplifying breathing signals and detection of snoring of a sleeping patient through a Salter Labs nasal cannula. This device is intended for adult and pediatric (excluding neonatal and infant) use.
The ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is a thermal resistive thermistor designed to monitor oral/nasal thermal airflow temperature and pressure changes during sleep studies. The ThermiSense is intended for use with a nasal cannula and polysomnography headbox or pressure transducers, such as, BiNAPS Nasal Airflow Transducer. This device is intended for adult and pediatric (excluding neonatal and infant) use.
Product codes (comma separated list FDA assigned to the subject device)
MNR, BZQ
Device Description
The Salter Labs BiNAPS Nasal Airflow Pressure and Snore Transducer is a two output channel device used to acquire respiratory low pressure waves and low air flow that are sensed through a Nasal Cannula typically worn by a subject during a sleep diagnostic session. It is used to convert changes in air pressure and flow, occurring during sleep, into electrical signals that can be measured by polysomnography equipment. The Nasal Cannula directs the airflow and pressure waves generated by breathing and snoring from the nares and mouth of a patient through a luer lock fitting and then into a cup shaped plastic cylinder chamber sealed closed at the open end by a fitting and then into a cup shaped plastic cylinder chamber sealed closed at the open end by a piezo-electric ceramic element. The piezo element, when flexed by the impinging air pressure changes, generates a proportional electric voltage. This voltage is attenuated and filtered by subsequent passive electronic circuitry composing the sensor. The Salter Labs Airflow Pressure Transducer does not require a power source.
ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is composed of a Thermistor as the element which changes resistance as airflow from the patient is delivered across the element of the thermistor. 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 of the patient in order to be the most effective change in temperature.
The Thermistor is mounted in the Cannula to position the thermistor properly under the nares and in the airflow path of the mouth. The Thermistor is covered with a heat shrink tubing to protect it from moisture from the patient. The Thermistor requires a battery source in order to derive a current flow through the circuit. This battery source is 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
Nares and mouth
Indicated Patient Age Range
Adult and pediatric (excluding neonatal and infant)
Intended User / Care Setting
Polysomnography equipment during sleep disorder studies / 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)
The BiNAPS Nasal Airflow Pressure and Snore Transducer and the ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal were tested to verify that the new material bond and performance characteristics of flow rate, back pressure, and tubing bond strength did not impact the strength or performance of the modified Airflo w Pressure Transducer and the modified Airflow Sensor after the material change.
Key results:
- Maximum back pressure was found to be less than 2 psi, passing the specification of = 2 lbs), passing the specification.
- Device dimensions are unchanged.
- The modified devices meet all specifications at the 3 year test point for aging (shelf life).
- Sampling flow rate (max): 0.5 lpm
- Sampling backpressure @ max flow:
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2016
Salter Labs Mara Caler Director, Regulatory Affairs 2365 Camino Vida Roble Carlsbad, California 92011
Re: K151874
Trade/Device Name: BiNAPS Nasal Airflow and Snore Transducer: ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR, BZQ Dated: March 17, 2016 Received: March 18, 2016
Dear Ms. Caler:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151874
Device Name
BiNAPS Nasal Airflow Pressure and Snore Transducer
ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal
Indications for Use (Describe)
The BiNAPS Nasal Airflow Pressure and Snore Transducer (using the pressure transducer) is an accessory intended for use with polysomnography equipment during sleep disorder studies for the purpose of detecting and amplifying breathing signals and detection of snoring of a sleeping patient through a Salter Labs nasal cannula. This device is intended for adult and pediatric (excluding neonatal and infant) use.
The ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is a thermal resistive thermistor designed to monitor oral/ nasal thermal airflow temperature and pressure changes during sleep studies. The ThermiSense is intended for use with a nasal cannula and polysomnography headbox or pressure transducers, such as, BiNAPS Nasal Airflow Transducer. This device is intended for adult and pediatric (excluding neonatal and infant) use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807) is provided:
510 (k) Summary
A. Submitter:
Salter Labs 2365 Camino Vida Robles Carlsbad, CA 92011 Telephone: 760-795-7094 Fax: 760-683-6797
B: Contact Person:
Mara Caler Director, Regulatory Affairs
C: Date Prepared:
13 April 2016
D. Device Names:
| Trade Name | Common Name | Classification Name | Product Code |
|---|---|---|---|
| BiNAPS Nasal Airflow | |||
| Pressure and Snore | |||
| Transducer | Airflow Pressure | ||
| Transducer | Ventilatory Effort | ||
| Recorder | MNR | ||
| ThermiSense Oral/Nasal | |||
| Thermal AirFlow Sensor | |||
| with Airflow Pressure | |||
| Cannulas, Nasal and | |||
| Oral/Nasal | Airflow Sensor | Monitor, Breathing | |
| Frequency | BZQ |
| Regulation Number: | 868.2375 |
|---|---|
| Classification: | II |
| Classification Panel: | Anaesthesiology |
Predicate Devices:
This submission demonstrates substantial equivalence to the predicate devices: K051313, Airflow Pressure Transducer K080922, Airflow Sensor
4
E. Device Descriptions
The Salter Labs BiNAPS Nasal Airflow Pressure and Snore Transducer is a two output channel device used to acquire respiratory low pressure waves and low air flow that are sensed through a Nasal Cannula typically worn by a subject during a sleep diagnostic session. It is used to convert changes in air pressure and flow, occurring during sleep, into electrical signals that can be measured by polysomnography equipment. The Nasal Cannula directs the airflow and pressure waves generated by breathing and snoring from the nares and mouth of a patient through a luer lock fitting and then into a cup shaped plastic cylinder chamber sealed closed at the open end by a fitting and then into a cup shaped plastic cylinder chamber sealed closed at the open end by a piezo-electric ceramic element. The piezo element, when flexed by the impinging air pressure changes, generates a proportional electric voltage. This voltage is attenuated and filtered by subsequent passive electronic circuitry composing the sensor. The Salter Labs Airflow Pressure Transducer does not require a power source.
ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is composed of a Thermistor as the element which changes resistance as airflow from the patient is delivered across the element of the thermistor. 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 of the patient in order to be the most effective change in temperature.
The Thermistor is mounted in the Cannula to position the thermistor properly under the nares and in the airflow path of the mouth. The Thermistor is covered with a heat shrink tubing to protect it from moisture from the patient. The Thermistor requires a battery source in order to derive a current flow through the circuit. This battery source is 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.
F. Intended Use
Intended / Indications for Use
The BiNAPS Nasal Airflow Pressure and Snore Transducer (using the pressure transducer) is an accessory intended for use with polysomnography equipment during sleep disorder studies for the purpose of detecting and amplifying breathing signals and detection of snoring of a sleeping patient through a Salter Labs nasal cannula. This device is intended for adult and pediatric (excluding neonatal and infant) use.
The ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is a thermal resistive thermistor designed to monitor oral/nasal thermal airflow temperature and pressure changes during sleep studies. The ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is intended for use with a nasal cannula and polysomnography headbox or pressure transducers, such as, BiNAPS Nasal Airflow Pressure and Snore Transducer. This device is intended for adult and pediatric (excluding neonatal and infant) use.
5
Substantial Equivalence Table: G.
Comparison of Technological Characteristics with the Predicate Device
The proposed BiNAPS Nasal Airflow Pressure and Snore Transducer and ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal are substantially equivalent to the predicate devices.
| Characteristic | Predicate device | Modified device |
|---|---|---|
| Intended use | The BiNAPS Nasal Airflow Pressure and | |
| Snore Transducer is an accessory intended | ||
| for use with polysomnography equipment | ||
| during sleep disorder studies for the | ||
| purpose of detecting and amplifying | ||
| breathing signals and detection of snoring | ||
| of a sleeping patient through a Salter Labs | ||
| nasal cannula. | ||
| The ThermiSense Oral/Nasal Thermal | ||
| AirFlow Sensor with Airflow Pressure | ||
| Cannulas, Nasal and Oral/Nasal 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. | Unchanged | |
| Intended use | ||
| population | Patients undergoing sleep diagnosis studies | Unchanged |
| Principles of | ||
| operation | The detection and amplification of | |
| breathing signals and detection of snoring | ||
| of a sleeping patient through a Salter Labs | ||
| nasal cannula. | Unchanged | |
| Airflow output | Output is a nasal pressure airflow | |
| waveform. Output is connected to a | ||
| polygraph's AC jackbox with 1.5mm safety | ||
| connectors. Snoring can also be | ||
| superimposed onto the airflow waveform | ||
| as shown in the example on the next page. | ||
| This is accomplished by setting higher | ||
| values for the high frequency filter and the | ||
| sampling rate for the airflow channel. | Unchanged | |
| Snore output | Output is a snoring waveform derived from | Unchanged |
6
| Characteristic | Predicate device | Modified device |
|---|---|---|
| snore vibrations on the nasal pressure | ||
| signal. The channel has internal low | ||
| frequency filter to remove the airflow | ||
| signal and to provide a flat baseline | ||
| between snores. Output is connected to a | ||
| polygraph's AC jackbox with 1.5mm safety | ||
| connectors. | ||
| Clinical setting | Prescription use sleep diagnosis study | Unchanged |
| Device characteristics | Non-sterile | Unchanged |
The only difference between the modified BiNAPS Nasal Airflow Pressure and Snore Transducer and the modified ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal and predicate devices is a material modification used in the cannulas from PVC (DEHP and DIDP) to (DINCH and DOPT). The materials used in the remainder of the devices are unchanged.
| Features | Predicate Airflow
Pressure
Transducer &
Airflow Sensor | Modified Airflow
Pressure Transducer
& modified Airflow
Sensor | Performance
Testing |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------|
| Material
Formulation | PVC, DIDP
PVC, DEHP | PVC, DINCH
PVC, DOTP | Biocompatibility
and
Performance |
H. Performance Data
The BiNAPS Nasal Airflow Pressure and Snore Transducer and the ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal were tested to verify that the new material bond and performance characteristics of flow rate, back pressure, and tubing bond strength did not impact the strength or performance of the modified Airflo w Pressure Transducer and the modified Airflow Sensor after the material change.
The test results demonstrate that the BiNAPS Nasal Airflow Pressure and Snore Transducer and the ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal are substantially equivalent to the predicate devices
7
| Criteria | Predicate specifications | Modified devices | Comments |
|---|---|---|---|
| Back pressure | |||
| (flow rates): | Shall not have a back | ||
| pressure that exceeds | |||
| $3$ psi at a maximum | |||
| flow rate in ambient | |||
| of 5°C, 20°C, and | |||
| 40°C. | Maximum back | ||
| pressure was found | |||
| to be less than $2$ psi. | The modified | ||
| devices passed all | |||
| specifications | |||
| Bond Strength | |||
| (tensile | |||
| strength): | The bonded | ||
| components of the set | |||
| will have a bond | |||
| strength that is $\ge 2$ | |||
| lbs. when pulled at a | |||
| rate of 5 inches per | |||
| minute. | The bond strength | ||
| test achieved over $2$ | |||
| times the minimum | |||
| allowable value. | The modified | ||
| devices passed | |||
| all specifications | |||
| Device | |||
| dimensions: | Unchanged. | Unchanged. | The modified |
| devices use the | |||
| same molds and are | |||
| unchanged from the | |||
| predicate devices | |||
| Aging (shelf | |||
| life) | Not included | 3 years | The modified |
| devices meet all | |||
| specifications at the | |||
| 3 year test point |
Performance Testing Summary
The modified Sleep Diagnostics Cannulas meet established Salter Labs performance specifications.
| Characteristic | Predicate | New Device | Result |
|---|---|---|---|
| Performance | |||
| Sampling flow rate (max) | .5 lpm | .5 lpm | Same |
| Sampling backpressure @ max flow |