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.

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.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the BiNAPS Nasal Airflow Pressure and Snore Transducer and the ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal. This document is a 510(k) summary submitted to the FDA, focusing on demonstrating substantial equivalence to predicate devices, primarily due to a material change in the cannulas.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (Predicate Specifications)	Reported Device Performance (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 ≥ 2 lbs. when pulled at a rate of 5 inches per minute.	The bond strength test achieved over 2 times the minimum allowable value (meaning > 4 lbs).	The modified devices passed all specifications.
Device Dimensions	Unchanged from predicate devices.	Unchanged.	The modified devices use the same molds and are unchanged from the predicate devices.
Aging (Shelf Life)	Not included (for predicate, but introduced for modified)	3 years	The modified devices meet all specifications at the 3-year test point.
Sampling Flow Rate (max)	0.5 lpm	0.5 lpm	Same
Sampling Backpressure @ max flow	< 0.64 psi	< 0.64 psi	Same
Biocompatibility	Not explicitly stated as a numerical criterion for the predicate, but implicitly required for medical devices.	Passed all parameters: Irritation, Sensitization, Cytotoxicity.	The materials passed all biocompatibility parameters.

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

The document does not specify a sample size for the test set in terms of number of devices or subjects. The testing described is primarily for device performance characteristics (e.g., back pressure, bond strength, flow rate) and biocompatibility of the revised materials. This is not a study involving human subjects for clinical efficacy or diagnostic accuracy.

The data provenance is prospective testing of the modified devices to compare their physical and performance characteristics against the established specifications from the predicate devices. The country of origin for the data is not explicitly stated, but given the FDA submission, it can be inferred to be from Salter Labs, Carlsbad, California, USA, or their designated testing facilities.

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

This type of study does not involve human experts to establish "ground truth" in the clinical sense (e.g., diagnosis). The ground truth here is the engineering specifications and performance benchmarks derived from the predicate devices and industry standards. These benchmarks are established by device engineers and quality assurance personnel, whose qualifications are not detailed in this summary but are implicit in medical device manufacturing.

4. Adjudication Method for the Test Set

There is no "adjudication method" in the sense of clinical agreement (e.g., 2+1, 3+1). The "adjudication" is a direct comparison of the test results against the predefined numerical and qualitative specifications for each characteristic (e.g., is back pressure < 2 psi less than 3 psi? Yes).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes performance testing of a physical device, not an AI algorithm for diagnostic interpretation by multiple human readers.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not an algorithm, and therefore, no standalone (algorithm-only) performance study was conducted.

7. The Type of Ground Truth Used

The ground truth used is primarily engineering specifications and performance benchmarks derived from the predicate devices and industry standards. For biocompatibility, the ground truth refers to established biocompatibility standards (e.g., ISO 10993 series), against which the material's performance (irritation, sensitization, cytotoxicity) is measured.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI. The testing described pertains to physical and material properties.

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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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

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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

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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)

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 AirflowPressure and SnoreTransducer	Airflow PressureTransducer	Ventilatory EffortRecorder	MNR
ThermiSense Oral/NasalThermal AirFlow Sensorwith Airflow PressureCannulas, Nasal andOral/Nasal	Airflow Sensor	Monitor, BreathingFrequency	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

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E. Device Descriptions

F. Intended Use

Intended / Indications for 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.

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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 andSnore Transducer is an accessory intendedfor use with polysomnography equipmentduring sleep disorder studies for thepurpose of detecting and amplifyingbreathing signals and detection of snoringof a sleeping patient through a Salter Labsnasal cannula.The ThermiSense Oral/Nasal ThermalAirFlow Sensor with Airflow PressureCannulas, Nasal and Oral/Nasal is used asa cannula accessory with existing recordingdevices and data acquisition systems in asleep laboratory setting to support thediagnostic recording of nasal and or oralairflow. The subject device itself performsno diagnostic functions, and only supportsthe diagnostic recording of airflow for useas an accessory component to apolysomnography recorder.	Unchanged
Intended usepopulation	Patients undergoing sleep diagnosis studies	Unchanged
Principles ofoperation	The detection and amplification ofbreathing signals and detection of snoringof a sleeping patient through a Salter Labsnasal cannula.	Unchanged
Airflow output	Output is a nasal pressure airflowwaveform. Output is connected to apolygraph's AC jackbox with 1.5mm safetyconnectors. Snoring can also besuperimposed onto the airflow waveformas shown in the example on the next page.This is accomplished by setting highervalues for the high frequency filter and thesampling rate for the airflow channel.	Unchanged
Snore output	Output is a snoring waveform derived from	Unchanged

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Characteristic	Predicate device	Modified device
	snore vibrations on the nasal pressuresignal. The channel has internal lowfrequency filter to remove the airflowsignal and to provide a flat baselinebetween snores. Output is connected to apolygraph's AC jackbox with 1.5mm safetyconnectors.
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 AirflowPressureTransducer &Airflow Sensor	Modified AirflowPressure Transducer& modified AirflowSensor	PerformanceTesting
MaterialFormulation	PVC, DIDPPVC, DEHP	PVC, DINCHPVC, DOTP	BiocompatibilityandPerformance

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

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Criteria	Predicate specifications	Modified devices	Comments
Back pressure(flow rates):	Shall not have a backpressure that exceeds$3$ psi at a maximumflow rate in ambientof 5°C, 20°C, and40°C.	Maximum backpressure was foundto be less than $2$ psi.	The modifieddevices passed allspecifications
Bond Strength(tensilestrength):	The bondedcomponents of the setwill have a bondstrength that is $\ge 2$lbs. when pulled at arate of 5 inches perminute.	The bond strengthtest achieved over $2$times the minimumallowable value.	The modifieddevices passedall specifications
Devicedimensions:	Unchanged.	Unchanged.	The modifieddevices use thesame molds and areunchanged from thepredicate devices
Aging (shelflife)	Not included	3 years	The modifieddevices meet allspecifications at the3 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	< .64 psi	< .64 psi	Same

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I. Clinical / Non-Clinical

No clinical patient testing was required for this submission.

The following biocompatibility testing was performed. The materials passed all parameters:

. Irritation
Sensitization ●
Cytotoxicity ●

J. Conclusions

The BiNAPS Nasal Airflow Pressure and Snore Transducer and the ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal data and test results demonstrate that the devices are substantially equivalent to the predicate devices.

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).