(633 days)
The Embla BreathSensor provides a qualitative air flow signal by oral and/or nasal temperature sensitive resistive components for recording onto a recording system in support of airflow analysis and sleep studies.
The Embla BreathSensor does not provide any diagnostic conclusion about the patient's condition to the user.
The Embla BreathSensor user is a qualified medical practitioner in a hospital environment only who will exercise their professional judgment in using this information.
The Embla BreathSensors (Model 970 Series) are airflow thermistors used as an accessory to a polysomnogram (PSG) or sleep study recording system. The BreathSensor family is comprised of two different variations: Models 971 Adult and Model 974 Small Adult/Child.
The BreathSensors are for use with any standard PSG amplifier or recorder. An interface cable connects the BreathSensor to the polysomnography equipment.
Embla BreathSensors are designed to provide a qualitative measure of respirations (flow) from the mouth and/or nose. The user selects the appropriate size of BreathSensor based on their clinical judgment.
The nasal and/or oral temperature sensor elements are carbon ink placed on a substrate. The carbon ink is the temperature sensitive material. Silver ink interfaces with the carbon ink temperature sensing elements to provide a connection to the interface cable.
The Embla BreathSensors are non-sterile, single patient use, disposable devices.
The Embla BreathSensors are a medical device used to provide a qualitative airflow signal for sleep studies. The device utilizes oral and/or nasal temperature-sensitive resistive components to record airflow onto a recording system.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria with ranges or thresholds for performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various evaluations. The acceptance criterion for each evaluation is simply "Pass", indicating that the device met the specified requirements for that test.
| Feature | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate, meeting specific requirements) | Reported Device Performance |
|---|---|---|
| Dimensions | Verification of dimensions. | Pass |
| Labels and Labeling | Verification of label and labeling content for variations. | Pass |
| Material | Verification of specified materials. | Pass |
| Biocompatibility of patient contact materials | Supported with final finished form cytotoxicity, sensitization, and irritation evaluations. | Pass |
| Resistance | Verify BreathSensor base resistance. | Pass |
| Temperature Sensitivity | Verify minimum temperature sensitivity of resistance change per ℃. | Pass |
| Performance Testing | Comparison with predicate Disposable Flow Sensor, evaluation of qualitative airflow response with Interface Cable. | Pass |
| Electromagnetic compatibility | Compliance with IEC 60601-1-2:2014, 4th edition (for BreathSensor and Interface Cable). | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for any of the performance tests.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. The studies are described as "evaluations conducted to confirm compliance with performance requirements," suggesting they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. Given the nature of the device (a qualitative airflow sensor), the "ground truth" for its performance tests likely refers to objective measurements against established standards or comparisons with the predicate device, rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method. As noted above, the evaluation seems to rely on objective measurements and comparisons rather than subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done or reported. The device is a qualitative airflow sensor that provides a signal, not a diagnostic algorithm that human readers would use to make decisions. Therefore, a study to measure human reader improvement with or without AI assistance is not applicable here.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
Yes, the studies described are for standalone device performance. The performance tests (dimensions, material, resistance, temperature sensitivity, biocompatibility, EMC) evaluate the physical and electrical characteristics of the Embla BreathSensors and its interface cable, independent of a human user's interpretation of the signal provided by the device. The "Performance Testing" which involves "Comparison with predicate Disposable Flow Sensor, evaluation of qualitative airflow response with Interface Cable" also appears to be a standalone assessment of the device's ability to generate the expected signal.
7. Type of Ground Truth Used:
The ground truth used for these evaluations appears to be a combination of:
- Objective measurements against engineering specifications: For features like dimensions, resistance, and temperature sensitivity.
- Compliance with recognized standards: For biocompatibility (cytotoxicity, irritation, sensitization evaluations) and electromagnetic compatibility (IEC 60601-1-2:2014).
- Comparison to predicate device performance: For qualitative airflow response during performance testing.
8. Sample Size for the Training Set:
Not applicable. This device is a hardware sensor, not an artificial intelligence or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As stated above, this device does not involve a training set.
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September 27, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Embla Systems (Embla) Sanjay Mehta Director, Quality Assurance & Regulatory Affairs 1 Hines Road, Suite 202 Kanata, ON, CA K2K 3C7
Re: K180001
Trade/Device Name: Embla BreathSensors Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: Class II Product Code: MNR Dated: August 26, 2019 Received: August 29, 2019
Dear Sanjay Mehta:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K180001
Device Name Embla BreathSensors
Indications for Use (Describe)
The Embla BreathSensor provides a qualitative air flow signal by oral and/or nasal temperature sensitive resistive components for recording onto a recording system in support of airflow analysis and sleep studies.
The Embla BreathSensor does not provide any diagnostic conclusion about the patient's condition to the user.
The Embla BreathSensor user is a qualified medical practitioner in a hospital environment only who will exercise their professional judgment in using this information.
Type of Use (Select one or both, as applicable)
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------- | ----------------------------------------------- |
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Image /page/3/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is written in a teal sans-serif font, with a registered trademark symbol next to the "s". Below "natus" is the word "neurology" in a smaller, italicized, black sans-serif font. The logo is simple and clean, with a focus on the company name.
510(K): K180001, EMBLA BREATHSENSORS
K180001 510(k) Summary
510(k) Summary This summary is provided to support the 510(k) pre-market notification for the Embla BreathSensors.
| Company Name: | Embla Systems (Embla)1 Hines Road, Suite 202Kanata, ON, CA, K2K 3C7 |
|---|---|
| Company Contact: | Mr. Sanjay MehtaDirector, Quality Assurance & Regulatory AffairsPhone: (905) 287-5055Email: Sanjay.Mehta@natus.com |
| Date Summary Prepared: | September 27, 2019 |
| Trade Name: | Embla BreathSensors |
| Common Name: | Thermistor for Air Flow |
| Classification Name: | Breathing Frequency Monitor21 CFR 868.2375Product Code: MNRClass II |
| Predicate Device: | K913749 EdenTrace Airflow 3171, Sleep Lab Airflow 3170EdenTec Corporation (Primary predicate)K042253 SleepSense Sleep Disorder SensorsS.L.P. Ltd |
Product Description
The Embla BreathSensors (Model 970 Series) are airflow thermistors used as an accessory to a polysomnogram (PSG) or sleep study recording system. The BreathSensor family is comprised of two different variations: Models 971 Adult and Model 974 Small Adult/Child.
The BreathSensors are for use with any standard PSG amplifier or recorder. An interface cable connects the BreathSensor to the polysomnography equipment.
Embla BreathSensors are designed to provide a qualitative measure of respirations (flow) from the mouth and/or nose. The user selects the appropriate size of BreathSensor based on their clinical judgment.
The nasal and/or oral temperature sensor elements are carbon ink placed on a substrate. The carbon ink is the temperature sensitive material. Silver ink interfaces with the carbon ink temperature sensing elements to provide a connection to the interface cable.
The Embla BreathSensors are non-sterile, single patient use, disposable devices.
Intended Use of the Device
The Embla BreathSensor provides a qualitative air flow signal by oral and/or nasal temperature resistive resistive resistive components for recording onto a recording system in support of airflow analysis and sleep studies. The Embla BreathSensor does not provide any diagnostic conclusion about the patient's condition to the user. The Embla BreathSensor user is a qualified medical practitioner in a hospital environment who will exercise their professional judgment in using this information.
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Image /page/4/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, and the word "neurology" is in a black italicized sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand.
Summary of Technological Characteristics
The BreathSensors are single patient use, disposable sensors applied to a patient below the nose, (above the mouth), to support a qualitative indication of airflow from the nostrils and/or mouth. The BreathSensors are a form of thermistor, indicating airflow by temperature change. The accessory interface cables connect between the BreathSensor and user equipment for display and recording by the user's equipment.
Table 1 provides a side-by-side comparison of the BreathSensors to the predicate device applied to support this premarket notification.
| Table 1: Substantial Equivalence Technical Characteristics | ||||
|---|---|---|---|---|
| Feature | BreathSensorsUnder Review | EdenTrace Airflow3171, Sleep LabAirflow 3170(Primary PredicateK913749) | S.L.P. LtdSleepSense SleepDisorder Sensors(Predicate K042253) | EquivalenceComments |
| Intended Use | Disposable temperaturesensitive sensor tosupport recordingairflow. | Disposable temperaturesensitive sensor tosupport recordingairflow. | Disposable temperaturesensitive sensor tosupport recordingairflow. | Same |
| Indications forUse | The EmblaBreathSensor provides aqualitative air flowsignal by oral and/ornasal temperaturesensitive resistivecomponents forrecording onto arecording system insupport of airflowanalysis and sleepstudies.The EmblaBreathSensor does notprovide any diagnosticconclusion about thepatient's condition tothe user.The EmblaBreathSensor user is aqualified medicalpractitioner who willexercise theirprofessional judgmentin using thisinformation.Rx only | The airflow signal isprovided by oral and/ ornasal temperaturesensitive components.Accessory single useairflow sensors are usedto provide resistancechanges as affected bytemperature changes inairflow representinginhaled and exhaled air.Rx only | SleepSense sensorsprovide a qualitativemeasure of a patient'sphysiologicalparameters forrecording onto an FDA-cleared data acquisitionsystem. Their targetpopulation: Childrenand adult patients whoare screened duringsleep disorder studies.Their environment ofuse is usually at a sleeplaboratory or sometimesat the patient's home.Rx Only | Both the EmblaBreathSensors underreview and primarypredicate Airflow Sensorsprovide oral and/or nasaltemperature sensitivecomponents.The population of use ofthe Embla BreathSensorsunder review and primarypredicate EdenTec AirflowSensors are similar.The variations of theprimary predicate AirflowSensors and EmblaBreathSensors underreview are identified by aModel variation name(Adult, Small Adult /Child).All three devices applyinterface cables asapplicable to condition thesignal for medicalprofessional user'srecording equipment.All Rx OnlyThe Embla BreathSensorsunder review provideadditional detail withregard to the indications. |
| Contraindication | Contraindicated for useon patients who exhibit | None | None | The allergic reaction totape adds clarification on |
| Table 1: Substantial Equivalence Technical Characteristics | ||||
| Feature | BreathSensorsUnder Review | EdenTrace Airflow3171, Sleep LabAirflow 3170(Primary PredicateK913749) | S.L.P. LtdSleepSense SleepDisorder Sensors(Predicate K042253) | EquivalenceComments |
| allergic reactions toadhesive tape. | use. | |||
| Environment ofUse | Hospitals | Hospitals, clinics andhome. | Hospitals, clinics (sleeplabs) and home. | The Embla Breath Sensorshave a hospitalenvironment of use. |
| Sensorvariations | BreathSensorAdult, Small Adult /Child | Airflow SensorAdult, Small Adult,Child, Infant, Preemie | Disposable ThermalFlow SensorAdult, Child, ExtraSmall | SimilarThe medical professionalselects the size ofBreathSensor that best fitstheir patient with regard toplacement of nasal and oralBreathSensor elements. |
| TemperatureSensingElements | Breath SensorNasal and Oral: Adult,Small Adult / Child, | Airflow SensorNasal and Oral: Adult,Small Adult, Child,InfantOral only: Preemie | Disposable Flow SensorNasal and Oral, Oralonly options: Adult,Child, Extra Small | SimilarThe primary predicatevariation names of SmallAdult and Child arerenamed to one variation. |
| BreathSensor:Single patientuse, disposable | Yes | Yes | Yes | Same |
| Qualitativetemperatureoutput | Yes | Yes | Yes | SameThe signal output from theBreathSensor is aqualitative signal basedupon the difference inambient and exhaled air.The medical professionalwill adjust signal amplitudeon the recordingequipment. |
| Duration of use | Duration of a sleepstudy, anticipated to beup to 12 hours | Duration of a sleepstudy | Duration of a sleepstudy | Same |
| Patient appliedlocation | Between upper lip andnostrils | Between upper lip andnostrils | Between upper lip andnostrils | Same |
| Sensor materials | Carbon InkSilver InkPolyesterTape | Carbon InkSilver InkPolyester (Mylar)Tape | Unknown | Carbon ink is thetemperature sensitivematerial. The conductivesilver ink conducts thesignal to the interface cableinput connector. Thecarbon and silver ink areplaced on a polyestersubstrate. The polyestersubstrate and ink are |
| Table 1: Substantial Equivalence Technical Characteristics | ||||
| Feature | BreathSensorsUnder Review | EdenTrace Airflow3171, Sleep LabAirflow 3170(Primary PredicateK913749) | S.L.P. LtdSleepSense SleepDisorder Sensors(Predicate K042253) | EquivalenceComments |
| covered by tape. | ||||
| Patient contactmaterial | Micro-Pore,Micro-Foam Tape | Micro-Pore Tape | Unknown | EquivalentFinal finished formBreathSensors have beenevaluated for cytotoxicity,irritation and sensitizationwith passing results. |
| Sterility | Supplied non-sterile | Supplied non-sterile | Supplied non-sterile | Same |
| AccessoryInterface cables | YesActive | YesPassive and active | YesPassive and active | SimilarActive interface cablevariations are available.The interface cablesconnect to the medialprofessional's amplifier,recording equipment,supporting transfer of theBreathSensor thermistorsignal to their equipment. |
| AccessoryInterface cable:Active Cable | YesBattery powered,filtering and conversionof sensor thermistor tothermocouple sensorsignal. | YesBattery Powered,filtering and conversionof sensor thermistor tothermocouple sensorsignal. | YesBattery Powered,filtering and conversionof sensor thermistor tothermocouple sensorsignal. | EquivalentThe active interface cableshave sensor and userrecording equipmentcompatible connectors andare battery powered(internal).The active interface cablesare battery-powered by aninternal non-userreplaceable battery. Theactive interface cablesprovide filtering andconversion of thethermistor sensor signal tothermocouple sensor signalfor presentation to theuser's recording equipment |
| Accessoryinterface cable:Reusable | Yes | Yes | Yes | Same |
| Connection touser'sequipment | YesAccessory InterfaceCable | YesAccessory InterfaceCable | YesAccessory InterfaceCable | Same |
| Interface cablevariations | Active | Active and passive | Active and passive | SimilarThe active interface cablesinterface the BreathSensor |
| Table 1: Substantial Equivalence Technical Characteristics | ||||
| Feature | BreathSensorsUnder Review | EdenTrace Airflow3171, Sleep LabAirflow 3170(Primary PredicateK913749) | S.L.P. LtdSleepSense SleepDisorder Sensors(Predicate K042253) | EquivalenceComments |
| to recording equipment. |
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Image /page/5/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal color and in a larger font. Below that, the word "neurology" is in a smaller, black font. There is a registered trademark symbol to the right of the word "natus".
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Image /page/6/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a teal color and in a larger font. Below that, the word "neurology" is in a smaller, black font. There is a registered trademark symbol to the right of the word "natus".
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Image /page/7/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is written in a teal, sans-serif font. Below that, the word "neurology" is written in a black, sans-serif font. The logo is simple and modern.
As noted, the differences do not affect substantial equivalence of safety and effectiveness:
- A contraindication is added for patients who may have allergic reactions to adhesive tape. .
- . The BreathSensors are supported by available accessory interface cable(s).
Performance Tests to Demonstrate Substantial Equivalency
To establish the technical equivalency of the BreathSensors, evaluations were conducted to confirm compliance with performance requirements. Table 2 summarizes evaluations and results supporting substantial equivalence.
| Table 2: Summary of Evaluations Supporting Substantial Equivalence | ||
|---|---|---|
| Feature | Evaluation Summary | Result |
| Dimensions | Verification of dimensions. | Pass |
| Labels and Labeling | Verification of label and labeling content for variations. | Pass |
| Material | Verification of specified materials. | Pass |
| Biocompatibility of patientcontact materials | Supported with final finished form cytotoxicity, sensitization and irritationevaluations. | Pass |
| Resistance | Verify BreathSensor base resistance. | Pass |
| Temperature Sensitivity | Verify minimum temperature sensitivity of resistance change per ℃. | Pass |
| Performance Testing | Comparison with predicate Disposable Flow Sensor, evaluation of qualitative airflowresponse with Interface Cable. | Pass |
| Electromagneticcompatibility | BreathSensor and Interface Cable compliance with IEC 60601-1-2:2014,4th edition | Pass |
Conclusion
The Embla BreathSensors meet performance requirements. The intended use and technology of the Embla BreathSensors are similiar to the predicate devices.
§ 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).