(633 days)
Not Found
No
The device description and intended use focus on providing a qualitative airflow signal based on temperature sensing. There is no mention of AI or ML in the device description, performance studies, or key metrics. The device acts as a sensor, not an analytical tool using AI/ML.
No
Explanation: The device is used to provide a qualitative airflow signal for recording onto a system in support of airflow analysis and sleep studies. It does not provide any diagnostic conclusions or therapeutic benefit to the patient.
No
The "Intended Use / Indications for Use" section explicitly states, "The Embla BreathSensor does not provide any diagnostic conclusion about the patient's condition to the user." It provides a qualitative airflow signal for recording onto a system in support of airflow analysis and sleep studies, not a diagnostic conclusion itself.
No
The device description explicitly states that the Embla BreathSensors are physical components (airflow thermistors) with temperature-sensitive resistive elements and an interface cable, indicating it is a hardware device, not software-only.
Based on the provided information, the Embla BreathSensor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Embla BreathSensor Function: The Embla BreathSensor measures airflow from the mouth and/or nose using temperature-sensitive components. It is applied externally to the patient and does not analyze any bodily fluids or tissues.
- Intended Use: The intended use is to provide a qualitative airflow signal for recording onto a system in support of airflow analysis and sleep studies. It explicitly states that it "does not provide any diagnostic conclusion about the patient's condition to the user."
Therefore, the Embla BreathSensor is a medical device used for physiological monitoring during sleep studies, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MNR
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and/or nasal, Between upper lip and nostrils
Indicated Patient Age Range
Children and adult patients
Intended User / Care Setting
qualified medical practitioner in a hospital environment only
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)
Performance Tests to Demonstrate Substantial Equivalency:
To establish the technical equivalency of the BreathSensors, evaluations were conducted to confirm compliance with performance requirements.
Evaluations and Results:
- Dimensions: Verification of dimensions. Result: Pass.
- Labels and Labeling: Verification of label and labeling content for variations. Result: Pass.
- Material: Verification of specified materials. Result: Pass.
- Biocompatibility of patient contact materials: Supported with final finished form cytotoxicity, sensitization and irritation evaluations. Result: Pass.
- Resistance: Verify BreathSensor base resistance. Result: Pass.
- Temperature Sensitivity: Verify minimum temperature sensitivity of resistance change per ℃. Result: Pass.
- Performance Testing: Comparison with predicate Disposable Flow Sensor, evaluation of qualitative airflow response with Interface Cable. Result: Pass.
- Electromagnetic compatibility: BreathSensor and Interface Cable compliance with IEC 60601-1-2:2014, 4th edition. Result: Pass.
Conclusion: The Embla BreathSensors meet performance requirements. The intended use and technology of the Embla BreathSensors are similar to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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) |
|---|---|
| -------------------------------------------------- | ----------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301)443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------ |
3
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 202
Kanata, ON, CA, K2K 3C7 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Mr. Sanjay Mehta
Director, Quality Assurance & Regulatory Affairs
Phone: (905) 287-5055
Email: Sanjay.Mehta@natus.com |
| Date Summary Prepared: | September 27, 2019 |
| Trade Name: | Embla BreathSensors |
| Common Name: | Thermistor for Air Flow |
| Classification Name: | Breathing Frequency Monitor
21 CFR 868.2375
Product Code: MNR
Class II |
| Predicate Device: | K913749 EdenTrace Airflow 3171, Sleep Lab Airflow 3170
EdenTec Corporation (Primary predicate)
K042253 SleepSense Sleep Disorder Sensors
S.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.
4
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 | BreathSensors | |||
| Under Review | EdenTrace Airflow | |||
| 3171, Sleep Lab | ||||
| Airflow 3170 | ||||
| (Primary Predicate | ||||
| K913749) | S.L.P. Ltd | |||
| SleepSense Sleep | ||||
| Disorder Sensors | ||||
| (Predicate K042253) | Equivalence | |||
| Comments | ||||
| Intended Use | Disposable temperature | |||
| sensitive sensor to | ||||
| support recording | ||||
| airflow. | Disposable temperature | |||
| sensitive sensor to | ||||
| support recording | ||||
| airflow. | Disposable temperature | |||
| sensitive sensor to | ||||
| support recording | ||||
| airflow. | Same | |||
| Indications for | ||||
| Use | 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 who will | ||||
| exercise their | ||||
| professional judgment | ||||
| in using this | ||||
| information. | ||||
| Rx only | The airflow signal is | |||
| provided by oral and/ or | ||||
| nasal temperature | ||||
| sensitive components. | ||||
| Accessory single use | ||||
| airflow sensors are used | ||||
| to provide resistance | ||||
| changes as affected by | ||||
| temperature changes in | ||||
| airflow representing | ||||
| inhaled and exhaled air. | ||||
| Rx only | SleepSense sensors | |||
| provide a qualitative | ||||
| measure of a patient's | ||||
| physiological | ||||
| parameters for | ||||
| recording onto an FDA- | ||||
| cleared data acquisition | ||||
| system. Their target | ||||
| population: Children | ||||
| and adult patients who | ||||
| are screened during | ||||
| sleep disorder studies. | ||||
| Their environment of | ||||
| use is usually at a sleep | ||||
| laboratory or sometimes | ||||
| at the patient's home. | ||||
| Rx Only | Both the Embla | |||
| BreathSensors under | ||||
| review and primary | ||||
| predicate Airflow Sensors | ||||
| provide oral and/or nasal | ||||
| temperature sensitive | ||||
| components. | ||||
| The population of use of | ||||
| the Embla BreathSensors | ||||
| under review and primary | ||||
| predicate EdenTec Airflow | ||||
| Sensors are similar. | ||||
| The variations of the | ||||
| primary predicate Airflow | ||||
| Sensors and Embla | ||||
| BreathSensors under | ||||
| review are identified by a | ||||
| Model variation name | ||||
| (Adult, Small Adult / | ||||
| Child). | ||||
| All three devices apply | ||||
| interface cables as | ||||
| applicable to condition the | ||||
| signal for medical | ||||
| professional user's | ||||
| recording equipment. | ||||
| All Rx Only | ||||
| The Embla BreathSensors | ||||
| under review provide | ||||
| additional detail with | ||||
| regard to the indications. | ||||
| Contraindication | Contraindicated for use | |||
| on patients who exhibit | None | None | The allergic reaction to | |
| tape adds clarification on | ||||
| Table 1: Substantial Equivalence Technical Characteristics | ||||
| Feature | BreathSensors | |||
| Under Review | EdenTrace Airflow | |||
| 3171, Sleep Lab | ||||
| Airflow 3170 | ||||
| (Primary Predicate | ||||
| K913749) | S.L.P. Ltd | |||
| SleepSense Sleep | ||||
| Disorder Sensors | ||||
| (Predicate K042253) | Equivalence | |||
| Comments | ||||
| allergic reactions to | ||||
| adhesive tape. | use. | |||
| Environment of | ||||
| Use | Hospitals | Hospitals, clinics and | ||
| home. | Hospitals, clinics (sleep | |||
| labs) and home. | The Embla Breath Sensors | |||
| have a hospital | ||||
| environment of use. | ||||
| Sensor | ||||
| variations | BreathSensor | |||
| Adult, Small Adult / | ||||
| Child | Airflow Sensor | |||
| Adult, Small Adult, | ||||
| Child, Infant, Preemie | Disposable Thermal | |||
| Flow Sensor | ||||
| Adult, Child, Extra | ||||
| Small | Similar | |||
| The medical professional | ||||
| selects the size of | ||||
| BreathSensor that best fits | ||||
| their patient with regard to | ||||
| placement of nasal and oral | ||||
| BreathSensor elements. | ||||
| Temperature | ||||
| Sensing | ||||
| Elements | Breath Sensor | |||
| Nasal and Oral: Adult, | ||||
| Small Adult / Child, | Airflow Sensor | |||
| Nasal and Oral: Adult, | ||||
| Small Adult, Child, | ||||
| Infant | ||||
| Oral only: Preemie | Disposable Flow Sensor | |||
| Nasal and Oral, Oral | ||||
| only options: Adult, | ||||
| Child, Extra Small | Similar | |||
| The primary predicate | ||||
| variation names of Small | ||||
| Adult and Child are | ||||
| renamed to one variation. | ||||
| BreathSensor: | ||||
| Single patient | ||||
| use, disposable | Yes | Yes | Yes | Same |
| Qualitative | ||||
| temperature | ||||
| output | Yes | Yes | Yes | Same |
| The signal output from the | ||||
| BreathSensor is a | ||||
| qualitative signal based | ||||
| upon the difference in | ||||
| ambient and exhaled air. | ||||
| The medical professional | ||||
| will adjust signal amplitude | ||||
| on the recording | ||||
| equipment. | ||||
| Duration of use | Duration of a sleep | |||
| study, anticipated to be | ||||
| up to 12 hours | Duration of a sleep | |||
| study | Duration of a sleep | |||
| study | Same | |||
| Patient applied | ||||
| location | Between upper lip and | |||
| nostrils | Between upper lip and | |||
| nostrils | Between upper lip and | |||
| nostrils | Same | |||
| Sensor materials | Carbon Ink | |||
| Silver Ink | ||||
| Polyester | ||||
| Tape | Carbon Ink | |||
| Silver Ink | ||||
| Polyester (Mylar) | ||||
| Tape | Unknown | Carbon ink is the | ||
| temperature sensitive | ||||
| material. The conductive | ||||
| silver ink conducts the | ||||
| signal to the interface cable | ||||
| input connector. The | ||||
| carbon and silver ink are | ||||
| placed on a polyester | ||||
| substrate. The polyester | ||||
| substrate and ink are | ||||
| Table 1: Substantial Equivalence Technical Characteristics | ||||
| Feature | BreathSensors | |||
| Under Review | EdenTrace Airflow | |||
| 3171, Sleep Lab | ||||
| Airflow 3170 | ||||
| (Primary Predicate | ||||
| K913749) | S.L.P. Ltd | |||
| SleepSense Sleep | ||||
| Disorder Sensors | ||||
| (Predicate K042253) | Equivalence | |||
| Comments | ||||
| covered by tape. | ||||
| Patient contact | ||||
| material | Micro-Pore, | |||
| Micro-Foam Tape | Micro-Pore Tape | Unknown | Equivalent | |
| Final finished form | ||||
| BreathSensors have been | ||||
| evaluated for cytotoxicity, | ||||
| irritation and sensitization | ||||
| with passing results. | ||||
| Sterility | Supplied non-sterile | Supplied non-sterile | Supplied non-sterile | Same |
| Accessory | ||||
| Interface cables | Yes | |||
| Active | Yes | |||
| Passive and active | Yes | |||
| Passive and active | Similar | |||
| Active interface cable | ||||
| variations are available. | ||||
| The interface cables | ||||
| connect to the medial | ||||
| professional's amplifier, | ||||
| recording equipment, | ||||
| supporting transfer of the | ||||
| BreathSensor thermistor | ||||
| signal to their equipment. | ||||
| Accessory | ||||
| Interface cable: | ||||
| Active Cable | Yes | |||
| Battery powered, | ||||
| filtering and conversion | ||||
| of sensor thermistor to | ||||
| thermocouple sensor | ||||
| signal. | Yes | |||
| Battery Powered, | ||||
| filtering and conversion | ||||
| of sensor thermistor to | ||||
| thermocouple sensor | ||||
| signal. | Yes | |||
| Battery Powered, | ||||
| filtering and conversion | ||||
| of sensor thermistor to | ||||
| thermocouple sensor | ||||
| signal. | Equivalent | |||
| The active interface cables | ||||
| have sensor and user | ||||
| recording equipment | ||||
| compatible connectors and | ||||
| are battery powered | ||||
| (internal). | ||||
| The active interface cables | ||||
| are battery-powered by an | ||||
| internal non-user | ||||
| replaceable battery. The | ||||
| active interface cables | ||||
| provide filtering and | ||||
| conversion of the | ||||
| thermistor sensor signal to | ||||
| thermocouple sensor signal | ||||
| for presentation to the | ||||
| user's recording equipment | ||||
| Accessory | ||||
| interface cable: | ||||
| Reusable | Yes | Yes | Yes | Same |
| Connection to | ||||
| user's | ||||
| equipment | Yes | |||
| Accessory Interface | ||||
| Cable | Yes | |||
| Accessory Interface | ||||
| Cable | Yes | |||
| Accessory Interface | ||||
| Cable | Same | |||
| Interface cable | ||||
| variations | Active | Active and passive | Active and passive | Similar |
| The active interface cables | ||||
| interface the BreathSensor | ||||
| Table 1: Substantial Equivalence Technical Characteristics | ||||
| Feature | BreathSensors | |||
| Under Review | EdenTrace Airflow | |||
| 3171, Sleep Lab | ||||
| Airflow 3170 | ||||
| (Primary Predicate | ||||
| K913749) | S.L.P. Ltd | |||
| SleepSense Sleep | ||||
| Disorder Sensors | ||||
| (Predicate K042253) | Equivalence | |||
| Comments | ||||
| to recording equipment. |
5
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".
6
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".
7
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 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 | 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.