(192 days)
No
The description focuses on a simple thermocouple-based sensor detecting temperature changes for respiration, with no mention of AI or ML algorithms for signal processing or interpretation.
No
The device is a sensor used to detect respiratory airflow for diagnostic purposes (polysomnography devices), not to treat a medical condition.
No
The device is a sensor that measures temperature changes related to respiration for use with polysomnography devices, providing an indication of respiration airflow rather than diagnosing a condition itself.
No
The device description clearly states it is a "Maxxi Flow sensor" which is a physical, thermocouple-based sensor that detects temperature changes. It also mentions different length sizes (3ft and 7ft) and compatibility with other hardware (Neurovirtual PSG devices). This indicates a hardware component is central to the device's function.
Based on the provided information, the Maxxi Flow sensor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Maxxi Flow sensor measures temperature changes of air inhaled and exhaled by the patient. It does not analyze blood, urine, tissue, or any other biological sample taken from the body.
- The intended use is for monitoring respiration airflow. This is a physiological measurement, not a diagnostic test performed on a sample.
- The device description focuses on the physical sensor and its function in detecting temperature changes of breath. There is no mention of reagents, assays, or any other components typically associated with IVDs.
The Maxxi Flow sensor is a physiological monitoring device used in conjunction with polysomnography equipment to assess respiratory patterns during sleep.
N/A
Intended Use / Indications for Use
The Maxxi Flow sensor is a respiratory sensor. It is placed under the patient's and produce a signal that is directly proportional to the temperature changes of air inhaled and exhaled during respiration. Maxxi Flow sensors generate a small analog electrical signal that provides a clear, reliable indication of respiration airflow. This sensor is intended to be used with polysomnography devices and adult patients.
Intended to be use in a sleep laboratory, clinics or hospitals.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
MAXXI FLOW SENSOR Thermocouple based sensors detect change of breath temperature between ambient temperature (inhalation) and lung temperature (exhalation). A thermocouple placed in front of a nostril detects breathing as a temperature change.
The product is offered in 2 different length sizes, 3ft and 7ft.
Maxxi Flow sensor is compatible with Neurovirtual PSG devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nostrils
Indicated Patient Age Range
Adults
Intended User / Care Setting
sleep laboratory, clinics or hospitals
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)
Non-clinical Testing:
The test performance comparing the Maxxi Flow and the predicate device Easy Flow manufactured by S.L.P Ltd was performed and the summary results are show in the summary below.
Test: Parts Dimensions
Description: Verify if the dimensions of the thermocouple unit are within the acceptable range and equivalent to the predicate
Criteria: Allowance: +-10%
Results: The dimensions of the thermocouple unit are within the acceptable criteria as when compared to the predicate device.
Test: Cable Length
Description: Verify if the wire lead length is within the acceptable range and equivalent to the predicate
Criteria: Expected: 3 ft and 7 ft Allowance: +-5%
Results: The cable length of the sensor is within the acceptable criteria as when compared to the predicate device.
Test: Visual Conditions
Description: Verify the visual aspects of the product and equivalency with the predicate. Cable aspects, labeling, flexibility, plastic finishing, and connector conditions.
Criteria: All aspects must be substantially equivalent to the predicate device.
Results: Maxxi Flow sensor was inspected, and the result is equivalent to the predicate device.
Test: Sensor Resistance
Description: Verify the resistance of the sensor using the ohmmeter in a controlled test environment where the temperature is stable.
Criteria: Expected: 0-10 ohms
Results: The Maxxi Flow was inspected, and the resistance is between the acceptable criteria range. (2.0 ohms)
Test: Output signals Frequency and Amplitude Tests
Description: The sensor Maxxi Flow and the predicate Easy Flow were connected to the same PSG recorder and the acquired data was compared in frequency and amplitude.
Criteria: Allowance: +-15%
Results: Both sensors acquired equivalent signals within the acceptable range.
Additionally, the test performance with different environment temperatures was performed. The results showed exact same frequency as the predicate, with minimal difference on voltage amplitude and resistance measurement values.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
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December 14, 2020
Neurovirtual USA, Inc. Eduardo Faria CEO 3303 W Commercial Blvd #100 Fort Lauderdale, Florida 33309
Re: K201495
Trade/Device Name: Maxxi Flow Sensor Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: November 10, 2020 Received: November 12, 2020
Dear Eduardo Faria:
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 Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201495
Device Name Maxxi Flow Sensor
Indications for Use (Describe)
The Maxxi Flow sensor is a respiratory sensor. It is placed under the patient's and produce a signal that is directly proportional to the temperature changes of air inhaled and exhaled during respiration. Maxxi Flow sensors generate a small analog electrical signal that provides a clear, reliable indication of respiration airflow. This sensor is intended to be used with polysomnography devices and adult patients.
Intended to be use in a sleep laboratory, clinics or hospitals.
| 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 shows the logo for Neurovirtual. The logo consists of a stylized waveform in shades of orange on the left, followed by the word "NEUROVIRTUAL" in blue. The "O" in "NEUROVIRTUAL" is replaced with an orange circle.
510(k) SUMMARY
Submitter's Name: Neurovirtual USA, Inc.
Owner / Operator Registration Number: 3006125362 FEI Number: 3006125362 Manufacture Registration Number: 3006125362
Address: 3303 W Commercial Blvd #100 Fort Lauderdale, FL 33309 USA
Phone and Fax Numbers
Phone: (786) 693-8200 Fax: (305) 393-8429
Contact Person: Eduardo J. Faria
Preparation Date: December 11, 2020
Classification Name:
Common / Usual Name: Breathing frequency monitor Proprietary Name: Maxxi Flow Sensor Product Code: MNR Class: Class II Regulation: 21 CFR 868.2375
Device Description:
MAXXI FLOW SENSOR Thermocouple based sensors detect change of breath temperature between ambient temperature (inhalation) and lung temperature (exhalation). A thermocouple placed in front of a nostril detects breathing as a temperature change.
The product is offered in 2 different length sizes, 3ft and 7ft.
Maxxi Flow sensor is compatible with Neurovirtual PSG devices.
Substantial Equivalence:
The Maxxi Flow Sensor is substantial equivalent with the following products:
Primary Predicate
| 510(k) Number | Model | Company |
|---|---|---|
| K922112 | Thermocouple Flow Sensor (Easy Flow) | S.L.P. Ltd. |
| Former EPM INFORMATION SYSTEMS, INC. |
Reference device:
| 510(k) Number | Model | Company |
|---|---|---|
| K981445 | ULTIMA AIRFLOW SENSOR | BRAEBON MEDICAL CORP. |
The reference predicate was added in order to support to demonstrate the substantial equivalence with the subject device because it has similar anatomical and technological characteristics, as well it is not powered with battery which is the same as the subject device.
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Image /page/4/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform graphic in shades of orange, followed by the word "NEUROVIRTUAL" in blue, block letters. The "O" in Neurovirtual is replaced with an orange circle.
-
- Indications for Use:
| Indications for Use Comparison | ||
|---|---|---|
| Neurovirtual | S.L.P. Ltd. | Braebon |
| Maxxi Flow Sensor | Thermocouple Flow Sensor (Easy flow) | ULTIMA AIRFLOW SENSOR |
| The Maxxi Flow sensor is a respiratory | ||
| sensor. It is placed under the patient's | ||
| nostrils and produce a signal that is | ||
| directly proportional to the temperature | ||
| changes of air inhaled and exhaled during | ||
| respiration. Maxxi Flow sensors generate | ||
| a small analog electrical signal that | ||
| provides a clear, reliable indication of | ||
| respiration airflow. This sensor is intended | ||
| to be used with polysomnography devices | ||
| and adult patients. |
Intended to be use in a sleep laboratory,
clinics or hospitals. | The Easy flow sensor is a respiratory
sensor. It is placed under the patient's
nostrils and produce a signal that is
directly proportional to the temperature
changes of air inhaled and exhaled during
respiration. Easy flow sensors generate a
small analog electrical signal that
provides a clear, reliable indication of
respiration airflow. This sensor is
intended to be used in polysomnography
devices
Intended to be use in a sleep laboratory,
clinics or hospitals | A Qualitative measure of respiratory
airflow for recording onto a data
acquisition system. |
2. Technological Characteristics Comparison:
The predicate devices used to establish substantial equivalence for the Maxxi Flow Sensor are outlined below. This section of this submission will provide a comparison of design, materials, and technical specifications of the Maxxi Flow Sensor to each of the predicate devices stratified by functional modality.
| Specifications Comparison | |||
|---|---|---|---|
| Device | Neurovirtual | ||
| Maxxi Flow Sensor | S.L.P. Ltd. | ||
| Thermocouple Flow Sensor (Easy | |||
| flow) | Braebon | ||
| ULTIMA AIRFLOW SENSOR | |||
| 510(k) Number | K201495 | K922112 | K981445 |
| Regulation | 21 CFR 868.2375 | 21 CFR 868.2375 | 21 CFR 868.2375 |
| Classification | MNR | BZQ | BZQ |
| Target population | Adults | All Ages | All Ages |
| Environment | sleep laboratory, clinics or | ||
| hospitals | sleep laboratory, clinics or | ||
| hospitals | sleep laboratory, clinics or | ||
| hospitals | |||
| Application | Respiratory thermocouple flow | ||
| sensor | Respiratory thermocouple flow | ||
| sensor | Respiratory thermocouple flow | ||
| sensor | |||
| Mechanical application | Sensor is placed under the | ||
| patient's nostrils | Sensor is placed under the | ||
| patient's nostrils | Sensor is placed under the | ||
| patient's nostrils | |||
| Structure | Thermocouple elements | ||
| covered by TPC plastic | |||
| injection with a wire to | |||
| connect to the PSG amplifier. | Thermocouple elements covered | ||
| by TPC plastic injection with a wire | |||
| to connect to the PSG amplifier. | Thermocouple elements | ||
| covered by TPC plastic injection | |||
| with a wire to connect to the | |||
| PSG amplifier. | |||
| Contact Material | Thermoplastic elastomers | ||
| (TPC-ETs) | Thermoplastic elastomers (TPC- | ||
| ETs) | Thermoplastic elastomers (TPC- | ||
| ETs) | |||
| Wire Material | Insulated Teflon wire | Insulated Teflon wire | Insulated Teflon wire |
| Wire Colors | White | White | White |
| Connector | DIN 42-802 | ||
| touch proof | DIN 42-802 | ||
| touch proof | DIN 42-802 | ||
| touch proof | |||
| Signal output | AC signal | AC signal | AC signal |
| Signal Frequency range | 0-30 HZ | 0-30 HZ | 0-30 HZ |
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| Sensor Resistance |