Maxxi Snore Sensor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 16, 2020 Neurovirtual USA, INC. Eduardo Faria CEO 3303 W Commercial Blvd #100 Fort Lauderdale, Florida 33309 Re: K191095 Trade/Device Name: Maxxi Snore Sensor Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: December 27, 2019 Received: December 31, 2019 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 {1}------------------------------------------------ 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 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 (QS) 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 Division 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191095 Device Name Maxxi Snore Sensor #### Indications for Use (Describe) The Maxxi Snore Sensor is a device intended to acquire snore bursts. It responds to snoring and other sounds in the audio range picked up through the skin and convert them to a small analog voltage that provides an indication of the presence of these sound/vibration bursts. 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) | | |------------------------------------------------------------------------------------------------------------------------------------|--| | <span style="white-space: nowrap;"> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | | <span style="white-space: nowrap;"> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | #### 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 PRAStaff@fda.hhs.gov "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." {3}------------------------------------------------ Image /page/3/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. The "O" in Neurovirtual is replaced with a solid orange circle. The waveform graphic is on the left side of the logo, and the text is on the right. ### Section 5 510(k) SUMMARY A) Submitter's Name: Neurovirtual USA, Inc. Owner / Operator Registration Number: 9091724 Manufacture Registration Number: 3006125362 - B) Address: 3303 W Commercial Blvd #100 Fort Lauderdale, FL 33309 USA - C) Phone and Fax Numbers Phone: (786) 693-8200 Fax: (305) 393-8429 - D) Contact Person: Eduardo J. Faria - E) Preparation Date: December 27, 2019 - F) Classification Name: Common / Usual Name: Breathing frequency monitor Proprietary Name: Maxxi Snore Sensor Product Code: MNR Class: Class II Regulation: 21 CFR 868.2375 - G) Device Description: MAXXI SNORE SENSOR piezo electric based sensors detect sound and vibration of the snore through skin contact. The sensor is placed on the patient neck surface where it can easily detect the snoring bursts during the sleep study. The product is offered in 2 different length sizes, 3ft and 7ft. The sensor is compatible with any recording device with the DIN 42-802 receptacle which is the gold standard for PSG recording machines. ## H) Substantial Equivalence: The Maxxi Snore Sensor is equivalent with the following products: | 510(k) Number | Model | Company | |---------------|----------------|--------------------------------------------------------| | K941759 | SNORING SENSOR | S.L.P. Ltd.<br>Former EPM INFORMATION<br>SYSTEMS, INC. | {4}------------------------------------------------ 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 on the left, followed by the word "NEUROVIRTUAL" in blue. The "O" in "NEUROVIRTUAL" is replaced with a solid orange circle. # 1. Indications for Use/Intentions for Use: | Intention for Use Comparison | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Neurovirtual | S.L.P. Ltd. | | Maxxi Snore Sensor | Snoring Sensor | | The Maxxi Snore Sensor is a device intended to<br>acquire snore bursts. It responds to snoring and<br>other sounds in the audio range picked up<br>through the skin and convert them to a small<br>analog voltage that provides an indication of<br>the presence of these sound/vibration bursts.<br>This sensor is intended to be used with<br>polysomnography devices and adult patients. | The Snoring Sensor is a device intended to<br>acquire snore bursts. It responds to snoring and<br>other sounds in the audio range picked up<br>through the skin and convert them to a small<br>analog voltage that provides an indication of<br>the presence of these sound/vibration bursts.<br>This sensor is intended to be used with<br>polysomnography devices and adult patients. | | Intended to be use in a sleep laboratory, clinics<br>or hospitals. | Intended to be use in a sleep laboratory, clinics<br>or hospitals. | # 2. Technological Characteristics Comparison: The predicate devices used to establish substantial equivalence for the Maxxi Snore Sensor are outlined below. This section of this submission will provide a comparison of design, materials, and technical specifications of the Maxxi Snore Sensor to each of the predicate devices stratified by functional modality. | Technological Characteristics Comparison | | | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Neurovirtual<br>Maxxi Snore Sensor | S.L.P. Ltd.<br>Snoring Sensor | | 510(k) Number | K191095 | K941759 | | Classification | BZQ | BZQ | | Target population | Adults | Adults | | Environment | sleep laboratory, clinics or hospitals | sleep laboratory, clinics or hospitals | | Principle of operation | The mechanism of snoring is<br>vibration of anatomical structures in<br>the pharyngeal airway. The sensor is<br>placed on the side of the patient neck<br>in order to capture the movement or<br>vibration during the snore's events.<br><br>Crystalline materials produce small<br>amounts of electricity when a force is<br>applied that changes their shape in<br>some way. These are called<br>piezoelectric materials. When the<br>small amounts of vibration applied to<br>the Maxxi Snore crystal, a small<br>voltage is produced for a PSG device<br>amplify and display the signal in the<br>sleep study.<br><br>The signal output for snoring is called<br>snore bursts.<br><br>Based on the snore signals during the | The mechanism of snoring is vibration<br>of anatomical structures in the<br>pharyngeal airway. The sensor is<br>placed on the side of the patient neck<br>in order to capture the movement or<br>vibration during the snore's events.<br><br>Crystalline materials produce small<br>amounts of electricity when a force is<br>applied that changes their shape in<br>some way. These are called<br>piezoelectric materials. When the<br>small amounts of vibration applied to<br>the Maxxi Snore crystal, a small<br>voltage is produced for a PSG device<br>amplify and display the signal in the<br>sleep study.<br><br>The signal output for snoring is called<br>snore bursts.<br><br>Based on the snore signals during the | {5}------------------------------------------------ Image /page/5/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 dark blue. The "O" in "NEUROVIRTUAL" is replaced by a solid orange circle. The waveform graphic is positioned to the left of the text, with a horizontal line extending from the waveform to the beginning of the word "NEUROVIRTUAL". | | sleep study the physician will qualify,<br>quantify and along with the other<br>sleep parameters determine the<br>diagnose of the sleep disorder. | | sleep study the physician will qualify,<br>quantify and along with the other<br>sleep parameters determine the<br>diagnose of the sleep disorder. | | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------|--| | Parent device | To work in conjunction with a<br>polysomnography device. | | To work in conjunction with a<br>polysomnography device. | | | Mechanical application | Sensor is placed on patient's neck | | Sensor is placed on patient's neck | | | Structure | Piezo-electric element covered by<br>TPC plastic injection with a wire to<br>connect to the PSG amplifier. | | Piezo-electric element covered by TPC<br>plastic injection with a wire to connect<br>to the PSG amplifier. | | | Contact Material | Thermoplastic elastomers (TPC-ETs) | | Thermoplastic elastomers (TPC-ETs) | | | Wire Material | Insulated Teflon wire | | Insulated Teflon wire | | | Wire Colors | White | | White | | | Connector | DIN 42-802<br>touch proof | | DIN 42-802<br>touch proof | | | Signal output | AC signal | | AC signal | | | Signal Frequency range | 0-500 HZ | | 0-500 HZ | | | Amplitude sensitivity<br>range | 0-500uV | | 0-500uV | | | Sensor diameter | 18mm | | 18mm | | | Cable length | 3ft and 7ft | | 3ft and 7ft | | | Package | Plastic bag | | Plastic bag | | | Image | Image: sensor | | Image: sensor | | Discussion: The Maxxi Snore and the predicate device Snoring Sensor manufactured by S.L.P Ltd., are substantially equivalent in technology, function, and intended use: both sensors are indicated to provide snoring signal for sleep disordered breathing; both devices use the same method of action; both devices use equivalent material and both devices provide equivalent output signals. # I) Applied Standards: In order to reach high quality and effectiveness the Maxxi Snore Sensor is produced in compliance with the quality management standard ISO 13485:2003, "Medical Devices, Quality Management Systems: Requirements for Requlatory Purposes" and FDA GMP "Good Manufacturing Practices". ISO 10993 for Cytotoxicity, Skin Sensitization and Irritation Studies IEC 60601-1, IEC 60601-1-1 ## J) Performance Testing: The test performance comparing the Maxxi Snore and the predicate device Snoring Sensor manufactured by S.L.P Ltd was performed and the summary results are show below. {6}------------------------------------------------ Image /page/6/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 by a solid orange circle. | Test | Description | Criteria | Results | |----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Parts<br>Dimensions | Verify if the dimensions of the<br>Piezo electric unit are within<br>the acceptable range and<br>equivalent to the predicate | Allowance: +-10% | The dimensions of the piezo<br>electric unit are within the<br>acceptable criteria as when<br>compared to the predicate<br>device. | | Cable Length | Verify if the cable length is<br>within the acceptable range<br>and equivalent to the predicate | Expected: 3 ft and 7 ft<br>Allowance: +-5% | The cable length of the sensor is<br>within the acceptable criteria as<br>when compared to the predicate<br>device. | | Visual Conditions | Verify the visual aspects of the<br>product and equivalency with<br>the predicate. Cable aspects,<br>labeling, flexibility, plastic<br>finishing, and connector<br>conditions. | All aspects must be<br>substantially<br>equivalent to the<br>predicate device. | Maxxi Snore sensor was<br>inspected, and the result is<br>equivalent to the predicate<br>device. | | Output signals<br>Frequency and<br>Amplitude Tests | The sensor Maxxi Snore and<br>the predicate Snoring Sensor<br>were connected to the same<br>PSG recorder and the acquired<br>data was compared in<br>frequency and amplitude. | Allowance: +-15% | Both sensors acquired equivalent<br>signals within the acceptable<br>range. | Discussion: The Maxxi Snore and the predicate device Snoring Sensor manufactured by S.L.P Ltd., are substantially equivalent in technology, function, and intended use: both sensors are indicated to provide respiratory signal for sleep disordered breathing; both devices use the same method of action; both devices use equivalent material and both devices provide equivalent output signals.