Who is the manufacturer of NomadAir PMU810?

Neurotronics, Inc. filed the 510(k) submission for NomadAir PMU810 (K220631).

What is the FDA product code for NomadAir PMU810?

GWL. It is classified under 21 CFR 882.1835 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for NomadAir PMU810?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NomadAir PMU810?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NomadAir PMU810

Q: What are the predicate devices for NomadAir PMU810?

NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 (K092699).

K220631 · Neurotronics, Inc. · GWL · Jul 15, 2022 · Neurology

Device Facts

Record ID	K220631
Device Name	NomadAir PMU810
Applicant	Neurotronics, Inc.
Product Code	GWL · Neurology
Decision Date	Jul 15, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1835
Device Class	Class 2

Intended Use

The NomadAir PMU810 is intended to record physiological signals acquired from a patient for archival in a sleep study. Data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep-disordered breathing (SDB). The NomadAir PMU810 is intended for use within a hospital, laboratory, clinic, nursing home, or patient's home. The NomadAir PMU810 is intended for use on adults only under the direction of a physician or qualified sleep technician. The NomadAir PMU810, or any accessory, does not include or trigger alarms, and is not intended to be used alone as, or a critical component of, an alarm or alarm system; an apnea monitor or apnea monitoring system; or a life monitor or life monitoring system.

Device Story

Portable sleep recorder; records physiological signals (SpO2, pulse, airflow, respiratory effort, body position, activity, poly channel) for sleep studies. Input via RIP belt, pulse oximeter probe, nasal cannula, and optional sensors (thermocouple, EMG/ECG electrodes). Data stored in internal FLASH memory; downloaded to PC via USB for analysis by clinician using polysomnography software. Used in hospital, clinic, or home; operated by patient (setup) and clinician (configuration/analysis). No real-time alarms or life-monitoring functions. Benefits patient by enabling home-based sleep-disordered breathing diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing verified signal accuracy, CMRR, input impedance, pressure sensor accuracy, sampling rates, oximetry functionality, wireless communication, data transfer, and battery life. All tests passed.

Technological Characteristics

Enclosure: Medical-grade ABS plastic (Lustran 348). Sensing: Silicon pressure sensor, MEMS accelerometer, pulse oximetry, integrated RIP driver. Power: 1 AA battery. Connectivity: USB for data transfer; LTE/Bluetooth (disabled). Sampling rate: 250 Hz. Dimensions: 103mm x 74mm x 28mm. Weight: 135g. Non-sterile.

Indications for Use

Indicated for adult patients requiring physiological signal recording for sleep studies to aid in the diagnosis of sleep-disordered breathing (SDB). Intended for use in hospitals, clinics, laboratories, nursing homes, or home environments under the direction of a physician or sleep technician. Contraindicated for use as a standalone alarm, apnea monitor, or life monitoring system.

Regulatory Classification

Identification

A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Predicate Devices

NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 (K092699)

Reference Devices

ApneaTrak (K192624)

Related Devices

K140861 — SOMNOTOUCH RESP · Somnomedics GmbH · Jan 30, 2015
K033402 — PORTABLE SLEEP DATA RECORDER (PSDR) · Pro-Tech Services, Inc. · Jun 30, 2004
K061764 — MEDIBYTE, MODEL MP8 · Braebon Medical Corp. · Sep 6, 2006
K071782 — MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES · Micromed S.P.A. · Jan 10, 2008
K060708 — SOMNOSCREEN · Somnomedics GmbH & Co. KG · Jan 24, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ July 15, 2022 Image /page/0/Picture/1 description: The image shows 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. Neurotronics, Inc. James "Cody" Smith Quality Manager 4500 NW 27th Ave, Ste. C2 Gainesville, Florida 32606 Re: K220631 Trade/Device Name: NomadAir PMU810 Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, MNR Dated: June 3, 2022 Received: June 15, 2022 Dear James "Cody" Smith: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K220631 Device Name NomadAir PMU810 #### Indications for Use (Describe) The NomadAir PMU810 is intended to record physiological signals acquired from a patient for archival in a sleep study. Data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep-disordered breathing (SDB). The NomadAir PMU810 is intended for use within a hospital, laboratory, clinic, nursing home, or patient's home. The NomadAir PMU810 is intended for use on adults only under the direction of a physician or qualified sleep technician. The NomadAir PMU810, or any accessory, does not include or trigger alarms, and is not intended to be used alone as, or a critical component of, * an alarm or alarm system: * an apnea monitor or apnea monitoring system; or * a life monitor or life monitoring system. | 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 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}------------------------------------------------ #### General Information 1 Preparation Date: 2-18-22 ## Submitter/Holder Neurotronics®, Inc. 4500 NW 27th Ave STE C2 Gainesville, FL 32606 Tel: (352) 372-9955 Website: https://www.neurotronics.com/ Primary Contact Person: Name: James "Cody" Smith Title: Quality Manager Phone: (352) 372-9955 Ext. 515 Email: quality@neurotronics.com {4}------------------------------------------------ ### NomadAir PMU810 #### Regulatory Information 2 | Subject Device Name | NomadAir PMU810 | |-----------------------|---------------------------------| | Classification Names | Amplifier, Physiological Signal | | Device Classification | II | | Common Name | Portable Sleep Recorder | | FDA Product Code | GWL, MNR | | CFR References | 21 CFR 882.1835 | | Review Panel | Neurology | #### 3 Identification of Predicate Device From a regulatory perspective, Neurotronics®, Inc. regards the NomadAir PMU810 to be substantially equivalent to other legally marketed devices including the predicate the NOMAD, Polysmith Sleep System K092699 and the Reference Device ApneaTrak K192624. #### Subject Device Description ব The NomadAir PMU810 is a portable device that records physiological signals used for sleep studies. The device can be worn on the chest or the wrist and is attached to the patient using a RIP belt or a disposable strap comected directly to the patient also wears a pulse oximeter probe, a nasal cannula, and an optional sensor, such as a RIP belt, thermocouple, EMG electrode, or ECG electrode. During the typical workflow of using the clinical user configures the device for a patient. The clinician will give the patient instructions on how to attach the device and send the unit and accessories home with the patient. Before going to bed, the patient will connect everything, then go to sleep. The Nomad Air records the signals from the sensors and saves the data to internal memory. The patient may perform up to 3 sleep studies before returning the device. Once the device, they can connect it to a PC using a USB cable and download the study for analysis. {5}------------------------------------------------ #### റ Indications for Use Per the current proposed product labeling, the indications for use for the NomadAir PMU810 are quoted as follows: The NomadAir PMU810 is intended to record physiological signals acquired from a patient for archival in a sleep study. Data may be analyzed on dedicated polysomnography software ruming on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep-disordered breathing (SDB). The NomadAir PMU810 is intended for use within a hospital, laboratory, clinic, nursing home, or patient's home. The NomadAir PMU810 is intended for use on adults only under the direction of a physician or qualified sleep technician. The NomadAir PMU810, or any accessory, does not include or trigger alarms, and is not intended to be used alone as, or a critical component of, - an alarm or alarm system; - . an apnea monitor or apnea monitoring system; or - a life monitor or life monitoring system. ● Please note that the above indication is slightly reworded to the already cleared indications for the predicate NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800, K092699 and updated accordingly per current FDA Guidance. The indications for use statement also provides further clarification that is complementary to the cleared predicate indications for use. #### Substantial Equivalence Discussion 6 Any modifications between the predicate device are provided in detail in this submission, while the table below is a summary. The review of the indications for use and comparison characteristics provided in Table 1 demonstrate that NomadAir PMU810 is substantially equivalent to the predicate device, NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800, K092699 and the reference device ApneaTrak K192624. {6}------------------------------------------------ # 510(k) Summary Traditional 510K ## NomadAir PMU810 ## Table 1. Summary Comparison of Characteristics | Device Characteristic | Proposed Device NomadAir PMU810 | Primary Predicate Device | Reference Device ApneaTrak, K192624 | Comparison Analysis: Same/ Substantially Equivalent / Modified / Not Applicable | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | Product Name | NomadAir PMU810 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 | ApneaTrak | N/A-Differences do not impact safety or efficacy. | | Manufacturer | Neurotronics®, Inc. | Neurotronics®, Inc. | Cadwell Industries, Inc | N/A-Differences do not impact safety or efficacy. | | FDA Product Code | GWL, MNR, DQA | GWL, MNR, DQA | OLV, MNR | Substantially Equivalent across the predicate and reference devices. | | CFR Reference | 21 CFR 882.1835 | 21 CFR 882.1835 | 21 CFR 882.1400 | Same as predicate | | Device Class | II | II | II | Same | | 510(k) reference | TBD | K092699 | K192624 | N/A-Differences do not impact safety or efficacy. | | Prescription or OTC | Prescription Only | Prescription Only | Prescription Only | Same | | Implanted Device | No | No | No | Same | | Indications for use statement | The NomadAir PMU810 is | The Nomad device is | The Cadwell ApneaTrak | Substantially Equivalent - Minor wording differences do not impact safety or efficacy. | | | The NomadAir PMU810 is intended to record physiological signals acquired from a patient for archival in a sleep study. Data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep-disordered breathing (SDB). | The Nomad device is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The bio-potentials are transferred to Polysmith polysomnography software running on a personal computer. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders. | The Cadwell ApneaTrak device is intended for home sleep testing, including the acquisition of physiological and environmental data. The recorded signals are then transmitted to a PC so that they can be viewed. ApneaTrak is intended for use on patients older than 2 years of age. | | | | The NomadAir PMU810 is intended for use within a hospital, laboratory, clinic, nursing home, or patient's home. | The device is intended for use on both adults and children under the direction of a physician or qualified sleep technician. The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study, such as Limb Movement, Body Position, Respiration Effort, and SpO2. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal | ApneaTrak is intended for use in hospitals, sleep centers and other sleep testing environments, including the patient's home. ApneaTrak is intended to be used when prescribed by a qualified healthcare provider for use on patients suspected of sleep disorders, specifically Sleep Disordered Breathing (SDB) and requires review by qualified medical personnel. ApneaTrak is NOT intended to perform automatic diagnosis. | | | | The NomadAir PMU810 is intended for use on adults only under the direction of a physician or qualified sleep technician. | | | | | | The NomadAir PMU810, or any accessory, does not include or trigger alarms, and is not intended to be | | | | {7}------------------------------------------------ Traditional 510K {8}------------------------------------------------ Traditional 510K | used alone as, or a critical | computer by a qualified | | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--| | component of, | sleep clinician to aid in the | | | • an alarm or alarm system; | diagnosis of Sleep Disorders. | | | • an apnea monitor or apnea monitoring system; or | This device, or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system. | | | • a life monitor or life monitoring system. | This device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system. | | | | The device is not sterile | | {9}------------------------------------------------ Traditional 510K | Device Characteristic | Proposed Device NomadAir PMU810 | Primary Predicate Device NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800, K092699 | Reference Device ApneaTrak, K192624 | Comparison Analysis: Same/ Substantially Equivalent / Modified / Not Applicable | |----------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Target Population | Adults | Adults and Children | Patients 2 years and older | Modified - Removing children from the target population does not impact safety or efficacy for adults. | | Environment for Use | * hospital * laboratory * clinic * nursing home * patient's home | * medical facility * physician's office * laboratory * clinic * nursing home * Outside a medical facility under direct supervision of a medical professional | Home or clinical environment | Substantially Equivalent - Home use is specified in the subject device rather than generic statement of outside of a medical facility. This is substantially equivalent. | | Reusable or Single Use | Reusable | Reusable | Reusable | Same | | Sold Sterile or Non-Sterile | Non-sterile | Non-sterile | Non-sterile | Same | | Physical Characteristics | * Weight: 135g * Size: 103mm x 74mm x 28mm * Enclosure Material: Medical Grade ABS Plastic | * Weight: 176g * Size: 125mm x 71mm x 25mm * Enclosure Material: ABS Plastic | * Weight: 143.5g * Size: 115 mm X 73 mm X 25 mm * Enclosure Material: ABS Plastic | Substantially Equivalent - Slight variations in size and weight do not impact safety or efficacy. | | Power Source | Battery powered using 1 AA battery | Battery powered using 2 AA batteries | Internally powered using li-ion rechargeable battery | Substantially Equivalent - All devices powered with different types of battery. | | Device Characteristic | Proposed Device NomadAir PMU810 | Primary Predicate Device NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800, K092699 | Reference Device ApneaTrak, K192624 | Comparison Analysis: Same/ Substantially Equivalent / Modified / Not Applicable | | Patient Isolation | Device is battery-powered with no connection to mains during patient use. | Device is battery-powered with no connection to mains during patient use. | Device is battery-powered with no connection to mains during patient use. | Same | | Primary Communications Interface | USB | USB | USB | Same | | Wireless Interface | * LTE * Bluetooth - transmitter equipped, but disabled | * Bluetooth | * Bluetooth - transmitter equipped, but disabled | Modified - The difference between Bluetooth and LTE does not impact safety or efficacy because both interfaces are FCC approved modules. Additionally, the wireless interface does not impact the intended use of the device. | {10}------------------------------------------------ Traditional 510K {11}------------------------------------------------ Traditional 510K | Device Characteristic | Proposed Device NomadAir PMU810 | Primary Predicate Device NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800, K092699 | Reference Device ApneaTrak, K192624 | Comparison Analysis: Same/ Substantially Equivalent / Modified / Not Applicable | |-----------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Number of Channel Inputs | 4 | 8 | 8 | Modified - The subject device has less channels than the predicate. The subject device has 1 respiratory channel compared to 3 respiratory channels on the predicate, 1 poly channel to 2 EMG channels, and does not have a DC channel. These channels on the predicate are extra and are not required for home sleep studies. Their absence does not impact safety or efficacy. | | Mode of Operation | Device is attached to a strap that secures the device while on the patient. | Device goes into a pouch which is secured with a strap. | Device is attached to a strap that secures the device while on the patient. | Substantially Equivalent | {12}------------------------------------------------ Traditional 510K | Device | Proposed Device | Primary Predicate Device | Reference Device | Comparison Analysis: | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | NomadAir PMU810 | NOMAD SLEEP SYSTEM | ApneaTrak, K192624 | Same/ Substantially | | | | RECORDER, MODEL | | Equivalent / Modified / | | | | PMU800, K092699 | | Not Applicable | | Connections to Patient | * RIP belt for respiratory effort * Probes for pulse oximetry * Plastic cannula for pressure sensing * Poly channel supports standard sleep sensors/electrodes | * Probes for pulse oximetry * Plastic cannula for pressure sensing * Device inputs support standard sleep sensors | * RIP or PVDF belts for respiratory effort * Probes for pulse oximetry * Plastic cannula for pressure sensing * Plastic snore microphone | Modified - Predicate does not support direct RIP belt connection, but reference device does. RIP belt can still be used with predicate, but it requires it to be connected to a RIP driver that is connected to the device. Differences do not impact safety or efficacy. | | Display Type | LEDs on device for sensor connection and device status | LED on device for device status | LEDs on device for signal check and device status | Substantially Equivalent - Predicate does not have LEDs for signal check, however reference device does. | | Internal Memory/ Data Storage | Internal FLASH memory | Fixed microSD card | On-board storage | Substantially Equivalent - Memory is not removable in all devices. Difference in storage type does not impact safety or efficacy. | | Recording Time | Up to 24 hours | Up to 24 hours | Up to 24 Hours | Same | | Device Characteristic | Proposed Device NomadAir PMU810 | Primary Predicate Device NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800, K092699 | Reference Device ApneaTrak, K192624 | Comparison Analysis: Same/ Substantially Equivalent / Modified / Not Applicable | | Channels / Signals Recorded | Channels * SpO2 * Pulse * Airflow or Nasal/Mask Pressure * Snore (Derived) * Respiratory Effort * Body Position * Activity * Poly (Can be used for Leg Movement, Respiratory, EMG, ECG, etc.) | Channels * SpO2 * Pulse * Airflow * Snore (Derived) * Respiratory Effort * Body Position * Leg Movement * DC | Channels * SpO2 * Pulse * Airflow * Nasal/Mask Pressure * Snore * Respiratory Effort * Body Position * Activity * EEG, EOG, EMG, ECG | Modified - Subject device does not have a DC channel, but neither does the reference device. Subject device has an Activity channel, as does the reference device. Subject device does not have an EEG channel, but neither does the predicate. None of these channels are required channels for home sleep studies. | | Sensor Technology | * Silicon pressure sensor * MEMS accelerometer position/activity sensor * Pulse oximetry * Integrated RIP driver for respiratory effort * Poly input supports common sleep sensors | * Silicon pressure sensor * Mechanical position sensor * Pulse oximetry * Inputs support common sleep sensors | * Solid state pressure sensor * Solid state position/activity sensor * Pulse oximetry * Respiratory effort sensors (RIP or PVDF technology) * Snore Microphone * Gold cup electrodes * Ag/AgCL electrodes | Modified - Subject device uses a MEMS accelerometer, which is a type of solid-state sensor, like the reference device. Subject device also has an internal respiratory effort sensor, as does the reference device. Subject device does not have snore or EEG technologies, but neither does the predicate. None of these differences impact safety or efficacy. | | Device Characteristic | Proposed Device NomadAir PMU810 | Primary Predicate Device NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800, K092699 | Reference Device ApneaTrak, K192624 | Comparison Analysis: Same/ Substantially Equivalent / Modified / Not Applicable | | Access to recorded data | Recorded data stored in the device. When the device is connected to a PC via USB cable, the device provides access to the data through a file transfer protocol. | Recorded data stored in the device. When the device is connected to a PC via USB cable, the device provides access to the data through a file transfer protocol. | Recorded data is stored in the device. When the device is connected to a PC via USB cable, the device provides access to its internal memory. | Substantially Equivalent - Data is accessed through connection to a PC via USB cable. Subject and predicate devices do not have direct access to internal memory, just the ability to transfer the data. Difference does not impact safety or efficacy. | | Recorded data format | All channels of recorded data are stored in device- specific format. | All channels of recorded data are stored in device- specific format. | All channels of recorded data are stored in EDF data format. | Substantially Equivalent - Differences in data format do not impact safety or efficacy. | {13}------------------------------------------------ Traditional 510K {14}------------------------------------------------ Traditional 510K ### NomadAir PMU810 #### 7 Software The development of the NomadAir complies with IEC 62304 Standard- medical device software life cycle processes. #### Sterilization and Shelf Life 8 The NomadAir PMU810 does not have a claimed shelf life, therefore this section is not applicable. The NomadAir PMU810 is sold non-sterile. Therefore, this section is not applicable. {15}------------------------------------------------ #### Biocompatibility 9 The NomadAir PMU810 is intended to be worn for less than 24 hours, and no material is made with natural rubber latex. Additionally, the device enclosure is made from a medical-grade resin (Lustran 348) that meets of ISO 10993 for short-term skin contact. Biocompatibility testing was not performed specifically for this submission. ### 10 Performance Testing - Bench Performance bench tests of NomadAir PMU810 have been performed, see Table from the performance bench testing demonstrate that NomadAir PMU810 has met the functional requirements and is substantially equivalent to the predicate device. Performance bench testing is provided in detail in this submission. | Study | Acceptance Criteria | Results | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | AC Signal Accuracy | Accuracy of recorded signal is +/- the greater of 5 uV or 5%. | Pass | | CMRR Test | Poly channel shows CMRR >= 90 dB. | Pass | | Input Impedance | Pass specification: Input impedance >=20 MOhm | Pass | | Pressure Sensor Test | Accuracy of pressure sensor is +/- 1 cmH2O. | Pass | | Body Position Test | Confirm all transition and hysteresis angles are within specifications | Pass | | Sampling Rate Test | Base sampling rate is 250 Hz +/- 0.05% | Pass | | Oximetry Test | Channel shows valid reading when sensor is correctly applied to subject. Channel shows zero when probe is disconnected or removed from subject. | Pass | | Wireless Communication Test | Device transmits event driven status message and timed snapshot status messages successfully. | Pass | | Data Transfer Speed Test | Files transfer in <1 minute per 8 hours of recorded data. | Pass | | Pressure Sensor Accuracy Test | Accuracy of pressure sensor is +/- 1 cmH2O when the temperature is at 5 °C and 40 °C (+/- 3 °C) | Pass | | Bootloader Test | Device starts into bootloader when powered on by USB with user button held pressed. | Pass | | Input Noise Test | RIP and Poly channels have <= 6 uVp-p of input noise (0.53 Hz to 60 Hz) | Pass | | Battery Life Test | NomadAir records for a minimum of 24 hours after 72 hours of standby time | Pass | ### Table 2. Performance Testing Summary {16}------------------------------------------------ Traditional 510K ### NomadAir PMU810 | Study | Acceptance Criteria | Results | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Operating Modes and Indicator Test | All LED indicators display correctly in all modes. | Pass | | Cleaning Test | After performing cleaning cycles that represent typical device usage over the expected service life, device is not damaged and passes dielectric strength test. | Pass | | Data File and Storage Test | Log events are saved with the data with the correct timestamp. | Pass | | Power Interruption Recovery Test | Device recovers from power interruption by resuming state prior to interruption for all operating modes. | Pass | | Power Interruption From Rough Handling | Device suffers no power interruption when handled roughly | Pass | | RIP Driver Test | Peak to trough measurement is greater than 750 uV for 1" deflection of belt. Peak to trough noise is within -40 to 40 uV | Pass | ### 11 Conclusion The subject device NomadAir PMU810 is substantially equivalent to the predicate device. NomadAir PMU810 shares a substantially equivalent design, indications for use and technology (i.e. features, materials, and principles of operation) with the predicate device and no new elements pertaining to safety or effectiveness have been identified.