(133 days)
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.
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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 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 | 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 |
| 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 |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only refers to "Performance bench tests" and mentions that they "demonstrate that NomadAir PMU810 has met the functional requirements." It does not specify the sample size used for these tests. Furthermore, it does not provide any information regarding the provenance of data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not mention the use of experts to establish ground truth for the test set. The performance tests described are bench tests, which compare device output against predefined technical specifications rather than interpretations by human experts.
4. Adjudication Method for the Test Set
Since the ground truth for the "test set" (bench testing) is based on technical specifications and measurements, an adjudication method like 2+1 or 3+1 is not applicable and therefore not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
The provided text does not indicate that an MRMC comparative effectiveness study was done. The studies mentioned are bench tests of the device's technical performance. There is no mention of human readers, AI assistance, or an effect size of improvement with AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The studies described are standalone bench tests of the device's hardware and software components against technical specifications. The device itself (NomadAir PMU810) is a physiological signal recorder. Data collected by the device "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)." This suggests the device's output is intended to be interpreted by a human, rather than the device making a diagnosis itself. Therefore, while it undergoes standalone technical testing, it's not a standalone diagnostic algorithm in the sense of making a diagnosis without human input.
7. The Type of Ground Truth Used
The ground truth used for the performance tests is based on technical specifications and measurable physical quantities. For example:
- AC Signal Accuracy: +/- the greater of 5 uV or 5%
- CMRR Test: >= 90 dB
- Input Impedance: >= 20 MOhm
- Pressure Sensor Accuracy: +/- 1 cmH2O
- Sampling Rate: 250 Hz +/- 0.05%
- Battery Life: minimum of 24 hours
- RIP Driver Test: Peak to trough measurement > 750 uV for 1" deflection of belt
These are engineering and performance metrics, not clinical outcomes, expert consensus, or pathological findings.
8. The Sample Size for the Training Set
The provided text does not mention a training set because the device described, NomadAir PMU810, is a physiological signal amplifier and recorder. It does not appear to employ machine learning or AI algorithms that would require a distinct "training set" for model development. The performance testing focuses on its ability to accurately acquire and record physiological signals according to engineering specifications.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the method for establishing its ground truth is not applicable.
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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
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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
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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)
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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
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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.
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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.
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510(k) Summary Traditional 510K
NomadAir PMU810
Table 1. Summary Comparison of Characteristics
| DeviceCharacteristic | Proposed DeviceNomadAir PMU810 | Primary Predicate Device | Reference DeviceApneaTrak, K192624 | Comparison Analysis:Same/ SubstantiallyEquivalent / Modified /Not Applicable |
|---|---|---|---|---|
| Product Name | NomadAir PMU810 | NOMAD SLEEP SYSTEMRECORDER, MODELPMU800 | ApneaTrak | N/A-Differences do notimpact safety or efficacy. |
| Manufacturer | Neurotronics®, Inc. | Neurotronics®, Inc. | Cadwell Industries, Inc | N/A-Differences do notimpact safety or efficacy. |
| FDA ProductCode | GWL, MNR, DQA | GWL, MNR, DQA | OLV, MNR | Substantially Equivalentacross the predicate andreference 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 notimpact safety or efficacy. |
| Prescription orOTC | Prescription Only | Prescription Only | Prescription Only | Same |
| Implanted Device | No | No | No | Same |
| Indications foruse statement | The NomadAir PMU810 is | The Nomad device is | The Cadwell ApneaTrak | Substantially Equivalent -Minor wording differencesdo not impact safety orefficacy. |
| The NomadAir PMU810 isintended to recordphysiological signalsacquired from a patientfor archival in a sleepstudy. Data may beanalyzed on dedicatedpolysomnographysoftware running on apersonal computer by aqualified sleep clinician toaid in the diagnosis ofsleep-disorderedbreathing (SDB). | The Nomad device isintended to amplify andrecord physiologic potentialsused for Polysomnography(PSG) or Sleep Studies. Thebio-potentials aretransferred to Polysmithpolysomnography softwarerunning on a personalcomputer. Qualifiedpractitioners use theinformation to scorePolysomnograms anddiagnose Sleep Disorders. | The Cadwell ApneaTrakdevice is intended forhome sleep testing,including the acquisitionof physiological andenvironmental data. Therecorded signals are thentransmitted to a PC sothat they can be viewed.ApneaTrak is intended foruse on patients older than2 years of age. | ||
| The NomadAir PMU810 isintended for use within ahospital, laboratory, clinic,nursing home, or patient'shome. | The device is intended foruse on both adults andchildren under the directionof a physician or qualifiedsleep technician. The deviceis intended to measure,amplify, and recordphysiological signalsacquired from a patient forarchival in a Sleep Study,such as Limb Movement,Body Position, RespirationEffort, and SpO2. The datamay be analyzed in real-timeor offline on dedicatedpolysomnography softwarerunning on a personal | ApneaTrak is intended foruse in hospitals, sleepcenters and other sleeptesting environments,including the patient'shome. ApneaTrak isintended to be used whenprescribed by a qualifiedhealthcare provider foruse on patients suspectedof sleep disorders,specifically SleepDisordered Breathing(SDB) and requires reviewby qualified medicalpersonnel.ApneaTrak is NOTintended to performautomatic diagnosis. | ||
| The NomadAir PMU810 isintended for use on adultsonly under the directionof a physician or qualifiedsleep technician. | ||||
| The NomadAir PMU810,or any accessory, does notinclude or trigger alarms,and is not intended to be |
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Traditional 510K
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Traditional 510K
| used alone as, or a critical | computer by a qualified | |
|---|---|---|
| component of, | sleep clinician to aid in the | |
| • an alarm or alarmsystem; | diagnosis of Sleep Disorders. | |
| • an apnea monitor orapnea monitoringsystem; or | This device, or anyaccessory, is not to be usedalone as an apnea monitoror as a component in anapnea monitoring system. | |
| • a life monitor or lifemonitoring system. | This device, or anyaccessory, is not to be usedalone as a life supportdevice or as a criticalcomponent of a life supportsystem. | |
| The device is not sterile |
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Traditional 510K
| DeviceCharacteristic | Proposed DeviceNomadAir PMU810 | Primary Predicate DeviceNOMAD SLEEP SYSTEMRECORDER, MODELPMU800, K092699 | Reference DeviceApneaTrak, K192624 | Comparison Analysis:Same/ SubstantiallyEquivalent / Modified /Not Applicable |
|---|---|---|---|---|
| TargetPopulation | Adults | Adults and Children | Patients 2 years and older | Modified -Removing children from thetarget population does notimpact safety or efficacy foradults. |
| Environment forUse | * hospital* laboratory* clinic* nursing home* patient's home | * medical facility* physician's office* laboratory* clinic* nursing home* Outside a medical facilityunder direct supervision of amedical professional | Home or clinicalenvironment | Substantially Equivalent -Home use is specified in thesubject device rather thangeneric statement of outsideof a medical facility. This issubstantially equivalent. |
| Reusable orSingle Use | Reusable | Reusable | Reusable | Same |
| Sold Sterile orNon-Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| PhysicalCharacteristics | * Weight: 135g* Size: 103mm x 74mm x28mm* Enclosure Material:Medical Grade ABS Plastic | * Weight: 176g* Size: 125mm x 71mm x25mm* Enclosure Material: ABSPlastic | * Weight: 143.5g* Size: 115 mm X 73 mm X25 mm* Enclosure Material: ABSPlastic | Substantially Equivalent -Slight variations in size andweight do not impact safetyor efficacy. |
| Power Source | Battery powered using 1AA battery | Battery powered using 2 AAbatteries | Internally powered usingli-ion rechargeablebattery | Substantially Equivalent -All devices powered withdifferent types of battery. |
| DeviceCharacteristic | Proposed DeviceNomadAir PMU810 | Primary Predicate DeviceNOMAD SLEEP SYSTEMRECORDER, MODELPMU800, K092699 | Reference DeviceApneaTrak, K192624 | Comparison Analysis:Same/ SubstantiallyEquivalent / Modified /Not Applicable |
| Patient Isolation | Device is battery-poweredwith no connection tomains during patient use. | Device is battery-poweredwith no connection to mainsduring patient use. | Device is battery-poweredwith no connection tomains during patient use. | Same |
| PrimaryCommunicationsInterface | USB | USB | USB | Same |
| WirelessInterface | * LTE* Bluetooth - transmitterequipped, but disabled | * Bluetooth | * Bluetooth - transmitterequipped, but disabled | Modified -The difference betweenBluetooth and LTE does notimpact safety or efficacybecause both interfaces areFCC approved modules.Additionally, the wirelessinterface does not impact theintended use of the device. |
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Traditional 510K
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Traditional 510K
| DeviceCharacteristic | Proposed DeviceNomadAir PMU810 | Primary Predicate DeviceNOMAD SLEEP SYSTEMRECORDER, MODELPMU800, K092699 | Reference DeviceApneaTrak, K192624 | Comparison Analysis:Same/ SubstantiallyEquivalent / Modified /Not Applicable |
|---|---|---|---|---|
| Number ofChannel 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 ofOperation | 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 |
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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 toPatient | * RIP belt for respiratoryeffort* Probes for pulseoximetry* Plastic cannula forpressure sensing* Poly channel supportsstandard sleepsensors/electrodes | * Probes for pulse oximetry* Plastic cannula forpressure sensing* Device inputs supportstandard sleep sensors | * RIP or PVDF belts forrespiratory effort* Probes for pulseoximetry* Plastic cannula forpressure sensing* Plastic snoremicrophone | Modified -Predicate does not supportdirect RIP belt connection,but reference device does.RIP belt can still be used withpredicate, but it requires it tobe connected to a RIP driverthat is connected to thedevice. Differences do notimpact safety or efficacy. |
| Display Type | LEDs on device for sensorconnection and devicestatus | LED on device for devicestatus | LEDs on device for signalcheck and device status | Substantially Equivalent -Predicate does not have LEDsfor signal check, howeverreference device does. |
| InternalMemory/ DataStorage | Internal FLASH memory | Fixed microSD card | On-board storage | Substantially Equivalent -Memory is not removable inall devices. Difference instorage type does not impactsafety or efficacy. |
| Recording Time | Up to 24 hours | Up to 24 hours | Up to 24 Hours | Same |
| DeviceCharacteristic | Proposed DeviceNomadAir PMU810 | Primary Predicate DeviceNOMAD SLEEP SYSTEMRECORDER, MODELPMU800, K092699 | Reference DeviceApneaTrak, K192624 | Comparison Analysis:Same/ SubstantiallyEquivalent / 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. |
| SensorTechnology | * 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. |
| DeviceCharacteristic | Proposed DeviceNomadAir PMU810 | Primary Predicate DeviceNOMAD SLEEP SYSTEMRECORDER, MODELPMU800, K092699 | Reference DeviceApneaTrak, K192624 | Comparison Analysis:Same/ SubstantiallyEquivalent / Modified /Not Applicable |
| Access torecordeddata | Recorded data stored inthe device. When thedevice is connected to aPC via USB cable, thedevice provides access tothe data through a filetransfer protocol. | Recorded data stored in thedevice. When the device isconnected to a PC via USBcable, the device providesaccess to the data through afile transfer protocol. | Recorded data is stored inthe device. When thedevice is connected to aPC via USB cable, thedevice provides access toits internal memory. | Substantially Equivalent -Data is accessed throughconnection to a PC via USBcable. Subject and predicatedevices do not have directaccess to internal memory,just the ability to transfer thedata. Difference does notimpact safety or efficacy. |
| Recorded dataformat | All channels of recordeddata are stored in device-specific format. | All channels of recordeddata are stored in device-specific format. | All channels of recordeddata are stored in EDFdata format. | Substantially Equivalent -Differences in data format donot impact safety or efficacy. |
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Traditional 510K
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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.
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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 tosubject. Channel shows zero when probe is disconnected orremoved 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 temperatureis at 5 °C and 40 °C (+/- 3 °C) | Pass |
| Bootloader Test | Device starts into bootloader when powered on by USB with userbutton 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
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NomadAir PMU810
| Study | Acceptance Criteria | Results |
|---|---|---|
| Operating Modes and IndicatorTest | All LED indicators display correctly in all modes. | Pass |
| Cleaning Test | After performing cleaning cycles that represent typical device usageover the expected service life, device is not damaged and passesdielectric 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 tointerruption for all operating modes. | Pass |
| Power Interruption From RoughHandling | Device suffers no power interruption when handled roughly | Pass |
| RIP Driver Test | Peak to trough measurement is greater than 750 uV for 1" deflectionof 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.
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).