(133 days)
No
The summary describes a device that records physiological signals for later analysis by a clinician using separate software. There is no mention of the device itself performing any analysis or incorporating AI/ML. The performance studies are bench tests, not clinical studies evaluating algorithmic performance.
No
The device is intended to record physiological signals for diagnostic purposes (to aid in the diagnosis of sleep-disordered breathing), not for direct treatment or therapy.
No
The device is intended to record physiological signals for archival in a sleep study, which can then be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep-disordered breathing (SDB). The device itself does not perform the diagnosis, but rather aids in the process by providing data.
No
The device description explicitly states it is a "portable device that records physiological signals" and is "worn on the chest or the wrist and is attached to the patient using a RIP belt or a disposable strap". It also mentions connecting to sensors like a pulse oximeter probe, nasal cannula, and optional sensors. This indicates a physical hardware component that acquires and stores data, not solely software.
Based on the provided information, the NomadAir PMU810 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- NomadAir PMU810 Function: The NomadAir PMU810 records physiological signals acquired from a patient. These are signals measured directly from the patient's body (e.g., breathing patterns, heart rate, body position) using sensors attached to the patient. This is an in vivo measurement, not an in vitro test on a sample.
- Intended Use: The intended use is to record these signals for archival in a sleep study to aid in the diagnosis of sleep-disordered breathing. This process involves collecting data from the patient's body during sleep, not analyzing a biological sample.
Therefore, the NomadAir PMU810 falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GWL, MNR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults only
Intended User / Care Setting
Qualified sleep clinician, physician or qualified sleep technician / hospital, laboratory, clinic, nursing home, or patient's home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance 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: AC Signal Accuracy
Acceptance Criteria: Accuracy of recorded signal is +/- the greater of 5 uV or 5%.
Results: Pass
Study: CMRR Test
Acceptance Criteria: Poly channel shows CMRR >= 90 dB.
Results: Pass
Study: Input Impedance
Acceptance Criteria: Input impedance >= 20 MOhm
Results: Pass
Study: Pressure Sensor Test
Acceptance Criteria: Accuracy of pressure sensor is +/- 1 cmH2O.
Results: Pass
Study: Body Position Test
Acceptance Criteria: Confirm all transition and hysteresis angles are within specifications
Results: Pass
Study: Sampling Rate Test
Acceptance Criteria: Base sampling rate is 250 Hz +/- 0.05%
Results: Pass
Study: Oximetry Test
Acceptance Criteria: Channel shows valid reading when sensor is correctly applied to subject. Channel shows zero when probe is disconnected or removed from subject.
Results: Pass
Study: Wireless Communication Test
Acceptance Criteria: Device transmits event driven status message and timed snapshot status messages successfully.
Results: Pass
Study: Data Transfer Speed Test
Acceptance Criteria: Files transfer in
§ 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).
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)
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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 |