(446 days)
No
The document describes "new algorithms" for arrhythmia detection but does not explicitly mention or provide details about the use of AI or ML techniques. The performance study focuses on comparing the device's output to a "Gold Standard" ECG, which is typical for algorithm validation but doesn't necessarily indicate AI/ML.
No.
The device is described as a "diagnostic aid for the detection of sleep related breathing disorders" and provides "supplemental information to its PRDI/PAHIC" and "additional information to that of the WP200U cleared capabilities of detecting sleep disorders," but it does not treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The WP200U is a diagnostic aid for the detection of sleep related breathing disorders." While it specifies that certain parameters are not for sole diagnosis, the device's overall purpose is to aid in diagnosis.
No
The device description explicitly lists multiple hardware components including a finger PAT probe, actigraph, chest sensor (optional), electronics, power supply, and wrist strap. While it includes software for analysis, it is not solely software.
Based on the provided text, the WatchPAT™200U (WP200U) device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- WatchPAT™200U Function: The WatchPAT™200U is a non-invasive device that measures physiological signals directly from the patient's body (wrist, finger, chest) to aid in the diagnosis of sleep-related breathing disorders and provide supplemental information about sleep staging and potential arrhythmias. It does not analyze samples taken from the body.
Therefore, the WatchPAT™200U falls under the category of a medical device used for physiological monitoring and diagnosis, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The WatchPAT™200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP200U's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHIC. The WP200U's PSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.
PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The Watch-PAT200U System (WP200U) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders Respiratory disturbance index (pRDI), apnea - hypopnea index (pAHI), central apnea - hypopnea index (pAHIc) and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. In accordance with physician discretion, the WP200U may be connected to a chest sensor for measuring snoring level, body position states and chest movements.
The WP200U device consists of the following: (1) unified finger PAT probe to measure PAT and oximeter signals; (2) actigraph, which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist; (3) chest sensor to measure snoring level, body position and chest movements (optional); (4) electronics, which include a controller that records the signals provided by the uPAT finger probe, actigraph and chest sensor; (5) Tamper-Proof Bracelet (Optional); (6) power supply; (7) Wrist strap and (8) Management and Analysis Software Program.
The subject WP200U introduces new algorithms to its software allowing the identification of arrhythmia events occurred during the night - Atrial Fibrillation and Premature Beats.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical plethysmography
Anatomical Site
Wrist, finger and chest (optional)
Indicated Patient Age Range
PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.
Intended User / Care Setting
Intended user of the Arrhythmia output: Physician
Intended Use Environment: Home Use
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
One hundred and fifty-seven (157) subjects were evaluated in an overnight sleep study using the subject device and a single-lead ECG recorded by a PSG system in a sleep lab.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance testing was performed to evaluate the capability of WP200U To identify arrhythmic events: Atrial fibrillation and premature beats, by comparing the subject device against "Gold Standard" cardiologist-scored ECG channel of a polysomnography (PSG). One hundred and fifty-seven (157) subjects were evaluated in an overnight sleep study using the subject device and a single-lead ECG recorded by a PSG system in a sleep lab. Overall, the test results demonstrated acceptable performance of the subject device in detecting clinically relevant arrhythmic events (atrial fibrillation and premature beats) as supplemental information to its sleep information.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
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March 21, 2022
Itamar Medical, Ltd. % Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004-1109
Re: K203839
Trade/Device Name: Watch-PAT200U (WP200U) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: Class II Product Code: MNR Dated: February 17, 2022 Received: February 17, 2022
Dear Jonathan Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203839
Device Name Watch-PAT200U (WP200U)
Indications for Use (Describe)
The WatchPAT™200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP200U's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHIC. The WP200U's PSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.
PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K203839 - 510(K) SUMMARY
- Applicant's Name: Itamar Medical Itd. 9 Halamish st. Caesarea 3088900, Israel Tel: +972 4 617 7000 Fax: +972 4 627 5598
- Contact Person: Jonathan Kahan, Esq. Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202)637-5794 Fax: (202)637-5910 Email: jonathan.kahan@hoganlovells.com
Date Prepared: March 21, 2022
Trade Name: Watch-PAT200U (WP200U)
Common or Usual Name: Ventilatory Effort Recorder
Classification Name: Breathing Frequency Monitor
Medical Specialty: Anesthesiology
Product Code: Ventilatory Effort Recorder, MNR
Device Class: Class II
Regulation Number: 868.2375
Panel: Anesthesiology
Predicate Devices:
- Primary predicate: Watch-PAT200U ("WP200U") (Itamar-Medical), cleared under ● K161579; product code MNR (ventilatory effort recorder).
- . Reference device: Compumedics Somté PSG System (Compumedics), cleared under K072201; product code MNR (ventilatory effort recorder)
- Reference device: Melys Atrial Fibrillation Monitor (Advanced Fluidics), cleared ● Receivers, K132206; product coode DXH (Transmitters and under Electrocardiograph, Telephone)
4
Intended Use / Indication for Use:
The Watch-PAT200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"). PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP200U's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP200U's PSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.
PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.
Device Description:
The Watch-PAT200U System (WP200U) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders Respiratory disturbance index (pRDI), apnea - hypopnea index (pAHI), central apnea - hypopnea index (pAHIc) and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. In accordance with physician discretion, the WP200U may be connected to a chest sensor for measuring snoring level, body position states and chest movements.
The WP200U device consists of the following: (1) unified finger PAT probe to measure PAT and oximeter signals; (2) actigraph, which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist; (3) chest sensor to measure snoring level, body position and chest movements (optional); (4) electronics, which include a controller that records the signals provided by the uPAT finger probe, actigraph and chest sensor; (5) tamper-Proof Bracelet (Optional); (6) power supply; (7) Wrist strap and (8) Management and Analysis Software Program.
The subject WP200U introduces new algorithms to its software allowing the identification of arrhythmia events occurred during the night - Atrial Fibrillation and Premature Beats.
5
Beside the introduction of the new arrhythmia information, the SW provides identical output information as that previously provided for the predicate.
The additional arrhythmia information presented by the modified WP200U device follows the AASM (American Academy of Sleep Medicine) guidelines to provide the sleep physician with information regarding cardiac events occurred during the night. The WP200U arrhythmia feature is to be used for informational use only, to flag patients suspected of having arrhythmias, thereby aiding the physician to decide if further arrhythmia investigation is needed. The device is not intended to be used as a diagnostic device for cardiac arrhythmia and it is not intended to replace traditional methods of diagnosis. The WP200U's arrhythmia detection is not intended for use in life supporting or sustaining systems or monitor and alarm devices.
The new analysis provides the sleep physician with additional information to that of the WP200U cleared capabilities of detecting sleep disorders, to be considered in conjunction with the physician's knowledge of patient background, clinical history, symptoms, and other diagnostic information.
Substantial Equivalence:
Intended Use
The intended use of the subject Watch-PAT200U ("WP200U") remains exactly the same as the intended use of its predicate, the WP200U (K161579) as a home device for diagnosis of sleep related breathing disorders.
The WP200U's new analysis of cardiac arrhythmia is offered as supplemental information to its sleep information. The device is not intended to be used as a diagnostic device for any cardiac arrhythmia. All other information supplied, is the same as the information supplied by the predicate device.
For the added capability of identifying arrythmia during sleep, the company selected a reference device, Somté PSG System, cleared under K072201 intended for recording physiological parameters to aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians. The-Somté includes an analysis package for arrhythmia detection and classification ('ECG Analysis package'). It also provides ECG statistics during respiratory events and R-R interval (heart rate).
The intended use statement as previously cleared in K161579 was not changed and this capability of providing information regarding the cardiac arrythmia events is specified in the labeling of the subject device and does not raise additional or new questions of safety or effectiveness.
6
| Itamar Medical's | Primary predicate - | Reference - | Reference - Melys | Comparison | |
|---|---|---|---|---|---|
| Watch-PAT200U | Itamar Medical's | Compumedics's | atrial fibrillation | ||
| (Subject device) | Watch-PAT200U | Somté | monitor | ||
| (K161579) | (K072201) | (K132206) | |||
| Product Code | MNR | MNR | MNR | DXH | |
| Manufacturer | Itamar Medical | Itamar Medical | Compumedics | Advanced Fluidics, | |
| LLC | |||||
| Indications | The Watch-PAT200U | The Watch-PAT200U | The Somté PSG is | The Melys Atrial | Substantially |
| for Use | (WP200U) device is a | (WP200U) device is a | intended for use in | Fibrillation Monitor | Equivalent to |
| non-invasive home | non-invasive home | the recording, | is indicated for self- | the predicate | |
| care device for use | care device for use | displaying, analysis, | testing by patients, | (Watch- | |
| with patients | with patients | printing and storage | who have been | PAT200U) - the | |
| suspected to have | suspected to have | of human biological | diagnosed with, or are | intended use | |
| sleep related | sleep related | parameters such as | susceptible to | remains a | |
| breathing disorders. | breathing disorders. | heart and muscle | developing, atrial | diagnostic | |
| The WP200U is a | The WP200U is a | activity, eye | fibrillation and who | device to detect | |
| diagnostic aid for the | diagnostic aid for the | movement, breathing | would like to monitor | sleep related | |
| detection of sleep | detection of sleep | and body movements | and record their heart | breathing | |
| related breathing | related breathing | to assist in the | rhythms on an | disorders. | |
| disorders, sleep | disorders, sleep | diagnosis of various | intermittent basis. | For the added | |
| staging (Rapid Eye | staging (Rapid Eye | sleep disorders or | capabilities of | ||
| Movement (REM) | Movement (REM) | sleep related | arrhythmia | ||
| Sleep, Light Sleep, | Sleep, Light Sleep, | respiratory or cardiac | output, as | ||
| Deep Sleep and | Deep Sleep and | disorders. The Somté | specified in the | ||
| Wake), snoring level | Wake), snoring level | PSG is designed for | labeling, the | ||
| and body position. | and body position. | ambulatory and | WP200U is | ||
| The WP200U | The WP200U | mobile operation and | equivalent to the | ||
| generates a peripheral | generates a peripheral | can be used in either | reference device | ||
| arterial tonometry | arterial tonometry | the patient's home, | - Somté system. | ||
| ("PAT") Respiratory | ("PAT") Respiratory | the hospital or other | |||
| Disturbance Index | Disturbance Index | environments, thus | |||
| ("PRDI"), Apnea- | ("PRDI"), Apnea- | enabling patients to | |||
| Hypopnea index | Hypopnea index | be investigated under | |||
| ("PAHI"), Central | ("PAHI"), Central | as realistic conditions | |||
| Apnea-Hypopnea | Apnea-Hypopnea | as possible. The | |||
| index ("PAHIc"), | index ("PAHIc"), | Somté PSG is only to | |||
| PAT sleep staging | PAT sleep staging | be used under the | |||
| identification | identification | direction of a | |||
| (PSTAGES) and | (PSTAGES) and | physician. | |||
| optional snoring level | optional snoring level | ||||
| and body position | and body position | ||||
| discrete states from | discrete states from | ||||
| an external integrated | an external integrated | ||||
| snoring and body | snoring and body | ||||
| position sensor. The | position sensor. The | ||||
| WP200U's PSTAGES | WP200U's PSTAGES | ||||
| Itamar Medical's | |||||
| Watch-PAT200U | |||||
| (Subject device) | Primary predicate - | ||||
| Itamar Medical's | |||||
| Watch-PAT200U | |||||
| (K161579) | Reference - | ||||
| Compumedics's | |||||
| Somté | |||||
| (K072201) | Reference - Melys | ||||
| atrial fibrillation | |||||
| monitor | |||||
| (K132206) | Comparison | ||||
| and snoring level and | |||||
| body position provide | |||||
| supplemental | |||||
| information to its | |||||
| PRDI/PAHI/PAHIc. | |||||
| The WP200U's | |||||
| PSTAGES and | |||||
| snoring level and | |||||
| body position are not | |||||
| intended to be used as | |||||
| the sole or primary | |||||
| basis for diagnosing | |||||
| any sleep related | |||||
| breathing disorder, | |||||
| prescribing treatment, | |||||
| or determining | |||||
| whether additional | |||||
| diagnostic assessment | |||||
| is warranted. | |||||
| PAHIc is indicated | |||||
| for use in patients 17 | |||||
| years and older. All | |||||
| other parameters are | |||||
| indicated for 12 years | |||||
| and older | and snoring level and | ||||
| body position provide | |||||
| supplemental | |||||
| information to its | |||||
| PRDI/PAHI/PAHIc. | |||||
| The WP200U's | |||||
| PSTAGES and | |||||
| snoring level and | |||||
| body position are not | |||||
| intended to be used as | |||||
| the sole or primary | |||||
| basis for diagnosing | |||||
| any sleep related | |||||
| breathing disorder, | |||||
| prescribing treatment, | |||||
| or determining | |||||
| whether additional | |||||
| diagnostic assessment | |||||
| is warranted. | |||||
| PAHIc is indicated | |||||
| for use in patients 17 | |||||
| years and older. All | |||||
| other parameters are | |||||
| indicated for 12 years | |||||
| and older | |||||
| User | |||||
| Population | Adult and | ||||
| adolescence (from | |||||
| age 12) | Adult and | ||||
| adolescence (from | |||||
| age 12) | Adult | Adult | Identical to | ||
| primary | |||||
| predicate | |||||
| WP200U | |||||
| Intended Use | |||||
| Environment | Home Use | Home Use | Hospitals and home | ||
| use | Home Use | Identical | |||
| Channels | PAT, | ||||
| pulse rate, oximetry, | |||||
| actigraphy, snoring, | |||||
| body position, chest | |||||
| movement | PAT, | ||||
| pulse rate, oximetry, | |||||
| actigraphy, snoring, | |||||
| body position, chest | |||||
| movement | ECG, EEG, EOG, | ||||
| Respiratory signals, | |||||
| position | PPG | Identical to | |||
| primary | |||||
| predicate | |||||
| WP200U |
To show
equivalent in
technology for
arrhythmia
output: Melys
uses
Photoplethysmo
graphy method |
| | Itamar Medical's
Watch-PAT200U
(Subject device) | Primary predicate -
Itamar Medical's
Watch-PAT200U
(K161579) | Reference -
Compumedics's
Somté
(K072201) | Reference - Melys
atrial fibrillation
monitor
(K132206) | Comparison |
| Analysis
output | Respiratory
indices (pRDI, pAHI,
PAHIc)
Sleep stages
(REM, light, deep and
wake)
Snoring level
Body position
discrete states
Heart rate
statistics
Oximetry
statistics | Respiratory
indices (pRDI, pAHI,
PAHIc)
Sleep stages
(REM, light, deep
and wake)
Snoring level
Body position
discrete states
Heart rate
statistics
Oximetry
statistics
No arrhythmia output | Respiratory
indices
Sleep stages
Arousal detection
PLM
Snores
Position
Heart rate
statistics
Oximetry
statistics
Potential Bruxism | Alerts user of an
irregularity in
their pulse,
specifically AFib,
through a light
indicator. | All analysis
output provided
in the subject
WP200U is also
provided in the
primary
predicate
device. The new
arrhythmia
analysis did not
alter or
influence the
respiratory
indices and
sleep stage
generated by the
WP200U
Software.
Subset to Somté
reference
device. The
Somté includes
additional
cardiac disorder
outputs which
the WP200U
does not
include. |
| | Arrhythmia flagging
output:
Suspected Atrial
Fibrillation (AFib):
• Total duration in
sleep
• Longest event
duration
Premature beats:
• Events per
minute | | ECG analysis
software:
• Automatic
analysis with
statistics and
histograms
• QRS complex
classification
• Arrhythmia
detection and
classification
• ECG statistics
during respiratory
events
• Trend data for ST
segment and
normal
• R-R interval
(heart rate)
• Heart rate
variability
analysis
• 24 hour ECG
with full
disclosure trace | | to detect atrial
fibrillation from
the finger. |
| | Itamar Medical's
Watch-PAT200U
(Subject device) | Primary predicate -
Itamar Medical's
Watch-PAT200U
(K161579) | Reference -
Compumedics's
Somté
(K072201) | Reference - Melys
atrial fibrillation
monitor
(K132206) | Comparison |
| | | | display and
printing
ECG template
classification and
editing | | |
| Components | uPAT finger
probe
Actigraph
Controller
Microphone
Accelerometer
Analysis software
Chest sensor
(optional)
External Tamper-
Proof Bracelet
(optional)
Software Program | uPAT finger
probe
Actigraph
Controller
Microphone
Accelerometer
Analysis software
Chest sensor
(optional)
External Tamper-
Proof Bracelet
(optional)
Software Program | Respiratory Effort
Channels - Abdomen
and Thorax
Airflow
Pressure
Snore
Body position
SpO2
Pulse Rate
Pulse wave
ECG
EEG/EMG/EOG | Atrial Fibrillation
Monitor
Finger Sensor
(K101692) | Identical to
primary
predicate
WP200U |
| Sensors
Placement | Wrist, finger and
chest (optional) | Wrist, finger and
chest (optional) | Wrist, finger, face,
leg, chest and
abdomen | finger | Identical to
primary
predicate
WP200U.
In addition, both
the WP200U
and the
reference device
use a finger PPG
sensor to detect
atrial fibrillation |
| Intended user
of the
Arrhythmia
output | Physician | No arrhythmia output | Physician | End user (self-testing
by user) | Identical to
Somté reference
device |
| Arrhythmia
monitoring
period | During prescribed
sleep study | No arrhythmia output | During prescribed
sleep study | Spot check during
wake (recommended
4 consecutive
measurements of 10
seconds) | Identical to
Somté reference
device |
| | Itamar Medical's
Watch-PAT200U
(Subject device) | Primary predicate -
Itamar Medical's
Watch-PAT200U
(K161579) | Reference -
Compumedics's
Somté
(K072201) | Reference - Melys
atrial fibrillation
monitor
(K132206) | Comparison |
| Arrhythmia
output
technological
characteristic | PPG | No arrhythmia output | ECG | PPG | Both the subject
and the
reference
device. Melys.
device use PPG
technology for
arrhythmia
output |
Comparison of Technological Characteristics with the predicate device
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The technological characteristics and principles of operation of the subject device are identical to the predicate WP200U device (K161579). The subject WP200U, like its predicate, is a ventilatory effort recorder that utilizes PAT™ (Peripheral Arterial Tone) technology. Both devices utilize a patient-worn device used at home for aiding in the diagnosis of sleep related breathing disorders based on the PAT signal.
The technological characteristics for the following elements are identical between the subject and predicate devices:
- . A wrist worn Control Unit with actigraphy
- Finger Probe (uPAT probe) based on optical plethysmography that records: ●
- O PAT™ signal
- o Arterial blood oxygen
- Chest sensor (SBP/RESBP) that measures: ●
- Snoring level o
- o Body position states
- o Chest movement
- Tamper-Proof Bracelet (Optional)
- Power Supply (battery/charger)
The difference between the subject device and the predicate:
- . Modification within the Management and Analysis Software of the subject device: The software of the subject device is similar to that of the primary predicate device, except for the introduction of a new algorithm to identify episodes of irregular heart rhythms - Atrial Fibrillation (AFib) and Premature beats. The subject device utilizes the same technological characteristics, but with different SW analysis of the signals for the newly added SW feature.
- The subject device also has similar technological characteristics to the reference . device Melys Atrial Fibrillation Monitor device ("Melys") cleared under
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K 132206, a portable device for measuring and displaying heart rate irregularity and pulse rate using PPG technology. The reference device is used to support the use of PPG technology from a finger sensor to provide information regarding heart rate irregularity and that these differences do not raise new questions of safety and effectiveness.
The subject WP200U principle of operation is identical to the primary predicate devices' principles of operation.
Note: While the WP200U uses PAT technology utilizing PPG to determine heart rhythm and the reference uses ordinary PPG, these changes do not affect the heart rate. The unique feature of the PAT is the use of a uniform pressure field which helps to avoid venous pooling, artifacts and improve signal's dynamic range.
Performance Testing
A series of safety and performance testing were performed. These tests include:
Electrical Safety and Electromagnetic Compatibility
Electrical safety and EMC testing were conducted on the WatchPAT200U device. The system complies with the IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) and AM1:2012 for Safety, and IEC 60601-1-2:2014 for EMC.
Electrical Safety for Home Healthcare Environment
Electrical safety testing for the home healthcare environment was conducted on the WatchPAT200U device. The system complies with the IEC 60601-1-11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
Software Verification and Validation Testing
Software verification and validation testing was performed to demonstrate that the software in the subject device performs according to its specifications. The software for this device was considered as a "moderate" level of concern since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Clinical Testing
Clinical performance testing was performed to evaluate the capability of WP200U To identify arrhythmic events: Atrial fibrillation and premature beats, by comparing the subject device against "Gold Standard" cardiologist-scored ECG channel of a polysomnography (PSG). One hundred and fifty-seven (157) subjects were evaluated in an overnight sleep study using the subject device and a single-lead ECG recorded by a
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PSG system in a sleep lab. Overall, the test results demonstrated acceptable performance of the subject device in detecting clinically relevant arrhythmic events (atrial fibrillation and premature beats) as supplemental information to its sleep information.
The performance testing demonstrates that the WP200U is substantially equivalent to its predicates and does not raise different questions of safety or effectiveness.
Summary
Based on the performance testing, including the electrical safety, electromagnetic testing, clinical study, and software verification and validation, Itamar Medical Ltd. concludes that the WP200U System is substantially equivalent to its predicates and does not raise any new or different concerns about safety or effectiveness.