(43 days)
No
The document explicitly states that it does not mention AI, DNN, or ML. The description focuses on signal processing and analysis algorithms, not AI/ML techniques.
No
The device is described as a "diagnostic aid for the detection of sleep related breathing disorders" and provides various indices and identifiers for these conditions, but it does not treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The WP300 is a diagnostic aid for the detection of sleep related breathing disorders."
No
The device description explicitly lists hardware components such as a wrist worn Control Unit, uPAT probe, and optional chest sensor, indicating it is not solely software.
Based on the provided text, the WatchPAT300 is an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is described as a "diagnostic aid for the detection of sleep related breathing disorders". While it's a home care device, its primary purpose is to provide diagnostic information.
- Parameters Generated: It generates various indices (PRDI, PAHI, PAHIC) and provides information on sleep staging, snoring, and body position. These are all parameters used in the diagnosis of sleep disorders.
- Comparison to Predicates: The text explicitly states the subject WatchPAT300 is "identical in its intended use and indications for use to the cleared predicate WP200U (K203839) and the cleared predicate WP300 (K180775)". Looking up these predicate devices would likely confirm their IVD classification.
- Software Analysis: The device uses "Management and Analysis Software (SW)" to process the collected data and generate the diagnostic parameters. This software component is crucial for the diagnostic function.
While it's a non-invasive device used in a home setting, its core function is to provide data and indices that aid in the diagnosis of a medical condition (sleep related breathing disorders). This aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the "specimens" are the physiological signals collected from the patient.
N/A
Intended Use / Indications for Use
The WatchPAT300 is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP300 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 WP300 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 WP300's PSTAGES and snoring level and body position provide supplemental information to its PRDIPAHIC. The WP300'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
MNR
Device Description
The subject WatchPAT300 (WP300) is identical in its intended use and indications for use to the cleared predicate WP200U (K203839) and the cleared predicate WP300 (K180775). The subject WP300 combines the software arrhythmia feature of the WP200U cleared predicate (K203839) into the WP300 cleared predicate (K180775).
The subject WP300 consists of: A wrist worn Control Unit, Actigraphy (in the Control Unit), Wrist Strap, Power Supply (battery), uPAT probe, Chest sensor (optional), Tamper-Proof Bracelet (optional), and Management and Analysis Software (SW).
The subject WP300, like the predicate WP200U and predicate WP300, uses the same offline Management and Analysis Software (SW). The 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 arrhythmia detection is not intended for use in life supporting or sustaining systems or monitor and alarm devices. It provides the sleep physician with additional information to that of the WP300 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Home Use (Care Setting)
Physician (Intended user of the Arrhythmia output)
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)
SW verification and validation was performed on the subject WP300 device with the SW containing the additional arrhythmia feature as per the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The testing and acceptance criteria are the same as those in the predicate devices. Bench testing was previously conducted on the predicate WP300 (in K180775) to show that the acquisition system of the WP300 and WP200U are generating the same input signals to the analysis algorithms. Specifically, the equivalence of the PAT and the actigraphy signals which are used in the newly added arrhythmia algorithm were tested. This testing provides evidence that the WP300 signals are equivalent to the WP200U signals.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
September 14, 2022
Itamar Medical, Ltd % Jonathan Kahan Partner Hogan Lovells Us Llp 553 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K222331
Trade/Device Name: WatchPAT300 (WP300) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: August 2, 2022 Received: August 2, 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.
1
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 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222331
Device Name WatchPAT300 (WP300)
Indications for Use (Describe)
The WatchPAT300 is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP300 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 WP300 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 WP300's PSTAGES and snoring level and body position provide supplemental information to its PRDIPAHIC. The WP300'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
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 |
| ------------------- | ------------------------------------------------------------------------------------------------------------------- |
|---|
- Jonathan Kahan, Esq. Contact Person: 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: August 2, 2022
- Trade Name: WatchPAT300 (WP300)
- 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 Device:
- . Watch-PAT200U ("WP200U") (Itamar Medical Ltd), cleared under K203839; product code MNR
Reference Device:
- · Watch-PAT300 ("WP300") (Itamar Medical Ltd.) cleared under K180775; product code MNR
Purpose of the Special 510(k):
The subject WP300 combines the software arrhythmia feature of the WP200U cleared predicate (K203839) into the WP300 cleared predicate (K180775).
4
Intended Use
The WatchPAT300 is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP300 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 WP300 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 WP300's PSTAGES and snoring level and body position provide supplemental information to its PRD/PAHI/PAHIc. The WP300'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. PAHlc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.
Device Description
The subject WatchPAT300 (WP300) is identical in its intended use and indications for use to the cleared predicate WP200U (K203839) and the cleared predicate WP300 (K180775). The subject WP300 combines the software arrhythmia feature of the WP200U cleared predicate (K203839) into the WP300 cleared predicate (K180775).
The subject WP300 consists of: A wrist worn Control Unit, Actigraphy (in the Control Unit), Wrist Strap, Power Supply (battery), uPAT probe, Chest sensor (optional), Tamper-Proof Bracelet (optional), and Management and Analysis Software (SW).
The subject WP300, like the predicate WP200U and predicate WP300, uses the same offline Management and Analysis Software (SW). The 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 arrhythmia detection is not intended for use in life supporting or sustaining systems or monitor and alarm devices. It provides the sleep physician with additional information to that of the WP300 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.
Technological Characteristics
The subject WP300 has the same technological characteristics as the predicates WP300 and WP200U to which it has been modified.
Identically to WP200U and WP300, the subject WP300 device is a ventilatory effort recorder that utilizes Peripheral Arterial Tone (PAT) signal. It is a patient-worn device used at home for aiding in the diagnosis of sleep related breathing disorders based on the PAT signal. In all 3 systems, the controller part of the device is worn on the wrist and records the PAT signal and blood oxygen saturation levels in the distal part of the finger-mounted probe based on an optical plethysmographic method, and the wrist motion from an embedded actigraphy. The following report output information is provided by the cleared WP200U, cleared WP300,
5
and the subject WP300 using the same offline SW and algorithms that analyze recorded data to present respiratory disturbance index (pRDI), Apnea Hypopnea Index (pAHI), Central Apnea Hypopnea Index (pAHIc), sleep stages (pSTAGES - REM Sleep, Light Sleep, Deep Sleep, Wake), snoring level and body position discrete states. The new arrhythmia information in the subject WP300's report is identical to the one in the cleared WP200U.
The subject WP300, identically to both predicates, consists of the same components: (1) Same unified PAT probe (uPAT) is used to measure the PAT and oximetry signals; (2) an embedded actigraph which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist: (3) Electronics, which include a microprocessor that records the information supplied by the uPAT finger probe, actigraph and chest movement; and (4) chest sensor (SBP/RESBP sensors same as in the predicates).
The SW characteristics of the subject WP300 and the predicate WP300 are the same except for the newly added SW algorithm that was cleared for use in the WP200U (K203839) to identify or 'flaq' the patient for further arrhythmia investigation (Atrial Fibrillation and Premature Beats). This additional SW algorithm is the proposed modification to the subject WP300.
The hardware (HW) of the subject WP300 is the same as the HW of the predicate WP300 (K180775). Further, the HW of the WP300 was designed to provide identical signals to that of the predicate WP200U. The differences in HW between the WP300 and the WP200U devices have been thoroughly discussed and found to be substantially equivalent in K180775.
The cleared arrhythmia SW alqorithm from the predicate WP200U added to the subject WP300 does not alter the technological characteristics of the device or its principles of operation.
Performance Data
SW verification and validation was performed on the subject WP300 device with the SW containing the additional arrhythmia feature as per the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The testing and acceptance criteria are the same as those in the predicate devices. Bench testing was previously conducted on the predicate WP300 (in K180775) to show that the acquisition system of the WP300 and WP200U are generating the same input signals to the analysis algorithms. Specifically, the equivalence of the PAT and the actigraphy signals which are used in the newly added arrhythmia algorithm were tested. This testing provides evidence that the WP300 signals are equivalent to the WP200U signals.
Substantial Equivalence
The subject WP300 has the same intended use as both previously cleared predicate devices, WP300 and WP200U. The WP300's new SW arrhythmia feature 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 and the differences in HW between the WP200U (in which the new SW feature for Arrhythmia detection was cleared) and the subject WP300 do not raise new questions of safety or effectiveness.
6
| Subject WP300 | WP200U (K203839) | WP300 (K180775) | Comparison | |
|---|---|---|---|---|
| (Primary Predicate) | (Reference device) | |||
| Intended Use | The Watch-PAT300 (WP300) | |||
| device is a non-invasive | ||||
| home care device for use | ||||
| with patients suspected to | ||||
| have sleep related breathing | ||||
| disorders. The WP300 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 WP300's | ||||
| PSTAGES and snoring level | ||||
| and body position provide | ||||
| supplemental information to | ||||
| its PRDI/PAHI/PAHI/PAHIc. The | ||||
| WP300's PSTAGES and | ||||
| snoring level and body | ||||
| position are not intended to | ||||
| be used as the sole or | ||||
| primary basis for diagnosinq | ||||
| 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 | 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/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 | The Watch-PAT300 (WP300) | |||
| device is a non-invasive | ||||
| home care device for use | ||||
| with patients suspected to | ||||
| have sleep related breathing | ||||
| disorders. The WP300 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 WP300's | ||||
| PSTAGES and snoring level | ||||
| and body position provide | ||||
| supplemental information to | ||||
| its PRDI/PAHI/PAHI/PAHIc. The | ||||
| WP300'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 | Same | |||
| User | ||||
| Population | Adult and adolescence (from | |||
| age 12) | Adult and adolescence (from | |||
| age 12) | Adult and adolescence (from | |||
| age 12) | Same | |||
| Intended Use | ||||
| Environment | Home Use | Home Use | Home Use | Same |
| Channels | PAT, Pulse rate, Oximetry, | |||
| Actigraphy, Snoring, Body | ||||
| Position, Chest Movement | PAT, Pulse rate, Oximetry, | |||
| Actigraphy, Snoring, Body | ||||
| Position, Chest Movement | PAT, Pulse rate, Oximetry, | |||
| Actigraphy, Snoring, Body | ||||
| Position, Chest Movement | Same | |||
| · Respiratory indices (pRDI, | ||||
| pAHI,pAHIc) | · Respiratory indices (pRDI, | |||
| pAHI,pAHIc) | · Respiratory indices (pRDI, | |||
| pAHI,pAHIc) | Same | |||
| Subject WP300 | WP200U (K203839) | WP300 (K180775) | Comparison | |
| SW Analysis | ||||
| output | Sleep stages (REM, light, deep and wake) Snoring level Body position discrete states Heart rate statistics Oximetry statistics | Sleep stages (REM, light, deep and wake) Snoring level Body position discrete states Heart rate statistics Oximetry statistics | Sleep stages (REM, light, deep and wake) Snoring level Body position discrete states Heart rate statistics Oximetry statistics | |
| Arrhythmia flagging output: Suspected Atrial Fibrillation (AFib): Total duration in sleep Longest event duration Premature beats: Events per minute | Arrhythmia flagging output: Suspected Atrial Fibrillation (AFib): Total duration in sleep Longest event duration Premature beats: Events per minute | No Arrhythmia output | Same as | |
| WP200U | ||||
| Input uPAT | ||||
| Probe | Itamar proprietary probe only | Itamar proprietary probe only | Itamar proprietary probe only | Same |
| HW | ||||
| Components | uPAT finger probe Smaller device with improved graphics, OLED screen Actigraph Controller Chest sensor (optional) External Tamper-Proof Bracelet (optional) | uPAT finger probe Device with LCD screen Actigraph Controller Chest sensor (optional) External Tamper-Proof Bracelet (optional) | uPAT finger probe Smaller device with improved graphics, OLED screen Actigraph Controller Chest sensor (optional) External Tamper-Proof Bracelet (optional) | Same as |
| WP300. uPAT | ||||
| probe, Chest | ||||
| sensor, and | ||||
| Tamper-Proof | ||||
| Bracelet are | ||||
| the same for all | ||||
| 3 devices. | ||||
| Power Supply | One OTS 1.5V Alkaline AAA | |||
| battery | ||||
| OR | ||||
| One rechargeable AAA 1.2V | ||||
| Nickel-metal hydride (NiMH) | ||||
| battery | Proprietary, rechargeable | |||
| Lithium Ion Battery | One OTS 1.5V Alkaline AAA | |||
| battery | ||||
| OR | ||||
| One rechargeable AAA 1.2V | ||||
| Nickel-metal hydride (NiMH) | ||||
| battery | Same as | |||
| WP300 | ||||
| Sensors | ||||
| Placement | Wrist, finger and chest | |||
| (optional) | Wrist, finger and chest | |||
| (optional) | Wrist, finger and chest | |||
| (optional) | Same | |||
| Intended user | ||||
| of the | ||||
| Arrhythmia | ||||
| output | Physician | Physician | No Arrhythmia output | Same as |
| WP200U | ||||
| Arrhythmia | ||||
| Monitoring | ||||
| period | During prescribed | |||
| sleep study | During prescribed | |||
| sleep study | No Arrhythmia output | Same as | ||
| WP200U | ||||
| Arrhythmia | ||||
| output | ||||
| technological | ||||
| characteristic | PPG | PPG | No Arrhythmia output | Same as |
| WP200U |
7
8
Conclusions
The subject WP300 has the same technological characteristics and principles of operation as its predicates and the new SW arrhythmia feature does not raise any new questions of safety or effectiveness. Substantial equivalence of the subject device has been proven towards both predicates, and the differences in HW between the WP200U (in which the new SW feature for Arrhythmia detection was cleared) and the subject WP300 do not raise new questions of safety or effectiveness. Based on the above Itamar Medical Ltd. concludes that the WP300 is substantially equivalent to its predicates and does not raise any new or different concerns about safety or effectiveness.