(59 days)
Not Found
No
The summary describes a device that uses sensors and software to analyze physiological signals (PAT, oximetry, actigraphy) to aid in the diagnosis of sleep disorders. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The analysis is based on established physiological measurements and signal processing, not AI/ML algorithms.
No
The device is described as a "diagnostic aid for the detection of sleep-related breathing disorders," and its "PREM is 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." This indicates it's for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The WP200i is a diagnostic aid for the detection of sleep-related breathing disorders and rapid eye movement ("REM") sleep stages."
No
The device description explicitly lists multiple hardware components including a finger PAT probe, embedded pulse oximeter, embedded actigraph, electronics, and a power supply, in addition to the device software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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.
- Device description: The WATCH PATTM 200i is described as a non-invasive home care device that measures physiological signals from the finger and wrist (PAT signal, blood oxygen saturation, actigraphy). It does not involve the analysis of samples taken from the body.
- Intended Use: The intended use is to aid in the diagnosis of sleep-related breathing disorders by analyzing these non-invasive physiological signals.
Therefore, the WP200i falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The WATCH PAT™ 200i ("WP200i") is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep-related breathing disorders and rapid eye movement ("REM") sleep stages. The WP200i generates a peripheral arterial tonometry ("PAT"), respiratory disturbance index ("PRDI"), and PAT REM sleep stage identification ("PREM"). The WP200i's PREM provides supplemental information to its PRDI. The WP200i's PREM is 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.
The WP200i is not indicated for children less than 17 years old. The WP200i is contraindicated for patients with latex allergy.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The WATCH-PAT200i System (WP200i) is a non-invasive home care device for use with patients suspected to having sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep related breathing disorders and rapid eye movement ("REM") sleep stag, based on Peripheral Arterial Tonometry (PAT); a noninvasive technology.
The WP200i System is a compact version of the WP100S System, both consist of: (1) a finger PAT probe, which is used to detect the PAT signal; (2) an embedded pulse oximeter using a second probe that is attached to another finger for measuring blood oxygen saturation; (3) an embedded actigraph which is used to determine periods of sleep based on the motion of the wrist; (4) Electronics which include a controller that records the information supplied by the PAT finger probe, oximeter, and actigraph; (5) the device software; and (6) a power supply.
The device is worn on the wrist, and continuously measures the relative state of the vasomotor activity in the distal part of the finger, by a finger-mounted probe based on a plethysmographic method. The measured signal is acquired from a self contained, optopneumatic sensor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal part of the finger
Indicated Patient Age Range
not indicated for children less than 17 years old. (i.e. 17 years old and above)
Intended User / Care Setting
home care
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)
A series of safety and performance testing, including bench testing were performed to demonstrate that the modified WP200i System does not raise any new questions of safety and efficacy. These tests include:
- Electrical and electromagnetic testing
- Software verification and validation
- Electronics design verification test
- Performance testing demonstrating the accuracy of the captured signals and device's reproducibility
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.
Not Found
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
KOY1037
510(k) SUMMARY
JUN - 9 2008
| Applicant's Name: | Itamar Medical Itd.
2 Ha'eshel st.
Caesarea 38900, Israel
Tel: +972 4 617 7000
Fax: +972 4 627 5598 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jonathan Kahan, Esq.
Hogan & Hartson, L.L.P.
Columbia Square
555 Thirteenth Street, NW
Washington, DC 20004-1109
Tel: (202)637-5794
Fax: (202)637-5910 |
| | and
Dorit Winitz, Ph. D
Biomedical Strategy (2004) Ltd.
Moshe Aviv Tower, 34th Floor,
7 Jabotinsky Street
Ramat Gan 52520, Israel
Tel: +972-3-612-3281
Fax: +972-3-612-3282
dorit@ebms.co.il |
| Date Prepared: | March, 2008 |
| Trade Name: | Watch-PAT 200i ("WP200i") |
| Common Name: | Ventilatory Effort Recorder |
. 1
1
Classification:
21 CFR 868.2375 Class:II MNR (Ventilatory Effort Recorder).
Classification Name: Breathing Frequency Monitor
Medical Specialty: Anesthesiology
Predicate Devices:
Watch-Pat100S ("WP100S") (Itamar Ltd), cleared under K042916; product code MNR (ventilatory effort recorder).
Device Description:
The WATCH-PAT200i System (WP200i) is a non-invasive home care device for use with patients suspected to having sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep related breathing disorders and rapid eye movement ("REM") sleep stag, based on Peripheral Arterial Tonometry (PAT); a noninvasive technology.
The WP200i System is a compact version of the WP100S System, both consist of: (1) a finger PAT probe, which is used to detect the PAT signal; (2) an embedded pulse oximeter using a second probe that is attached to another finger for measuring blood oxygen saturation; (3) an embedded actigraph which is used to determine periods of sleep based on the motion of the wrist; (4) Electronics which include a controller that records the information supplied by the PAT finger probe, oximeter, and actigraph; (5) the device software; and (6) a power supply.
The device is worn on the wrist, and continuously measures the relative state of the vasomotor activity in the distal part of the finger, by a finger-mounted probe based on a plethysmographic method. The measured signal is acquired from a self contained, optopneumatic sensor.
Intended Use:
The WATCH PAT™ 200i ("WP200i") is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep-related breathing disorders and rapid eye movement ("REM") sleep stages. The WP200i generates a peripheral arterial tonometry ("PAT"), respiratory disturbance index ("PRDI"), and PAT REM sleep stage identification ("PREM"). The WP200i's PREM provides supplemental information to its PRDI. The WP200i's PREM is 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. The WP200i is not indicated for children less than 17 years old. The WP200i is contraindicated for patients with latex allergy.
2
Performance Data & Substantial Equivalence
The WP100i System is substantially equivalent in all aspects, including tcchnological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available WP100S System, cleared under K042916.
The principle changes between the devices include minor hardware modifications that were made to the controller components to enable more compact design and lower power consumption.
A series of safety and performance testing, including bench testing were performed to demonstrate that the modified WP200i System does not raise any new questions of safety and efficacy. These tests include:
- 트 Electrical and electromagnetic testing
- l Software verification and validation
- 트 Electronics design verification test
- 트 Performance testing demonstrating the accuracy of the captured signals and device's reproducibility
Based on these tests results, Itamar Medical Ltd. believes that the WP200i System is substantially equivalent to the cleared WP100S System without raising new safety and/or effectiveness issues.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2008
Itamar Medical Limited C/O Mr. Jonathan S. Kahan Regulatory Affairs Consultant Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K081037
Trade/Device Name: Watch-PATTM 200i Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: May 13, 2008 Received: May 13, 2008
Dear Mr. 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 – Mr. Kahan
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K081037
Device Name: WATCH PATTM 200i
Indications for Use:
The WATCH PATTM 200i ("WP200i") is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep-related breathing disorders and rapid eye movement ("REM") sleep stages. The WP200i generates a peripheral arterial tonometry ("PAT"), respiratory disturbance index ("PRDI'), and PAT REM sleep stage identification ("PREM"). The WP200i's PREM provides supplemental information to its PRDI. The WP200i's PREM is 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.
The WP200i is not indicated for children less than 17 years old. The WP200i is contraindicated for patients with latex allergy.
Prescription Use X (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K08 1037 |
|---|---|
| ---------------- | ---------- |