(69 days)
The Watch-PAT100S (WP100S) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S is a diagnostic aid for the detection of sleep related breathing disorders and rapid eye movement ("REM") sleep stages. The WP100S generates a peripheral arterial tonometry ("PAT") respiratory disturbance index ("PRDI") and PAT REM sleep stage identification ("PREM"). The WP100S's PREM provides supplemental information to its PRDI. The WP100S'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 WP100S is not indicated for children less than 17 years old. The WP100S is contraindicated for patients with latex allergy.
The WP100S uses peripheral arterial tonometry to generate apnea indices ("PRDIs") and identify REM sleep stages ("PREMs"). The device's primary components include a cleared oximeter and actigraph, an associated computer analysis program, a battery and charger, and a carrying case.
The provided text does not contain detailed acceptance criteria and a specific study proving the device meets them with the level of detail requested in the prompt. It primarily serves as a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than a standalone performance study against pre-defined acceptance criteria.
However, based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document states, "Clinical data demonstrates that the device is as safe and effective as manual scoring of polysomnography ("PSG") and automated scoring of the BioSleep in detection REM sleep stages. Clinical data also demonstrated that the WP100S is at least as safe and effective as the Watch-PAT100 in detecting sleep apnea."
This implies that the acceptance criteria are based on equivalence to the predicate devices and manual PSG scoring. However, specific numerical thresholds (e.g., sensitivity, specificity, accuracy percentages, or correlation coefficients) for this equivalence are not provided.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| As safe and effective as manual scoring of PSG for REM detection | "the device is as safe and effective as manual scoring of polysomnography ("PSG") ... in detection REM sleep stages." (Specific metrics like sensitivity/specificity/accuracy or agreement rates are not provided in the summary) |
| As safe and effective as automated scoring of BioSleep for REM detection | "the device is as safe and effective as ... automated scoring of the BioSleep in detection REM sleep stages." (Specific metrics like sensitivity/specificity/accuracy or agreement rates are not provided in the summary) |
| At least as safe and effective as the Watch-PAT100 for detecting sleep apnea | "the WP100S is at least as safe and effective as the Watch-PAT100 in detecting sleep apnea." (Specific metrics like sensitivity/specificity/accuracy or agreement rates are not provided in the summary) |
| Does not raise new issues of safety or effectiveness | "The minor technological differences between the WP100S and its predicate devices, namely the WP100S's software modifications, raise no new issues of safety or effectiveness. Clinical data demonstrate that the WP100S is as safe and effective as its predicates." (This is a qualitative statement, no specific safety endpoints are detailed in the provided text) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The document only mentions "Clinical data demonstrates..." without specifying the number of subjects or the study design (retrospective/prospective, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The ground truth for REM detection is mentioned as "manual scoring of polysomnography ("PSG")". While this implies expert involvement (sleep technologists or physicians), the number of experts and their specific qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text. For manual PSG scoring, standard adjudication methods would typically be used, but they are not detailed here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document mentions "manual scoring of polysomnography" for comparison. However, it does not describe an MRMC study or any scenario where human readers used AI assistance. The WP100S is presented as a diagnostic aid that generates indices, not as a system to assist human readers in interpreting other data. Therefore, an effect size of human improvement with AI assistance is not applicable and not reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device (WP100S) is described as a "non-invasive home care device" that "generates a peripheral arterial tonometry ("PAT") respiratory disturbance index ("PRDI") and PAT REM sleep stage identification ("PREM")". This implies a standalone algorithm-only performance for generating these indices. The comparison is made between the device's output and manual PSG scoring or predicate devices' automated scoring.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for REM detection is "manual scoring of polysomnography ("PSG")". For sleep apnea detection, the ground truth for the Watch-PAT100 (which WP100S is compared to) would also likely be PSG, but this is not explicitly stated for WP100S's sleep apnea detection in this summary.
8. The sample size for the training set
This information is not provided in the given text.
9. How the ground truth for the training set was established
This information is not provided in the given text.
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DEC 29 2004
510(k) SUMMARY
Itamar's Watch PAT 100S
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Itamar Medical Ltd. 2 Ha'eshel Street, P.O. Box 3579 Caesarea 38900 Israel
011-972-4-617-7000 Phone: 011-972-4-627-5598 Facsimile:
Koby Sheffy, Ph.D. Contact Person:
September 27, 2004 · Date Prepared:
Name of Device and Name/Address of Sponsor
Watch-PAT 100S
Itamar Medical Ltd. 2 Ha'eshel Street, P.O. Box 3579 Caesarea 38900 Israel
Common or Usual Name
Ventilatory Effort Recorder
Classification Name
Breathing Frequency Monitor (21 C.F.R. § 868.2375)
Predicate Devices
Itamar's Watch PAT 100 ("WP100") Oxford BioSignal's BioSleep ("BioSleep")
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Intended Use / Indications for Use
The Watch-PAT100S (WP100S) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S is a diagnostic aid for the detection of sleep related breathing disorders and rapid eye movement ("REM") sleep stages. The WP100S generates a peripheral arterial tonometry ("PAT") respiratory disturbance index ("PRDI") and PAT REM sleep stage identification ("PREM"). The WP100S's PREM provides supplemental information to its PRDI. The WP100S'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 WP100S is not indicated for children less than 17 years old. The WP100S is contraindicated for patients with latex allergy.
Technological Characteristics
The WP100S uses peripheral arterial tonometry to generate apnea indices ("PRDIs") and identify REM sleep stages ("PREMs"). The device's primary components include a cleared oximeter and actigraph, an associated computer analysis program, a battery and charger, and a carrying case.
Performance Data
Clinical data demonstrates that the device is as safe and effective as manual scoring of polysomnography ("PSG") and automated scoring of the BioSleep in detection REM sleep stages. Clinical data also demonstrated that the WP100S is at least as safe and effective as the Watch-PAT100 in detecting sleep apnea.
Substantial Equivalence
The WP100S is substantially equivalent to manual scoring of PSG data and a combination of the WP100 and the BioSleep. The WP100S has the same intended use as the WP100, very similar indications as a combination of the WP100 and the BioSleep, and the same hardware and principles of operation as the WP100. The minor technological differences between the WP100S and its predicate devices, namely the WP100S's software modifications, raise no new issues of safety or effectiveness. Clinical data demonstrate that the WP100S is as safe and effective as its predicates. Thus, the WP100S is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 2004
Itamar Medical Limited C/O Mr. Jonathan S. Kahn Regulatory Counsel Hogan & Hartson, L.L.P 555 Thirteenth Street, NW Washington, DC 20004
Re: K042916
Trade/Device Name: Watch-PAT 100S Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: October 21, 2004 Received: October 21, 2004
Dear Mr. Kahn:
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.
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Page 2 - Mr. Kahn
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 vour 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/dsma/dsmamain.html
Sincerely yours,
Charles
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
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Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Watch-PAT 100S
Indications for Use:
The Watch-PAT 100S ("WP100S") device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S is a diagnostic aid for the detection of sleep related breathing disorders and rapid eye movement ("REM") sleep stages. The WP100S generates a peripheral arterial tonometry ("PAT") respiratory disturbance index ("PRDI") and PAT REM sleep stage identification ("PREM"). The WP100S's PREM provides supplemental information to its PRDI. The WP100S'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 WP100S is not indicated for children less than 17 years old. The WP100S is contraindicated for patients with latex allergy.
Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (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: | K042916 |
|---|---|
| ---------------- | --------- |
\\DC - 87424/0001 - 2034236 v2
§ 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).