(88 days)
The SleepWizard is intended for use in collecting and displaying physiological data to be used in diagnosing sleep disorders such as obstructive sleep apnea in patients weighing over 20 kg in a clinical or home environment.
The system is set up by the clinician using the computer, which is connected to the Data Collector by a cable connecting to the RS232 port, or by a modem. The computer is optically isolated from the Data Collector by circuitry on the Power Board. The patient is prepared for the sleep study as described in the Clinician's Guide and Patient's Guide (Attachments 1 and 3, respectively). A Ground Electrode is connected to the Data Collector and the patient to ensure that the signals collected all are at the same ground potential. Various sensors are connected to the patient and either directly to the Data Collector or to the Extension Box which in rurn is connected to the Data Collector. During the study itself, physiologic signals are detected by the sensors. Except for the pulse oximeter, these signals are then amplified by amplifiers. Each amplifier is designed so that it dedicated to a specific sensor so that all signals are at +3 volts after amplification. The signals are then sent to the Deta Collector, where they are stored and periodically written on the Flashcard. If the Data Collector and computer are both connected to modems, the clinician can view the computer screen while it is being collected from the patient. At the conclusion of data collection (i.e., at the end of the sleep study) the Plashcard is removed from the Data Collector and inserted into the computer so that the data may be processed and printed out for analysis purposes.
The provided text describes a 510(k) summary for the Nellcor Puritan Bennett SleepWizard, a sleep disorders data recorder. The document primarily focuses on demonstrating substantial equivalence to a predicate device and functional testing, rather than detailed performance studies with acceptance criteria for diagnostic accuracy.
Therefore, the requested information, particularly regarding specific acceptance criteria for diagnostic performance, a detailed study proving it, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies, is not available in the provided text.
The document states: "No clinical studies were required to support a substantial equivalence determination, except for connecting the device to a healthy person and running the system to verify that readable, appropriate signals were being generated." This indicates that the focus of the submission was on functional verification and regulatory equivalence, not on a clinical performance study with diagnostic accuracy metrics against a ground truth.
Here's what can be extracted based on the prompt's requirements, with explicit notation where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Capable of meeting stated performance specifications | SleepWizard passed all tests. |
| Device output is readable | SleepWizard passed all tests. |
| Complies with November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" | SleepWizard passed all tests. |
| Software tested in accordance with August 29, 1991 "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review" | SleepWizard passed all tests. |
| Generate readable, appropriate signals (for limited clinical verification) | Verified by connecting to a healthy person and running the system. |
| Operate safely in its intended environment | Concluded to operate safely. |
| Be effective in fulfilling its intended use (collecting and displaying physiological data for diagnosing sleep disorders) | Concluded to be effective in fulfilling its intended use. |
Missing Information: The document does not provide specific quantitative acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) or detailed performance metrics beyond "passed all tests" and "generated readable, appropriate signals."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: "a healthy person" (singular).
- Data Provenance: Not explicitly stated, but implies a simple verification conducted by the manufacturer, likely in a controlled environment. Retrospective/Prospective: Given the limited scope ("healthy person"), it's more akin to a prospective, single-case demonstration.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- The ground truth for the "healthy person" test was simply the expectation of "readable, appropriate signals" from a healthy individual, rather than a diagnostic ground truth established by experts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "test" was a basic functional verification, not a diagnostic assessment requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No. The document explicitly states, "No clinical studies were required to support a substantial equivalence determination, except for connecting the device to a healthy person..."
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Standalone Study: No. The device is a "Sleep Disorders Data Recorder" intended to collect and display data for clinicians to use in diagnosing. It does not appear to contain an automated diagnostic algorithm that would require a standalone performance study.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the limited verification described, the "ground truth" was a basic expectation of normal physiological signals from a healthy individual, rather than expert consensus on a sleep disorder, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a data recorder, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. The device does not utilize a training set.
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Image /page/0/Picture/0 description: The image shows a logo with a black abstract shape on the left and the text "NELLCOR PURITAN BENNETT" on the right. The text is stacked vertically, with each word on a separate line. The font appears to be sans-serif and bolded.
Nellour Pichian Bennest Inc. 10200 Valley Victor Houd Filen Praunct 1404 553-4
8:22 24 125% 6.2 329.5423 Fax
FEB - 4 1997
510(k) SUMMARY
NELLCOR PURITAN BENNETT SleepWizard
November 7, 1996
1.0 Submitter Information
Nellcor Puritan Bennett 10200 Valley View Road Eden Prairie, MN 55344
Chris Hadland Submitter's Name: (6) 2) 941-3006 Phone: Fax Number: (612) 829-5423 Summary Preparation Date: October 25, 1996
2.0 Device Name
Nellcor Puritan Bennett SleepWizard Proprietary Name:
Sleep Disorders Data Recorder Common Name:
Classification Name: MNR, Ventilatory Effort Recorder, per 21 CFR 868.2375
3.0 Predicate Device Equivalence
We are claiming substantial equivalence to the Nellcor Puritan Bennett SANDMAN, cleared for commercial distribution per K934599 and K943673.
4.0 Device Description
The system is set up by the clinician using the computer, which is connected to the Data Collector by a cable connecting to the RS232 port, or by a modem. The computer is optically isolated from the Data Collector by circuitry on the Power Board. The patient is prepared for the sleep study as described in the Clinician's Guide and Patient's Guide (Attachments 1 and 3, respectively). A Ground Electrode is connected to the Data Collector and the patient to ensure that the signals collected all are at the same ground potential. Various sensors are connected to the patient and either directly to the Data Collector or to the Extension Box which in rurn is connected to the Data Collector.
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During the study itself, physiologic signals are detected by the sensors. Except for the pulse oximeter, these signals are then amplified by amplifiers. Each amplifier is designed so that it dedicated to a specific sensor so that all signals are at +3 volts after amplification. The signals are then sent to the Deta Collector, where they are stored and periodically written on the Flashcard. If the Data Collector and computer are both connected to modems, the clinician can view the computer screen while it is being collected from the patient.
At the conclusion of data collection (i.e., at the end of the sleep study) the Plashcard is removed from the Data Collector and inserted into the computer so that the data may be processed and printed out for analysis purposes.
ર્ડ.0 Intended Use
The SleepWitard is intended for use in collecting and displaying physiological data to be used in diagnosing sleep disorders such as obstructive sleep apnea in patients weighing over 20 kg in a clinical or home environment.
Comparison of Technological Characteristics 6.0
The device has the same technological characteristics as the predicate device, except that the SleepWizzed is battery powered and the SANDMAN is powered by AC Mains. This clearly raises no new concerns regarding safety and effectiveness as both technologies are well understood.
7.0 Summary of Performance Testing
Functional testing was performed to confirm that Sisep Wizard is capable of 7-1 meeting its stated performance specifications and that the device output is readable. SleepWizard passed all tests.
Testing was performed to confirm that SleepWizard complies with the 7.2 November 1993 draft "Reviewer Guidance for Promarket Notification Submissions" published by the Division of Cardiovascular, Respiratory, and Neurological Devices. Sleep Wizard passed all tests.
All software was tested in accordance with the August 29, 1991 "Reviewers 7.3 Guidance for Computer Controlled Medical Devices Undergoing 510(k)Review" published by the Office of Device Evaluation. SleepWizard passed all tests.
No clinical studies were required to support a substantial equivalence 7.4 determination, except for connecting the device to a healthy person and running the system to verify that readable, appropriate signals were being generated.
8.0 Conclusions
We conclude that the SleepWizord meets its stated performance specifications and criteria outlined in the Roviewers Guidance publications referenced above. We conclude that the SleepWizard will operate safely in its intended environment and be effective in fulfilling its intended use.
§ 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).