The DeVilbiss Sleep Recorder is intended for screening patients suspected of or exhibitina symptoms of sleep disorders. The DeVilbiss Sleep Recorder can be used with an autotitrating CPAP to record the results of CPAP treatment for adults diagnosed with sleep apnea syndrome. Patients suffering from excessive daytime sleepiness should be referred to a sleep disorder specialist. The results of an unattended screening are insufficient to identify all possible medical disorders that may produce these symptoms. This device is intended to aid the physician in diagnosing adult sleep apnea. A qualified medical professional should score the device's recorded signals to determine respiratory events.

Device Description

The DeVilbiss Sleep Recorder consists of a main control box, a chest mounted interface box and several sensors mounted to the patient. The main control box contains a Novametrix oximeter board, the microcontroller and memory board, four AA battery compartment and connectors for external devices. The main control box is intended to be placed on a night stand or near the patient's bed. A chest mounted interface box containing body position sensors and connections for a nasal thermistor, a nasal cannula, snore microphone and three ECG leads is attached to the patient. The sensors used for a standard diagnostic recording are: 1. ECG leads (3) 2. Snore Microphone 3. Nasal Thermistor or Nasal Cannula 4. Oximeter Probe 5. Body Position sensor (inside chest box)

AI/ML Overview

Here's an analysis of the provided text regarding the DeVilbiss Sleep Recorder (K012437) in relation to acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, explicit quantitative acceptance criteria for device performance are not detailed. The summary states the device's performance tests and clinical trials demonstrated "substantial equivalence to the predicate devices based on types of sensors, battery operation, real time monitoring, presentation and analysis of the recorded data and intended use." It also mentions "tests confirming accuracy of the recorded data to the product specifications and the conformance to electrical standards applied for a Class II Type CF device."

Without specific numerical targets for accuracy, sensitivity, specificity, or agreement with a reference standard, a table of "acceptance criteria" versus "reported performance" cannot be fully constructed.

However, the reported demonstration of performance is that the device achieved substantial equivalence to its predicate devices (Bio-Logic Sleep Scan K962103 and Nellcor Puritan Bennett (Melville) Ltd. Sandman Sleep Data Storage System K934599) through performance tests and clinical trials. This substantial equivalence is the de facto "acceptance" based on the FDA's 510(k) pathway.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated. The document refers to "performance tests and clinical trials" without specifying the number of participants or cases involved in these studies.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies are referred to generally as "performance tests and clinical trials." Given the submission is to the US FDA, it is highly probable the data was generated or is applicable to the US market, but no specific geographic origin is provided.
Retrospective or Prospective: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document states: "A qualified medical professional should score the device's recorded signals to determine respiratory events." and "The information in the study is hand scored for respiratory events and used by a healthcare professional to determine if CPAP treatment is a preferred approach."
Number of Experts: Not specified.
Qualifications of Experts: "Qualified medical professional" and "healthcare professional." Specific qualifications (e.g., "radiologist with 10 years of experience" or "board-certified sleep physician") are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified. The phrase "hand scored for respiratory events" does not indicate any specific adjudication process if multiple scorers were involved.

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:

MRMC Study: No. This device is an ambulatory sleep recorder that collects physiological signals. The analysis is "performed on one or more channels to determine SpO2 desaturations, heart rate shifts and Pulse Transit Time (PTT) shifts." There is no mention of "AI assistance" or comparative effectiveness studies involving human readers improving with or without AI. The device functions as a data collection tool, and a human scorer interprets its output.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Study: The device is not intended for standalone diagnosis. The document explicitly states: "The information in the study is hand scored for respiratory events and used by a healthcare professional to determine if CPAP treatment is a preferred approach." and "A qualified medical professional should score the device's recorded signals to determine respiratory events." This signifies a human-in-the-loop process is mandatory for diagnosis. The device is a "portable recording system" that aids the physician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: The ground truth for determining "respiratory events" is effectively expert scoring/interpretation by "a qualified medical professional" or "healthcare professional" based on the recorded signals. This is implicit in the statements regarding hand scoring and professional interpretation. There is no mention of a more objective ground truth like pathology or long-term outcomes data for direct correlation with the device's signal detection.

8. The sample size for the training set:

Training Set Sample Size: Not applicable/not stated. As described, this device is a physiological signal recorder. There is no mention of a machine learning or AI component that would require a distinct "training set" in the context of supervised learning algorithms. The device's "performance tests and clinical trials" would typically focus on the accuracy of its measurements against established standards or predicate devices, rather than training a diagnostic algorithm.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable, as there's no evident training set for an AI/ML algorithm within the device description. The device's function is to record physiological data accurately. The "ground truth" for its validation would be the accuracy of these recorded signals against known benchmarks or the predicate device's signals, not a diagnostic classification that would typically be trained.

Summary

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K012437

UUL 1 6 2002

DeVilbiss Sleep Recorder 510(k) Summary

	Page 1 of 2
Submitter's Name:	Sunrise Medical HHG Inc.Respiratory Products Division100 DeVilbiss DriveSomerset, PA 15501-0635
Contact Person:	James P. Froehlich(814) 443-7692
Date Prepared:	July 5, 2001
Trade or Proprietary Name:	DeVilbiss Sleep Recorder
Common or Usual Name:	Ambulatory sleep recorder
DeVilbiss Model Number:	RM60
Establishment Registration Number:	DeVilbiss # 2515872
Device Class:	Class II
Classification Name:	Ventilatory Effort Recorder CFR # 868.2375MNR
Legally Marketed Predicate Device:	510(k) Registration #
Bio-Logic Sleep Scan	K962103
Nellcor Puritan Bennett (Melville) Ltd. Sandman Sleep Data Storage System	K934599

Description of Device:

1. ECG leads (3)
1. Snore Microphone
1. Nasal Thermistor or Nasal Cannula
1. Oximeter Probe
1. Body Position sensor (inside chest box)

A patient is fitted with the ECG leads for proper placement by a healthcare professional. The snoring channel is adjusted for optimum sensitivity while monitoring the patient then takes the DeVilbiss Sleep Recorder home and connects the chest box and oximeter probe to the main control box before going to bed. The recording duration is 8 hours max, unless the batteries are low. The DeVilbiss Sleep Recorder will stop recording early if necessary to conserve enough battery energy to download the recorded data.

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DeVilbiss Sleep Recorder 510(k) Summary

Page 2 of 2

After the DeVilbiss Sleep Recorder data is downloaded to a PC, analysis is performed on one or more channels to determine SpO2 desaturations, heart rate shifts and Pulse Transit Time (PTT) shifts. The information in the study is hand scored for respiratory events and used by a healthcare professional to determine if CPAP treatment is a preferred approach.

Statement of Intended Use:

The DeVilbiss Sleep Recorder is a portable recording system for recording of adult sleep parameters. The basic model records oxygen saturation, airflow, chest impedance, patient body position and snoring. Pulse Transit Time (PTT) and heart rate are available as optional channels. The intended environment for use of the device is in the patient's home or within an institutional setting on the order of a physician. This device is intended to aid the physician in diagnosing adult sleep apnea. A qualified medical professional should score the device's recorded signals to determine respiratory events. The DeVilbiss Sleep Recorder or any of its components should not be used as a life support device, life support system, or as a critical component of a life support device or life support system.

General Theory of Operation:

The DeVilbiss Sleep Recorder consists of a battery powered data collection unit with sensors that monitor physiological signals. The data collection unit is connected to the sensors via a small case (chest box) that is held on the patient's chest by an elastic belt. The chest box contains a 5 position sensor for body position information, three high impedance ECG electrode inputs, an input for a snore sensor, an input for a nasal thermistor and a fitting for attaching a nasal cannula. The sensors are fitted to a patient by a medical professional and the signals are verified. Two ECG electrodes are placed on opposite sides of the chest, just below the sternum. A reference electrode is placed on the lower abdomen. The ECG leads are color coded for correct connection to the chest box. The snore sensor is attached by an adhesive ring to the side of the neck. The nasal thermistor is positioned on the upper lip, with one element located at each nostril and one extending toward the mouth. A nasal air flow signal can be obtained using a nasal cannula instead of the thermistor. A switch on the chest box selects between thermistor or cannula for the airflow signal.

Conclusion:

The performance tests and clinical trials completed on the DeVilbiss Sleep Recorder demonstrate substantial equivalence to the predicate devices based on types of sensors, battery operation, real time monitoring, presentation and analysis of the recorded data and intended use. The safety and effectiveness is demonstrated by the tests confirming accuracy of the recorded data to the product specifications and the conformance to electrical standards applied for a Class II Type CF device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

IJUL 1 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jim Froehlich Senior Project Engineer Sunrise Medical HHG, Incorporated Respiratory Products Division 100 DeVilbiss Drive Somerset, Pennsylvania 15501-0635

Re: K012437

Trade/Device Name: DeVilbiss Sleep Recorder, Model RM60 Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: April 19, 2002 Received: April 22, 2002

Dear Mr. Froehlich:

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 vour 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 statutes and regulations administered by other Federal agencies.

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Page 2 -- Mr. Jim Froehlich

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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

Time 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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17.0 DeVilbiss Sleep Recorder Indications for Use Statement

Page 1 of 1

1012437 510(k) Number (if known) : Not known

Device Name: DeVilbiss Sleep Recorder

Indications for Use

Contraindications

The DeVilbiss Sleep Recorder or any of its components should not be used as a life support device, life support system, or as a critical component of a life support device or life support system.

Lillatras

(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices 510(k) Number .

Regulation Number and Section

§ 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).