NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM

K070326 · Widemed, Ltd. · MNR · May 5, 2007 · Anesthesiology

Device Facts

• Record ID: K070326
• Device Name: NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
• Applicant: Widemed, Ltd.
• Product Code: MNR · Anesthesiology
• Decision Date: May 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Noga Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of respiratory related sleep disorders. The Noga System is intended to be used for analysis, display, redisplay (retrieve), summarize, reports generation and networking of physiological data received from a physiological activity monitoring device. Physiological data includes: ECG, SpO2, EtCO2 and Impedance respiration. This system is to be used under the supervision of a physician.

Device Story

Noga System is a web-based software application for analyzing physiological data from third-party monitoring devices. Inputs include ECG, SpO2, EtCO2, and impedance respiration signals. Software converts raw data into a standard format, performs automated scoring of sleep stages (wake/sleep), detects respiratory events (apnea/hypopnea), and calculates Apnea/Hypopnea Index (AHI). System generates summary reports and displays data via standard web browser. Used in clinical settings under physician supervision to assist in diagnosing respiratory-related sleep disorders. Benefits include automated analysis and efficient data management, aiding clinical decision-making by providing objective sleep metrics.

Clinical Evidence

Clinical study validated Noga System accuracy against gold-standard PSG and Morpheus predicate. Primary endpoints included AHI calculation and respiratory event detection. Results showed high AHI correlation across devices. For AHI ≥15 cutoff, Noga demonstrated 100% sensitivity and 92.7% specificity vs. gold-standard, and 92.8% sensitivity and 94.8% specificity vs. Morpheus predicate.

Technological Characteristics

Web-based software program. Processes third-party physiological signals (ECG, SpO2, EtCO2, Impedance). Architecture based on Morpheus software with modular layering for maintenance. Operates on standard personal computers via Internet Explorer. Complies with IEC 60601-1-4 (programmable medical systems) and ISO 14971 (risk management).

Indications for Use

Indicated for use as an aid in the diagnosis of respiratory-related sleep disorders in patients undergoing physiological monitoring. To be used under physician supervision.

Regulatory Classification

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.

Predicate Devices

• Morpheus M 1 (K022506)
• Silent Night V (K000253)
• ALICE-5 PSG (K040595)

Submission Summary (Full Text)

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# 510(K) SUMMARY

# 510(K) Number K_K070326

MAY 2 5 2007

# 5.1 Applicant's Name: WideMed LTD 10, ha'sadnaot st. Herzliya 46733, Israel Tel: [phone] Fax: [phone]

5.2 Contact Person:

Dorit Winitz, Ph.D. Biomedical Strategy (2004) Ltd. 7 Jabotinsky Street. Ramat Gan 52520, Israel Tel: [phone] Fax: [phone] Mail: [e-mail]

5.3 Date Prepared: January 2007

5.4 Trade Name:

Noga Automated Sleep Study Scoring and Data Management System

5.5 Classification Name: Ventilatory Effort Recorder / Breathing Frequency Monitor

5.6 Medical Specialty: Anesthesiology

5.7 Product Code: Ventilatory Effort Recorder, MNR.

5.8 Device Class: Class II

5.9 Regulation Number: 868.2375

5.10 Panel: Anesthesiology

#### 5.11 Predicate Device:

- 1. The Morpheus M 1 (WideMed, Ltd.), cleared under K022506.
- 2. The Silent Night V (Sleep Solutions, Inc.), cleared under K000253.
- 3. Gold standard PSG manual scoring (e.g., manual scoring of ALICE-5 PSG, cleared under K040595)

5-3

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# 5.15 Substantial Equivalence:

# Intended Use

With regard to its intended use, the Noga System is substantially equivalent to the combination of its predicate devices, all enable an automatic analysis of physiological acquired signals and are intended for providing information on sleep disordered breathing (SDB) for use as an aid for the diagnosis of respiratory related sleep disorders.

# Technological Characteristics and Mode of Operation

Similarly to Morpheus, the Noga System is a computer program analyzing third party's physiological input signals. Both devices convert these raw data signals from their respective recorder device [PSG (Morpheus) or physiological activity monitoring device (Noga)} into WideMed standard format prior to analysis.

The Noga software program is based on the Morpheus software program with the changes required to support the analysis of limited set of signals. The core software components and architecture are substantially equivalent, while minor differences include changes in modularity and layering that do not have a functional consequence, but were implemented to enhance software maintenance and reliability.

# Performance Testing

Software verification and validation testing was conducted to evaluate the performance of the Noga System and to verify that it performs according to its specifications described in the Software Requirements Specifications (SRS).

A clinical study was conducted to validate the accuracy of the Noga System to detect respiratory related sleep disorders against both a gold-standard PSG and the Morpheus predicate device. The number of respiratory events and the total sleep time as measured by the Noga System with regard to the gold-standard result in an accurate representation of AHI. Statistical analysis of the test results indicated high correlation of AHI across devices. Further analysis indicated that the sensitivity of Noga for a cutoff of AHI ≥15 is 100% and specificity is 92.7% when compared to gold-standard, and 92.8% sensitivity and 94.8% specificity when compared to the Morpheus predicate.

#### Summary

Based on the performance testing results, including software verification and validation process and the analysis of the similarities and differences, WideMed Ltd believes that the Noga System is substantially equivalent to its predicates without raising new issues of safety or effectiveness.

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# 5.12 Performance Standards:

- 1. IEC 60601-1-4 + A1, Medical electrical equipment Part 1: General requirements for safety 4. Collateral Standard: Programmable electrical medical systems, Edition 1.1, 2000-4
- 2, ISO 14971-1, Application of risk management to medical devices, 2000.

# 5.13 Intended Use / Indication for Use:

The Noga Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of respiratory related sleep disorders.

The Noga System is intended to be used for analysis, display, redisplay (retrieve), summarize, reports generation and networking of physiological data received from a physiological activity monitoring device.

Physiological data includes: ECG, SpO2, EtCO2 and Impedance respiration

This system is to be used under the supervision of a physician.

## 5.14 Device Description:

The Noga Automated Study Scoring and Data Management System (Noga System) is a Web-based computer program (software), intended for use as an aid to the diagnosis of respiratory-related sleep disorders.

The Noga System is designed to process the raw signal data acquired by a third party physiological activity monitoring device in standard medical download format, analyze them, obtain the study's analysis results, generate summary reports, and display the signals' data and reports on a personal computer, using a standard Internet Explorer Browser.

Signals from the physiological activity monitoring device include the following:

- 에 ECG
- Impedance respiration 하
- EtCO2 트
- I SpO2

Scoring Analysis includes:

- 트 Apnea/Hypopnea Index (AHI)
- 에 Sleep Staging (Sleep - Wake stages, and Total Sleep Time)
- Respiratory Events Detection (Apnea and Hypopnea)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WideMed Limited C/O Dorit Winitz, Ph. D. Regulatory Affairs Consultant BioMedical Strategy (2004) Limited 7 Jabotinsky Street Ramat-Gan 52520 ISRAEL

MAY 25 2007

Re: K070326

Trade/Device Name: Noga Automated Sleep Study Scoring and Data Management System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: April 30, 2007 Received: May 3, 2007

Dear Dr. Winitz:

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 - Dr. Winitz

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suite Y. Michaud MD

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

510(k) Number (if known):

K070326

Device Name: Noga Automated Sleep Study Scoring and Data Management System

Indications for Use:

The Noga Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of respiratory related sleep disorders.

The Noga System is intended to be used for analysis, display, redisplay (retrieve), summarize, reports generation and networking of physiological data received from a physiological activity monitoring device.

Physiological data includes: ECG, SpO2, EtCO2 and Impedance respiration.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

KO-703-26

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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C(k) Number: