(89 days)
Not Found
No
The summary describes automated scoring and analysis based on physiological data, but does not mention AI, ML, or any related concepts like training sets or complex algorithms typically associated with AI/ML in this context.
No
The Noga System is a diagnostic aid, processing data from physiological monitoring devices to assist in the diagnosis of respiratory-related sleep disorders. It does not provide any treatment or therapy.
Yes
The device explicitly states its intended use is "as an aid for the diagnosis of respiratory related sleep disorders" and "as an aid to the diagnosis of respiratory-related sleep disorders."
Yes
The device is explicitly described as a "computer program (software)" and a "Web-based computer program (software)" that processes data acquired by a separate third-party physiological monitoring device. It does not include or rely on any specific hardware component for its primary function beyond a standard computer and internet browser.
Based on the provided information, the Noga Automated Sleep Study Scoring and Data Management System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Noga System processes physiological data (ECG, SpO2, EtCO2, Impedance respiration) acquired directly from a physiological activity monitoring device connected to the patient. It does not analyze biological samples like blood, urine, or tissue.
- The intended use and device description clearly state it processes physiological data. The focus is on analyzing signals from the body, not on testing samples taken from the body.
Therefore, while it is a medical device used in the diagnosis of respiratory-related sleep disorders, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MNR
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:
- ECG
- Impedance respiration
- EtCO2
- SpO2
Scoring Analysis includes:
- Apnea/Hypopnea Index (AHI)
- Sleep Staging (Sleep - Wake stages, and Total Sleep Time)
- Respiratory Events Detection (Apnea and Hypopnea)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This system is to be used under the supervision of a physician.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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
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: +972 9 951 4159 Fax: +972 9 951 4158
5.2 Contact Person:
Dorit Winitz, Ph.D. Biomedical Strategy (2004) Ltd. 7 Jabotinsky Street. Ramat Gan 52520, Israel Tel: +972-3- 6123281 Fax: +972-3-6123282 Mail: dorit@ebms.co.il
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:
-
- The Morpheus M 1 (WideMed, Ltd.), cleared under K022506.
-
- The Silent Night V (Sleep Solutions, Inc.), cleared under K000253.
-
- Gold standard PSG manual scoring (e.g., manual scoring of ALICE-5 PSG, cleared under K040595)
5-3
1
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.
2
5.12 Performance Standards:
-
- 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)
3
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.
4
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 (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 (240) 276-3150 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
5
INDICATIONS FOR USE
510(k) Number (if known):
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)
Page 1 of 1
ign-Off) Acting Chist
sion of Anesthesiology, General Hospital,
icon Control, Dental Devices
C(k) Number: