The Morpheus Ox Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid in the detection of Chevne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI), in a Cardiac patient population that is suspected of having Sleep Disordered Breathing (SDB). The Morpheus Ox System is intended to be used for analysis, display, redisplay (retrieve), reports generation and networking of physiological data received from an oximeter device. It does not perform automatic classification of respiratory events as central or obstructive. This system is to be used under the supervision of a physician.

Morpheus Ox displays heart rate, saturation and photoplethysmograph signals, acquired from an oximeter device. Morpheus Ox may also display signals including: EtCO2, Respiratory impedance, Plethysmograph Derived Respiratory (PDR) calculated signal, Activity, ECG, EEG, P flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, IPAP.

Device Description

The Morpheus Ox System is designed to process the raw signal data acquired by an oximeter 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 oximeter device include the following:

o Saturation
o Photoplethysmograph signal

Scoring analysis and display includes:

O Cheyne-Stokes Respiration (CSR)
0 Apnea/Hypopnea Index (AHI)
o Display of acquired signals such as EtCO2, Respiratory impedance, Photoplethysmograph Derived Respiratory (PDR) calculated signal, ECG, EEG, P flow, T flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, IPAP, and Heart rate.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Morpheus Ox Automated Sleep Study Scoring and Data Management System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity values) that the device must meet. Instead, the "Performance Testing" section broadly states that the study was conducted "to validate the accuracy of the Morpheus Ox System against both a gold-standard PSG and predicate device."

Therefore, I will present the reported device performance as described in the "Substantial Equivalence" section, where it highlights its capabilities in relation to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Aid in diagnosing sleep-related breathing disorders	The Morpheus Ox System is intended for use as an aid in diagnosing sleep-related breathing disorders, similar to cleared predicate devices.
Aid in detection of Cheyne-Stokes Respiration (CSR)	The Morpheus Ox System is indicated to aid in the detection of Cheyne-Stokes Respiration (CSR). This is noted as being similar to ApneaLink and SOMNOscreen devices, which also provide CSR information.
Estimation of Apnea Hypopnea Index (AHI)	The Morpheus Ox System is indicated to estimate Apnea Hypopnea Index (AHI). This is noted as being similar to SOMNOscreen, Noga System, and ARES devices, which also calculate AHI.
Processing and analysis of raw signal data from an oximeter	Like the Noga System, the Morpheus Ox System processes raw signal data from an oximeter device, analyzes signals, obtains study results, generates reports, and displays data on a PC using Internet Explorer. This demonstrates its capability in handling the defined data processing pipeline.
Display of additional physiological signals from an oximeter	The Morpheus Ox System is indicated to display heart rate, saturation, and photoplethysmograph signals, as well as other signals like EtCO2, Respiratory impedance, PDR, Activity, ECG, EEG, P flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, and IPAP, consistent with information provided by cleared predicates.
Functionality as a software-only program	The device functions as a software-only program used in conjunction with a cleared pulse oximeter, and its core software components and architecture are substantially equivalent to the Noga System.
Used in a Cardiac patient population suspected of SDB	The system's specific application to a cardiac patient population suspected of Sleep Disordered Breathing is an intended use, which the "Performance Testing" aimed to validate. The text does not provide specific performance metrics for this population but states the clinical study validated accuracy against gold-standard PSG and predicate.

Study Details

The provided text describes a clinical study conducted for performance validation.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). It only mentions "a clinical study was conducted."
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not specified in the provided text.
Adjudication Method for the Test Set:
- Not specified in the provided text.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study is not explicitly mentioned. The study is described as validating the accuracy of the device "against both a gold-standard PSG and predicate device," implying a standalone or comparative study of the device, not an assessment of human readers with vs. without AI assistance.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment of the algorithm appears to have been conducted. The text states: "...a clinical study was conducted to validate the accuracy of the Morpheus Ox System against both a gold-standard PSG and predicate device." This refers to evaluating the Morpheus Ox System (the algorithm/software) directly.
The Type of Ground Truth Used:
- The primary ground truth used was "a gold-standard PSG" (Polysomnography). The text states: "...a clinical study was conducted to validate the accuracy of the Morpheus Ox System against both a gold-standard PSG and predicate device." Polysomnography is generally considered the gold standard for diagnosing sleep disorders.
Sample Size for the Training Set:
- Not specified in the provided text. The text mentions "The Morpheus Ox software program is based on the Noga software program with the changes required to support its intended use and indications for use from the analysis of a different set of signals." This might imply that some underlying training or development was based on data used for the Noga system, but no specific training set size for Morpheus Ox is given.
How the Ground Truth for the Training Set was Established:
- Not specified in the provided text. Given that Morpheus Ox is based on the Noga system, the ground truth for the Noga system's training would likely have involved expert-scored PSG recordings, but this is not explicitly stated for Morpheus Ox's development.

Summary

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510(k) SUMMARY

510(k) Number K_l |3 | 4

5.1 Applicant's Name:	WideMed LTD10, Ha'sadnaot st.Herzliya 46733, IsraelTel: +972 9 951 4159Fax: +972 9 951 4158
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5.2 Contact Person: John Smith, M.D., J.D. Hogan Lovells US LLP Columbia Square 555 Thirteenth Street. NW Washington, DC 20004 T +1 202 637 5600 F +1 202 637 5910 www.hoganlovells.com

5.3 Date Prepared: May 4, 2011

5.4 Trade Name:	Morpheus Ox Automated Sleep StudyScoring and Data Management System
5.5 Classification Name:	Ventilatory Effort Recorder / BreathingFrequency Monitor

5.6 Medical Specialty: Anesthesiology
5.7 Product Code: Ventilatory Effort Recorder, MNR
5.8 Device Class: Class II
રું. તે જે Regulation Number: 21 C.F.R. §868.2375
5.10 Panel: Anesthesiology

5.11 Predicate Devices:

l . The Noga Automated Sleep Study Scoring and Data Management System (WideMed, Ltd.), cleared under K070326
1. Apnealink (Resmed, Germany) cleared under K070263
1. ARES (Advanced Brain Monitoring, Inc, USA) cleared under K071230
Somnomedics SOMNOscreen (Somnomedics GMBH & Company KG.); 4. cleared under K060708

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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
1. ISO 14971-1, Application of risk management to medical devices, 2007.

5.13 Intended Use / Indication for Use:

5.14 Device Description:

Signals from the oximeter device include the following:

o Saturation
o Photoplethysmograph signal

Scoring analysis and display includes:

O Cheyne-Stokes Respiration (CSR)
0 Apnea/Hypopnea Index (AHI)
o Display of acquired signals such as EtCO2, Respiratory impedance, Photoplethysmograph Derived Respiratory (PDR) calculated signal,

ﺗﻤﻤ

()

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ECG, EEG, P flow, T flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, IPAP, and Heart rate.

5.15 Substantial Equivalence:

Intended Use

ో

Like the cleared predicate devices, the Morpheus Ox System is intended for use as an aid in diagnosing sleep related breathing disorders. Accordingly, the device meets its first requirement of substantial equivalence.

Additionally, the Morpheus Ox System is further indicated to aid in the detection of Cheyne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI). Likewise, the ApneaLink and SOMNOscreen devices provide CSR information, and the SOMNOscreen, Noga System and ARES device calculate the AHI. This information may be used to assist physicians in the diagnosis of sleep related breathing disorders. The Morpheus Ox System is further indicated to display other information obtained from the connected photoplethysmograph system, consistent with information provided by the cleared predicates.

The use of Morpheus Ox System in cardiac patients exclusively to provide information to assist in diagnosis of sleep related breathing disorders, and especially in the detection of CSR and estimation of AHI, does not alter the intended diagnostic effect of the device, namely the provision of information that can be used to assist in diagnosis of such disorders.

Technological Characteristics

Like the cleared Noga System, the Morpheus Ox System is a software-only program that is used in conjunction with a cleared pulse oximeter device. Both devices process the raw signal data acquired by a pulse oximeter system in standard medical format, analyze the signals, 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. The Morpheus Ox software program is based on the Noga software program with the changes required to support its intended use and indications for use from the analysis of a different set of signals. The core software components and architecture are substantially equivalent.

Performance Testing

Software verification and validation testing was conducted to evaluate the performance of the Morpheus Ox System and to verify that it performs according to its specifications described in the Software Requirements Specifications (SRS). In addition, a clinical study was conducted to validate the accuracy of the Morpheus Ox System against both a gold-standard PSG and predicate device.

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Summary

Based on the performance testing results, including software verification and validation process and the analysis of the similarities and differences, the Morpheus Ox System is substantially equivalent to its predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Deganit Barak-Shinar C/O Dr. John Smith Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004

AUG 31 2011

Re: K111314

Trade/Device Name: Morpheus Ox 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: August 17, 2011 Received: August 17, 2011

. Dear Dr. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Smith

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809 htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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): _ _ _ _ ____________________________________________________________________________________________________________________________________________

Device Name: Morpheus Ox Automated Sleep Study Scoring and Data Management System

Indications for Use:

The Morpheus Ox Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid in the detection of Cheyne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI), in a Cardiac patient population that is suspected of having Sleep Disordered Breathing (SDB). The Morpheus Ox System is intended to be used for analysis, display, redisplay (retrieve), reports generation and networking of physiological data received from an oximeter device. It does not perform automatic classification of respiratory events as central or obstructive. This system is to be used under the supervision of a physician.

Prescription Use	√
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K 113

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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).