MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM

K022506 · Widemed, Ltd. · MNR · May 15, 2003 · Anesthesiology

Device Facts

• Record ID: K022506
• Device Name: MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
• Applicant: Widemed, Ltd.
• Product Code: MNR · Anesthesiology
• Decision Date: May 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Morpheus™ 1 Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders. The Morpheus™ 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. This device is to be used under the supervision of a physician.

Device Story

Morpheus™ 1 is a software-based system for processing data from sleep monitoring devices. It performs automated scoring of sleep studies, allows for manual re-scoring, displays and retrieves study data, generates reports, and supports data networking. Used in clinical settings under physician supervision, the system assists clinicians in evaluating sleep and respiratory-related disorders by streamlining data analysis and management. The output provides summarized diagnostic information to support clinical decision-making regarding patient sleep health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based system for data analysis, scoring, and reporting. Operates as a computer program for processing inputs from sleep monitoring hardware. Features include automated scoring algorithms, manual re-scoring interface, data display, report generation, and networking capabilities.

Indications for Use

Indicated for use as an aid in the diagnosis of sleep and respiratory disorders in patients undergoing sleep study 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

• Compumedics Sleep Monitoring System (K955841)

Submission Summary (Full Text)

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MAY 1 5 2003

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Morpheus™ 1, Automated Sleep Study Scoring and Data Management System

510(k) Number:

Company Name:

WideMed Ltd.

Contact Person: David Solomon, Ph.D., R&D Director

> Telephone: [phone]. [phone] Fax:

## Trade Name:

Morpheus™ 1, Automated Sleep Study Scoring and Data Management System.

Classification name: Breathing Frequency Monitor

Classification: MNR

## Predicate Device:

Compumedics Sleep Monitoring System, Compumedics Sleep Pty. Ltd, Australia cleared under 510(k) no. K955841.

## Indications for Use:

The Morpheus™ 1 Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

The Morpheus 100 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

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

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# Substantial Equivalence:

The Morpheus™ 1, Automated Sleep Study Scoring and Data Management
System has the same intended use and the same principle of operation as the Compumedics Sleep Monitoring System, cleared under 510(k) no. K955841 and is therefore substantially equivalent to that device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2003

Mr. David Solomon WideMed Limited Omer Industrial Park, Building 8c POB 3002 Omer 84965 ISRAEL

Re: K022506

Trade/Device Name: Morpheus™ 1 Automated Sleep Study Scoring and Data Management System Regulation Number: 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: II Product Code: MNR Dated: March 9, 2003 Received: March 14, 2003

Dear Mr. Solomon:

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.

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Page 2 – Mr. David Solomon

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 you 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/dsma/dsmamain.html

Sincerely yours,

Patricio Curciffa

Susan Runner, DDS, MA Interim 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): | K022506 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Morpheus ^™ 1, Automated Sleep Study Scoring and Data Management System |
| Indications for Use: | The Morpheus ^™ 1 Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders. |
| | The Morpheus ^™ 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. |
| | This device is to be used under the supervision of a physician. |

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Concurrence of CDRH, Office of Device Evaluation (ODE):

signature

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

510(k) Number: K022506

Prescription Use
(Per 21 CFR 801.109)
OR

Over the Counter Use