(289 days)
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.
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 document primarily focuses on the FDA 510(k) clearance for the Morpheus™ 1 Automated Sleep Study Scoring and Data Management System, establishing its substantial equivalence to a predicate device. It does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested table and study description based on the provided text. The document is an FDA letter and a declaration of indications for use, not a clinical study report.
{0}------------------------------------------------
MAY 1 5 2003
Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be rotated. The text includes a combination of letters and numbers, with the sequence 'KOZZ' visible, followed by '22506'. The handwriting is in black ink against a white background, and the overall impression is that of a note or label.
Image /page/0/Picture/2 description: The image shows the text "510(k) Summary:". The text is in a bold, sans-serif font. The text is left-aligned and appears to be the beginning of a document or section heading. The text is black on a white background.
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: +972-8-690-9488. +972-8-690-9489 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.
{1}------------------------------------------------
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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract image of an eagle.
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.
{3}------------------------------------------------
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 (301) 594-4646. 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 (301) 443-6597 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
{4}------------------------------------------------
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. |
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
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
§ 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).