SOMNOLYZER 24X7

K083620 · The Siesta Group North America · MNR · Mar 6, 2009 · Anesthesiology

Device Facts

• Record ID: K083620
• Device Name: SOMNOLYZER 24X7
• Applicant: The Siesta Group North America
• Product Code: MNR · Anesthesiology
• Decision Date: Mar 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Somnolyzer 24X7 is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders. Somnolyzer 24X7 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.

Device Story

Somnolyzer 24X7 is a software system for automated analysis of sleep studies. It ingests physiological data recorded by electrodes and sensors (sleep, respiratory, and movement signals). The software performs automatic scoring of these signals, allowing for manual rescoring, data display, retrieval, summarization, and report generation. Used in clinical settings under physician supervision, the system assists clinicians in evaluating sleep and respiratory-related disorders by providing quantitative parameters. The output facilitates clinical decision-making by streamlining the analysis of complex sleep study data.

Clinical Evidence

Clinical performance testing was conducted to validate the system's automated scoring capabilities. No specific sensitivity, specificity, or AUC metrics were provided in the summary document.

Technological Characteristics

Software-based system for automated analysis of physiological signals (sleep, respiratory, movement). Processes data from external electrodes and sensors. Generates quantitative reports for clinical evaluation. Operates as a networked software application.

Indications for Use

Indicated for use as an aid in the diagnosis of sleep and respiratory disorders in patients undergoing sleep studies. 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 TM 1, Automated Sleep Study Scoring and Data System (K022506)

Submission Summary (Full Text)

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© 2008 The Siesta Group

K083620

#### 6 2009 MAR

#### 510 (k) SUMMARY

#### The Siesta Group Somnolyzer® 24X7

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Applicant:

The Siesta Group North America, Inc. 5475 Airport Terminal Road Salisbury, MD 21804 Telephone: [phone] Facsimile: [phone]

Contact Person:

Zvi Ladin, PhD. Principal Boston MedTech Advisors, Inc. 990 Washington Street Suite #204 Dedham, MA 02026 Telephone: [phone] x104 Facsimile: [phone] Email: [e-mail]

Date Prepared:

#### December 4, 2008

# Name of Device and Name/Address of Sponsor

Trade/Proprietary Name: Somnolyzer® 24X7 Common Name: Sleep Analysis System

| Classification Name: | Ventilatory Effort Recorder |
|-----------------------|-----------------------------------------------|
| Classification Panel: | Anesthesiology and Respiratory Devices Branch |
| C.F.R. Section: | 21 C.F.R. § 868.2375 |

Manufacturing Facility:

The Siesta Group, GmbH Schlosshoferstrasse 11/3 Vienna 1210 Austria

#### Predicate Devices

Morpheus TM 1, Automated Sleep Study Scoring and Data System by Widemed, Ltd. cleared under 510(k) #K022506.

The Siesta Group - Somnolyzer 24x7 510(k) Submission Section 6 - 510 (k) Summary

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# © 2008 The Siesta Group

#### Intended Use / Indications for Use

Somnolyzer 24X7 is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

Somnolyzer 24X7 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.

### Technological Characteristics

Somnolyzer 24X7 is a software system for automatic analysis of sleep, respiratory and movement information recorded during sleep studies. It processes information recorded during sleep by electrodes and sensors attached to the body. It generates reports that include quantitative sleep, breathing and motion parameters, used to evaluate sleep and respiratory-related disorders.

#### Performance Data

Clinical performance testing was conducted.

## Substantial Equivalence

Somnolyzer 24X7 has the same intended use and indications for use, principles of operation and performance characteristics as the predicate device and is therefore substantially equivalent to the predicate device.

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Image /page/2/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

& 2009 MAR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Siesta Group North America Incorporated C/o Zvi Ladin, Ph.D Principal Boston MedTech Advisors, Incorporated 990 Washington Street, Suite 204 Dedham, Massachusetts 02026

Re: K083620

> Trade/Device Name: Somnolyzer® 24X7 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: December 5, 2009 Received: December 8, 2009

Dear Dr. Ladin:

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. Ladin

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Michaels, M.D.

Ginette Y. Michaud. M.D. Acting 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:

Somnolyzer® 24X7

Indications For Use:

Somnolyzer 24X7 is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

Somnolyzer 24X7 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.

Prescription Use X (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)

Susan Cunne

ﻧ ﺍﻟﺮﺍﺋﺮ . ﺍﻟﻘﺮﺁﻥ Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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