(88 days)
Not Found
No
The document describes "automatic analysis" but does not explicitly mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is described as a software program intended as an aid for diagnosis, analysis, and report generation of sleep and respiratory disorders. It processes information from monitoring devices, but does not provide treatments or therapies itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Somnolyzer 24X7 is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders."
Yes
The device is explicitly described as a "computer program (software)" and a "software system" that processes data received from external monitoring devices. It does not include any hardware components itself.
Based on the provided information, the Somnolyzer 24X7 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Somnolyzer 24X7's function: The description clearly states that Somnolyzer 24X7 processes information recorded during sleep by electrodes and sensors attached to the body. This is a non-invasive method of data collection from the body's physiological signals, not the analysis of samples taken from the body.
- Intended Use: The intended use is to aid in the diagnosis of sleep and respiratory disorders by analyzing data from monitoring devices. This aligns with the analysis of physiological signals, not in vitro samples.
Therefore, the Somnolyzer 24X7 falls under the category of a medical device that analyzes physiological data, not an in vitro diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
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.
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
under the supervision of a physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
© 2008 The Siesta Group
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: (443) 944-8189 Facsimile: (443) 944-8191
Contact Person:
Zvi Ladin, PhD. Principal Boston MedTech Advisors, Inc. 990 Washington Street Suite #204 Dedham, MA 02026 Telephone: (781) 407 0900 x104 Facsimile: (781) 407 0901 Email: zladin@bmtadvisors.com
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
1
© 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.
2
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.
3
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 (240) 276-0120. 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 (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. 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
4
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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