(30 days)
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No
The description mentions a "computer-assisted program" for data analysis, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on data collection, storage, and basic analysis according to pre-defined software programs.
No
The primary purpose of this device is to collect and analyze sleep data for diagnostic purposes, not to provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to assist the user in diagnosing patients with sleep disorders."
No
The device description explicitly states it receives input from "bio-physical amplifiers" and converts analog data to digital, indicating the presence of hardware components beyond just software.
Based on the provided information, the SomnoStar a Series Sleep System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The SomnoStar system collects physiological data from a sleeping patient (e.g., brain waves, heart rate, breathing). It doesn't analyze biological samples like blood, urine, or tissue.
- The intended use is to assist in diagnosing sleep disorders by collecting and analyzing physiological data. This is a function of a physiological monitoring and analysis system, not an IVD.
- The device description focuses on receiving input from biophysical amplifiers and processing that data. This aligns with physiological data acquisition and analysis.
Therefore, the SomnoStar a Series Sleep System falls under the category of a physiological monitoring and analysis device used to assist in the diagnosis of sleep disorders, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SomnoStar a Series Sleep System is intended to assist the user in diagnosing patients with sleep disorders by collecting physiological data from a sleeping patient, assisting the user in performing analysis of sleep data, and printing a hard-copy report of these data.
The SomnoStar a Series Sleep System is indicated for use to assist the user(s) In diagnosing patients with sloep disorders; by collecting physiological data from a sleeping patient, assisting the user(s) in performing analysis of sleep data and printing a hard copy of these data. The data is collected, staged and scored with a computerassisted program.
Product codes (comma separated list FDA assigned to the subject device)
OLV
Device Description
The SomnoStar a Sleep System receive Input from bio-physical amplifiers, analyze these data according to software programs designed for use on computer systems included in the system configuration and output data in the form of reports generated by the printer option to the systems. Various components of the systems can be designed into already-existing sleep laboratories. A more detailed description is contained in the Operator's Manual.
In use, the SomnoStar a Series Sleep System receives input from optional bloghysical amplifiers, up to 32 channels in each, which is converted from analog to digital data and stored in a computer storage medium.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SensorMedics SomnoStar a Series Sleep System is equivalent to the SensorMedios 4000 Series Sleep System distributed under 510(k) K915856. The primary difference is the inclusion of a different, optional bio-physical amplifier, the Cephalo Pro, to replace either the AmpStar or Dynagraph II blophysical amplifiers. Because there are no performance differences caused by using the Caphalo Pro, no additional clinical or non-clinical tests were performed or submitted in the premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for SensorMedics. The logo consists of two parts: a curved shape on the left and the word "SensorMedics" on the right. The curved shape is thick and black, and it partially surrounds the words "Thermo Respiratory Group" which are stacked on top of each other. The word "SensorMedics" is written in a bold, sans-serif font.
SomnoStar & Serles Sleep System - Summary of Safety and Effectiveness
Submitter:
SensorMedics Corporation 22705 Savl Ranch Parkway Yorba Linda, CA 92887 714-283-2228
Date Prepared: August 1, 2001
Contact: Earl Draper
Proprietary Name: SomnoStar a Series Sleep System
Common Name: Sleep Analysis System
Classification Name: Device. Sleep Assessment
Intended Use:
The SomnoStar a Series Sleep System is intended to assist the user in diagnosing patients with sleep disorders by collecting physiological data from a sleeping patient, assisting the user in performing analysis of sleep data, and printing a hard-copy report of these data.
Device Description:
The SomnoStar a Sleep System receive Input from bio-physical amplifiers, analyze these data according to software programs designed for use on computer systems included in the system configuration and output data in the form of reports generated by the printer option to the systems. Various components of the systems can be designed into already-existing sleep laboratories. A more detailed description is contained in the Operator's Manual.
Cilnical and Non-Clinical Tests of Equivalancy:
The SensorMedics SomnoStar a Series Sleep System is equivalent to the SensorMedios 4000 Series Sleep System distributed under 510(k) K915856. The primary difference is the inclusion of a different, optional bio-physical amplifier, the Cephalo Pro, to replace either the AmpStar or Dynagraph II blophysical amplifiers. Because there are no performance differences caused by using the Caphalo Pro, no additional clinical or non-clinical tests were performed or submitted in the premarket notification.
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cara . Modi . RV
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing strength and freedom. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", indicating the organization's name and country.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Larry Murdock Vice President of Marketing SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, California 92887
Re: K012085
Trade/Device Name: SomnoStar Alpha Series Sleep System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV Dated (Date on orig SE ltr): July 2, 2001 Received (Date on orig SE Itr): July 3, 2001
APA - y LUIL
Dear Mr. Murdock:
This letter corrects our substantially equivalent letter of August 2, 2001.
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.
2
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/CDRH0ffices/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.
M
I
I
Sincerely vours.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page_____ 이
510(k) Number (if known): K012085
Device Name: SomnoStar a (Alpha) Series Sleep System
Indications For Use:
The SomnoStar a Series Sleep System is indicated for use to assist the user(s) In diagnosing patients with sloep disorders; by collecting physiological data from a sleeping patient, assisting the user(s) in performing analysis of sleep data and printing a hard copy of these data. The data is collected, staged and scored with a computerassisted program.
In use, the SomnoStar a Series Sleep System receives input from optional bloghysical amplifiers, up to 32 channels in each, which is converted from analog to digital data and stored in a computer storage medium.
The SomnoStar a Series System is not intended to be used alone or in combination with another product as a life support device, a life support system, or as a critical component to a life support device or system. We do not claim compatibility with diagnostic imaging equipment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) Division of General, Restorative and Neurological Devices | ||
| 510(k) Number | K012085 | |
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) |