(30 days)
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.
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.
The provided document is a 510(k) premarket notification for the SomnoStar Alpha Series Sleep System. It mainly focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information on specific acceptance criteria and a study proving those criteria.
However, based on the provided text, here's what can be inferred and what is explicitly stated:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific performance metrics. The primary claim is substantial equivalence to the SensorMedics 4000 Series Sleep System (K915856). The key difference mentioned is the inclusion of an optional bio-physical amplifier, the Cephalo Pro, which replaces either the AmpStar or Dynagraph II bio-physical amplifiers.
Reported Device Performance:
"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."
This implies that the performance of the new device (SomnoStar Alpha Series with Cephalo Pro) is considered to be the same as the predicate device (SensorMedics 4000 Series Sleep System). Therefore, the "reported device performance" is essentially that it functions equivalently to the established predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document explicitly states: "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." This means there was no new test set generated for this 510(k) submission. The equivalence relies on the established performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no new test set was generated or evaluated. The ground truth would have been established for the predicate device, but details are not provided here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new test set was generated or evaluated.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a sleep analysis system, not an AI-assisted diagnostic tool for human readers in the context of an MRMC study. It collects and assists in analyzing physiological data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the device's ability to collect and display data, and "assisting the user in performing analysis of sleep data." The device itself is a "Sleep Analysis System." The claim of "no performance differences" implies that its standalone function (data collection, analysis assistance, reporting) is equivalent to the predicate device. However, a dedicated standalone study proving this for the new iteration is stated as not performed since the change was a component swap with no performance impact.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the predicate device, the implied "ground truth" would likely involve expert consensus among sleep specialists (polysomnographers) for the proper staging and scoring of sleep data, validated by clinical use and potentially comparisons to established sleep disorder diagnoses. However, for this 510(k), no new ground truth was established as no new tests were performed.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven device in the sense of needing a "training set" for an algorithm to learn from data. It's a system for collecting and analyzing pre-defined physiological signals.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device.
{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) |
§ 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).