(245 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on recording, displaying, and printing physiological data without mentioning any analytical or interpretive functions that would typically involve AI/ML.
No
The device is intended to record, display, and print physiological information for diagnostic purposes, not to treat or cure a disease or condition.
Yes
Explanation: The device is intended to record and display physiological information to clinicians/physicians for the documentation of sleep or other physiological disorders, which implies a diagnostic purpose.
No
The device description explicitly states it is a "totally digital recorder utilizing 16 channels of input Gata" and is available in "ambulatory as well as desktop configurations," indicating it includes hardware components for data acquisition.
Based on the provided information, this device 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. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The description clearly states that the Embla system records, displays, and prints physiological information like EEG. This involves measuring electrical activity and other physical signals directly from the patient's body, not analyzing samples taken from the body.
- Intended Use: The intended use is to document various sleep or other physiological disorders by recording these in-vivo signals.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic tests.
Therefore, the Embla polysomnographic system is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Embla is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where patients require documentation of various sleep or other physiological disorders.
Product codes
OLV
Device Description
The device is an EEG and physiological signs recorder. The Embla device is a totally digital recorder utilizing 16 channels of input data. The device is available in ambulatory as well as desktop configurations.
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
clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Alice 4, Healthdyne, Inc. (K922106)
Reference Device(s)
Alice 3, Healthdyne, Inc. (K971867), New SensorMedics Corp. (K915856), Sleep System Series 4000 DigiTrace Instruments, Inc. (K910771), New England Medical Monitoring Computer/ELB EEG Home Monitoring Company DigiTrace Sleep Computer Laboratories, Inc. (K944833), Easy Cadwell (K94603), EG (K946094), Oxford Medilog, Inc. Medilog 9000 System (K830295), Oxford Medilog, Inc. Model 9000 Recording & Electrophysiology System (K860456)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "F" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other. The text is in a bold, sans-serif font. The logo is black and white.
916-342-4133 FAX: 916-343-4541
JAN 6 1998
1971813
15 October 1997
510 ( k ) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
Electroencephalograph Classification name: A.
Electroencephalagraph, EEG Common/usual name: monitor, EEG recorder, sleep recorder, etc.
Proprietary name: Embla
- Healthdyne, Inc. Alice Substantial equivalence: B. Alice 4, Healthdyne, Inc. (K922106), 3, Sensormedics SensorMedics Corp. (K971867), New (K915856), System Sleep Series 4000 DigiTrace Instruments, Inc. England Medical Monitoring Computer/ELB EEG Home Monitoring England Medical (K910771) , New Lunch Box Monitoring Company DigiTrace Sleep Computer Laboratories, Inc. Easy Cadwell (K944833), (K94603), EG (K946094), Oxford Medilog, Inc. Medilog 9000 System (K830295), Oxford Medilog, Inc. Model 9000 Recording & Electrophysiology System (K860456), and others.
- Device Description: The device is an EEG and C. physiological signs recorder.
- Embla is a polysomnographic system Intended use: D. that is intended to record, display, and print
1
EEG and other physiological information to EEG and other physicians. The device will be clinicians/physicians. The os sleep centers
used in hospitals, institutions, sleep centers used in hospitals, institutions, onvironments where of various or clinics, of ocure documentation patients require doodaologic disorders.
- The Embla device Technological characteristics: E. is a totally digital recorder utilizing 16
is a totally digital recorder utilizing is is a totally digital recorder the device is channels of input Gata.
available in ambulatory as well as desktop configurations.
Sincerely, FERGUSON MEDICAL
Frank Fergus
Frank Ferguson Official Correspondent (FDA)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three distinct lines forming the body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Frank Ferguson Official Correspondent Ferguson Medical 3407 Bay Avenue Chico, California 95973
Re: K971813
Trade/Device Name: Embla Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV Dated (Date on orig SE Itr): October 15, 1997 Received (Date on orig SE ltr): October 20, 1997
Dear Mr. Ferguson:
This letter corrects our substantially equivalent letter of January 16, 1998.
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.
APR - 9 2012
3
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/CDRHOffices/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/ReportaProblem/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.
Sincerely yours,
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
4
K971813 10(k) Number (If known):
Device Name: Embla
Indications For Use:
Embla is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/ The device will be used in hospitals, physicians. institutions, sleep centers or clinics, or other test environments where patients require documentation of various sleep or other physiological disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDBO)
Concurrence of CDRH, Office of Device Evaluation (ODE)
picole
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)