(88 days)
Not Found
No
The document describes a biological signal recorder and monitoring system. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections. The focus is on data acquisition and storage.
No
The device is described as being for "recording, displaying, monitoring, printing and storage of human bioparameters" and for "diagnoses," which are diagnostic rather than therapeutic purposes. It does not provide any treatment.
Yes
The device description states, "There are applications for the BIOSACA in neurological, cardiology and sleep disorder diagnoses," indicating its use in diagnosing conditions.
No
The device description explicitly states it is a "multi-functional and an ambulatory recording device" and a "biological signal recorder able to receive and record up to 22 bioparameters," 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 devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the BIO SA CA equipment focuses on recording, displaying, monitoring, printing, and storing human bioparameters directly from the body (brain, heart, muscle activity, eye movement, breathing, body movements). This involves external sensors and electrodes applied to the patient, not the analysis of biological samples.
The device is clearly designed for physiological monitoring and recording, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The BIO SACA equipment is indicated for use in the recording, displaying, monitoring, printing and storage of human bioparameters such as brain, heart and muscle activity, eye movement, breathing and body movements. The B I 0 5 A C A is designed for stationary, ambulatory and mobile operation and may be used in either the patient's home, the hospital or other environments, enabling patients to be investigated under as realistic conditions as possible. The B I 0 5 A C A unit is intended for use on an adult population. It is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, OLV
Device Description
The BIOSACA is a multi-functional and an ambulatory recording device. It is an ambulatory system for the recording, monitoring, storage and transfer of up to 22 bioparameters such as brain, heart and muscle activity, eye movement, blood pressure, breathing, body movements etc. There are applications for the BIOSACA in neurological, cardiology and sleep disorder diagnoses. Function The BIOSACA is a biological signal recorder able to receive and record up to 22 bioparameters - 16 from two headboxes, AC and/or DC, three from the pulse oximeter and three from the sensor pad,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not specified (records bioparameters such as brain, heart, muscle activity, eye movement, breathing, body movements)
Indicated Patient Age Range
adult population
Intended User / Care Setting
patient's home, the hospital or other 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): 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
§ 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
BIOSYS
JUL 2 3 1999
K 991446
510(k) Summary
Safety and effectiveness information concerning the Biosaca from Biosys AB is summarized below.
| Date Prepared | April 22, 1999 |
|---|---|
| Applicant | BIOSYS AB (publ) |
| Vasaplatsen 8 | |
| SE-411 34 Göteborg | |
| Telephone: +46 31 774 21 25 | |
| Fax: +46 31 13 98 54 | |
| e-mail: info@biosys.se | |
| Contact | Anne Mari Nedevska, Technical Administration Manager |
| Device Name | BIOSACA |
| Common Name | Biological Signal Recorder |
| Classification | The BIOSACA has been placed into class II (Reference K984580). |
| Product Code Name 21 CFR | |
| GWQ, OLV Electroencephalograph 882.1400 | |
| Submission | |
| Correspondent | Jane B. Campbell |
| J. & D. Campbell Associates, Inc. | |
| 485 LaRoe Road | |
| Chester, New York 10918 | |
| Tel. 914-469-4289 | |
| Fax. 914-469-4212 | |
| e-mail: jdca@warwick.net |
1
・・)
(
Predicate Devices B | 0 S A C A , Biosys AB (K984580)
Embla, Flaga hf. (K971813)
Device Description The BIOSACA is a multi-functional and an ambulatory recording device. It is an ambulatory system for the recording, monitoring, storage and transfer of up to 22 bioparameters such as brain, heart and muscle activity, eye movement, blood pressure, breathing, body movements etc. There are applications for the BIOSACA in neurological, cardiology and sleep disorder diagnoses. Function The BIOSACA is a biological signal recorder able to receive and record up to 22 bioparameters - 16 from two headboxes, AC and/or DC, three from the pulse oximeter and three from the sensor pad, Intended Use The BIO SACA equipment is indicated for use in the recording, displaying, monitoring, printing and storage of human bioparameters such as brain, heart and muscle activity, eye movement, breathing and body movements. The BIOSACA is designed for stationary, ambulatory and mobile operation and may be used in either the patient's home, the hospital or other environments, enabling patients to be investigated under as realistic conditions as possible. The BIOSACA unit is intended for use on an adult population. It is not intended for use as life support equipment such
as vital signs monitoring in intensive care units.
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biosys AB c/o Ms. Jane B. Campbell J. & D. Campbell Associates Inc. 485 LaRoe Road Chester, New York 10918
Re: K991446
Trade/Device Name: Biosaca System, Model 800 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): April 22, 1999 Received (Date on orig SE Itr): April 26, 1999
Dear Ms. Campbell:
This letter corrects our substantially equivalent letter of July 23, 1999.
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
Page 2 - Ms. Jane B. Campbell
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 (OS) 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/CDRH/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/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
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
4
Indications for Use Statement
510(k) Number (if known):
Device Name:
Indications for Use:
The BIO SA CA equipment is indicated for use in the recording, displaying, monitoring, printing and storage of human bioparameters such as brain, heart and muscle activity, eye movement, breathing and body movements.
K 991446
BIOSACA
The B I 0 5 A C A is designed for stationary, ambulatory and mobile operation and may be used in either the patient's home, the hospital or other environments, enabling patients to be investigated under as realistic conditions as possible.
The B I 0 5 A C A unit is intended for use on an adult population. It is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Division Sign-Off)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991446
Prescription Use
(Per 21 CFR 801.109)
। .
OR
Over the Counter Use