BIOSACA SYSTEM

{0}------------------------------------------------ ं की मौजूद में बाद में बाद में कि महीने की मौजूद में बाद में बाद में कि महीने की मांग की में बाद में कि महीने की मांग की में बाद में कि महीने की मांग की में बाद में कि महीने 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ## 510(k) Summary K984580 Safety and effectiveness information concerning the Biosaca from Biosys AB is summarized below. | Date Prepared | December 18, 1998 | | | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------| | Applicant | BIOSYS AB (publ)<br>Vasaplatsen 8<br>SE-411 34 Göteborg<br>Telephone: +46 31 774 21 25<br>Fax: +46 31 13 98 54<br>e-mail: info@biosys.se | | | | Contact | Anne Mari Nedevska, Technical Administration Manager | | | | Device Name | BIOSACA | | | | Common Name | Biological Signal Recorder | | | | Classification | No formal classification name or number has been assigned for devices such as the Biosaca. Stand-alone devices for the same use as the Biosaca include the following: | | | | Panel | Product Code | Name | 21 CFR | | 84 | GWQ | Electroencephalograph | 882.1400 | | 84 | GYE | Physiological telemetry system | 882.1855 | | 84 | GWP | Electromyography | 882.5050 | | 84 | LEL | Sleep Assessment Device | | | 80 | FLS | Breathing frequency | 868.2375 | | 73 | MNR | Ventilatory effort recorder | 868.2375 | | 74 | DPS | Electrocardiography (ECG) | 870.2340 | | 74 | DQA | Pulse Oximeter | 870.2700 | | 73 | DRX | Electrocardiograph electrode | 870.2360 | Błosys AB (publ). Vasaplatsen B SE-411 34 Goteborg Telephone +46(0)31 774 21 25 Fax +46(0)31 13 98 54 E-mall info@blosys.se {1}------------------------------------------------ . . ... . . . . . . . ﺤ ー・ー . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . | Submission | | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Correspondent | Jane B. Campbell<br>J. & D. Campbell Associates, Inc.<br>485 LaRoe Road<br>Chester, New York 10918<br>Tel. 914-469-4289<br>Fax. 914-469-4212<br>e-mail: jdca@warwick.net | | Predicate Devices | Compumedics Sleep Monitoring System, Compumedics<br>Sleep Pty. Ltd (K955841)<br>Embla, Flaga hf. (K971813) | | Device Description | The BIOSACA is a multi-functional and an ambulatory<br>recording device. It is a portable system for the recording,<br>monitoring, storage and transfer of up to 22 bioparameters<br>such as brain, heart and muscle activity, eye movement,<br>blood pressure, breathing, body movements etc. There are<br>applications for the BIOSACA in neurological, cardiology<br>and sleep disorder diagnoses. | | Function | The BIOSACA is a biological signal recorder able to receive<br>and record up to 22 bioparameters - 16 from two headboxes,<br>AC and/or DC, three from the pulse oximeter and three from<br>the sensor pad. | | Intended Use | The intended use for the BIOSACA is to record, monitor,<br>display, print, store and transfer bioparameters such as brain,<br>heart and muscle activity, eye movement, blood pressure,<br>breathing and body movements.<br>The BIOSACA unit is intended to be used on an Adult<br>population and for use at home or in health care facilities. It<br>is not intended for use as life support equipment such as vital<br>signs monitoring in intensive care units. The unit may be<br>used for electrocardiography, electroencephalography,<br>electromyography, electrooculography ballistocardiography | **54** E-mall info@blosys.se {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 with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002 Biosys AB c/o Jane B.Campbell J. D. Campbell Associates 485 Laroe Road Chester, New York 10918 APR - 9 2012 Re: K984580 Trade/Device Name: BIOSACA Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, DQA, GWQ, MNR Dated (Date on orig SE ltr): December 18, 1998 Received (Date on orig SE ltr): December 23, 1998 Dear Ms. Campbell: This letter corrects our substantially equivalent letter of March 12, 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. {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 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/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/ResourcesforYou/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 Image /page/3/Picture/8 description: The image shows the handwritten word "for" in cursive script. The letter 'f' has a large, sweeping loop that extends both above and below the baseline. The letters 'o' and 'r' are connected and smaller in size compared to the 'f'. Enclosure {4}------------------------------------------------ ## Indications for Use Statement K984580 510(k) Number (if known): Device Name: BIOSACA Indications for Use: : . .. The BIOSACA equipment is indicated for use in the recording, displaying, The BIOSACA equipment is materials increases and non-biological signals for sleep monitoring, printing and storage of otoroge of the conceptalography (EEG), disorder and epilepsy investigations as a visuality (EMG), Electrooculography (EOG), Ballistocardiography, etc. BIOSACA is designed for both stationary and (DOO), Ballisiocal diography, cood in either the patient's home or the hospital. mobile operation and may be toos an which can be recorded directly from the Blological siguals are encourted organis are recorded using indirect methods such as pation. Non-of air (breathing), blood pressure, etc. The equipment is suitable for home use as the patient needs only a minimal amount I he equipment is surations for none setsem has no lights or sounds that could confuse the patient. Signals may be stored for later or may be viewed directly in contuse the patient. Sights may over . When monitoring, the operator sees the signals at the same time as they are recorded. The Biosaca unit is intended for use on an adult population and at home or I he Diosaca alle 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 General Restorative Devices 9845 Am Prescription Use (Per 21 CFR 801.109)