(88 days)
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.
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.
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,
This document is a 510(k) summary for the BIOSACA device, a biological signal recorder. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the BIOSACA device. Instead, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, the B | 0 S A C A from Biosys AB (K984580), and Embla, Flaga hf. (K971813).
Therefore, a table of acceptance criteria and reported device performance as typically understood for a novel performance study cannot be created from this document. The "performance" described leans more towards the functional capabilities and intended use matching the predicate devices.
| Acceptance Criteria (Functional/Intended Use Equivalence) | Reported Device Performance (Matching Predicate) |
|---|---|
| Ability to receive and record up to 22 bioparameters. | The BIOSACA is able to receive and record up to 22 bioparameters. |
| Record 16 parameters from two headboxes (AC and/or DC). | Records 16 from two headboxes, AC and/or DC. |
| Record 3 parameters from pulse oximeter. | Records 3 from the pulse oximeter. |
| Record 3 parameters from sensor pad. | Records 3 from the sensor pad. |
| Capable of recording, displaying, monitoring, printing, and storage of human bioparameters (brain, heart, muscle activity, eye movement, breathing, body movements). | The BIOSACA 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. |
| Designed for stationary, ambulatory, and mobile operation. | The BIOSACA is designed for stationary, ambulatory and mobile operation. |
| Usable in patient's home, hospital, or other environments. | May be used in either the patient's home, the hospital or other environments. |
| Intended for use on an adult population. | The BIOSACA unit is intended for use on an adult population. |
| Not intended as life support or vital signs monitoring in intensive care units. | It is not intended for use as life support equipment such as vital signs monitoring in intensive care units. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. A 510(k) submission primarily relies on demonstrating equivalence through technical characteristics, performance data (often bench testing), and sometimes clinical data from the predicate device itself, rather than a new clinical study with a defined test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. As no specific clinical test study with a ground truth is described, the concept of experts establishing ground truth for a test set is not applicable to the content of this summary.
4. Adjudication Method for the Test Set
This information is not provided. Since no specific clinical test study with a test set is described, there's no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. The BIOSACA is a signal recording device, not an AI-assisted diagnostic tool, so such a study would not be typically performed.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
A standalone performance study (algorithm only) was not done or not described. The device is a biological signal recorder, not an algorithm with independent diagnostic capabilities. Its "performance" is in its ability to accurately record and display signals, not to generate diagnoses independently.
7. Type of Ground Truth Used
The type of ground truth used is not applicable for this 510(k) summary as no specific clinical performance study with a defined ground truth for diagnostic accuracy is presented. The "ground truth" for a signal recorder would generally relate to the accuracy and fidelity of the recorded signals compared to the actual physiological events, which would be established through engineering validation and bench testing, rather than expert consensus on diagnostic outcomes, pathology, or outcomes data in a clinical trial context.
8. Sample Size for the Training Set
This information is not provided. The device is a signal recorder, not an AI/ML model that would typically have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable. Since the device is a biological signal recorder and not an AI/ML model, there is no "training set" or ground truth for a training set in the machine learning sense. The device's functionality is based on established engineering principles for capturing and processing bioelectrical signals.
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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 8SE-411 34 GöteborgTelephone: +46 31 774 21 25Fax: +46 31 13 98 54e-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 | |
| SubmissionCorrespondent | Jane B. CampbellJ. & D. Campbell Associates, Inc.485 LaRoe RoadChester, New York 10918Tel. 914-469-4289Fax. 914-469-4212e-mail: jdca@warwick.net |
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・・)
(
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.
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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
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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
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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
§ 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).