(80 days)
Not Found
No
The description mentions "advanced signal processing" and "computerized analysis system" to combine vital signs into an index, but does not use terms like AI, ML, or describe any learning or adaptive capabilities. The focus is on a weighted average and identifying changes based on this index.
No.
The device functions as an accessory for monitoring patient vital signs and calculating an index of patient status; it does not directly treat or manage a disease or condition.
No
This device provides a patient status index based on vital signs, which is explicitly stated as an "adjunct to and is not intended to replace vital signs monitoring." While it identifies changes in patient status, it does not explicitly state that it makes a diagnosis.
Yes
The device description explicitly states that BioSign™ Central Station is a "software accessory" and a "software device" that operates on a "standard PC, or personal computer." While it interacts with hardware (patient monitors or clinical information systems), the device itself, as described, is the software component. The performance studies mention "hardware and software" testing, but the device description focuses solely on the software aspect running on a standard computer.
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.
- Device function: The BioSign™ Central Station processes physiological signals (heart rate, respiration rate, temperature, oxygen saturation, and blood pressure) obtained from patient monitors. It does not analyze samples taken from the patient's body.
- Intended Use: The intended use describes the device as an accessory to patient monitors and a tool for healthcare professionals to assess patient status based on vital signs. This is a form of patient monitoring and data analysis, not in vitro testing.
Therefore, the BioSign™ Central Station falls under the category of a patient monitoring accessory or clinical information system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BioSign™ Central Station is an accessory to nulti-parameter patient monitors (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.
The BioSign ™ Central Station provides the clinician with a patient status index (BioSign™ Index) based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The BioSign™ index is a single measure of the patient's condition and represents how different the patient's vital signs are with respect to normality. BioSign™ is an adjunct to and is not intended to replace vital signs monitoring.
The BioSign™ Central Station displays BioSign indices for multiple patients.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician
Product codes
MWI
Device Description
BioSign™ Central Station is a software accessory to standard multiple parameter physiological patient monitors (bedside or ambulatory) or clinical information systems. It operates on a standard PC, or personal computer.
BioSign™ is a software device that through advanced signal processing can combine physiological signals in order to produce a single index (BioSign index) representation of patient condition.
BioSign™ is a computerized analysis system that can accept multiple channels of physiological data (for example heart rate, respiratory rate, temperature, blood pressure and oxygen saturation as inputs). Through advanced signal processing, BioSign can identify changes in patient status.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
non-pediatric
Intended User / Care Setting
health care professionals / high dependency care patients
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification: Design verification testing of the BioSign™ Central Station hardware and software against the specified requirements has been conducted and the BioSign™ device has been found to meet the specifications.
Design validation: Design validation testing of the BioSign™ index model has been conducted and concluded that device specifications conformed with user needs and intended use.
Electrical Safety: The BioSign™ Central Station is composed of standard, off the shelf PC computer components. There is no contact with the patient and the user assumes no risk greater than that when using a standard desk-top personal computer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
510(k) Summary
AUG 3 1 2007
1. General Information
Trade Name of Device:
Common/Usual Name:
Classification Name:
Submitters Name and Address:
OBS Medical Hamilton Crossing 4 12900 N. Meridian St Carmel, IN 46032 Tel 317-581-9236 Fax 317-581-8941
"BioSign™ Central Station"
Accessory to multi-parameter patient monitor (bedside or ambulatory)
Physiological Patient Monitor (without
arrhythmia detection or alarms)
Manufacturer:
Oxford BioSignals Limited Brook House 174 Milton Park Abingdon Oxon OX14 4SE United Kingdom
2. Device Description
BioSign™ Central Station is a software accessory to standard multiple parameter physiological patient monitors (bedside or ambulatory) or clinical information systems. It operates on a standard PC, or personal computer.
BioSign™ is a software device that through advanced signal processing can combine physiological signals in order to produce a single index (BioSign index) representation of patient condition.
BioSign™ is a computerized analysis system that can accept multiple channels of physiological data (for example heart rate, respiratory rate, temperature, blood pressure and oxygen saturation as inputs). Through advanced signal processing, BioSign can identify changes in patient status.
1
3. Indications for Use
The BioSign ™ Central Station is an accessory to multi-parameter patient monitors (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.
The BioSign™ Central Station provides the clinician with a status index (BioSign™ Index) based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The BioSign™ index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality. BioSign™ is an adjunct to and is not intended to replace vital signs monitoring.
The BioSign™ Central Station displays BioSign indices for multiple patients.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
4. Substantial Equivalence
The BioSign™ Central Station device is substantially equivalent to the following devices:
Predicate device: BioSign™ Company: OBS Medical 510(K) Number: K053112
The BioSign™ Central Station is a software accessory to multi-parameter physiological pattent monitors and as such is substantially equivalent to the BioSign™ bedside monitor.
BioSign™ Central Station is substantially equivalent to BioSign in that its displayed graphical representation of the fused vital signs is created by computer analysis and provides decision support to a clinician in the determination of normality based on a model derived from historic clinical data. Both devices are adjuncts to vital sign monitoring. Both devices use the same algorithm to fuse the vital signs and display the BioSign index.
Please note BioSign™ Central Station, does not include any alarms or parameter thresholds. BioSign is an adjunct to and is not intended to replace vital sign monitoring
ડ. Performance Studies
Design verification: Design verification testing of the BioSign™ Central Station hardware and software against the specified requirements has been conducted and the BioSign™ device has been found to meet the specifications.
2
Prepared 13 August 2007
Design validation: Design validation testing of the BioSign™ index model has been conducted and concluded that device specifications conformed with user needs and intended use.
Electrical Safety: The BioSign™ Central Station is composed of standard, off the shelf PC computer components. There is no contact with the patient and the user assumes no risk greater than that when using a standard desk-top personal computer.
6. Conclusion
Based upon the indications for use and performance studies the BioSign™ Central Station has been shown to be substantially equivalent for its intended use.
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Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2007
OBS Medical c/o Mr. Wayne Nethercutt Director, Regulatory and Clinical Affairs 1290 N. Meridian Carmel, IN 46032
Re: K071606
BioSign™ Central Station Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: August 13, 2007 Received: August 17, 2007
Dear Mr. Nethercutt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Wayne Nethercutt
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.
Sincerely vours.
Bremerton, Wa
Bram Ø. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number K071606
Device Name: BioSign™ Central Station
Indications For Use:
The BioSign™ Central Station is an accessory to nulti-parameter patient monitors (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.
The BioSign 146 Central Station provides the clinician with a patient status index (BioSign™ Index) based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The BioSign™ index is a single measure of the patient's condition and represents how different the patient's vital signs are with respect to normality. BioSign™ is an adjunct to and is not intended to replace vital signs monitoring.
The BioSign™ Central Station displays BioSign indices for multiple patients.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician
Prescription Use X AND/OR Over-The-Counter Use (21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
B.Brammer
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