BIOSIGN

K053112 · Oxford Biosignals Limited · MWI · Jan 31, 2006 · Cardiovascular

Device Facts

• Record ID: K053112
• Device Name: BIOSIGN
• Applicant: Oxford Biosignals Limited
• Product Code: MWI · Cardiovascular
• Decision Date: Jan 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

BioSign™ is an accessory to a multi-parameter patient monitor (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those nonpediatric high dependency care patients for whom multi-parameter patient monitoring has been routine. BioSign™ provides the clinician with a trend graph of the patient status index based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The patient status index 140 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. Warning: Federal (USA) law restricts this device to sale by or on the order of a physician

Device Story

BioSign™ is a software accessory for medical-grade computers; integrates with bedside/ambulatory multi-parameter patient monitors or clinical information systems. Inputs: heart rate, respiration rate, temperature, oxygen saturation, blood pressure. Processing: advanced signal processing and data fusion; calculates a weighted average patient status index representing deviation from normality. Output: real-time trend graph of patient status index. Usage: clinical setting; operated by healthcare professionals. Benefit: provides decision support by synthesizing multiple vital signs into a single measure of patient condition; assists clinicians in identifying changes in patient status.

Clinical Evidence

Bench testing only. Design verification confirmed hardware and software meet specified requirements. Design validation confirmed the patient status index model conforms to user needs and intended use. Electrical safety testing performed per BS EN 60601-1-1:2001.

Technological Characteristics

Software accessory operating on standard medical-grade computers. Employs advanced signal processing and data fusion algorithms. Connectivity via integration with patient monitors or clinical information systems. Complies with BS EN 60601-1-1:2001 safety standards.

Indications for Use

Indicated for non-pediatric high dependency care patients requiring routine multi-parameter monitoring. Used by healthcare professionals as an adjunct to vital signs monitoring.

Regulatory Classification

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.

Predicate Devices

• Propaq 200 Series Monitors (K012451)
• Sonicaid System 8002 (K992607)
• A-2000 EEG Monitor with BIS (K030267)

Submission Summary (Full Text)

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JAN 3 1 2006

#### 1. General Information

| Trade Name of Device: | “BioSign™” |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Accessory to multi-parameter patient<br>monitor (bedside or ambulatory) |
| Classification Name: | Monitor, physiological, patient |
| Submitters Name and Address: | Oxford BioSignals Ltd<br>Magdalen Centre<br>Oxford Science Park<br>Oxford<br>OX4 4GA<br>United Kingdom<br>Tel [phone]<br>Fax [phone] |
| Manufacturer: | Oxford BioSignals Ltd<br>Magdalen Centre<br>Oxford Science Park<br>Oxford |

### 2. Device Description

BioSign™ is a software accessory to standard multiple parameter physiological patient monitors (bedside or ambulatory) or clinical information systems. It operates on a standard medical grade computer.

OX4 4GA

United Kingdom

BioSign™ is a software device embedded in a standard medical grade computer that through advanced signal processing can combine physiological signals in order to produce a single graph representation of patient condition.

BioSign™ is a computerized analysis system that can accept multiple channels of physiological data (for example heart rate, respiratory rate, temple viauncis of pressure and oxygen saturation as inputs). Through advanced signal procession, BioSign can identify changes in patient status.

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#### 3. Indications for Use

KO53112 2/3 Ilcations for Use
BioSign™ is an accessory to a multi-parameter patient monitor (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 multiparameter patient monitoring has been routine.

. .

BioSign™ provides the clinician with a trend graph of the patient status index based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The patient status 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.

#### 4. Substantial Equivalence

The BioSign™ device is substantially equivalent to the following devices:

Propaq 200 Series Monitors (K012451) multi-parameter physiological patient monitors. BioSign™ is a software accessory to multi-parameter physiological patient monitors and as such is substantially equivalent to the Propaq 200.

BioSign™ is an adjunct to a patient monitor and displays real time monitoring of heart rate, respiration rate, blood pressure, temperature and oxygen saturation and, therefore, the BioSign™ display is substantially equivalent to the Propag 200 series display, which provides real time monitoring of each physiological channel.

BioSign™ additionally provides a real time trend display of the data fusion of these vital signs.

Sonicaid System 8002 (K992607) is a software accessory for the computerized analysis of antepartum cardiotocograms (CTGs). It informs the clinician whether a CTG meets a number of criteria that are indicative of a normal CTG .These criteria were established by examination of historical clinical data.

BioSign™ is substantially equivalent to Sonicaid System 8002 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.

A-2000 EEG Monitor with BIS (K030267) is an EEG monitoring system that monitors the state of the brain of an anesthetized or sedated patient. Raw EEG information obtained from patient sensors is processed with the complex Bispectral Index (BIS) algorithm and a number between 1 and 100 calculated and displayed to the clinician. This BIS index and associated trend graph provides a direct indication of the patient's level of anesthesia.

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K053112 3/3 BioSign™ is substantially equivalent to the A-2000 EEG Monitor with BIS in that it also takes a patient's physiological signals and processes them in order to provide the clinician with an index and associated trend graph indicative of the patient's state.

#### 5. Performance Studies

Design verification: Design verification testing of the BioSign™ 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™ patient status index model has been conducted and concluded that device specifications conforms invith user needs and intended use.

Electrical Safety: BioSign™ systems comply with BS EN 60601-1-1:2001, "Safety requirements for medical electrical systems."

#### 6. Conclusion

Based upon the indications for use and performance studies BioSign™ has been shown to be substantially equivalent for its intended use.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2006

Oxford BioSignals Limited c/o Mr. Howard M. Holstein Regulatory Counsel Hogan & Hartson, LLP 555 13m 24 NW Washington DC 20004

Re: K053112

Trade/Device Name: BioSignTM Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II Product Code: MWI Dated: November 4, 2005 Received: November 4, 2005

Dear Mr. Holstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have deterniined 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.

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

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Page 2 - Mr. Howard M. Holstein

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmon for

Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 4

# INDICATIONS FOR USE

510(k) Number (if known): K05 3112

Device Name: BioSign™

### Indications For Use:

BioSign™ is an accessory to a multi-parameter patient monitor (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those nonpediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.

BioSign™ provides the clinician with a trend graph of the patient status index based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The patient status index 140 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

Warning: Federal (USA) law restricts this device to sale by or on the order of a physician

Prescription 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. tummana
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Division of Cardiovascular Devices
510(k) Number K053112