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

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.

AI/ML Overview

The provided 510(k) summary for the BioSign™ Central Station discusses design verification and design validation but does not provide specific acceptance criteria or a detailed study report that proves the device meets those criteria.

Here's an analysis based on the provided text, highlighting what's present and what's missing:

Acceptance Criteria and Device Performance

The document states:

"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 testing of the BioSign™ index model has been conducted and concluded that device specifications conformed with user needs and intended use."

However, the specific acceptance criteria (e.g., performance metrics, thresholds for accuracy, sensitivity, specificity, or correlation) and the reported device performance metrics are NOT provided in this summary. The document broadly states that the device "meets the specifications" and "conformed with user needs," but offers no quantitative data.

Detailed Analysis of Study Information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Specifics NOT provided in document)	Reported Device Performance (Specifics NOT provided in document)
No specific quantitative acceptance criteria are detailed in the provided text. The document broadly refers to "specified requirements" and "user needs and intended use."	No specific quantitative performance metrics are detailed in the provided text. The document states the device "has been found to meet the specifications" and "conformed with user needs."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text. The device is said to be based on a "model derived from historic clinical data" (referring to the predicate device, BioSign™ K053112), but no specifics are given for the BioSign™ Central Station's validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided summary. This device is an accessory that provides an index; it doesn't involve human readers interpreting images, so an MRMC study would be out of scope for its function.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document states "Design validation testing of the BioSign™ index model has been conducted and concluded that device specifications conformed with user needs and intended use." This implies an assessment of the algorithm's performance. However, no specific details of this standalone performance, metrics, or study design are provided. The device calculates a "BioSign™ index" as a "single measure of a patient's condition."

7. The type of ground truth used

The summary mentions the BioSign™ Index is based on "a model derived from historic clinical data." This suggests that the ground truth for establishing the "normality" model was based on historic clinical data and potentially clinical outcomes or expert labels within that data. However, how the ground truth for the validation test set was established is not explicitly stated.

8. The sample size for the training set

Sample Size: Not specified. The predicate device's model was "derived from historic clinical data," but no numbers are given for the volume of this data.

9. How the ground truth for the training set was established

The ground truth for the model is described as being "derived from historic clinical data." This implies that the 'normality' model and the weighting of the five vital signs were established by analyzing historical patient data, presumably labeled with patient states or outcomes. The precise method of how ground truth was established within this "historic clinical data" (e.g., physician diagnosis, pathology, specific vital sign thresholds indicating certain states) is not detailed.

Summary of Missing Information:

The 510(k) summary provides a high-level overview of design verification and validation, but it significantly lacks specific, quantitative details regarding:

Acceptance criteria: What performance metrics (e.g., accuracy, reliability measures) did the device need to achieve?
Device performance results: What were the quantitative results from the verification and validation studies?
Study design details: Sample sizes for test and training sets, data provenance, ground truth establishment specifics, and expert qualifications.

This level of detail is typically found in more comprehensive study reports submitted to the FDA, rather than the summary provided here.

Summary

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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™ 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.

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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.

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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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K071606

INDICATIONS FOR USE

510(k) Number K071606

Device Name: BioSign™ Central Station

Indications For Use:

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

Page 1 of

Regulation Number and Section

§ 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).