Visensia with Alert is an accessory to multi-parameter patient monitors (bedside, ambulatory, or centralized location) or clinical information systems and is indicated for use by health care professionals with those non-paediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.

Visensia® provides the clinician with a patient status index (Visensia® Index) based on a weighted average of five or four vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The Visensia 9 Index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality. Visensia with Alert is an adjunct to and is not intended to replace vital sign monitoring and as such does not contain alarms, but alerts the physician to changes in the patient's physiological status.

When a Visensia® Alert has activated, it means that the Visensia® Index has reached and/or surpassed the default threshold and indicates that attention should be brought to the patient.

Device Description

Visensia® is a software accessory to standard multiple parameter physiological patient v benturs (bedside or ambulatory) or clinical information systems. It operates on a standard PC, or personal computer.

Visensia® is a software device that through advanced signal processing can combine physiological signals in order to produce a single index (Visensia® index) representation of patient condition.

Visensia® is a computerized analysis system that can accept multiple channels of Prisonological data (for example heart rate, respiratory rate, temperature, blood pressure and oxygen saturation as inputs). Through advanced signal processing, Visensia® can identify changes in patient status.

AI/ML Overview

The provided text describes Visensia® with Alert, a software accessory that generates a "patient status index" (Visensia® Index) based on vital signs. It also has an alert function to indicate changes in a patient's physiological status.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the device's performance (e.g., a specific sensitivity or specificity for detecting patient deterioration). Instead, it focuses on design verification and validation, and clinical data showing effectiveness.

Therefore, the table will reflect the general statements made about performance:

Acceptance Criteria (Implicit/General Statements)	Reported Device Performance (Summary from text)
Device meets specified requirements.	Design verification testing confirmed Visensia® hardware and software meet specifications.
Device specifications conform with user needs and intended use.	Design validation testing concluded device specifications conformed with user needs and intended use for the index model.
Effectiveness of Visensia® for patient status indexing.	Clinical data illustrates the effectiveness of Visensia® and its usefulness.
Effectiveness of the alert function in correlation with patient deterioration.	Clinical data correlates patient deterioration with the alerting function.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Clinical Testing: Clinical data illustrates the effectiveness of Visensia and the usefulness of he alert function. The data correlates patient deterioration with alerting function."

Sample Size for Test Set: Not specified in the provided text. The document only generally mentions "Clinical data."
Data Provenance: Not specified in the provided text. It does not mention the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical testing.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The document focuses on the device's standalone performance and its clinical utility rather than comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance assessment was conducted, implied by the "Performance Studies" section.

"Design verification: Design verification testing of Visensia® hardware and software against the specified requirements has been conducted and Visensia® has been found to meet the specifications."
"Design validation: Design validation testing of Visensia® index model has been conducted and concluded that device specifications conformed with user needs and intended use."
"Clinical Testing: Clinical data illustrates the effectiveness of Visensia and the usefulness of he alert function. The data correlates patient deterioration with alerting function."

These statements suggest that the algorithm's performance in generating the index and alerts was evaluated, independently of human interpretation, though the specifics of this evaluation are limited.

7. Type of Ground Truth Used

The document indicates that the "Clinical data illustrates the effectiveness of Visensia and the usefulness of he alert function. The data correlates patient deterioration with alerting function."

This implies that the ground truth for clinical testing was based on observed "patient deterioration" as determined by clinical assessment. However, the specific methodology for defining and confirming "patient deterioration" (e.g., specific clinical outcomes, physician diagnosis, or a composite score) is not detailed.

8. Sample Size for the Training Set

The document makes no mention of a "training set" or its sample size. The description of the device's development implies that the model for the Visensia® Index was developed and refined using historical clinical data, as stated in the substantial equivalence comparison to Sonicaid System 8002: "Visensia®... provides decision support to a clinician in the determination of normality based on a model derived from historic clinical data." However, the size of this historical dataset is not provided.

9. How the Ground Truth for the Training Set Was Established

The document indicates that the model for determining normality was "derived from historic clinical data." Analogous to the predicate device Sonicaid System 8002 where "criteria were established by examination of historical clinical data." This implies that the ground truth for developing the model was based on retrospective analysis of historical clinical data, likely interpreted by experts or defined by established clinical criteria for "normality" or "patient status." However, the specifics of how this ground truth was established (e.g., number of experts, specific criteria) are not detailed.

Summary

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K081140
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510(k) Summary

Prepared on July 8, 2008

1.	General Information	JUL 1 7 2008
	Trade Names of Device:	Visensia®Visensia® with AlertVisensia® Alert
	Common/Usual Name:	Accessory to multi-parameter patientmonitor (bedside or ambulatory)
	Classification Name:	Physiological Patient Monitor (witharrhythmia detection or alarms)
	Submitters Name and Address:	OBS Medical11495 N Pennsylvania St., Ste 250Carmel, IN 46032Tel 317-581-3937Fax 317-581-8941
	Manufacturer:	OBS Medical11495 N Pennsylvania St., Ste 250Carmel, IN 46032Tel 317-819-3937

2. Device Description

Fax 317-581-8941

Visensia® is a software device that through advanced signal processing can combine physiological signals in order to produce a single index (Visensia® index) representation of patient condition.

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K081140
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Indications for Use 3.

Visensia® with alert is an accessory to multi-parameter patient monitors (bedside, ambulatory, or v liselism - what alon is an information systems and is indicated for use by health care centrailed location) or ennival diatric high dependency care patients for whom multi-parameter patient monitoring has been routine.

Visensia® provides the clinician with a patient status index (Visensia® Index) based on a weighted vicense of five or four vital signs namely heart rate, respiration rate, temperature, oxygen avolution and blood pressure. The Visensia® Index is a single measure of a patient's condition buttuneon and oto a present the patient's vital signs are with respect to normality. Visensia with Alert is an adjunct to and is not intended to replace vital sign monitoring and as such does with I nort is an as ante the physician to changes in the patient's physiological status.

When a Visensia® Alert has activated, it means that the Visensia® Index has reached and/or which a vibensia - Freeville and indicates that attention should be brought to the patient.

Substantial Equivalence 4.

Visensia® is substantially equivalent to the following devices:

Predicate device: A-2000 EEG Monitor with BIS

Company: Aspect Medical Systems

510(K) Number: K030267

STO(IS) Number : K650207.
A-2000 EEG Monitor with BIS 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 of an allesment200 or sedator patent france (BIS) algorithm and a number between 1 and 100 processed will the comprex Disposular in this BIS index and associated trend graph provides a carect indication of the patient's level of anaesthesia and includes an alerts or alarm feature.

Visensia® is substantially equivalent to the A-2000 EEG Monitor with BIS in that it also takes a vitionslar 16 subscallians of equal and processes them in order to provide the clinician with an index and associated trend graph indicative of the patient's state.

Predicate device: Propaq 200 Series multi-parameter physiological monitor Company: Welch Allyn Protocol, Inc 510(K) Number: K012451

510(1) Number : N012451 is substantially equivalent to the Propaq 200. Visensia® and Propaq 200 provide real time Is substantially of heart rate, respiration rate, blood pressure, temperature and oxygen saturation. Visensia® additionally provides a real time trend display of the data fusion of these vital signs.

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Predicate device: Sonicaid System 8002 Company: Oxford Instruments Medical 510(K) Number: K992607

STO(X) Number 11272007
Sonicaid System 8002 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 our indicative of a normal CTG .These criteria were established by examination of historical clinical data.

Visensia® is substantially equivalent to Sonicaid System 8002 in that its displayed graphical v lociolor is bucculations 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.

Predicate device: Equivital™ Company: Hidalgo 510(K) Number: K061993

The Equivital™ device combines physiological parameters in to one index, "Physiological I Ic Equivitar " and provides indications and alerts if physiology exceeds predefined boundaries. Visensia " combines physiological parameters into one index, the Visensia "Index (VSI), and

క. Performance Studies

Design verification: Design verification testing of Visensia® hardware and software against the specified requirements has been conducted and Visensia® has been found to meet the specifications.

Design validation: Design validation testing of Visensia® index model has been conducted and concluded that device specifications conformed with user needs and intended use.

Electrical Safety: Visensia® 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.

Clinical Testing: Clinical data illustrates the effectiveness of Visensia and the usefulness of he alert function. The data correlates patient deterioration with alerting function.

6. Conclusion

Based on the indications for use and performance studies, Visensia® is substantially equivalent to currently marketed devices for its intended use.

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Image /page/3/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 three stripes forming its body and wing. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2008

OBS Medical c/o Mr. Wayne Nethercutt Vice President, Clinical and Regulatory Affairs 11495 N. Pennsylvania St. Ste., 250 Carmel, IN 46032

Re. Kool 140

Trade Name: Visensia ® with Alert Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II Product Code: MHX Dated: July 8, 2008 Received: July 10, 2008

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.

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

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Page 2 -Mr. Wayne Nethercutt

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, prease contact CBRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vo Bram D. 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: K081140

Device Name: Visensia® with Alert

Indications For Use:

When a Visensia® Alert has activated, it means that the Visensia® Index has reached and/or surpassed the default threshold and indicates that attention should be brought to the patient.

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

AND/OR Over-The-Counter Use Prescription Use X (21 CFR 801 Subpart C) (21 CFR 801 Subpart Di

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

elamoe

of Cardiovascular Devices

Page 1 of

510(k) Number

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.