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-pediatric 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® 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® is an adjunct to and is not intended to replace vital sign monitoring.

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® software is a computerized analysis software program designed as an adjunct to standard patient monitors or medical information systems. It operates by forming an aggregate score of patient status based on five vital signs; heart rate; respiratory rate; temperature; noninvasive blood pressure and arterial oxygen saturation. The aggregate score, the Visensia® Index, is displayed on a scale of 0-5, with 0 representing the normal end of the scale and 5 representing extreme physiological deterioration. An audible and visual alert is provided when the Visensia® index exceeds a threshold value for a period of time. The Visensia® Index is calculated whenever new data is received.

The Visensia® display consists of a combination of the following:

An identifier for each monitored patient and location .
The Visensia® Index value for each patient (shown as a number, trend or other graphical . representation).
The vital signs for each patient (shown as a number, trend or other graphical . representation).
A status bar area showing the state of the system .

Visensia® may also be implemented as a data processing server with no graphical interface.

AI/ML Overview

The provided document is a 510(k) summary for the Visensia® device, which is an adjunct to multi-parameter patient monitors for calculating a patient status index. However, it does not contain the specific details required to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The document states:

"The Visensia® Index is displayed on a scale of 0-5, with 0 representing the normal end of the scale and 5 representing extreme physiological deterioration."
"An audible and visual alert is provided when the Visensia® index exceeds a threshold value for a period of time."
"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® Index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality."

It also mentions "Performance Testing" with "satisfactory results for the release" which involved:

Unit Testing
Integration Testing
System Testing (on the completed product operating on representative hardware and communicating with a Philips MP30 patient monitor and an emulated clinical information system).

The document focuses on demonstrating substantial equivalence to its predicate device (K081140) by describing changes to features like alerts, the algorithm (re-factored but no change to design), data handling, and labelling, and confirming those changes did not alter the intended use.

Therefore, I cannot provide the detailed information requested regarding:

A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for the Visensia® Index or its alerts, nor does it present specific performance metrics from a study against such criteria.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. The device is an "adjunct" and not replacing human monitoring.
If a standalone study was done: The document describes system testing on the "completed product" but does not provide details of a standalone clinical performance study assessing its accuracy against a ground truth.
The type of ground truth used: Not mentioned. Given the device provides an "index of patient status," a ground truth would likely involve clinical outcomes, expert assessment of patient deterioration, or some other validated metric of patient health status correlated with vital signs.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

In summary, this document is a Special 510(k) submission, confirming that modifications to an existing device (Visensia®) do not alter its safety or effectiveness compared to the predicate. It does not present new clinical study data with acceptance criteria for the device's diagnostic performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for OBS Medical. The logo is in black and white and includes the text "OBS" and "Medical". There is also a heart rate line in the middle of the logo. The date "JUN 15 2011" is printed on the right side of the image.

110953

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SECTION 7 SPECIAL 510(k) SUMMARY

This Special 510(k) Summary provides the following information:

. General information
A description of the device, including the indications for use and technology; �
. Concise summary of the performance testing supporting the submission;

General Information

Trade Name of Device:	"Visensia®"
Establishment Registration Number:	3005768010
Common/Usual Name:	Adjunct to multi-parameter patient monitor
Classification Group:	MHX
Classification Name:	Physiological Patient Monitor (with arrhythmia detection or alarms)
Classification Regulation:	870.1025
Classification Panel:	Circulatory Systems Devices

Submitters Name and Address: OBS Medical

Manufacturer:

10401 North Meridian St., Ste 300 Indianapolis, IN 46290 Tel 317-319-3980 Fax 317-581-8941

OBS Medical 174 Milton Park Abingdon, Oxfordshire, OX 14 4SE United Kingdom Tel +44 (0)1235 432 050 Fax +44 (0)800 130 3108

Device Description

Visensia V3 Special 510k Submission

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Image /page/1/Picture/0 description: The image shows the logo for OBS Medical. The logo has the letters "OBS" on the top line, with a horizontal line underneath. The word "Medical" is on the second line in a larger font. The horizontal line extends to the right of the letters "OBS" and is shaped like a heart rate graph.

K110953 $ 7/5

representing extreme physiological deterioration. An audible and visual alert is provided when the Visensia® index exceeds a threshold value for a period of time. The Visensia® Index is calculated whenever new data is received.

The Visensia® display consists of a combination of the following:

An identifier for each monitored patient and location .
The Visensia® Index value for each patient (shown as a number, trend or other graphical . representation).
The vital signs for each patient (shown as a number, trend or other graphical . representation).
A status bar area showing the state of the system .

Visensia® may also be implemented as a data processing server with no graphical interface.

Substantial Equivalency Similarities

The table below indicates the similarities and differences between the modified Visensia® device and its predicate device.

Feature	Predicate Device: Visensia®with AlertK081140	Modified Device: Visensia®DeviceK110953	Data SupportingChange
IntendedUse	Visensia® with alert is anaccessory to multi-parameterpatient monitors (bedside,ambulatory, or centralizedlocation) or clinicalinformation systems and isindicated for use by health careprofessionals with those non-pediatric high dependency carepatients for whom multi-parameter patient monitoringhas been routine.Visensia® provides the clinicianwith a patient status index(Visensia® Index) based on aweighted average of five or(four) vital signs namely heartrate, respiration rate,temperature, oxygen saturationand blood pressure. TheVisensia® Index is a singlemeasure of a patient's	Indication/Intended Use of themodified device as described in itslabelling has not changed alongwith the proposed labelling whichincludes the User Guide,Installation and ConfigurationManual, Booklet for Visensia,Case Label and CD Label forVisensia.	None

	condition and represents howdifferent the patient's vitalsigns are with respect tonormality. Visensia® is anadjunct to and is not intendedto replace vital sign
	monitoring.When a Visensia® alert hasactivated, it means that theVisensia® Index has reachedand/or surpassed the defaultthreshold and indicates thatattention should be brought tothe patient.
Alerts	Variable Alert	Same variable alert, but now ableto be set for individual bed fromthe interface by clinicians.	Visensia®RequirementsSpecification (011-0106-FS),Design Specification(011-0114-DS) andVisensia® V3.1Summary Report(011-0155-DTR)
Algorithm	Visensia® Algorithm	Visensia® Algorithm re-factoredto improve software integrity.No change to the design of thealgorithm.	Visensia® IndexSpecification (011-0107-FS),Visensia® IndexDesign Specification(011-0143-DS) andVisensia® V3.1Summary Report(011-0155-DTR)
DataHandling	Continuous and Periodic dataselectable as options	Continuous and periodic datadefinition and rules updated toenable automated handling	Visensia®RequirementsSpecification (011-0106-FS),Design Specification(011-0114-DS) andVisensia® V3.1Summary Report(011-0155-DTR)

	Blood Pressure Scaling isbased on Mean and StandardDeviation of SDA	Blood Pressure scaling nowdepends on whether SDA is aboveor below the Mean, to take intoconsideration Hypo-tensive events.	Visensia®RequirementsSpecification (011-0106-FS),Design Specification(011-0114-DS) andVisensia® V3.1Summary Report(011-0155-DTR)
	Median Filtering for vital signvalues	Median Filtering applied tohistorical non-periodic data whenused alongside periodic data.	Visensia®RequirementsSpecification (011-0106-FS),Design Specification(011-0114-DS) andVisensia® V3.1Summary Report(011-0155-DTR)
Labelling	Manuals and Labelling	Updates to Manuals and Labellingto reflect new formatting styles.	Visensia® UserGuide (011-0131-LMAN), Visensia®Installation andConfigurationManual (011-0130-LMAN),Booklet forVisensia® V3Software (011-0127-LMAN),Case Label forVisensia® V3Software (011-126-LAB) andCD Label forVisensia® V3Software (011-0125-LAB)

Visensia V3 Special 510k Submission

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Image /page/2/Picture/0 description: The image shows the logo for OBS Medical. The logo consists of the letters "OBS" in bold, black font, with a horizontal line extending from the "S" to the right, forming a stylized electrocardiogram (ECG) waveform. Below the letters "OBS" is the word "Medical" in a bold, italicized font.

K110953

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Image /page/3/Picture/0 description: The image shows the logo for OBS Medical. The letters "OBS" are in bold, black font, and there is a line underneath them that resembles an EKG. Below the line, the word "Medical" is written in a bold, italicized, black font.

In summary, the OBS Medical Ltd Visensia® product described in this submission is, in our opinion, substantially equivalent to the predicate device (K081140).

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Performance Testing

The following testing has been carried out:

Unit Testing has been carried out by developers on individual software modules of the . system. Modules are tested in isolation from the rest of the system.
Integration Testing has been carried out with all modules integrated in to a single . software build. These test that the modules work correctly when integrated and is conducted during the system testing process. This is conducted at this point due to the design of the Software architecture.
System Testing has been carried out on the completed product. This includes the full . software device operating on representative hardware and communicating with a Philips MP30 patient monitor and an emulated clinical information system.

In summary, all the required testing has been carried out with satisfactory results for the release.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three overlapping wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OBS Medical c/o Ms. Barbara J. Uggen-Davis Chief Operating Officer 10401 North Meridian, Ste. 300 Indianapolis , IN 46290

JUN 1 5 2011

Re: K110953 Visensia® Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MHX Dated: May 15, 2011 Received: May 16, 2011

Dear Ms. Uggen-Davis:

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 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 - Ms. Barbara J. Uggen-Davis

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 (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.

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/ReportaProblem/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.

Sincerely yours,

Bram D. Zuckerman, M.D.

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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Image /page/7/Picture/1 description: The image shows the logo for OBS Medical. The logo has the letters "OBS" on the top line, with a horizontal line extending from the right side of the "S" to the right. To the right of the letters, there is a line graph that resembles an EKG. The word "Medical" is on the second line, below the letters "OBS".

SECTION 6

INDICATIONS FOR USE

510(k) Number (if known): K110953

Device Name: Visensia®

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 D)

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

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K

Page 1 of

Visensia V3 Special 510k Submission

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.