(71 days)
Not Found
No
The description focuses on a weighted average calculation of vital signs and does not mention AI or ML techniques. The performance studies described are standard software testing methods, not AI/ML model validation.
No
The device is described as an "accessory to multi-parameter patient monitors" and "computerized analysis software" that provides a patient status index based on vital signs. It is an adjunct to monitoring and is "not intended to replace vital sign monitoring," which indicates it is for monitoring and alerting purposes, not active treatment or therapy.
Yes
The device provides a "patient status index (Visensia® Index)" which is a "single measure of a patient's condition" based on vital signs, with an alert for when the "Visensia® Index has reached and/or surpassed the default threshold and indicates that attention should be brought to the patient." This indicates the device is used to interpret physiological data to identify a medical condition or risk, fitting the definition of a diagnostic device.
Yes
The device description explicitly states "Visensia® software is a computerized analysis software program" and describes its function as processing data from external patient monitors or clinical information systems. While it operates on hardware, the device itself is the software component.
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: Visensia® with alert is a software accessory that analyzes real-time physiological data (vital signs) collected by patient monitors. It does not analyze samples taken from the patient's body.
- Intended Use: The intended use clearly states it's an "accessory to multi-parameter patient monitors" and provides a "patient status index" based on vital signs. This is about monitoring and interpreting live physiological data, not analyzing biological samples.
Therefore, Visensia® with alert falls under the category of a medical device that processes and interprets physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MHX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
non-pediatric
Intended User / Care Setting
health care professionals / bedside, ambulatory, or centralized location
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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.
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
§ 870.1025 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.
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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
$1/5
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® 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
Visensia V3 Special 510k Submission
1
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 Alert
K081140 | Modified Device: Visensia®
Device
K110953 | Data Supporting
Change |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | 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 | Indication/Intended Use of the
modified device as described in its
labelling has not changed along
with the proposed labelling which
includes the User Guide,
Installation and Configuration
Manual, Booklet for Visensia,
Case Label and CD Label for
Visensia. | None |
| | | | |
| | 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. | | |
| Alerts | Variable Alert | Same variable alert, but now able
to be set for individual bed from
the interface by clinicians. | Visensia®
Requirements
Specification (011-
0106-FS),
Design Specification
(011-0114-DS) and
Visensia® V3.1
Summary Report
(011-0155-DTR) |
| Algorithm | Visensia® Algorithm | Visensia® Algorithm re-factored
to improve software integrity.
No change to the design of the
algorithm. | Visensia® Index
Specification (011-
0107-FS),
Visensia® Index
Design Specification
(011-0143-DS) and
Visensia® V3.1
Summary Report
(011-0155-DTR) |
| Data
Handling | Continuous and Periodic data
selectable as options | Continuous and periodic data
definition and rules updated to
enable automated handling | Visensia®
Requirements
Specification (011-
0106-FS),
Design Specification
(011-0114-DS) and
Visensia® V3.1
Summary Report
(011-0155-DTR) |
| | | | |
| | Blood Pressure Scaling is
based on Mean and Standard
Deviation of SDA | Blood Pressure scaling now
depends on whether SDA is above
or below the Mean, to take into
consideration Hypo-tensive events. | Visensia®
Requirements
Specification (011-
0106-FS),
Design Specification
(011-0114-DS) and
Visensia® V3.1
Summary Report
(011-0155-DTR) |
| | Median Filtering for vital sign
values | Median Filtering applied to
historical non-periodic data when
used alongside periodic data. | Visensia®
Requirements
Specification (011-
0106-FS),
Design Specification
(011-0114-DS) and
Visensia® V3.1
Summary Report
(011-0155-DTR) |
| Labelling | Manuals and Labelling | Updates to Manuals and Labelling
to reflect new formatting styles. | Visensia® User
Guide (011-0131-
LMAN), Visensia®
Installation and
Configuration
Manual (011-0130-
LMAN),
Booklet for
Visensia® V3
Software (011-0127-
LMAN),
Case Label for
Visensia® V3
Software (011-126-
LAB) and
CD Label for
Visensia® V3
Software (011-0125-
LAB) |
Visensia V3 Special 510k Submission
2
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.
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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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Image /page/4/Picture/0 description: The image shows the logo for OBS Medical. The logo has the text "OBS" on the top line, with a horizontal line underneath. The word "Medical" is on the bottom line in a larger font. There is a heart rate line to the right of the text.
K110953
$5/5
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.
5
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.
6
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:
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.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
2
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