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® 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Device Story
Visensia is a software accessory for multi-parameter patient monitors or clinical information systems; operates on standard PCs. Inputs: heart rate, respiratory rate, temperature, blood pressure, oxygen saturation. Processing: advanced signal processing combines these inputs into a single 'Visensia Index' representing patient condition relative to normality. Output: Visensia Index and trend graph displayed to clinicians; alerts triggered when index surpasses default thresholds. Context: used in clinical settings (bedside, ambulatory, centralized) by healthcare professionals. Purpose: adjunct to standard monitoring; provides decision support by alerting clinicians to physiological status changes; aids in early detection of patient deterioration.
Clinical Evidence
Clinical data provided illustrates the effectiveness of the Visensia Index and the utility of the alert function. Data demonstrates a correlation between patient deterioration and the device's alerting function. Design validation confirmed that the Visensia index model specifications conform to user needs and intended use.
Technological Characteristics
Software-based accessory operating on standard off-the-shelf PC hardware. Utilizes advanced signal processing algorithms to perform data fusion of physiological inputs (heart rate, respiration rate, temperature, oxygen saturation, blood pressure). Provides a single index (Visensia Index) and trend display. No direct patient contact; no specialized energy source required beyond standard PC power.
Indications for Use
Indicated for non-paediatric high dependency care patients already undergoing routine multi-parameter vital sign monitoring. Used by healthcare professionals to monitor patient status via a single index derived from vital signs.
Regulatory Classification
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.
Special Controls
*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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## 510(k) Summary
# Prepared on July 8, 2008
| 1. | General Information | JUL 1 7 2008 |
|----|------------------------------|--------------------------------------------------------------------------------------------------------------|
| | Trade Names of Device: | Visensia®<br>Visensia® with Alert<br>Visensia® Alert |
| | Common/Usual Name: | Accessory to multi-parameter patient<br>monitor (bedside or ambulatory) |
| | Classification Name: | Physiological Patient Monitor (with<br>arrhythmia detection or alarms) |
| | Submitters Name and Address: | OBS Medical<br>11495 N Pennsylvania St., Ste 250<br>Carmel, IN 46032<br>Tel 317-581-3937<br>Fax 317-581-8941 |
| | Manufacturer: | OBS Medical<br>11495 N Pennsylvania St., Ste 250<br>Carmel, IN 46032<br>Tel 317-819-3937 |
### 2. 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.
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.
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.
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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:
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.
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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
