Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a noncritical care setting for assessment of increased risk of access site stenosis in patients with grafts, as an aid for vascular access site management. The software is to be used with data generated from hemodialysis machines manufactured by Fresenius and Cobe/Gambro.
Device Story
Vasc-Alert is software for monitoring hemodialysis access site patency. It ingests pressure and flow rate data routinely collected by Fresenius and Cobe/Gambro hemodialysis machines. The software applies the Vascular Access Pressure Ratio (VAPR) algorithm to these inputs to calculate VAPR values for each treatment session. These values are stored in a database. The system identifies patterns of three consecutive high VAPR readings and generates reports for medical staff. Used in dialysis centers by healthcare professionals, the output serves as a clinical decision support tool to prompt closer examination for incipient stenosis and proactive intervention. By identifying patients at risk, the device aims to prevent access site closure.
Clinical Evidence
No formal clinical trial data provided. Substantial equivalence supported by side-by-side testing comparing Vasc-Alert to predicate devices. Results indicated Vasc-Alert identified more patients at risk than predicates, with the majority of these patients developing access site complications within 3 months, validating the device's ability to indicate developing stenosis.
Technological Characteristics
Software-based analysis system. Inputs: pressure and flow rate data from hemodialysis machines. Algorithm: Vascular Access Pressure Ratio (VAPR) test. Connectivity: Internet-based data input module. Components: data recording/parsing module, VAPR calculation module, pattern identification module, report generation module.
Indications for Use
Indicated for patients with grafts undergoing hemodialysis to assess increased risk of access site stenosis. Intended for use by healthcare professionals in noncritical care settings.
Regulatory Classification
Identification
A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
Predicate Devices
Transonic HD01 Hemodialysis Monitor (K960817 and K980906)
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# JUL 1 1 2003
# K030456 PAGE 1 OF 2 510(K) Summary
# 510(K) SUMMARY
#### Submitter's Name
Vasc-Alert L.L.C. 1807 W. Sunnyside Ave. Suite 301 Chicago, IL 60640
### Contact Person
| John Kennedy, President | |
|-------------------------|----------------------------------|
| Phone: | (773) 334-8177 |
| Fax: | (773) 334-8187 |
| E-Mail: | jkennedy@openchannelsoftware.com |
# Date of preparation of this summary: December 30, 2002
# General Information
| Proprietary Name | Vasc-Alert: Vascular Data Analysis for Access Site Monitoring |
|---------------------|----------------------------------------------------------------------------------------------------------|
| Common / Usual Name | Hemodialysis access site patency monitoring software |
| Classification Name | System, Hemodialysis, Access Recirculation Monitoring |
| Equivalent Devices | The Transonic HD01 Hemodialysis Monitor (K960817 and K980906)<br>and Medisystems Access Alert (K002372). |
# Device Description
Vasc-Alert is a software program for alerting dialysis center personnel of an increased risk of access site stenosis for individual hemodialysis patients. Vasc-Alert utilizes measurements routinely collected during a dialysis treatment by the hemodialysis machine, such as pressure and flow rate, and applies a previously published algorithm called the Vascular Access Pressure Ratio (VAPR) test to these measurements. The average VAPR test result for each treatment session is stored in a Vasc-Alert database. If a patient has a high reading in three consecutive dialysis sessions, a report is issued to the medical staff indicating that the patient should be examined more closely for the onset of stenosis. Hemodialysis center personnel can use the report as a tool to proactively monitor for incipient stenosis and prompt proactive intervention to avoid site closure.
Vasc-Alert comprises five main components or modules:
- 해 A module for recording, transferring and parsing data collected by dialysis center machines.
- A module for calculating the VAPR values from treatment data. 특
- A module for identifying significant patterns in the calculated VAPR data that will prompt an alert (i.e., 3 high readings in a row for a patient).
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K030456
PAGE 2 OF 2
510(K) Summary
- A module for generating reports and sending these out to center personnel. 트
- An internet-based data input module. I
### Intended Use
Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a noncritical care setting for assessment of increased risk of access site stenosis in patients with grafts, as an aid for vascular access site management. The software is to be used with data generated from hemodialysis machines manufactured by Fresenius and Cobe/Gambro.
### Substantial Equivalence Comparison
The Vasc-Alert device is substantially equivalent to both the Transonic Flow Monitor and the Access Alert product because it has the same intended use (detection of the buildup of stenosis in the access site), and has proven in side-by-side testing that they can detect the same 'at risk' patients. The devices cited as equivalent also use essentially the same technology in their analysis (pressure and flow). Access Alert uses the same physical measurements as an indication of stenosis (pressure measurement). The Transonic Flow Monitor measures flow, which is directly related to pressure of Bernoulli's Principle. While Vasc-Alert identified more patients at risk than the other technologies, the majority of these patients did in fact develop complications in their access sites within 3 months, proving that Vasc-Alert can be used as an indication of stenosis developing in the access site.
### Safety and Effectiveness
The system is considered to be a MINOR risk for users and patients because:
- T it does not control a life supporting or life-sustaining device,
- it does not control the delivery of potentially harmful energy, 비
- 트 it does not control treatment delivery,
- it does not provide diagnostic information on which treatment or therapy is based, such that if I misapplied it could result in serious injury or death,
- I it does not perform vital signs monitoring.
As a practical matter, the reports generated by Vasc-Alert merely prompt medical staff to examine the patient more closely to confirm the degree of stenosis present and its location. Such an examination is common practice prior to any intervention.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2003
Mr. John Kennedy President Vasc-Alert L.L.C. 1807 W. Sunnyside Suite 301 CHICAGO IL 60640
Re: K030456
Trade/Device Name: Vasc-Alert Regulation Number: 21 CFR \$876.5820 Regulation Name: Hemodialysis systems and accessories Regulatory Class: II Product Code: 78 KOC Dated: June 13, 2003 Received: June 16, 2003
Dear Mr. Kennedy:
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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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 one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known): K030456
Device Name: Vasc-Alert
Indications for Use:
Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a noncritical care setting for assessment of increased risk of access site stenosis in patients, as an aid for vascular access site management. The software is to be used with data generated from hemodialysis machines manufactured by Fresenius and Cobe/Gambro.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
*Prescription Use* ✓
David A. Lynn
(Division Sign-Off) n of Reproductive. Al
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.
