The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, by a trained person who is considered competent in the use of the device. The SC+ Blood Tubeset is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System.
Device Story
Hemodialysis delivery system for acute/chronic renal failure; utilizes dialysis water from external RO units to produce dialysate. System comprises SC+ Machine, single-use Dialysate Cartridge, and sterile Blood Tubeset. Machine features water circuit, blood leak/air-in-blood detectors, pneumatic interface, peristaltic blood pump, and sensors. Cartridge performs mixing/proportioning via membrane pumps and monitors conductivity, pressure, and temperature. Tubeset provides extracorporeal access via arterial/venous lines, pressure transducer pods, and venous drip chamber. Used in acute/chronic care facilities by trained operators. Modifications include 3G/4G cellular data transmission to Quanta Service Portal, software update capability, and streamlined priming/air removal workflows. Output informs clinical decision-making regarding fluid removal and dialysis therapy. Benefits include controlled fluid removal and renal replacement therapy.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical safety, electromagnetic compatibility, software verification, human factors validation, and biological safety testing.
Technological Characteristics
System uses PVC and PP blood tubing. Machine includes peristaltic blood pump, membrane pumps for dialysate proportioning, conductivity/pressure/temperature sensors, and air/blood leak detectors. Connectivity via 3G/4G cellular and ethernet. Software-controlled with GUI. Sterilization for tubeset is sterile/non-pyrogenic. Complies with consensus standards for hemodialysis systems.
Indications for Use
Indicated for patients with acute and/or chronic renal failure requiring hemodialysis with or without ultrafiltration in acute or chronic care facilities. Requires physician prescription and administration by trained, competent personnel.
Regulatory Classification
Identification
A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
Special Controls
*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 12, 2021
Quanta Dialysis Technologies Ltd Sam Drew Risk and Regulatory Manager 1-3 Tything Road Alcester, Warwickshire B49 6EU UNITED KINGDOM
K210661 Re:
> Trade/Device Name: SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: KDI, FJK Dated: July 12, 2021 Received: July 13, 2021
Dear Sam Drew:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carolyn Y. Neuland, Ph.D. Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K210661
Device Name SC+ Hemodialysis Machine SC+ Dialysate Cartridge SC+ Blood Tubeset
Indications for Use (Describe) SC+ Hemodialysis Machine/ SC+ Dialysate cartridge
The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, by a trained person who is considered competent in the use of the device.
SC+ Blood Tubeset
The SC+ Blood Tubeset is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows a logo with a dark blue circle that has a break in the lower right quadrant. A small turquoise square fills the break in the circle. The logo is simple and modern, with a clean design.
K210661 510(k) Summary Date of preparation: 12th July 2021
# 510(k) Summary
The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92
## 1.1 Manufacturer
Quanta Dialysis Technologies Ltd Tything Road, Alcester, Warwickshire, B49 6EU, United Kingdom
## 1.2 Contact
Sam Drew Sam.drew@quantadt.com +44 01789 400043
## 1.3 Device information
The SC+ Hemodialysis system comprises of the SC+ Hemodialysis Machine, the SC+ Dialysate Cartridge and the SC+ Blood Tubeset.
#### 1.3.1 SC+ Machine & Dialysate Cartridge
#### General Device Information 1.3.1.1
| Trade Name | SC+ Machine & SC+ Dialysate Cartridge |
|---------------------|------------------------------------------------------------------------|
| Common Name | Hemodialysis Delivery System |
| Product Code | KDI |
| Device | Dialyzer, High Permeability With Or Without<br>Sealed Dialysate System |
| Classification Name | High permeability hemodialysis system |
| Regulation Number | 21 CFR §876.5860 |
| Device Class | Class II |
| Review Panel | Gastroenterology/Urology |
Table 1: SC+ Device and Dialysate Cartridge general device information
{4}------------------------------------------------
## 1.3.1.2 Predicate Device Information:
| Trade Name | SC+ Machine & SC+ Dialysate Cartridge |
|---------------------|------------------------------------------------------------------------|
| Common Name | Hemodialysis Delivery System |
| Product Code | KDI |
| Device | Dialyzer, High Permeability With Or Without<br>Sealed Dialysate System |
| Classification Name | High permeability hemodialysis system |
| Regulation Number | 21 CFR §876.5860 |
| Device Class | Class II |
| Review Panel | Gastroenterology/Urology |
| 510(k) reference | K193670 |
| Date of Clearance | 2020-12-23 |
Table 2: SC+ device and Dialysate Cartridge predicate device information
#### SC+ Blood Tubeset 1.3.2
#### 1.3.2.1 General Device Information
| Trade Name | SC+ Blood Tubeset |
|---------------------|---------------------------------------------------------------|
| Common Name | Blood Tubing Set |
| Product Code | FJK |
| Device | SC+ Blood Tubeset |
| Classification Name | Set, tubing, blood, with and without anti-regurgitation valve |
| Regulation Number | 21 CFR §876.5820 |
| Device Class | Class II |
| Review Panel | Gastroenterology/Urology |
Table 3: SC+ Blood Tubeset general device information
#### 1.3.2.2 Predicate Device Information:
| Trade Name | SC+ Blood Tubeset |
|---------------------|-------------------------------------------------------------------|
| Common Name | Blood Tubing Set |
| Product Code | FJK |
| Device | SC+ Blood Tubeset |
| Classification Name | Set, tubing, blood, with and without anti-<br>regurgitation valve |
| Regulation Number | 21 CFR §876.5820 |
| Device Class | Class II |
| Review Panel | Gastroenterology/Urology |
| 510(k) reference | K193670 |
| Date of Clearance | 2020-12-23 |
Table 4: SC+ Blood Tubeset predicate device information
{5}------------------------------------------------
# 1.4 Device Description
The SC+ is a hemodialysis delivery system intended for acute and chronic dialysis therapy with or without ultrafiltration in an acute of chronic care facility. The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.
### 1.4.1 SC+ Hemodialysis System
The SC+ Hemodialysis System is intended for acute and chronic dialysis therapy, with or without ultrafiltration, utilizing Dialysis Water (from standalone Reverse Osmosis (RO) units or a central RO ring main) to produce dialysate. The SC+ Hemodialysis system is for use in patients with arteriovenous (AV) fistula or central venous catheter access.
The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.
The SC+ Machine consists of a water circuit (heater, de-aeration module, etc) blood leak detector, air in blood detector, a pneumatic interface for the dialysate cartridges, a peristaltic blood pump and various other sensors. The dialysate cartridge contains the following; conductivity monitors, interfaces for pressure and temperature measurement, membrane pumps to perform mixing/proportioning in order to produce dialysis fluid and the controlled removal of fluid from a patient with acute and/or chronic renal failure based on a physician's prescription. The dialysate fluid is manufactured using dialysis water purified externally by reverse osmosis that is heated to approximately 37℃ and subsequently deaerated within the machine before entering the cartridge.
The SC+ Blood Tubeset is a single use, sterile device consisting of an arterial line, a venous line, connections to a standard dialyzer, a saline line, three pressure transducer pods integrated into a single unit, a venous drip chamber, and a line for heparin infusion.
# 1.5 Device Modifications
This 510(k) covers the following modifications:
- Addition of two-way wireless transmission capability for machine data ●
- Updated user workflows and interface for ease of use and streamlining ●
## 1.6 Indications for Use
### 1.6.1 SC+ Hemodialysis Machine & Dialysate Cartridge
The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, by a trained person who is considered competent in the use of the device.
### 1.6.2 SC+ Blood Tubeset
The SC+ Blood Tubeset is a single use, disposable arterial and venous bloodline
{6}------------------------------------------------
set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System.
#### 1.7 Technological Characteristics
#### Changed SC+ device vs SC+ device as cleared in K193670 1.7.1
The technological characteristics of the SC+ Machine and SC+ Dialysate Cartridge are considered to be equivalent to the predicate device, SC+ device and dialysate cartridge (K193670). A summary of the similarities and differences is provided in the table below.
| | Subject Device | Predicate<br>Device |
|------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---------------------|
| | SC+ (K210661) | SC+ (K193670) |
| Indicated for use in patients with acute and/or chronic renal failure, with<br>or without ultrafiltration in an acute or chronic care facility | ✓ | ✓ |
| Use of purified water for dialysate production | ✓ | ✓ |
| Use of third-party accessories, including dialyzers, endotoxin retentive<br>filters, acid and bicarbonate | ✓ | ✓ |
| Application of consensus standards | ✓ | ✓ |
| Device is software controlled and utilize Graphic User Interface (GUI). | ✓ | ✓ |
| Design and Construction - Blood pump, alarms, alerts, air detector<br>mechanism, and blood leak detectors. | ✓ | ✓ |
Table 5: Technological Characteristics of the SC+ Machine and predicate
Differences between the subject device and the predicate device:
- The subject device utilizes 3G/4G cellular communications to transmit machine . data (non-clinical) to the Quanta Service Portal and download software updates (duplicating the predicate device's ethernet connectivity as cleared in K193670)
- The subject device has streamlined process with regards to air in venous line removal and priming
{7}------------------------------------------------
#### Changed SC+ Blood Tubeset vs SC+ Blood Tubeset device as cleared in 1.7.2 K193670
The technological characteristics of the SC+ Blood Tubeset are considered to be equivalent to the predicate device, SC+ Blood Tubeset (K193670). A summary of the similarities and differences is provided in the table below.
| | Subject<br>Device | Predicate<br>Device |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-----------------------------------|
| | SC+ Blood<br>Tubeset<br>(K210661) | SC+ Blood<br>Tubeset<br>(K193670) |
| Intended Use: To provide extracorporeal access<br>during hemodialysis | ✓ | ✓ |
| Materials: Primary fluid path materials are Polyvinyl<br>Chloride (PVC) and Polypropylene (PP). | ✓ | ✓ |
| Design & Construction: Polyvinyl Chloride (PVC)<br>tubing of various lengths and diameters, with color<br>coded pinch clamps, color coded injection ports,<br>heparin line, saline line, and pressure monitoring<br>components. | ✓ | ✓ |
| Sterility: Sterile, single use, non-pyrogenic. | ✓ | ✓ |
| Priming Volume: | ≤165ml | ≤165ml |
| Needle configuration: Double needle | ✓ | ✓ |
Table 6: Technological Characteristics of the SC+ Blood Tubeset and predicate
Differences between the subject device and the predicate device:
- . The subject device includes a luer activated valve (needless valve/ air removal port) on the venous bloodline for streamlined air removal
- . The saline spike preconnected to the arterial bloodline is replaced with a recirculation luer (this recirculation luer is a component as cleared in K193670)
# 1.8 Summary of Verification and Validation Activities
The following performance testing, developed in accordance with appropriate FDA guidance documents and relevant standards, has been performed on the Modified Device to support the determination of substantial equivalence:
{8}------------------------------------------------
- Performance testing to verify maintenance of the Electrical Safety and Electromagnetic Compatibility profiles
- Software verification
- Human Factors validation testing •
- Biological safety testing •
# 1.9 Conclusion
The modified devices are substantially equivalent to the predicate devices
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.
