K250508 · Vantive US Healthcare, LLC · KDI · Aug 1, 2025 · Gastroenterology, Urology
Device Facts
Record ID
K250508
Device Name
AK 98 Dialysis Machine (955607)
Applicant
Vantive US Healthcare, LLC
Product Code
KDI · Gastroenterology, Urology
Decision Date
Aug 1, 2025
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5860
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The Baxter AK 98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or home use.
Device Story
Standalone hemodialysis machine for chronic/hospital care environments; operated by trained clinicians. Inputs: high purity water, dialysate concentrates, blood via extracorporeal circuit. System pumps blood, monitors arterial/venous pressure, and prepares dialysate (temperature, flow, composition). Includes 'Diascan' clearance measurement and ultrafiltration profiling. Outputs: treated blood returned to patient; monitoring data. If faults occur, machine enters patient-safe state (e.g., dialyzer bypass). Clinicians use output to manage dialysis therapy and fluid removal. Benefits: effective renal replacement therapy for patients with renal failure or fluid overload.
Clinical Evidence
No clinical data. Substantial equivalence supported by functional performance testing, biocompatibility testing, and extractables/leachables assessment of the modified tubing component.
Technological Characteristics
Standalone hemodialysis delivery system. Materials include platinum-cured silicone tubing. Features: dialysate conductivity monitoring, isolated ultrafiltration, ultrafiltration control/supervision (IEC 60601-2-16), air/blood leak detection, temperature monitoring, and anticoagulant administration. Connectivity: HL7 protocol for clinical information system (CIS) integration. Disinfection: heat and chemical programs.
Indications for Use
Indicated for patients with chronic or acute renal failure or fluid overload requiring intermittent hemodialysis and/or isolated ultrafiltration. Patient population: body weight 25 kg or more. Contraindications: not for self-care or home use.
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.”
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FDA U.S. FOOD & DRUG ADMINISTRATION
August 1, 2025
Vantive US Healthcare LLC
Kristen Bozzelli
Senior Manager, Regulatory Affairs
One Baxter Parkway, Building 6
Deerfield, IL 60015
Re: K250508
Trade/Device Name: AK 98 Dialysis Machine (955607)
Regulation Number: 21 CFR§ 876.5860
Regulation Name: High permeability hemodialysis system
Regulatory Class: II
Product Code: KDI
Dated: July 3, 2025
Received: July 3, 2025
Dear Kristen Bozzelli:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K250508 - Kristen Bozzelli
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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K250508 - Kristen Bozzelli
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Gema Gonzalez -S
Maura Rooney
Assistant 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K250508
Device Name
AK 98 Dialysis Machine (955607)
Indications for Use (Describe)
The Baxter AK 98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or home use.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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K250508
Page 1 of 7
Vantive
510(k) Summary
July 30, 2025
OWNER:
Vantive US Healthcare LLC
One Baxter Parkway
Building 6
Deerfield, IL 60015
CONTACT PERSON:
Kristen Bozzelli
Senior Manager, Regulatory Affairs
Telephone: 1-224-948-5585
Fax: 1-224-948-2111
kristen.bozzelli@vantive.com
IDENTIFICATION OF THE DEVICE:
Common Name: Hemodialysis Delivery System
Trade/Device Name: AK 98 Dialysis Machine (955607)
Classification Panel: Gastroenterology and Urology
Regulation Number: 21 CFR 876.5860
Regulation Name: High Permeability Hemodialysis System
Regulatory Class: Class II
Product Code: KDI
Table 1. Product Codes in this Submission
| Product Code | Name |
| --- | --- |
| 955607 | AK 98 Dialysis Machine |
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Kantive
K250508
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# PREDICATE DEVICE:
Table 2. Predicate Device
| Proposed | Predicate | | | |
| --- | --- | --- | --- | --- |
| Device | Device | 510(k) Submitter | Predicate 510(k) | Clearance Date |
| AK 98 Dialysis Machine | AK 98 Dialysis Machine | Baxter Healthcare Corporation | K232467 | September 14, 2023 |
# DESCRIPTION OF THE DEVICE:
The AK 98 Dialysis Machine is a standalone hemodialysis machine intended for use as a single patient dialysis machine to perform HD treatments of patients with renal failure or fluid overload. The Vantive AK 98 Dialysis Machine is intended to be used in a chronic dialysis or hospitale care environment for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 Dialysis Machine is intended to be used on patients with a body weight of 25 kg or more.
To perform hemodialysis therapy, the AK 98 system needs a high purity water source and the appropriate consumables for treatment, including but not limited to: cleaning products, ultrafilters, acid and base dialysate concentrates, bloodlines, and dialyzers.
In hemodialysis therapies, the AK 98 is used to pump the blood through the extracorporeal circuit and to monitor the arterial and venous pressure, but the blood directly contacts only the disposable bloodline and dialyzer, not the monitor itself.
The fluid unit of the AK 98 Dialysis Machine is used to produce the dialysis fluid (with the correct temperature, flow, and composition) from reverse osmosis water and concentrates (dry or liquid) and to transport the dialysis fluid through the dialyzer. The fluid unit offers Profiling of Ultrafiltration and/or conductivity, it also offers isolated Ultrafiltration. The fluid unit also includes "Clearance Measurement" (Diascan). The fluid unit maintains the dialysis fluid flow through the dialyzer and controls ultrafiltration. If a fault occurs, the machine enters a patient safe state, which, depending upon the fault, can include actions such as bypassing the dialyzer.
The fluid path of the AK 98 is composed of a variety of different materials, including silicone tubing.
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Kantive
K250508
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# INDICATIONS FOR USE PROPOSED DEVICE:
The Baxter AK 98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician.
The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or Home use.
# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The differences between the predicate AK 98 dialysis machine and the proposed AK 98 dialysis machine as discussed in the AK 98 Device Comparison Table are considered substantially equivalent. See the comparison in Table 3.
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Vantive
K250508
Table 3. AK 98 Device Comparison
| Features | Predicate Device Cleared under K232467 | Proposed Device AK 98 Hemodialysis System | Assessment of Differences |
| --- | --- | --- | --- |
| Intended Use/ Indications for Use | The Baxter AK 98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or Home use. | Same | Not Applicable |
| Treatment modalities | Hemodialysis - HD DN/SP treatment - HD SN/SP treatment | Same | Not Applicable |
| Dialysate conductivity monitoring | Yes | Same | Not Applicable |
| Isolated UF | Yes | Same | Not Applicable |
| Ultrafiltration Control | Yes | Same | Not Applicable |
| Ultrafiltration Supervision | Yes, supervision in accordance with IEC 60601-2-16, 4th edition | Same | Not Applicable |
| Ultrafiltration accuracy | Between ±50 and ±100 g/h, depending on ultrafiltration rate | Same | Not Applicable |
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Kantive
K250508
Table 3. AK 98 Device Comparison
| Features | Predicate Device Cleared under K232467 | Proposed Device AK 98 Hemodialysis System | Assessment of Differences |
| --- | --- | --- | --- |
| | Note: Ultrafiltration accuracy calculated per section 13.1.6 in the AK 98 Operator’s Manual Ultrafiltration control: 50 mL or ± 50 mL/h x passed or treatment time (h) or ± 2.5% of the accumulated UF volume, whichever is largest
Provided the highest set UF rate (4 L/h), the worst-case accuracy is 100 g/h (based on ± 2.5% of the accumulated UF volume). | | |
| Air detector | Yes | Same | Not Applicable |
| Blood leak detector | Yes | Same | Not Applicable |
| Temperature monitoring | Yes | Same | Not Applicable |
| Fail-safe response during power failure | Yes | Same | Not Applicable |
| Prescription profiling | Conductivity profiling (Na, HCO₃) | Same | Not Applicable |
| Disinfection programs | Heat
Chemical | Same | Not Applicable |
| Anti coagulant administration rate | 0 – 10.0 ml/h | Same | Not Applicable |
| Anti coagulant bolus | 0 – 10.0 ml | Same | Not Applicable |
| Blood flow rate | 20 – 600 ml/min | Same | Not Applicable |
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K250508
Page 6 of 7
Vantive
Table 3. AK 98 Device Comparison
| Features | Predicate Device Cleared under K232467 | Proposed Device AK 98 Hemodialysis System | Assessment of Differences |
| --- | --- | --- | --- |
| Blood flow rate accuracy | For pre-pump pressure range from -200 mmHg to 0 mmHg: ±10 ml/min or ±10% of the set point value, whichever is the largest | Same | Not Applicable |
| Dialysate flow rate | 300 – 800 ml/min | Same | Not Applicable |
| Dialysate flow rate accuracy | ±10% or 50 ml/min whichever is largest | Same | Not Applicable |
| Transmembrane pressure | -200 – +500 mmHg (calculated value) set of LIMITS | Same | Not Applicable |
| Net fluid removal rate | 0 – 4 L/h | Same | Not Applicable |
| Dialysate temperature | 33 – 40 °C | Same | Not Applicable |
| Dialysate conductivity set range | 9 – 16 mS/cm | Same | Not Applicable |
| Arterial pressure | -400 - +300 mmHg | Same | Not Applicable |
| Venous pressure | +10 - +500 mmHg | Same | Not Applicable |
| Blood pressure measurements (BPM) | Yes | Same | Not Applicable |
| IT connectivity | Yes
Integrates with CIS (clinical information system) using HL7 protocol | Same | Not Applicable |
| Silicone Tubing | Peroxide-cured and Platinum-cured tubing | Platinum-cured tubing | Performance, biocompatibility, and extractables testing demonstrates that the difference in the curing process does not impact the performance or safety of the AK 98 Hemodialysis System |
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Kantive
K250508
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# DISCUSSION OF NONCLINICAL TESTS:
Functional performance testing, biocompatibility testing, and extractables and leachables assessment was conducted on the AK 98 dialysis machine with the proposed platinum-cured silicone tubing. This testing confirms that the AK 98 dialysis machine remains as safe and effective as the predicate AK 98 dialysis machine and is substantially equivalent.
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.
