Guglielmi Detachable Coils (GDC®): For embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable; and for embolizing other vascular malformation such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature. Fibered Platinum Coil, .035" Type: For arterial and venous embolizations in the peripheral vasculature. Berenstein Liquid Coil: For the embolization of vascular malformations of the peripheral, coronary and neuro vasculature. Occlusion Coils (except Fibered Platinum Coil .035" Type and Berenstein Liquid Coil): Coils are intended to obstruct or reduce blood flow in the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations and arteriovenous fistulas when devascularization prior to definitive surgical resection is desirable. Guidewires: Target Therapeutics Steerable Guidewires are designed to assist in the delivery of Tracker Infusion Catheters to selected vascular sites. Tracker® Infusion Catheter: Tracker Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. Stealth® Dilation Catheter: The Stealth Dilation Catheter System is intended for the dilatation of peripheral vasculature (PTA). This device is not intended for use in the coronary arteries. Coil Pusher: The coil pusher is a guidewire-like device consisting of a stainless steel wire with a radiopaque gold marker at its tip. The coil pusher is intended to be used by the physician in deploying the coil to the site. Guidewire Introducer: The guidewire introducer consists of a cannula and luer used to introduce guidewires into catheter hubs or hemostatic valves. Guidewire Torquer: The guidewire torquer was developed to enhance control of torqueable guidewires during intravascular placement. Rotating Hemostatic Valve: To maintain a fluid tight seal at the point of entry when a guiding catheter or sheath is used to support the placement of a therapeutic or diagnostic catheter. Shaping Mandrel: The Shaping Mandrel is a stainless steel accessory device used by physicians to form or shape a catheter tip to suit the requirements of a particular case. Valve Wire: The Valve Wire is used in conjunction with Stealth balloon dilatation catheters to seal the distal end of the balloon section enabling it to be inflated.
Device Story
Device family includes Guglielmi Detachable Coils (GDC), occlusion coils, infusion catheters, dilatation catheters, and accessories (guidewires, torquers, valves, pushers, mandrels). Used by neurosurgeons/interventional radiologists in clinical settings for vascular embolization, PTA, and catheter delivery. GDC coils deployed to occlude aneurysms/malformations; infusion catheters deliver contrast/therapeutic agents; dilatation catheters perform PTA. Accessories facilitate device navigation, torque control, and hemostasis. Physician operates devices under fluoroscopic guidance. Benefits include minimally invasive management of high-risk/inoperable intracranial aneurysms and vascular malformations, and effective peripheral vessel dilatation.
Clinical Evidence
Bench testing only. No clinical data presented. Testing included visual/dimensional inspection, functional performance (detachment time, tensile strength, tip flexibility, static rupture, torque control), biocompatibility (FTIR spectragraphs of materials), and sterile barrier/packaging integrity.
Technological Characteristics
Materials: Dacron, PTFE, platinum, stainless steel, polyethylene, silicone, polypropylene, polycarbonate, polyurethane. Energy: Mechanical. Connectivity: None. Sterilization: Not specified. Form factor: Catheters, coils, guidewires, and accessories. Software: None.
Indications for Use
Indicated for patients requiring embolization of intracranial aneurysms, vascular malformations (AVMs, fistulae), or peripheral/coronary vascular procedures; PTA for peripheral vasculature; and accessory support for catheter/guidewire delivery and manipulation. Contraindicated for coronary artery use for Stealth Dilation Catheters.
Regulatory Classification
Identification
A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
Special Controls
*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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K971395
July 14, 1997
## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS, CLASS III CERTIFICATION STATEMENT, CERTIFICATION OF IDENTICAL MATERIALS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
#### a) Summary of Safety and Effectiveness
#### CONTACT PERSON:
Roxane Baxter Manager, Regulatory Affairs Target Therapeutics, Inc. 47201 Lakeview Blvd. Fremont, CA 94538-6530
## DEVICE NAMES:
Please refer to Table 1 (Page 10)
### DEVICE DESCRIPTIONS:
Please refer to Table 1 (Page 10)
#### INDICATIONS FOR USE:
Please refer to Table 2 (Pages 13 and 14)
#### PREDICATE DEVICES:
- · Guglielmi Detachable Coil K962503
- · GUIDEWIRES
- Dasher K950069, K915115
- Taper K924987, K880762
- Seeker K912293, K922912
- Stubbie K912293
- · OCCLUSION COILS
- Fibered Platinum Coil, .035" Type K955293
- Berenstein Liquid Coil K964112
- Occlusion Coils K914786
- · TRACKER Infusion Catheters K925813
- · STEALTH Dilatation Catheters K915895
- · ACCESSORIES
- Rotating Hemostatic Valve K873971
- Guidewire Introducer K873972
- Guidewire Torquer K860840
- Coil Pusher K911779, K891688
- Shaping Mandrel K951159
- Valve Wire K915895, K90428
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TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION:
Table 1 summarizes the testing done in support of a determination of substantial equivalence. Testing in support of this submission may be found in Section 6 beginning on page 37.
| Product Family | Functional<br>Tests | Chemical Degradation /<br>Biocompatibility Tests | Sterile Barrier Test |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Guglielmi<br>Detachable Coil<br>(GDC®) | • Visual / Dimensional<br>Inspection<br>• Detachment Time<br>• Bushing Leak Test<br>• Tensile Strength<br>Reference Section 6E,<br>Page 118 | FTIR spectragraphs<br>generated for:<br>• Dacron Fiber<br>• PTFE Bushing<br>• Teflon Spray<br>Reference Section 6E,<br>Page 119 and 125 | Packaging Integrity /<br>Microbial Challenge Test<br>(Tracker-18 used for<br>representative product<br>packaging)<br>Reference:<br>Section 6E, Page 119 and<br>Section 6F, Page 130 |
| Occlusion Coils | • Visual / Dimensional<br>Inspection<br>• Fiber Integrity<br>Reference Section 6D,<br>Page 106 | FTIR spectragraph<br>generated for:<br>• Dacron Fiber<br>Reference Section 6D,<br>Page 107 and 114 | Packaging Integrity /<br>Microbial Challenge Test<br>(Tracker-18 used for<br>representative product<br>packaging)<br>Reference:<br>Section 6D, Page 107 and<br>Section 6F, Page 130 |
| Tracker Infusion<br>Catheters | • Visual / Dimensional<br>Inspection<br>• Tip Flexibility<br>• Static Rupture<br>• Tensile Strength<br>• Coating Integrity<br>Reference Section 6B,<br>Page 65 | FTIR spectragraphs<br>generated for:<br>• Polyethylene<br>• Polyethylene w/<br>Silicone Coating<br>• Silicone Coating<br>• Polypropylene<br>• Polycarbonate Hub<br>• Polyurethane Luer<br>Fitting<br>• Polycarbonate RHV<br>Reference Section 6B,<br>Page 67 and 76 | Packaging Integrity /<br>Microbial Challenge Test<br>(Tracker-18 used for<br>representative product<br>packaging)<br>Reference:<br>Section 6B, Page 67 and<br>Section 6F, Page 130 |
| Table 1 |
|-------------------------------------------------|
| Summary of Tests - By Product or Product Family |
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## Table 1 (cont.) Summary of Tests - By Product or Product Family
| Product Family | Functional<br>Tests | Chemical Degradation /<br>Biocompatibility Tests | Sterile Barrier Test |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| STEALTH Balloon<br>Dilatation Catheters | • Visual / Dimensional<br>Inspection<br>• Static Rupture<br>• Valve Wire Sealing<br>• Silicone Coating<br>Integrity<br>Reference Section 6C,<br>Page 90 | FTIR spectragraphs<br>generated for:<br>• Silicone Coating<br>• Polyethylene<br>- distal shaft<br>- proximal shaft<br>- balloon tubing<br>Reference Section 6C,<br>Page 90 and 99 | Packaging Integrity /<br>Microbial Challenge Test<br>(Tracker-18 used for<br>representative product<br>packaging)<br>Reference:<br>Section 6C, Page 90 and<br>Section 6F, Page 130 |
| Guidewires | • Visual / Dimensional<br>Inspection<br>• Tip Stiffness<br>• Tensile Strength<br>• Turns to Failure<br>• Teflon Adhesion<br>- Spray coating<br>- Laminated tubing<br><br>Reference Section 6A,<br>Page 39 | FTIR spectragraphs<br>generated for:<br>• Teflon Spray Coating<br>• Teflon Tubing,<br>Laminated<br>• Silicone Coating<br><br>Reference Section 6A,<br>Page 41 and 59 | Packaging Integrity /<br>Microbial Challenge Test<br>(Tracker-18 used for<br>representative product<br>packaging)<br>Reference:<br>Section 6A, Page 41 and<br>Section 6F, Page 130 |
| Accessories | | | |
| Guidewire Torquer | • Visual / Dimensional<br>Inspection<br>• Component<br>Compatibility Test<br>• Grip Test<br><br>Reference Section 6A,<br>Page 40 | N/A - no body contact | Packaging Integrity /<br>Microbial Challenge Test<br>(Tracker-18 used for<br>representative product<br>packaging)<br>Section 6F, Page 130 |
| Guidewire Introducer | • Visual / Dimensional<br>Inspection<br>• Introducer Pull Test<br><br>Reference Section 6A,<br>Page 40 | N/A - no body contact | Packaging Integrity /<br>Microbial Challenge Test<br>(Tracker-18 used for<br>representative product<br>packaging)<br>Section 6F, Page 130 |
| Product Family | Functional<br>Tests | Chemical Degradation /<br>Biocompatibility Tests | Sterile Barrier Test |
| Accessories (cont.)<br>Rotating Hemostatic<br>Valve | • Visual / Dimensional<br>Inspection<br>Reference Section 6B,<br>Page 84 | FTIR spectrograph<br>generated for:<br>• Polycarbonate<br>Reference Section 6B,<br>Page 84 and 94 | Packaging Integrity /<br>Microbial Challenge Test<br>(Tracker-18 used for<br>representative product<br>packaging)<br>Reference:<br>Section 6F, Page 130 |
| Shaping Mandrel | Covered under testing<br>done for guidewires.<br>Reference Section 6A,<br>Page 66 | Covered under testing<br>done for guidewires.<br>Reference Section 6A. | " |
| Valve Wire | Covered under testing<br>done for guidewires.<br>Reference Section 6A. | FTIR spectrographs<br>generated for:<br>• Teflon coating<br>• Silicone coating<br>Covered under testing<br>done for guidewires.<br>Reference Section 6A. | " |
| Coil Pushers | • Visual / Dimensional<br>Inspection<br>• Tip Stiffness<br>• Tensile Strength<br>• Turns to Failure<br>• Teflon Adhesion<br>- Spray coating<br>- Laminated tubing<br>Reference Section 6A,<br>Page 39 | FTIR spectrograph<br>generated for:<br>• Teflon coating<br>Covered under testing<br>done for guidewires.<br>Reference Section 6A. | " |
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## Table 1 (cont.) Summary of Tests - By Product or Product Family
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Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Roxane Baxter Manager, Regulatory affairs Target Therapeutics 47201 Lakeview Boulevard Fremont, California 94538-6530
JUL 14 1997
K971395 Re: Various Class II and Class III devices (add shelf life) Requlatory Class: II and III (Two and Three) Product Codes: 74 DQX, 74 GBK, 74 LIT, 74 KRD, 74 DYG, and 84 HCG Dated: April 14, 1997 Received: April 15, 1997
Dear Ms. Baxter:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Fractice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act
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#### Page 2 - Ms. Roxane Baxter
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification (i.e., with a shelf life of either 36 or 50 months, depending on the device). 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1__of_1
# TARGET THELAPEUTIC
## 510(k) Number (if known): K971395 Device Name: See table below
Indications For Use: See table below
| Device Name | Indications |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Guglielmi Detachable Coils (GDC®) | For embolizing certain intracranial aneurysms that - because of their morphology, their location, or the<br>patient's general medical condition - are considered by the treating neurosurgical team to be a) very high<br>risk for management by traditional operative techniques, or b) inoperable; and for embolizing other<br>vascular malformation such as arteriovenous malformations and arteriovenous fistulae of the neuro<br>vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral<br>vasculature. |
| Occlusion Coils: | |
| Fibered Platinum Coil, .035" Type | For arterial and venous embolizations in the peripheral vasculature |
| Berenstein Liquid Coil | For the embolization of vascular malformations of the peripheral, coronary and neuro vasculature. |
| Occlusion Coils (except Fibered<br>Platinum Coil .035" Type and<br>Berenstein Liquid Coil) | Coils are intended to obstruct or reduce blood flow in the peripheral and neurovasculature. They are<br>intended for use in the interventional radiologic management of arteriovenous malformations and<br>arteriovenous fistulas when devascularization prior to definitive surgical resection is desirable. |
| Guidewires | Target Therapeutics Steerable Guidewires are designed to assist in the delivery of Tracker Infusion<br>Catheters to selected vascular sites. |
| Tracker® Infusion Catheter | Tracker Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast<br>media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and<br>neurovasculature. |
| Stealth® Dilation Catheter | The Stealth Dilation Catheter System is intended for the dilatation of peripheral vasculature (PTA). This<br>device is not intended for use in the coronary arteries. |
| Coil Pusher | The coil pusher is a guidewire-like device consisting of a stainless steel wire with a radiopaque gold<br>marker at its tip. The coil pusher is intended to be used by the physician in deploying the coil to the site. |
| Guidewire Introducer | The guidewire introducer consists of a cannula and luer used to introduce guidewires into catheter hubs<br>or hemostatic valves. |
| Guidewire Torquer | The guidewire torquer was developed to enhance control of torqueable guidewires during intravascular<br>placement. |
| Rotating Hemostatic Valve | To maintain a fluid tight seal at the point of entry when a guiding catheter or sheath is used to support the<br>placement of a therapeutic or diagnostic catheter. |
| Shaping Mandrel | The Shaping Mandrel is a stainless steel accessory device used by physicians to form or shape a<br>catheter tip to suit the requirements of a particular case. |
| Valve Wire | The Valve Wire is used in conjunction with Stealth balloon dilatation catheters to seal the distal end of the<br>balloon section enabling it to be inflated. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
_
(Division Sign-Off)
Division of Cardiovascular. Respiratory, and Neurological Devices
510(k) Number_k 471395
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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.
