The intended use of the UCR Spinal System, polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, set screws, and components, is substantially equivalent to the intended use of the predicate device. The intended use of the UCR Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The intended use of the UCR Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The intended use and indications of the UCR Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T-L-S and are as follows:
Device Story
UCR Spinal System is a posterior, non-cervical spinal fixation system; includes polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, and caps. Components are manufactured from titanium alloy; instruments utilize stainless steel, aluminum, Radel, and silicone. System is supplied non-sterile; requires high-temperature steam sterilization before use. Intended for surgical implantation by physicians to stabilize thoracic, lumbar, and sacral spinal segments to facilitate fusion. Provides mechanical immobilization for patients with spinal instabilities or deformities. Benefits include structural support during biological fusion process; implants may be removed after solid fusion is achieved in specific spondylolisthesis cases.
Clinical Evidence
Bench testing only. No clinical data provided. Mechanical strength testing performed to demonstrate equivalence to predicate components.
Technological Characteristics
Titanium alloy implants; stainless steel, aluminum, Radel, and silicone instruments. Polyaxial screw/rod fixation system. Non-sterile; requires high-temperature steam sterilization. Mechanical stabilization principle. No software or electronic components.
Indications for Use
Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for: degenerative disc disease (DDD), spondylolisthesis (including severe Grades 3-4 at L5-S1), trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), spinal tumor, pseudoarthrosis, and failed previous fusion. Contraindications include cervical spine use.
Regulatory Classification
Identification
(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
Special Controls
*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
{0}------------------------------------------------
### UCR Spinal System
### 510(K) SUMMARY
Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.
| Submitter Information: | SeaSpine, Inc.<br>Contact: Diana Smith<br>2302 La Mirada Drive<br>Vista, CA 92081-7862<br>Phone: 760-727-8399 Fax: 760-727-8809 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | SeaSpine, Inc.<br>Contact: Diana Smith, Manager of<br>Regulatory Affairs and Quality Assurance<br>2302 La Mirada Drive<br>Vista, CA 92081-7862<br>Phone: 760-727-8399 Fax: 760-727-8809 |
| Date Summary Prepared: | November 19, 2004 |
| Classification Name: | Pedicle Screw Spinal System<br>MNH (Class II) - 888.3070(b)(1)<br>MNI (Class II) - 888.3070(b)(1)<br>NKB (Class III) – 888.3070(b)(2)<br>Spinal Interlaminal Fixation Orthosis<br>KWP (Class II) – 888.3050 |
| Common/Usual Name: | Polyaxial Screws, Polyaxial Reduction<br>Screws, Cross Links, Crossbars, Rods, Caps,<br>Components, and Instruments |
| Device Trade Name: | UCR Spinal System |
The primary device used for comparison in this summary is SeaSpine Inc.'s existing UCR Spinal System (K993503, K021623, and K032739/S1).
1. Intended Use: (The statements of intended use are identical.)
The intended use of the UCR Spinal System, polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, set screws, and components, is substantially equivalent to the intended use of the prodicate device. The intended use of the UCR Spinal System is as a temporary or permanent posterior, non-cervical implant to
। 8
{1}------------------------------------------------
### UCR Spinal System
correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use of the UCR Spinal System, when used as a Pedicic Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:
- . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- severe spondylolisthesis (Grades 3 and 4) of the US-S1 vertebra in skeletally . mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- . spondylolisthesis,
- . trauma (i.e., fracture or dislocation),
- . spinal stenosis,
- . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- . spinal tumor.
- pseudoarthrosis, and/or ◆
- . failed previous fusion.
The intended use and indications of the UCR Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to TI-I.S. and are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis .
- trauma (i.e., fracture or dislocation), .
- . spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), �
- . tumor,
- pseudarthosis, and/or
- failed previous fusion. �
### 2. Description:
The UCR Spinal System includes titanium alloy polyaxial and polyaxial reduction screw assemblics. Both screw types will be offered in numerous widths and lengths. The screw assembly is comprised of a screw body, washer, and housines. Both! screws are designed to be compatible with and work in conjunction with the components w
19
Page 2 of 4
{2}------------------------------------------------
### UCR Spinal System
the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The UCR Spinal System will also include titanium alloy cross links, crossbars, rods, and caps. The cross links will come in one size, the crossbars in five sizes, the rods in two diameters, and the caps in two sizes. The cross link assemblies are comprised of a nut and hook while the crossbar assemblies are made up of two bars, two locking screws, a coupler, and a pin. All of these devices are designed to be compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The UCR Spinal System will offer a wide variety of instruments that range from insitu rod benders to modular taps. These various instruments will be made primarily from various grades of stainless steel with a fcw components made from aluminum, titanium alloy, Radel, and silicone. These items are supplied "NON-STERILE" and must be sterilized prior to use.
#### 3. Technological Characteristics:
The polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, and components in this submission have been designed as an addition to the current UCR Spinal System. The devices being added to the UCR Spinal System have substantially equivalent technological characteristics to the predicate devices and are designed to be compatible with and work in conjunction with the current components in the UCR Spinal System. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.
### 4. Comparison Analysis:
The overall designs of the UCR Spinal System polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, and components are substantially equivalent to the predicate devices. See Table 1 on the following page for a companison of the UCR Spinal System polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, and components to the predicate devices.
Page 3 of 4
20
{3}------------------------------------------------
# Ko43232
# UCR Spinal System
| Feature | UCR Spinal System<br>(new components) | UCR Spinal System<br>(current) | Substantially<br>Equivalent |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------|
| Intended Use | The intended use of the UCR Spinal System<br>is as a temporary or permanent posterior,<br>non-cervical implant to correct spinal<br>disorders and provide stabilization of the<br>spine to permit the biological process of<br>spinal fusions to occur. | Similar | Yes |
| Indications for Use | • Degenerative disc disease (DDD) as<br>defined by back pain of discogenic origin<br>with degeneration of the disc confirmed by<br>patient history and radiographic studies,<br>• spondylolisthesis,<br>• trauma (i.e., fracture or dislocation),<br>• spinal stenosis,<br>• deformities or curvatures (i.e., scoliosis,<br>kyphosis, and/or lordosis).<br>• tumor,<br>• pseudarthosis, and/or<br>• failed previous fusion. | Similar | Yes |
| Design | Polyaxial screws, polyaxial reduction<br>screws, cross links, crossbars, rods, caps,<br>and components | Similar | Yes |
| Screw Sizes | See prints | Similar | Yes |
| Cross Links | See prints | Similar | Yes |
| Crossbars | See prints | Similar | Yes |
| Rods | See prints | Similar | Yes |
| Caps | See prints | Similar | Yes |
| Material | Titanium alloy | Similar | Yes |
| Sterile | Non-sterile | Similar | Yes |
| Method of<br>Sterilization | High-temperature steam | Similar | Yes |
| Mechanical Strength | See test results | Similar | Yes |
Table 1: Summary of Design Comparison
21
Page 4 of 4
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol that resembles an abstract bird or human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2004
Ms. Diana Smith Manager of Regulatory Affairs and Quality Assurance SeaSpine, Inc. 2302 La Miranda Drive Vista, California 92081
Re: K043232
Trade/Device Name: UCR Spinal System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: III Product Code: NKB, KWP, MNH, MNI Dated: November 17, 2004 Received: November 22, 2004
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{5}------------------------------------------------
Page 2 - Ms. Diana Smith
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 (240) 276-0120. 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 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,
Lila witte
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
### Indications for Use Statement
510(k) Number (if known): K043232
Device Name: UCR Spinal System
Indications for Use:
The intended use of the UCR Spinal System, polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, set screws, and components, is substantially equivalent to the intended use of the predicate device. The intended use of the UCR Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use of the UCR Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally . mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis, .
- trauma (i.e., fracture or dislocation), ●
- spinal stenosis, .
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (21 CFR 807 Subpart C)
(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 General, Restoration and Neurological Devices
| 510(k) Number | K043232 |
|---------------|---------|
|---------------|---------|
Page 1 of 2
Page 1 of 2<sup>25</sup>
{7}------------------------------------------------
## Indications for Use Statement continued
The intended use and indications of the UCR Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T L J and are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis .
- trauma (i.e., fracture or dislocation), .
- . spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
- . tumor.
- pseudarthosis, and/or .
- failed previous fusion.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
# Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Page 2 of 2
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.
