FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
K041903 · Fujinon, Inc. · FDF · Nov 10, 2004 · Gastroenterology, Urology
Device Facts
Record ID
K041903
Device Name
FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
Applicant
Fujinon, Inc.
Product Code
FDF · Gastroenterology, Urology
Decision Date
Nov 10, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Device Story
Fujinon G5 Colonoscopes are flexible endoscopes used by physicians for visualization, diagnosis, and treatment of the lower digestive tract. The device captures optical images of the rectum and large intestine, transmitting them to a processor (EPX-201 or VP-402) for display on a monitor. The G5 upgrade introduces ergonomic and usability improvements: repositioned jet water wash port (J-Port) to the distal end; removal of internal check valves in favor of external, removable valves to facilitate cleaning; modified forceps inlet port with a rubber cap for improved suction/seal; and compatibility with the CA-500 cleaning adaptor. The device is operated by a physician in a clinical setting. Output allows real-time visualization for diagnostic assessment and guidance during endoscopic procedures, potentially improving patient outcomes through accurate diagnosis and minimally invasive treatment.
Clinical Evidence
Bench testing only. The device underwent EMC testing and design verification. Patient contact materials are identical to predicate devices. No clinical data was required or provided.
Technological Characteristics
Flexible fiber-optic/video endoscope. Distal end diameter 12.8-12.9mm; working length 1690mm; 140-degree field of view. Features include suction/air/water channels, forceps channel (3.8mm), and bending section (up to 180 degrees). Connectivity via S-connector to proprietary processors (EPX-201/VP-402). Reprocessing via cleaning/disinfection/sterilization protocols using CA-500 adaptor. Materials are identical to predicate devices.
Indications for Use
Indicated for visualization, diagnosis, and endoscopic treatment of the rectum and large intestine in patients requiring lower digestive tract examination.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Fujinon Double Balloon Enteroscopy System (K040048)
Submission Summary (Full Text)
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NOV I 0 2000
# 510 (k) Summary
2041903
Pg 1 of 4
#### Date Prepared [21 CFR 807.92(a)(1)]
July 9, 2004
# Submitter's Information [21 CFR 807.92(a)(1)]
Joseph M. Azary C/o Fujinon Inc. 543 Long Hill Avenue Shelton, CT. 06484
Azary Technologies has received authorization to submit this 510(k) on bealf of the sponsor Fujinon Inc., 10 Azaly Tochilonographias 10001 07470, Establishment Registration# 2431293.
# Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are: Fujinon G5 Colonoscopes Common Name: Colonoscope Classification: Class II, 21 CFR 876.1500, FDF
#### Predicate Device [21 CFR 807.92(a)(3)}
- Fujinon EC-400HL -- K944620 .
- Fujinon EC-200LR -- K944759 .
The G5 changes were described and cleared by FDA in the 510(k) submission for the Fujinon Double Balloon Enteroscopy System - K040048.
This 510(k) captures some minor design changes that have occurred during the evolution of the product line I his 310(k) captures some manor economic the changes are believed to be minor, the 510(k) is being submitted to account for "design resp" and to ensure that FDA has the most current information concerning the Fujinon Colonoscopes.
The subject device have the same indications for use, composition of patient contact materials, viewing di-I the subject device for the same instructs in sterilization method as the predicate. The subject devices use the same processors and peripherals as the predicate device.
The main differences between the subject device and predicate device are as follows:
- Minor differences with observation range, field of view, diameter, and length. .
- The subject device includes the G5 upgrade, which is characterized by the following minor differ-. ences:
- The L-Port has been eliminated. The L-port functioned as a lens wash port . Doctors had ం the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens.
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pg. 2 of 4
This function was eliminated because demand was low and it was rarely used by the surgeons.
- The J-Port was repositioned. The J-Port is used as a jet water wash port. The J-Port was 0 repositioned based on doctor feedback. The port was moved from the bottom part to the top (end) of the scope. There was also a desire to eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging.
- processing and cleaning, as well as pr. The new port is smaller and comes with a rubber ಂ A OF foresps into port and rubber cap help increase suction and reduce leakage.
- The jet wash line check valve was removed. Internal check valves were removed to elimio I he jet wasn' nine chook vario nee to facilitate cleaning, disinfection, and sterilization. The valves are now external and removable.
- The suction and air/water cylinders and valves were upgraded. They were updated to ac-O The subtion and walves. The function of the valves is the same.
- continodate the FOV, which is the rubber forceps inlet valve cover. This helps create a wa-ಂ tertight seal when the endoscope is used.
- Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be con-ಂ nected to tubes for cleaning.
## Description of the Device [21 CFR 807.92(a)(4)]
The Fujinon G5 Colonoscopes are medical endoscopes used for visualization of the lower digestive tract, spe-I fic rujilor OJ Colonosooper and miagnosis, and endoscopic treatment of the rectum and large intestine.
The G5 colonoscopes include minor changes that improve the useability, ergonomics, and cleaning of the dei ile CJ colonoscopes motuor minor onanges and increased as a lens wash port. Doctors had the option vices. The OJ Scopes do not have it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons.
The J-Port was repositioned. The J-Port is used as a jet water wash port. The J-Port was repositioned based on I he s- on was reportioned from the bottom part to the top (end) of the scope. There was also a desire to eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging.
A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduce leakage.
The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for I ho joi wasn' mile only raire ning, disinfection, and sterilization. The valves are now external and removable.
The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same.
The G5 colonoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning.
The G5 colonoscopes are used with a processor (EPX-201 for EC-250HL5 and VP-402 for EC-450HL5), a I he UJ connioscopy unit, and a cart. Each colonoscope is packaged in a protective carrying case with lens
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Kc 4 1903
pg 3 of 4
cleaner, sillcon oil, forceps valve, waterproof cap, S connector cap, adapters, valves, and the Operation Manual.
The Fujinon G5 colonoscopes are used in conjunction with other perified in the Operation Manual such as:
- Light Source .
- Processor ●
- Cart �
- Data Keyboard �
- Foot Switch .
- 4 Monitor
- Video Printer 4
- Camera and Hard Copy Unit 4
- VCR e
- ElectroSurgical Instruments t
| | EC-450HL5 | EC-250HL5 |
|---------------------------|-------------|-------------|
| Viewing Direction | Forward | Forward |
| Observation Range | 3-100mm | 7-100mm |
| Field of View | 140 degrees | 140 degrees |
| Image Size | Super Image | Super Image |
| Distal End Diameter | 12.8mm | 12.9mm |
| Flexible Portion Diameter | 12.8mm | 12.8mm |
| Bending Capacity UP | 180 degrees | 180 degrees |
| Bending Capacity DOWN | 180 degrees | 180 degrees |
| Bending Capacity LEFT | 160 degrees | 160 degrees |
| Bending Capacity RIGHT | 160 degrees | 160 degrees |
| Forceps Channel Diameter | 3.8mm | 3.8mm |
| Working Length | 1690mm | 1690mm |
| Total Length | 1990mm | 1990mm |
#### Specifications for EC-450HL5 and EC-250HL5
#### Intended Use [21 CFR 807.92(a)(5)}
The device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
#### Technological Characteristics [21 CFR 807.92(a)(6)]
Fujinon, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device have the same indications for use, composition of patient contact material, viewing direction, image size, bending, and reprocessing/sterilization method as the predicate. The subject devices use the same processors and peripherals as the predicate devices.
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K 04, 903
pg 4 ct 4
The main differences are the minor changes associated with the G5 upgrade. The G5 changes were previously cleared by FDA in the 510(k) submission for the Fujinon Double Balloon Enteroscopy System --K040043.
### Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subjected to and passed EMC testing requirements. The patient contact materials in the colonoscopes are identical to the materials used in the predicate device.
#### Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2004
Fujinon, Inc. c/o Mr. Joseph M. Azary Azary Technologies"" LLC 543 Long Hill Avenue SHELTON CT 06484
Re: K041903
Trade/Device Name: Fujinon Inc. G5 Colonoscopes Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FDF Dated: October 17, 2004 Received: October 19, 2004
Dear Mr. Azary:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed be are costine device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the enorologics to e enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1770, and clares 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 do ice, 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 Apple 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}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrb/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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RO4 1903 510(k) Number (if known):
Device Name: Fujinon Inc. G5 Colonoscopes
The device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
**Page 4**
(Per 21 CFR 801.109)
Nareuc hoadon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
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.
