K051886 · Olympus Medical Systems Corporation · FBN · Nov 14, 2005 · Gastroenterology, Urology
Device Facts
Record ID
K051886
Device Name
OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
Applicant
Olympus Medical Systems Corporation
Product Code
FBN · Gastroenterology, Urology
Decision Date
Nov 14, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopic surgery within the biliary tract and pancreatic duct in conjunction with DUODENOSCOPE with an instrument channel with a minimum diameter of ¢ 4.2mm.
Device Story
The XCHF-BP160F is a choledochoscope designed for biliary and pancreatic duct visualization and surgery. It functions as a hybrid device, utilizing a fiber bundle for image transmission and a high-resolution CCD in the control section to convert images into video signals for display on a monitor. The device is inserted through the instrument channel of a compatible duodenoscope (e.g., TJF series) to reach the Papilla of Vater. It is operated by a physician in a clinical setting. The output provides real-time visualization of the biliary and pancreatic tracts, facilitating diagnostic and therapeutic procedures such as biopsy. The device benefits patients by enabling minimally invasive access to these ducts for endoscopic surgery.
Clinical Evidence
No clinical data. Bench testing only, including thermal safety, optical performance, reprocessing, mechanical durability, mechanical safety, and risk analysis. Biocompatibility was confirmed via comparison to predicate devices.
Technological Characteristics
Hybrid imaging system using fiber bundle and CCD. Insertion diameter 2.9–3.7mm; channel diameter 1.2mm. Complies with IEC 60601-1, IEC 60601-1-1, and IEC 60601-2-18. Patient-contacting materials are biocompatible.
Indications for Use
Indicated for endoscopic observation and surgery within the biliary tract and pancreatic duct. Used in conjunction with a duodenoscope having an instrument channel of at least 4.2mm diameter.
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.
Predicate Devices
OES Transduodenal Choledochoscope, CHF type B20 (K904799)
EVIS EXERA Bronchofiber-videoscope BF type XP160F (K033225)
Submission Summary (Full Text)
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NOV I 4 2005
K051886
pg 1 of 3
June .27. 2005
# SMDA 510(k) SUMMARY
# "Olympus Choledochoscope Model XCHF- BP160F"
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.
#### A. General Information 1. Applicant : Olympus Medical Systems Corp. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Registration number : 8010047 2. Official Correspondent : Laura Storms-Tvler Executive Director, Regulatory Affairs and Quality Assurance Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058, USA Telephone : 631-844-5688 Facsimile : 631-844-5554 E-mail : Laura Storms-Tyler@olympus.com Registration number : 2429304 3. Manufacturer : Aizu Olympus Co., Ltd. 500 Aza Muranishi Ooaza, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima, 965-8520 Japan Registration number : 9610595
#### B. Device Identification
- 1. Common/Usual Name : Choledochoscope
- 2. Device Name : OLYMPUS CHOLEDOCHOSCOPE Model XCHF- BP160F
#### 3. Classification Name
| AER Number<br> | -------<br>I<br>lassification<br>Name<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1956 | TOOLUCE '<br>Sode |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| 876 1500<br>al O. .<br>S<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A . Production of the company of the company of the company of the company of the comments of the country of the country of the country of the country of the country of the c | holedochoscone<br>nexioie<br>C<br>and the first of the country of the county of the county of the county of<br>Company of Concess of Concess of Concession of Concession Comparis of Concession Comparis of Concession of Concession of Concession of Concession of Concession of Concession<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | STATUTE OF COLUMN OF CONSULER OF CONSULER OF CONSULER OF<br>FBN |
# C. Identification of the predicate or legally marketed device(s)
The following listed devices are the predicate medical devices;
| Model | 510(k)# | Manufacturer | Class | P-code |
|-------------------------------------------------------|----------|-----------------------------|-------|--------|
| OES Transduodenal Choledocho-<br>scope, CHF type B20 | #K904799 | Olympus Optical Co.,<br>Ltd | II | KOG |
| EVIS EXERA Bronchofiber-<br>videoscope BF type XP160F | #k033225 | Olympus Optical Co.,<br>Ltd | II | EOQ |
#### D. General Description
This instrument has been designed to be used with Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories and other ancillary equipment for endoscopy and endoendoscopic surgery within the biliary tract and pancreatic duct in conjunction with the TJF-duodenoscope.
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Ko51886
pg 2 of 3
#### E. Device Description
The XCHF-BP160F Choledochoscope is basically identical to the predicate device, OES Transduodenal Choledochofiberscope CHF type B20 except that the subject device is equipped with the high resolution CCD in the control section, in addition to the fiber bundle in the insertion tube. Images are transmitted through the fiber bundle and converted by the CCD in the control section to video signals. This is a hybrid technology and substantially equivalent to another Olympus predicate device, Olympus bronchoscope, model BF type XP160F(K033225).
The XCHF-BP160F Choledochoscope is used in conjunction with the TJF-duodenoscope with an instrument channel with a minimum diameter of ¢ 4.2mm, such as Olympus TJF type 100. TJF type 140, TJF type 160F/VF and TJF type M20 duodenoscopes. The XCHF-BP160F Choledochoscope is safety and effectively delivered through the upper gastrointestinal (G) tract to the Papilla of Vater) by traveling through the instrument channel of the TJF-duodenoscopes. At this point, XCHF-BP160F Choledochoscope can directly observe the billiary tract or pancreatic duct.
The technique of using a TJF-duodenoscope to introduce a Choledochoscope, such as the subject device, into the common bile duct is similar to the method commonly used to introduce catheters, stents and other accessories into the biliary tract and pancreatic duct.
#### F. Summary
In summary, the new Choledochoscope, XCHF-BP160F is basically identical to the predicate device in intended use, similar in specification, performance and materials. The subject device differs in that the indication for use have been expanded to include observation of the pancreatic duct, and the high resolution CCD is installed in the control section.
#### G. Design
The Choledochoscope XCHF-BP160F has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1:1998+ Amendment 1:1991+Amendment 2:1995, IEC 60601-1-1:2000 and IEC60601-2-18: 1996+ Amendment1:2000.
#### H. Intended use of the device
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and ancillary equipment or endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with DUODENOSCOPE with an instrument channel with a minimum diameter of ¢ 4.2mm.
#### I. Comparison Technological Characteristics
Comparison between the subject device and predicate device is as follow:
| Items | XCHF-BP160F<br>(Subject Device) | CHF type B20<br>(Predicate Device)<br>K904799 | BF type XP160F<br>(Predicate Device)<br>K033225 |
|--------------------|---------------------------------|-----------------------------------------------|-------------------------------------------------|
| Imaging system | CCD | Optical fiber bundle | CCD |
| Insertion diameter | $\phi$ 2.9 – 3.7mm | $\phi$ 4.5mm | $\phi$ 2.8mm |
| Channel diameter | $\phi$ 1.2mm | $\phi$ 1.7mm | $\phi$ 1.2mm |
| Angulation (U / D) | U=70°, D=70° | U=160°, D=100° | U=180°, D=130° |
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Kc51886
pg 3 of 3
### J. Conclusion
Olympus Medical Systems Corp. has performed non-clinical tests such as thermal safety, optical performance, reprocessing, mechanical durability, mechanical safety and risk analysis to confirm the safety or effectiveness of the XCHF-BP160F Choledochoscope. In addition, EMC standard and electric safety will be performed before we market it.
Furthermore, all patient contacting materials used in the device have completed biocompatibility studies with the predicate device.
When compared to the predicate devices, the XCHF-BP160F Choledochoscope does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness. Therefore, no clinical tests have been conducted on this device.
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Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement. The central symbol is a stylized depiction of a bird or abstract shape, composed of three curved lines that suggest movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2005
Ms. Laura Storms-Tyler Executive Director Regulatory Affairs and Quality Assurance Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-9058
Re: K051886
Trade/Device Name: Choledochoscope, XCHF-BP160F Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBN Dated: September 29, 2005 Received: October 4, 2005
Dear Ms. Storms-Tyler:
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 (Premarket Approval), 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin manieling of substantial equivalence of your device to a legally prematication. The I Dri mailig of outs.
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 If you desire specific advice for your de roo on 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 Also, picase note the regulation entitled, formation on your responsibilities under the Act from the 807.77). I ou may obtain only Echolai missistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. hogdon
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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# Indication for Use Statement
510(k) Number (if known) : Device Name: Choledochoscope, XCHF- BP160F Indications for Use :
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopic surgery within the biliary tract and pancreatic duct in conjunction with DUODENOSCOPE with an instrument channel with a minimum diameter of ¢ 4.2mm.
Prescription Use (Per 21 CFR 801 Subpart D)
AND I OR
Over-The-Counter Use_
( 21 CFR 801 Subpart C)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Lagermann
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number
7
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.
