K161355 · Invendo Medical GmbH · FDF · Aug 25, 2016 · Gastroenterology, Urology
Device Facts
Record ID
K161355
Device Name
invendoscopy E200 System
Applicant
Invendo Medical GmbH
Product Code
FDF · Gastroenterology, Urology
Decision Date
Aug 25, 2016
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The invendoscopy E200 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. The colonoscope component of the invendoscopy E200 System, the invendoscope SC200, is a sterile single-use disposable device. The invendoscope SC200 cannot be reprocessed.
Device Story
System provides visualization and access to adult lower GI tract; consists of sterile single-use invendoscope SC200, invendo SPU E200 (signal processing unit), invendo ScopeController, and drying adapter. Distal tip of SC200 features CMOS camera, LEDs, working channel for biopsies/polypectomies, and ports for insufflation, irrigation, and suction. Operator uses ScopeController to manipulate tip deflection, fluid functions, and image recording. SPU E200 processes video signals for display. Used in clinical settings by physicians. System enables endoscopic surgery and diagnostics; single-use design eliminates reprocessing requirements, potentially reducing cross-contamination risks.
Clinical Evidence
Bench testing only. Validated against IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, ISO 10993 (biocompatibility), IEC 62366 (usability), and various ASTM standards for packaging integrity. Risk analysis performed per ISO 14971:2007. Results confirmed system functioned as intended and met all specifications.
Technological Characteristics
System components: SC200 colonoscope (synthetic plastics), SPU E200, ScopeController. CMOS imaging; LED illumination. Deflection via water-filled bellows. Irrigation via peristaltic pump. Connectivity: SPU E200 processes video. Sterilization: Ethylene oxide (ISO 11135). Biocompatibility: ISO 10993-1, -5, -7, -10. Packaging standards: ASTM F88, F1929, F1886, F2096, D4169.
Indications for Use
Indicated for adult patients requiring visualization and diagnostic/therapeutic access to the lower gastrointestinal tract, including anus, rectum, sigmoid colon, cecum, and ileocecal valve, for endoscopy and endoscopic surgery.
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2016
invendo medical GmbH Oliver v. Ruepprecht Head of RA/QA Peterhofstr. 3b Kissing, Bavaria 86438 GERMANY
Re: K161355
> Trade/Device Name: invendoscopy E200 System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF Dated: July 15, 2016 Received: July 18, 2016
Dear Oliver v. Ruepprecht:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K161355
Device Name invendoscopy E200 System
#### Indications for Use (Describe)
The invendoscopy E200 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
The colonoscope component of the invendoscopy E200 System, the invendoscope SC200, is a sterile single use disposable device. The invendoscope SC200 cannot be reprocessed.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/2 description: The image shows the logo for "nvendo medical". The text is in gray, with the words "nvendo medical" in a larger font and "STERILE SINGLE-USE ENDOSCOPY" in a smaller font below. To the right of the text is a circular orange logo with a white swirl inside.
## Applicant Information
| Name: | invendo medical GmbH |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Peterhofstr. 3b<br>86438 Kissing<br>Germany |
| Contact: | Oliver v. Ruepprecht<br>Head of QA/RA<br>Phone : +49 – 8233 – 744 98 16<br>Fax : +49 – 8233 – 744 98 15<br>Mail : oliver.ruepprecht@invendo-medical.de |
Date Prepared: 13.May 2016
# Identification of the proposed device
| Device Name | invendoscopy E200 System |
|---------------------|----------------------------------------------------------------------------------------------------------------------|
| Components | invendoscope SC200 (SC200 colonoscope)<br>invendo SPU E200<br>invendo ScopeController<br>invendo E200 Drying Adapter |
| Common Name | Colonoscopy System |
| Classification/name | Class II (876.1500) / Colonoscope and Accessories, flexible/rigid |
| Product Code | FDF |
| Review Panel | Gastroenterology/Urology |
# Predicate Devices
| K100624 | invendo C20 Colonoscopy System |
|---------|----------------------------------|
| K121582 | invendo C25 Colonoscopy System |
| K100584 | Olympus EVIS EXERA II 180 SYSTEM |
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## Intended Use
The invendoscopy E200 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
The colonoscope component of the invendoscopy E200 System, the invendoscope SC200, is a sterile single-use disposable device. The invendoscope SC200 cannot be reprocessed.
## Device Description
The invendoscopy E200 System consists of an invendoscope SC200, an invendo SPU E200, an invendo ScopeController and an invendo E200 Drying Adapter.
The invendoscope SC200 is a sterile single-use disposable colonoscope. The distal tip of the colonoscope is deflectable and equipped with a CMOS camera and LEDs for illumination. A working channel is incorporated for biopsies and polypectomies. The invendoscope SC200 is furthermore equipped with insufflation, irrigation and suction functions.
The invendo SPU E200 contains the video signal processing technology which enables the endoscope to illuminate, view, record and transmit video data of endoscopic images. The invendo SPU E200 supplies the colonoscope and controls its functions according to the commands of the operator.
The operator uses the invendo ScopeController unit to control the invendoscopy E200 System. The invendo ScopeController allows the operator to control following functions of the colonoscope: deflection of the tip; insufflation; irrigation and suction. The invendo ScopeController also allows the user to record images.
| Technology/Specification | Comparison to predicate devices |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Deflection technology and<br>deflecting capability | Same technology as invendo SC20 colonoscope (K121582);<br>both devices work with water-filled bellows and are<br>pressure controlled |
| Irrigation | Same performance as invendo SC20 colonoscope<br>(K121582); irrigation control via peristaltic pump instead of<br>pressure chamber as by the invendo SC20 colonoscope |
The invendo E200 Drying Adapter is intended to support drying of the inner parts of the invendo SPU E200. It is used to connect a waste container to the invendo SPU E200.
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| Technology/Specification | Comparison to predicate devices |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Insufflation | Same performance and control technology as invendo<br>SC20 colonoscope (K121582) |
| Suction | Identical to the invendo SC20 colonoscope (K121582) |
| Light Source | Identical to the invendo SC20 colonoscope (K121582) |
| Camera | Same technology (CMOS) as SC20 colonoscope (K121582);<br>Both the camera of the SC20 colonoscope and the<br>invendoscope SC200 works with standard resolution. |
| Diameter | Identical to the invendo SC20 colonoscope (K121582) |
| Working Length | Similar length as Olympus colonoscope (K100584); The<br>working length of the invendoscope SC200 is longer than<br>the working length of the Olympus colonoscope. The<br>difference has no impact on safety or efficiency because<br>the introduction deep depends from operator's decision. |
| Working channel | Identical to the invendo SC20 colonoscope (K121582) |
| Insertion | Manually pushed as the Olympus colonoscope (K100584) |
| Sterility | The invendoscope SC200 is sterile delivered, the predicate<br>devices are unsterile delivered<br>The invendo SPU E200, the invendo ScopeController and<br>the invendo E200 Drying Adapter is unsterile delivered as<br>the predicate devices. |
| Material | The materials of the invendoscope (synthetic plastics) and<br>the predicate devices are different but the whole device is<br>biocompatible as required by the ISO10993-1 Standard. |
#### Performance testing
The following non-clinical testing was performed to validate the design and to assure conformity with the following design standards:
- IEC 60601-1 "Medical electrical equipment part 1 General requirements for safety" incl. national deviations
- IEC 60601-2-18 "Medical electrical equipment part 2 Particular requirements for the basic safety and essential performance of endoscopic equipment"
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- IEC 60601-1-2 "Medical electrical equipment part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility –Requirements and tests"; including national deviations FCC CFR 47 part 15
- ISO 10993-5; -7; -10 "Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity"; Part 7: Ethylene Oxide Sterilization Residuals"; Part 10: Tests for irritation and skin sensitization"
- -IEC 62366 "Medical devices: Application of usability engineering to medical devices"
- -ASTM 4169 "Standard Practice for Performance Testing of Shipping Containers and Systems"
- -ASTM F88 "Standard Test Method for Seal Strength of Flexible Barrier Materials"
- ASTM F1929 "Standard Test Method for Detecting Seal Leaks in Porous Medical -Packaging by Dye Penetration"
- -ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- -ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- -ISO 11135 "Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices"
- -Evaluation of insertion forces
In all instances, the invendoscopy E200 System functioned as intended, performed as well as or better than the predicate and met individual test specifications.
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
## Substantial Equivalence
The invendoscopy E200 System has the same intended use and indications for use, and similar technological characteristics and principles of operation as the predicate devices.
The minor technological differences between the invendoscopy E200 System and its predicate devices raise no new issues of safety or effectiveness.
Performance data demonstrate that the device is as safe and effective as the predicate devices. Thus, the invendoscopy E200 System is substantially equivalent to its predicate devices.
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.
