L10 LED Light Source with AIM, L11 LED Light Source with AIM
K191046 · Stryker · OWN · May 10, 2019 · Gastroenterology, Urology
Device Facts
Record ID
K191046
Device Name
L10 LED Light Source with AIM, L11 LED Light Source with AIM
Applicant
Stryker
Product Code
OWN · Gastroenterology, Urology
Decision Date
May 10, 2019
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Device Story
The Stryker L10 and L11 LED Light Source with AIM is an endoscopic illumination system used during minimally invasive surgery. It utilizes an electronic driver to control RGB LEDs and a near-infrared laser diode, combining light via dichroic mirrors into a fiber output bundle connected to a laparoscope. The device is used with intravenously administered SPY AGENT GREEN (ICG). The laser excites the ICG in vessels, causing infrared emission captured by a camera control unit and displayed on a surgical monitor. Operated by surgeons in clinical settings, the system provides real-time visible and near-infrared fluorescence imaging to assist in visual assessment of blood flow, tissue perfusion, biliary ducts, and ureter transillumination. It serves as an adjunct to standard white light and intraoperative cholangiography, aiding clinical decision-making by providing enhanced visualization of anatomical structures and perfusion.
Clinical Evidence
Bench testing only. Imaging studies compared fluorescence performance between SPY AGENT GREEN and another commercially available ICG agent, demonstrating no visible difference in fluorescence.
Technological Characteristics
System includes light source console, SafeLight cable, and ICG imaging agent. Uses RGB LEDs and near-infrared laser diode. Light coupled via dichroic mirrors to fiber output. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-18. Reusable device.
Indications for Use
Indicated for patients undergoing minimally invasive surgery or open/laparoscopic procedures requiring endoscopic visible and near-infrared fluorescence imaging, including assessment of vessels, blood flow, tissue perfusion, biliary duct visualization, and ureter transillumination.
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
Stryker AIM Light Source and SafeLight Cable (K173866)
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Stryker Agatha Szeliga Regulatory Affairs Manager 5900 Optical Court San Jose, California 95138
May 10, 2019
Re: K191046
Trade/Device Name: L10 LED Light Source with AIM, L11 LED Light Source with AIM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN, FCS, FCW Dated: April 19, 2019 Received: April 19, 2019
Dear Agatha Szeliga:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Stevenson, For Acting Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K191046
Device Name
Stryker L10 and L11 LED Light Source with AIM (Advanced Imaging Modality)
#### Indications for Use (Describe)
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standardof-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
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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This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.
## Submitter:
| Applicant | Stryker Endoscopy<br>5900 Optical Court<br>San Jose, CA 95138 |
|----------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Agatha Szeliga<br>Regulatory Affairs Manager<br>Tel: 604-422-7516<br>Fax: 604-232-9841<br>E-mail: agatha.szeliga@stryker.com |
| Date Prepared | April 19, 2019 |
## Subject Device:
| Name of Device | Stryker L10 and L11 LED Light Source with AIM (Advanced Imaging Modality) | |
|----------------------|---------------------------------------------------------------------------|--|
| Common or Usual Name | Light Source, Illuminator | |
| Classification Name | Confocal Optical Imaging1 (21 C.F.R. §876.1500) | |
| | Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020) | |
| | Light Source, Fiberoptic, Routine3 (21 C.F.R. §876.1500) | |
| Regulatory Class | II | |
| Product Code | OWN1 | |
| | FCS2 | |
| | FCW3 | |
| 510(k) Review Panel | General & Plastic Surgery1 | |
| | Gastroenterolgoy/ Urology2,3 | |
1When used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging 2When used to trans-illuminate the ureter during open or laparoscopic surgical procedures 3When used to provide standard endoscopic visible light to support real-time endoscopic visible imaging
# Predicate Device(s):
| Stryker AIM Light Source and SafeLight Cable | K173866 |
|----------------------------------------------|---------|
| L11 LED Light Source with AIM | K182160 |
Note: The predicate devices have not been subject to a design-related recall.
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# Device Description:
The Stryker AIM LED Light Source (L10 & L11) is part of the Stryker Infrared Fluorescence (IRF) Imaging System, which is an endoscopic illumination and imaging system for real-time high definition (HD) visible light and near-infrared fluorescence imaging of indocyanine green (ICG) during minimally invasive surgery.
The Stryker Infrared Fluorescence Imaging System consists of the following main components:
- . A light source console and a light cable for outputting light within a visible light spectrum as well as near-infrared light spectrum;
- . A camera control unit for processing near-infrared and visible light images, and a coupler that is attached to the laparoscope and camera head (cleared separately);
- A laparoscope for visible light and near-infrared light illumination and imaging ● (cleared separately)
- An imaging agent kit containing ICG ●
The Stryker AIM LED Light Source uses an illuminator with a laser light source to illuminate the area of surgery. The device is used in conjunction with ICG to achieve its intended use in fluorescence angiography. The ICG is administered intravenously prior to image obtainment. A laser light is illuminated to the site of the surgery using a laparoscope. Absorption of laser light causes excitation of the ICG in the vessels resulting in emission of infrared light at a different wavelength. The camera system captures the infrared emission, processes the image and displays it on a surgical monitor.
### Indications for Use:
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
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| Feature | Subject Device | Predicate Device | Predicate Device |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|--------------------------------------------------------------------|
| | Stryker L10 and L11 LED<br>Light Source with AIM | Stryker AIM Light<br>Source and SafeLight<br>Cable | L11 LED Light Source<br>with Advanced<br>Imaging Modality<br>(AIM) |
| Manufacturer | Stryker Endoscopy | Same as subject device | Same as subject device |
| Submission<br>Reference | Current Submission | K173866 | K182160 |
| Intended Use | Endoscopic visible and near-<br>infrared imaging during<br>surgical procedures | Same as subject device | Same as subject device |
| Indications<br>for Use | See NOTE 1 | See NOTE 2 | See NOTE 3 |
| Imaging<br>Modes | White Light<br>Near-infrared - Fluorescence<br>Near-infrared -<br>Transillumination | Same as subject device | Same as subject device |
| Safety<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60825-1<br>IEC 60601-2-18 | Same as subject device | Same as subject device |
| Components | Light Source and SafeLight<br>Cable | Light Source and<br>SafeLight Cable | Light Source and<br>SafeLight Cable |
| | SPY AGENT™ GREEN Kit | ICG Imaging Agent Kits | ICG Imaging Agent Kits |
| Principle of<br>Operation | An electronic driver controls<br>Red/Green/Blue LEDs and a<br>near-infrared laser diode<br>which are combined through<br>dichroic mirrors and<br>projected onto an output light<br>collimator. A fiber output<br>bundle can be inserted into<br>the light source to couple<br>light to the distal end and into<br>an endoscope. | Same as subject device | Same as subject device |
| Light Source/<br>Laser | RGB LEDs<br>Infrared laser | Same as subject device | Same as subject device |
| Single Use or<br>Reusable | Reusable | Same as subject device | Same as subject device |
| Contrast<br>Imaging<br>Agent | SPY AGENT™ GREEN<br>(Indocyanine green for<br>injection, USP) | Indocyanine green (ICG) | Indocyanine green<br>(ICG) |
# Comparison of Technological Characteristics with the Predicate Device:
NOTE 1: Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment
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of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperaphy. The devices are not intended for standalone use for biliary duct visualization.
The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
NOTE 2: The Stryker® AIM Light Source and SafeLight Cable are indicated for use to provide realtime endoscopic visible and near-infrared fluorescence imaging. The Stryker® AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near infrared imaging.
Fluorescence imaging of biliary ducts with the Stryker® AIM Light Source and SafeLight Cable are intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
NOTE 3: The L11 AIM Light Source and SafeLight™ Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and Safe Light Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the L1 1 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. The L11 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
# Performance Testing:
The labeling modification proposed within this 510(k) submission for the Stryker L10 and L11 LED Light Source with AIM does not have an impact on the performance characteristics of the devices that were cleared in the previous submissions.
Bench testing was performed to demonstrate compatibility of the Stryker L10 and L11 LED Light Source with AIM with Stryker's SPY AGENT™ GREEN (Indocyanine green for Injection, USP). Results from the imaging studies demonstrated that there was no visible difference observed in fluorescence between Stryker's SPY AGENT™ GREEN and another commercially available ICG imaging agent.
### Conclusions:
The information presented within this Special 510(k) premarket notification demonstrates that the Stryker L10 and L11 LED Light Source with AIM is substantially equivalent in design, intended use, principle of operation, technological characteristics and safety features to the predicate devices. There are no new issues of safety and/or effectiveness introduced as a result of the labeling modification proposing the use of the Stryker L10 and L11 Light Source with AIM in conjunction with SPY AGENT™ GREEN imaging agent. It has been demonstrated that the Stryker L10 and L11 LED Light Source with AIM is compatible for use in fluorescence angiography with Stryker's SPY AGENT™ GREEN imaging agent.
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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.
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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?
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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.
