The aScope 5 Uretero is a sterile, single-use, flexible, digital video ureteroscope intended to be used for endoscopic access and visual guidance in the upper urinary tract. aScope 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel. aScope 5 Uretero is intended for patients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for visualization and examination with a flexible ureteroscope, and for removal of renal and ureter calculi. The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.
Device Story
Ambu aScope 5 Uretero is a sterile, single-use, flexible digital video ureteroscope; aBox 2 is a reusable digital monitor. System captures live video of upper urinary tract via distal tip camera and LED illumination. Physician operates scope manually using handle control button for distal end deflection; working channel allows instrument passage, fluid suction, and irrigation. aBox 2 processes, displays, records, and stores imaging data on 12.8" LCD screen. Used in clinical settings for ureteroscopy procedures. Output provides real-time visualization to assist clinicians in diagnosis and stone removal. Benefits include single-use sterility, reducing cross-contamination risk, and integrated digital imaging for improved procedural guidance.
Clinical Evidence
Bench testing only. Verification tests included insertion dimensions, working channel performance, bending, irrigation, suction, and functionality. Optical performance validated per ISO 8600-3 (field of view, direction of view, sharpness, depth of field, intensity, distortion, resolution, color, noise, dynamic range). Photobiological safety (IEC 62471), electrical safety (IEC 60601-1, IEC 60601-2-18), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993 series) were confirmed. Transportation and sterilization validation (ISO 11135) were successfully completed.
Technological Characteristics
Sterile, single-use flexible ureteroscope; reusable digital video processor (aBox 2). Features distal tip camera, LED light source, and manual deflection control. Working channel with two inlets. Connectivity: integrated 12.8" LCD monitor with external monitor output. Sterilization: Ethylene Oxide. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1/2-18. Bench testing per ISO 8600-3.
Indications for Use
Indicated for patients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy for visualization, examination, and removal of renal and ureter calculi using a flexible ureteroscope.
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
LithoVue Single-Use Digital Flexible Ureteroscope (K153049)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 24, 2024
Ambu A/S Sanjay Parikh Senior Director, OA/RA Ambu Inc. 6721 Columbia Gateway Drive, Suite 200 Columbia, Maryland 21046
Re: K233630
> Trade/Device Name: Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: November 13, 2023 Received: May 28, 2024
Dear Sanjay Parikh:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
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the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark R. Kreitz -S
for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K233630
Device Name
Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2
Indications for Use (Describe)
The aScope 5 Uretero is a sterile, single-use, flexible, digital video ureteroscope intended to be used for endoscopic access and visual quidance in the upper urinary tract.
aScope 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel.
aScope 5 Uretero is intended for patients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for visualization and examination with a flexible ureteroscope, and for removal of renal and ureter calculi.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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| | | K233630, Page 1 of 3 | |
|-----------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------|
| 510(k) #: K233630 | | 510(k) Summary | Prepared on: 2024-05-26 |
| Contact Details | | | 21 CFR 807.92(a)(1) |
| Applicant Name | | Ambu A/S | |
| Applicant Address | | Baltorpbakken 13 Ballerup 2750 Denmark | |
| Applicant Contact Telephone | | +4542940776 | |
| Applicant Contact | | Mrs. Mingye Zhang | |
| Applicant Contact Email | | mzha@ambu.com | |
| Correspondent Name | | Ambu Inc. | |
| Correspondent Address | | 6721 Columbia Gateway Drive, Suite 200 Columbia MD 21046<br>United States | |
| Correspondent Contact Telephone | | +1 443 831 9844 | |
| Correspondent Contact | | Mr. Sanjay Parikh | |
| Correspondent Contact Email | | sap@ambu.com | |
| Device Name<br>21 CFR 807.92(a)(2) | | | |
| Device Trade Name | | Ambu® aScope™ 5 Uretero (Standard Deflection);<br>Ambu® aScope™ 5 Uretero (Reverse Deflection);<br>Ambu® aBox™ 2 | |
| Common Name | | Endoscope and accessories | |
| Classification Name | | Ureteroscope And Accessories, Flexible/Rigid | |
| Regulation Number | | 876.1500 | |
| Product Code | | FGB | |
| Legally Marketed Predicate Devices<br>21 CFR 807.92(a)(3) | | | |
| Predicate # | | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K153049 | LithoVue Single-Use Digital Flexible Ureteroscope | | FGB |
| K230332 | Ambu® aBox™ 2 | | FET |
| Device Description Summary<br>21 CFR 807.92(a)(4) | | | |
The Ambu® aScope™ 5 Ureteroscopy System is a combination of an endoscope, Ambu® aScope™ 5 Uretero and a displaying unit, the Ambu® aBox™ 2.
The Ambu® aScope™ 5 Uretero is a sterile, digital video ureteroscope. The Ambu® aScope™ 5 Uretero can be used in retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for providing endoscopic access and visual
{5}------------------------------------------------
guidance to and in the upper urinary tract.
The Ambu® aScope™ 5 Uretero is available in one size and can be operated by either left or right hand. The Ambu® aScope™ 5 Uretero can be used with endoscopic accessories. The working channel system allows the passage instruments, instillation/ suction of fluids. The aScope 5 Uretero is intended to be used with a compatible Ambu displaying unit - Ambu® aBox™ 2.
The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.
The Ambu® aBox™ 2 has the following physical and performance characteristics:
- · Can process and display live imaging data from Ambu® aScope™ 5 Uretero to a monitor
- · Can record, store and transport image data from Ambu® aScope™ 5 Uretero
- Is a portable device with an integrated monitor, and the possibility to connect to an external monitor
# Intended Use/Indications for Use
The aScope 5 Uretero is a sterile, single, digital video ureteroscope intended to be used for endoscopic access and visual quidance in the upper urinary tract.
aScope 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel.
aScope 5 Uretero is intended for patients requiring retrograde (transurethral) and/or antegrade
- (percutaneous) ureteroscopy procedures for visualization and examination with a flexible
ureteroscope, and for removal of renal and ureter calculi.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.
## Indications for Use Comparison
Ambu® aScope™ 5 Uretero has the same indications for use as the predicate device. Ambu® aBox™ 2 has the same indications for use as the predicate device.
## Technological Comparison
Ambu® aScope™ 5 Uretero and its predicate device have the following same technological characteristics:
• Both devices control the maneuverable distal end by moving the control button at the handle.
- · Both devices have a working channel with two inlets.
- · Both devices have a camera at distal tip of insertion cord and use LED light source to illuminate.
- · Both devices are designed to connect to a compatible monitor.
- Both devices are sterilized by Ethylene Oxide.
Ambu® aScope™ 5 Uretero differs from its predicate device in some technical specifications, including insertion portion and field of view. The differences do not introduce issues for safety and performance. Ambu® aScope™ 5 Uretero has passed the performance testing.
Ambu® aBox™ 2 and its predicate device have the following same technological characteristics:
· Both are video processors displaying live video-imaging data of the connected visualization device to a monitor.
- · Both provide video output formats, recording and data storage and data transport functions.
· Both share certain technical functionalities such as brightness contrast and sharpness adjustment as well as zoom function.
· Both devices are portable and have an integrated monitor and offers the possibility of connection to an external monitor.
#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following tests were performed to verify/validate the performance of the Ambu® aScope™ 5 Ureters System:
Verification tests including:
- · Insertion portion dimensions and performance
- · Working channel performance
- · Bending performance
- Irrigation performance
- · Suction performance
## 21 CFR 807.92(a)(5)
#### 21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
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· Functionality
Optical performance tests including:
- · Field of view (ISO 8600-3)
· Direction of view (ISO 8600-3)
• Sharpness and Depth of field
- · Image intensity uniformity
- · Geometric distortion
- · Resolution
- Color performance
- Noise performance
- Dynamic range
Photobiological safety according to IEC 62471 Transportation study according to ASTM D4169 Sterilization validation according to ISO 11135 Stability study to document shelf life according to ASTM F1980 Sterile packaging integrity
Biocompatibility has been assessed according to:
· Physical and/or chemical information addressed according to ISO 10993-1
· Cytotoxicity tested according to ISO 10993-5
· Irritation tested according to ISO 10993-23
- · Sensitization tested according to ISO 10993-10
- · Material-mediated pyrogenicity tested according to ISO 10993-11
· Acute Systemic Toxicity tested according to ISO 10993-11
Electrical Safety and performance according to IEC 60601-1 and IEC 60601-2-18 Electromagnetic Compatibility according to IEC 60601-1-2
In all instances, the Ambu® aScope™ 5 Uretero System performed as expected and met the test specifications set.
N/A
All included bench tests, which have been designed to evaluate substantial equivalence as well as the product's conformity to established quality and performance measures, have been successfully conducted, and have passed the predefined acceptance criteria.
As a result, it is concluded that the devices constituting the Ambu® aScope™ 5 Ureteroscopy System meet their predefined specifications, perform as intended and are equivalent to the predicate devices listed in the Predicates and Substantial Equivalence section.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
