The LumiRex Single-Use Digital Flexible Ureteroscope is a single-use video endoscope designed for use with Contra Healthcare Solutions video processors, urology accessories, and other ancillary equipment used in urology and urological procedures.
Device Story
Single-use flexible video ureteroscope; inserts through urethra into urinary tract/kidney. Features integrated light source and camera for real-time visualization; working channel allows fluid irrigation and passage of instruments (biopsy forceps, cytology brushes, stone retrieval baskets). Operates via wired or wireless connection to a Video Processor Unit using specific adapters. Wireless adapter includes battery for improved maneuverability. Video Processor Unit displays images, controls LED, and exports data to USB media. Used in clinical settings by healthcare providers to facilitate urological procedures; provides direct visualization to assist in diagnosis and therapeutic intervention.
Clinical Evidence
Bench testing only. No clinical data presented. Validation included sterilization (ISO 11135), biocompatibility (ISO 10993), software verification (IEC 62304), electrical safety/EMC (IEC 60601 series), and functional performance testing (ISO 8600 series, ISO 80369-7). Comparative optical testing demonstrated performance equivalent to predicate.
Technological Characteristics
Single-use flexible endoscope; ethylene oxide sterilization. Features LED illumination, CMOS camera, and working channel. Connectivity via wired or wireless (battery-powered) adapters. Video processor supports mains or lithium battery power. Complies with ISO 8600-1/3/4, ISO 80369-7, IEC 62471, and ISO 10993 standards.
Indications for Use
Indicated for use in urology and urological procedures requiring visualization of the urinary tract and interior of the kidney.
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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FDA U.S. FOOD & DRUG ADMINISTRATION
April 28, 2025
Contra Healthcare Solutions, LLC
John O'Connor
President
105 Lincoln Avenue
Butler, Pennsylvania 16001
Re: K243532
Trade/Device Name: LumiRex Ureteroscope
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FGB
Received: March 31, 2025
Dear John O'Connor:
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.
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).
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K243532 - John O'Connor
Page 2
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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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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K243532 - John O'Connor
Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 J. Antonino -S
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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K243532 | ? |
| Please provide the device trade name(s). | | ? |
| LumiRex Ureteroscope | | |
| Please provide your Indications for Use below. | | ? |
| The LumiRex Single-Use Digital Flexible Ureteroscope is a single-use video endoscope designed for use with Contra Healthcare Solutions video processors, urology accessories, and other ancillary equipment used in urology and urological procedures. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
LumiRex Ureteroscope
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K243532
| 510(k) #: K243532 | 510(k) SummaryPage 1 of 3 | Prepared on: 2025-04-28 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Contra Healthcare Solutions, LLC | |
| Applicant Address | 105 Lincoln Avenue Butler PA 16001 United States | |
| Applicant Contact Telephone | 724-285-6324 | |
| Applicant Contact | Mr. John O'Conner | |
| Applicant Contact Email | joconnor@alpinsurgical.com | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | LumiRex Ureteroscope | |
| Common Name | Ureteroscope | |
| Classification Name | Endoscope and accessories | |
| Regulation Number | 876.1500 | |
| Product Code(s) | FGB | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K172098 | Pusen Medical Video Endoscope System | FGB |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The LumiRex Single-Use Ureteroscope is a flexible video-based medical device designed for insertion through the urethra into the urinary tract. It comprises a long, thin tube equipped with a light source and a camera to provide real-time visualization of the urinary tract and interior of the kidney. The ureteroscope also features a working channel that allows for installation of fluids, the passage of various instruments, such as biopsy forceps, cytology brushes, biopsy brushes, and stone retrieval baskets to facilitate urology and ureteroscopy procedures.
The ureteroscope can be used wired or wireless through a Wireless Scope Adapter or Wired Scope Adapter. The adapter's transmit images from the ureteroscope to the Video Processor Unit where the user can view the image from the ureteroscope, control the LED, and save and export images from the ureteroscope onto USB removable media. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| The LumiRex Single-Use Digital Flexible Ureteroscope is a single-use video endoscope designed for use with Contra Healthcare Solutions video processors, urology accessories, and other ancillary equipment used in urology and urological procedures. | | |
| Indications for Use Comparison | | 21 CFR 807.92(a)(5) |
| The subject device LumiRex Ureteroscope has the same indications for use as the predicate device Pusen Medical Video Endoscope system (K172098). | | |
| Technological Comparison | | 21 CFR 807.92(a)(6) |
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K243532
Overview of Similarities
Page 2 of 3
The subject device and the predicate device have the same basic form factor, digital video and illumination sources, and are both single-use. Both devices utilize a video processing unit to view and control the image displayed to the user.
## Overview of Differences
The subject device allows the user to operate the device wirelessly and wired through respective adapters while the predicate device only has the option of wired use. The LumiRex Ureteroscope when used with the Wired Scope Adapter of the subject device is operated in the same manner as the predicate device. The Wireless Scope Adapter of the subject device has a built-in battery powering the ureteroscope and allows better maneuverability and convenience during use for healthcare providers. The risks of wireless use have been assessed and found to be acceptable. The functionality of the ureteroscope with wireless adapter has been validated.
The subject device video processing unit can be powered by the mains or lithium battery, while the predicate device's video processing unit is powered only by mains.
Comparative testing between the subject device and predicate device showed that the subject device has a wider field of view but same depth of view.
The above differences between the subject and predicate device do not raise different questions of safety and effectiveness.
## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical validation testing was performed to demonstrate the safety and effectiveness of the device. The following tests were performed:
### Sterilization and Shelf-Life
Ethelyne Oxide Sterilization of LumiRex Single-Use Bronchoscope has been evaluated to ISO 11135:2014. Sterile Barrier was evaluated to ISO 11607-2:2019 and ASTM F1980 for accelerated aging methodology. The shelf life of the LumiRex Single-Use Bronchoscope has validated.
### Reprocessing
Reprocessing of reusable components of the LumiRex Single-Use Bronchoscope has been evaluated in accordance with:
- Guidance for Industry and FDA Staff – Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling issued March 17, 2025
- AAMI TIR12:2020 Designing, testing, and labeling reusable medical devices for reprocessing health care facilities: A guide for medical device manufacturers
- AAMI/ANSI/ISO 11737-1:2018 Sterilization of health care products-Microbiological Methods Part 1: Determination of the Population Microorganisms on produce
- ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ANSI/AAMI/ISO 17665-1:2006/(R)2013 Sterilization of health care products – Moist heat – Part 1 Requirements for the development, validation, and routine control of a sterilization process for medical devices
- AAMI ST98:2022 Cleaning validation of health care products- Requirements for development and validation of a cleaning process for medical devices
### Biocompatibility
The biocompatibility evaluation for the LumiRex device was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process" issued September 4, 2020, and International Standard 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," FDA recognition number 258 for:
- Cytotoxicity (10993-5:2009)
- Sensitization (10993-10:2021)
- Systemic Toxicity (10993-11:2017)
- Pyrogenicity (10993-11:2017)
- Irritation (10993-23:2021)
### Software
Software verification and validation testing has been conducted in compliance with IEC 62304 Edition 1.1 2015-06 (which is the principal normative standard applied), ANSI/AAMI/IEC ES60601-1:2005/(R)2012 and A1:2012 and the FDA guidance documents "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (11-Jan-2002) and "FDA Guidance for the Content of Premarket Submissions for Device Software Functions" (14-June-2023).
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K243532
# Cybersecurity
The cybersecurity of LumiRex Bronchoscope system was evaluated in conformance to "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued September 2023.
# Electrical Safety and Electromagnetic Compatibility
The LumiRex Single-Use Bronchoscope, Wired Scope Adapter, Wireless Scope Adapter, Wireless Scope Adapter Charging Cradle, and LumiRex Video Processor have undergone the following Electrical Safety and Electromagnetic Compatibility testing, complying with IEC 60601-1:2005/IEC 60601-1-2:2014+A1:2020/AMD2:2020, IEC 60601-1-2:2014+A1:2020, and IEC 60601-2-18 (3rd edition).
# Bench Testing
- ISO 80369-7:2021 Small-bore Connectors for Liquids and Gases in Healthcare Applications
- ISO 8600-1:2015 Endoscopes – General Requirements
- ISO 8600-3:2019 Endoscopes – Determination of field of view and direction of view of endoscopes with optics
- ISO 8600-4:2014 Endoscopes – Determination of maximum width of insertion portion
- IEC 62471:2006 Photobiological Safety
- Camera Image Quality
- Spatial Resolution MTF (ISO 12233)
- Signal to noise Ratio (ISO 15739)
- Dynamic Range
- Depth of Field
- Geometric Distortion
- Image Intensity Uniformity
- Color performance
- System Functional Testing
- Performance characteristics such as leaking, irrigation, bending, articulating bending angle, endurance of bending section, instrument and accessory compatibility, and bending section radius
# Verification in Differences of Design
Scope Adapter – Evaluation of the LumiRex Bronchoscope for Reprocessing, Software, Electrical Safety, Electromagnetic Compatibility, and System Functional Testing, FDA Guidance Document - Electromagnetic Compatibility (EMC) of Medical Devices (June 6, 2022) – Section J – Common Electromagnetic (EM) Emitters, and IEEE/ANSI C63.27-2021 demonstrated that the device in design of the subject device in use wired/wireless scope adapters met requirements in the referenced standards and/or matched the performance of the predicate device. The results met the requirements defined in the standard and/or matched the performance of the predicate device. Insertion Tube – To verify the design of the maneuverable portion, performance characteristic testing and testing per ISO 8600-1:2015 was performed. The bending performance of the LumiRex Bronchoscope met the requirements defined in the standard. Image and Optical Characteristics – To verify the image and optical performance of the LumiRex Bronchoscope, comparative testing was performed between the predicate and subject device for Camera Image Quality, and Determination of Field of View and Direction of View (ISO 8600-3:2019). The results met the requirements defined in the standard and demonstrated substantially equivalent performance to the predicate device.
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Part 1 — Search, results, and everyday workflows 16 min
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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.
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.
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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.
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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?
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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.
