K162128 · Medivators, Inc. · FEB · Dec 21, 2016 · Gastroenterology, Urology
Device Facts
Record ID
K162128
Device Name
Scope Buddy Plus Endoscope Flushing Aid
Applicant
Medivators, Inc.
Product Code
FEB · Gastroenterology, Urology
Decision Date
Dec 21, 2016
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.
Device Story
Scope Buddy Plus is an electro-mechanical flushing aid used during the manual cleaning phase of endoscope reprocessing. It replaces manual syringe-based fluid delivery. The device uses an external peristaltic pump and 24-hour multi-use connection tubing to draw detergent or rinse water from a container and deliver precise volumes through endoscope channels, as defined by the endoscope manufacturer's instructions. It is operated by clinical staff in a reprocessing environment. The device features a software-controlled user interface and a built-in timer to ensure delivery of required fluid volumes. It does not perform high-level disinfection or cleaning itself; it serves only as a delivery mechanism to assist the manual cleaning process. By automating fluid delivery, it ensures consistent adherence to manufacturer-specified cleaning protocols, reducing variability compared to manual syringe flushing.
Clinical Evidence
Bench testing only. Testing included functional performance (detergent dosing accuracy and fluid delivery flow rates to meet manufacturer requirements), electrical safety and electromagnetic compatibility (IEC 61010-1, IEC 61326-1), software validation per FDA guidance, and human factors/usability evaluation per IEC 62366-1.
Technological Characteristics
Electro-mechanical device; external peristaltic pump; 24-hour multi-use connection tubing; software-controlled user interface; built-in timer. Electrical safety/EMC compliant with IEC 61010-1 and IEC 61326-1. Designed for use with flexible, immersible endoscopes.
Indications for Use
Indicated for use in the manual cleaning phase of reprocessing flexible, immersible endoscopes to deliver specific volumes of detergent solution and rinse water to endoscope channels as specified by the endoscope manufacturer.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three faces in profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
Medivators Inc. Kristin Padilla Regulatory Affairs Associate 14605 28th Ave. North Minneapolis, Minnesota 55447
Re: K162128
Trade/Device Name: Scope Buddy Plus Endoscope Flushing Aid Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: November 23, 2016 Received: November 28, 2016
Dear Kristin Padilla:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K162128
Device Name Scope Buddy Plus Endoscope Flushing Aid
Indications for Use (Describe)
Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, all caps. Below "MEDIVATORS" is the text "A Cantel Medical Company" in a smaller blue font. The circular graphic appears to be a stylized representation of waves or lines.
# 510(k) Summary
| Date Prepared: | December 12, 2016 |
|----------------------|---------------------------------------------------------------------------|
| Manufacturer: | Medivators Inc., a Cantel Medical Company |
| Address: | 14605 28th Avenue North<br>Minneapolis, MN 55447<br>(800) 328-3345 |
| Official Contact: | Kristin Bergeson Padilla<br>Regulatory Affairs Associate, Medivators Inc. |
| Trade Name: | Scope Buddy Plus Endoscope Flushing Aid |
| Common Name: | Accessories, Cleaning, For Endoscope |
| Classification Name: | Endoscope and accessories |
| Product Code: | FEB |
| Device Class: | II |
| Regulation No: | 876.1500 |
Medivators Inc. has supplied the following information to the US Food and Drug Administration to support substantial equivalence of Scope Buddy Plus to other endoscope flushing aid devices currently cleared for sale in the United States of America.
## 1. Intended Use
Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.
#### 2. Device Description
The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. These fluid volumes are defined by the endoscope manufacturer. Scope Buddy Plus is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver an endoscope manufacturer specified volume of fluid to the endoscope channels. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.
## 3. Comparison to Other Devices in Commercial Distribution Within the United States
Scope Buddy Plus is equivalent in intended use, function and fundamental technology to its predicate device, Fluid Pump CP-3 cleared under 510(k) K914524.
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Image /page/4/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, sans-serif font. Below the company name, the text "A Cantel Medical Company" is written in a smaller, blue, sans-serif font. The overall design is clean and corporate, reflecting the company's medical focus.
#### Similarities Between Subject and Predicate Devices
Scope Buddy Plus and its predicate device, Fluid Pump CP-3, have the same intended use, fundamental technology and performance. Both the subject device and the predicate device are similar in that the intended use replicates the mechanical means of fluid delivery to endoscope channels in the same manner as a manual syringe would be used. Both devices are used during the manual cleaning phase of endoscope reprocessing to deliver fluid volumes to the endoscope channels according to the endoscope manufacturer's instructions. Both devices are similar in fundamental technology and general performance.
#### Differences Between Subject and Predicate Devices
The main notable differences between the subject device, Scope Buddy Plus, and the predicate, Fluid Pump CP-3, are the connection tubing and software. Scope Buddy Plus utilizes an external peristaltic pump with 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) while the predicate device utilizes internal fluid pumps with reusable tubing set connections. The subject device utilizes a software controlled user interface while the predicate device utilizes analog circuitry control. In addition, the subject device does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing while the predicate device bears cleaning and disinfection efficacy claims.
A device comparison table which supports substantial equivalence of the subject device to the predicate device is provided below:
| Device Parameters | Subject Device – Scope Buddy Plus<br>Endoscope Flushing Aid | Predicate Device – Fluid Pump CP-3<br>(K914524) |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Trade Name | Scope Buddy Plus Endoscope Flushing Aid | Fluid Pump CP-3 |
| Regulation Number | 876.1500 | 876.1500 |
| Device Class | Class II | Class II |
| Certification Panel | Gastroenterology/Urology | Gastroenterology/Urology |
| Product Code | FEB | FEB |
| Intended Use | To pump fluids through the channels<br>of flexible, immersible endoscopes | To pump fluids through the channels of<br>flexible, immersible endoscopes |
| Type of Machine<br>Function | Electro-mechanical | Electro-mechanical |
| Connection Tubing | 24 hour multi-use connection tubing | Reusable tubing set connections |
| Software Controlled<br>User Interface | Yes | No |
| Fluid Delivery Flow<br>Rate Performance | Meet or exceed the endoscope<br>manufacturer's requirements for fluid<br>delivery through endoscope channels | Meet or exceed the endoscope<br>manufacturer's requirements for fluid<br>delivery through endoscope channels |
| Mechanism of Action | External peristaltic fluid pump with<br>built-in timer | Internal fluid pump with built-in timer |
| Schematic Flow | Flushing liquids are placed into a | Flushing liquids are placed into a |
#### Table 1 - Device Comparison Table
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Image /page/5/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, which contains several horizontal lines. To the right of the graphic is the word "MEDIVATORS" in blue, with the text "A Cantel Medical Company" in a smaller font below it.
| | container, pre-cleaning basin or sink.<br>A tubing set pulls fluid from the<br>container, basin or sink via action from<br>the external peristaltic pump. The fluid<br>continues to flow through the tubing<br>set which is connected to the<br>endoscope channels. The fluid is then<br>pumped through the endoscope<br>channels. | medical washing tray. An intake tubing<br>set pulls fluid from the washing tray and<br>into and through two internal fluid<br>pumps. The fluid is then expelled from<br>the pumps through discharge tubing sets<br>which are connected to the endoscope<br>channels. The fluid is then pumped<br>through the endoscope channels. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Amount of Cleaning<br>Liquid | Amount sufficient to meet or exceed<br>the endoscope manufacturer's<br>requirements for volume of fluid<br>delivery through endoscope channels. | Amount sufficient to meet or exceed the<br>endoscope manufacturer's requirements<br>for volume of fluid delivery through<br>endoscope channels. |
| Time for Cleaning<br>Liquid Circulation | Variable, the length of the cleaning<br>liquid circulation time is sufficient to<br>deliver cleaning liquid volumes that<br>meet or exceed the endoscope<br>manufacturer's requirements. | Variable, the length of the cleaning<br>liquid circulation time is determined by<br>setting a timer. |
## 4. Summary of Non-Clinical Performance Data
Medivators has conducted the following testing to demonstrate the substantial equivalence of Scope Buddy Plus:
- Functional Performance Testing
- Detergent Dosing to demonstrate the ability of the subject device to dose a set volume of O detergent.
- Fluid Delivery Flow Rate to determine the flushing times required by the subject device o to meet endoscope manufacturers' requirements for fluid volumes delivered to endoscope channels during manual cleaning.
- . Electrical Safety and Electromagnetic Compatibility in accordance with IEC 61010-1 and IEC 61326-1. respectively.
- Software Validation as recommended per FDA's guidance for the Content of Premarket ● Submissions for Software Contained in Medical Devices.
- Human Factors/Usability Evaluation to validate that users can safely and effectively use the ● subject device per IEC 62366-1 and FDA's guidance for Applying Human Factors and Usability Engineering to Medical Devices.
## 5. Conclusion
Scope Buddy Plus is substantially equivalent to predicate device Fluid Pump CP-3 cleared under 510(k) K914524. Based on the intended use, fundamental technology and performance data, the subject device Scope Buddy Plus is substantially equivalent to and is as safe and as effective as the legally marketed predicate device.
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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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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.
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.
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Reading rule for every project: how many summaries do you read in full?
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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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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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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.
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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.
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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.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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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.
