The FastClamp Endoscopic Clamping System is indicated for use in laparoscopic procedures for the surgeon to clamp endoscopic instruments in a fixed position for a period of time.
Device Story
FastClamp Endoscopic Clamping System is a non-sterile, reusable laparoscopic instrument; comprises table clamp for operating table accessory rail and instrument clamp for locking instruments in position. Used in laparoscopic procedures by surgeons to maintain fixed instrument positioning. Device provides stable platform for endoscopic instruments; supports simulated liver weights up to 4kg. Bench testing confirms static holding capability for 5mm and 10mm diameter instruments under 1kg load and bed frame fixation stability under 10kg load. Device is reusable, validated for 200 clean/autoclave cycles.
Clinical Evidence
Bench testing only. Testing included jaw capability (static holding of 5mm/10mm bars under 1kg load), bed frame fixation (stability under 10kg load), and simulated liver retraction (up to 4kg). Biocompatibility testing (cytotoxicity, extractivity) performed per ISO 10993-1. Sterilization validated per ISO 17665. Device demonstrated functional integrity after 200 autoclave cycles.
Technological Characteristics
Reusable laparoscopic clamping system. Materials biocompatible per ISO 10993-1. Mechanical clamping mechanism; manual operation. Sterilization via moist heat (autoclave) per ISO 17665 (135°C for 30 minutes). No electronic components, software, or connectivity.
Indications for Use
Indicated for use in laparoscopic procedures to clamp endoscopic instruments in a fixed position for a period of time. No specific patient population, age, or gender restrictions stated.
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
Laparoscopic Retractors - Cardinal Health, Inc. (K092684)
Mediflex Flex Arm Systems - Mediflex surgical products (pre-amendments device)
Thompson Retractor - Thompson Surgical Instruments, Inc. (pre-amendments device)
Submission Summary (Full Text)
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# SECTION 5:
# 510(k) SUMMARY
| Submitter: | Surgical Innovations plc.<br>Clayton Wood House<br>6 Clayton Wood Bank<br>Leeds<br>LS16 6QZ<br>United Kingdom<br><br>Tel.: +44 113 230-7597<br>Fax: +44 113 230-7598 | SEP | 7 2010 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------|
| Contact Person: | Mike White<br>Product Development Director | | |
| Date Summary<br>Prepared: | 10 February 2010 | | |
| Trade Name: | FastClamp Endoscopic Clamping System | | |
| Common Name: | Endoscope and accessories | | |
| Classification Name: | Laparoscope, General and Plastic Surgery<br>(21 CFR 876.1500, Product Code GCJ) | | |
| Equivalent to: | Laparoscopic Retractors- Cardinal Health, Inc. (K092684)<br>FISSO Holding System - Baitella AG (K070509).<br>Mediflex Flex Arm Systems - Mediflex surgical products (pre-amendments device).<br>Thompson Retractor - Thompson Surgical Instruments, Inc. (pre-amendments device) | | |
月100442
:
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The FastClamp Endoscopic Clamping System is a non sterile, reusable, Device Description: laparoscopic clamp instrument. It comprises a table clamp to securely attach to the operating table accessory rail, and an instrument clamp to lock the instrument in place once the instrument has been positioned.
The FastClamp Endoscopic Clamping System is indicated for use in Intended Use: laparoscopic procedures for the surgeon to clamp endoscopic instruments in a fixed position for a period of time.
## Substantial Equivalence:
1
Determination of substantial equivalence for the FastClamp Endoscopic Clamping System was based on comparison to the predicate devices in terms of intended use and device technological characteristics, such as design features, materials of composition, principle of operation and presentation. The FastClamp Endoscopic Clamping System is substantially equivalent to the Laparoscopic Retractors in terms of their intended use. The FastClamp Endoscopic Clamping System is substantially equivalent to the FISSO Holding System, MediFlex Flex Arm Systems, and Thompson Retractor in terms of the intended use, design features, material, sterilization, principle of operation and presentation.
{2}------------------------------------------------
### Nonclinical tests summary
## 1. Bench Testing
## FastClamp Jaw capability testing
For this test the input criteria was determined to be:
- 5mm (between Ø4.2- Ø7.4) and 10mm (Ø9.2- Ø11.4) nominal test bars remain static . between the jaws when a load of 1kg is applied.
- 5mm and 10mm nominal test bars (between Ø4.2- Ø7.4 and Ø9.2- Ø11.4) are positioned . in appropriate recess in the jaws and the locking mechanism can be deployed.
The pass results in TN100346 (Exhibit 6) show that the FastClamp Endoscopic Clamping system passes the input criteria, capable of accommodating a range of instruments between Ø4.2- Ø7.4 and Ø9.2- Ø11.4 , and gripping them to withstand a load of 1kg.
## Fast Clamp bed frame fixation testing
For this test the input criteria was determined to be:
- FastClamp Endoscopic clamping system is attached to the bed rail over drape; it does not . move when a load of 10kg is applied to front, back and both sides.
The pass results in TN100346 (Exhibit 6) show that the FastClamp Endoscopic Clamping system passes the input criteria to withstand a load of 10kg applied to front, back and both sides. It provides an extremely strong and stable instrument platform once it has been correctly adjusted, and locked into position.
## Recommended loadings for FastClamp Endoscopic Clamping System
For this test the input criteria was determined to be:
- The FastClamp Endoscopic Clamping System is capable of holding the liver retractor and . supporting simulated liver weight of 4kg.
The pass results in TN100384 show that FastClamp Endoscopic Clamping system passes the input criteria: capable of holding a liver retractor in a static position during retraction of simulated liver weights up to 4kg which is double the weight of the average male adult liver.
{3}------------------------------------------------
#### Packaging drop testing
For this test the input criteria was determined to be:
- Pass in accordance with pass criteria ASTM D4169-1996. After 100% inspection of . product after dropping from a height of 610mm, there should be no visible defects found in the product.
The pass results in TN100372 (Exhibit 7) show that the FastClamp Endoscopic Clamping System passes the input criteria where the packaging remained in one piece and the product was not damaged in any way.
#### 2. FastClamp Justification of 2 year useable lifespan
For this test the input criteria was determined to be:
- The FastClamp Endoscopic Clamping System is capable of passing 200 full clean, wash and . autoclave cycles, and still functions safely and correctly.
The pass results in TN100362 (Exhibit 10) show that FastClamp Endoscopic Clamping system passes the input criteria, capable of functioning safely after 200 full clean, wash and autoclave cycles. The cosmetic change in color is due to the temperature during autoclaving, and once the change has occurred, there is no evidence of deterioration in the properties of function of the plating.
#### 3. FastClamp steam sterilization validation
The steam sterilization process used for FastClamp Endoscopic Clamping System has been validated in accordance with ISO 17665 Sterilization of health care products – Moist heat. The results showed that the sterilization requirement has been satisfied in accordance with ISO17665. FastClamp Endoscopic Clamping System Instruction for Use (IFU) has been updated to reflect the sterilization parameters which are 135°C for 30 minutes using gravity displacement with 90 minutes minimum dry time.
The full report of this testing is provided in TN100420.
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#### 4. Materials Biocompatibility
From ISO 10993-1:2002, FastClamp Endoscopic Clamping System is an external communicating device with duration < 24 hours, therefore initial tests for consideration are:
- 1. Cytotoxicity
.
- 2. Sensitization
- 3. Intracutaneous reactivity.
In order to minimize animal tests, an extractivity test was conducted to determine the necessity for sensitization and intracutaneous reactivity.
#### 1. Cytotoxicity Test
The result has showed that the extract of the negative control (polypropylene filters) was noncytotoxic to L929 cells under the conditions of this test.
The extract of the positive control (rubber bands) was cytotoxic to L929 cells under the conditions of this test.
The extract of the test material was non-cytotoxic.
The full report of this testing (ref. TN 100359) is provided in Exhibit 9.
#### 2. Extractivity Testing
...
The gravimetric and visual results show that no significant levels of extractable material were found. As such it is considered that the ISO 10993-10 skin irritation and skin sensitization tests should not be conducted. The justification for this is that if no measureable levels of extractable material are produced then it would only be the extractant that is being assessed.
The full report of this testing (ref. TN 100359) is provided in Exhibit 9
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Surgical Innovations plc. % Mr. Mike White Product Development Director Clayton Wood House 6 Clayton Wood Bank Leeds, LS16 6QZ United Kingdom
7 2010 SEP
Re: K100442
Trade/Device Name: FastClamp Endoscopic Clamping System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: July 12, 2010 Received: July 14, 2010
Dear Mr. White:
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.
{6}------------------------------------------------
Page 2 - Mr. Mike White
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the text 'k100442 page 1 of 1' in a handwritten style. The text appears to be a page number or document identifier. The handwriting is clear and legible, with the numbers and letters easily distinguishable.
## SECTION 4:
SEP 7 2010
### INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not known
Device Name:
FastClamp Endoscopic Clamping System
Indications for Use:
Use in laparoscopic procedures for the surgeon to clamp endoscopic instruments in a fixed position for a period of time.
Prescription Use X
(Per 21 CFR 801 Subpart D)
AND/ OR
Over-The-Counter Use _
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Neil
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100442
10
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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.
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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.
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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.
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.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
