Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
K221629 · Covidien · GAG · Feb 22, 2023 · General Hospital
Device Facts
Record ID
K221629
Device Name
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
Applicant
Covidien
Product Code
GAG · General Hospital
Decision Date
Feb 22, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4740
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.
Device Story
Tri-Staple™ 2.0 Black Circular Reloads are single-use, sterile components for the Signia™ battery-powered, microprocessor-controlled surgical stapler. The system uses ID-chips to interface reloads with the power handle. The device deploys three height-progressive rows of titanium staples (4.0mm, 4.5mm, 5.0mm) to accommodate extra-thick tissue (2.25–3.0mm). Operation involves push-button powered tissue compression, stapling, and knife-blade resection of excess tissue to create circular anastomoses. Used in sterile operating rooms by qualified medical professionals. The system provides electronic feedback and software-controlled Adaptive Compression Technology (ACT) to ensure consistent staple lines. Benefits include powered, consistent staple formation compared to manual force, reducing user variability in complex alimentary tract surgeries.
Clinical Evidence
No clinical data provided. Substantial equivalence demonstrated via non-clinical performance testing, including bench-top, ex-vivo, and in-vivo pre-clinical studies, chronic GLP healing/anastomotic index studies, usability testing (IEC 62366-1), software V&V (IEC 62304), electrical safety/EMC (IEC 60601-1/1-2), and biocompatibility (ISO 10993).
Technological Characteristics
Titanium staples (ASTM F67 Grade I); triple staggered row configuration with graduated staple heights (4.0/4.5/5.0mm). Powered, microprocessor-controlled stapling with Adaptive Compression Technology (ACT). Connectivity via ID-chips in reloads/adapters. Sterilization: Ethylene oxide (EO). Software-controlled firing and error handling.
Indications for Use
Indicated for patients requiring alimentary tract surgery, specifically for creation of end-to-end, end-to-side, and side-to-side anastomoses in open or laparoscopic procedures.
Regulatory Classification
Identification
Surgical stapler for external use: A specialized prescription device used to deliver compatible staples to skin during surgery. Surgical stapler for internal use: A specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following:
(A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type;
(B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force;
(C) Measurement of staple line strength;
(D) Confirmation of staple line integrity; and
(E) In vivo confirmation of staple line hemostasis.
(ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device.
(iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed.
(iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) Performance data must demonstrate the sterility of the device.
(vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
(viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.
(ix) Labeling of the device must include the following:
(A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity.
(B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including:
(
*1* ) Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness;(
*2* ) Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures;(
*3* ) Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage;(
*4* ) Avoidance of use of the stapler on the aorta;(
*5* ) Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure;(
*6* ) Ensuring stapler compatibility with staples; and(
*7* ) Risks specifically associated with the crossing of staple lines.(C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling.
(D) List of staples with which the stapler has been demonstrated to be compatible.
(E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device.
(F) Information regarding tissues on which the stapler is intended to be used.
(G) Identification of safety mechanisms of the stapler.
(H) Validated methods and instructions for reprocessing of any reusable device components.
(I) An expiration date/shelf life.
(x) Package labels must include critical information and technical characteristics necessary for proper device selection.
EEA™ circular stapler with Tri-Staple™ technology (K192330)
Submission Summary (Full Text)
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March 3, 2023
Covidien Katherine Choi Sr. Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K221629
Trade/Device Name: Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Adapters) Regulation Number: 21 CFR 878.4740 Regulation Name: Surgical stapler Regulatory Class: Class II Product Code: GAG, GDW
Dear Katherine Choi:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 02/22/2023. Specifically, FDA is updating this SE Letter, the Primary Product Code and the Secondary Product Code were reversed, as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Mark Trumbore, Office of Product Evaluation and Quality, 301-796-5436, Mark.Trumbore@FDA.HHS.Gov.
Sincerely,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.03.03
09:01:33-05'00'
Mark Trumbore Assistant Director THT4A1: Robotically-Assisted Surgical Device Team DHT4A: Devision of General Surgery Devices OHT4: Division of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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February 22, 2023
Covidien Katherine Choi Sr. Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K221629
Trade/Device Name: Tri-Staple™ 2.0 Black Circular Reloads (for use with Sigmia™ Circular Adapters) Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: January 23, 2023 Received: January 23, 2023
Dear Katherine Choi:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.02.22
15:15:45 -05'00'
Mark Trumbore Assistant Director THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgerv Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
#### Device Name
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
#### Indications for Use (Describe)
The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-toside anastomoses in both open and laparoscopic surgeries.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# Appendix H
Updated 510(k) Summary
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# 510(k) Summary
#### DATE PREPARED:
January 23, 2023
### SUBMITTER:
Covidien 60 Middletown Avenue North Haven, CT 06473 USA
### CONTACT PERSON:
Katherine Y. Choi, RAC Sr. Principal Regulatory Affairs Specialist Telephone: (203) 492-8412
#### IDENTIFICATION OF DEVICE:
Proprietary/Trade Name: Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) Classification Name: Staples, Implantable Regulation Number: 21 CFR 878.4740 Device Class: Class II Product Code: GAG (Primary), GDW (Secondary) Review Panel: General and Plastic Surgery Common Name: Surgical Stapler
#### PREDICATE DEVICES:
| | Primary Predicate | Secondary Predicate |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 510(k) Number | K182475 (Mar 14, 2019) | K192330 (Jan 23, 2020) |
| Proprietary/Trade<br>Name | Signia Circular Adapters (for use with<br>Signia Staplers), Tri-Staple 2.0<br>Circular Reloads (for use with Signia<br>Circular Adapters) | EEA™ circular stapler with Tri-<br>Staple™ technology |
| Classification Name | Staple, Implantable | Staple, Implantable |
| Regulation Number | 21 CFR 878.4750 | 21 CFR 878.4750 |
| Device Class | Class II | Class II |
| Product Code | GDW, GAG | GDW |
| Review Panel | General and Plastic Surgery | General and Plastic Surgery |
| Common Name | Surgical Stapler | Surgical Stapler |
# DEVICE DESCRIPTION:
The Tri-Staple™ 2.0 black circular reloads place a circular triple staggered row of titanium staples. After staple formation, the knife blade resects the excess tissue, creating a circular anastomosis such as endto-end, end-to-side, or side-to-side anastomosis as the user sees fit. The new circular reloads will be offered for an extra thick tissue thick is identified by the black staple quide. The circular reloads deploy three height-progressive rows of 4.0 mm. 4.5 mm staples. The Tri-Staple™ technology incorporated in the black reload is essentially the same as the legally-marketed K192330 in terms of reload design. The Tri-Staple™ 2.0 black circular reloads are provided sterile for single use, and available in three lumen sizes: 28, 31, and 33 mm. The Tilt-Top™ anvil is available with all circular reloads.
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The Tri-Staple™ 2.0 black reloads are for use with the previously-marketed Signia™ Circular Adapter. as part of the Signia™ stapler. The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads. The Signia™ stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surqical procedures where surgical stapling is indicated. Signia™ Stapler can be used for both linear and circular stapling application depending on the software version installed in the Signia™ power handle.
As part of this submission, additional design improvements implemented since K182475 are described.
This submission also addresses the new requirements applicable to the powered circular stapler under FDA's Final Order 2021-22041 and the new FDA's quidance titled "Surgical Staplers and Staples for Internal use - Labeling Recommendations." (issued on October 8, 2021).
### INDICATIONS FOR USE:
The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.
### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
All Tri-Staple™ 2.0 circular reloads are, as implied by the product name, designed with Covidien's proprietary Tri-Staple™ technology incorporates the triple staggered rows of titanium staples with different stable height in each staple row. It has a stepped configuration whereby the staples in the outer most row are the tallest and the staples in the inner most row are the smallest. The staple cartridge has a sloping tissue surface which provides for a graduated tissue gap, and provides for each row of staples to effectively have its own tissue qap.
The Tri-Staple™ 2.0 black reloads are for use with Signia™ stapler, which employs the powered stapling technology. The advantages of powered stapling, such as push-button operations, software-controlled tissue compression, stapling, and cutting are included, which resulted in consistent staple lines when compared to the manual instrument where the same actions are achieved through the user's manual force. After staple formation, the knife blade resects the excess tissue, creating a circular anastomosis.
Above fundamental technologies stay the same as K182475 except for the following design difference: The new reloads will be offered for an extra thick tissue range, which is identified by the black staple guide. The reloads deploy three (3) height-progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples. The Tri-Staple™ technology incorporated in the new 'black' reloads is identical to the marketed manual circular staplers cleared under K192330.
#### SUBSTANTIAL EQUIVALENCE:
The below table summarizes the similarities and differences between the subject and predicate devices.
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| Feature | Subject Device | Primary Predicate K182475 | Secondary Predicate K192330 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Signia™ stapler, when used with the<br>Signia™ circular adapters and Tri<br>Staple™ 2.0 circular single use reloads,<br>has applications throughout the<br>alimentary tract for the creation of end-<br>to-end, end-to-side, and side-to-side<br>anastomoses in both open and<br>laparoscopic surgeries. | The Signia™ stapler, when used with the<br>Signia™ circular adapters and Tri<br>Staple™ 2.0 circular single use reloads,<br>has applications throughout the<br>alimentary tract for the creation of end-<br>to-end, end-to-side, and side-to-side<br>anastomoses in both open and<br>laparoscopic surgeries. | The EEA™ Circular Stapler with Tri-<br>Staple™ Technology has application<br>throughout the alimentary tract for the<br>creation of end-to-end, end-to-side and<br>side-to-side anastomoses in both open<br>and laparoscopic surgeries. |
| Target Anatomy | Alimentary tract | Alimentary tract | Alimentary tract |
| Surgical<br>procedures | Both open and laparoscopic surgeries | Both open and laparoscopic surgeries | Both open and laparoscopic surgeries |
| Operating<br>Principle | Software-controlled and powered by a<br>built-in battery with push button controls.<br>The CTC is now called Adaptive<br>Compression Technology (ACT). | Software-controlled and powered by a<br>built-in battery with push button controls,<br>and Controlled Tissue Compression<br>(CTC) feature | Manual - activated by squeezing the<br>handle firmly as far as it will go. |
| Stapler Shaft<br>Length | Circular Adapter - Standard: 25cm<br>Circular Adapter - XL: 30cm | Circular Adapter - Standard: 25cm<br>Circular Adapter - XL: 30cm | Standard length: 22cm<br>Extra length XL: 35cm |
| Audible Feedback | Electronic beeps | Electronic beeps | Manual clicks |
| Firing Force | Pushing the toggle key to fire | Pushing the toggle key to fire | Manual squeezing to fire |
| Safety Features | Error handlings and Recovery modes | Error handlings and Recovery modes | Safety Lever (red color) |
| Intelligent | Yes - provides intelligent interface of | Yes - provides intelligent interface of | No - manual instrument without any ID |
| interface | reloads and adapters with ID-chips | reloads and adapters with ID-chips | chips or electronic parts |
| Biocompatibility | Evaluated per ISO 10993 series and<br>FDA 2016 biocompatibility guidance | Evaluated per ISO 10993 series and<br>FDA 2016 biocompatibility guidance | Evaluated per ISO 10993 series and<br>FDA 2016 biocompatibility guidance |
| Circular Reloads | | | |
| Staple Design | Tri- Staple™ Technology | Tri- Staple™ Technology | Tri-Staple™ Technology |
| Staple Rows | 3 staggered rows of staples with different<br>staple height in each staple row | 3 staggered rows of staples with different<br>staple height in each staple row | 3 staggered rows of staples with different<br>staple height in each staple row |
| Staple Material | Titanium per ASTM F67 Grade I | Titanium per ASTM F67 Grade I | Titanium per ASTM F67 Grade I |
| Guide Color | Black | Purple | Black |
| Staple Height | 4.0mm, 4.5mm 5.0mm | 3.0mm, 3.5mm, 4.0mm | 4.0mm, 4.5mm 5.0mm |
| Closed Heights | 1.5mm, 1.75mm, 2.0mm | 1.2mm, 1.5mm, 1.75mm | 1.5mm, 1.75mm, 2.0mm |
| Indicated Tissue | Extra Thick (black) reloads: | Medium/Thick (purple) reloads: | Extra Thick (black) reloads: |
| Thickness Range | 2.25 - 3.0mm (0.090" - 0.120") | 1.5 - 2.25mm (0.060" - 0.090") | 2.25 - 3.0mm (0.090” – 0.120") |
| Shell Diameter/<br>Lumen Sizes | 28mm/31mm/33mm | 21mm/25mm/28mm/31mm/33mm | 28mm/31mm/33mm<br>25mm added later by K202507 |
| Sterilization | Ethylene oxide (EO) | Ethylene oxide (EO) | Ethylene oxide (EO) |
| Biocompatibility<br>-Reloads | Evaluated per ISO 10993 series and<br>FDA 2016 biocompatibility guidance | Evaluated per ISO 10993 series and<br>FDA 2016 biocompatibility guidance | Evaluated per ISO 10993 series and<br>FDA 2016 biocompatibility guidance |
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# SUMMARY OF STUDIES:
Non-clinical performance data - The following studies have been performed to demonstrate substantial equivalence to the predicate devices. When possible, applicable FDA-recognized standards were considered:
- . Stability/Shelf-Life study for the single use devices
- Performance testing such as bench top, ex-vivo, and in-vivo pre-clinical testing ●
- Usability study performed following the FDA's 2016 guidance as well as IEC ● 62366-1
- . Chronic GLP study performed to evaluate the performance in healing metrics and anastomotic index
To address additional design improvements implemented to the previously cleared device. the following supporting data has been included:
- Disinfection validation performed per the FDA 2015 reprocessing guidance .
- . Reliability data supporting the extended end of life of the reusable devices
- ' Biocompatibility evaluation conducted in accordance with the FDA's 2020 guidance and ISO 10993-1
- Software verification & validation activities completed following the FDA's ● guidance documents and IEC 62304
- Cleaning reprocessing validated following the FDA 2015 reprocessing guidance ●
- Electrical safety testing repeated per ANSI/AAMI ES 60601-1 & IEC 60601-1 and ● electromagnetic compatibility (EMC) testing per IEC 60601-1-2
MR safety information has been previously cleared via K182475 and no change has been made to impact MR characteristics, but testing has been repeated per the latest applicable standards.
Previously demonstrated compliance for the following aspects remains unimpacted:
- Sterilization reprocessing validated following the FDA 2015 reprocessing ● guidance
- . Ethylene oxide (EO) sterilization validation for the single use devices with a minimum Sterility Assurance Level (SAL) of 10-6
Clinical performance data – No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated through non-clinical studies.
#### CONCLUSION:
Based upon the supporting data summarized above, we concluded that the new Tri-Staple™ 2.0 black circular reloads, when used with the already-marketed Signia™ stapler, are as safe and effective as the legally marketed predicate devices, and do not raise different questions of safety and effectiveness than the predicate devices.
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Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
