K220364 · Roche Diabetes Care, Inc. · FMK · Apr 5, 2022 · General, Plastic Surgery
Device Facts
Record ID
K220364
Device Name
Accu-Chek Safe-T-Pro Uno Lancing Device
Applicant
Roche Diabetes Care, Inc.
Product Code
FMK · General, Plastic Surgery
Decision Date
Apr 5, 2022
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4850
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Accu-Chek Safe-T-Pro Uno lancing device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
Device Story
Sterile, single-use, disposable lancing device; used by healthcare professionals for capillary blood sampling. Device features spring-driven mechanism; needle retracted and concealed before/after use to prevent sharps injury; rendered inoperative after single use. Operation involves pressing release button against site; no priming required. Provides blood sample for diagnostic testing. Benefits include sharps injury prevention and standardized sampling depth (1.5 mm) with 28-gauge needle.
Clinical Evidence
Bench testing only. Mechanical design verification and validation testing performed per FDA guidance for sharps injury prevention features and 21 CFR 878.4850.
Technological Characteristics
Sterile, single-use, spring-driven lancing device. 28-gauge needle; 1.5 mm penetration depth. Integral sharps injury prevention mechanism (retractable needle). Gamma irradiation sterilization. Manual operation via release button.
Indications for Use
Indicated for capillary blood sampling in adults and children 1 year and older (fingertip) or children under 1 year (heel) by healthcare professionals.
Regulatory Classification
Identification
The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Special Controls
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
*Single use only blood lancet without an integral sharps injury prevention feature* —(1)*Identification.* A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
*Multiple use blood lancet for single patient use only* —(1)*Identification.* A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
*Multiple use blood lancet for multiple patient use* —(1)*Identification.* A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class III (premarket approval).(3)
*Date PMA or notice of completion of a PDP is required:* A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 5. 2022
Roche Diabetes Care, Inc. Julia Best Regulatory Affairs Consultant 9115 Hague Road Indianapolis, Illinois 46055
Re: K220364
Trade/Device Name: Accu-Chek Safe-T-Pro Uno Lancing Device Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class II Product Code: FMK Dated: February 3, 2022 Received: February 8, 2022
Dear Julia Best:
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. 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 (QS) 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/cdrl-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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery 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
Submission Number (if known)
K220364
Device Name
Accu-Chek Safe-T-Pro Uno Lancing Device
Indications for Use (Describe)
The Accu-Chek Safe-T-Pro Uno lancing device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
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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### K220364 K220364 - Accu-Chek Safe-T-Pro Uno Lancing Device 510(k) Summary
## Contact Details [21 CFR 807.92(a)(1)] Applicant Name: Roche Diabetes Care, Inc. Applicant Address: 9115 Hague Road Indianapolis, IN 46250-0457; United States of America Applicant Contact Telephone: +49 173 3198175 Applicant Contact: Mrs. Julia Best Applicant Contact Email: julia.best@roche.com
## Device Name [21 CFR 807.92(a)(2)]
Device Trade Name: Accu-Chek Safe-T-Pro Uno Lancing Device Common Name: Blood Lancets Classification Names: Single use only blood lancet with an integral sharps injury prevention feature Regulation Number: 878.4850, Class II Product Code: FMK
## Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)]
Predicate #: K101145 Predicate Trade Name: SurgiLance Safety Lancets Product Code: FMK
## Device Description Summary [21 CFR 807.92(a)(4)]
The Accu-Chek Safe-T-Pro Uno Lancing Device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
## Intended Use/Indications for Use [21 CFR 807.92(a)(5)]
The Accu-Chek Safe-T-Pro Uno Lancing Device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals.
It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
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#### K220364
# K220364 - Accu-Chek Safe-T-Pro Uno Lancing Device 510(k) Summary
| | Predicate Device - SurgiLance K101145 | Candidate Device - Accu-Chek Safe-T-Pro Uno<br>Lancing Device K220364 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>description | The SurgiLance Safety Lancet is a needle or blade<br>device used to prick a test site to draw a micro-<br>sample of blood which can then be tested for an<br>array of diagnostic assays.<br>The SurgiLance Safety Lancet is safely retracted<br>and concealed before and after use. Once the lancet<br>is used, it is rendered inoperative, providing added<br>safety for patient and clinician. The device is<br>discarded after use. | The Accu-Chek Safe-T-Pro Uno lancing device is a<br>needle used for capillary blood sampling for use in<br>diagnostic testing.<br>The Accu-Chek Safe-T-Pro Uno lancing device contains a<br>sharps injury prevention feature where the lancet is<br>retracted and concealed before and after use. Once the<br>lancet is used, it is rendered inoperative. The device is<br>designed for single use only. |
| Intended use | The SurgiLance Safety Lancet is a puncture device<br>to obtain micro blood samples. The SurgiLance<br>Safety Lancet has a sharps prevention feature to<br>protect the user from a needlestick injury. | The Accu-Chek Safe-T-Pro Uno lancing device is a<br>sterile, single-use, disposable lancing device intended to<br>be used by healthcare professionals.<br>It is designed for capillary blood sampling from the<br>fingertip of adults and children 1 year and older or, if the<br>patient is a child under 1 year, from the heel. |
| Intended Users | Healthcare professionals and consumers | Healthcare professionals only |
| Number of<br>Uses | Single use only with integral sharps injury<br>prevention feature | Same |
| | Predicate Device - SurgiLance K101145 | Candidate Device - Accu-Chek Safe-T-Pro Uno<br>Lancing Device K220364 |
| Device images | Image: SurgiLance K101145 | Image: Accu-Chek Safe-T-Pro Uno Lancing Device K220364 |
| Lancet<br>Sterility | Yes, gamma irradiation | Same |
| Needle Gauge<br>and Depth<br>levels | Six models for different depth settings,<br>differentiated by casing color:<br>Yellow: 21 Gauge – 1.0 mm depth<br>Gray: 21 Gauge – 1.8 mm depth<br>Orange: 21 Gauge – 2.2 mm depth<br>Pink: 21 Gauge – 2.8 mm depth<br>Lime: 18 Gauge – 1.8 mm depth<br>Blue: 18 Gauge – 2.3 mm depth | Only one model:<br>28 Gauge needle – 1.5 mm depth |
| Mechanical<br>loading | Spring-driven | Same |
| | Predicate Device - SurgiLance K101145 | Candidate Device - Accu-Chek Safe-T-Pro Uno<br>Lancing Device K220364 |
| Load and<br>firing | Loading / priming the device is not required.<br>Press red end of lancet down against test site to<br>activate lancet mechanism. | Loading / priming the device is not required.<br>Press release button to activate lancet mechanism. |
| Anatomical<br>sites | Test site Fingertip | Fingertip (adults and children 1 year and older) Heel (child under 1 year) |
| Sharps injury<br>prevention | The SurgiLance Safety Lancet has a passive safety<br>mechanism that automatically activates after use<br>requiring no action by the user. The lancet is safely<br>retracted and concealed before and after use. Once<br>the lancet is used, it is rendered inoperative. | Same |
## Similarities / Differences from Candidate Device to Predicate Device
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## K220364 K220364 - Accu-Chek Safe-T-Pro Uno Lancing Device 510(k) Summary
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#### K220364
# K220364 - Accu-Chek Safe-T-Pro Uno Lancing Device 510(k) Summary
## Non-Clinical Testing Summary and Conclusions [21 CFR 807.92(b)]
Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification & validation testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device. See more in attached Verification Summary.
#### Conclusions
The predicate and the candidate device are both used to obtain a blood sample for diagnostic testing. Furthermore, both are sterile, single-use lancets with a sharps injury prevention feature, following the same mechanical load mechanism. In conclusion, the Accu-Chek Safe-T-Pro Uno Lancing Device is substantially equivalent to the SurgiLance Safety Lancets. The Accu-Chek Safe-T-Pro Uno Lancing device is safe and effective for its intended use, and performs as well or better than the legally marketed predicate device.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
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.
