VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
K233682 · STERIS Corporation · OVY · Dec 15, 2023 · General Hospital
Device Facts
Record ID
K233682
Device Name
VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
Applicant
STERIS Corporation
Product Code
OVY · General Hospital
Decision Date
Dec 15, 2023
Decision
SESE
Submission Type
Special
Regulation
21 CFR 880.6887
Device Class
Class 2
Indications for Use
The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.
Device Story
The VERIFY Spore Test Strip (STS) is a biological indicator used to monitor liquid chemical sterilization cycles. It consists of a filter paper strip inoculated with Geobacillus stearothermophilus spores, enclosed in a glassine envelope. The user places the STS into a STERIS automated liquid chemical sterilant processing system using a transfer clip. After the sterilization cycle, the user aseptically transfers the strip into a provided vial containing modified tryptic soy broth with a phenol red pH indicator. The vial is incubated at 55-60°C for at least 24 hours. A red, non-turbid result indicates a pass (spore kill achieved); a yellow or turbid result indicates a fail. The device provides a means to verify that the process achieved conditions to kill at least 5 logs of spores, though it does not confirm full cycle performance. It is intended for use by healthcare personnel in clinical settings.
Clinical Evidence
No clinical data. Bench testing only. Verification activities included population wash-off testing and bacteriostasis testing, both of which met acceptance criteria.
Technological Characteristics
Filter paper carrier inoculated with Geobacillus stearothermophilus (7953) spores; enclosed in glassine envelope. Media: modified tryptic soy broth with phenol red pH indicator. Shelf life: 12 months at 2-24°C and 30-80% RH. No software or electronic components.
Indications for Use
Indicated for users of STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E, SYSTEM 1 endo, and enspire 3000 Series) to assess spore kill efficacy of S40 Sterilant use dilution.
Regulatory Classification
Identification
The spore test strip consists of a carrier or strip with a known number of spores, at least 5 log10 per strip, of known resistance to a particular liquid chemical sterilant in a liquid chemical sterilant processing system. A “no growth” result from the spore test strip after the specified predetermined incubation period indicates that the liquid chemical sterilization process achieved the conditions necessary to kill the specified minimum number of viable spores on the test strip which is 5 log10 spores/strip; it does not confirm the expected full performance of the liquid chemical sterilant processing cycle because full performance is a 6 log10 spore kill in a full liquid chemical sterilization cycle.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1)
*Spore strip characterization.* (i) Population of viable spores on strip shall be a minimum of 5 log10 after physical wash off of spores from the strip by exposure to liquid chemical sterilant in the liquid chemical sterilant processing system, which should be validated over the claimed shelf life.(ii) The resistance characteristics of the viable spores on the strip should be defined and be validated over the claimed shelf life.
(iii) The spore strip description should address the carrier material, how the spores are placed on the carrier, and whether there is any feature that minimizes spore wash off. Bacteriostasis of the spore strip materials should be evaluated.
(iv) Incubation time for viable spores on the strip should be validated under the specified incubation conditions over the claimed shelf life.
(2)
*Simulated Use Testing.* Simulated use testing should demonstrate performance of spore test strip in liquid chemical sterilant/high level disinfectant under worst case in use conditions over the claimed shelf life.(3)
*Labeling.* Labeling should specify appropriate instructions, warnings, cautions, limitations, and information relating to viable spore population, resistance characteristics, and interpretation of a “no growth” result.
In combination with the general controls of the FD&C Act, the Steris Verify Spore Test Strip for S40 for use in the Steris System 1E Liquid Chemical Sterilant Processing System is subject to the following special controls to provide reasonable assurance of the safety and effectiveness of the device type of Spore Test Strip:
- (1) Spore Strip Characterization
- Population of viable spores on strip shall be a minimum of 5 log10 after 1. physical wash-off of spores from the strip by exposure to liquid chemical sterilant in the liquid chemical sterilant processing system, which should be validated over the claimed shelf life.
- ii. The resistance characteristics of the viable spores on the strip should be defined and be validated over the claimed shelf life.
- iii. The Spore Strip description should address the carrier material, how the spores are placed on the carrier, and whether there is any feature that minimizes spore wash-off. Bacteriostasis of the Spore Strip materials should be evaluated.
- iv. Incubation time for viable spores on the strip should be validated under the specified incubation conditions over the claimed shelf life.
- (2) Simulated Use Testing: Simulated use testing should demonstrate performance of spore test strip in liquid chemical sterilant/high level disinfectant under worst case in use conditions over the claimed shelf life.
- (3) Labeling: Labeling should specify appropriate instructions, warnings, cautions, limitations, and information relating to viable spore population, resistance characteristics, and interpretation of a "no growth" result.
Predicate Devices
VERIFY Spore Test Strip for S40 Sterilant (K231746)
Submission Summary (Full Text)
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December 15, 2023
STERIS Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K233682
Trade/Device Name: VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE Regulation Number: 21 CFR 880.6887 Regulation Name: Spore Test Strip Regulatory Class: Class II Product Code: OVY Dated: November 16, 2023 Received: November 16, 2023
Dear Gregory Land:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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.
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
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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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K233682
Device Name
VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
Indications for Use (Describe)
The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liguid chemical sterilization cvcle.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary For K233682 VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 (440) 354-2600
Gregory Land Contact Lead Regulatory Affairs Specialist (440) 392-7424
Summary Date December 13, 2023
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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#### 1. Device Name
Trade Name:
Device Classification: Common Name: Classification Name: Classification Panel: Classification Number: Product Code
VERIFY Spore Test Strip for S40 Sterilant Concentrate II Spore Test Strip Liquid Chemical Processing System General Hospital and Personal Use Devices Panel 21 CFR 880.6887 OVY
#### 2. Predicate Device
VERIFY Spore Test Strip for S40 Sterilant - K231746
#### Device Description 3.
The Spore Test Strip for S40 Sterilant Concentrate (STS) consists of a 1 % in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The STS are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. The transfer clip is used to remove the STS from the glassine envelope and serves to hold the strip in a fixed location in either the enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (enspire CLCSPS) or the SYSTEM 1E or SYSTEM 1 endo Liquid Chemical Sterilant Processing system. After the cycle concludes, the transfer clip is used to aseptically transfer the STS from the processor into the growth media for incubation at 55-60°C for a minimum of 24 hours but may be incubated for up to 7 days. If the media remains red and non-turbid, the user interprets the results as a pass. If the media color turns yellow or is turbid, the user interprets the result as a fail. The shelf life is 12 months when stored at 2-24°C and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.
There are no changes to the strip itself for this submission; only an expansion to the exposure time to the chemical sterilant.
#### 4. Intended Use:
The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant Concentrate use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on
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the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.
#### ട. Technological Characteristic Comparison Table
The modified device and its predicate are physically identical. The only difference is the modified device has an expanded contact time with the liquid chemical sterilant. Table 1 summarizes the predicate and subject device comparison in tabular format.
| Table 1. Device Comparison Table | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Feature | Modified<br>VERIFY Spore Test Strip for<br>S40 Sterilant Concentrate | Predicate K231746<br>VERIFY Spore Test Strip for<br>S40 Sterilant Concentrate | Comparison |
| Intended<br>use | The VERIFY Spore Test Strip for<br>S40 Sterilant Concentrate is<br>intended to provide users with a<br>means to assess spore kill by S40<br>Sterilant use dilution in the<br>STERIS automated Liquid<br>Chemical Sterilant Processing<br>Systems (SYSTEM 1E and<br>SYSTEM 1®endo Liquid<br>Chemical Sterilant Processing<br>Systems and enspire 3000 Series<br>Cleaning and Liquid Chemical<br>Sterilant Processing System). A<br>"no growth" result from the<br>VERIFY Spore Test Strip for S40<br>Sterilant Concentrate after 24<br>hours of incubation indicates that<br>the liquid chemical sterilization<br>process achieved the conditions<br>necessary to kill at least 1 x 105<br>viable spores (5 logs) on the spore<br>test strip (STS). It does not<br>confirm the expected full<br>performance of the liquid chemical<br>sterilization cycle. | The VERIFY Spore Test Strip for<br>S40 Sterilant Concentrate is<br>intended to provide users with a<br>means to assess spore kill by S40<br>Sterilant use dilution in the<br>STERIS automated Liquid<br>Chemical Sterilant Processing<br>Systems (SYSTEM 1E and<br>SYSTEM 1®endo Liquid<br>Chemical Sterilant Processing<br>Systems and enspire 3000 Series<br>Cleaning and Liquid Chemical<br>Sterilant Processing System). A<br>"no growth" result from the<br>VERIFY Spore Test Strip for S40<br>Sterilant Concentrate after 24<br>hours of incubation indicates that<br>the liquid chemical sterilization<br>process achieved the conditions<br>necessary to kill at least 1 x 105<br>viable spores (5 logs) on the spore<br>test strip (STS). It does not<br>confirm the expected full<br>performance of the liquid chemical<br>sterilization cycle. | Identical |
| Organism | Geobacillus stearothermophilus<br>7953 spores | Geobacillus stearothermophilus<br>7953 spores | Identical |
| Viable<br>Spore<br>Population | At manufacture: ≥1.5 x 105 CFU<br>Post-Builders: ≥ 1.0 x 105 CFU | At manufacture: ≥1.5 x 105 CFU<br>Post-Builders: ≥ 1.0 x 105 CFU | Identical |
## Table 1. Device Comparison Table
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### STERIS SPECIAL 510(k) PREMARKET NOTIFICATION VERIFY® SPORE TEST STRIP FOR S40 STERILANT
| Feature | Modified<br>VERIFY Spore Test Strip for<br>S40 Sterilant Concentrate | Predicate K231746<br>VERIFY Spore Test Strip for<br>S40 Sterilant Concentrate | Comparison |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------|
| Resistance<br>characterist<br>ics | At 1635 ppm PAA:<br>• D-value 12 – 26 seconds<br>• Survival Time ≥ 38 seconds<br>• Kill Time ≥ 239 seconds | At 1635 ppm PAA:<br>• D-value 12 – 26 seconds<br>• Survival Time ≥ 38 seconds<br>• Kill Time ≥ 239 seconds | Identical |
| LCSPS<br>cycle<br>parameters | • >1820 mg/L PAA<br>• 6 minutes (+ up to 9 minute and<br>30 second Warm/Mix Phase)<br>• 45.5 - 60°C | • >1820 mg/L PAA<br>• 6 minutes<br>• 45.5-60°C | Similar |
| Culture<br>Conditions | • Trypticase Soy Broth Based<br>Media<br>• Incubation Temp.: 55-60°C<br>• Incubation Time: 24 hours<br>minimum; up to 7 days | • Trypticase Soy Broth Based<br>Media<br>• Incubation Temp: 55-60°C<br>• Incubation Time: 24 hours<br>minimum; up to 7 days | Identical |
| Carrier<br>Material | Filter paper | Filter paper | Identical |
| Primary<br>Packaging | • 20 BIs in Glassine<br>• 20 Media Vials | • 20 BIs in Glassine<br>• 20 Media Vials | Identical |
| Shelf Life | 12 months | 12 months | Identical |
#### 6. Summary of Non-Clinical Testing
Shown in Table 2 is the new testing which was performed to evaluate the modified device.
Table 2. Summary of verification activities.
| Test | Acceptance Criteria | Result |
|--------------------------------|--------------------------------------------------------------------|--------|
| Population Wash Off<br>Testing | The modification does not affect the<br>performance of the device. | Pass |
| Bacteriostasis Testing | The modification does not affect the<br>performance of the device. | Pass |
#### 7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K231746), Class II (21 CFR 880.6887), product code OVY.
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.
