K150729 · Nexera Medical, Inc. · ONT · Dec 29, 2015 · General, Plastic Surgery
Device Facts
Record ID
K150729
Device Name
SpectraShield 9500 Surgical N95 Respirator
Applicant
Nexera Medical, Inc.
Product Code
ONT · General, Plastic Surgery
Decision Date
Dec 29, 2015
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4040
Device Class
Class 2
Indications for Use
The SpectraShield 9500 Surgical Mask is a single use, disposable, surgical mask, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator, and inactivates 99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions. In vitro tests have demonstrated 99.99% inactivation on the surface of the outer layer of the mask when tested against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes: H1N1 (A/California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A /Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/Lee/40. No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti-influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator. The SpectraShield 9500 Surgical Mask is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.
Device Story
SpectraShield 9500 is a molded, 4-layer surgical mask; features 2-ply meltblown polypropylene middle layer sandwiched between polyester nonwoven fabric layers. Outer layer embedded with silver-copper zeolite agent for antibacterial/antiviral surface activity. Device includes aluminum nose strip and 2 elastic polyamide straps. Used in occupational settings to protect wearers from microorganisms, body fluids, and particulates. Surface treatment inactivates bacteria and influenza viruses upon contact; however, it does not protect against pathogens inhaled around mask edges. No clinical studies compare efficacy against untreated masks. Benefits include reduced surface pathogen load during 8-hour continuous use.
Clinical Evidence
No clinical studies conducted. Evidence is based on bench testing: bacterial filtration efficiency (99.9%), particulate filtration (99.87% at 0.1 microns), fluid resistance (160 mmHg), and in vitro viral/bacterial reduction assays. Biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity) per ISO 10993 passed. Gas-off and leach-off testing confirmed antibacterial/antiviral particles remain within safe inhalation/ingestion limits.
Technological Characteristics
4-layer molded mask: 2-ply meltblown polypropylene core, polyester nonwoven outer/inner layers. Outer layer embedded with silver-copper zeolite. Aluminum nose strip; polyamide/elastic straps. ASTM F1862 (fluid resistance), ASTM F2299 (particulate filtration), ASTM F2101 (BFE), Mil M36954C (differential pressure). Biocompatibility per ISO 10993-10/11. Non-sterile.
Indications for Use
Indicated for occupational use as a single-use, disposable surgical mask to protect against microorganisms, body fluids, and particulate material. Suitable for use by adults in occupational settings.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2015
Nexera Medical Inc. Mr. Paul Sallarulo, President & CEO 3343 West Commercial Blvd. Suite 103 Ft. Lauderdale, FL 33309
K150729 Re:
> Trade/Device Name: SpectraShield Model 9500 Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Mask Regulatory Class: II Product Code: ONT Dated: November 30, 2015 Received: December 1, 2015
Dear Mr. Sallarulo,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K150729
Device Name SpectraShield model 9500 Surgical Mask
#### Indications for Use (Describe)
The SpectraShield 9500 Surgical Mask is a single use, disposable, surgical mask, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator, and inactivates 99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.
In vitro tests have demonstrated 99.99% inactivation on the surface of the mask when tested against the following seasonal, pandemic, avian, swine influenza viruses: Influenza A subtypes: H1N1 (A/ California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/ Lee/40.
No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti-influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator.
The SpectraShield 9500 Surgical Mask is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.
| Type of Use (Select one or both, as applicable) | | | |
|-------------------------------------------------|-----------------------------------------------|--|--|
| Prescription Use (Part 21 CFR 801 Subpart D) | 区 Over-The-Counter Use (21 CFR 801 Subpart C) | | |
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Image /page/3/Picture/0 description: The image shows the logo for "NEXERA MEDICAL". The word "NEXERA" is in large, bold, blue font, except for the "X" which is green and has a blue diamond shape above it. Below "NEXERA" is the word "MEDICAL" in a smaller, thinner, black font.
# Section 5.0: 510(k) SUMMARY (K150729)
| 510(k) | NexEra Medical, Inc. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner: | 3343 West Commercial Blvd, Suite 103 Ft. Lauderdale, FL 33309 |
| Contact: | Paul Sallarulo, President CEO |
| Phone: | 954-495-2020, x 2031 |
| Fax: | 954-491-7281 |
| Date Summary Prepared: | December 29, 2015 |
| Device: | |
| Trade Name: | SpectraShield model 9500 Surgical Mask |
| Common /Classification Name: | Surgical mask |
| Class: | II |
| Classification Product Code: | ONT |
| Regulation Number: | 21 CFR 878.4040 |
| Predicate Device Information: | K120244 SpectraShield 9500 Surgical N95 Respirator K122702 BioFriend™ BioMask ™ N95 Surgical Respirator |
| Device Description: | The SpectraShield model 9500 Surgical Mask is a molded shape surgical mask composed of 4 layers of material, molded to form the mask. A 2-ply meltblown polypropylene middle layer is sandwiched by inner and outer layers of 100% polyester nonwoven fabric. The inner and outside layers of polyester nonwoven fabric include fibers that have been embedded with an antibacterial/antiviral agent to provide antibacterial and antiviral performance. The mask has 2 elastic straps (not made with natural latex) and an aluminum nose strip. |
| Intended Use: | The SpectraShield 9500 Surgical Mask is a single use, disposable, surgical mask, tested for continuous use up to 8 hours, embedded with a zeolite carrier containing a silver- copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator, and |
3343 West Commercial Blvd., Suite 103 - Ft. Lauderdale, FL 33309 USA
Telephone: 954-495-2020 ~ Fax: 954-495-7281 ~ www.nexeramed.com
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Image /page/4/Picture/0 description: The image shows the logo for "NEXERA MEDICAL". The word "NEXERA" is in large, bold, sans-serif font, with "NEX" in blue and "ERA" in blue, and the "X" in green. Above the "X" is a blue diamond shape. Below "NEXERA" is the word "MEDICAL" in smaller, sans-serif font, with the letters spaced out.
inactivates 99.99% of test influenza viruses after 5 minutes of contact with the surface of the mask. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.
In vitro tests have demonstrated 99.99% inactivation on the surface of the outer layer of the mask when tested against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes: H1N1 (A/California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A /Puerto Rico/8/1934), H3N2 (A/Wisconsin/67/2005, A/Brisbane/10/2007, A/Hong Kong/8/1968, A/Victoria/3/75), H2N2 ( A/2/Japan/305/1957); Avian Flu (bird flu) subtypes: Avian Influenza A (H5N1), Avian Influenza A (H9N2), Swine Flu subtype: H1N1 (A/Swine/1976/1931), Equine Flu subtypes: H3N8 (A/Equine/2/Miami/1963), Influenza B strains: B/Florida/4/2006, B/Brisbane/60/2008, B/Lee/40.
No clinical studies have been conducted comparing the ability of an untreated surgical mask and the SpectraShield model 9500 surgical mask to protect the wearer from infection, and the antibacterial/anti-influenza virus treatment cannot affect pathogens that are inhaled around the edges of the respirator.
The SpectraShield 9500 Surgical Mask is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material.
## 510(k) Summary Device Comparison Table
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Image /page/5/Picture/0 description: The image shows the logo for "NEXERA MEDICAL". The word "NEXERA" is in large, bold, blue font, except for the "X", which is green and has a blue diamond shape above it. Below "NEXERA" is the word "MEDICAL" in a smaller, bold, black font.
| | Subject Device | Predicate Device<br>K120244 SpectraShield | Predicate Device<br>K122702 BioFriendTM<br>BioMaskTM |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K150729 | K120244 | K122702 |
| Company | NexEra Medical, Inc. | NexEra Medical, Inc. | Filligent (HK) Limited |
| Name/Model | SpectraShield Model<br>9500 Surgical Mask *<br>(*with amended Intended<br>use Statement) | SpectraShield Model<br>9500 Surgical Respirator | BioFriendTM BioMaskTM<br>N95 Surgical Respirator:<br>Professional BF-200-3013AN |
| Fabrics | Nonwoven polyester<br>containing a silver-copper<br>zeolite (antibacterial /<br>aniviral agent) and a<br>meltblown polypropylene<br>substrate. | Nonwoven polyester<br>containing a silver-copper<br>zeolite (antibacterial agent)<br>and a meltblown<br>polypropylene substrate. | 4 layers: spun-bond<br>polypropylene, cellulose /<br>polyester, meltblown<br>polypropylene, spunbond<br>polypropylene. Copper &<br>zinc ion treatment and a<br>hydrophilic plastic coating. |
| Nosepiece | 100% Aluminum | 100% Aluminum | 100% Aluminum |
| Straps | (2) Polyamide fiber and<br>elastic straps, not made<br>with natural latex | (2) Polyamide fiber and<br>elastic straps, latex free | Polyamide/spandex elastic<br>straps, latex free |
| Mask Style | Molded shape | Molded shape | Convex shape |
| Fluid Resistance ASTM<br>F1862 | Pass: Fluid Resistant @<br>160mm Hg | Pass: Fluid Resistant @<br>160mm Hg | 160 mm Hg |
| Particulate Filtration<br>ASTM<br>Efficiency<br>F2299 | Pass: 99.87% at 0.1<br>microns | Pass: 99.87% at 0.1<br>microns | >99.9% |
| Differential Pressure<br>Mil M36954C | Pass: 4.3mm H20/cm2 | Pass: 4.3mm H20/cm2 | 4.9mm H20/cm2 |
| Bacterial Filtration<br>Efficiency<br>ASTM<br>F2101 | Pass: 99.9% | Pass: 99.9% | >99.9% |
| | Subject Device | Predicate Device<br>K120244 SpectraShield | Predicate Device<br>K122702 BioFriend™<br>BioMask ™ |
| Flammability Class<br>16CFR 1610 | Class 1 | Class 1 | Class 1 |
| Cytotoxicity 10993-10…
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.
