Disposable Sampler Inactivated Transport Media, Nest ITM
Applicant
Wuxi Nest Biotechnology Co., Ltd.
Product Code
QBD · Microbiology
Decision Date
Sep 20, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 866.2950
Device Class
Class 2
Indications for Use
NEST ITM is an enclosed system intended for the collection, inactivation, stabilization and transportation of pharyngeal and nasal swabs suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from the collection site to the testing laboratory. The specimen transported in NEST ITM can be used for molecular detection in the laboratory.
Device Story
NEST ITM is an enclosed system for collecting, inactivating, and stabilizing viral specimens from pharyngeal and nasal swabs. The device consists of a polypropylene tube containing a chemical medium (guanidine isothiocyanate, TCEP, sodium acetate, PEG-8000, Tris HCl). Upon collection, the medium lyses cells, disrupts lipid membranes, denatures proteins, inactivates enzymes, and stabilizes viral RNA. The device is used at the point of collection (e.g., clinic) by healthcare providers and transported to a laboratory. The inactivation process provides a >4.0 log reduction in viral concentration within 10 seconds, reducing biohazard risk for laboratory personnel. Specimens remain stable for up to 15 days at 2-8°C or 25°C. Laboratory staff use the stabilized specimen for downstream molecular detection (e.g., PCR). The device benefits patients and staff by ensuring sample integrity during transport while mitigating infection risk.
Clinical Evidence
No clinical data. Bench testing only. Analytical performance included Limit of Detection (LoD) studies (5.0 x 10^2 copies/mL for all three viruses), viral stability studies over 15 days at 4°C and 25°C (maximum variation 0.9 Ct), and viral inactivation studies (>4.0 log reduction at 10 seconds).
Technological Characteristics
Polypropylene tube (5 mL/10 mL); flocked nylon fiber swab with ABS rod. Media components: Guanidine isothiocyanate, TCEP, sodium acetate, PEG-6000, Tris, HCl, purified water. Shelf life: 12 months. Single-use. Non-sterile tube; sterile swab. Complies with ASTM F1980-2016, ASTM D4169-2016, ISO 11607-1/2, ISO 15223-1, ISO 14971, and CLSI MM13-A.
Indications for Use
Indicated for collection, inactivation, stabilization, and transport of pharyngeal and nasal swabs suspected of containing adenovirus, influenza A virus, or parainfluenza virus 2 for molecular detection in a laboratory setting.
Regulatory Classification
Identification
A microbial nucleic acid storage and stabilization device is a device that consists of a container and reagents intended to stabilize microbial nucleic acids in human specimens for subsequent isolation and purification of nucleic acids for further molecular testing. The device is not intended for preserving morphology or viability of microorganisms.
Special Controls
The special controls for this device are: (1) The intended use for the 21 CFR 809.10 labeling must include a detailed description of microorganisms and types of human specimens intended to be preserved. (2) The 21 CFR 809.10(b) labeling must include: (i) A detailed device description, including all device components. (ii) Performance characteristics from applicable analytical studies, including but not limited to, nucleic acid stability and microorganism inactivation. (iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing. (iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies. (3) Design verification and validation must include the following: (i) Overall device design including all device components and all control elements incorporated into the analytical validation procedures. (ii) Thorough description of the microorganisms and methodology used in the validation of the device including, but not limited to, extraction platforms and assays used for the detection of preserved nucleic acids. (iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.
*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of microorganisms and types of human specimens intended to be preserved.
(2) The labeling required under § 809.10(b) of this chapter must include the following:
(i) A detailed device description, including all device components;
(ii) Performance characteristics from applicable analytical studies, including nucleic acid stability and microorganism inactivation;
(iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing; and
(iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies.
(3) Design verification and validation must include the following:
(i) Overall device design, including all device components and all control elements incorporated into the analytical validation procedures;
(ii) Thorough description of the microorganisms and methodology used in the validation of the device including, extraction platforms and assays used for the detection of preserved nucleic acids; and
(iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
## I Background Information:
A 510(k) Number
K210440
B Applicant
Wuxi Nest Biotechnology Co., Ltd.
C Proprietary and Established Names
Disposable Sampler Inactivated Transport Media, Nest ITM
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QBD | Class II | 21 CFR 866.2950 - Microbial Nucleic Acid Storage And Stabilization Device | MI - Microbiology |
## II Submission/Device Overview:
A Purpose for Submission:
To make a substantial equivalence determination for the NEST ITM for the collection, transport and storage of viral specimens to the laboratory for downstream testing.
B Measurand:
Storage and stability of nucleic acids from adenovirus, influenza A virus or parainfluenza virus 2
C Type of Test:
Microbial nucleic acid storage and stabilization device
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K210440 - Page 2 of 9
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
NEST ITM is an enclosed system intended for the collection, inactivation, stabilization and transportation of pharyngeal and nasal swabs suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from the collection site to the testing laboratory. The specimen transported in NEST ITM can be used for molecular detection in the laboratory.
### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
### D Special Instrument Requirements:
None
## IV Device/System Characteristics:
### A Device Description:
NEST ITM is an enclosed system intended for the collection, inactivation stabilization and transportation of swabs suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from the collection site to the testing laboratory. The specimen transported in NEST ITM can be used for molecular detection in the laboratory.
The preservation media tubes are made of polypropylene and are filled with Inactivated Transport Media. The tubes are packaged with or without sterile swabs. The specifications for the tubes and medium are listed as follows:
- A plastic screw-cap tubes filled with 1.0, 1.5, 2.0, 3.0 or 6.0 mL of medium
- A plastic screw-cap tube filled with a range of media and package with a nasopharyngeal swab
- A plastic screw-cap tube filled with a range of media and package with an oropharyngeal swab
### B Principle of Operation:
The device components are intended to inactivate influenza A virus, parainfluenza virus 2, lyse cells, disrupt/lyse lipid membranes, denatures proteins, inactivates enzymes, and stabilize viral RNA. The transport device is designed for storage of specimens between 2-8°C and 25 °C (for up to 15 days).
The media contains the following reagents:
- Guanidine Isothiocyanate
- TCEP
- Sodium Acetate
- PEG-8000
- Tris HCl
- purified water
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V Substantial Equivalence Information:
A Predicate Device Name(s): PrimeStore MTM
B Predicate 510(k) Number(s): DEN170029
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K210440 | DEN170029 |
| --- | --- | --- |
| Device Trade Name | Disposable sampler inactivated transport media, Nest ITM | PrimeStore MTM |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | NEST ITM is an enclosed system intended for the collection, inactivation, stabilization and transportation of pharyngeal and nasal swabs suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from the collection site to the testing laboratory. The specimen transported in NEST ITM can be used for molecular detection in the laboratory. | PrimeStore MTM is intended for the stabilization, transportation and inactivation of infectious unprocessed nasal washes suspected of containing Influenza A virus RNA. PrimeStore MTM is also intended for the stabilization, transportation and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples. |
| Inactivation tested | >4.0 log reduction in concentration at 10 seconds | Same |
| Storage temperatures | 2-8 °C up to 25°C | Same |
| General Device Characteristic Differences | | |
| Specimen stability | NEST ITM preserves Adenovirus, Influenza | Primestore MTM medium preserves influenza A |
K210440 - Page 3 of 9
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| | A virus or Parainfluenza virus 2 for 15 days at 2-8 °C and 25°C | RNA for up to 8 days at 27°C and 29 days at 4°C |
| --- | --- | --- |
| Specimen Type | Nasopharyngeal or Oropharyngeal Swab | Nasal washes and sputum samples |
| Analyte | Nasopharyngeal or Oropharyngeal swab suspected of containing Adenovirus, Influenza A virus or Parainfluenza virus 2. | Nasal wash suspected of containing Influenza A virus. Sputum samples suspected of containing MTB. |
VI Standards/Guidance Documents Referenced:
Special controls that are applicable to regulation 21 CFR 866.2950.
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
N/A
2. Linearity:
N/A
3. Analytical Specificity/Interference:
N/A
4. Assay Reportable Range:
N/A
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Shelf life: The shelf life for the NEST ITM is 12 months after the date of manufacture. The stability of the NEST ITM was performed using Realtime and Accelerated stability on a total of three (3) lots. Stability looked for bacterial and fungal growth in the media along with properties of the media, appearance, pH, and then confirmed with viral stabilization at room
K210440 - Page 4 of 9
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temperature to the claimed 15 days demonstrating the stability of nucleic acids was not diminished with the age of media.
Sterilization: The DNA/RNA Shield Collection tube with media are not sold as sterile nor are they intended to be sterilized by the user. These vials are single use devices that do not require cleaning by the operator. The Swabs are individually packages and sold as sterile.
# 6. Detection Limit:
a) LoD testing was conducted to determine the lowest concentration of analyte that can be detected with a greater than $95\%$ detection rate. The LoD studies for Adenovirus, Influenza A, and Parainfluenza virus 2 were designed using validated assays to establish a concentration of organisms used for additional testing noted below.
LoD testing was initially performed by spiking multiple concentrations of Adenovirus, Influenza A, and Parainfluenza virus 2 into contrived matrix and spiking it onto a swab. Adenovirus, Influenza A, and Parainfluenza virus 2 were spike at a final concertation range of $1.0 \times 10^{4}$ , $1.0 \times 10^{3}$ , $5.0 \times 10^{2}$ , and $1.0 \times 10^{2}$ copies/mL into the NEST ITM with a swab. A validated PCR assay was used to determine the LoD to be $5.0 \times 10^{2}$ copies/mL for each of the three viruses. Table 1 below shows the results of preliminary LoD for Adenovirus, influenza A, and Parainfluenza virus 2.
Table 1. Preliminary Limit of Detection
| Concentration (copies/mL) | Adenovirus, 5 Reps Average (Ct) | SD (Ct) | Influenza A, 5 Rep Average (Ct) | SD (Ct) | Parainfluenza virus 2, 5 Rep Average (Ct) | SD (Ct) |
| --- | --- | --- | --- | --- | --- | --- |
| 1.0x104 | 29.3 | 0.18 | 32.04 | 1.08% | 31.07 | 1.08% |
| 1.0x103 | 32.0 | 0.26 | 34.75 | 2.11% | 34.28 | 2.18% |
| 5.0x102 | 34.3 | 0.95 | 35.48 | 1.97% | 36.89 | 2.98% |
| 1.0x102 | >40 | - | >40 | - | >40 | - |
Confirmatory LoD testing was provided at a concentration of $5.0 \times 10^{2}$ copies/mL with 20 replicates. The validated assay had an LoD with an acceptance criteria of virus detection at a concentration range $5.0 \times 10^{2}$ copies/mL. The same detection range was replicated with the NEST ITM and further determine by the concentration that yielded at least a $95\%$ of the replicates were recoverable within this range. At a concentration of $5.0 \times 10^{2}$ copies/mL, 20 of 20 replicates had recoverable concentrations. Viral nucleic acids were extracted using a nucleic acid (DNA/RNA) extraction and purification kits (spin column) (SC903-50) (Wuxi TechstarTechnology Co., Ltd.) and amplified using the respective kits on the ABI 7500. The average $C_{t}$ values for each virus are listed below in Table 2.
K210440 - Page 5 of 9
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Table 2. Limit of detection ${\mathrm{C}}_{\mathrm{t}}$ values for each virus
| | Ct Value | | |
| --- | --- | --- | --- |
| Replicates | Adenovirus | Influenza A | Parainfluenza virus 2 |
| 1 | 36.2 | 32.0 | 38.0 |
| 2 | 37.0 | 32.4 | 38.2 |
| 3 | 38.1 | 35.4 | 37.8 |
| 4 | 38.1 | 35.2 | 36.7 |
| 5 | 36.8 | 35.4 | 36.4 |
| 6 | 36.9 | 37.0 | 38.4 |
| 7 | 35.5 | 35.8 | 37.3 |
| 8 | 36.1 | 35.0 | 35.2 |
| 9 | 37.2 | 35.4 | 35.9 |
| 10 | 35.8 | 35.7 | 36.5 |
| 11 | 37.7 | 35.8 | 36.2 |
| 12 | 36.3 | 35.8 | 36.2 |
| 13 | 36.4 | 35.3 | 34.2 |
| 14 | 37.5 | 36.2 | 35.3 |
| 15 | 36.7 | 34.1 | 36.1 |
| 16 | 35.7 | 35.6 | 35.1 |
| 17 | 37.0 | 35.9 | 36.6 |
| 18 | 37.0 | 35.7 | 35.8 |
| 19 | 36.8 | 36.2 | 37.5 |
| 20 | 37.1 | 35.0 | 36.3 |
| AVG: | 36.8 | 35.2 | 36.3 |
| SD: | 0.73 | 1.2 | 1.1 |
LoD testing at $5.0 \times 10^{2}$ copies/mL resulted in all 20 replicates for the concentration meeting the pre-defined acceptance criteria.
# b) Viral Stability
The stability of Adenovirus, Influenza A, and Parainfluenza virus 2 at $1 \times$ LoD ( $5.0 \times 10^{2}$ copies/mL) was evaluated by spiking virus into simulated matrix incubated in the NEST ITM at refridgerated temperature ( $4^{\circ} \mathrm{C}, 39^{\circ} \mathrm{F}$ ) for 15 days (see Table 3), and ambient temperature ( $25^{\circ} \mathrm{C}, 77^{\circ} \mathrm{F}$ ) for 15 days (see Table 4). Validated PCR assays was used to determine stability of Adenovirus, Influenza A, and Parainfluenza virus 2 in the NEST ITM. The stability study analyzed a total of three lots near the manufacturer claimed 12-month stability. Testing used at least 20 replicates for each virus, time point and storage condition. An initial time point designated as Day 0 was included as the initial $C_{t}$ average for each of the two temperature ranges tested. Testing at three time points was performed at Day 0, 9 and 15 for refrigerated temperature ( $2-8^{\circ} \mathrm{C}, 36-39^{\circ} \mathrm{F}$ ), and three time points, Day 0, 9, and 15, for ambient temperature ( $25^{\circ} \mathrm{C}, 77^{\circ} \mathrm{F}$ ).
The validated PCR assays were run with all applicable controls to valid and confirm the detection of the target virus, Adenovirus, Influenza A, and Parainfluenza virus 2. A predefined acceptance criteria of $(+/-)$ $3.0\mathrm{C_t}$ from the initial time zero value was the acceptance criteria.
K210440 - Page 6 of 9
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Table 3. Adenovirus, Influenza A, and Parainfluenza 2 virus (5.0x10² copies/mL) stability at 4°C
| | Day 0 | Day 9 | Day 15 |
| --- | --- | --- | --- |
| Adenovirus AVG (Ct): | 36.0 | 36.7 | 36.9 |
| CV (Ct): | 2.15% | 1.8% | 2.0% |
| Influenza A AVG (Ct): | 35.4 | 35.4 | 35.7 |
| CV (Ct): | 2.0% | 2.3% | 2.5% |
| Parainfluenza 2 AVG (Ct): | 36.1 | 37.0 | 37.0 |
| CV (Ct): | 2.0% | 2.0% | 2.4% |
Table 4. Adenovirus, Influenza A, and Parainfluenza 2 virus (5.0x10² copies/mL) stability 25°C
| | Day 0 | Day 9 | Day 15 |
| --- | --- | --- | --- |
| Adenovirus AVG (Ct): | 36.1 | 37.0 | 36.9 |
| CV (Ct): | 2.0% | 2.4% | 2.0% |
| Influenza A AVG (Ct): | 35.3 | 36.1 | 35.3 |
| CV (Ct): | 2.4% | 2.6% | 2.1% |
| Parainfluenza 2 AVG (Ct): | 36.2 | 36.9 | 37.0 |
| CV (Ct): | 2.3% | 2.6% | 2.1% |
Stability testing of RNA from whole Adenovirus, Influenza A, and Parainfluenza virus 2 were spiked into matrix and stored in NEST ITM, resulted in a maximum average variation of 0.8 Cₜ over 15 days at 25°C and a maximum variation of 0.9 Cₜ over 15 days at 2-8°C.
c) Inactivation
Adenovirus, Influenza A, and Parainfluenza virus 2 at a concentration of 1.0 x 10⁷ TCID₅₀/ml was incubated with NEST ITM for 10 seconds. Each virus only and NEST ITM were also incubated accordingly to serve as controls. Adenovirus, Influenza A, and Parainfluenza 2 virus (virus alone), Virus and NEST ITM, or NEST ITM alone was then incubated on to cell cultures after incubation. Four days after inoculation, the cells were fixed and stained with 0.06% crystal violet in 1% glutaraldehyde. Cells that did not take up the stain were considered evidence of a viral cytopathic effect (CPE) and as a result were considered a measure of viral viability. The titer of the virus CPE was calculated and recorded as the TCID₅₀.
Inactivation time:
The NEST ITM showed no cytotoxicity on MDCK cells at a 1:1,000 dilution factor and greater; therefore at least a 1:1,000 dilution factor is needed to avoid a direct cytotoxic effect of the NEST ITM. Adenovirus, Influenza A, and Parainfluenza virus 2, were then exposed to NEST ITM for 10 seconds prior to serial 10 fold dilutions and incubations
K210440 - Page 7 of 9
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(final concentration $\leq 10^{3}\mathrm{TCID}_{50} / \mathrm{mL}$ ), while Influenza Adenovirus, Influenza A, and Parainfluenza virus 2 samples had viral loads of greater than $1.0 \times 10^{6} \mathrm{TCID}_{50}$ of virus and NEST ITM alone was diluted 1:1000 to see no CPE. The NEST ITM rapidly inactivated all viruses tested with a $>4.0$ log reduction at a 1:10 specimen to media concentration at 10 seconds. Viral CPE could not be observed at $< 3.0$ logs due to cellular destruction by NEST ITM See Table 5 below.
Table 5 Adenovirus, Influenza A, and Parainfluenza virus 2 inactivation in NEST ITM
| 10s incubation | Adenovirus TCID50(log) | Influenza A TCID50(log) | Influenza A TCID50(log) |
| --- | --- | --- | --- |
| Virus only | 6.14 | 6.75 | 6.63 |
| Virus and NEST ITM | < 3.0 | < 3.0 | < 3.0 |
| NEST ITM only* | ≤ 3.0 | ≤ 3.0 | ≤ 3.0 |
* NEST ITM shows cytotoxicity on MDCK cells when diluted to 1:1,000.
NEST ITM must be used at a ratio of at least 1:10 at a minimum of 10 seconds exposure time to demonstrate inactivation of Adenovirus, Influenza A, and Parainfluenza virus 2. Measuring Adenovirus, Influenza A, and Parainfluenza virus 2 inactivation below $1 \times 10^{3}$ $\mathrm{TCID}_{50}$ was not possible because of the cytotoxic affects NEST ITM has on the cell culture based assay.
7. Assay Cut-Off:
N/A
B Comparison Studies:
1. Method Comparison with Predicate Device:
N/A
2. Matrix Comparison:
N/A
C Clinical Studies:
1. Clinical Sensitivity:
N/A
2. Clinical Specificity:
N/A
K210440 - Page 8 of 9
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3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
N/A
D Clinical Cut-Off:
N/A
E Expected Values/Reference Range:
N/A
F Other Supportive Instrument Performance Characteristics Data:
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K210440 - Page 9 of 9
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1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
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Exact 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.
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Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
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Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
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Reading rule for every project: how many summaries do you read in full?
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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.
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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.
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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.
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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.
