Post-market surveillance reports from OUS jurisdictions; Medical literature
The sponsor utilized post-market safety data from OUS jurisdictions and a review of medical literature to support the benefit-risk determination, noting a lack of reported adverse events for this type of device.
General population in OUS jurisdictions where the device is marketed
Not applicable for this study
Adverse event reporting
Indications for Use
Zap-It! is indicated for temporarily reducing the itching caused by mosquito bites.
Device Story
Zap-It! is a handheld, non-powered, piezoelectric stimulator used for temporary relief of mosquito bite itching. Device operates by applying cutaneous piezoelectric stimulation directly to the local site of the insect bite. User-operated; intended for over-the-counter use. Mechanism involves generating a limited electrical output via piezoelectric effect to alleviate skin reactions. Device is portable; requires no external power source. Clinical benefit is the reduction of pruritus associated with mosquito bites. Safety is managed through labeling and characterization of electrical output to prevent burns or tissue damage.
Clinical Evidence
No clinical data provided. Evidence basis is non-clinical bench testing, including characterization of electrical output specifications (total charge, current, voltage, pulse duration) and mechanical durability testing to ensure device integrity over its labeled lifespan.
Technological Characteristics
Piezoelectric stimulator; ABS plastic patient-contacting material. Output: 13 kV, 0.7 mA, 20 µS pulse duration. Mechanical activation via push button. Standalone, non-sterile, hand-held form factor. No software/firmware.
Indications for Use
Indicated for temporary reduction of itching caused by mosquito bites in the general population.
Regulatory Classification
Identification
A limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites is a device intended to alleviate skin reactions associated with insect bites via cutaneous, piezoelectric stimulation at the local site of the bite.
Special Controls
In combination with the general controls of the FD&C Act, the Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites is subject to the following special controls:
- 1. Appropriate testing to characterize the electrical output specifications of the device (i.e., total charge delivered, maximum instantaneous output current, maximum instantaneous output
voltage, pulse duration, charge density) must be conducted.
- 2. Mechanical bench testing must demonstrate that the device will withstand the labeled number duration of uses.
- 3. All elements of the device that may contact the patient must be assessed to be biocompatible.
- 4. Labeling must include:
- a. Validated instructions which addresses the following:
- i. Identification of areas of the body which are appropriate and not appropriate for contact with the device;
- ii. Whether use of the device in conjunction with flammable materials (e.g., insect repellent) is appropriate;
- iii. Use of the device on or near implanted devices;
- iv. How to identify the correct type of skin condition
- b. Technical parameters of the device [maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration].
- Language to direct end-users to contact the device manufacturer and MedWatch if C. they experience any adverse events with this device.
- d. The anticipated number of device uses prior to failure.
In combination with the general controls of the FD&C Act, the Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.is subject to the following special controls:
- 1. Appropriate testing to characterize the electrical output specifications of the device (i.e., total charge delivered, maximum instantaneous output current, maximum instantaneous output voltage, pulse duration, charge density) must be conducted.
- 2. Mechanical bench testing must demonstrate that the device will withstand the labeled number duration of uses.
- 3. All elements of the device that may contact the patient must be assessed to be biocompatible.
- 4. Labeling must include:
- a. Validated instructions which addresses the following:
- i. Identification of areas of the body which are appropriate and not appropriate for contact with the device;
- ii. Whether use of the device in conjunction with flammable materials (e.g., insect repellent) is appropriate;
- iii. Use of the device on or near implanted devices;
- iv. How to identify the correct type of skin condition
- b. Technical parameters of the device [maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration].
- c. Language to direct end-users to contact the device manufacturer and MedWatch if they experience any adverse events with this device.
- d. The anticipated number of device uses prior to failure.
*Classification.* Class II (special controls). The special controls for this device are:(1) Appropriate testing to characterize the electrical output specifications of the device (
*i.e.,* total charge delivered, maximum instantaneous output current, maximum instantaneous output voltage, pulse duration, charge density) must be conducted.(2) Mechanical bench testing must demonstrate that the device will withstand the labeled number duration of uses.
(3) All elements of the device that may contact the patient must be assessed to be biocompatible.
(4) Labeling must include:
(i) Validated instructions which addresses the following:
(A) Identification of areas of the body which are appropriate and not appropriate for contact with the device.
(B) Whether use of the device in conjunction with flammable materials (
*e.g.,* insect repellent) is appropriate.(C) Use of the device on or near implanted devices.
(D) How to identify the correct type of skin condition.
(ii) Technical parameters of the device (maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration).
(iii) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device.
(iv) The anticipated number of device uses prior to failure.
Submission Summary (Full Text)
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## EVALUATION OF AUTOMATIC CLASS III DESIGNATION (DE NOVO) FOR ZAP-IT!
### REGULATORY INFORMATION
FDA identifies this generic type of device as:
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites. A limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites is a device intended to alleviate skin reactions associated with insect bites via cutaneous, piezoelectric stimulation at the local site of the bite.
NEW REGULATION NUMBER: 21 CFR 882.5894
CLASSIFICATION: II (Exempt from premarket notification review, subject to the limitations in 21 CFR 882.9)
PRODUCT CODE: OSG
### BACKGROUND
DEVICE NAME: Zap-It!
DE NOVO REQUEST: DEN100024
DATE OF DE NOVO REQUEST: September 8, 2010
REQUESTOR CONTACT: Ecobrands, Ltd. #2 - 36 Stratford Road London, W8 6QA, UK Phone: + 44-0-20-7460-8101 Fax: +44-0-20-7565-8779
### REQUESTOR'S RECOMMENDED CLASSIFICATION: II
#### INDICATIONS FOR USE
Zap-It! is indicated for temporarily reducing the itching caused by mosquito bites.
### Limitations
The Zap-It! device is available as an over-the-counter (OTC) device.
Please refer to the package insert for a complete list of Warnings and Precautions
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regarding the appropriate use of the Zap-It! device. The following statements are limitations of the device explicitly noted in the labeling:
### Warnings
Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted electrical device. Such use could cause electric shock, burns, or electrical interference.
Do not use Zap-It! in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when you are using the product.
Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).
Do not use over viral lesions, as safety studies have not been performed to determine the effect of the Zap-It! on viral lesions; therefore, the effects are unknown.
Do not use on flammable materials. It may cause them to burn and burn your skin.
Zap-It! should not be used after applying insect repellent until it has fully dried to the touch, as repellant may be flammable and cause skin burns if ignited.
For external use only. Do not apply the Zap-It! inside the mouth or other body cavity as pain or injury may occur.
Do not apply the Zap-It directly to your eyes as this could cause damage to your evesight.
Do not use the Zap-It! in situations where electrical stimulation could put you at risk of injury, such as while driving a car or operating machinery.
Cutaneous burns are a danger when applying repeated electrical stimulus to the skin in rapid succession, and the repeated excessive use of the device on bites has not been studied.
### Precautions
Do not use Zap-It! to remove the toxins or infection associated with mosquito bites. Zap-It! was only found in clinical studies to temporarily remove the itching. If you believe your mosquito bite is infected, seek medical attention.
Do not use in the bath or shower as water may cause the device to not properly function.
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The safety and effectiveness has not been established in neonates, infants and children.
Do not apply Zap-It! to your lips as this may cause pain.
Dispose of this device responsibly at the end of its useful life.
Discontinue use if irritation occurs.
Keep out of the reach of children.
Use caution if stimulation is applied over areas of skin that lack normal sensation.
The Zap-It! is a medical device. Do not let children play with Zap-It!.
# CONDITIONS OF EXEMPTION
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites are appropriate for exemption from premarket notification, subject to the limitations of exemptions identified in 21 CFR 882.9, because the applicable special controls and general controls provide reasonable assurance of safety and effectiveness, if device manufacturers follow the special controls requirements. Examples of exceeding the limitations of exemption are where the output (absolute charge delivered or current) exceeds the specifications for this device, the indications is for something other than itching or the indications specify bites other than insect bites.
Exemption from the requirement of premarket notification for limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites does not mean that these devices would be exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's proposal to exempt these devices from the requirement of premarket notification [510(k)] is based, in part, on the assurance of safety and effectiveness provided by other regulatory controls, such as current good manufacturing practice requirements (21 CFR part 820) and the identified special controls.
# DEVICE DESCRIPTION
The Zap-It! is a hand held device, consisting primarily of housing, a push button (which the user depresses to excite the piezoelectric crystal), a "Piezo unit" (containing piezoelectric crystal) and electrical output terminals (placed flush to the user's skin) intended to deliver electrical current to the skin. Please refer Figure 1 below for a graphical representation of the device:
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Image /page/3/Figure/0 description: This image shows a diagram of a device with several labeled parts. The device has a handle and a flat end designed to be placed on the skin surface. The diagram labels parts such as the "Push button", "Carrying lanyard loop", "Piezo unit", "Body", "Electrode wires", and "Electrode output terminals". The "Piezo length" is labeled as "1.1 ins" and the "Piezo width" is labeled as "0.2 ins".
Figure 1 - Graphical Representation of the Device
The user of the device places the end of the device containing the electrode output terminals (the end of the device opposite the push button) flush against the skin, at the site of the mosquito bite. The push button is manually depressed, which mechanically deforms the piezoelectric crystal, and electrical charge (high voltage, low amperage) travels via the electrode wires to the skin. Electrical charge may reach the skin via electrical conductive channel between the electrode terminals and skin, or electrical conductive channel through a small air gap to the skin (electrical spark). The deposition of the charge in the skin is intended to reduce the itch associated with the underlying mosquito bite.
The user may repeat activation of the device (a maximum of five activations per bite) until the mosquito bite itch has been satisfactorily reduced; however, the user is also instructed that repeated use at the same site increases the risk of mild cutaneous burns.
The device is designed for external, limited duration intact skin contact in an environment free from fluids and is provided non-sterile.
The device contains no software.
The Zap-It! Device is for over-the-counter (OTC) use. as described in the package insert.
## SUMMARY OF PERFORMANCE TESTING
## Characterization of Electrical Output (Oscilloscope Tracings)
To characterize device electrical output, oscilloscope tracings of the output were provided, under loads of 500, 2000, and 10,000 ohms to simulate the load presented by dry skin, while using a controlled and repeatable pressure to activate the piezoelectric element. Oscilloscope tracings were also provided under a load of 50 ohms to simulate the load presented by wet skin. The device output, as characterized by oscilloscope
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tracings measured in open circuit, was 13 kV, 0.7 mA, and 20 µS pulse duration.
## Performance Testing, Mechanical Failure (or Degradation)
The sponsor provided testing which evaluated the ability of the device to confer charge after 5000 device actuations. This testing showed that the device still conferred charge, though after 5000 actuations, a 34% decrease in measured open circuit voltage was observed.
## Biocompatibility Analysis
The patient-contacting material is a specific acrylonitrile butadiene styrene (ABS). Justification was provided supporting biocompatibility of this material for an externallycontacting device.
## Human Performance Testing
The effect of the device on mosquito bite itch (device benefit) was evaluated in a clinical trial in which 53 healthy subjects 18-65 years of age with a history of mosquito bite reaction but with no active skin lesions were enrolled.
## Study Design
Subjects were randomized 1:1 to active treatment (n = 27) versus placebo (n = 26). Each subject received a single mosquito bite under controlled conditions on the volar surface of the non-dominant forearm. Subjects were then instructed to test the device according to package instructions.
The sham (control) device was identical in appearance and function to the device, including the generation of an electrical discharge from piezoelectric crystals activated through mechanical stress. However, the sham device contained false electrical wires that did not transmit the electrical charge to the skin surface.
Itching was assessed using a visual analog scale (VAS) ranging from 0 (no itching) to 100 (severe itching). A mosquito bite was induced at t=0. A baseline assessment was made at t=5 minutes after the mosquito bite and prior to device use.
Assessments of itching were made following device/sham use at 15, 25, 40 minutes and 1, 2, 3, 4, 6, and 24 hours after the mosquito bite. These were compared to the baseline assessment made 5 minutes after the mosquito bite and prior to device use.
The primary effectiveness outcome was a responder analysis defined as the proportion of subjects whose itching at t=15 minutes decreased 40% relative to the baseline itching at t=5 minutes using the VAS in each study arm.
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The key secondary outcome measure was an assessment of the length and width of edema (i.e., swelling of the erythematous area) associated with an individual mosquito bite.
## Results
Both the active (test) and placebo groups had similar baseline VAS scores for itching, with each group demonstrating a decreasing score over time. The primary endpoint was based on an individual success criterion of a 40% or greater relative decrease in Degree of Itching on the VAS from t=5 minutes to t=15 minutes. Out of 27 test subjects, 19 met the success criterion. Out of 26 placebo subjects, 3 met the success criteria. The difference in responder rates between the two study arms was statistically significant (p<0.05). There was an improvement in the reported mean VAS score for the active group compared to the placebo group following application of the device as illustrated in Figure 2 below. The mean VAS at baseline for each study group was very similar. The differences of the mean VAS between study groups were found to be statistically significant using t tests for two independent samples (p<0.05) at all time points after the baseline measurement at t=5 minutes.
Image /page/5/Figure/3 description: This image shows a line graph comparing the mean VAS scores of a placebo group and a test group over a 24-hour period. The x-axis represents time points, including t=5m, t=15m, t=25m, t=40m, t=1h, t=2h, t=3h, t=4h, t=6h, and t=24h. The y-axis represents the mean VAS scores, ranging from 0 to 70. The placebo group consistently has higher VAS scores than the test group at each time point.
Both the active and placebo groups had similar baseline erythematous area sizes; slightly more edema was observed in the active group but scores were similar at the final 24-hour assessment point. This observed difference was not statistically significant.
Subjects were monitored for 24 hours and no adverse events were noted.
Based on the similarities of skin between adults and adolescents, the data collected on adult population was extrapolated to justify the safe and effective use of the device on the adolescent population.
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## LABELING (PACKAGE INSERT)
To mitigate concerns regarding cutaneous burns, the following instruction is included in the labeling:
Press the button a maximum of 5 times per mosquito bite.
To mitigate concerns regarding mechanical failure (or degradation), the following statement is included in the labeling:
The device's effectiveness will, however, degrade over time. If after several (e.g., 1,000) uses, you no longer feel the slight pinching or prickling sensation when you activate the device or you no longer get relief from the mosquito bite when using the device, it is time to dispose of the device and purchase a new one.
To mitigate concerns regarding interference with implanted and patient care devices, the following warnings are included in the labeling:
Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted electrical device. Such use could cause electric shock, burns, or electrical interference.
Do not use Zap-It! in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when you are using the product.
To mitigate concerns regarding damage to sensitive tissues of the body, the following warnings are included in the labeling:
For external use only. Do not apply the Zap-It! inside the mouth or other body cavity as pain or injury may occur.
Do not use over viral lesions, as safety studies have not been performed to determine the effect of the Zap-It! on viral lesions; therefore, the effects are unknown.
Do not apply the Zap-It directly to your eyes as this could cause damage to your eyesight.
Do not apply Zap-It! to your lips as this may cause pain.
To mitigate concerns regarding infection and damage to sensitive tissues, the following contraindication is included in the labeling:
Do not apply stimulation over oven wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).
DEN100024 De Novo Summary
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To mitigate concerns regarding ignition of flammable substances, the following warnings are included in the labeling:
Do not use on flammable materials. It may cause them to burn and burn your skin.
Zap-It! should not be used after applying insect repellent until it has fully dried to the touch, as repellant may be flammable and cause skin burns if ignited.
To mitigate concerns regarding the lack of treatment of other medical conditions that are not intended to be treated with this device, the following precautions are included in the labeling:
Do not use Zap-It! to remove the toxins or infection associated with mosquito bites. Zap-It! was only found in clinical studies to temporarily remove the itching. If you believe your mosquito bite is infected, seek medical attention.
Furthermore, regarding the above concern, instructions are included in the labeling for the user to correctly identify mosquito bites.
To mitigate concerns regarding failure to identify the correct population (specifically children), the following precaution is included in the labeling:
The safety and effectiveness has not been established in neonates, infants and children.
To mitigate concerns regarding failure to report malfunctions or adverse events for this OTC device, the following instructions are included in the labeling:
Please inform the manufacturer about eventual problems or malfunctions to reinforce post-market surveillance. If you experience adverse events when using the device, please contact MedWatch at 1-800-332-1088 or the internet at: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
Finally, the output parameters [maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration] are included in the labeling:
Maximum output voltage (instantaneous): 13kV Maximum output current (amperage): 0.7mA Duration of single discharge: 10 microseconds
The Zap-It! device complies with the labeling requirements under 21 CFR 801 and the recommendations within FDA's Guidance on Medical Device Patient Labeling (2001).
The Zap-It! device is available as an OTC device.
DEN100024 De Novo Summary
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# Labeling Comprehension Study
The Zap-It! device is intended for over-the-counter (OTC) use. Consequently, to ensure that the device could be used according to the proposed labeling and instructions for use, the sponsor conducted a labeling comprehension study. The study included 15 subjects who were instructed to read the device labeling and subsequently complete a questionnaire. The questionnaire included 24 questions, each of which was intended to test the ability of each subject to understand the use of the device. The results indicated that patients understood the cautionary language and instructions for how to use the device.
# RISKS TO HEALTH
Risks to health based on the technological characteristics of the Zap-It! were identified. Table 1 identifies the risks to health that may be associated with the use of limited output transcutaneous piezoelectric electrical stimulators for skin reactions associated with insect bites as well as the methods used to mitigate each risk.
| Identified Risk | Mitigation Measure |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Cutaneous burns | Characterization of Electrical Output<br>Labeling |
| Adverse skin reactions | Biocompatibility Assessment |
| Damage to sensitive tissue (e.g., eyes,<br>lips, inside mouth, open wounds) | Labeling |
| Infection | Labeling |
| Burns and other injuries due to ignition<br>of flammable substances which may be<br>used in the same intended use<br>environment (e.g., insect repellant) | Labeling |
| Interference with implanted devices and<br>other patient care devices | Labeling |
| Failure to identify correct population<br>and condition | Labeling |
| Device failure | Non-clinical (Bench) Testing<br>Labeling |
| | Table 1: Identified Risks to Health and Mitigation Measures | |
|--|--------------------------------------------------------------|--|
| | | |
# SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites is subject to the following special controls:
- 1. Appropriate testing to characterize the electrical output specifications of the device (i.e., total charge delivered, maximum instantaneous output current, maximum instantaneous output
{9}------------------------------------------------
voltage, pulse duration, charge density) must be conducted.
- 2. Mechanical bench testing must demonstrate that the device will withstand the labeled number duration of uses.
- 3. All elements of the device that may contact the patient must be assessed to be biocompatible.
- 4. Labeling must include:
- a. Validated instructions which addresses the following:
- i. Identification of areas of the body which are appropriate and not appropriate for contact with the device;
- ii. Whether use of the device in conjunction with flammable materials (e.g., insect repellent) is appropriate;
- iii. Use of the device on or near implanted devices;
- iv. How to identify the correct type of skin condition
- b. Technical parameters of the device [maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration].
- Language to direct end-users to contact the device manufacturer and MedWatch if C. they experience any adverse events with this device.
- d. The anticipated number of device uses prior to failure.
### BENEFIT/RISK DETERMINATION
The human performance study demonstrated a reduction of itching following mosquito bites when this device was used. No adverse events were reported during the human performance study. Given the limited duration of the output and the small amount of charge delivered to the patient for one actuation, risks associated with the device are low.
Additionally, this device and devices similar to this device are on the market outside of the United States (OUS). A minimal number of adverse events have been reported and no regulatory actions have been taken in OUS jurisdictions in which this device is legally marketed, nor do any reports appear in the literature regarding adverse events for this type of device.
In conclusion, the data support that for the reduction of itch associated with mosquito bites, the probable benefits outweigh the probable risks. These data also suggest that the individual patient's benefit from the device can be variable. In addition, the risks of the device can be mitigated by the use of general and special controls, including the labeling mitigations for the intended population.
### CONCLUSION
The de novo request for the Zap-It! is granted and the device is classified under the following:
Product Code: OSG Device Type: Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites Class: II (exempt from premarket notification. subject to the limitations in 21 CFR 882.9) Regulation: 21 CFR 882.5894
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.
