The intended us of ProSim 4 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure and Non-invasive blood pressure. The intended user is a trained biomedical equipment technician who is performing periodic preventative maintenance checks on patient monitors in service. Users can be associated with hospitals, clinics, original equipment manufacturers and independent service companies that repair and service medical equipment. The end user is a technically trained individual, specializing in medical instrumentation technology. The ProSim is intended to be used in the laboratory environment and is not intended for use on patients, or to test devices while connected to patients. This product line is not intended to be used to calibrate medical equipment. ProSim is intended for over-the counter use.
Device Story
ProSim 4, 6, and 8 are portable, battery-powered vital signs simulators used by biomedical technicians in laboratory settings to test/verify patient monitor performance. Devices generate electrical signals (ECG, respiration, IBP, temperature, cardiac output) and pneumatic pulses (NIBP) to simulate patient physiology; ProSim 6/8 also provide optical signals for pulse oximetry testing. Input is via touchscreen/soft keys; output is simulated physiological signals delivered to the monitor under test. Devices replace multiple legacy simulators by combining functions into a single, compact, plastic-cased unit. Data is processed via embedded firmware on PCBs. Results are used by technicians to perform preventive maintenance and verify monitor specifications. Benefits include improved portability, consolidated testing capabilities, and reduced maintenance time for healthcare facility equipment.
Clinical Evidence
No clinical data. Bench testing only. Laboratory studies verified performance against published specifications using representative patient monitors. Software validation confirmed device functionality.
Technological Characteristics
Plastic injection-molded case; embedded processors with firmware; stepper motor/piston pump for NIBP; LCD touch/soft screen; Li-Ion rechargeable battery; USB communication port. Simulates ECG, respiration, IBP, NIBP, temperature, cardiac output, and SpO2. Sterilization not applicable (laboratory use).
Indications for Use
Indicated for biomedical technicians to test/verify patient monitor performance via electronic/pneumatic simulation of physiological parameters (ECG, respiration, invasive/non-invasive blood pressure, temperature, cardiac output, SpO2, and fetal/maternal signals). Not for use on patients or for calibration.
Regulatory Classification
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
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K110429
SEP - 2 2011
Image /page/0/Picture/2 description: The image shows the logo for Fluke Biomedical. The word "FLUKE" is in large, bold, sans-serif font. Below the word "FLUKE" is the word "Biomedical" in a smaller, bold, sans-serif font. There is a line above the word "Biomedical".
#### Section III -510(k) Summary of Safety and Effectiveness
#### Submitter:
Fluke Biomedical 6920 Seaway Blvd Everett WA. 98203 (440) 498-2579 -Phone (440-349-2307) - Fax John Nelson -Contact Person
#### Device Name:
- ◆ Trade Name - ProSim 4
- . Common Name -Vital Signs Simulator
- Classification Name Monitor, Cardiac /System, Measurement, Blood-Pressure, Non-Invasive per . 21 CFR 870.2300/870.1130
- Product Codes -DRT, DXN .
#### Devices for Which Substantial Equivalence is Claimed:
- MedSim300B Submitted as MedSim300 under 510(k) K935817 ◆
- Cufflink .
#### Device Description:
#### Principles of Operation
Fluke Biomedical's ProSim 4 (hereafter referred to as the ProSim) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals and non-invasive blood pressure pulses. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.
#### Technological Characteristics
ProSim vital signs simulator consists of the following components:
1) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
2) Plastic iniection molded case parts.
3) Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
4) Liquid Crystal Touch Screen Display for user interface. User interface follows modern and ergonomic concepts.
5) Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.
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Image /page/1/Picture/0 description: The image shows the logo for Fluke Biomedical. The word "FLUKE" is in large, bold, sans-serif font on a gray background. Below the word "FLUKE" is the word "Biomedical" in a smaller, bold, sans-serif font. There is a black line above the word "Biomedical".
#### Intended Use of the Device:
The intended us of ProSim 4 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure and Non-invasive blood pressure.
The intended user is a trained biomedical equipment technician who is performing periodic preventative maintenance checks on patient monitors in service. Users can be associated with hospitals, clinics, original equipment manufacturers and independent service companies that repair and service medical equipment. The end user is a technically trained individual, specializing in medical instrumentation technology.
The ProSim is intended to be used in the laboratory environment and is not intended for use on patients, or to test devices while connected to patients. This product line is not intended to be used to calibrate medical equipment.
ProSim is intended for over-the counter use.
#### Summary of Technological Characteristics:
The ProSim 4 is substantially equivalent to one other legally marketed device in the United States. The ProSim functions in a manner similar to and is intended for the same use as the MedSim300B and Cufflink manufactured by Fluke Biomedical.
The ProSim 4 is similar to the MedSim300B and Cufflink in that it is a cordless battery-operated device, uses LCD display, and allows user to simulate physiological parameters to verify the operation of patient monitors. The ProSim differs from the MedSim300B and Cufflink in that the ProSim combines the features of each of these devices into one device and is touch screen operated.
| Features | ProSim 4 | MedSim 300B<br>(K935817) | Cufflink<br>(K942546) | Difference |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Intended Use | The intended use of<br>ProSim 4 is to test and<br>verify the basic<br>operation of patient<br>monitoring devices or<br>systems used to monitor<br>various physiological<br>parameters of a patient,<br>including ECG,<br>Respiration, Invasive<br>blood pressure and<br>Non-Invasive blood<br>pressure.<br>The intended user is a<br>trained biomedical<br>equipment technician<br>who is performing<br>periodic preventative<br>maintenance checks on<br>patient monitors in<br>service. Users can be<br>associated with<br>Hospitals, clinics,<br>original equipment<br>manufacturers or<br>independent service<br>companies that repair<br>and service medical | To test operation<br>of patient monitors<br>by simulating<br>physiological<br>parameters,<br>including: ECG,<br>respiration, blood<br>pressure,<br>temperature and<br>cardiac output. | To test operation of<br>Non-Invasive Blood<br>Pressure (automated<br>Sphygmomanometers<br>simulator). | None |
| | equipment. The end<br>user is a technically<br>trained individual,<br>specializing in medical<br>instrumentation<br>technology.<br>The ProSim product line<br>is intended to be used in<br>the laboratory<br>environment and is not<br>intended for use on<br>patients, or to test<br>devices while connected<br>to patients. This product<br>line is not intended to be<br>used to calibrate<br>medical equipment and<br>not intended for over the<br>counter use. | | | |
| Construction | Plastic case. | Aluminum case. | Aluminum case. | Lighter more<br>compact plastic<br>casing. |
| Size | ProSim 4: 7.1 L x 3.7 W<br>x 2.2 H inches. | 10 L x 7 W x 3 H<br>inches. | 15 L x 12.5 W x 5 H<br>inches. | Combination<br>instrument<br>smaller than<br>sum of<br>predicate<br>devices. |
| Weight | ProSim 4: 1.9 lbs. | 3.55 lbs. | 15 lbs. | Lighter. |
| Display | ¼ VGA graphic LCD<br>Touch Color Display. | 2 by 24 character<br>LCD. | 8 by 20 character<br>alphanumeric<br>display & 64 by 240<br>graphical display. | More display,<br>Touch Screen<br>and Color. |
| Function Key | ProSim 4: Touchscreen. | Soft. | Soft. | ProSim 4:<br>Touchscreen. |
| ECG leads | 10 binding posts;<br>compatible w/<br>disposable snaps, 3.2<br>mm or 4.0 mm<br>electrodes, and banana<br>plugs (with or without<br>adapter). | 10 binding posts;<br>compatible w/<br>disposable snaps.<br>3.2 mm or 4.0 mm<br>electrodes, and<br>banana plugs. | N/A | None. |
| IBP Channels | Independent BP<br>channels w/ sensitivity<br>control (5 or 40<br>uV/V/mmHg); cable<br>interface w/ monitors.<br>ProSim 4: 1 channel. | 4 independent BP<br>channels w/<br>sensitivity control<br>(5 or 40<br>uV/V/mmHg);<br>cable interface w/<br>monitors. | N/A | Number of<br>channels<br>reduced per<br>market<br>requirements<br>and use. |
| Communications<br>Port | USB. | RS232. | RS232. | Change from<br>RS232 to USB<br>data port with<br>advancement in<br>technology. |
| Battery test | Multiple levels of battery life indication. | Limited low battery indication. | No battery. | Predicate devices only check at one level. ProSim checks battery status at multiple charge levels. |
| Power | Li-Ion rechargeable battery w/ low battery indicator; or battery eliminator (115VAC) transformer certified to CSA. | 2 X 9V alkaline battery w/ low battery indicator; or battery eliminator (115VAC) transformer certified to CSA C22.2. 231 series M89). | No Battery- AC line powered only. | Longer operating life with modern battery technology. |
| Lead configuration | 12 leads. | 12 leads. | N/A | None. |
| Output impedances | 500 to 2000ohms to RL. | 500 to 2000ohms to RL. | N/A | None. |
| Amplitude accuracy | +/- 2% setting lead II. | +/- 5%, 2Hz @ 1.0 mV p-p SQ wave Lead II. | N/A | More accurate on newer devices due to market preferences and technology improvements. |
| NSR rates | ProSim 4: 30 to 320 BPM. | 30 to 300 BPM. | N/A | Wider range due to market preferences. |
| NSR amplitudes | ProSim 4: 1mV | 50 uV to 5.5mV. | N/A | ProSim 4: Limited amplitude for basic simulation. |
| Pediatric or Neonatal ECG | R Wave width reduced to 40 ms. | R Wave width reduced to 40 ms. | N/A | None. |
| Square and/or Pulse waves | ProSim 4: Pulse at 60ms / 2Hz. | Square at 2 Hz and 0.125 Hz. | N/A | ProSim 4: Provides what is required for a basic simulation. |
| Pacemaker | ProSim 4: 1 ms width, 3mV. | 0.1 to 2.0 ms width, -700 to +700 mV | N/A | ProSim 4: Basic simulation for targeted market. |
| Cable connector | ECG leads, 10 binding postings. | ECG leads, 10 binding postings. | N/A | None. |
| Normal baseline impedances | 500 to 2000 ohms ref. to RL. | 500 to 2000 ohms ref. to RL. | N/A | None. |
| Lead selections | LA or LL. | I or II (LA or LL). | N/A | None. |
| Impedance variation | ProSim 4: 1.0 ohm | 0 to 3 ohms. | N/A | ProSim 4: Basic simulation for targeted market. |
| Respiration<br>rates | ProSim 4: 10, 20, 30,<br>40, 50, 60, 70, 80, 90 &<br>100 brpm. | 15, 20, 30, 40, 60,<br>120 brpm. | N/A | More<br>Respiration<br>rates due to<br>market<br>requirements<br>and use. |
| Apnea | ProSim 4: Off &<br>Continuous. | Off, Continuous,<br>momentary, 12 &<br>32 s. | N/A | ProSim 4: Less<br>apneas for<br>basic simulation<br>and target<br>market. |
| Cable connector | ECG leads, binding<br>posts. | ECG leads,<br>binding posts. | N/A | None |
| I/O impedance | 300 ohms. | 300 ohms. | N/A | None. |
| Exciter range | 2 to 16 V/DC to 5kHz. | 2 to 16 V/DC to 4<br>kHz | N/A | Higher<br>frequency<br>range driven by<br>market trend<br>and technology. |
| Transducer<br>Sensitivity | ProSim 4: 5 uV/V/mmHg | 5 or 40<br>uV/V/mmHg. | N/A | ProSim 4:<br>Fewer<br>selections for<br>basic simulation<br>and target<br>market. |
| Level accuracy | +/- (1% setting +<br>1mmHg). | +/- 1% full scale;<br>+/- 1mmHg. | N/A | None. |
| Static pres.<br>Selection | Manual. | Manual and<br>automatic. | N/A | Limited<br>selection mode<br>per target<br>market and use. |
| Dynamic BP<br>selections | ProSim 4: Arterial and<br>left ventricle. | Arterial, left and<br>right ventricle,<br>pulmonary artery,<br>pulmonary wedge,<br>Swan-Ganz. | N/A | ProSim 4:<br>Fewer<br>selections for<br>basic simulation<br>and target<br>market. |
| Static BP<br>selections | ProSim 4: 0, 80, 160 &<br>250 mmHg | -10, -5, 0, 20, 30,<br>40, 80, 100, 200,<br>250 & 300 mmHg. | N/A | ProSim 4:<br>Fewer<br>selections for<br>basic simulation<br>and target<br>market. |
| Cable connector | DIN style. | DIN style. | N/A | None. |
| Manometer | 0 to 400 mmHg | N/A | Max. 499.75 mmHg | Lower range<br>following<br>market<br>requirements. |
| Leak Test | Source pressure, seal<br>off, measure change in<br>pressure over time. | N/A | Source pressure,<br>seal off, measure<br>change in pressure<br>over time. | None. |
| Over Pressure<br>Test | Increase pressure until<br>device under tests vents<br>to atmosphere. | N/A | Increase pressure<br>until device under<br>tests vents to<br>atmosphere. | None. |
| Simulation | ProSim 4:<br>Systolic/Diastolic Adult –<br>60/30, 120/80, 150/100<br>& 200/150; Neonatal<br>35/15 & 70/40. | N/A | Systolic/Diastolic<br>simulations. Adult<br>60/30 to 255/195. | ProSim 4:<br>Fewer<br>selections for<br>basic<br>simulation.<br>Adult and<br>Neonatal. |
| Synchronization<br>to ECG | ProSim 4: Up to 150<br>BPM | N/A | 30 to 240 BPM | ProSim 4:<br>Limited for<br>basic<br>simulation. |
. 0000006
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. په چهاچ پ
5/14
. 000009
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#### Non-Clinical Test Data:
Laboratory studies have been conducted with a representative patient monitor to verify and validate the ProSim 4 will perform within its' published specifications.
- NPI-02042011-00001 ProSim 4 Bench test summary and results. .
The ProSim 4 software has been successfully validated to confirm the performance of the device.
#### Clinical Test Data:
Clinical testing has not been conducted on this product.
#### Conclusion:
Based upon the laboratory studies, similar technological/performance characteristics as compared to the predicate devices, and successful validation of the ProSim 4 software, the performance of the ProSim 4 is deemed to be substantially equivalent to the MedSim300B and Cufflink.
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Image /page/6/Picture/0 description: The image shows the logo for Fluke Biomedical. The logo consists of the word "FLUKE" in a bold, sans-serif font, with the word "Biomedical" underneath it in a smaller font. The logo is surrounded by a textured background, which gives it a slightly distressed look. The image also contains a handwritten number, "7/".
#### Device Name:
- Trade Name -ProSim 6, ProSim 8 .
- . Common Name -Vital Signs Simulator
- Classification Name Monitor, Cardiac /System, Measurement, Blood-Pressure, Non-Invasive per . 21 CFR 870.2300/870.1130
- Product Codes -- DRT, DXN .
#### Devices for Which Substantial Equivalence is Claimed:
- MedSim300B Submitted as MedSim300 under 510(k) K935817 .
- Index 2MF SPO2 Originally submitted and cleared under 510(k) K933519. Currently marketed . as Index 2MF which was ruled as a general purpose device on Feb 11, 1998 (K974293)
- . Cufflink
#### Device Description:
#### Principles of Operation
Fluke Biomedical's ProSim 6 and ProSim 8 (hereafter referred to as the ProSim) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals, non-invasive blood pressure (NIBP) pressure pulses, temperature electrical signal, cardiac output electrical signal, and pulse oximetry SPO2 optical simulated light attenuation. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.
#### Technological Characteristics
ProSim vital signs simulator consists of the following components:
l ) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
- 2) Plastic injection molded case parts.
- 3) Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
- 4) Liquid Crystal Display for user interface. User interface follows modern and ergonomic concepts.
- 5) Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.
#### Intended Use of the Device:
The intended us of ProSim 6 and ProSim 8 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure, Non-invasive blood pressure and Cardiac output. Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional.
The intended user is a trained bioment technician who is performing periodic preventative maintenance checks on patient monitors in service. Users can be associated with hospitals, cliginal equipment manufacturers and independent service companies that repair and service medical equipment. The end user is a technically trained individual, specializing in medical instrumentation technology,
000011
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The ProSim is intended to be used in the laboratory environment and is not intended for use on patients, or to test devices while connected to patients. This product line is not intended to be used to calibrate medical equipment.
ProSim is intended for over-the counter use.
#### Summary of Technological Characteristics:
The ProSim is substantially equivalent to one other legally marketed device in the United States. The ProSim functions in a manner similar to and is intended for the same use as the MedSim300B, Index 2 and Cufflink manufactured by Fluke Biomedical.
The ProSim is similar to the MedSim300B, Index 2 and Cufflink in that it is a cordless battery-operated device, uses LCD display, and allows user to simulate physiological parameters to verify the operation of patient monitors. The ProSim differs from the MedSim300B, Index 2 and Cufflink in that the ProSim combines the features of each of these devices into one device.
| Features | ProSim 6 &<br>ProSim 8 | MedSim 300B<br>(K935817) | Index 2<br>(K 933519) | Cufflink<br>(K942546) | Difference |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The intended use of<br>ProSim 6 and<br>ProSim 8 is to test<br>and verify the basic<br>operation of patient<br>monitoring devices<br>or systems used to<br>monitor various<br>physiological<br>parameters of a<br>patient, including<br>ECG, Respiration,<br>Invasive blood<br>pressure, Non-<br>invasive blood<br>pressure,<br>Temperature,<br>Cardiac output and<br>SpO2.<br>The intended user is<br>a trained biomedical<br>equipment<br>technician who is<br>performing periodic<br>preventative<br>maintenance checks<br>on patient monitors<br>in service. Users can<br>be associated with<br>Hospitals, clinics,<br>original equipment<br>manufacturers or<br>independent service<br>companies that<br>repair and service<br>medical equipment.<br>The end user is a<br>technically trained<br>individual,<br>specializing in | To test operation<br>of patient monitors<br>by simulating<br>physiological<br>parameters,<br>including: ECG,<br>respiration, blood<br>pressure,<br>temperature and<br>cardiac output. | To test operation of<br>Pulse Oximeters by<br>simulating the visible<br>and infrared light<br>absorption. | To test operation<br>of<br>Non-Invasive Blood<br>Pressure (automated<br>Sphygmomanometers<br>simulator). | Additional<br>functions of<br>noninvasive<br>blood pressure<br>and pulse<br>oximetry<br>simulation |
| | medical<br>instrumentation<br>technology.<br><br>The ProSim product<br>line is intended to<br>be used in the<br>laboratory<br>environment and is<br>not intended for use<br>on patients, or to<br>test devices while<br>connected to<br>patients. This<br>product line is not<br>intended to be used<br>to calibrate medical<br>equipment and not<br>intended for over<br>the counter use. | | | | |
| Construction | Plastic case. | Aluminum case. | Plastic case. | Aluminum case. | Lighter more<br>compact<br>plastic casing |
| Size | 5.7 L x 11.9 W x 3.4<br>H inches. | 10 L x 7 W x 3 H<br>inches. | 10 L x 10.5 W x 4 H<br>inches. | 15 L x 12.5 W x 5 H<br>inches. | Combination<br>instrument<br>smaller than<br>sum of<br>predicate<br>devices. |
| Weight | 4.1 lbs. | 3.55 lbs. | 4 lbs. | 15 lbs. | Lighter. |
| Display | ¼ VGA graphic<br>LCD Color Display. | 2 by 24 character<br>LCD. | 2 by 24 character<br>LCD. | 8 by 20 character<br>alphanumeric<br>display & 64 by 240<br>graphical display. | More display,<br>Color. |
| Function<br>Key | Soft. | Soft. | Soft. | Soft. | None. |
| ECG leads | 10 binding posts;<br>compatible w/<br>disposable snaps,<br>3.2 mm or 4.0 mm<br>electrodes, and<br>banana plugs (with<br>or without adapter). | 10 binding posts;<br>compatible w/<br>disposable snaps,<br>3.2 mm or 4.0 mm<br>electrodes, and<br>banana plugs. | N/A | N/A | None. |
| High level<br>ECG | BNC jack for<br>0.5V/mV output<br>into 50 Ohm<br>impedance. | ¼" standard phone<br>jack w/ lead II<br>waveform at<br>.2V/mV of ECG<br>lead II signal. Use<br>w/ analog input,<br>high level, central<br>station monitors or<br>recorders. | N/A | N/A | Output to<br>oscilloscope<br>via BNC is<br>preferred by<br>customers. |
| IBP<br>Channels | Independent BP<br>channels w/<br>sensitivity control (5<br>or 40 uV/V/mmHg);<br>cable interface w/<br>monitors.<br>2 channels. | 4 independent BP<br>channels w/<br>sensitivity control<br>(5 or 40<br>uV/V/mmHg);<br>cable interface w/<br>monitors. | N/A | N/A | Number of<br>channels<br>reduced per<br>market<br>requirements<br>and use. |
| | (500 – 2000)<br>control; lead select<br>control. | Impedance (500 –<br>2000) control; lead<br>select control. | | | |
| Temperature | Yes, fixed temp.<br>probe select control<br>(400 or 700 YSI)<br>series probes. | Yes, fixed or<br>variable temp.<br>probe select<br>control (400 or 700<br>YSI) series probes. | N/A | N/A | None. |
| Cardiac<br>output | Yes, cable connect<br>w/ monitor. | Yes, cable connect<br>w/ monitor. | N/A | N/A | None. |
| Communicat<br>ions Port | USB. | RS232. | RS232. | RS232.…
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.