K171954 · Clearline MD · OKL · Jan 25, 2018 · General Hospital
Device Facts
Record ID
K171954
Device Name
ClearLine IV
Applicant
Clearline MD
Product Code
OKL · General Hospital
Decision Date
Jan 25, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5445
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
ClearLine IV™ is intended for detection and automatic removal of air in intravenous (IV) lines during administration of IV solutions, blood, and blood products. It is indicated for use in critical care areas such as the operating room (OR), postanesthesia care unit (PACU), and intensive care unit (ICU). ClearLine IV™ is placed between the patient and the V source and can be used with or without fluid warmers.
Device Story
ClearLine IV system consists of a control unit and a sterile, single-use disposable cartridge. Device is placed between IV source and patient. Ultrasonic sensors in control unit monitor fluid line for air bubbles. Upon detection, system automatically closes patient line and diverts fluid to waste collection bag. Once sensors detect liquid again, patient flow resumes. Used in OR, PACU, and ICU by clinicians. Provides status updates via LCD interface. Benefits patient by preventing air embolism during IV therapy. Modifications from predicate include redesigned cartridge for improved flow and updated user interface.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including performance verification (air detection/removal, solenoid response, flow rates), software validation, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), sterilization validation (ISO 11135), and biocompatibility (ISO 10993). Human factors study conducted per FDA guidance.
Technological Characteristics
System comprises a control unit and single-use cartridge. Cartridge materials: PVC, Polycarbonate, MBS (biocompatibility per ISO 10993). Sensing: Ultrasonic. Power: AC line or rechargeable battery. Connectivity: Standalone. Sterilization: EtO. Software: Embedded, controls solenoid and sensor monitoring. Dimensions: 5.5" x 5" x 5".
Indications for Use
Indicated for patients in critical care settings (OR, PACU, ICU) requiring IV administration of solutions, blood, or blood products; device detects and removes air from IV lines.
Regulatory Classification
Identification
An intravascular administration set, automated air removal system, is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the intravascular fluid. The device may include an air identification mechanism, software, an air removal mechanism, tubing, apparatus to collect removed air, and safety control mechanisms to address hazardous situations.
Special Controls
In combination with the general controls of the FD&C Act, the AirPurge System is subject to the following special controls:
- (1) Provide an argument demonstrating that all reasonably foreseeable hazards have been adequately addressed with respect to the persons for whose use the device is represented or intended and the conditions of use for the device, which includes the following:
- (i) Description of the device indications for use, design and technology, use environments, and users in sufficient detail to determine that the device complies with all special controls.
- (ii) Demonstrate that controls are implemented to address device system hazards and their causes.
- (iii)Include a justification supporting the acceptability criteria for each hazard control.
- (iv)A traceability analysis demonstrating that all credible hazards have at least one corresponding control and that all controls have been verified and validated in the final device design.
- (2) Appropriate software verification, validation, and hazard analysis must be performed.
- (3) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible.
- (4) Performance data must demonstrate the sterility of fluid path contacting components and the shelf-life of these components.
- (5) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC).
- (6) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
- (i) Device system and component reliability testing must be conducted.
- (ii) Fluid ingress protection testing must be conducted.
- (iii)Testing of safety controls must be performed to demonstrate adequate mitigation of hazardous situations, including sensor failure, flow control failure, improper device position, device malfunction, infusion delivery error, and release of air to the patient.
- (7) A human factors validation study must demonstrate that use hazards are adequately addressed.
- (8) The labeling must include the following:
- (i) The device's air identification and removal response time.
- (ii) The device's minimum air volume identification sensitivity.
- (iii)The minimum and maximum flow rates at which the device is capable of reliably detecting and removing air.
- (iv)Quantification of any fluid loss during device air removal operations as a function of flow rate.
*Classification.* Class II (special controls). The special controls for this device are:(1) Provide an argument demonstrating that all reasonably foreseeable hazards have been adequately addressed with respect to the persons for whose use the device is represented or intended and the conditions of use for the device, which includes the following:
(i) Description of the device indications for use, design, and technology, use environments, and users in sufficient detail to determine that the device complies with all special controls.
(ii) Demonstrate that controls are implemented to address device system hazards and their causes.
(iii) Include a justification supporting the acceptability criteria for each hazard control.
(iv) A traceability analysis demonstrating that all credible hazards have at least one corresponding control and that all controls have been verified and validated in the final device design.
(2) Appropriate software verification, validation, and hazard analysis must be performed.
(3) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of fluid path contacting components and the shelf life of these components.
(5) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC).
(6) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Device system and component reliability testing must be conducted.
(ii) Fluid ingress protection testing must be conducted.
(iii) Testing of safety controls must be performed to demonstrate adequate mitigation of hazardous situations, including sensor failure, flow control failure, improper device position, device malfunction, infusion delivery error, and release of air to the patient.
(7) A human factors validation study must demonstrate that use hazards are adequately addressed.
(8) The labeling must include the following:
(i) The device's air identification and removal response time.
(ii) The device's minimum air volume identification sensitivity.
(iii) The minimum and maximum flow rates at which the device is capable of reliably detecting and removing air.
(iv) Quantification of any fluid loss during device air removal operations as a function of flow rate.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 25, 2018
ClearLine MD % Sheila Hemeon-Heyer Founder and President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002
Re: K171954
Trade/Device Name: ClearLine IVTM Regulation Number: 21 CFR 880.5445 Regulation Name: Intravascular Administration Set, Automated Air Removal System Regulatory Class: Class II Product Code: OKL Dated: December 22, 2017 Received: December 26, 2017
Dear Ms. Sheila Hemeon-Heyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina
Kiang-S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K171954
Device Name
ClearLine IV™
Indications for Use (Describe)
ClearLine IV™ is intended for detection and automatic removal of air in intravenous (IV) lines during administration of IV solutions, blood, and blood products. It is indicated for use in critical care areas such as the operating room (OR), postanesthesia care unit (PACU), and intensive care unit (ICU). ClearLine IV™ is placed between the patient and the V source and can be used with or without fluid warmers.
Type of Use (Select one or both, as applicable)
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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## 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted per the requirements of 21 CFR 807.92.
| A. | Submitter: | Heyer Regulatory Solutions LLC | |
|----|------------|--------------------------------|--|
| | | P.O. Box 2151 | |
| | | Amherst, MA 01004-2151 | |
| | | Contact: Sheila Hemeon-Heyer | |
| | | Sheila@heyer-regulatory.com | |
- B. Manufacturer/ ClearLine MD 300 Trade Center, Suite 5400 510(k) Applicant: Woburn, MA 01801 Contact: Rick Romeo VP Operations, Quality and Regulatory Affairs (781) 933-6500 rromeo@clearlinemd.com
- C. Date Prepared: January 16, 2018
#### D. Device Name and Classification Information:
| Trade Name: | ClearLine IV™ |
|----------------------|-------------------------------------------------|
| Classification Name: | Intravascular Administration Set, Automated Air |
| | Removal System |
| Regulation: | 21 CFR 880.5445 |
| Product Code: | OKL |
| Review Panel: | General Hospital |
| Class: | II |
- DEN080009, AirPurge™ System E. Predicate Device(s):
#### F. Summary Device Description:
The ClearLine IV™ is a modification to the predecessor device, the AirPurge™ System. Both devices consist of two main components, the control unit and the sterile, single-use disposable cartridge. The control unit is mounted to the I.V. pole using a pole clamp attached to the back of the control unit. The disposable cartridge is loaded onto the control unit and connected to the infusion line between the infusion source and the patient. During infusion, air entering the cartridge will be detected by an ultrasonic sensor in the control unit, which will automatically close the patient line and divert the fluid flow containing the air to the waste collection bag. A second ultrasonic sensor in the control unit monitors the line to the waste collection bag. When both sensors detect liquid again, flow to the patient is resumed.
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Both the ClearLine IV™ and AirPurge™ have the same air detection and removal response time of less than 60 msec. Both devices can detect air bubbles as small as 25 µL with fluid volume loss per purge of 0.1 mL at a typical flow rate of 300 mL/hr.
The modifications resulting in the ClearLine™ IV are:
- . Redesign of the cartridge for improved fluid flow
- . Redesign of the user interface to provide more comprehensive information to the user
#### G. Indications for Use Statement:
ClearLine IV™ is intended for detection and automatic removal of air in intravenous (IV) lines during administration of IV solutions, blood, and blood products. It is indicated for use in critical care areas such as the operating room (OR), postanesthesia care unit (PACU), and intensive care unit (ICU). ClearLine IV is placed between the patient and the IV source and can be used with or without fluid warmers.
#### H. Technical Comparison with Predicate Device
The table below provides a side-by-side comparison of the modified to legally marketed device.
| | Cleared Device<br>AirPurge™ System<br>(DEN080009) | Modified Device<br>ClearLine IV™ | Same or Discussion of<br>Differences |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The AirPurge™ is intended for<br>detection and automatic removal<br>of air in intravenous (IV) lines<br>during administration of<br>intravenous solutions, blood and<br>blood products. It is indicated for<br>use in the Operating Room and<br>post anesthesia care areas. The<br>AirPurge™ System is placed<br>distal to I.V. bags using gravity<br>feed or pressure, and may be<br>used with or without fluid<br>warmers. | ClearLine IV™ is intended for<br>detection and automatic removal<br>of air in intravenous (IV) lines<br>during administration of IV<br>solutions, blood, and blood<br>products. It is indicated for use in<br>critical care areas such as the<br>operating room (OR), post-<br>anesthesia care unit (PACU), and<br>intensive care unit (ICU).<br>ClearLine IV is placed between<br>the patient and the IV source and<br>can be used with or without fluid<br>warmers. | Clarification added that<br>device is used in critical<br>care areas, including the<br>ICU. Clarification added to<br>assure that the device is<br>placed between the patient<br>and IV source |
| System<br>Components | Control unit<br>Sterile, single-use disposable<br>cartridge<br>Waste outlet line<br>Waste collection bag | Control unit<br>Sterile, single-use disposable<br>cartridge<br>Waste outlet line<br>Waste collection bag | Same |
| | Cleared Device<br>AirPurge™ System<br>(DEN080009) | Modified Device<br>ClearLine IV™ | Same or Discussion of<br>Differences |
| Air detection<br>and removal<br>response time | Less than 60 msec | Less than 60 msec | Same |
| Minimal<br>detectable air<br>volume | 25 µL | 25 µL | Same |
| Flow rates for<br>reliable<br>detection and<br>air removal | 1 mL/min to 600 mL/min | 1 mL/min to 600 mL/min | Same |
| Fluid loss<br>during air<br>removal as a<br>function of flow<br>rate | 600 mL/min: ~10 mL<br>300 mL/hr: ~0.1 mL | 600 mL/min: ~10 mL<br>300 mL/hr: ~0.1 mL | Same |
| Software<br>controlled | Yes | Yes | Same |
| Indicators and<br>alarms | Discrete LEDs with limited<br>characters | Status displayed on LCD and<br>longer text messages provide<br>more descriptive information to<br>user | Redesigned I/O enables<br>more informative<br>messaging regarding device<br>status |
| Method of<br>detecting air | Ultrasonic sensors | Ultrasonic sensors | Same |
| Patient<br>contacting<br>materials<br>(cartridge) | Medical grade polymers:<br>PVC<br>SAN<br>ABSD | Medical grade polymers:<br>PVC<br>Polycarbonate<br>MBS | Biocompatibility of all fluid<br>path materials confirmed by<br>testing conducted in<br>conformance with<br>applicable ISO 10993<br>standards. |
| Cartridge<br>Sterilization | EtO | EtO | Same |
| Power | AC line and rechargeable battery<br>operation. Adapter rated at 15<br>watts. AC Source: 100-240V, 50-<br>60 Hz, 400 mA. 5 hours typical<br>battery life on fully charged<br>battery. | AC line and rechargeable battery<br>operation. Adapter rated at 15<br>watts. AC Source: 100-240V, 50-<br>60 Hz, 400 mA. 5 hours typical<br>battery life on fully charged<br>battery. | Same |
| Control Unit<br>Dimensions | H 5.5 in (14 cm)<br>W 5 in (13 cm)<br>D 5 in (13 cm) | H 5.5 in (14 cm)<br>W 5 in (13 cm)<br>D 5 in (13 cm) | Same |
| Control Unit<br>Weight (with<br>battery) | 2.3 lbs (1.05 kg) | 2.3 lbs (1.05 kg) | Same |
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#### l. Non-Clinical Testing
The following non-clinical testing was conducted for verification and validation of the system requirements and to support substantial equivalence under this 510(k). All testing met the pre-defined acceptance criteria and were considered to have passed.
- a. Performance testing to verify the following functional requirements
- i. System start-up upon inserting the cartridge and closing the controller door
- ii. Cartridge priming
- iii. Cartridge leak testing
- iv. Air sensor response time (ultrasound sensors) at low and high flow rates
- v. Air detection to solenoid reaction time at low and high flow rates
- vi. Detection and removal of air bubbles ≥ 25 µl at low and high flow rates when infusing water and blood, with and without a fluid warmer
- vii. Detection and removal of air bubbles ≥ 25 µl at low and high flow rates when infusing lipids
- viii. System operation when the unit is tilted in any of four directions (forward, backward, left, right)
- ix. System operation when used with in-line filters and small diameter extension tubing
- x. System operation when used with infusion and syringe pumps
- xi. System power and battery requirements
- xii. Solenoid life expectancy testing
- b. Software verification and validation testing of all software requirements including:
- i. Controller start-up self-test
- ii. Software monitoring of system operation
- iii. Controller interface operations, including alarm situations (high and medium priorities)
- c. Electrical safety testing in conformance with IEC/EN 60601-1:2006 + A1:2013 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- d. Electromagnetic compatibility testing in conformance with IEC 60601-1-2:2007 General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests and IEC 60601-1-2:2014 for Special Environments (immunity to low frequency equipment found in the OR such as electrosurgery and RFID)
- e. Sterilization validation for the sterile cartridge
- i. Validation of the EtO sterilization cycle according to ISO 11135 to an SAL of 10-6
- ii. EtO residuals testing according to ISO 10993-7:2008
- iii. LAL testing according to USP <85>
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- f. Biocompatibility testing on the finished, sterilized cartridge (fluid contacting pathway) in compliance with ISO 10993 and FDA's guidance, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," June 16, 2016. Device is categorized as externally communicating, prolonged contact, indirect blood contacting.
- ISO 10993-5:2009: Cytotoxicity MEM elution test i.
- ii. ISO 10993-10:2010: Sensitization: guinea pig maximization
- iii. ISO 10993-10:2010: Intracutaneous reactivity in rabbits
- ISO 10993-11:2006: Acute systemic toxicity in mice iv.
- ISO 10993-11:2006 and USP <151> Pyrogen Test: Material-V. mediated pyrogenicity test in rabbits
- i. ISO 10993-4:2002 and ASTM F756-13: Direct contact and indirect contact hemolysis testing
- ISO 10993-4:2002: Complement activation testing ii.
- iii. ISO 10993-18:2005: Chemical characterization and toxicological risk assessment
- Package validation testing of cartridge pouches after 2X EtO sterilization g. was conducted at time 0, after environmental conditioning per ISTA 2A and distribution conditioning per ASTM D4169-16, and after accelerated aging per ASTM F1980-16. Tests conducted included:
- i. Seal strength test according to ASTM F88/F88M-15
- ii. Bubble leak test according to ASTM F2096-11
- h. Cartridge integrity and functionality testing was also conducted on samples that had been subjected to the 2X sterilization, environmental, distribution, and aging conditions. Tests conducted included:
- i. Cartridge leak test
- ii. Verification of bubble detection and removal at low and high flow rates
- i. A summative human factors study and Human Factors Engineering Report per FDA's guidance on "Applying Human Factors and Usability Engineering to Medical Devices," February 3, 2016.
#### J. Clinical Testing
Clinical testing was not required to support this 510(k).
#### K. Conclusion
The information and testing presented in this 510(k) demonstrate that the ClearLine IV™ is substantially equivalent to the predicate device, the AirPurge™ System.
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.
