Power-Trialysis Slim-Cath Short-Term Dialysis Catheters are recommended for use in attaining short term vascular access for hemodialysis, apheresis, and hemoperfusion treatments. This device is intended for insertion in the internal jugular, femoral, or subclavian vein as required. The catheter is also intended for short term access to the central venous system for intravenous therapy and blood sampling.
Device Story
Power-Trialysis Slim-Cath is a triple-lumen, short-term dialysis catheter made of thermosensitive polyurethane that softens at body temperature. Two lumens (venous/arterial) facilitate hemodialysis, hemoperfusion, and apheresis; a third independent distal lumen allows for IV therapy, power injection of contrast media, and central venous pressure monitoring. Used in clinical settings, the catheter is inserted by a clinician into the internal jugular, femoral, or subclavian vein using Seldinger or percutaneous techniques. The device provides continuous blood flow for dialysis and access for medication/fluid delivery. Clinicians use the output (e.g., blood flow, pressure monitoring) to manage dialysis treatments and patient fluid/medication status. Benefits include combined dialysis access and power-injectable central venous access in a single device, reducing the need for multiple venous access points.
Clinical Evidence
Bench testing only. Performance data included kink resistance, priming volumes, assembly leak/burst, guidewire fit, dialysis/gravity flow, catheter collapse, tip tensile strength, and recirculation. Hemolysis testing conducted per ASTM F1841:1997 (R 2005). All tests met predetermined acceptance criteria.
Technological Characteristics
Thermosensitive polyurethane construction; triple-lumen design; atraumatic tapered tip; skived lumen openings. Lengths: 12.5, 15, 20, 24, 30 cm. Insertion: Seldinger or percutaneous. Power injection capability (max 5 mL/sec).
Indications for Use
Indicated for short-term (<30 days) vascular access for hemodialysis, hemoperfusion, and apheresis in patients requiring central venous access via jugular, femoral, or subclavian vein. Includes third lumen for IV therapy, power injection of contrast media (max 5 mL/sec), and central venous pressure monitoring.
Regulatory Classification
Identification
A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device. (2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
Special Controls
*Classification.* (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
*1* ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
*2* ) Proper care and maintenance of the device and device exit site;(
*3* ) Removal of the device;(
*4* ) Anticoagulation;(
*5* ) Management of obstruction and thrombus formation; and(
*6* ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure in profile, with three faces overlapping to symbolize health, human services, and the relationship between them. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2015
C.r. Bard, Inc. Bryan Stone Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT 84116
Re: K141531
> Trade/Device Name: Power-Trialysis Slim-Cath Short-Term Dialysis Catheter Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: NIE Dated: April 2, 2015 Received: April 7, 2015
Dear Bryan Stone,
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 Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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
{1}------------------------------------------------
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
In addition, we have determined that your device kit contains Lidocaine and ChloraPrep which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Food and Drug Administration Center for Drug Evaluation and Research Office of Unapproved Drugs and Labeling Compliance 10903 New Hampshire Ave. Silver Spring. MD 20993 (301) 594-0101
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
{2}------------------------------------------------
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/2/Picture/3 description: The image shows the text "Herbert P. Lerner -S" in a simple, sans-serif font. The text is arranged horizontally, with the name "Herbert P. Lerner" followed by a hyphen and the letter "S". The text is black and the background is white.
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
## Indications for Use
510(k) Number (if known) K141531
#### Device Name
Power-Trialysis Slim-Cath Short-Term Dialysis Catheter
Indications for Use (Describe)
The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with the letters connected to each other. Below the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, sans-serif font.
# 510(k) Summary
21 CFR 807.92(a)
| General<br>Provisions | Submitter Name: | Bard Access Systems, Inc. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| | Contact Person: | Elizabeth U. Peterson<br>Regulatory Affairs Specialist |
| | Telephone Number: | (801) 522-5472 |
| | Fax Number: | (801) 522-5425 |
| | Date of Preparation: | November 12, 2014 |
| Subject Device | Trade Name: | Power-Trialysis™ Slim-Cath™ Short-Term Dialysis<br>Catheter |
| | Common Name: | Short-Term Dialysis Catheter |
| | Classification Name: | Catheter, Hemodialysis, Triple Lumen, Non-<br>Implanted |
| | Product Code: | NIE |
| | Classification | |
| | Regulation: | 21 CFR §876.5540 |
| Predicate<br>Device | Trade Name: | Power-Trialysis™ Short-Term Dialysis Catheter |
| | Common Name: | Short-Term Dialysis Catheter |
| | Classification Name: | Catheter, Hemodialysis, Triple Lumen, Non-<br>Implanted |
| | Product Code: | NIE |
| | Classification | |
| | Regulation: | 21 CFR §876.5540 |
| | Premarket Notification: | K133456<br> |
| | Concurrence Date: | September 24, 2014 |
| Device<br>Description | Power-Trialysis™ Slim-Cath™ Short-Term Dialysis Catheters are made of<br>thermosensitive polyurethane, which softens when exposed to body<br>temperature. The catheter is divided into three separate lumens permitting<br>continuous blood flow. Both the venous (blue) and the arterial (red) lumens<br>may be used for hemodialysis, hemoperfusion, and apheresis treatments. The<br>distal (purple) lumen is completely independent from the two dialysis lumens<br>and may be used for intravenous therapy, power injection of contrast media,<br>and central venous pressure monitoring. The distal lumen can also be accessed<br>for blood draws and infusion of medications. | |
| Intended Use | Power-Trialysis" Slim-Cath™ Short-Term Dialysis Catheters are recommended<br>for use in attaining short term vascular access for hemodialysis, apheresis, and<br>hemoperfusion treatments. This device is intended for insertion in the internal<br>jugular, femoral, or subclavian vein as required. The catheter is also intended<br>for short term access to the central venous system for intravenous therapy and<br>blood sampling. | |
| Indications For<br>Use | The Power-Trialysis" Slim-Cath™ Short-Term Dialysis Catheter, with a third<br>internal lumen for intravenous therapy, power injection of contrast media, and<br>central venous pressure monitoring, is indicated for use in attaining short-term<br>(less than 30 days) vascular access for hemodialysis, hemoperfusion, and<br>apheresis treatments. The catheter is intended to be inserted in the jugular,<br>femoral, or subclavian vein as required. The maximum recommended infusion<br>rate is 5 mL/sec for power injection of contrast media. | |
| Technological<br>Characteristics | Vascular access for hemodialysis, hemoperfusion, and apheresis treatments<br>with the additional power injectable third lumen is the technological principle<br>for both the subject and predicate devices.<br>At a high level, the subject and predicate devices are based on the following<br>same technological elements:<br>Short term use (<30 days).<br>●<br>Insertion technique- Seldinger (over-the-guidewire) or percutaneous<br>●<br>procedure into one of the large central veins to place the catheter.<br>Catheter is intended to be inserted in the jugular, femoral, or<br>●<br>subclavian vein as required.<br>Catheter tip placement is in the central venous system with the<br>●<br>Superior Vena Cava (SVC) preferred.<br>●<br>Catheter length 12.5 cm, 15 cm, 20 cm, 24 cm, and 30 cm.<br>The tip configuration is an atraumatic tapered tip. The catheter is<br>●<br>skived to create the venous and arterial lumen openings. The power-<br>injectable lumen opening is distal to the venous and arterial lumen<br>openings.<br>The following technological differences exist between the subject and<br>predicate devices:<br>Optimization of lumens<br>●<br>Reduction of French size<br>●<br>Reduction in the size of side holes.<br>●<br>The differences are not critical to the intended use of the device and do not<br>raise any new questions regarding safety or effectiveness. | |
| | Verification and validation activities were designed and performed in<br>accordance with Design Controls as per 21 CFR §820.30. The following<br>performance data were referenced in support of the substantial equivalence<br>determination. | |
| Safety &<br>Performance<br>Testing | Kink Resistance testing was performed to determine the propensity of a<br>catheter shaft to kink when exposed to a bending environment | |
| | Priming Volumes were determined to provide information for labeling. | |
| | Assembly Leak testing was performed to ensure previous conditioning did not<br>cause the test articles to leak. | |
| | Assembly Burst testing was performed post power injection to ensure the<br>multiple power injection conditioning did not cause the material of the test<br>articles to weaken. | |
| | Comparison of Use Pressure to Burst Pressure was completed to ensure the<br>catheter will not see high enough pressures during power injection to cause<br>damage to the catheter. | |
| | Guidewire Fit testing was performed to ensure use compatibility between the<br>catheters and guidewires. | |
| | Dialysis Flow testing was performed to ensure the catheter configurations<br>satisfy established flow rate requirements under labeled dialysis procedural<br>pressures. | |
| | Gravity Flow testing was performed to determine the flow rate of normal<br>saline through the power injectable lumen. | |
| | Catheter Collapse for Dialysis Lumens testing was performed to ensure the<br>catheter lumens will not collapse at established pressure requirements that<br>could be achieved during hemodialysis procedures. | |
| | Hemolysis testing was performed by infusing and aspirating blood through the<br>catheters. The evaluation was conducted in accordance with ASTM<br>F1841:1997 (R 2005) | |
| | Tip Tensile testing was performed to ensure the catheter tip will not detach<br>under worst case tensile conditions. | |
| | Recirculation testing was performed to determine the percentage of<br>recirculation of the catheter in forward and reverse flows. | |
| | The subject device met all predetermined acceptance criteria derived from the<br>above listed references and demonstrated substantially equivalent performance<br>as compared to the cited predicate device. | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the subject Power-Trialysis™ Slim-Cath™ Short-Term<br>Dialysis Catheter meets the requirements that are considered sufficient for its<br>intended use and demonstrates that the subject device is substantially<br>equivalent to the predicate device cited. | |
{5}------------------------------------------------
{6}------------------------------------------------
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.
