Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
Applicant
Covidien, LLC
Product Code
FJS · Gastroenterology, Urology
Decision Date
Jul 27, 2018
Decision
SESK
Submission Type
Traditional
Regulation
21 CFR 876.5630
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Argyle™ Peritoneal Dialysis Catheter and Kits: The peritoneal catheter is indicated for acute and chronic peritoneal dialysis. The peritoneal dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques. Argyle (TM) Presternal Peritoneal Catheter and Kits: The presternal peritoneal catheter is indicated for acute and chronic peritoneal dialysis. The Peritoneal Dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques. Argyle(TM) Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter: The Two Part Titanium Luer Adapter is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter. The Two Part Titanium Luer Adapted to provide a permanent threaded closure when used with a standard continuous ambulatory peritoneal dialysis (CAPD) transfer set. Argyle(TM) Adult Peritoneal Dialysis Accessory Titanium Catheter Extender: The Titanium Catheter Extender is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter. The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.
Device Story
Single-lumen silicone catheters; facilitate bi-directional flow of dialysate into/out of abdominal cavity; include felt cuffs for tissue ingrowth/stabilization. Kits include introducers, needles, guidewires, tunneling stylets, and accessories (titanium luer adapters, catheter extenders). Used in clinical settings for acute/chronic dialysis; inserted by surgeons/clinicians via open, laparoscopic, or percutaneous techniques. Titanium accessories provide secure connections or length extensions. MR status updated to MR Safe or MR Conditional. No design changes; submission supports expanded indication for laparoscopic placement.
Clinical Evidence
No clinical data provided. Bench testing included biocompatibility (ISO 10993-1: cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, chronic toxicity) and design verification for laparoscopic insertion through ports.
Indicated for acute and chronic peritoneal dialysis in patients requiring peritoneal access. Catheters may be inserted via open, laparoscopic, or percutaneous surgical techniques.
Regulatory Classification
Identification
(1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments. (3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles. (4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
Special Controls
*Classification.* Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.
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July 27, 2018
Covidien, llc Carol Ming Sr. Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048
Re: K180485
> Trade/Device Name: Argyle™ Peritoneal Dialysis Catheter and Kits; Argyle™ Presternal Peritoneal Dialysis Catheter and Kits; Argyle™ Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter; Argyle™ Adult Peritoneal Dialysis Accessory Titanium Catheter Extender Regulation Number: 21 CFR& 876.5630 Regulation Name: Peritoneal Dialysis System and Accessories Regulatory Class: II Product Code: FJS, FKO Dated: June 26, 2018 Received: June 27, 2018
Dear Carol Ming:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 legally 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/tray. The general controls 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.
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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.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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,
Joyce M. Whang -S
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
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## Indications for Use
510(k) Number (if known) K180485
Device Name
Argyle(TM) Peritoneal Dialysis Catheter and Kits; Argyle(TM) Presternal Peritoneal Dialysis Catheter and Kits; Argyle(TM) Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter; Argyle(TM) Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
### Indications for Use (Describe)
Argyle(TM) Peritoneal Dialysis Catheter and Kits:
The peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The peritoneal dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.
Argyle (TM) Presternal Peritoneal Catheter and Kits:
The presternal peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The Peritoneal Dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.
Argyle(TM) Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter:
The Two Part Titanium Luer Adapter is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter. The Two Part Titanium Luer Adapted to provide a permanent threaded closure when used with a standard continuous ambulatory peritoneal dialysis (CAPD) transfer set.
Argyle(TM) Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
The Titanium Catheter Extender is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter.
The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.
Type of Use (Select one or both, as applicable)
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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K180485 Page 1 of 5
### 510(k) Summary 5.
#### 5.1 Submitter
| | Covidien, llc<br>15 Hampshire Street<br>Mansfield, MA 02048 |
|-----------------|------------------------------------------------------------------------|
| Contact Person: | Carol Ming<br>Sr. Regulatory Affairs Specialist<br>Phone: 508.452.1443 |
| Date Prepared: | July 27, 2018 |
#### 5.2 Device Names and Classifications:
| Trade Name: | Argyle™ Peritoneal Dialysis Catheter and Kits |
|--------------------|---------------------------------------------------------------------------|
| Common Name: | Peritoneal catheter (PD catheter) |
| Regulation Number: | 21 CFR 876.5630 |
| Regulation Name: | Peritoneal Dialysis System and Accessories |
| Product Code: | FJS |
| Classification: | Class II |
| Trade Name: | Argyle™ Presternal Peritoneal Dialysis Catheter and Kits |
| Common Name: | Peritoneal catheter (PD catheter) |
| Regulation Number: | 21 CFR 876.5630 |
| Regulation Name: | Peritoneal Dialysis System and Accessories |
| Product Code: | FJS |
| Classification: | Class II |
| Trade Name: | Argyle™ Peritoneal Dialysis Accessory Two Part Titanium Luer<br>Adapter |
| Common Name: | Titanium Connector (2 part) |
| Regulation Number: | 21 CFR 876.5630 |
| Regulation Name: | Peritoneal Dialysis System and Accessories |
| Product Code: | FKO |
| Classification: | Class II |
| Trade Name: | Argyle™ Adult Peritoneal Dialysis Accessory Titanium Catheter<br>Extender |
| Common Name: | Titanium catheter extender |
| Regulation Number: | 21 CFR 876.5630 |
| Regulation Name: | Peritoneal Dialysis System and Accessories |
| Product Code: | FJS |
| Classification: | Class II |
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#### 5.3 Predicate Device
Flex-Neck® ExxTended™ PD Catheter & Accessories, FJS, K071167
#### Device Description 5.4
The Argyle™ Peritoneal Dialysis Catheter products are single lumen catheters for acute and chronic peritoneal dialysis to allow consistent bi-directional flow of dialysate into and out of the abdominal cavity. One or more cuffs are bonded on to the catheter tubing, which allows for tissue ingrowth to maintain placement of the catheter. All catheters are made of translucent silicone rubber tubing containing a radiopaque stripe, with felt cuffs available to provide catheter stabilization by virtue of tissue in-growth.
The Argyle™ peritoneal dialysis catheter comes in a variety of lengths and cuff configurations including straight, curled, and Swan Neck catheter styles. The Argyle™ peritoneal dialysis catheter kit contains the basic items needed to insert a peritoneal catheter: a straight or Swan Neck Tenckhoff or Curl Cath catheter with single or double cuff (specified at time of order), a 16 Fr/Ch pull-apart introducer, an 18 G introducer needle, a 12 mL syringe, a J/straight guidewire, tunneling stylet, #11 scalpel, gauze sponges, Beta-Cap™ adapter, cap, clamp, and instructions.
The Argyle™ presternal peritoneal dialysis catheters include the curl catheter and Swan Neck catheter styles. The curl catheter segment contains a felt cuff. The Swan Neck Presternal catheter is a segment of catheter tubing with a Swan Neck bend and two cuffs. It is connected by a double-barbed connector to the intraperitoneal segment of the curl catheter. The Argyle™ presternal peritoneal dialysis catheter kit contains the basic items needed to insert a peritoneal catheter: a 16 Fr/Ch pull-apart introducer, an 18 G introducer needle, a 12 mL syringe, a J/straight guidewire, tunneling stylet, #11 scalpel, gauze sponges, Beta-CapTM adapter, cap, clamp, titanium connector, and instructions.
The titanium adapter is a two-piece luer-lock system with a barbed end and a threaded cover. The adapter is designed to provide a permanent threaded closure when used with a standard CAPD transfer set.
The adult catheter extender is double barbed and made of titanium. The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.
| Model Names/Types | Indications |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Peritoneal Dialysis Catheter and Kits | The peritoneal catheter is indicated for acute and<br>chronic peritoneal dialysis.<br>The peritoneal dialysis catheter may be inserted<br>using open, laparoscopic or percutaneous surgical<br>techniques. |
#### 5.5 Indications for Use
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| Model Names/Types | Indications |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Presternal Peritoneal Catheters and Kit | The presternal peritoneal catheter is indicated for<br>acute and chronic peritoneal dialysis.<br>The Peritoneal Dialysis catheter may be inserted<br>using open, laparoscopic or percutaneous surgical<br>techniques. |
| Peritoneal Dialysis Accessory Two<br>Part Titanium Luer Adapter | The Two Part Titanium Luer Adapter is indicated<br>for acute and chronic peritoneal dialysis, to be<br>used with the Argyle(TM) Peritoneal Dialysis<br>Catheter and the Argyle(TM) Presternal<br>Peritoneal Dialysis Catheter.<br>The Two Part Titanium Luer Adapter is designed<br>to provide a permanent threaded closure when<br>used with a standard continuous ambulatory<br>peritoneal dialysis (CAPD) transfer set. |
| Adult Peritoneal Dialysis Accessory<br>Titanium Catheter Extender | The Titanium Catheter Extender is indicated for<br>acute and chronic peritoneal dialysis, to be used<br>with the Argyle(TM) Peritoneal Dialysis Catheter<br>and the Argyle(TM) Presternal Peritoneal<br>Dialysis Catheter.<br>The adult catheter extender is used to extend a<br>catheter by connecting two portions of the<br>peritoneal catheter tubing. |
#### Comparison to Predicate Device 5.6
This submission addresses the Peritoneal Dialysis Catheter and Kits and the Peritoneal Dialysis Presternal Catheter and Kits. Also included in the submission are accessories used with these devices, the Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter and the Adult Peritoneal Dialysis Accessory Titanium Catheter Extender. The new information presented in this submission is for the addition of the laparoscopic placement to the indications for use in the IFUs for the PD catheters and kits. In addition, the MR status of the devices in this submission is being added to the IFUs for the devices.
The Merit device, the Flex-Neck® ExxTended™ PD Catheter & Accessories, is being used as a predicate device as the IFU for the Flex-Neck® ExxTended™ PD Catheter & Accessories includes the option for laparoscopic placement in the indications for use statement. The updates to the IFUs did not entail any design changes to the subject devices.
The predicate and proposed PD catheter devices and accessories are the same devices and accessories, as this submission addresses only adding an indication to the Instructions for Use (IFU) for inserting the peritoneal dialysis catheters through a port, laparoscopically. The IFUs for the devices are also being updated to indicate the devices as having MR Safe or MR Conditional status.
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The PD catheters and accessories have an equivalent design, materials and principles of operation and technology when compared to the predicate device. The indications for use of the PD catheters is being updated to include an indication for laparoscopic placement. The MR Safe or MR Conditional status of the devices and accessories is also being included in the updated IFUs for these products.
- Intended Use: Peritoneal Dialysis catheters are intended to provide access for acute and ● chronic peritoneal dialysis. The catheter functions as a means to deliver and extract peritoneal dialysis solution in and out of the patient's peritoneal cavity.
- Materials: The materials of the proposed PD Catheters and accessories are the same as ● the predicate devices.
- . Principles of Operation and Technology: The technology of the proposed devices and accessories and the predicate device is the same.
- Performance: The performance of the proposed PD Catheters and accessories remains unchanged and continues to meet the performance specifications.
#### Performance Data 5.7
# Biocompatibility:
The biocompatibility evaluation was conducted for an externally communicating, tissue/bone/dentin, and permanent duration (>30 days) device. The series of testing was conducted utilizing the PD Catheter and using Good Laboratory Practice (GLP). The testing procedures are based on the requirements of ISO 10993-1 and the following series of testing was conducted utilizing the Argyle Peritoneal Dialysis Catheter:
- . Cytotoxicity
- Sensitization
- Irritation
.
- Acute Systemic Toxicity ●
- Subchronic Toxicity ●
- Genotoxicity
- o AMES
- o
- 0 Mouse Micronucleaus
- Implantation
- Chronic Toxicity ●
The results of the biocompatibility tests conducted on the PD catheter meet the ISO 10993 requirements and have been deemed acceptable.
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## Performance Testing:
Design verification testing was performed with the proposed device to support the indication expansion for laparoscopic insertion, including evaluation of insertion through a 7mm/8mm port (trocar).
The updates being made to the IFUs to include insertion through a port under laparoscopic visualization was subjected to validation testing by clinicians. Finally, test results are included to verify that the catheters and accessories are MRI Safe or MR Conditional. The IFUs for the catheters and accessories have been updated to include that information.
All performance testing met acceptance criteria and supports the determination of substantial equivalence to the predicate devices and accessories.
## Performance Testing (Animal)
None Provided
## Performance Testing (Clinical)
None Provided
#### 5.8 Conclusions
Medtronic has demonstrated that the Peritoneal Dialysis (PD) Catheters are substantially equivalent to the predicate device and supports the update to the indications for use to include the laparoscopic placement indication.
In addition, Argyle™ peritoneal dialysis catheter's manufactured with silicone tubing and radiopaque stripe strip are considered to be MR Safe, while the Argyle™ presternal peritoneal dialysis catheters plus titanium connectors are considered MR Conditional.
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.
