Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air from the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections. Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
Device Story
NMI PDC II is a percutaneous drainage catheter consisting of a flexible tube with an open distal tip, drainage holes, and a lubricious surface. Distal end features pigtail or J-Tip configuration; some models include radiopaque markers for placement guidance. Proximal hub assembly includes a Luer lock for connection to fluid collection devices. Accessories include metal or plastic stiffening cannulas and optional trocars. Used by clinicians for percutaneous drainage of fluid or air from chest, abdomen, pelvis, urinary system, and biliary tree. Device facilitates fluid removal to treat conditions like abscesses, cysts, and pneumothorax. Benefits include minimally invasive fluid management.
Clinical Evidence
Bench testing only. Performance testing compared the proposed device to the predicate. Biocompatibility testing performed in accordance with ISO 10993-1.
Technological Characteristics
Flexible tube with open distal tip, drainage holes, and lubricious surface. Distal configurations: pigtail or J-Tip. Includes radiopaque markers. Proximal Luer lock hub. Accessories: metal/plastic stiffening cannulas, trocar. Biocompatibility per ISO 10993-1.
Indications for Use
Indicated for percutaneous drainage of fluid or air from the chest, abdomen, and pelvis (including abscesses, cysts, pneumothoraces, pleural empyemas, lung abscesses, mediastinal collections), the urinary system, and the biliary tree. For prescription use.
Regulatory Classification
Identification
A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.
Special Controls
*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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# K103353
510(k) Summary for the NMI PDC II
JAN 1 4 2011
# Date prepared: 15-November-2010
# A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
## B. Contact
Wanda Carpinella Sr. Manager, Global Regulatory Affairs 508-658-7929
#### C. Device Name
Trade Name:
Common/Usual name:
Classification Name:
Lorraine M. Hanley Director, Global Regulatory Affairs 508-658-7945
To be determined
Percutaneous Drainage Catheter
FGE-Catheter, Biliary, Diagnostic 21CFR §876.5010, Class II
LJE-Catheter, Nephrostomy, General & Plastic Surgery
21CFR8878.4200, Unclassified
GBX-Catheter, Nephrostomy, General & Plastic Surgery
21CFR§878.4200, Class I
GBO-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I
D. Predicate Device(s)
Common/Usual name: Classification Name:
Premarket Notification(s):
- - - - - -- -- -- -- -- -- -- -- -- -- -- --NMI PDC
FGE-Biliary Catheter and Accessories 21CFR 8800.5010, Class II K093392 LJE-Catheter, Nephrostomy, General & Plastic Surgery 21CFR §878.4200, Unclassified GBX-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I GBO-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I
5-2
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K103353
pg 2 of 2
## E. Device Description
The proposed percutaneous drainage catheter consists of a flexible tube with an open distal tip, drainage holes and a lubricious surface. The distal end of the device has either a pigtail or J-Tip configuration. Some catheter models have a radiopaque marker to aid the user in placement. The proximal hub assembly of the device provides a Luer lock hub to allow the user to connect to a fluid collection device. Accessories include a Metal Stiffening Cannula and Plastic Stiffening Cannula and some sets include an additional Trocar.
#### F. Intended Use
- l Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothorax, biliary, nephrostomy, urinary, pleural empyemas, lung abscess, and mediastinal collections.
- । Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.
- Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. ।
## G. Technological Characteristics
The proposed device has similar materials, design and components and technological characteristics as predicate percutaneous drainage catheters.
#### H. Performance Data
The proposed drainage catheters were tested and compared to predicate devices. Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence. Results of biocompatibility testing performed in accordance with ISO 10993-1 demonstrate the proposed device is acceptable for its intended use.
### I. Conclusion
Based on responses to questions posed in the FDA's Decision Making Tree, the proposed devices are substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Wanda Carpinella Sr. Manager, Regulatory Affairs Navilyst Medical, Inc. 26 Forest Street MARLBOROUGH MA 01752
JAN 1 4 2011
Re: K103353
Trade/Device Name: NMI Percutaneous Drainage Catheter (PDC) II Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: December 16, 2010 Received: December 17, 2010
Dear Ms. Carpinella:
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 i 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.
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
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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 1,000-0050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Coopliance. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffree mber (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Hubert Lewin MD
Herbert P. Lerner, M.D., Director (Acting) 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):
Device Name:
NMI Percutaneous Drainage Catheter (PDC) II
Indications for Use:
Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air from the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections.
Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.
Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
Prescription Use (21 CFR 801 Subpart D) And/Or
K 103158
AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 8
Concurrence of CDRH, Office of Device Evaluation (ODE)
ಸಿ
Heidi Lemur to
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.
