K980870 · Rusch, Inc. · EZL · Jun 9, 1998 · Gastroenterology, Urology
Device Facts
Record ID
K980870
Device Name
RUSCH SILICONE FOLEY CATHETER
Applicant
Rusch, Inc.
Product Code
EZL · Gastroenterology, Urology
Decision Date
Jun 9, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5130
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The Rusch Silicone Foley Balloon Catheter is used to drain fluids to and from the urinary tract.
Device Story
Rüsch Silicone Foley is a single-use, sterile, retention-type urological catheter. Device consists of a silicone shaft with an integrated retention balloon, a connecting funnel, and a Luer-activated valve. Available in sizes 8 Fr to 26 Fr with cylindrical, Coude, or Tiemann tips; pediatric versions include a stylet for placement. One lumen facilitates fluid drainage; a second lumen manages balloon inflation/deflation with sterile water; three-lumen models allow for urinary tract flushing. Profile shafts with drainage channels and coated options are available. Device is used in clinical settings for urinary tract management.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Silicone catheter with silicone retention balloon, ported distal tip, and silicone funnel. Available in sizes 8 Fr to 26 Fr. Configurations include cylindrical, Coude, and Tiemann tips. Features include Luer-activated valve, optional coating, and optional profile shafts with drainage channels. Pediatric models include a stylet. Sterilization method not specified.
Indications for Use
Indicated for drainage of fluids to and from the urinary tract in patients requiring catheterization.
Regulatory Classification
Identification
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).
Predicate Devices
Bard, Bardex (not specified)
Mentor, 4 Sure (not specified)
Submission Summary (Full Text)
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# JUN - 9 1998
## 510 (k) Summary
### Submitter Name, Address, and Date of Submission. 1 .
Mr. James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452
(603) 532-7706 Telephone: (603) 532-8211 Facsimile:
Same as above Contact:
### Name of the Device, Common, Proprietary (if Known), and 2. Classification.
Classification Name: Urological Catheter
Common Name: Foley Catheter
Proprietary Name: Rüsch Silicone Foley
### Identification of the legally marketed device to which ന the submitter claims equivalence.
The Rusch Silicone Foley is substantially equivalent to the Bard, Bardex® and Mentor, 4 Sure®,
#### 4 . Description of the Device.
The Rusch Silicone catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation and deflation of the balloon. The distal end has two opposite eye holes, which are used On the Tiemann tip there is one hole. for drainage. Cylindrical, Coude and Tiemann tips are available versions of this product. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve.
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Pediatric sizes are available with the same configurations as the adult with the additional feature of a stylet that is inserted prior to the catheter placement. This product is available in sizes 8 Fr to 26 Fr, smooth and profile shafts. Both shafts are available in coated form. Profile shafts provide drainage channels along the shaft length.
#### 5. Intended Use of the Device.
The Rusch Silicone Foley is used to drain fluids to and from the urinary tract.
### ର . Summary of Technological Characteristics.
The following technological characteristics are the same as or equivalent to predicate devices:
The silicone catheter with silicone balloon, ported distal tip, and silicone funnel with and without coating, is equivalent to predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 9 199
Mr. James R. Whitney Group Regulatory Affairs Associate Rusch International Tall Pines Park Jaffrey, New Hampshire 03452
Re: K980870 Rusch Silicone Foley Catheters Dated: May 29, 1998 Received: June 1, 1998 Regulatory Class: II 21 CFR §876.5130/Product Code: 78 EZL
Dear Mr. Whitney:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and 1 that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
W. Liao Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________ Rüsch Silicone Foley Catheter
Indications for Use:
The Rusch Silicone Foley Balloon Catheter is used to drain fluids to and from the urinary tract.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Stalling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use_
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.
