The IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication in conjunction with an established gastrostomy tract, or using a Stamm Procedure. The gastrostomy tube may also be used for gastric decompression.
Device Story
Kit facilitates percutaneous gastrostomy tube placement for enteral feeding, medication administration, or gastric decompression. Includes IYUNNI™ Soft Tip Introducer Dilator; used in conjunction with established gastrostomy tracts or Stamm procedures. Operated by clinicians in clinical settings. Device provides access to stomach; output is the established tube for therapeutic delivery or decompression. Benefits include minimally invasive access for patients unable to ingest food orally.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Kit includes gastrostomy tube and soft tip introducer dilator. Sterilized via ethylene oxide gas per AAMI protocol. Packaged in tray with Tyvek lid. No software or electronic components.
Indications for Use
Indicated for percutaneous gastrostomy tube placement for feeding, medication delivery, or gastric decompression in patients requiring enteral access. Contraindicated in patients with granulation tissue, infection, or stoma irritation at the site. Not for vascular use.
Regulatory Classification
Identification
A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).
Special Controls
*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Predicate Devices
Bard® Dilation Kit with Tri-Funnel Gastrostomy Tube (K063118)
{0}------------------------------------------------
K092049
1 of 3
# SECTION 9 510(K) SUMMARY
#### FOI RELEASABLE
OCT - 9 2009
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, SaiNath Intellectual Properties, LLC is required to submit with this Premarket Notification " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." SaiNath Intellectual Properties. LLC choose to submit a summary of information respecting safety and effectiveness.
| Common/Usual Name: | Tube, Gastro-Enterostomy |
|-----------------------|------------------------------------------------------------------------------------------|
| Trade Name: | IYUNNI™ 3ID Tri-Funnel<br>Gastrostomy Tube Kit |
| Classification Name: | 78 KNT Gastrointestinal Tube & Accessories |
| CFR Reference: | 21 CFR §876.5980, Class II |
| Classification Panel: | Gastroenterology/Urology |
| Submitter Name: | SaiNath Intellectual Properties, LLC<br>9438 Pebble Beach Ct. West<br>Seminole, FL 33777 |
| Contact Person: | I.V.S. Nath |
#### INDICATIONS FOR USE
Contact Person:
The IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication in conjunction with an established gastrostomy tract, or using a Stamm Procedure. The gastrostomy tube may also be used for gastric decompression.
#### CONTRAINDICATIONS
Contraindications for this device are those specific to patients where evidence of granulation tissue, infection or stoma irritation are present. The product must NEVER be used in the vasculature.
{1}------------------------------------------------
K092049
283
## POTENTIAL COMPLICATIONS
Complications may include, but are not limited to minor wound infections at stoma site; leakage of gastric contents; gastrocolic fistula; and sepsis.
# DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
SaiNath Intellectual Properties, LLC believes that the IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit is substantially equivalent to the currently marketed Bard® Dilation Kit with Tri-Funnel Gastrostomy Tube and Kimberly-Clark* Introducer Kit. Figure 9-1 compares the descriptive characteristics of these products.
## PERFORMANCE CHARACTERISTICS
The components of the IYUNNI™ 31D Tri-Funnel Gastrostomy Tube Kit has the same characteristics as those devices that are currently marketed. There is no change in the performance characteristics or intended use.
## PACKAGING AND STERILIZATION
The IYUNNI™ 3ID Tri-funnel Gastrostomy Tube Kit will be packaged in a tray and sealed with a Tyvek lid. The IYUNNI" 3ID Tri-Funnel Gastrostomy Tube Kit will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization.
## CONCLUSION
SaiNath Intellectual Properties, LLC believes that the I IYUNNI™ 3ID Tri-funnel Gastrostomy Tube Kit is substantially equivalent to the currently marketed devices. Figure 9-1 compares the descriptive characteristics of these products. As demonstrated in Figure 9-1, the IYUNNI" 3ID Tri-Funnel Gastrostomy Tube Kit is equivalent in its indications for use, design, and materials.
{2}------------------------------------------------
K092049
3 of 3
# FIGURE 9-1: SIMILARITIES AND DIFFERENCES BETWEEN IYUNNI" 3ID I I GURD > FOTATIATION TUBE KIT, BARD® DILATION KIT WITH TRI-FUNNEL GASTROSTOMY TUBE AND KIMBERLY-CLARK* INTRODUCER KIT
| | IYUNNI™ 3ID Tri-<br>Funnel Gastrostomy<br>Tube Kit | Bard® Dilation Kit<br>with Tri-Funnel<br>Gastrostomy Tube | Kimberly-Clark*<br>Introducer Kit |
|----------------------------------------|----------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------|
| | (This 510(K)) | (K063118) | (K080253) |
| USE | | | |
| Indications | Feeding,<br>medication, gastric<br>decompression | Feeding,<br>medication, gastric<br>decompression | Feeding,<br>medication, gastric<br>decompression |
| Route of<br>Administration | Percutaneous | Percutaneous | Percutaneous |
| GASTROSTOMY<br>TUBE | | | |
| | | | |
| KIT<br>COMPONENTS | | | |
| IYUNNI™ Soft Tip<br>Introducer Dilator | Yes | No | No |
| External Dilator | No | Yes | Yes |
Premarket Notification, IYUNNI™ 31D Tri-Funnel Gastrostomy Tube Kit, July 2, 2009 Proprietary and Confidential Information of SaiNath Intellectual Properties, LLC
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine. The symbol features a staff with three intertwined snakes and a pair of wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SaiNath Intellectual Properties, LLC % Christopher Paradies, Ph.D. FOWLER WHITE BOGGS, P.A. 501 East Kennedy Blvd., Suite 1700 TAMPA FL 33602
OCT - 9 2009
Re: K092049
Trade/Device Name: IYUNNI" 3ID Tri-Funnel Gastrostomy Tube Kit Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: September 24, 2009 Received: September 29, 2009
Dear Dr. Paradies:
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 to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment ate 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, market the device, subject to the general controls provisions of the 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 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
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.
{4}------------------------------------------------
Page 2 - Dr. Christopher Paradies
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
horm M. Whay
Janine M. Morris, Director (Acting) ি Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{5}------------------------------------------------
#### C. INDICATIONS FOR USE
510(k) Number (if known):
To-Be-Determined K092049
Device Name:
IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit
Indications for Use:
The IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication using a Percutaneous Endoscopic Gastrostomy procedure. The gastrostomy tube may also be used for gastric decompression.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-counter Use (21 CFR 801 Subpart C)
7
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ami M. Whang
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
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.
