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 Description

The IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit is a gastrostomy tube kit. The kit components include the IYUNNI™ Soft Tip Introducer Dilator.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device and, as such, does not contain information about a study based on the criteria you've outlined for evaluating the performance of AI/ML-driven devices.

The document is for the IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit, which is a physical medical device (a gastrostomy tube), not a software or AI/ML diagnostic tool. Therefore, the concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "experts to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "training set sample size," or "how ground truth for training set was established" are not applicable in the context of this submission.

Instead, the submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. This is a regulatory pathway for lower-risk devices where the primary evidence of safety and effectiveness comes from showing that the new device has similar technological characteristics and performs comparably to a device already cleared by the FDA.

Here's how the provided information relates to the acceptance criteria for a physical medical device's 510(k) submission:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: For this type of device, "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity. Instead, acceptance is based on demonstrating substantial equivalence to predicate devices, meaning the new device is as safe and effective as the predicate. This is typically shown by comparing design, materials, indications for use, and performance characteristics (e.g., sterilization methods, packaging) to the predicate devices.
Reported Device Performance: The document explicitly states: "The components of the IYUNNI™ 3ID 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." The performance is implicitly "equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. There is no "test set" in the sense of a dataset for algorithm evaluation. The evaluation is based on a comparison of device characteristics and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no ground truth establishment for a diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable.

8. The sample size for the training set:

Not applicable.

9. How the ground truth for the training set was established:

Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (a gastrostomy tube kit) and relies on demonstrating substantial equivalence to predicate devices rather than the types of performance studies and metrics that would be applicable to an AI/ML diagnostic or assistive device. The "acceptance criteria" are met by matching the safety and effectiveness profile of already cleared devices through design, material, and functional comparisons.

Summary

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K092049
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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-FunnelGastrostomy 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, LLC9438 Pebble Beach Ct. WestSeminole, FL 33777
Contact Person:	I.V.S. Nath

INDICATIONS FOR USE

Contact Person:

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.

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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.

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K092049
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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-Funnel GastrostomyTube Kit	Bard® Dilation Kitwith Tri-FunnelGastrostomy Tube	Kimberly-Clark*Introducer Kit
	(This 510(K))	(K063118)	(K080253)
USE
Indications	Feeding,medication, gastricdecompression	Feeding,medication, gastricdecompression	Feeding,medication, gastricdecompression
Route ofAdministration	Percutaneous	Percutaneous	Percutaneous
GASTROSTOMYTUBE

KITCOMPONENTS
IYUNNI™ Soft TipIntroducer 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

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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.

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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

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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)

(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

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
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).(b)
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.