The IYUNNI™ 31D Tri-Funnel Feeding 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. The gastrostomy tube may also be used for gastric decompression.

Device Description

The IYUNNI™ 31D Tri-Funnel Gastrostomy Tube Kit is a percutaneous endoscopic gastrostomy tube kit comprising the Bard® Tri-Funnel Gastrostomy Tube along with the IYUNNI™ Soft Tip Introducer Dilator. Now, SaiNath Intellectual Properties intends to introduce its own gastrostomy tube as part of this kit. The Bard® Tri-Funnel Gastrostomy Tube is an all silicone tube with a balloon as the internal bolster and a silicone external bolster. The TYUNNI™ 3ID Tri-Funnel Feeding Tube kit will include, in addition to a gastrostomy tube the IYUNNI™ Soft Tip Introducer Dilator and a silicone external bolster.

AI/ML Overview

This document is a 510(k) Premarket Notification for the IYUNNI™ 3ID Tri-Funnel Feeding Tube Kit. It aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove specific performance metrics against pre-defined acceptance criteria in the manner of a clinical trial for an AI device.

Therefore, the requested information components for AI device studies are largely not applicable to this type of regulatory submission. This document focuses on demonstrating that a new medical device is as safe and effective as a legally marketed predicate device, primarily through comparison of technological characteristics, materials, and intended use, often supported by bench testing and biocompatibility data.

Here's a breakdown of why many of your requested items are not found in this document:

AI Device vs. Medical Device: This submission is for a physical medical device (gastrostomy tube kit), not an AI/software as a medical device. As such, the concepts of "device performance," "ground truth," "training set," "test set," "experts," "adjudication," or "MRMC studies" in the context of an AI algorithm's diagnostic or predictive capabilities are not relevant here.

Let's address the requests based on what is available in the provided text:

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

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices: - Same intended use. - Same technological characteristics (design, materials, manufacturing processes). - Does not raise new safety or performance questions.	The proposed IYUNNI™ 3ID Tri-Funnel Feeding Tube Kit is presented as being the "same design, materials, and manufacturing processes of the predicate IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit (K092049)." "Testing has been performed and all components, subassemblies, and/or full devices met the specifications for the completed tests, including performance bench testing balloon inflation testing, and biocompatibility testing of the non-latex polyurethane film, which is the same material used in the predicate device." Conclusion states: "SaiNath Intellectual Properties, LLC has demonstrated that the proposed IYUNNI™ 3ID Tri-Funnel Feeding Tube Kit is substantially equivalent in intended use and indications to the predicate devices" and "Technological differences have been qualified through biomaterial assessments and bench testing, the result of which did not raise new safety or performance questions."
Component Certification: - Components are legally marketed pre-amendments, exempt from premarket notification, or found substantially equivalent through premarket notification.	The submitter certifies that the components of the kit are either legally marketed pre-amendments devices, exempt from premarket notification, or found to be substantially equivalent through the premarket notification process for their intended use. Specific mention is made that the kit includes a "currently marketed gastrostomy tube preassembled with a soft tip introducer dilator, which has been found substantially equivalent."

Acceptance Criteria

Reported Device Performance

Substantial Equivalence to Predicate Devices: - Same intended use. - Same technological characteristics (design, materials, manufacturing processes). - Does not raise new safety or performance questions.

The proposed IYUNNI™ 3ID Tri-Funnel Feeding Tube Kit is presented as being the "same design, materials, and manufacturing processes of the predicate IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit (K092049)." "Testing has been performed and all components, subassemblies, and/or full devices met the specifications for the completed tests, including performance bench testing balloon inflation testing, and biocompatibility testing of the non-latex polyurethane film, which is the same material used in the predicate device." Conclusion states: "SaiNath Intellectual Properties, LLC has demonstrated that the proposed IYUNNI™ 3ID Tri-Funnel Feeding Tube Kit is substantially equivalent in intended use and indications to the predicate devices" and "Technological differences have been qualified through biomaterial assessments and bench testing, the result of which did not raise new safety or performance questions."

Component Certification: - Components are legally marketed pre-amendments, exempt from premarket notification, or found substantially equivalent through premarket notification.

The submitter certifies that the components of the kit are either legally marketed pre-amendments devices, exempt from premarket notification, or found to be substantially equivalent through the premarket notification process for their intended use. Specific mention is made that the kit includes a "currently marketed gastrostomy tube preassembled with a soft tip introducer dilator, which has been found substantially equivalent."

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. This is a physical device submission, not an AI study involving a test set of data. The "testing" mentioned refers to bench testing and biocompatibility assessments, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As this is not an AI device, there is no "ground truth" to be established by experts for a test set in the context of diagnostic or predictive performance.

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

Not Applicable. No test set or adjudication method is described for this physical medical device.

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 device, and therefore, an MRMC study comparing human performance with and without AI assistance is not relevant or included.

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

Not Applicable. As this is not an AI algorithm, a standalone performance study in that context is not relevant. The "performance data" refers to bench testing of the physical components.

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

Not Applicable. There is no "ground truth" in the AI sense for this physical device. The "truth" in this context is whether the physical components meet their engineering specifications and perform as intended during bench testing, and whether the materials are biocompatible, as compared to the predicate device.

8. The sample size for the training set

Not Applicable. This is a physical medical device. There is no AI model requiring a training set.

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

Not Applicable. As there is no training set for an AI model, there's no ground truth to establish for it.

Summary

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APR 1 G 2010

SECTION 9 510(K) SUMMARY

FOI RELEASABLE

1. Submitter:

SaiNath Intellectual Properties, LLC 9438 Pebble Beach Ct. West Seminole, FL 33777 Telephone: 813-222-1190 Fax: 813-229-8313

Contact: Christopher Paradies Date Prepared: January 18, 2010

2. Device:

Trade Name: IYUNNI™ 3ID Tri-Funnel Feeding Tube Kit Classification Name: 78 KNT Gastrointestinal Tube & Accessories Regulation Number: 876.5980 Product Code: KNT Classification: Class II

3. Predicate Device:

IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit, K092049 Bard® Dilation Kit with Tri-Funnel Gastrostomy Tube, K063118 Kimberly-Clark* Introducer Kit, K080253

4. Device Description:

5. Intended Use:

The IYUNNI" 3ID Tri-Funnel Feeding 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. The gastrostomy tube may also be used for gastric decompression.

Premarket Notification IYUNNI™ 3ID Tri-Funnel Feeding Tube Kit, January 18, 2010 Proprietary and Confidential Information of SaiNath Intellectual Properties, LLC

Page 86

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K100173
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6. Technological Characteristics

The proposed IYUNNI™ 3ID Tri-Funnel Feeding Tube Kit is the same design, materials, and manufacturing processes of the predicate IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit (K092049).

7. Performance Data:

Testing has been performed and all components, subassemblies, and/or full devices met the specifications for the completed tests, including performance bench testing balloon inflation testing, and biocompatibility testing of the non-latex polyurethane film, which is the same material used in the predicate device.

8. Conclusion:

SaiNath Intellectual Properties, LLC has demonstrated that the proposed IYUNNI" 3ID Tri-Funnel Feeding Tube Kit is substantially equivalent in intended use and indications to the predicate devices, IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit, K092049; Bard® Dilation Kit with Tri-Funnel Gastrostomy Tube, K063118; Kimberly-Clark* Introducer Kit, K080253. Technological differences have been qualified through biomaterial assessments and bench testing, the result of which did not raise new safety or performance questions.

Figure 9-1 compares the descriptive characteristics of these products. As demonstrated in Figure 9-1, the IYUNNI" 3ID Tri-Funnel Feeding Tube Kit is equivalent in its indications for use, design, and materials.

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K100173

SECTION 6 KIT CERTIFICATION

I certify that the following components of my kit are either (1) legally marketed preamendments devices, (2) exempt from premarket notification (consistent with the exemption criteria doscribed in the classification regulation(s) and the limitations of exemptions from Section 510(k) of the act (e.g., 862.9) or (3) have been found to be substantially equivalent through the premarket notification process for the use(s) for which the kit is to be intended (i.e., I am not claiming or causing a new use for the component(s)).

The IYUNNI™ 31D Tri-Funnel Feeding Tube Kit marketing clearance is subject to this 510(k), but is however, a kit including a currently marketed gastrostomy tube preassembled with a soft tip introducer dilator, which has been found substantially equivalent.

I further certify that the component of this kit, of which the component is listed below, will be either purchased in bulk or pre-packaged in a single unit dosege when reasonably available. These items will be assembled in a tray, sealed Tyvek container and sterlized prior to shipment. Bach kit will contain a preassembled soft tip introducer dillator inserted in a gastrostomy tube.

I.V.S. Nath

Premarket Notification IYUNNI™ 31D Tri-Funnel Feeding Tube Kit, January 18, 2010 Proprietary and Confidential Information of SaiNath Intellectual Properties, LLC

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR 1 0 2010

Mr. I.V.S. Nath President SaiNath Intellectual Properties LLC 9438 Pebble Beach Ct. West LARGO FL 33777

Re: K100173

Trade/Device Name: IYUNNI™ 31D Tri-Funnel Feeding Tube Kit Regulation Number: 21 CFR $876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 18, 2010 Received: January 21, 2010

Dear Mr. Nath:

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 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, 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 - Mr. I.V.S. Nath

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 (QS) 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/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 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,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K100173
181

Ü INDICATIONS FOR USE

510(k) Number (if known):

To Be Determined

K100173

Device Name:

IYUNNI™ 3ID TRI-FUNNEL FEEDING TUBE KIT

Indications for Use:

The IYUNNI™ 31D Tri-Funnel Feeding 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 ਮ (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)

(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Deyices 510(k) Number

Premarket Notification IYUNNI™ 31D Tri-Funnel Feeding Tube Kit, January 18, 2010 Proprietary and Confidential Information of SalNath Insellectual Propertits, LLC

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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.