(85 days)
Not Found
No
The summary describes a mechanical medical device (gastrostomy tube kit) and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device, a gastrostomy tube, is used for feeding, medication administration, and gastric decompression, all of which are interventions aimed at managing or improving a patient's health condition.
No
Explanation: The device is a feeding tube kit used for percutaneous placement of a gastrostomy tube for feeding, medication, or gastric decompression. It is an interventional/therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components like a gastrostomy tube, introducer dilator, and external bolster, indicating it is a hardware-based medical device kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the percutaneous placement of a gastrostomy tube for feeding, medication, and gastric decompression. This is a therapeutic or supportive medical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical tube and associated components used for delivering substances into the stomach or removing substances from the stomach. It does not involve analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting biomarkers, pathogens, or any other diagnostic indicators.
Therefore, the IYUNNI™ 31D Tri-Funnel Feeding Tube Kit falls under the category of a medical device used for treatment or support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrostomy tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit, K092049, Bard® Dilation Kit with Tri-Funnel Gastrostomy Tube, K063118, Kimberly-Clark* Introducer Kit, K080253
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows handwritten text, with the top line reading "K100/73". Below this, there is a smaller line of text that reads "162". The handwriting is in a dark ink, contrasting with the white background.
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:
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.
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
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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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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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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
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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