(94 days)
Not Found
No
The 510(k) summary describes a standard gastrostomy tube kit and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for medical purposes such as feeding, medication delivery, and gastric decompression, which are therapeutic functions.
No
The device is a gastrostomy tube kit used for feeding, medication, and gastric decompression, not for diagnosing medical conditions.
No
The device description explicitly states it is a "gastrostomy tube kit" and lists physical components like a "Soft Tip Introducer Dilator," indicating it is a hardware medical device.
Based on the provided information, the IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit is not an IVD (In Vitro Diagnostic) device.
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 procedure performed directly on the patient's body, not on samples taken from the body.
- Device Description: The device is a gastrostomy tube kit, which is a medical device used for direct patient care.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for therapeutic and supportive purposes.
N/A
Intended Use / 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 in conjunction with an established gastrostomy tract, or using a Stamm Procedure. The gastrostomy tube may also be used for gastric decompression.
Product codes
KNT
Device Description
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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 |
| 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 |
| 9438 Pebble Beach Ct. West | |
| 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.
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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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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 Gastrostomy
Tube Kit | Bard® Dilation Kit
with Tri-Funnel
Gastrostomy Tube | Kimberly-Clark*
Introducer Kit |
|----------------------------------------|----------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------|
| | (This 510(K)) | (K063118) | (K080253) |
| USE | | | |
| Indications | Feeding,
medication, gastric
decompression | Feeding,
medication, gastric
decompression | Feeding,
medication, gastric
decompression |
| Route of
Administration | Percutaneous | Percutaneous | Percutaneous |
| GASTROSTOMY
TUBE | | | |
| | | | |
| KIT
COMPONENTS | | | |
| IYUNNI™ Soft Tip
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
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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)
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(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