IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT

K102572 · Sainath Intellectual Properties, LLC · KNT · Dec 27, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K102572
• Device Name: IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT
• Applicant: Sainath Intellectual Properties, LLC
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Dec 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The kit is used for percutaneous bladder drainage and to drain fluids to and from the urinary tract. The usage of this product is identical to previous devices, which have the same technological characteristics.

Device Story

The IYUNNI™ 3ID Suprapubic Cystostomy Tube Kit is a medical device kit designed for percutaneous bladder drainage. The kit comprises two primary components: the IYUNNI™ Suprapubic Cystostomy Tube and the IYUNNI™ Soft Collar Introducer Dilator. It is intended for use in clinical settings to facilitate the drainage of fluids to and from the urinary tract. The device functions as a mechanical catheter system; it does not utilize electronic, software, or algorithmic components. The kit is used by healthcare professionals to provide bladder access and drainage, potentially benefiting patients requiring long-term or temporary urinary diversion.

Clinical Evidence

Bench testing only. All components, subassemblies, and full devices met required specifications for completed tests.

Technological Characteristics

The kit consists of a suprapubic cystostomy tube and a soft collar introducer dilator. The device is a mechanical catheter system. No electronic, software, or energy-based components are utilized. Technological characteristics are stated to be similar to the predicate devices in design, materials, and manufacturing processes.

Indications for Use

Indicated for suprapubic bladder catheterization and drainage of fluids to and from the urinary tract.

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

• IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit (K092049)
• Rüsch Suprapubic Catheter Tray/Kit (K970021)
• Rüsch Supraflex™ Suprapubic Catheter (K952187)

Submission Summary (Full Text)

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# DEC 2 7 2010

102572 SECTION 5/Page 5-1 510(K) SUMMARY

# SAINATH INTELLECTUAL PROPERTIES, LLC

# FOI RELEASABLE

#### 1. Submitter:

SaiNath Intellectual Properties, LLC 9438 Pebble Beach Ct. West Seminole, FL 33777 Telephone: [phone] Fax: [phone]

Contact: Christopher Paradies Date Prepared: August 27, 2010

#### 2. Device:

Trade Name: IYUNI™ 3ID Suprapubic Cystostomy Tube Kit Classification Name: 78 KOB Suprapubic Catheter & Accessories Regulation Number: 876.5980 Product Code: KOB Classification: Class II

## 3. Predicate Device:

IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit, K092049 Rüsch Suprapubic Catheter Tray/Kit, K970021 Rüsch Supraflex™ Suprapubic Catheter, K952187

## 4. Device Description:

The kit consists of two major components: IYUNNI™ Suprapubic Cystostomy Tube and IYUNNI™ Soft Collar Introducer Dilator. The kit is used for percutaneous bladder drainage.

Premarket Notification, IYUNNI" 3ID Suprapubic Cystostomy Catheter Kit, August 27, 2010 Proprietary and Confidential Information of SaiNath Intellectual Properties, LLC

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### 5. Intended Use:

The kit is used for percutaneous bladder drainage and to drain fluids to and from the urinary tract. The usage of this product is identical to previous devices, which have the same technological characteristics.

# 6. Technological Characteristics

The proposed IYUNNI™ 3ID Suprapubic Catheter kit is similar in design, materials, and manufacturing processes to the predicates IYUNNI™ 3ID Tri-Funnel Gastrostomy Tube Kit. K092049; Rüsch Supraflex™ Suprapubic Catheter Kit, K952187; and the Rüsch Suprapubic Tray/Kit, 970021.

### 7. Performance Data: .

Testing has been performed and all components, subassemblies, and/or full devices met the requires specifications for the completed tests.

### 8. Conclusion:

SaiNath Intellectual Properties, LLC has demonstrated that the proposed IYUNNI™ 3ID Suprapubic Catheter Kit is substantially equivalent in intended use and indications to the predicate devices, I YUNNI™ 3 ID Tri-Funnel Gastrostomy Tube Kit, K092049; Rüsch SupraflexTM Suprapubic Catheter Kit, K952187; and the Rüsch Suprapubic Tray/Kit, 970021. Technological differences have been qualified through biomaterial assessments and bench testing, the result of which did not raise new safety or performance questions.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle's head and wing, rendered in black. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle symbol. The text is in all capital letters and is also black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

SaiNath Intellectual Properties LLC c/o Christopher Paradies, Ph.D. Fowler White Boggs P.A. 501 East Kennedy Blvd., Suite 1700 TAMPA FL 33602

GEC 2 7 100

Re: K102572

Trade/Device Name: IYUNNI'M 31D Suprapubic Catheter Kit Regulation Number: 21 CFR 8876.5090 Regulation Name: Suprapubic urological catheter and accessories Regulatory Class: II Product Code: KNT Dated: December 6, 2010 Received: December 10, 2010

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 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/tray 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/tray. 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 (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K102572

DHC 2 7. 2010

SECTION 4\Page 4-1 INDICATIONS FOR USE

510(k) Number (if known):

To Be Determined K 182

IYUNNI™ Suprapubic Catheter Kit

02577

Device Name:

Indications for Use:

The IYUNNI" 3ID Suprapubic Cystostomy Kit is indicated for use in suprapubic bladder catherization and drainage of fluids to and from the urinary tract.

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)

on Signof Reproductive, Gastro-Renal, and

Premarket Notification, IYUNNI™ 31D Suprapubic Cystostomy Catheter Kit, August 27, 2010 Proprietary and Confidential Information of SaiNath Intellectual Properties, LLC