(110 days)
Not Found
No
The summary describes a mechanical device for bladder drainage and does not mention any software, algorithms, or AI/ML terms.
Yes
The device is indicated for suprapubic bladder catheterization and drainage of fluids to and from the urinary tract, which are therapeutic interventions.
No
Explanation: The device is a suprapubic cystostomy kit used for drainage of fluids to and from the urinary tract, which is a therapeutic or interventional function, not a diagnostic one. Its intended use is to provide bladder catheterization and drainage, not to diagnose a condition.
No
The device description clearly states it is a "kit" consisting of physical components: a suprapubic cystostomy tube and a soft collar introducer dilator. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "suprapubic bladder catherization and drainage of fluids to and from the urinary tract." This describes a procedure performed on the patient's body (in vivo) for drainage, not a test performed on a sample of bodily fluid or tissue outside the body (in vitro) to diagnose a condition.
- Device Description: The device components are a tube and an introducer/dilator, which are tools used for the physical process of inserting a catheter and draining fluids. This aligns with an in vivo procedure.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic testing.
Therefore, the IYUNNI" 3ID Suprapubic Cystostomy Kit is a medical device used for a surgical/procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
The IYUNNI 3ID Suprapubic Cystostomy Kit is indicated for use in suprapubic bladder catherization and drainage of fluids to and from the urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
KOB, KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urinary 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 requires specifications for the completed tests.
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.
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.
0
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: 813-222-1190 Fax: 813-229-8313
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
1
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.
2
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.
·
3
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 (800) 638-2041 or (301) 796-7100 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
4
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