(183 days)
Not Found
No
The document describes a standard urinary drainage catheter and its performance testing, with no mention of AI or ML capabilities.
No.
The device is strictly for drainage and does not provide any therapeutic benefit or active treatment for a disease or condition.
No
Explanation: The device description states its purpose is for "drainage of the urinary bladder" and its intended use is "urological bladder drainage." There is no mention of it being used to diagnose any condition or collect diagnostic information.
No
The device description clearly describes a physical catheter with ports and a balloon, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "urological bladder drainage only." This is a therapeutic and diagnostic procedure performed directly on the patient's body, not on a sample taken from the body.
- Device Description: The device is a catheter designed to be inserted into the bladder for drainage. This is a medical device used for a procedure, not for analyzing a sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (like urine), reagents, or any process for determining the presence or absence of a condition or substance in a sample.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used for a procedure on the body itself.
N/A
Intended Use / Indications for Use
The 2-Way Kohli urinary drainage catheter is intended for urological bladder drainage only with a maximum patient indwelling time of
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 9, 2018
Nellie Medical, LLC % Christine Santagate Director, Boston Operations R&O Solutions 15 Standish Road Norfolk, MA 02056
Re: K172422
Trade/Device Name: Kohli Urinary Drainage Catheter Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: December 20, 2017 Received: December 27, 2017
Dear Christine Santagate:
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 (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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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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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172422
Device Name Kohli Urinary Drainage Catheter
Indications for Use (Describe)
The 2-Way Kohli urinary drainage catheter is intended for urological bladder drainage only with a maximum patient indwelling time of Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(K) SUMMARY
Submitter Information
| Submitter's Name: | Ron Adams |
|---|---|
| Address: | 18 Hillside Drive, Holliston, MA 01746 |
| Telephone: | 775-800-7300 |
| Fax: | 844-225-4600 |
| Contact Person: | Ron Adams |
| Telephone: | 775-800-7300 |
| Fax: | 844-225-4600 |
| Date Prepared: | December 13, 2017 |
| Trade Name: | Kohli Urinary Drainage Catheter |
| Common/Usual Name: | Urinary drainage catheter |
| Device Name: | Catheter, retention type, balloon |
| Registration Number(s): | 21 CFR 876.5130 |
| Regulation Description: | urological catheter and accessories |
| Class: | II |
| Product Code(s): | EZL |
Predicate Device(s):
- Primary: K063442 Degania Silicone All Silicone Foley Catheter, 2-Way, 3-Way and with . Temperature Sensor
- . Secondary: K142194 Emmy Medical, LLC, Cystosure Urinary Access System
Device Description:
The Kohli Urinary Drainage Catheter is intended for drainage of the urinary bladder.
The Kohli Urinary Drainage Catheter provides a single use access catheter with two ports: One for bladder drainage, and one for balloon inflation. The catheter encompasses only one balloon size (5cc) and length and it does not include any hydrophilic or antimicrobial coating
Indications for Use:
The 2-Way Kohli Urinary Drainage Catheter is intended for urological bladder drainage only with a maximum patient indwelling time