CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED

Q: Who is the manufacturer of CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED?

Cure Medical, LLC filed the 510(k) submission for CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED (K132500).

Q: What is the FDA product code for CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED?

EZD. It is classified under 21 CFR 876.5130 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED?

Cure Medical Cure Catheter (K072539); Cure Pediatric Catheter (K110653).

Q: Who can help prepare an FDA 510(k) submission like CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K132500 · Cure Medical, LLC · EZD · Dec 23, 2013 · Gastroenterology, Urology

Device Facts

Record ID	K132500
Device Name	CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
Applicant	Cure Medical, LLC
Product Code	EZD · Gastroenterology, Urology
Decision Date	Dec 23, 2013
Decision	SESE
Submission Type	Special
Regulation	21 CFR 876.5130
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The Cure Catheter ™ Hydrophilic Coated is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage. The urinary catheter comes in a variety of sizes, packaged sterile for single-use.

Device Story

Intermittent urinary catheter for bladder drainage; inserted through urethra. Device consists of medical-grade PVC catheter with hydrophilic polyvinyl pyrrolidone (PVP) coating and sterile water sachet for activation. Activation creates low-friction surface to minimize urethral trauma. Available in straight and Coudè tip configurations in various sizes. Used in clinical or home settings by patients or healthcare providers. Single-use, sterile packaging. Benefits include reduced friction during insertion, facilitating easier catheterization and potentially reducing urethral injury.

Clinical Evidence

No clinical data. Substantial equivalence supported by biocompatibility testing per FDA General Program memorandum #G95-1 and design verification/validation activities.

Technological Characteristics

Medical-grade PVC catheter; hydrophilic polyvinyl pyrrolidone (PVP) coating; sterile water sachet for activation. Straight and Coudè tip configurations. Various Charrière (Ch) gauge sizes. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for bladder drainage in male and female patients requiring intermittent catheterization. Available in various sizes for adult and pediatric use.

Regulatory Classification

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).

Predicate Devices

Cure Medical Cure Catheter (K072539)
Cure Pediatric Catheter (K110653)

Reference Devices

Astra Tech AB LoFric® Primo™ Single Use Urinary Catheter (K050874)
Coloplast SpeediCath (K023254)

Related Devices

K181445 — AMSure Hydrophilic Intermittent Catheter · Amsino International, Inc. · Oct 1, 2018
K200134 — Jimushi Sterile Urethral Catheter for single use · Hangzhou Jimushi Meditech Co., Ltd. · Jun 1, 2020
K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact · Well Lead Medical Co., Ltd. · Mar 5, 2025
K183461 — Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter · Teleflexmedical, Inc. · May 8, 2019
K212567 — PVC Hydrophilic Urethral Catheter · Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Dec 7, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Cure Medical - Cure Catheter® Hydrophilic Coated Special 510(k) Submission | 510(k) SUMMARY | | | | | | | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--| | Submitted by: | Ann Kenowsky, President Cure Medical, LLC 3700 Newport Blvd., #301 Newport Beach, CA 92663 949 673 8474 (Phone) 949 723 0564 (Fax) email: akenowsky@curemedical.com | | | | | | | Contact person: | John Beasley, MS, RAC (US) MedTech Review, LLC 257 Garnet Garden Street Henderson, NV 89015 612 889 5168 (Phone) email: john@medtechreview.com | | | | | | | Date Prepared: | 10 November 2013 | | | | | | | Trade Name: | Cure Catheter ™ Hydrophilic Coated | | | | | | | Common Name: | Urinary catheter for intermittent use | | | | | | | Classification Name: | Urological catheter | | | | | | | Device Class: | II | | | | | | | Procode: | EZD (catheter, straight) | | | | | | | CFR Reference: | 876.5130 | | | | | | | Predicate Device(s): | Cure Medical Cure Catheter K072539 Cure Pediatric Catheter K110653 | | | | | | | Reference Devices(s): | Astra Tech AB LoFric® Primo™ Single Use Urinary Catheter K050874 Coloplast SpeediCath K023254 | | | | | | | Device Description: | The Cure Catheter ™ Hydrophilic Coated is an intermittent urinary catheter intended to be used by adult and pediatric males and females for the purpose of bladder drainage. The catheter is manufactured with conventional medical grade PVC. The surface is coated with a hydrophilic low-friction coating (polyvinyl pyrrolidone, or PVP) and, when activated | | | | | | {1}------------------------------------------------ Cure Medical - Cure Catheter® Hydrophilic Coated Special 510(k) Submission | Intended Use: | with water it becomes slippery and ready to use. The straight and Coudè tip configurations have been designed to eliminate trauma to the urethra and are offered in a variety of sizes. Each catheter is provided in sterile, single-use packages. | |---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The Cure Catheter ™ Hydrophilic Coated is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. | The Cure Catheter ™ Hydrophilic Coated and listed predicate devices are all similar in device function, features, Technology Comparison: composition, and intended use as listed in the following table: | Characteristics | Proposed Device | Predicate Devices | | Reference Devices | | |-----------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | | Cure Catheter ™ Hydrophilic Coated | Cure Medical Cure Catheter™ | Cure Medical Cure Pediatric Catheter™ | Astra Tech AB LoFric® Primo™ Single Use Urinary Catheter | Coloplast SpeediCath | | 510(k) | / | K072539 | K110653 | K050874 | K023254 | | Device Features | Hydrophilic coated, with water sachet. Low friction between catheter and urethral mucosa. Ready to use. | No coating | No coating | Hydrophilic coated, with water integrated in the package. Low friction between catheter and urethral mucosa. | Hydrophilic coated. Low friction between catheter and urethral mucosa. Ready to use. | | Sizes¹ | Female 6 inch Straight Tip Ch 6, 8, 10, 12, 14, 16, 18 | Female Straight Tip 6 inch Ch 8, 10, 12, 14, 16, 18 | Pediatric, 10 inch Straight Tip, Ch 8, 10, 12, 14 | Female 150mm Ch 8, 10, 12, 14 | Female Ch 6, 8, 10, 12, 14, 16 | | | Male 16 inch Straight and Coudè Tip Ch 8, 10, 12, 14, 16, 18 | Male Straight Tip 16 inch Ch 8, 10, 12, 14, 16, 18 | | Female 200mm Ch 8, 10, 12, 14, 16, 18 | Male Ch 8, 10, 12, 14, 16, 18 | | | Pediatric 10 inch Straight Tip Ch 6, 8, 10, 12, 14 | | | Male Ch 8, 10, 12, 14, 16, 18, 20, 22, 24 | Tiemann Ch 10, 12, 14 | | | | | | Tiemann Ch 10, 12, 14, 16, 18 | Pediatric Ch 6, 8, 10 | | | | | | Pediatric 200mm Ch 6, 8, 10 | Boy Ch 6, 8, 10, 12 | | | | | | Boy Ch 6, 8, 10 | | 1 The name and the symbol "Ch" refer to the Charrière gauge scale, which is often called the French scale. {2}------------------------------------------------ | Characteristics | Proposed Device | Predicate Devices | | Reference Devices | | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | | Cure Catheter™ Hydrophilic Coated | Cure Medical Cure Catheter™ | Cure Medical Cure Pediatric Catheter™ | Astra Tech AB LoFric® Primo™ Single Use Urinary Catheter | Coloplast SpeediCath | | 510(k) | / | K072539 | K110653 | K050874 | K023254 | | Sterility | STERILE | STERILE | STERILE | STERILE | STERILE | | Packaging | Peel Pack | Peel Pack | Peel Pack | Peel Pack | Peel Pack | | Device composition | Polyvinyl Chloride (PVC) Catheter with DSM Comfort Coat - polyvinylpyrrolidone - Hydrophilic Material Coating - and sterile water sachet | Polyvinyl Chlorine Catheter without hydrophilic coating | Polyvinyl Chlorine Catheter without hydrophilic coating | Polyvinylchlori de catheter coated with polyvinylpyrrol idone and salt. Packaged with water sachet. | Polyurethane catheter coated with polyvinylpyrrol idone, placed in a saline solution containing polyvinylpyrrol idone. | | Intended Use | Intermittent catheterization, through the urethra, for the purpose of bladder drainage for males and females. | Intermittent catheterization, through the urethra, for the purpose of bladder drainage for males and females. | Intermittent catheterizatio n through the urethra for the purpose of bladder drainage for pediatric males and females. | Intermittent catheterization of the urethra. | Chronic urine retention. Post-void residual volume (PVR). Voiding dysfunctions. | #### Cure Medical - Cure Catheter® Hydrophilic Coated Special 510(k) Submission Studies conducted per US FDA General Program memorandum #G95-1 indicate that the Cure Catheter ™ Hydrophilic Coated is biocompatible and safe for its intended use. ### Performance Testing: Moreover, product evaluation, through design verification and design validation activities, supports the device's functionality without new questions of safety or effectiveness. #### The Cure Catheter ™ Hydrophilic Coated is substantially Conclusion of Comparison: equivalent to the currently marketed predicate devices. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 23, 2013 Cure Medical LLC c/o John Beasley, MS, RAC Founder and Senior consultant Medtech Review, LLC 257 Garnet Garden Street Henderson, NV 89015 Re: K132500 Trade/Device Name: Cure Catheter® Hydrophilic Coated Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZD Dated: November 25, 2013 Received: November 26, 2013 Dear Mr. John Beasley: We have reviewed vour 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. 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 {4}------------------------------------------------ Page 2 - Mr. John Beasley 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor YowIndustry/default.htm. 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 -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 {5}------------------------------------------------ Cure Medical - Cure Catheter ® Hydrophilic Coated Special 510(k) Submission ## Indications for Use 510(k) Number (if known): K132500 ## Device Name: Cure Catheter ® Hydrophilic Coated Indications for Use: The Cure Catheter ® Hydrophilic Coated is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage. The urinary catheter comes in a variety of sizes, packaged sterile for single-use. Prescription Use _____________________________________________________________________________________________________________________________________________________________ and/or Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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) # Herbert P. Lerner -S 2013.12.23 09:57:47 -05'00' Page 1 of 1 Cure Medical, LLC Page 023