Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter

Q: Who is the manufacturer of Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter?

Teleflexmedical, Inc. filed the 510(k) submission for Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter (K183461).

Q: What is the FDA product code for Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter?

GBM. 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 Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter?

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

Q: Who can help prepare an FDA 510(k) submission like Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter?

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.

K183461 · Teleflexmedical, Inc. · GBM · May 8, 2019 · Gastroenterology, Urology

Device Facts

Record ID	K183461
Device Name	Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
Applicant	Teleflexmedical, Inc.
Product Code	GBM · Gastroenterology, Urology
Decision Date	May 8, 2019
Decision	SESK
Submission Type	Traditional
Regulation	21 CFR 876.5130
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder.

Device Story

Single-use, sterile, disposable PVC intermittent catheters; shaft sizes 6-20 Fr; hydrophilic coating for lubrication. Variants include 'all-in-one' kits and closed systems with integrated collection bags and introducer tips to bypass the first 1.5" of the urethra. Used for bladder drainage; inserted through the urethra. Operated by clinicians or patients. Provides a pathway for urine to exit the bladder; reduces friction during insertion via hydrophilic coating; minimizes contamination risk in closed-system variants. Benefits include improved patient comfort and reduced risk of urethral trauma or infection during intermittent catheterization.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included visual inspection, flow rate, friction testing, and coating presence. Biocompatibility testing conducted per ISO 10993-1, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation and sensitization). Performance verified against ASTM F623 requirements.

Technological Characteristics

Materials: PVC (limited contact <24hr). Sensing/Actuation: Mechanical drainage. Energy: None. Dimensions: 6-20 Fr shaft, 40 cm length. Connectivity: None. Sterilization: Ethylene Oxide. Coating: Hydrophilic. Tip types: Nelaton, Olive, Tiemann, or introducer tip. Standards: ASTM F623, ISO 10993-1, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for adult and pediatric, male and female patients requiring urethral catheterization to pass urine from the bladder. Contraindicated in patients with insurmountable urethral obstructions, urethral injuries, or urethral inflammation.

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

Rusch FloCath (K000070)

Related Devices

K132500 — CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED · Cure Medical, LLC · Dec 23, 2013
K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact · Well Lead Medical Co., Ltd. · Mar 5, 2025
K251274 — EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits · HR Healthcare · Jan 29, 2026
K052440 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER · Mentor Corporation · Oct 11, 2005
K033023 — INTERMITTENT URETHRAL CATHETERS · Rusch Intl. · Dec 23, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 8, 2019 Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd., Suite 600 North Morrisville, NC 27560 Re: K183461 > Trade/Device Name: Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: April 5, 2019 Received: April 8, 2019 Dear Lori Pfohl: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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. Purva Pandya Acting, Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183461 #### Device Name Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles). #### Indications for Use (Describe) The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <div> ✖ </div> | |----------------------------------------------|-------------------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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." {3}------------------------------------------------ ## 510(k) Summary #### A. Name, Address, Phone and Fax Number of Applicant Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 Phone: 919-433-4831 919-361-3939 Fax: ### B. Contact Person Lori Pfohl Senior Regulatory Affairs Specialist ### C. Date Prepared May 7, 2019 ### D. Device Name Trade Name: Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) | Common Name: | Catheter, Urethral | |-----------------------|-------------------------------------| | Product Code: | GBM | | Regulation Number: | CFR 876.5130 | | Classification Name: | Urological catheter and accessories | | Classification: | II | | Classification Panel: | Gastroenterology/Urology | # E. Predicate Device This submission demonstrates substantial equivalence to the predicate device: # Rusch® FloCath - K000070 # F. Device Description The Teleflex Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are single use, disposable and sterile. The catheters are made of clear Teleflex Medical, Inc. {4}------------------------------------------------ polyvinylchloride (PVC) with vertically cut and softly rounded polished eyes and are coated with a hydrophilic coating. They are composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size ranges from 6-20 French gauge. The funnel is color coded to facilitate size identification. The Rusch® FloCath™ Quick is an "all-in-one catheter" that allows for convenience and the Rusch® MMG H2O™ is a closed system with integrated collection bag that allows for "no touch" catheterization due to an introducer tip that helps bypass the first 1.5" of the urethra. # G. Indications for Use The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder. # H. Contraindications - Insurmountable urethral obstructions - Urethral injuries - Urethral inflammation # I. Substantial Equivalence The subject device Teleflex Rusch FloCath Quick Hydrophilic Intermittent Catheter is substantially equivalent to the predicate devices with respect to intended use, technology and construction. The differences between the predicates and the subject devices are minor and any risks have been mitigated through testing. Table 07.1 summarizes the differences between the subject and predicate device. The subject devices are substantially equivalent to the predicate device: | Features | Teleflex Medical Rusch FloCath Quick Urological Catheter (Subject Devices 1) | Teleflex Medical Rusch MMG Urological Catheter (Subject Device 2) | Rusch FloCath - Uncoated or Coated Urological Catheter (Predicate Device-K000070) | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Classification Name | Urological Catheter and Accessories | Same | Same | | Regulation Number | 876.5130 | 876.5130 | Same | | FDA Procode | GBM | GBM | KOD | | Class | II | II | Same | | Indication for Use | The Rusch Hydrophilic Intermittent | The Rusch Hydrophilic Intermittent catheters (Rusch | The FloCath catheter is a tubular device that is inserted through the urethra | | | | | | | | catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder. | FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder. | and is used to pass fluids to or from urinary tracts. | | Contraindications | - Insurmountable urethral obstructions- Urethral injuries- Urethral inflammation | None | None | | Single Use | Yes | Yes | Same | | Population | Adult and Pediatric, Male and Female | Adult and Pediatric, Male and Female | Same | | Size Range | 6-20 Fr. | 6-20 Fr. | 5-30 Fr. | | Overall Length | 40 cm | 40cm | Same | | Shaft | Tubular | Tubular | Same | | Shaft Material | PVC (Mucosal and skin, limited contact <24hr) | PVC (Mucosal and skin, limited contact <24hr) | Same | | Coating | Hydrophilic | Hydrophilic | Uncoated or Hydrogel/ Hydrophilic Coating | | Biocompatibility | Evaluation and testing within the risk management process ISO 10993-1: Cytotoxicity ISO 10993-5 Sensitization ISO 10993-10 Skin Irritation ISO 10993-10 | Evaluation and testing within the risk management process ISO 10993-1: Cytotoxicity ISO 10993-5 Sensitization ISO 10993-10 Skin Irritation ISO 10993-10 | Same | | Tip | Nelaton, Olive, or Tiemann tip | Split introducer, introducer tip, and cap | Nelaton, Olive, or Tiemann tip | | Eyelets | Yes | Yes | Yes | | | solution | solution | | | Primary Packaging | Paper and film peel back | Paper and film peel back | Same | | Sterile | Yes | Yes | Same | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | Shelf-life | 5 Years | 5 Years | Same | # Table 07.1 - Comparison of Predicate vs. Subject Devices {5}------------------------------------------------ Teleflex Medical, Inc. {6}------------------------------------------------ ### J. Comparison to the Predicate Table 7.1 illustrates the similarities and differences between the subject and predicate device (K000070). The basic technological and operating principles are the same for both devices. Both the predicate and subject devices have same intended use. Both the subject and predicate devices are intended for similar patient populations adult and pediatric, male and female. Both the subject and predicate devices are disposable, non-sterile, single patient use devices. As evidenced by comparison Table 7.1, above, the subject FloCath Quick Hydrophilic Intermittent Catheter is substantially equivalent to the predicate device. There are no significant differences that would affect safety and efficacy. #### K. Performance Data The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include: - Visual Inspection - Flow Rate - Friction Test - Coating Presence - Biocompatibility - a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process - b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity - c. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization The testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device. The subject devices were tested to the requirements of ASTM F623. {7}------------------------------------------------ Cytotoxicity, Sensitization, Irritation, were performed to demonstrate biocompatibility of the patient contacting materials. Overall, the results are comparable to the predicate and support a determination of substantial equivalence. ## L. Conclusion The Rusch Hydrophilic Intermittent Catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder. The Rusch Hydrophilic Intermittent Catheters have the same intended use and technological characteristics as the predicate. Test results demonstrate that the subject devices meet their intended use and performs as well as or better than the legally marketed predicate device. It is for these reasons that the subject devices can be found substantially equivalent.