Rusch Intermittent Urethral Catheters
Device Facts
| Record ID | K173596 |
|---|---|
| Device Name | Rusch Intermittent Urethral Catheters |
| Applicant | Teleflex Medical |
| Product Code | EZC · Gastroenterology, Urology |
| Decision Date | Jan 29, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
Indications for Use
The Intermittent Urethral Catheters are indicated for routine drainage of fluids from the bladder. These catheters are not intended or designed for indwelling use.
Device Story
Rusch® Intermittent Urethral Catheters are single-use, sterile, uncoated PVC devices for routine bladder drainage. Available in Tiemann and Nelaton-Robinson tip configurations (sizes 10 Ch. to 24 Ch.). Operated by clinicians or patients; inserted through urethra to drain bladder; withdrawn and disposed after use. Device consists of tubular shaft, funnel, and drainage holes. Benefits include safe, temporary fluid removal. No indwelling use.
Clinical Evidence
Bench testing only. Testing included flow rate, catheter tensile properties, and break strength. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, skin irritation). Results confirm the device is as safe and effective as the predicate.
Technological Characteristics
Materials: PVC shaft and funnel with specific plasticizers. Dimensions: 10 Ch. to 24 Ch. (3.3 mm to 7.9 mm OD), 40 cm length. Configurations: Tiemann and Nelaton-Robinson tips with two drainage holes. Sterilization: Ethylene Oxide. Shelf-life: 5 years. Biocompatibility: ISO 10993-1, 10993-5, 10993-10.
Indications for Use
Indicated for routine bladder fluid drainage in patients requiring intermittent catheterization. Contraindicated in patients with insuperable urethral obstruction. Suitability must be assessed by a physician or qualified personnel.
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® Intermittent Urethral Catheters (K033023)
Submission Summary (Full Text)
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January 29, 2018
Teleflex Medical, Inc. Amanda Webb Manager, Regulatory Affairs 3015 Carrington Mill Blvd. Morrisville, NC 27560
Re: K173596
> Trade/Device Name: Rusch® Intermittent Urethral Catheters Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZC, EZD Dated: November 28, 2017 Received: November 29, 2017
Dear Amanda Webb:
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.
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.
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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,
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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#### Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-491-8960 Fax: 919-443-4996
# Contact Person
Amanda Webb Manager, Regulatory Affairs
# Date Prepared
1/23/2018
# Device Name
| Trade Name: | Rusch® Intermittent Urethral Catheter |
|--------------------|---------------------------------------------------|
| Common/Usual Name: | Urological Catheter |
| Regulation Number: | 21 CFR 876.5130 |
| Regulation Name: | Urological catheter and accessories |
| Regulation Class: | II |
| Product Code: | EZC - catheter, coude<br>EZD - catheter, straight |
| Panel: | Gastroenterology/Urology |
# Predicate Device Rusch® Intermittent Urethral Catheters -K033023
#### Device Description
The Rusch® Intermittent Urethral Catheters are single use, uncoated, disposable and sterile. The catheter is comprised of a tip, shaft, and funnel. The catheter tube is made of polovviny chiloride (PVC), the tip of a PVC/liquid colored PVC which is cured to the tube and a catheter funnel also made of PVC. The dimensions range from Charrièr (Ch.) Ch. 10 to Ch. 24 which is a range of 3.3 mm to 7.9 mm in Outer Diameter with a length 40 cm. The catheters are produced with two different tips - Tiemann and Nelaton-Robinson. Each catheter size has a color-coded tip.
The Nelaton-Robinson catheters have a size range from 10 Ch. to 24 Ch. and have two drainage holes. The Tiemann catheters have a size range from 12 Ch. and also have two drainage holes. Additionally the Tiemann and Nelaton-Robinson catheters also contain funnel adhesive solution to which the funnel is adhered to the shaft and hot embossing film or tint for printing text on the catheter.
#### Indications for Use
The Intermittent Urethral Catheters are indicated for routine drainage of fluids from the bladder. These catheters are not intended or designed for indwelling use.
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#### Contraindications
Insuperable obstruction of the urethra. However, the suitability of each patient must be individually assessed by a physician or other suitably qualified personnel.
# Substantial Equivalence
The subject device is substantially equivalent to the predicate device:
| Features | Teleflex Medical<br>Rusch<br>Intermittent<br>Urethral<br>Catheters (Subject<br>Device) | Rusch Urethral<br>Intermittent<br>Catheters<br>(Predicate Device-<br>K033023) | Comparison | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Similarities | Differences |
| Classification<br>Name | Catheter,<br>Urological | Catheter,<br>Urological | Devices are the<br>same | None |
| Regulation<br>Number | 876.5130 | 876.5130 | Devices are the<br>same | None |
| Class | II | II | Devices are the<br>same | None |
| Device<br>Description | The Intermittent<br>Urethral Catheters<br>consists of a<br>tubular shaft with<br>attached funnel<br>as connecting<br>device. PVC<br>material used in<br>the catheter.<br>The product sizes<br>range from 10<br>Ch. to 24 Ch.<br>The device shaft is<br>uncoated. | The Intermittent<br>Urethral Catheters<br>consists of a<br>tubular shaft with<br>attached funnel<br>as connecting<br>device. The PVC<br>material used in<br>the catheter.<br>The product sizes<br>range from 6 Ch.<br>to 24 Ch.<br>The device shaft<br>may be uncoated<br>or hydrophilic<br>coated. | Both devices are<br>intended for<br>intermittent<br>catheterization. | The<br>predicate,<br>Intermittent<br>Urethral<br>Catheters,<br>are offered<br>with or<br>without<br>hydrophilic<br>coating and<br>have a wide<br>range of<br>sizes.<br>The subject<br>device shaft<br>does not<br>have a<br>hydrophilic<br>coating, it is<br>uncoated. |
| Indication for Use | The Intermittent<br>Urethral<br>Catheters are<br>indicated for<br>routine drainage<br>of fluids from the<br>bladder. These<br>catheters are not<br>intended or<br>designed for<br>indwelling use. | The Intermittent<br>Urethral Catheters<br>are sterile, single-<br>use, flexible tubular<br>devices that are<br>inserted through the<br>urethra and used to<br>pass fluids to or<br>from urinary tracts. | Both the<br>predicates and<br>subject catheters<br>are sterile, single-<br>use devices that<br>pass fluids from<br>the<br>bladder/urinary<br>tract. | The predicate<br>devices<br>intended use<br>includes<br>passage of<br>fluids to or<br>from the<br>urinary tract.<br>The subject<br>Intermittent<br>Urethral<br>Catheters do<br>not include<br>the intended<br>use of<br>administration<br>of fluids to the<br>urinary tract. |
| Contraindications | Insuperable<br>obstruction of the<br>urethra. However,<br>the suitability of<br>each patient must<br>be individually<br>assessed by a<br>physician or other<br>suitably qualified<br>personnel. | None known | There are no<br>known<br>contraindications<br>for the predicate<br>devices. | The subject<br>Intermittent<br>Urethral<br>Catheters has<br>a<br>contraindicatio<br>n. |
| Single Use | Yes | Yes | Devices are the<br>same | None |
| Size Range | 10 Ch. - 24 Ch. | 6 Ch. - 24 Ch. | The subject<br>Intermittent<br>Urethral catheters<br>sizes are included<br>within the range<br>of the predicate<br>devices. | The predicate<br>devices have a<br>larger size<br>range. |
| Overall Length | Nominal 40 cm | Nominal 40 cm | Devices are the<br>same | None |
| Shaft | Tubular | Tubular | Devices are the<br>same | None |
| Shaft Material | | | Both devices are | The subject |
| | PVC | PVC | made with PVC | device is made with different plasticizer |
| Funnel Material | PVC | PVC | Both devices are made with PVC | The subject device is made with different plasticizer |
| Coating | Uncoated | Uncoated or Hydrophilic Coated | Both the predicate and subject Intermittent Urethral Catheters have uncoated catheters. | The predicate, Intermittent Urethral Catheters, also has coated catheters. |
| Biocompatibility | Evaluation and testing within the risk management process ISO 10993-1 | Evaluation and testing within the risk management process ISO 10993-1 | Biocompatibility studies of the devices conclude that the materials are safe for the intended use | None |
| Principal of Operation - Short Description of Use | Peel package open Insert catheter Empty bladder Withdraw catheter Dispose device | Peel package open Insert catheter Empty bladder Withdraw catheter Dispose device | Devices are the same | None |
| Catheter Tip Configurations | Tiemann and Nelaton- Robinson | Tiemann, Nelaton-Robinson, and Olive | The Tiemann and Nelaton-Robison configurations are offered for the predicate and subject devices. | The Olive tip configuration is offered for the predicate device. |
| Eyelets | Yes | Yes | Devices are the same | None |
| Primary Packaging | Paper and film peel back | Paper and film peel back | Devices are the same | None |
| Secondary Packaging | Corrugated box, quantity 50 | Corrugated box, quantity 100 | | The unit quantities in the secondary |
| | | | Secondary<br>packaging<br>material is the<br>same | packaging are<br>different for<br>the predicate<br>than for the<br>subject device. |
| Shipper Case | Corrugated board | Corrugated board | Devices are the<br>same | None |
| Sterile | Yes | Yes | Devices are the<br>same | None |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Devices are the<br>same | None |
| Shelf-life | 5 Years | 3 Years | Both devices<br>have a shelf-life<br>of at least 3 years | The subject<br>device,<br>Intermittent<br>Urethral<br>Catheters,<br>have a shelf-<br>life of 5 years. |
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# Non-clinical Performance testing
The bench testing performed verifies that the performance of the subject Intermittent Urethral Catheters are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- Flow Rate
- Catheter Tensile properties
- . Break Strength
- Cytotoxicity ISO 10993-5 ●
- Sensitization ISO 10993-10
- Skin Irritation ISO 10993-10
#### Conclusion
The Intermittent Urethral Catheters have demonstrated through comparison of design features and performance testing that the proposed device and the predicate device are substantially equivalent. Performance test results demonstrate that the subject device meets its intended use and is as safe, as effective, and performs as well as or better than the legally marketed predicate device. It is for these reasons that the subject device can be found substantially equivalent.
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