SpeediCath Flex Coude

K161672 · Coloplast Corp. · GBM · Sep 29, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K161672
• Device Name: SpeediCath Flex Coude
• Applicant: Coloplast Corp.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Sep 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The catheter is indicated for use by patients with urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is for male patients only.

Device Story

Sterile, single-use, hydrophilic-coated polyurethane catheter for intermittent bladder drainage. Designed for male patients with voiding dysfunction. Features a flexible, bendable tip that adapts to urethral curvature—remaining straight in straight passages and bending to a coudé-like profile in curved anatomies—to facilitate navigation through difficult urethral passages (e.g., enlarged prostate, strictures). Includes a protective sleeve to minimize touch during insertion. Operated by the patient for self-catheterization. Output is the drainage of urine from the bladder. Benefits include improved ease of use, hygienic insertion, and enhanced navigation through complex male urethral anatomies.

Clinical Evidence

No clinical trials in living patients. Evidence includes bench testing (flow rate, friction, tensile strength, connector security) and biocompatibility per ISO 10993-1. Pre-clinical study performed using male cadavers with difficult urethral anatomies (enlarged prostate, strictures) demonstrated performance comparable to standard coudé catheters for insertion and navigation.

Technological Characteristics

Hydrophilic-coated polyurethane catheter. Flexible tip design. Protective insertion sleeve. Pre-lubricated with saline. Bench testing standards: EN1616/EN1618, ASTM F623-99:2013 (flow rate), ASTM D1894:2014 (friction). Biocompatibility per ISO 10993-1 and FDA G95-1.

Indications for Use

Indicated for male patients with urine retention or post void residual volume (PVR) due to neurogenic or non-neurogenic voiding dysfunction.

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

• SpeediCath Standard (K023254)

Reference Devices

• VaPro Intermittent (K090960)
• VaPro Pocket (K143594)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 29, 2016

Coloplast Corp. Rebecca S. Roberts Regulatory Affairs Manager 1601 West River Road North Minneapolis, MN 55411

Re: K161672

> Trade/Device Name: SpeediCath Flex Coudé Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: August 30, 2016 Received: September 1, 2016

Dear Rebecca S. Roberts:

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 (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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Benjamin R. Fisher -S

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) K161672

Device Name SpeediCath Flex Coude'

Indications for Use (Describe)

The catheter is indicated for use by patients with urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The product is for male patients only.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## SpeediCath Flex Coudé 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

| Sponsor | Coloplast Corp<br>1601 West River Road North<br>Minneapolis, MN 55411<br>USA |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Rebecca S Roberts<br>Coloplast Corp<br>Phone [phone]<br>Fax [phone]<br>Email [e-mail] |
| Date of submission | 14 June 2016 |
| Proprietary trade name | SpeediCath Flex Coudé |
| Classification name | Urological catheter and accessories |
| Classification | Class II |
| Product code | GBM |
| Legally Marketed predicate(s) | Predicate device<br>K023254, SpeediCath Standard |
| | Manufacturer<br>Coloplast A/S |
| | Reference device(s)<br>K090960, VaPro Intermittent<br>K143594, VaPro Pocket |
| | Hollister Inc.<br>Hollister Inc. |
| Product description | The SpeediCath Flex Coudé catheter is a sterile single use<br>hydrophilic coated polyurethane catheter for men. The<br>catheter is to be used for intermittent drainage of the<br>bladder through the urethra by males with missing or<br>reduced bladder control. The catheter has a flexible<br>bendable tip that facilitates passage through the urethra to<br>the bladder. The catheter is shielded by a sleeve, which<br>serves as protection from the user's touch during insertion. |
| Indication for use | SpeediCath Flex Coudé is indicated for use by patients with<br>urine retention and patients with post void residual volume<br>(PVR) due to neurogenic and non-neurogenic voiding<br>dysfunction. The catheter is inserted into the urethra to<br>reach the bladder allowing urine to drain.<br>The product is for male patients only |
| Summary of technological<br>characteristics | The subject device has similar indications for use, design,<br>sizes materials and principles of operations as the predicate<br>device SpeediCath Standard (K023254). The subject device<br>includes the same coating and saline solution (pre-<br>lubrication) as the predicate device. The differences<br>between the subject device and predicate device are the<br>protective sleeve, the packaging configuration and the<br>flexible tip. The sleeve is for ease of use and hygienic<br>insertion and is similar to the protective sleeve of the<br>reference device VaPro Intermittent catheter (K090960).<br>The packaging modifications are made for discretion<br>improvements and are similar to the packaging<br>configuration of reference device VaPro Pocket (K143594).<br>The SpeediCath Flex Coudé catheter tip flexibility allows the<br>tip of the catheter to achieve different degrees of curvature,<br>rather than a fixed one as in the predicate and reference<br>devices. Under straight urethral passages, the flexible tip<br>will remain straight acting as a nelaton tip, whereas when<br>passing through curvatures the tip will bend progressively<br>and adopt the curved profile of a coudé tip. This enables<br>and facilitates passage through difficult, curved anatomies,<br>similar to the coudé tip (Tiemann variant) of the predicate<br>device. |
| Performance data - bench | Performance testing was conducted according to applicable<br>sections of voluntary standards in order to document the<br>following properties of the SpeediCath Flex Coudé catheter:<br>Flow rate according to EN1616/EN1618 & ASTM F623-99:2013 Coefficient of friction according to ASTM D1894:2014 Tensile strength according to EN1616/EN1618. Connector security according to EN1616. Biocompatibility according to ISO 10993-1 and applicable<br>parts of FDA Blue Book Memorandum #G95-1. All tests passed. |
| Performance data - clinical | Based on the clinical evaluation of available published data<br>it is evaluated that the SpeediCath Flex Coude' has a<br>safety and efficacy profile equivalent to the predicate<br>and reference devices. Furthermore, a pre-clinical study<br>was performed using male cadavers with difficult<br>urethral anatomies, resulting from enlarged prostate and<br>strictures. SpeediCath Flex Coude' was comparable to a<br>standard coude' catheter in terms of insertion and<br>navigation through difficult male anatomies. |
| Conclusion | Based on the test results and additional supporting<br>documentation provided in this premarket notification, the<br>proposed device demonstrates substantial equivalence to<br>the previously cleared predicate devices. |

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