SpeediCath Flex Coude Pro

K190620 · Coloplast · GBM · Jul 10, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K190620
• Device Name: SpeediCath Flex Coude Pro
• Applicant: Coloplast
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Jul 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SpeediCath Flex Coude Pro is indicated for use by patients with urine retention and patients with 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. Features bended flexible tip to facilitate urethral passage; protective sleeve shields catheter from user touch during insertion. Used by male patients with bladder control issues. Device supplied in 10Fr to 16Fr sizes with 33cm effective length. Hydrophilic coating (PVP-based) activated by wetting agent (PEG) for ready-to-use application. User inserts catheter into urethra to drain bladder. Benefits include ease of use for patients with limited dexterity via modified packaging pull-tab and reduced environmental impact through material changes in pouch and sleeve.

Clinical Evidence

Bench testing only. Testing included accelerated aging (ISO F1980-16), biocompatibility (ISO 10993-1), coefficient of friction (ASTM D1894:2014), transportation testing (ASTM D4169), catheter kink testing, tip integrity, packaging seal/peel force, flow rate (EN1616/EN1618, ASTM F623-99), tensile strength (EN1616/EN1618), and connector security (EN1616). All tests met pre-determined acceptance criteria.

Technological Characteristics

Polyurethane catheter with PVP-based hydrophilic coating and PEG wetting agent. Protective sleeve: polyethylene styrene isobutylene copolymer. Pouch: polyethylene and PETP. E-beam sterilization. Sizes: 10Fr-16Fr. Connectivity: None. Standards: ISO 10993-1, ASTM D1894, ASTM D4169, ASTM F623-99, EN1616/EN1618, ISO F1980-16.

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 Flex Coude' Pro (K180070)

Reference Devices

• SpeediCath Standard (K180258)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 10, 2019

Coloplast Corp Delaney McDougal Sr. Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411

Re: K190620

Trade/Device Name: SpeediCath Flex Coude Pro Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: GBM Dated: May 29, 2019 Received: May 30, 2019

# Dear Delaney McDougal:

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Glenn B. Bell. Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K190620

Device Name SpeediCath Flex Coudé Pro

#### Indications for Use (Describe)

SpeediCath Flex Coude Pro is indicated for use by patients with urine retention and patients with 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> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# TRADITIONAL 510(K) SUMMARY

| Submitted by: | Coloplast Corp<br>1601 West River Road North<br>Minneapolis, MN 55411 USA |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person : | Ms. Delaney McDougal<br>Coloplast Corp<br>Phone :[phone]<br>Email: [e-mail] |
| Date of Summary:<br>Trade or Proprietary Name: | July 10, 2019<br>SpeediCath Flex Coude' Pro |
| Common or Usual Name: | Catheter urethral |
| Regulation Name: | Urological catheter and accessories |
| Device Class: | Class II |
| Regulation Number:<br>Product Code: | 21CFR 876.5130<br>GBM |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | SpeediCath Flex Coude' Pro: K180070<br>Reference device: SpeediCath Standard: K180258 |
| Device Description: | The SpeediCath Flex Coude' Pro catheter is a sterile single use<br>hydrophilic coated polyurethane catheter for men. The catheter is to<br>be used for intermittent drainage of the bladder through the urethra by<br>males with missing or reduced bladder control. The catheter has a<br>bended flexible tip that facilitates passage through the urethra to the<br>bladder. The catheter is shielded by a sleeve, which serves as<br>protection form the user's touch during insertion. The SpeediCath<br>Flex Coude' Pro Catheters are offered with a 33cm effective length<br>and range in size from 10Fr to 16Fr. The hydrophilic coating makes<br>this single use catheter ready to use. |
| Indication for Use: | SpeediCath Flex Coude' Pro is indicated for use by patients with urine<br>retention and patients with post void residual volume (PVR) due to<br>neurogenic and non-neurogenic voiding dysfunction. The catheter is<br>inserted into the urethra to reach the bladder allowing urine to drain.<br>The product is for male patients only. |

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Technological The subject device has the same indications for use, design, catheter Characteristics: French sizes and lengths, and principles of operations as the predicate device. The device includes the same raw catheter coating and sleeve design. The differences between the subject device and predicate device is in the following: . Pouch material and dimensions Sleeve material and dimensions ● ● Wetting agent material and volume . Product variants - line extension

> Performance testing for SpeediCath Flex Coude' Pro was conducted according to applicable sections of voluntary standards in order to document the following properties of the SpeediCath Flex Coude' Pro catheter.

- Accelerated Aged (per ISO F1980-16) shelf life testing for ● coating and tip bend inspections
- . Biocompatibility according to ISO 10993-1 (2009) and FDA Guidance "Use of International Standards ISO 10993-1" (2016)
- . Coefficient of friction according to ASTM D1894: 2014
- Transportation testing per ASTM D4169 followed by assessments of coating performance and inspection of damage of packaging

The following tests were completed to determine the impact of the modifications based on assessment of the device risk documentation:

- Catheter kink testing
- Catheter tip integrity
- Coating inspection
- Proof of packing seal
- Peel force test of new material to test for ability to open ● packaging

The following performance specifications for SpeediCath Flex Coude' Pro were established based on performance testing of the predicate device according to applicable sections of voluntary standards.

- Flow rate according to EN1616/EN1618 and ASTM F623-● 99: 2013
- Tensile strength according to EN1616/EN1618
- Connector security according to EN1616 ●

All tests passed the pre-determined acceptance criteria. The proposed changes do not impact the performance specifications.

Summary of Non-Clinical Testing:

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# Substantial Equivalence Table:

| Item | Subject Device | Predicate Device |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | SpeediCath Flex Coude' Pro is<br>indicated for use by patients with<br>urine retention and patients with<br>post void residual volume (PVR)<br>due to neurogenic and<br>nonneurogenic voiding dysfunction.<br>The catheter is inserted into the<br>urethra to reach the bladder<br>allowing urine to drain. The product<br>is for male patients only. | SpeediCath Flex Coude' Pro is indicated<br>for use by patients with urine retention and<br>patients with post void residual volume<br>(PVR) due to neurogenic and non-<br>neurogenic voiding dysfunction. The<br>catheter is inserted into the urethra to<br>reach the bladder allowing urine to drain.<br>The product is for male patients only. |
| Sterility | E-beam | E-beam |
| Configuration | Tip: flexible bended tip | Tip: flexible bended tip |
| Materials | Catheter: Polyurethane<br>Hydrophilic coating: PVP based<br>Wetting agent: PEG<br>Protective sleeve: color pigment,<br>polyethylene styrene isobutylene<br>copolymer<br>Pouch: Polyethylene & PETP | Catheter: Polyurethane<br>Hydrophilic coating: PVP based<br>Wetting agent: PVP<br>Protective sleeve: color pigment and<br>polyethylene<br>Pouch: Polyethylene & PETP/aluminum |
| Pouch<br>Configurations | Single & double-loop (pocket-size)<br>Dimension:<br>Single: 249 mm L x 100mm W<br>Double: 186 mm L x 87 mm W | Single-loop<br>Dimension:<br>216 mm L<br>100 mm W |
| Biocompatibility | Per ISO 10993 | Per ISO 10993 |
| Friction | Per ASTM D 1894-14 | Per ASTM D 1894-14 |
| Flow rate | Per ASTM F 623-99 | Per ASTM F 623-99 |
| Tensile | Per EN 1616/1618 | Per EN 1616/1618 |
| Shelf life | 2 years | 2 years |
| Available sizes | Fr 10 - 16 single-<br>loop Fr 10 – 14<br>double-loop | Fr 10 – 16 single-loop |

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#### Substantial Equivalence Conclusion:

Based on the intended use, technological characteristics, safety and performance testing included in this submission, Coloplast considers the Product to be substantially equivalent to the currently marketed SpeediCath Flex Coude' Pro.

The SpeediCath Flex Coudé Pro differs from the predicate device in regards to the protective sleeve, primary packaging pouch, wetting agent, and product size variants. The protective sleeve has been updated to a larger overall width to accommodate additional wetting agent. The primary packaging pouch length was increased to allow for additional space inside the pouch for the product, the pull-tab from the predicate product has been removed and replaced with a circular hole in order to provide ease of opening for users with limited dexterity, and the aluminum layer within the pouch has been replaced with a PET layer in order to improve the environmental impact. The wetting agent used within the protective sleeve was updated from PVP water to PEG water which is currently used within the predicate device. The product line has been updated to make available a double-loop (pocket-size) variation which is currently available in the predicate device.