SpeediCath Soft
Device Facts
| Record ID | K200142 |
|---|---|
| Device Name | SpeediCath Soft |
| Applicant | Coloplast |
| Product Code | GBM · Gastroenterology, Urology |
| Decision Date | Jul 30, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
SpeediCath Soft 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 bladder allowing urine to drain. The product is for adult male patients only.
Device Story
SpeediCath Soft is a sterile, single-use, hydrophilic-coated polyurethane intermittent urinary catheter for adult males. It features a straight (Nelaton) tip and an integrated grip to protect the catheter from direct contact during insertion. The device is supplied in a foil pouch with a color-coded connector for size identification. The user inserts the catheter through the urethra into the bladder to facilitate urine drainage. The hydrophilic coating, activated by a saline/PEG wetting agent, reduces friction during insertion. The device is intended for use by patients with voiding dysfunction to manage urine retention. By providing a sterile, lubricated pathway for drainage, it helps prevent complications associated with chronic retention and improves patient quality of life. It is a manual device operated by the patient.
Clinical Evidence
Bench testing only. Performance was validated against recognized standards including ISO 10993-1 (biocompatibility), ASTM F1980-16 (aging), ASTM F623-99:2013/ISO 20696:2018 (flow rate, surface finish, dimensions, strength, kink stability), ASTM D1894:2014 (friction), and usability testing per EN 62366/ISO 62366-1. All tests met pre-determined acceptance criteria.
Technological Characteristics
Hydrophilic-coated polyurethane catheter; PVP-based coating; saline/PEG wetting agent. Straight (Nelaton) tip. Thermolast M TM7MED/LLDPE grip. Color-coded LLDPE connectors. Sterilized via e-beam (SAL 10^-6). Packaging: Polyamide/aluminum/PE foil pouch. Complies with ISO 10993, ISO 20696, ASTM F623, ASTM D1894.
Indications for Use
Indicated for adult male patients with urine retention and post void residual volume (PVR) due to neurogenic and 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 Coudé Pro (K190620)
Reference Devices
- SpeediCath Standard (K180258)
Submission Summary (Full Text)
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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.
July 30, 2020
Coloplast Ms. Delaney McDougal Sr. Regulatory Affairs Specialist 1601 West River Road North Minneapolis, Minnesota 55411
Re: K200142
Trade/Device Name: SpeediCath Soft Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: GBM Dated: July 17, 2020 Received: July 22, 2020
Dear Ms. 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 Actinclude 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
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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/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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Purva Pandya Acting 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) K200142
Device Name SpeediCath Soft
Indications for Use (Describe)
SpeediCath Soft 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 cather is inserted into the bladder allowing urine to drain.
The product is for adult male patients only.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SpeediCath Soft Traditional 510(k) Notification
Image /page/3/Picture/2 description: The image shows the Coloplast logo. The logo consists of a blue circular graphic on the left and the word "Coloplast" in blue font on the right. The circular graphic is made up of several horizontal lines that create a globe-like shape.
#### TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | Coloplast A/S<br>Holtedam1<br>3050 Humlebaek<br>Denmark |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Delaney McDougal<br>Senior Regulatory Affairs Specialist<br>Coloplast<br>1601 West River Road North<br>Minneapolis, MN 55411<br>612-380-8034<br>usdel@coloplast.com |
| Date of Summary: | January 21, 2020 |
| Trade or Proprietary<br>Name: | SpeediCath Soft<br>27010, 27012, 27014, 27016 |
| Common or Usual Name: | Catheter, Urethral |
| Classification Name: | Urological Catheter and Accessories |
| Classification: | Class II |
| Regulation Number: | 21 CFR 876.5130 |
| Product Code: | GBM |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | SpeediCath Flex Coudé Pro, K190620<br>Reference Device: SpeediCath Standard, K180258 |
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K200142, pg. 2 of 9 Coloplast SpeediCath Soft Traditional 510(k) Notification Device Description: The SpeediCath Soft is a sterile, single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by adult males with missing or reduced bladder control. The catheter has a grip which serves as protection from the user's touch and aids the user during insertion. Intended Use: Intermittent urinary drainage catheter SpeediCath Soft is indicated for use by patients with urine Indications for Use: 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 adult male patients only. Technological The subject device has the same intended use, indications for Characteristics: use, catheter sizes, technological characteristics, principles of operation, and performance specifications as the predicate The subject device includes the same catheter device. material, swelling medium (wetting agent), and hydrophilic coating as the predicate device. The differences between the subject device and predicate device are in the following: The subject device contains a grip, instead of a . protective sleeve as with the predicate device, which protects the catheter from direct contact with the user's touch and aids the user during insertion of the catheter. The material of the grip is the same material as the predicate device handle and connector (K190620). ● The subject device has a straight tip design instead of a pre-formed flexible curved tip (bended). The straight tip design was previously cleared under the reference device, K180258. The tip is composed of the same material as the catheter of the predicate device, (K190620). ● The subject device has a color-coded outer connector to aid in the identification of catheter sizes. The colorcoded outer connectors are identical to the connectors of the reference device (K180258).
- The primary packaging design of the subject device is a foil pouch consisting of a top foil (layers of
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SpeediCath Soft Traditional 510(k) Notification
Image /page/5/Picture/1 description: The image shows the text "K200192, pg. 3 of 9" at the top. Below the text is the Coloplast logo, which features a blue globe-like shape on the left and the word "Coloplast" in a bold, blue font on the right. The logo is likely a branding element for the company Coloplast.
polyamide/aluminum/polyamide) and a bottom foil polyamide/aluminum/low-density (layers of polyethylene) that are welded together which provides the sterile barrier of the device and contains a proof of seal for detection of the non-broken sterile barrier. The thickness of the aluminum layers in the top and bottom foils of the subject device packaging has been reduced in comparison to the reference device packaging (K180258) to improve the environmental footprint and cost-effectiveness of the packaging. The opening feature pull-ring was updated to an oval shape, versus a ring shape as with the reference device (K180258), for ease of opening. The primary packaging color, the print tape color and wall sticker dimensions and color were updated as part of a packaging alignment across the SpeediCath portfolio. The primary packaging configuration and dimensions are identical to those of the reference device packaging cleared under K180258.
- . The subject device has 10 mm distance between the drainage eyelets, whereas the reference device K180258, SpeediCath Standard, has 12 mm between eyelets. Additionally, the length from the edge of the first eyelet to the catheter tip (tip length) and the length from the bottom edge of the grip to the first eyelet (draining length) varies with the catheter size.
Comparison to the predicate device is provided in the Substantial Equivalence Table below.
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| Substantial Equivalence Table | | | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject device | Predicate device | Reference device |
| Product | SpeediCath Soft | SpeediCath Flex<br>Coudé Pro | SpeediCath Standard |
| 510(k) Number | Unassigned | K190620 | K180258 |
| Regulation<br>Name | Urological catheter and<br>accessories | Same | Same |
| Regulation<br>Number | 21 CFR 876.5130 | Same | Same |
| Product Code | GBM | Same | Same |
| Classification | II | Same | Same |
| Prescription<br>Device | Yes | Same | Same |
| Intended Use | Urinary catheter for<br>intermittent use | Same | Same |
| Indications for<br>Use | SpeediCath Soft is<br>indicated for use by<br>patients with urine<br>retention and patients<br>with post void residual<br>volume (PVR) due to<br>neurogenic and non-<br>neurogenic voiding<br>dysfunction. The<br>catheter is inserted into<br>the urethra to reach the<br>bladder allowing urine<br>to drain.<br>The product is for adult<br>male patients only. | SpeediCath Flex<br>Coudé Pro is<br>indicated for use by<br>patients with urine<br>retention and patients<br>with post void<br>residual volume<br>(PVR) due to<br>neurogenic and non-<br>neurogenic voiding<br>dysfunction. The<br>catheter is inserted<br>into the urethra to<br>reach the bladder<br>allowing urine to<br>drain.<br>The product is for<br>male patients only. | Urinary catheter for<br>intermittent use. The<br>catheter is intended for<br>use by patients with<br>chronic urine retention<br>and patients with a post<br>void residual volume<br>(PVR) due to<br>neurogenic and non-<br>neurogenic voiding<br>dysfunction. The<br>catheter is inserted into<br>the urethra to reach the<br>bladder allowing urine<br>to drain. |
| Condition of<br>Use | Intermittent use and<br>single use | Same | Same |
| Sterility | SAL 10-6 | Same | Same |
| | Subject device | Predicate device | Reference device |
| Product | SpeediCath Soft | SpeediCath Flex<br>Coudé Pro | SpeediCath Standard |
| Sterilization<br>Method | e-beam | Same | Same |
| Shelf Life | 2 years | Same | Same |
| Available Sizes | FR 10 / CH 10<br>FR 12 / CH 12<br>FR 14 / CH 14<br>FR 16 / CH 16 | Same | Male, FR 8 / CH 8<br>Male, FR 10 / CH 10<br>Male, FR 12 / CH 12<br>Male, FR 14 / CH 14<br>Male, FR 16 / CH 16<br>Male, FR 18 / CH 18<br>Tiemann, FR 10 / CH 10<br>Tiemann, FR 12 / CH 12<br>Tiemann, FR 14 / CH 14<br>Tiemann, FR 16 / CH 16<br>Female, FR 6 / CH 6<br>Female, FR 8 / CH 8<br>Female, FR 10 / CH 10<br>Female, FR 12 / CH 12<br>Female, FR 14 / CH 14<br>Female, FR 16 / CH 16<br>Boy, FR 6 / CH 6<br>Boy, FR 8 / CH 8<br>Boy, FR 10 / CH 10<br>Boy, FR 12 / CH 12<br>Pediatric, FR 6 / CH 6<br>Pediatric, FR 8 / CH 8<br>Pediatric, FR 10 / CH 10 |
| Catheter Outer<br>Diameter | FR 10 / CH 10: 3.3 mm<br>FR 12 / CH 12: 4.0 mm<br>FR 14 / CH 14: 4.7 mm<br>FR 16 / CH 16: 5.3 mm | Same | Same (male models) |
| Catheter<br>Materials | Polyurethane | Same | Similar |
| | Subject device | Predicate device | Reference device |
| Product | SpeediCath Soft | SpeediCath Flex<br>Coudé Pro | SpeediCath Standard |
| Catheter<br>Material<br>Flexural<br>Modulus | 4200 psi | Same | 10990 psi |
| Hydrophilic<br>Coating | Polyvinylpyrrolidone<br>(PVP) based | Same | Same |
| Wetting Agent | Saline solution with<br>PEG | Same | Same |
| Wetting Agent<br>Amount | 5.5±0.5 mL (all sizes) | 15±0.5 mL (all sizes) | Same |
| Tip<br>Configuration | Straight (Nelaton) tip | Flexible curved tip<br>(bended) | Straight (Nelaton) tip<br>and Tiemann tip |
| Straight Tip<br>Eyelets | 10 mm distance<br>between eyelets | NA | 12 mm distance between<br>evelets |
| Protective<br>Sleeve Material | N/A | Color pigment Master<br>Batch, polyethylene,<br>and styrene<br>isobutylene<br>copolymer (two<br>layers in middle) | N/A |
| Grip | Material: Thermolast<br>M TM7MED linear<br>low-density<br>polyethylene (LLDPE)<br>Master Batch 6%<br>turquoise 0A500342M | N/A | N/A |
| Connector | Color-coded,<br>FR / CH 10: Black<br>FR / CH 12: White<br>FR / CH 14: Green<br>FR / CH 16: Orange | Turquoise and White<br>(all sizes) | Same |
| Primary<br>Packaging | Foil pouch, thinner,<br>white | Single and double-<br>loop pouch packages,<br>gray | Similar, thicker, green |
| | Subject device | Predicate device | Reference device |
| Product | SpeediCath Soft | SpeediCath Flex<br>Coudé Pro | SpeediCath Standard |
| Packaging<br>Materials | Oriented polyamide,<br>aluminum, and low-<br>density PE, oval-<br>shaped opening feature | Inner layer: PE-peel<br>Outer layer: Printed<br>PETP/aluminum | Oriented polyamide,<br>aluminum, low-density<br>polyethylene, ring-<br>shaped opening feature |
| Packaging<br>Dimensions | 467 mm length<br>32 mm width | Large packaging<br>(single-loop):<br>249 mm length<br>100mm width<br>Small packaging<br>(double-loop):<br>186 mm length<br>87 mm width | Same |
| Effective<br>Catheter Length | Effective length<br>(according to ISO<br>20696:2018):<br>33cm (13 inches) | Same | Same |
| Biocompatibilit<br>y per<br>ISO 10993 | Complies | Same | Same |
| Low friction<br>(ASTM D1894-<br>14) | Complies | Same | Same |
| Flow rate<br>(ASTM F623-<br>99:2013) | Complies | Same | Same |
| Tensile<br>Strength<br>(DS/EN ISO<br>20696 Annex<br>H) | Complies | Same | Same |
# Substantial Equivalence Table
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SpeediCath Soft
Traditional 510(k) Notification
Image /page/7/Picture/3 description: The image contains the logo for Coloplast. The logo consists of a blue globe-like icon on the left and the word "Coloplast" in a bold, blue font on the right. The globe icon has horizontal lines across the top half and a solid blue color on the bottom half.
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SpeediCath Soft
# Traditional 510(k) Notification
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K200142, pg. 7 of 9
SpeediCath Soft
Image /page/9/Picture/2 description: The image shows the logo for Coloplast. The logo consists of a blue circular graphic on the left and the word "Coloplast" in blue text on the right. The circular graphic is made up of several horizontal lines that create a wave-like pattern.
### Traditional 510(k) Notification
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K200142, pg. 8 of 9
SpeediCath Soft
Traditional 510(k) Notification
Image /page/10/Picture/3 description: The image contains the logo for Coloplast. The logo consists of a blue circular graphic on the left and the word "Coloplast" in blue, sans-serif font on the right. The circular graphic is made up of several horizontal lines that curve to form a sphere-like shape.
Summary of Non-Clinical Testing / Performance Data: Performance testing for SpeediCath Soft was conducted according to applicable sections of non-recognized and recognized voluntary consensus standards in order to document the following properties of the SpeediCath Soft catheter. The following tests were completed to determine the impact of the proposed features based on assessment of the device risk documentation. The proposed features do not impact the performance specifications:
- Real Time and Accelerated Aging shelf life testing according to ASTM F1980-16
- . Biocompatibility according to ISO 10993-1 (2018) and FDA Guidance "Use of International Standards ISO 10993-1" (2016)
- Proof of packing seal strength and integrity ●
- . Peel force test of packaging material
- Transportation testing per ASTM D4169 followed by ● assessments of coating performance and inspection of damage of packaging
- Detach and re-attach force of the grip ●
- Flow rate according to ASTM F623-99:2013 and ISO ● 20696:2018
- Coefficient of friction according to ASTM D1894:2014
- Catheter coating friction ●
- pH
- Osmolality
- Surface Finish according to ISO 20696:2018
- Outer Diameter according to ISO 20696:2018 ●
- . Effective Shaft Length according to ISO 20696:2018
- Catheter Strength according to ISO 20696:2018
- Connector Security according to ISO 20696:2018
- Kink Stability according to ISO 20696:2018 ●
- Catheter Stiffness according to ISO 20696:2018
- . Peak Tensile Force according to ISO 20696:2018
- Usability per EN 62366:2008. ISO 62366-1:2015. . AAMI HE 75:2009 and FDA Guidance "Applying Human Factors and Usability Engineering to Optimize Medical Device Design, February 3, 2016"
All tests met the pre-determined acceptance criteria.
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K200142, pg. 9 of 9
Coloplast
SpeediCath Soft
Traditional 510(k) Notification
## Substantial Equivalence Conclusion:
Based on the intended use, technological characteristics, safety and performance testing included in this submission, Coloplast considers the SpeediCath Soft to be substantially equivalent to the currently marketed predicate device, SpeediCath Flex Coudé Pro.
SpeediCath Soft differs from the predicate device in regard to the grip to aid insertion, the color-coded outer connector, primary packaging materials, and catheter tip. The grip protects the catheter from direct contact with the user's touch and aids the user during insertion of the catheter. The colorcoded outer connector aids the user in the identification of catheter sizes. The primary packaging provides the sterile barrier of the device and contains a proof of seal for detection of the non-broken sterile barrier. The subject device has a straight tip whereas the predicate device has a pre-formed flexible curved tip (bended). The straight tip design was previously cleared under the reference device K180258. The described features do not raise any new questions of safety or effectiveness.
