Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and usability of a catheter, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is used to drain urine for patients with urine retention and voiding dysfunction, which directly addresses a health condition.

Diagnostic

No

Explanation: The device is a catheter used for draining urine, not for diagnosing medical conditions. Its function is PVR (post void residual volume) management, not diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "sterile, single use hydrophilic coated polyurethane catheter," which is a physical hardware device. The performance studies also focus on physical properties and testing of the catheter itself.

IVD (In Vitro Diagnostic)

Based on the provided information, the SpeediCath Soft is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for the drainage of urine from the bladder through the urethra. This is a direct interaction with the body for a therapeutic purpose (relieving urine retention), not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
Device Description: The device is a catheter, which is a physical tool inserted into the body. IVD devices typically involve reagents, instruments, or systems used to test samples like blood, urine, or tissue.
Performance Studies: The performance studies listed focus on the physical properties, biocompatibility, and usability of the catheter, which are relevant to a medical device used within the body, not an IVD device.

Therefore, the SpeediCath Soft is a medical device, specifically a catheter, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

GBM

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bladder, urethra

Indicated Patient Age Range

adult male patients only.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

SpeediCath Flex Coudé Pro, K190620

Reference Device(s)

SpeediCath Standard, K180258

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
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).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Summary

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.

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

1

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

2

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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3

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
Holtedam1
3050 Humlebaek
Denmark |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Delaney McDougal
Senior Regulatory Affairs Specialist
Coloplast
1601 West River Road North
Minneapolis, MN 55411
612-380-8034
usdel@coloplast.com |
| Date of Summary: | January 21, 2020 |
| Trade or Proprietary
Name: | SpeediCath Soft
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
Reference Device: SpeediCath Standard, K180258 |

4

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

5

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.

6

Substantial Equivalence Table
	Subject device	Predicate device	Reference device
Product	SpeediCath Soft	SpeediCath Flex
Coudé Pro	SpeediCath Standard
510(k) Number	Unassigned	K190620	K180258
Regulation
Name	Urological catheter and
accessories	Same	Same
Regulation
Number	21 CFR 876.5130	Same	Same
Product Code	GBM	Same	Same
Classification	II	Same	Same
Prescription
Device	Yes	Same	Same
Intended Use	Urinary catheter for
intermittent use	Same	Same
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 urethra to reach the
bladder allowing urine
to drain.
The product is for adult
male patients only.	SpeediCath Flex
Coudé 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.	Urinary catheter for
intermittent use. The
catheter is intended for
use by patients with
chronic 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.
Condition of
Use	Intermittent use and
single use	Same	Same
Sterility	SAL 10-6	Same	Same
	Subject device	Predicate device	Reference device
Product	SpeediCath Soft	SpeediCath Flex
Coudé Pro	SpeediCath Standard
Sterilization
Method	e-beam	Same	Same
Shelf Life	2 years	Same	Same
Available Sizes	FR 10 / CH 10
FR 12 / CH 12
FR 14 / CH 14
FR 16 / CH 16	Same	Male, FR 8 / CH 8
Male, FR 10 / CH 10
Male, FR 12 / CH 12
Male, FR 14 / CH 14
Male, FR 16 / CH 16
Male, FR 18 / CH 18
Tiemann, FR 10 / CH 10
Tiemann, FR 12 / CH 12
Tiemann, FR 14 / CH 14
Tiemann, FR 16 / CH 16
Female, FR 6 / CH 6
Female, FR 8 / CH 8
Female, FR 10 / CH 10
Female, FR 12 / CH 12
Female, FR 14 / CH 14
Female, FR 16 / CH 16
Boy, FR 6 / CH 6
Boy, FR 8 / CH 8
Boy, FR 10 / CH 10
Boy, FR 12 / CH 12
Pediatric, FR 6 / CH 6
Pediatric, FR 8 / CH 8
Pediatric, FR 10 / CH 10
Catheter Outer
Diameter	FR 10 / CH 10: 3.3 mm
FR 12 / CH 12: 4.0 mm
FR 14 / CH 14: 4.7 mm
FR 16 / CH 16: 5.3 mm	Same	Same (male models)
Catheter
Materials	Polyurethane	Same	Similar
	Subject device	Predicate device	Reference device
Product	SpeediCath Soft	SpeediCath Flex
Coudé Pro	SpeediCath Standard
Catheter
Material
Flexural
Modulus	4200 psi	Same	10990 psi
Hydrophilic
Coating	Polyvinylpyrrolidone
(PVP) based	Same	Same
Wetting Agent	Saline solution with
PEG	Same	Same
Wetting Agent
Amount	5.5±0.5 mL (all sizes)	15±0.5 mL (all sizes)	Same
Tip
Configuration	Straight (Nelaton) tip	Flexible curved tip
(bended)	Straight (Nelaton) tip
and Tiemann tip
Straight Tip
Eyelets	10 mm distance
between eyelets	NA	12 mm distance between
evelets
Protective
Sleeve Material	N/A	Color pigment Master
Batch, polyethylene,
and styrene
isobutylene
copolymer (two
layers in middle)	N/A
Grip	Material: Thermolast
M TM7MED linear
low-density
polyethylene (LLDPE)
Master Batch 6%
turquoise 0A500342M	N/A	N/A
Connector	Color-coded,
FR / CH 10: Black
FR / CH 12: White
FR / CH 14: Green
FR / CH 16: Orange	Turquoise and White
(all sizes)	Same
Primary
Packaging	Foil pouch, thinner,
white	Single and double-
loop pouch packages,
gray	Similar, thicker, green
	Subject device	Predicate device	Reference device
Product	SpeediCath Soft	SpeediCath Flex
Coudé Pro	SpeediCath Standard
Packaging
Materials	Oriented polyamide,
aluminum, and low-
density PE, oval-
shaped opening feature	Inner layer: PE-peel
Outer layer: Printed
PETP/aluminum	Oriented polyamide,
aluminum, low-density
polyethylene, ring-
shaped opening feature
Packaging
Dimensions	467 mm length
32 mm width	Large packaging
(single-loop):
249 mm length
100mm width
Small packaging
(double-loop):
186 mm length
87 mm width	Same
Effective
Catheter Length	Effective length
(according to ISO
20696:2018):
33cm (13 inches)	Same	Same
Biocompatibilit
y per
ISO 10993	Complies	Same	Same
Low friction
(ASTM D1894-

               | Complies                                                                                                                                                                                                                                                                                                                                                          | Same                                                                                                                                                                                                                                                                                                                                                                           | Same                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |

Substantial Equivalence Table

7

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.

8

SpeediCath Soft

Traditional 510(k) Notification

9

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

10

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.

11

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.