Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (catheter with urine bag) and its intended use for bladder drainage. There is no mention of AI, ML, image processing, or any software-based analytical capabilities that would suggest the use of AI/ML. The performance studies focus on bench and usability testing of the physical device.

Therapeutic

Yes
The device is a catheter set intended for bladder drainage in patients unable to promote natural urine flow or with significant residual urine, which is a therapeutic intervention.

Diagnostic

No.
The device description and intended use clearly state that it is a catheter for bladder drainage, which is a therapeutic intervention, not a diagnostic one. It helps with urine flow rather than identifying a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "sterile, single-use hydrophilic coated intermittent catheter with integrated urine bag," which are physical hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for bladder drainage in patients who cannot naturally void or have significant residual urine. This is a therapeutic/management function, not a diagnostic one.
Device Description: The device is a catheter with an integrated urine bag. It is used to physically drain urine from the bladder.
Lack of Diagnostic Function: There is no mention of the device being used to analyze urine or provide any diagnostic information about the patient's condition. IVDs are typically used to examine specimens (like urine, blood, tissue) to diagnose diseases or conditions.

Therefore, the SureCath Set is a medical device used for patient management (bladder drainage), not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

Product codes

EZD

Device Description

SureCath Set is a sterile, single-use hydrophilic coated intermittent catheter with integrated urine bag. An ampoule of saline solution is provided inside the urine bag. This saline solution from the ampoule is poured over the catheter to activate the coating before use.

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

male, female, and pediatric patients

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

Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions.

Biocompatibility testing against ISO 10993 standards (ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, ISO 10993-23) was performed to address cytotoxicity, irritation or intracutaneous reactivity, sensitization, material mediated pyrogenicity, acute systemic toxicity, and subacute toxicity.

Catheter performance testing was conducted according to ISO 20696: 2018, ASTM F623-19, and Coloplast Test Methods for aspects such as strength of connection between catheter and urine bag, aseptic insertion, coating activation by water, friction of coated catheter, tearing and emptying of urine bag, urine bag volume, and urine bag strength. Usability engineering was applied per EN/IEC 62366-1:2015/A1:2020.

Packaging integrity testing was conducted per ISO 11607-1:2020, DS EN ISO 20696: 2018, and ASTM D4169-22 to verify sterile barrier maintenance through shelf life and ensure no impact on device safety or efficacy due to transportation.

Accelerated aging studies for stability were conducted per ASTM F1980-21. The stability study investigated whether there were unexpected (significant) changes in product properties over the shelf-life of the device. The properties meet the acceptance criteria after the aging cycle, the device is therefore deemed to be stable for the defined shelf life.

Key results: The performance testing demonstrates the subject device is as safe and effective as the predicate device.

Key Metrics

Not Found

Predicate Device(s)

K973090

Reference Device(s)

K221401

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

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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 and Human Services logo. To the right of that 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.

November 26, 2024

Coloplast Corp Vallabha Tantry Senior Regulatory Specialist 1601 West River Road North Minneapolis, Minnesota 55441

Re: K242049

Trade/Device Name: SureCath Set Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 12, 2024 Received: October 30, 2024

Dear Vallabha Tantry:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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

2

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,

Jessica K. Nguyen -S

Jessica K. Nguyen, 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

Submission Number (if known)

K242049

Device Name

SureCath Set

Indications for Use (Describe)

The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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TRADITIONAL 510(K) SUMMARY

| Submitted by: | Coloplast A/S
Holtedam1
3050 Humlebaek
Denmark |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vallabha Tantry Sr. Regulatory Affairs Specialist
Coloplast
1601 West River Road North
Minneapolis MN 55411
Phone: +1 (612)-806-1798
Email: usvtan@coloplast.com |
| Date of Summary: | July 12, 2024 |
| Subject Device: | |
| Trade or Proprietary
Name: | SureCath Set |
| Item/Model Numbers: | 28012, 28013, 28001, 28002, 28003, 28004, 28014, 28005 /
28005S, 28006 / 28006S, 28007 / 28007S, 28008 / 28008S,
28009 / 28009S, 28010, 28017, 28018, 28019, 28026 /
28026S, 28027 / 28027S, 28028 / 28028S, 28029 / 28029S |
| Common Name: | Urological catheter and accessories |
| Regulation/Classification
Name: | Gastroenterology and Urology |
| Regulation Number: | 21 CFR 876.5130 |
| Product Code: | EZD |

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Review Panel:	Gastroenterology/Urology
Predicate Device:	K973090, Conveen EasiCath Set.
The predicate device has not been subject of a design-related
recall.
Reference Device:	K221401, Self-Cath and Self-Cath Plus
The reference devices have not been subject to a design-related
recall.
Device Description:	SureCath Set is a sterile, single-use hydrophilic coated
intermittent catheter with integrated urine bag. An ampoule of
saline solution is provided inside the urine bag. This saline
solution from the ampoule is poured over the catheter to
activate the coating before use.
Indications for Use:	The product is intended for use in male, female, and pediatric
patients requiring bladder drainage as determined by their
physician.
This device is indicated for those individuals unable to promote
a natural urine flow or for those individuals who have a
significant volume of residual urine following a natural
bladder-voiding episode.

Technological Characteristics Comparison

The table below summarizes the technological characteristics of SureCath Set as compared to the predicate device.

Parameter	Subject device	Predicate device	Reference Device
	SureCath Set	Conveen EasiCath Set	Self-Cath and Self-Cath
Plus
510(k) Number	Unassigned	K973070	K221401
Regulation Name	Gastroenterology and Urology	Gastroenterology and Urology	Gastroenterology and Urology
Regulation Number	21 CFR 876.5130	21 CFR 876.5130	21 CFR 876.5130
Product Code	EZD	EZD
KNX	EZD (Self-Cath)
EZL (Self-Cath Plus)
Classification	II	II	II
Parameter	Subject device	Predicate device	Reference Device
	SureCath Set	Conveen EasiCath Set	Self-Cath and Self-Cath
Plus
Prescription
Device	Yes	Yes	Yes
Intended Use	Intermittent
catheterization through
the urethra.	Intermittent
catheterization
through the urethra.	The product is intended
for intermittent
catheterization through
the urethra
Indications for
Use	The product is intended
for use in male, female,
and pediatric patients
requiring bladder
drainage as determined
by their physician.
This device is indicated
for those individuals
unable to promote a
natural urine flow or for
those individuals who
have a significant
volume of residual urine
following a natural
bladder-voiding
episode.	The Conveen
EasiCath Set is
indicated for use by
patients for
intermittent
Catherization for the
purpose of bladder
drainage.	Self-Cath and
Self-
Cath Plus are intended
for use in male, female,
and pediatric patients
(neonates, infants,
children,
adolescents,
and
transitional
adolescents) requiring
bladder drainage as
determined by their
physician. The devices
are indicated for those
individuals unable to
promote a natural urine
flow or for those
individuals who have a
significant volume of
residual urine following
a natural
bladder-
voiding episode.
Condition of
Use	Intermittent use and
single use	Same	Same
Device
Categorization
per
ISO 10993	Surface contacting
device in contact with
mucosal membrane for
a prolonged duration of
time (24 h