Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components, materials, and standard performance metrics of a catheter system, with no mention of AI or ML capabilities.

Therapeutic

Yes.
The device facilitates bladder drainage for individuals unable to promote natural urine flow or those with significant residual urine, which is a therapeutic intervention.

Diagnostic

No

This device is a catheter system for bladder drainage and urine collection, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a catheter, urine collection bag, lubricant, gloves, swab sticks, a wipe, and a drape. This indicates it is a hardware-based medical device, not software-only.

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 male adult patients who are unable to urinate naturally or have significant residual urine. This is a therapeutic and management function, not a diagnostic one.
Device Description: The device is a catheter system designed to collect urine directly into a bag. It facilitates the physical process of urine removal.
Lack of Diagnostic Function: There is no mention of the device being used to analyze urine for diagnostic purposes (e.g., detecting diseases, measuring biomarkers). The urine is simply collected.
No Mention of Diagnostic Tests: The performance studies focus on the physical and material properties of the catheter and collection bag, not on the accuracy or reliability of any diagnostic measurements.

IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the physical collection and management of urine.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Self-Cath Closed System is intended for use in male adult patients requiring bladder drainage as determined by their physician. The device is 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.

Self-Cath Closed System is intended for use in male and female adult 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 (comma separated list FDA assigned to the subject device)

FCM

Device Description

The Self-Cath Closed System is a disposable single-use, catheter designed for intermittent catheterization integrated with a urine collection bag. The device is sterilized with ethylene oxide (EO) sterilization. The catheter is made with PVC with DEHT as a plasticizer. The Self-Cath catheter used in the system is identical to the catheter recently cleared in K221401.The catheter is provided with a gel lubricant that is placed inside a urine bag, which is closed off with a protection cap (introducer tip cap). During use, the protection cap is removed, and the catheter is pushed out of the urine bag through the introducer tube and tip. The drainage end of the catheter is inside the bag allowing urine to be drained directly into the bag. The urine bag has a tear off section to open the urine bag for emptying. The Self-Cath Closed System includes gloves, swab sticks, a wipe, and a drape in addition to the components above.

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 patients (male and female)

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing for Self-Cath Closed System was conducted per applicable sections of non-recognized and recognized voluntary consensus standards, as well as established internal methods. The following tests were completed to determine the impact of the proposed material change based on assessment of the device risk documentation:

Biocompatibility testing and toxicological risk assessment based on chemical analysis according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2020)
Catheter performance according to ISO 20696:2018 (e.g. . Effective Length, Verification of Catheter Surface Finish, Verification of Catheter Effective Shaft Length) and EN ISO 8669-2:1996 for Urine collection bags (Rated Volume, Strength of Attachment of the inlet tubing)
Packaging sterile barrier integrity testing per ISO 11607-1 ●
Accelerated and Real Time aged shelf-life testing according ● to ASTM F1980-16

All tests met the pre-determined acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Self-Cath & Self-Cath Plus K221401

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Self-Cath Closed System, K070939

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 contains 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.

August 2, 2023

Coloplast Corporation Preeti Jain Head of Regulatory Affairs 1601 West River Road North Minneapolis, MN 55411

Re: K223821

Trade/Device Name: Self-Cath Closed System Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: FCM Dated: July 7, 2023 Received: July 7, 2023

Dear Preeti Jain:

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.

1

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 (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

510(k) Number (if known) K223821

Device Name Self-Cath Closed System

Indications for Use (Describe)

Self-Cath Closed System is intended for use in male adult patients requiring bladder drainage as determined by their physician. The device is 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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| Submitted by: | Coloplast A/S
Holtedam1
3050 Humlebaek
Denmark |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person : | Preeti Jain
Head of Regulatory Affairs, North America
Coloplast
1601 West River Road North
Minneapolis MN 55411
Phone: +1 (612)-413-5614
Email: uspj@coloplast.com |
| Date of Summary: | July 21, 2023 |
| Trade or Proprietary
Name: | Self-Cath Closed System |
| Item Numbers: | 50270/1108, 50271/C1110, 50272/1112, 50273/1114,
50274/1116, 50277/2114, 50281/2214, 50285/2614,
50286/2814, 50287/2816 |
| Common or Usual Name: | Intermittent Catheter, Urethral |
| Regulation Name: | Urological Catheter and Accessories |
| Regulation Number | 21 CFR 876.5130 |
| Device Class: | Class II |
| Product Code | FCM |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | Self-Cath & Self-Cath Plus K221401
The predicate device has not been subject of a design related
recall. |
| Reference Device: | Self-Cath Closed System, K070939
The reference device has not been subject of a design related
recall. |
| Device Description: | The Self-Cath Closed System is a disposable single-use,
catheter designed for intermittent catheterization integrated with
a urine collection bag. The device is sterilized with ethylene
oxide (EO) sterilization. The catheter is made with PVC with
DEHT as a plasticizer. The Self-Cath catheter used in the system
is identical to the catheter recently cleared in K221401.The
catheter is provided with a gel lubricant that is placed inside a
urine bag, which is closed off with a protection cap (introducer
tip cap). During use, the protection cap is removed, and the
catheter is pushed out of the urine bag through the introducer tube
and tip. The drainage end of the catheter is inside the bag
allowing urine to be drained directly into the bag. The urine bag
has a tear off section to open the urine bag for emptying.
The Self-Cath Closed System includes gloves, swab sticks, a
wipe, and a drape in addition to the components above. |
| Indications for Use: | Self-Cath Closed System is intended for use in male and female
adult 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. |

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Image /page/4/Picture/0 description: The image contains the logo for Coloplast. The logo consists of a blue, layered sphere on the left and the word "Coloplast" in blue, bold letters on the right. The sphere is made up of several horizontal layers, creating a textured effect.

Technological The subject devices have the same intended use, indications for Characteristics: use, principles of operation, technological characteristics, and performance specifications as the predicate device.

Product	Subject device	Predicate device	Reference device
Product	Self-Cath Closed
System	Self-Cath and Self Cath Plus	Self-Cath Closed
System
510(k) Number	K223821	K221401	K070939
Regulation Name	Urological catheter
and accessories	Urological catheter and
accessories	Same
Regulation Number	21 CFR876.5130	21 CFR 876.5130	Same
Product Code	FCM	EZD	Same
Classification	II	Same	Same
Prescription
Device	Yes	Same	Same
Intended Use	The product is
intended for
intermittent
catheterization through
the urethra	Same	Same
Indications for
Use	Self-Cath Closed
System is intended for
use in male and female
adult 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.	Self-Cath is 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.	Self-Cath CS Closed
System is intended
for use in male or
female patients
needing bladder
drainage as
determined by their
physician. More
specifically it is
intended for use
where drainage of the
bladder into a
suitable receptable
such as a commode
or bedpan is not
feasible or practical.
The device can be
used by either the
patient, once
appropriate training
has taken place, or by
a trained health care
professional.
Condition of Use	Intermittent and
Single-Use	Same	Same
Sterility	10-6	Same	Same
Sterilization
Method	Ethylene Oxide (EO),
Half cycle, Over-kill	Same	Same
Shelf Life	3 years	Same	Same
Variants	Male, Female	Male, Female and
Pediatrics	Same
Catheter
Materials	PVC with DEHT
(Shore A 70 and 80)	PVC with DEHT
(Shore A 70, 80 and

                                                                                                                                                                                                                                                                                                                                                                                                                                     | PVC with DEHP

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Image /page/5/Picture/0 description: The image contains the logo for Coloplast. The logo consists of a blue circular graphic on the left and the word "Coloplast" in a bold, blue font on the right. The circular graphic has a series of horizontal lines that appear to be a stylized representation of waves or layers.

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Image /page/6/Picture/1 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 on the right. The circular graphic is made up of several horizontal lines that create a layered effect.

Performance Data:

Performance testing for Self-Cath Closed System was conducted per applicable sections of non-recognized and recognized voluntary consensus standards, as well as established internal methods. The following tests were completed to determine the impact of the proposed material change based on assessment of the device risk documentation:

Biocompatibility testing and toxicological risk assessment based on chemical analysis according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2020)
Catheter performance according to ISO 20696:2018 (e.g. . Effective Length, Verification of Catheter Surface Finish, Verification of Catheter Effective Shaft Length) and EN ISO 8669-2:1996 for Urine collection bags (Rated Volume, Strength of Attachment of the inlet tubing)
Packaging sterile barrier integrity testing per ISO 11607-1 ●
Accelerated and Real Time aged shelf-life testing according ● to ASTM F1980-16

All tests met the pre-determined acceptance criteria.

The performance testing demonstrates the subject devices are as Conclusion: safe and effective as the predicate devices.