Who is the manufacturer of Self-Cath Closed System?

Coloplast filed the 510(k) submission for Self-Cath Closed System (K223821).

What is the FDA product code for Self-Cath Closed System?

FCM. It is classified under 21 CFR 876.5130 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Self-Cath Closed System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Self-Cath Closed System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Self-Cath Closed System

Q: What are the predicate devices for Self-Cath Closed System?

Self-Cath & Self-Cath Plus (K221401).

K223821 · Coloplast · FCM · Aug 2, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K223821
Device Name	Self-Cath Closed System
Applicant	Coloplast
Product Code	FCM · Gastroenterology, Urology
Decision Date	Aug 2, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5130
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Disposable, single-use intermittent catheter integrated with urine collection bag; intended for bladder drainage. Device includes catheter, gel lubricant, urine bag, introducer tube, and tip; accessories include gloves, swab sticks, wipe, and drape. User removes protection cap, pushes catheter through introducer tube/tip into urethra; urine drains directly into bag. Bag features tear-off section for emptying. Used by patients or healthcare professionals in clinical or home settings. Benefits include sterile, closed-system drainage for patients with urinary retention or residual urine.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-1), catheter performance (ISO 20696), urine bag performance (EN ISO 8669-2), sterile barrier integrity (ISO 11607-1), and shelf-life (ASTM F1980-16). All tests met pre-determined acceptance criteria.

Technological Characteristics

Intermittent catheter integrated with urine collection bag. Materials: PVC with DEHT plasticizer (catheter, bag, introducer tip), PVC with DINCH (introducer tube). Lubricant: Glycerin-based gel. Tip configurations: Straight, Olive Coudé, Tapered Coudé. Sizes: CH08–CH16. Sterilization: Ethylene Oxide (EO). Shelf life: 3 years. Standards: ISO 10993-1, ISO 20696, EN ISO 8669-2, ISO 11607-1, ASTM F1980-16.

Indications for Use

Indicated for male and female adult patients requiring bladder drainage due to inability to promote natural urine flow or significant residual urine volume following natural voiding.

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

Self-Cath & Self-Cath Plus (K221401)

Reference Devices

Self-Cath Closed System (K070939)

Related Devices

K032710 — CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT · Apogee Medical, Inc. · Jan 9, 2004
K080881 — CURE CATHETER CLOSED SYSTEM · Cure Medical, LLC · Jun 11, 2008
K160877 — United Urologics Closed System Catheter · Robling Medical, Inc. · May 20, 2016
K103043 — COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH · Adapta Medical, Inc. · Jan 7, 2011
K110862 — VAPRO PLUS INTERMITTENT CATHETER · Hollister Incorporated · Apr 26, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 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 font on the right. The circular graphic has a series of horizontal lines that create a layered effect. | 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. | {4}------------------------------------------------ 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 85) | PVC with DEHP (Shore A 70 and 80) | | Hydrophilic Gel- lubricant | Glycerin based gel | - | Same | | Tip Configuration | Straight tip Olive Coudé tip Tapered Coudé tip | Same | Same | | Catheter Outer Diameter | CH08 – CH16 | CH05 – CH 18 | Same | | Urine Bag | PVC with DEHT | - | PVC with DEHP | | Urine Bag Components: Introducer Tube | PVC with DINCH | - | PVC with DEHP | | Urine Bag Components: Introducer Tip | PVC with DEHT | - | PVC with DEHP | {5}------------------------------------------------ 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. {6}------------------------------------------------ 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.