(200 days)
No
The summary describes a standard intermittent urinary catheter and does not mention any AI or ML capabilities. The performance studies focus on material properties, biocompatibility, and physical performance, not algorithmic performance.
Yes
The device is described as a catheter for intermittent urinary catheterization, intended for bladder drainage in individuals unable to promote natural urine flow or with residual urine, which are therapeutic interventions.
No
Explanation: The device is a catheter used for bladder drainage and does not provide diagnostic information. Its intended use is to assist with urine flow, not to diagnose a condition.
No
The device description clearly states that Self-Cath and Self-Cath Plus are "single-use, sterile catheters for intermittent urinary catheterization," which are physical hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that Self-Cath and Self-Cath Plus are "single-use, sterile catheters for intermittent urinary catheterization." Their purpose is to drain urine directly from the bladder.
- Lack of Sample Analysis: The device does not analyze a sample of urine or any other bodily fluid in vitro (outside the body). It is a physical device used to facilitate the removal of urine in vivo (within the body).
Therefore, Self-Cath and Self-Cath Plus are medical devices used for bladder drainage, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
EZD
Device Description
Self-Cath and Self-Cath Plus devices are single-use, sterile catheters for intermittent urinary catheterization. Self-Cath is an uncoated catheter and Self-Cath Plus has a hydrophilic-coating. The catheters are sterilized by ethylene oxide (EO).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
male, female and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents)
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 and Self-Cath Plus 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 according to FDA Guidance . "Use of International Standard ISO 10993-1" (2020).
- Catheter performance according to ISO 20696:2018, ASTM F623-99:2013, and ASTM D1894:2014.
- 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)
Self-Cath, K100878
Reference Device(s)
Self-Cath Plus, K003784
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 2, 2022
Coloplast Preeti Jain Head of Regulatory Affairs - North America 1601 West River Road North Minneapolis, MN 55411
Re: K221401
Trade/Device Name: Self-Cath and Self-Cath Plus Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZD Dated: November 3, 2022 Received: November 4, 2022
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. You must comply with all the
1
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-regulatory-information/postmarketing-safetyreporting-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,
Negeen Haghighi -S
For
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) K221401
Device Name Self-Cath and Self-Cath Plus
Indications for Use (Describe)
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.
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
5. TRADITIONAL 510(K) SUMMARY
| 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: | December 2, 2022 |
| Subject Device: | |
| Trade or Proprietary
Name: | Self-Cath and Self-Cath Plus |
| Item/Model Numbers: | Self-Cath: 110, 112, 114, 116, 208, 210, 212, 214, 240, 305,
306, 308, 310, 408, 410, 412, 414, 416, 418, 450, 460, 608,
610, 612, 614, 806, 808, 810, 812, 814, 816, 818, 50201,
50202, 50203, 50204 |
| | Self-Cath Plus: 4110, 4112, 4114, 4116, 4210, 4212, 4214,
4306, 4308, 4310, 4408, 4410, 4412, 4414, 4416, 4418, 4608,
4610, 4612, 4614, 4808, 4810, 4812, 4814, 4816 |
| Common or Usual Name: | Intermittent Catheter, Urethral |
| Regulation/Classification
Name: | Urological Catheter and Accessories |
| Regulation/Classification
Number: | 21 CFR 876.5130 |
| Product Code: | EZD |
| Product Code Name: | Catheter, Straight |
4
| Review Panel: | Gastroenterology/Urology |
|---|---|
| Predicate Device: | Self-Cath, K100878 |
| The predicate device has not been subject of a design-related | |
| recall. | |
| Reference Device: | Self-Cath Plus, K003784 |
| The reference device has not been subject of a design-related | |
| recall. | |
| Device Description: | Self-Cath and Self-Cath Plus devices are single-use, sterile |
| catheters for intermittent urinary catheterization. Self-Cath is | |
| an uncoated catheter and Self-Cath Plus has a hydrophilic- | |
| coating. The catheters are sterilized by ethylene oxide (EO). | |
| Indications for Use: | 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. | |
| The subject and predicate devices have the same intended use. | |
| Technological | |
| Characteristics: | The subject devices have the same intended use, indications |
| for use, catheter size, principles of operation, technological | |
| characteristics, and performance specifications as the | |
| predicate device. |
The difference between the subject devices and predicate
device is as below:
The polyvinyl chloride (PVC) catheter and connector in
the subject devices contain Bis(2-ethylhexyl)
terephthalate (DEHT) softener (phthalate) The predicate device contains Bis(2-ethylhexyl) phthalate
(DEHP) softener. |
The difference in technological characteristics (softener) do
not raise different questions of safety and effectiveness.
5
Performance Data: Performance testing for Self-Cath and Self-Cath Plus 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 according to FDA Guidance . "Use of International Standard ISO 10993-1" (2020).
- . Catheter performance according to ISO 20696:2018, ASTM F623-99:2013, and ASTM D1894:2014.
- 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 Conclusion: are as safe and effective as the predicate device.