(70 days)
No
The 510(k) summary describes a physical medical device (catheter with collection bag) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to drain urine from the bladder in patients with voiding dysfunction, which is a therapeutic intervention for a medical condition.
No
This device is a catheter used for draining urine, not for diagnosing a condition or disease. Its function is to manage urine retention and post-void residual volume, which are symptoms, but the device itself does not provide diagnostic information.
No
The device description clearly indicates it is a physical catheter with an integrated collection bag, made of polyurethane, and intended for insertion into the urethra. This is a hardware medical device, not software.
Based on the provided text, the SpeediCath Flex Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to drain urine from the bladder through the urethra. This is a direct intervention on the body for therapeutic purposes (relieving urine retention and PVR).
- Device Description: The description details a catheter and collection bag for physical drainage of urine.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of a specimen.
The SpeediCath Flex Set is a medical device used for intermittent catheterization, which is a therapeutic procedure.
N/A
Intended Use / Indications for Use
SpeediCath Flex Set 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.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
The SpeediCath Flex Set is a sterile, single use hydrophilic coated polyurethane catheter for men with an integrated collection bag (urine bag) which provides ease of use during collection and emptying of urine. 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 protective sleeve which serves as protection from the user's touch and aids the user during insertion of the catheter into the urethra. The device is intended for use by prescription only. The device comes in FR size 10, 12, 14, and 16; corresponding to model numbers 28931, 28932, 28934, and 28936 respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder
Indicated Patient Age Range
adult males
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 SpeediCath Flex Set was conducted according to the applicable sections of non-recognized and recognized voluntary consensus standards, as well as established internal methods.
The performance of SpeediCath Flex Set met the requirements of:
- ISO 8669-2:1996 Urine collection bags - Part 2: Requirements and test methods
- ISO 20696:2018: Sterile urinary catheters and accessory devices for single use
- ASTM . F623-99:2013: Standard Performance Specification for Foley Catheters (Flow rate only)
- D1894:2014: Coefficient of friction
- Usability per 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"
- Biocompatibility according to ISO 10993-1 (2018) and . FDA Guidance "Use of International Standards ISO 10993-1" (2020)
- . ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and Systems
- Real Time and Accelerated Aging shelf life testing according to ASTM F1980-16
- Internal requirements for break-off tap force, cap/handle opening torque, drip-tight closure of handle and cap, pH and Osmolality of the wetting agent/hydrophilic coating, and protective sleeve welding strength
All tests met the pre-determined acceptance criteria.
The performance testing demonstrates the subject device is as safe and effective as the predicate device.
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.
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.
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
§ 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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 21, 2022
Coloplast Preeti Jain Head of Regulatory Affairs 1601 West River Road North Minneapolis, MN 55411
Re: K222059
Trade/Device Name: SpeediCath Flex Set Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 12, 2022 Received: July 13, 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.
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, 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) K222059
Device Name SpeediCath Flex Set
Indications for Use (Describe)
SpeediCath Flex Set 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.
| 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) |
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/1 description: The image contains the logo for Coloplast. The logo consists of a blue circular graphic on the left, which is made up of several horizontal lines. To the right of the graphic is the word "Coloplast" in a bold, blue sans-serif font.
K222059
Page 1 of 3
5.0 TRADITIONAL 510(K) SUMMARY
| Submitted by: | Coloplast A/S
Holtedam1
3050 Humlebaek
Denmark |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Preeti Jain
Head of Regulatory Affairs
Coloplast Corporation
1601 West River Road North
Minneapolis MN 55411
Phone: +1 612-413-5614
Email: uspj@coloplast.com |
| Date of Summary:
Trade or Proprietary
Name: | September 19, 2022
SpeediCath Flex Set |
| Common or Usual Name: | Catheter, Urethral |
| Classification Name: | Urological Catheter and Accessories |
| Classification: | Class II |
| Regulation Number: | 21 CFR 876.5130 |
| Product Code: | EZD |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | SpeediCath Flex Coudé Pro, K190620. The predicate device
has not been subject to a design-related recall. |
| Reference Device: | SpeediCath Compact Set, K121458. |
| Device Description: | The SpeediCath Flex Set is a sterile, single use hydrophilic
coated polyurethane catheter for men with an integrated
collection bag (urine bag) which provides ease of use during
collection and emptying of urine. 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 protective sleeve which serves as protection
from the user's touch and aids the user during insertion of the
catheter into the urethra. The device is intended for use by
prescription only. The device comes in FR size 10, 12, 14, and
16; corresponding to model numbers 28931, 28932, 28934, and
28936 respectively. |
4
SpeediCath Flex Set
Traditional 510(k) Notification Indications for Use:
Technological Characteristics:
Image /page/4/Picture/3 description: The image shows the Coloplast logo. The logo consists of a blue circular symbol on the left and the word "Coloplast" in blue on the right. The circular symbol is made up of several horizontal lines that are blue on the bottom and white on the top.
SpeediCath Flex Set 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.
The subject device has the same intended use, indications for use, catheter sizes, technological characteristics, principles of operation, and performance specifications as the predicate device. The subject device shares the same catheter as previously cleared SpeediCath devices (K161671 and K190620). The subject device has the same hydrophilic coating, swelling medium (wetting agent), protective sleeve, and primary packaging as the predicate device.
The differences between the subject device and predicate device are in the following:
- The subject device contains a 1,000 mL collection bag (urine bag) which is attached to the catheter connector via a bag connector.
- A cap has been added to the subject device which connects to the handle and seals the catheter and wetting agent in the protective sleeve.
- . The subject device outer connector is white, whereas the predicate device outer connector is turquoise.
- . The subject device has a flexible, straight tip. The predicate device has a flexible, bended (Coudé) tip.
The difference in technological characteristics do not raise different questions of safety and effectiveness.
5
Traditional 510(k) Notification
Image /page/5/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 on the right. The circular graphic is made up of several horizontal lines that create a sphere-like shape.
Summary of Non-Clinical Testing / Performance Data:
Performance testing for SpeediCath Flex Set was conducted according to the applicable sections of non-recognized and recognized voluntary consensus standards, as well as established internal methods.
The performance of SpeediCath Flex Set met the requirements of:
- ISO 8669-2:1996 Urine collection bags - Part 2: Requirements and test methods
- ISO 20696:2018: Sterile urinary catheters and accessory devices for single use
- ASTM . F623-99:2013: Standard Performance Specification for Foley Catheters (Flow rate only)
- D1894:2014: Coefficient of friction
- Usability per 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"
- Biocompatibility according to ISO 10993-1 (2018) and . FDA Guidance "Use of International Standards ISO 10993-1" (2020)
- . ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and Systems
- Real Time and Accelerated Aging shelf life testing ● according to ASTM F1980-16
- Internal requirements for break-off tap force, cap/handle opening torque, drip-tight closure of handle and cap, pH and Osmolality of the wetting agent/hydrophilic coating, and protective sleeve welding strength
All tests met the pre-determined acceptance criteria.
The performance testing demonstrates the subject device is as Conclusion: safe and effective as the predicate device.
Page 5-3