(452 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of a simple intermittent catheter, with no mention of AI or ML.
Yes
The device is a therapeutic device because its intended use is to drain urine from the bladder, which alleviates symptoms of chronic urine retention and neurogenic/non-neurogenic voiding dysfunction. This directly treats a medical condition.
No.
The device description and intended use clearly state that the catheter is used for draining urine from the bladder, which is a therapeutic function, not a diagnostic one. No diagnostic capabilities are mentioned.
No
The device description clearly states it is a physical catheter, a hollow polyurethane tube, and describes its packaging and sterilization, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The described device is a catheter designed to be inserted into the urethra and bladder to drain urine. This is a direct intervention on the body for therapeutic purposes (draining retained urine), not an examination of a specimen outside the body for diagnostic information.
- Intended Use: The intended use clearly states it's for draining urine in patients with chronic urine retention due to voiding dysfunction. This is a treatment for a physical condition.
- Device Description: The description focuses on the physical characteristics of the catheter and its packaging, not on reagents, analyzers, or other components typically associated with IVDs.
- Performance Studies: The performance studies listed are related to the physical and biological safety of the catheter itself (biocompatibility, friction, shelf-life, sterilization), not the analytical or clinical performance of a diagnostic test.
In summary, the SpeediCath Compact Male is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The catheter is indicated for use by patients with chronic urine retents with a 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 the urine to drain.
The catheter is intended for males only.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
The SpeediCath Compact Male is a sterile, ready to use intermittent catheter for males. It is a single use catheter and is sterilized using E-beam Irradiation.
The catheter is a hollow polyurethane tube that facilitates drainage of urine from the bladder through the urethra. SpeediCath Compact Male is available in one size FR/CH 12/18 and is for male users only.
The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside a tube, which together with a closure and plug make up the primary packaging and the sterile barrier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra to reach the bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients
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 Compact Male was conducted per applicable sections of voluntary and FDA consensus standards:
- Biocompatibility testing (cytotoxicity, irritation, ● sensitization, material mediated pyrogenicity 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)
- Coefficient of friction according to ASTM D1894:2014
- Accelerated and Real Time aged shelf-life testing ● according to ASTM F1980-16
- Sterilization dose setting according to ISO 11137-. 1:2015 and ISO/TS 13004:2013
The following tests were completed using established methods to determine the impact of the swelling medium modification based upon assessment of the risk documentation:
- . Catheter coating - dry out in air: to measure the friction 5 minutes after the catheter has been opened and removed from the primary packaging. As the user might not insert the catheter immediately after opening, the test is performed to verify that the coating after the catheter has been exposed to air in 5 minutes is still lubricated and not dry at insertion.
- . Catheters, objective friction measurement: to measure the friction of the catheter immediately after opening and removal from the primary packaging. After removal from the primary packing, the catheter is no longer immersed in swelling medium and ready for use.
- pH of the swelling medium: to measure the pH of swelling medium using a calibrated pH measure.
- . Osmolality of the swelling medium: to measure salt/molecules in the swelling medium using an osmometer.
Conclusion: 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.
Not Found
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 the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.
April 26, 2022
Coloplast Delaney McDougal Sr. Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K210250 Trade/Device Name: SpeediCath Compact Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: March 18, 2022 Received: March 21, 2022
Dear Delaney McDougal:
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)
Device Name SpeediCath Compact
Indications for Use (Describe)
The catheter is indicated for use by patients with chronic urine retents with a 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 the urine to drain.
The catheter is intended for males only.
| 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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3
K210250 Page 1 of 3
TRADITIONAL 510(K) SUMMARY
| Submitted by: | Coloplast A/S
Holtedam1
3050 Humlebaek
Denmark |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person : | Delaney McDougal
Senior Regulatory Affairs Specialist
Coloplast
1601 West River Road North
Minneapolis, MN 55411
Phone: +1 612-380-8034
Email: usdel@coloplast.com |
| Date of Summary: | April 21, 2022 |
| Trade or Proprietary
Name: | SpeediCath Compact |
| Item Numbers: | 28692, 28702 |
| Common or Usual Name: | Catheter, Urethral |
| Regulation Name: | Urological Catheter and Accessories |
| Regulation Number | 21 CFR 876.5130 |
| Device Class: | Class II |
| Product Code: | EZD |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | SpeediCath Compact Male, K143182
The predicate device has not been subject to a design-related
recall. |
4
| Device Description: | The SpeediCath Compact Male is a sterile, ready to use intermittent catheter for males. It is a single use catheter and is sterilized using E-beam Irradiation.
The catheter is a hollow polyurethane tube that facilitates drainage of urine from the bladder through the urethra. SpeediCath Compact Male is available in one size FR/CH 12/18 and is for male users only.
The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside a tube, which together with a closure and plug make up the primary packaging and the sterile barrier. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The catheter is indicated for use by patients with chronic urine retention and patients with a 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 the urine to drain.
The catheter is intended for males only.
The subject and predicate devices have the same intended use. |
| Technological Characteristics: | The subject device has 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 device and predicate device is in the following:
- Swelling medium in the subject device contains polyethylene glycol (PEG); the predicate contains polyvinylpyrrolidone (PVP).
The swelling medium resides between the catheter and the inner tube and lubricates the catheter coating.
The difference in technological characteristics (the swelling medium) do not raise different questions of safety and effectiveness. |
5
| Performance Data: | Performance testing for SpeediCath Compact Male was
conducted per applicable sections of voluntary and FDA
consensus standards: |
| ------------------- | --------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- Biocompatibility testing (cytotoxicity, irritation, ● sensitization, material mediated pyrogenicity 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)
- Coefficient of friction according to ASTM D1894:2014
- Accelerated and Real Time aged shelf-life testing ● according to ASTM F1980-16
- Sterilization dose setting according to ISO 11137-. 1:2015 and ISO/TS 13004:2013
The following tests were completed using established methods to determine the impact of the swelling medium modification based upon assessment of the risk documentation:
- . Catheter coating - dry out in air: to measure the friction 5 minutes after the catheter has been opened and removed from the primary packaging. As the user might not insert the catheter immediately after opening, the test is performed to verify that the coating after the catheter has been exposed to air in 5 minutes is still lubricated and not dry at insertion.
- . Catheters, objective friction measurement: to measure the friction of the catheter immediately after opening and removal from the primary packaging. After removal from the primary packing, the catheter is no longer immersed in swelling medium and ready for use.
- pH of the swelling medium: to measure the pH of swelling medium using a calibrated pH measure.
- . Osmolality of the swelling medium: to measure salt/molecules in the swelling medium using an osmometer.
Conclusion: The performance testing demonstrates the subject device is as safe and effective as the predicate device.