(449 days)
Not Found
No
The document describes a physical medical device (intermittent catheter) and its materials and performance characteristics. There is no mention of 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, which is a therapeutic intervention for patients with chronic urine retention and neurogenic voiding dysfunction.
No
The device is an intermittent catheter designed to drain urine from the bladder, not to diagnose or detect a medical condition.
No
The device description clearly describes a physical catheter with a hollow tube, hydrophilic coating, handle, and plug, which are all hardware components. The performance studies also focus on physical properties like biocompatibility, friction, and shelf life.
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 SpeediCath Compact and SpeediCath Compact Plus are physical devices (catheters) inserted into the body to drain urine. They do not analyze biological samples to provide diagnostic information.
- Intended Use: The intended use is for managing chronic urine retention and post-void residual volume, which is a therapeutic or management function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how the catheter facilitates urine drainage.
- Performance Studies: The performance studies listed are related to the physical properties, biocompatibility, and shelf life of the device, not the accuracy or performance of a diagnostic test.
Therefore, the SpeediCath Compact and SpeediCath Compact Plus are medical devices used for therapeutic purposes, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
SpeediCath Compact and SpeediCath Compact Plus is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is indicated for female patients only (adults and children of and above the age of 2 years). Choice of the catheter for the individual patient is made upon recommendation by the local health care professional.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
The SpeediCath Compact and SpeediCath Compact Plus are sterile, ready to use intermittent catheters for females. These are single use catheters. The subject catheters have a hollow polyurethane inner tube that facilitates drainage of urine from the bladder through the urethra. SpeediCath Compact is available in size FR/CH 8. FR/CH 12. and FR/CH 12. and FR/CH 14. SpeediCath Compact Plus is 2 cm longer than SpeediCath Compact and is available in FR/CH 10, FR/CH 12, and FR/CH 14. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside the inner tube, which together with a handle and plug make up the primary packaging and the sterile barrier.
After inserting the catheter through the urethra and into the bladder, urine flows through the polished evelets (holes) at the tip of the catheter, the handle, and the plug. The hydrophilic coating on the catheter, as well as the swelling medium, provide a lubricated surface for minimized friction through the urethra.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra to bladder
Indicated Patient Age Range
adults and children of and above the age of 2 years
Intended User / Care Setting
In presence of healthcare professional or self (after getting trained by a healthcare professional)
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)
- Biocompatibility testing (cytotoxicity, irritation, sensitivity, pyrogenicity and chemical . characterization) according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2016)
- 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. The results showed that the subject catheter met all the requirements:
- Catheter coating - dry out in air
- Catheters, objective friction measurement
- pH of the swelling medium
- Osmolality of the swelling medium
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.
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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.
March 8, 2022
Coloplast Delaney McDougal Senior Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K203637 Trade/Device Name: SpeediCath Compact SpeediCath Compact Plus Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: February 4, 2022 Received: February 8, 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) K203637
Device Name
SpeediCath Compact and SpeediCath Compact Plus
Indications for Use (Describe)
SpeediCath Compact and SpeediCath Compact Plus is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is indicated for female patients only (adults and children of and above the age of 2 years). Choice of the catheter for the individual patient is made upon recommendation by the local health care professional.
| 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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510 (k) Summary
1. Submitter Information
| 510 (k) submitter | Coloplast A/S |
|---|---|
| Address | Holtedam 1 |
| 3050 Humlebaek | |
| Denmark | |
| Contact Person | Delaney McDougal |
| Senior Regulatory Affairs Specialist | |
| Coloplast | |
| 1601 West River Road North Minneapolis, MN 55411 | |
| Telephone : 612-380-8034 | |
| Email : usdel@coloplast.com |
March 07, 2022 Preparation date
2. Device Name
| Trade Name of the Device | SpeediCath Compact
SpeediCath Compact Plus |
|---------------------------|-----------------------------------------------|
| Common Name | Catheter, Straight |
| Classification Name | Urological Catheter and Accessories |
| Classification Regulation | 21 CFR 876.5130 |
| Device Class | II |
| Panel | Gastroenterology/Urology |
| Product Code | EZD |
3. Predicate Device
| Owner | Coloplast Corp. |
|---|---|
| Trade Name of the Device | SpeediCath Compact |
| Classification Name | Urological Catheter and Accessories |
| Regulation Classification | 21 CFR 876.5130 |
| Device Class | II |
| Panel | Gastroenterology/Urology |
| Product Code | GBM |
| 510(k) Number | K072808 |
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4. Device Description
The SpeediCath Compact and SpeediCath Compact Plus are sterile, ready to use intermittent catheters for females. These are single use catheters. The subject catheters have a hollow polyurethane inner tube that facilitates drainage of urine from the bladder through the urethra. SpeediCath Compact is available in size FR/CH 8. FR/CH 12. and FR/CH 12. and FR/CH 14. SpeediCath Compact Plus is 2 cm longer than SpeediCath Compact and is available in FR/CH 10, FR/CH 12, and FR/CH 14. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside the inner tube, which together with a handle and plug make up the primary packaging and the sterile barrier.
After inserting the catheter through the urethra and into the bladder, urine flows through the polished evelets (holes) at the tip of the catheter, the handle, and the plug. The hydrophilic coating on the catheter, as well as the swelling medium, provide a lubricated surface for minimized friction through the urethra.
5. Indication For Use
SpeediCath Compact and SpeediCath Compact Plus is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and nonneuroqenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is indicated for female patients only (adults and children of and above the age of 2 years). Choice of model and size of the individual patient is made upon recommendation by the local health care professional.
| Device & Predicate
| Device(s): | K203637 | K072808 | |
|---|---|---|---|
| General Device | |||
| Characteristics | |||
| Device Name | SpeediCath Compact and | ||
| SpeediCath Compact Plus | SpeediCath Compact | ||
| Device Type | Intermittent Urinary Drainage | ||
| catheter | Intermittent Urinary Drainage | ||
| catheter | same | ||
| Indication for Use | SpeediCath Compact and SpeediCath | ||
| Compact Plus 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 | |||
| urine to drain. The product is | |||
| indicated for female patients only | |||
| (adults and children of and above the | |||
| age of 2 years). Choice of model and | |||
| size of the catheter for the individual | |||
| patient is made upon recommendation | |||
| by the local health care professional. | Speedicath compact 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 urine to | |||
| drain. | |||
| The catheter is for female patients only. | similar, | ||
| clarification | |||
| patient | |||
| population | |||
| added | |||
| Design | This catheter is a hollow | ||
| polyurethane inner tube with a | |||
| hydrophilic coating. | This catheter is a disposable | ||
| polyurethane catheter for females. | |||
| The catheter is pre-lubricated with | |||
| a hydrophilic coating. | same |
6. Comparison of the Technological Characteristics with Predicate Device
5
| Catheter Material | Polyurethane | Polyurethane | Same |
|---|---|---|---|
| Swelling Medium | Polyethylene Glycol (PEG) | Polyvinyl Pyrrolidone (PVP) | different |
| Catheter French | |||
| Size | SpeediCath Compact is available | ||
| in size FR/CH 8-14. | |||
| SpeediCath Compact Plus is | |||
| available in FR/CH 10-14. | SpeediCath Compact is available | ||
| in size FR/CH 8-14. | similar | ||
| Hydrophilic | |||
| coating | Polyvinylpyrrolidone | Polyvinylpyrrolidone | same |
| Storage | Exposure to extreme | ||
| temperatures (-18°C and up to | |||
| 60°C) for up to 24 hours will not | |||
| damage the product. | Exposure to extreme temperatures | ||
| (below 0°C and up to 60°C) for up | |||
| to 24 hours will not damage the | |||
| product. | similar | ||
| Provided Sterilized | Yes | Yes | same |
| User environment | In presence of healthcare | ||
| professional or self (after getting | |||
| trained by a healthcare | |||
| professional) | In presence of healthcare | ||
| professional or self (after getting | |||
| trained by a healthcare | |||
| professional) | same | ||
| Rx/OTC | Rx | Rx | same |
The subject device has the same intended use as the predicate device. As evidenced from the above table, the only difference between the subject device and predicate device is that the 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 activates the hydrophilic coating to create a lubricated surface. However, performance testing was conducted on the subject catheter, and it was established that the difference in swelling medium between the subject and the predicate does not raise different questions of safety or effectiveness.
7. Performance Data
Below is a list of the tests that have been performed and successfully completed for the subject catheter:
- Biocompatibility testing (cytotoxicity, irritation, sensitivity, pyrogenicity and chemical . characterization) according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2016)
- 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. The results showed that the subject catheter met all the requirements:
- Catheter coating - dry out in air
- Catheters, objective friction measurement ●
- pH of the swelling medium
- . Osmolality of the swelling medium
6
8. Conclusion
Based on the information presented in this submission, it can be concluded that the subject
device is substantially equivalent to the predicate. .