(384 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a catheter and its components, with no mention of AI or ML.
Yes
The device is described as allowing urine to drain from the bladder, which alleviates symptoms of chronic urine retention and voiding dysfunction, thus providing a therapeutic effect.
No
The device is a catheter used to drain urine from the bladder, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical medical device (catheter, urine bag, packaging) and the performance studies focus on physical and chemical properties, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to drain urine from the bladder through the urethra. This is a physical intervention for managing a physiological condition (urine retention/voiding dysfunction).
- Device Description: The device is a catheter, a physical tool for drainage.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like urine) in vitro to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples outside the body.
The device is a medical device used for treatment/management, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
SpeediCath Compact Set 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. This device is intended for females only.
Product codes
GBM
Device Description
The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for females. It is a single use catheter with an integrated urine bag. The catheter is a hollow polyurethane tube that facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in three sizes FR/CH 10, FR/CH 12 and FR/CH 14. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside a tube, which together with a cover and plug make up the primary packaging and the sterile barrier. The subject device is the same as the predicate device, apart from the swelling medium. The swelling medium resides between the catheter and the tube and lubricates the catheter. The swelling medium in the subject device contains polyethylene glycol (PEG), and the predicate contains polyvinylpyrrolidone (PVP).
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
Not Found
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 Compact Set was conducted per applicable sections of voluntary and FDA consensus standards: Sterilization validation was performed by conducting dose setting per ISO 11137-1:2015 and ISO/TS13004: 2013 Accelerated and Real Time aged shelf life testing according to ASTM F1980-16 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 Catheter coating friction per internal test method Finger test: adhesion, cohesiveness, uniformity, and smoothness per internal test method Corrosion according to EN ISO 20696:2018 and EN 1616:1997 pH of the swelling medium per internal test method Osmolality of the swelling medium per internal test method. All tests met the pre-determined acceptance criteria. The performance testing demonstrates the subject device is as safe and as effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SpeediCath Compact Set, K121457
Reference Device(s)
Not Found
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 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 2, 2020
Coloplast Michael Bumgarner Principal Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K192904
Trade/Device Name: SpeediCath Compact Set Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: September 30, 2020 Received: October 1, 2020
Dear Michael Bumgarner:
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,
Sharon M. Andrews 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) K192904
Device Name SpeediCath Compact Set
Indications for Use (Describe)
SpeediCath Compact Set 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. This device is intended for females 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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Image /page/3/Picture/1 description: The image shows the Coloplast logo, which includes a blue circular graphic with horizontal lines and the word "Coloplast" in blue text. Above the logo, there is the text "K192904" and "Page 1 of 3". The text indicates that this is the first page of a three-page document with the identifier K192904.
TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | Coloplast A/S
Holtedam1
3050 Humlebaek
Denmark |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael Bumgarner
Principal Regulatory Affairs Specialist
Coloplast
1601 West River Road North
Minneapolis, MN 55411
612-263-0488
usmbum@coloplast.com |
| Date of Summary: | 02 November 2020 |
| Trade or Proprietary
Name: | SpeediCath Compact Set |
| Common or Usual Name: | Catheter, Urethral |
| Classification Name: | Urological Catheter and Accessories |
| Regulation Number | 21 CFR 876.5130 |
| Classification: | Class II |
| Product Code: | GBM (catheter, urethral) |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | SpeediCath Compact Set, K121457
The predicate device has not been subject to a design related recall. |
This file contains proprietary information and should not be disclosed without the consent of Coloplast.
4
K192904 Traditional 510(k)
| Device Description: | The SpeediCath Compact Set is a sterile, ready to use intermittent
catheter for females. It is a single use catheter with an integrated
urine bag.
The catheter is a hollow polyurethane tube that facilitates drainage
of urine from the bladder through the urethra to the collection bag.
It is available in three sizes FR/CH 10, FR/CH 12 and FR/CH 14.
The catheter is hydrophilic coated and placed in a sterile solution
(swelling medium) inside a tube, which together with a cover and
plug make up the primary packaging and the sterile barrier. The
subject device is the same as the predicate device, apart from the
swelling medium. The swelling medium resides between the
catheter and the tube and lubricates the catheter. The swelling
medium in the subject device contains polyethylene glycol (PEG),
and the predicate contains polyvinylpyrrolidone (PVP). |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | SpeediCath Compact Set 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.
This device is intended for females only.
The subject and predicate device have the same intended use. |
| Performance Testing: | Performance testing for SpeediCath Compact Set was conducted per
applicable sections of voluntary and FDA consensus standards:
Sterilization validation was performed by conducting dose
setting per ISO 11137-1:2015 and ISO/TS13004: 2013Accelerated and Real Time aged shelf life testing according
to ASTM F1980-16Biocompatibility 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 D1894:2014Catheter coating friction per internal test methodFinger test: adhesion, cohesiveness, uniformity, and
smoothness per internal test methodCorrosion according to EN ISO 20696:2018 and EN
1616:1997pH of the swelling medium per internal test methodOsmolality of the swelling medium per internal test method |
All tests met the pre-determined acceptance criteria.
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Image /page/5/Picture/1 description: The image shows the Coloplast logo in blue, with the text "Coloplast" in a bold, sans-serif font. To the right of the logo, there is the text "K192904 Page 3 of" in a smaller, serif font. The logo and text are positioned at the top of the image.
Conclusion:
The subject and predicate device have different technological characteristics, specifically a different swelling medium. This difference in technological characteristics does not raise different questions about safety and effectiveness.
The performance testing demonstrates the subject device is as safe and as effective as the predicate device.
This file contains proprietary information and should not be disclosed without the consent of Coloplast.