(112 days)
K023254, SpeediCath Standard
No
The summary describes a physical catheter device and its performance characteristics, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a catheter used to drain urine from the bladder in patients with voiding dysfunction, which falls under the definition of a therapeutic intervention.
No
Explanation: This device is a catheter used for draining urine from the bladder, which is a therapeutic function. It does not perform any diagnostic measurements or analyses.
No
The device description clearly states it is a physical catheter made of polyurethane with a hydrophilic coating, designed for insertion into the urethra. It also mentions performance testing related to physical properties like flow rate, friction, and tensile strength, which are characteristic of a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The description clearly states that this device is a catheter inserted into the urethra to drain urine from the bladder. This is a direct interaction with the body for a therapeutic purpose (draining urine), not a test performed on a sample.
- Lack of Diagnostic Testing: There is no mention of any testing being performed on the urine or any other bodily fluid using this device. Its sole function is drainage.
The information provided describes a medical device used for a therapeutic procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The catheter is indicated for use by patients with 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 for male patients only.
Product codes (comma separated list FDA assigned to the subject device)
GBM
Device Description
The SpeediCath Flex Coudé catheter is a sterile single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by males with missing or reduced bladder control. The catheter has a flexible bendable tip that facilitates passage through the urethra to the bladder. The catheter is shielded by a sleeve, which serves as protection from the user's touch during insertion.
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 data - bench:
Performance testing was conducted according to applicable sections of voluntary standards in order to document the following properties of the SpeediCath Flex Coudé catheter:
Flow rate according to EN1616/EN1618 & ASTM F623-99:2013 Coefficient of friction according to ASTM D1894:2014 Tensile strength according to EN1616/EN1618. Connector security according to EN1616. Biocompatibility according to ISO 10993-1 and applicable parts of FDA Blue Book Memorandum #G95-1.
All tests passed.
Performance data - clinical:
Based on the clinical evaluation of available published data it is evaluated that the SpeediCath Flex Coude' has a safety and efficacy profile equivalent to the predicate and reference devices. Furthermore, a pre-clinical study was performed using male cadavers with difficult urethral anatomies, resulting from enlarged prostate and strictures. SpeediCath Flex Coude' was comparable to a standard coude' catheter in terms of insertion and navigation through difficult male anatomies.
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.
K023254, SpeediCath Standard
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.
K090960, VaPro Intermittent, K143594, VaPro Pocket
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2016
Coloplast Corp. Rebecca S. Roberts Regulatory Affairs Manager 1601 West River Road North Minneapolis, MN 55411
Re: K161672
Trade/Device Name: SpeediCath Flex Coudé Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: August 30, 2016 Received: September 1, 2016
Dear Rebecca S. Roberts:
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. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161672
Device Name SpeediCath Flex Coude'
Indications for Use (Describe)
The catheter is indicated for use by patients with 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 for male patients 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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SpeediCath Flex Coudé 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Sponsor | Coloplast Corp
1601 West River Road North
Minneapolis, MN 55411
USA |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Rebecca S Roberts
Coloplast Corp
Phone 612-344-4987
Fax 612-287-4138
Email usrrob@coloplast.com |
| Date of submission | 14 June 2016 |
| Proprietary trade name | SpeediCath Flex Coudé |
| Classification name | Urological catheter and accessories |
| Classification | Class II |
| Product code | GBM |
| Legally Marketed predicate(s) | Predicate device
K023254, SpeediCath Standard |
| | Manufacturer
Coloplast A/S |
| | Reference device(s)
K090960, VaPro Intermittent
K143594, VaPro Pocket |
| | Hollister Inc.
Hollister Inc. |
| Product description | The SpeediCath Flex Coudé catheter is a sterile single use
hydrophilic coated polyurethane catheter for men. The
catheter is to be used for intermittent drainage of the
bladder through the urethra by males with missing or
reduced bladder control. The catheter has a flexible
bendable tip that facilitates passage through the urethra to
the bladder. The catheter is shielded by a sleeve, which
serves as protection from the user's touch during insertion. |
| Indication for use | SpeediCath Flex Coudé 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 |
| Summary of technological
characteristics | The subject device has similar indications for use, design,
sizes materials and principles of operations as the predicate
device SpeediCath Standard (K023254). The subject device
includes the same coating and saline solution (pre-
lubrication) as the predicate device. The differences
between the subject device and predicate device are the
protective sleeve, the packaging configuration and the
flexible tip. The sleeve is for ease of use and hygienic
insertion and is similar to the protective sleeve of the
reference device VaPro Intermittent catheter (K090960).
The packaging modifications are made for discretion
improvements and are similar to the packaging
configuration of reference device VaPro Pocket (K143594).
The SpeediCath Flex Coudé catheter tip flexibility allows the
tip of the catheter to achieve different degrees of curvature,
rather than a fixed one as in the predicate and reference
devices. Under straight urethral passages, the flexible tip
will remain straight acting as a nelaton tip, whereas when
passing through curvatures the tip will bend progressively
and adopt the curved profile of a coudé tip. This enables
and facilitates passage through difficult, curved anatomies,
similar to the coudé tip (Tiemann variant) of the predicate
device. |
| Performance data - bench | Performance testing was conducted according to applicable
sections of voluntary standards in order to document the
following properties of the SpeediCath Flex Coudé catheter:
Flow rate according to EN1616/EN1618 & ASTM F623-99:2013 Coefficient of friction according to ASTM D1894:2014 Tensile strength according to EN1616/EN1618. Connector security according to EN1616. Biocompatibility according to ISO 10993-1 and applicable
parts of FDA Blue Book Memorandum #G95-1. All tests passed. |
| Performance data - clinical | Based on the clinical evaluation of available published data
it is evaluated that the SpeediCath Flex Coude' has a
safety and efficacy profile equivalent to the predicate
and reference devices. Furthermore, a pre-clinical study
was performed using male cadavers with difficult
urethral anatomies, resulting from enlarged prostate and
strictures. SpeediCath Flex Coude' was comparable to a
standard coude' catheter in terms of insertion and
navigation through difficult male anatomies. |
| Conclusion | Based on the test results and additional supporting
documentation provided in this premarket notification, the
proposed device demonstrates substantial equivalence to
the previously cleared predicate devices. |
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