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.

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.

AI/ML Overview

Here is an analysis of the provided FDA document regarding the SpeediCath Flex Coudé device, focusing on acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Reported Device Performance
Bench Testing
Flow rate	Passed (according to EN1616/EN1618 & ASTM F623-99:2013)
Coefficient of friction	Passed (according to ASTM D1894:2014)
Tensile strength	Passed (according to EN1616/EN1618)
Connector security	Passed (according to EN1616)
Biocompatibility	Passed (according to ISO 10993-1 and applicable parts of FDA Blue Book Memorandum #G95-1)
Clinical Performance (Cadaver Study)
Insertion & navigation in difficult male urethral anatomies	Comparable to a standard coudé catheter in terms of insertion and navigation through difficult male anatomies (enlarged prostate and strictures). Implies meeting performance equivalent to established devices for these challenging cases.
Clinical Performance (Clinical Evaluation of Published Data)	Safety and efficacy profile equivalent to the predicate and reference devices.

Note: The document states "All tests passed" for the bench performance data, implying that the acceptance criteria for each of these tests were met.

Sample Size and Data Provenance
- Test set (cadaver study): The document mentions "male cadavers with difficult urethral anatomies." It does not specify the exact number of cadavers used.
- Data Provenance (cadaver study): Not explicitly stated, but implies a laboratory setting for the "pre-clinical study." It is a prospective observational study in a pre-clinical setting.
- Clinical Evaluation: Based on "available published data," which would be retrospective analysis of existing clinical literature. No specific sample size mentioned for this review beyond the studies themselves.
Number of Experts and Qualifications for Ground Truth
- Cadaver Study: The document does not specify the number of experts or their qualifications involved in establishing "ground truth" or evaluating insertion/navigation in the cadaver study. It only states the device "was comparable to a standard coudé catheter." This comparison would likely have been made by experienced individuals, but their number and specific qualifications are not detailed.
- Clinical Evaluation: For the "clinical evaluation of available published data," the "experts" would be the authors of the published studies being reviewed. The document does not state how many individuals conducted this literature review or their qualifications.
Adjudication Method for the Test Set
- The document does not describe any formal adjudication method (like 2+1 or 3+1) for the cadaver study or the clinical evaluation. The comparison in the cadaver study ("comparable to a standard coudé catheter") implies a direct observation and assessment, but multi-reader adjudication is not mentioned.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study involving human readers with and without AI assistance was performed. This device is a medical device (catheter) for physical use, not an AI diagnostic/interpretive tool.
Standalone Performance (Algorithm Only)
- Not applicable. This is a physical medical device, not a software algorithm.
Type of Ground Truth Used
- Bench Testing: Engineering measurements and adherence to specified standards (e.g., ASTM, EN, ISO).
- Cadaver Study: Direct observation and assessment of the device's physical performance (insertion and navigation) in anatomical models (cadavers) with known difficult anatomies (enlarged prostate and strictures). The "ground truth" is the physical reality of successful navigation and the comparative ease with a predicate.
- Clinical Evaluation: Clinical outcomes and safety profiles reported in existing published literature for predicate and reference devices.
Sample Size for the Training Set
- Not applicable as this is a physical medical device, not a machine learning algorithm. The "development" or "training" would refer to design iterations and engineering evaluations, not a data-driven training set in the AI sense.
How the Ground Truth for the Training Set was Established
- Not applicable for the same reason as point 8. The "ground truth" for the device's design would stem from engineering principles, user needs, and clinical requirements for urinary catheterization.

Summary

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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 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 Corp1601 West River Road NorthMinneapolis, MN 55411USA
Contact Person	Rebecca S RobertsColoplast CorpPhone 612-344-4987Fax 612-287-4138Email 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 deviceK023254, SpeediCath Standard
	ManufacturerColoplast A/S
	Reference device(s)K090960, VaPro IntermittentK143594, VaPro Pocket
	Hollister Inc.Hollister Inc.
Product description	The SpeediCath Flex Coudé catheter is a sterile single usehydrophilic coated polyurethane catheter for men. Thecatheter is to be used for intermittent drainage of thebladder through the urethra by males with missing orreduced bladder control. The catheter has a flexiblebendable tip that facilitates passage through the urethra tothe bladder. The catheter is shielded by a sleeve, whichserves as protection from the user's touch during insertion.
Indication for use	SpeediCath Flex Coudé is indicated for use by patients withurine retention and patients with post void residual volume(PVR) due to neurogenic and non-neurogenic voidingdysfunction. The catheter is inserted into the urethra toreach the bladder allowing urine to drain.The product is for male patients only
Summary of technologicalcharacteristics	The subject device has similar indications for use, design,sizes materials and principles of operations as the predicatedevice SpeediCath Standard (K023254). The subject deviceincludes the same coating and saline solution (pre-lubrication) as the predicate device. The differencesbetween the subject device and predicate device are theprotective sleeve, the packaging configuration and theflexible tip. The sleeve is for ease of use and hygienicinsertion and is similar to the protective sleeve of thereference device VaPro Intermittent catheter (K090960).The packaging modifications are made for discretionimprovements and are similar to the packagingconfiguration of reference device VaPro Pocket (K143594).The SpeediCath Flex Coudé catheter tip flexibility allows thetip of the catheter to achieve different degrees of curvature,rather than a fixed one as in the predicate and referencedevices. Under straight urethral passages, the flexible tipwill remain straight acting as a nelaton tip, whereas whenpassing through curvatures the tip will bend progressivelyand adopt the curved profile of a coudé tip. This enablesand facilitates passage through difficult, curved anatomies,similar to the coudé tip (Tiemann variant) of the predicatedevice.
Performance data - bench	Performance testing was conducted according to applicablesections of voluntary standards in order to document thefollowing 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 applicableparts of FDA Blue Book Memorandum #G95-1. All tests passed.
Performance data - clinical	Based on the clinical evaluation of available published datait is evaluated that the SpeediCath Flex Coude' has asafety and efficacy profile equivalent to the predicateand reference devices. Furthermore, a pre-clinical studywas performed using male cadavers with difficulturethral anatomies, resulting from enlarged prostate andstrictures. SpeediCath Flex Coude' was comparable to astandard coude' catheter in terms of insertion andnavigation through difficult male anatomies.
Conclusion	Based on the test results and additional supportingdocumentation provided in this premarket notification, theproposed device demonstrates substantial equivalence tothe previously cleared predicate devices.

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Regulation Number and Section

§ 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.