SpeediCath Flex Coude Pro 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.

Device Description

The SpeediCath Flex Coude' Pro 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 bended flexible tip that facilitates passage through the urethra to the bladder. The catheter is shielded by a sleeve, which serves as protection form the user's touch during insertion. The SpeediCath Flex Coude' Pro Catheters are offered with a 33cm effective length and range in size from 10Fr to 16Fr. The hydrophilic coating makes this single use catheter ready to use.

AI/ML Overview

This document is an FDA 510(k) summary for the SpeediCath Flex Coudé Pro catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that "proves the device meets acceptance criteria" in the way one might describe a clinical trial for a diagnostic AI.

Here's an analysis based on your requested information, acknowledging that the nature of this submission (a device modification for a urological catheter) means some of your categories might not be directly applicable in the same way they would be for an AI diagnostic device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on the device meeting performance specifications established by voluntary standards and by testing conducted on a predicate device. The "device performance" is reported as "All tests passed the pre-determined acceptance criteria."

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Shelf Life	Accelerated Aged (ISO F1980-16) for coating and tip bend	Passed pre-determined acceptance criteria
Biocompatibility	ISO 10993-1 (2009) and FDA Guidance (2016)	Passed pre-determined acceptance criteria
Friction	ASTM D1894: 2014	Passed pre-determined acceptance criteria
Transportation	ASTM D4169, followed by coating performance & packaging inspection	Passed pre-determined acceptance criteria
Catheter Integrity	Kink testing	Passed pre-determined acceptance criteria
Catheter Integrity	Tip integrity	Passed pre-determined acceptance criteria
Coating	Coating inspection	Passed pre-determined acceptance criteria
Packaging Seal	Proof of packing seal	Passed pre-determined acceptance criteria
Packaging Opening	Peel force test of new material	Passed pre-determined acceptance criteria
Flow Rate	EN1616/EN1618 and ASTM F623-99: 2013	Passed pre-determined acceptance criteria (based on predicate)
Tensile Strength	EN1616/EN1618	Passed pre-determined acceptance criteria (based on predicate)
Connector Security	EN1616	Passed pre-determined acceptance criteria (based on predicate)

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each test. It refers to "Performance testing." For a physical device like a catheter, this would typically involve testing a statistically significant number of production units according to the applicable standards.
- "Data provenance" is not explicitly stated in terms of country of origin, but it is implied to be internal testing by the manufacturer, Coloplast Corp, based in Minneapolis, MN, USA. The studies are non-clinical (laboratory/bench testing).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device submission. Ground truth, in the context of diagnostic AI, usually refers to definitive diagnoses by experts or pathology. For a physical device, the "ground truth" is typically the physical property being measured (e.g., flow rate, tensile strength) as determined by standardized laboratory methods and equipment, which may be operated by qualified technicians or engineers, but not "experts" in the clinical diagnostic sense.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept relates to resolving discrepancies among multiple human readers for diagnostic tasks, which is not relevant to non-clinical bench testing of a physical medical device like a catheter.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device (catheter), not an AI diagnostic system. Therefore, no MRMC study, human readers, or AI assistance is involved.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance testing is defined by the objective measurements and pass/fail criteria established within the referenced voluntary standards (e.g., ISO, ASTM, EN). For example, a flow rate measurement would be compared against a specified minimum flow rate from the standard.
The sample size for the training set:
- Not applicable. This refers to AI/machine learning models. This submission is for a physical medical device.
How the ground truth for the training set was established:
- Not applicable. This refers to AI/machine learning models. This submission is for a physical medical device.

Summary of Study (Based on Provided Document):

The study described is a series of non-clinical bench and laboratory performance tests conducted to demonstrate the safety and effectiveness of the SpeediCath Flex Coudé Pro catheter and its substantial equivalence to a predicate device (SpeediCath Flex Coude' Pro: K180070). The new device is a modified version, with changes in pouch material/dimensions, sleeve material/dimensions, wetting agent material/volume, and product variants (line extension).

The studies performed include:

Accelerated Aged Shelf Life Testing: To assess the stability of the coating and tip bend over time, per ISO F1980-16.
Biocompatibility Testing: According to ISO 10993-1 and FDA Guidance to ensure the materials are safe for patient contact.
Coefficient of Friction Testing: Per ASTM D1894: 2014, to evaluate the lubricity of the catheter.
Transportation Testing: Per ASTM D4169, to assess the device and packaging's integrity after simulated shipping conditions.
Impact Testing (due to modifications): Includes catheter kink testing, catheter tip integrity, coating inspection, proof of packing seal, and peel force test of new material for ease of opening.
Performance Specifications (based on predicate device testing): Flow rate (EN1616/EN1618 and ASTM F623-99: 2013), tensile strength (EN1616/EN1618), and connector security (EN1616).

The document states that "All tests passed the pre-determined acceptance criteria," implying that the device performs as expected and meets the necessary safety and performance standards for its intended use, demonstrating substantial equivalence to the predicate device despite the minor modifications.

Summary

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July 10, 2019

Coloplast Corp Delaney McDougal Sr. Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411

Re: K190620

Trade/Device Name: SpeediCath Flex Coude Pro Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: GBM Dated: May 29, 2019 Received: May 30, 2019

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. 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

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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-regulatory-information/postmarketing-safety-reportingcombination-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,

for Glenn B. Bell. 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

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Indications for Use

510(k) Number (if known)

K190620

Device Name SpeediCath Flex Coudé Pro

Indications for Use (Describe)

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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TRADITIONAL 510(K) SUMMARY

Submitted by:	Coloplast Corp1601 West River Road NorthMinneapolis, MN 55411 USA
Contact Person :	Ms. Delaney McDougalColoplast CorpPhone :+1 612-380-8034Email: usdel@coloplast.com
Date of Summary:Trade or Proprietary Name:	July 10, 2019SpeediCath Flex Coude' Pro
Common or Usual Name:	Catheter urethral
Regulation Name:	Urological catheter and accessories
Device Class:	Class II
Regulation Number:Product Code:	21CFR 876.5130GBM
Review Panel:	Gastroenterology/Urology
Predicate Device:	SpeediCath Flex Coude' Pro: K180070Reference device: SpeediCath Standard: K180258
Device Description:	The SpeediCath Flex Coude' Pro catheter is a sterile single usehydrophilic coated polyurethane catheter for men. The catheter is tobe used for intermittent drainage of the bladder through the urethra bymales with missing or reduced bladder control. The catheter has abended flexible tip that facilitates passage through the urethra to thebladder. The catheter is shielded by a sleeve, which serves asprotection form the user's touch during insertion. The SpeediCathFlex Coude' Pro Catheters are offered with a 33cm effective lengthand range in size from 10Fr to 16Fr. The hydrophilic coating makesthis single use catheter ready to use.
Indication for Use:	SpeediCath Flex Coude' Pro is indicated for use by patients with urineretention and patients with post void residual volume (PVR) due toneurogenic and non-neurogenic voiding dysfunction. The catheter isinserted into the urethra to reach the bladder allowing urine to drain.The product is for male patients only.

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Technological The subject device has the same indications for use, design, catheter Characteristics: French sizes and lengths, and principles of operations as the predicate device. The device includes the same raw catheter coating and sleeve design. The differences between the subject device and predicate device is in the following: . Pouch material and dimensions Sleeve material and dimensions ● ● Wetting agent material and volume . Product variants - line extension

Performance testing for SpeediCath Flex Coude' Pro was conducted according to applicable sections of voluntary standards in order to document the following properties of the SpeediCath Flex Coude' Pro catheter.

Accelerated Aged (per ISO F1980-16) shelf life testing for ● coating and tip bend inspections
. Biocompatibility according to ISO 10993-1 (2009) and FDA Guidance "Use of International Standards ISO 10993-1" (2016)
. Coefficient of friction according to ASTM D1894: 2014
Transportation testing per ASTM D4169 followed by assessments of coating performance and inspection of damage of packaging

The following tests were completed to determine the impact of the modifications based on assessment of the device risk documentation:

Catheter kink testing
Catheter tip integrity
Coating inspection
Proof of packing seal
Peel force test of new material to test for ability to open ● packaging

The following performance specifications for SpeediCath Flex Coude' Pro were established based on performance testing of the predicate device according to applicable sections of voluntary standards.

Flow rate according to EN1616/EN1618 and ASTM F623-● 99: 2013
Tensile strength according to EN1616/EN1618
Connector security according to EN1616 ●

All tests passed the pre-determined acceptance criteria. The proposed changes do not impact the performance specifications.

Summary of Non-Clinical Testing:

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Substantial Equivalence Table:

Item	Subject Device	Predicate Device
Indications for Use	SpeediCath Flex Coude' Pro isindicated for use by patients withurine retention and patients withpost void residual volume (PVR)due to neurogenic andnonneurogenic voiding dysfunction.The catheter is inserted into theurethra to reach the bladderallowing urine to drain. The productis for male patients only.	SpeediCath Flex Coude' Pro is indicatedfor use by patients with urine retention andpatients with post void residual volume(PVR) due to neurogenic and non-neurogenic voiding dysfunction. Thecatheter is inserted into the urethra toreach the bladder allowing urine to drain.The product is for male patients only.
Sterility	E-beam	E-beam
Configuration	Tip: flexible bended tip	Tip: flexible bended tip
Materials	Catheter: PolyurethaneHydrophilic coating: PVP basedWetting agent: PEGProtective sleeve: color pigment,polyethylene styrene isobutylenecopolymerPouch: Polyethylene & PETP	Catheter: PolyurethaneHydrophilic coating: PVP basedWetting agent: PVPProtective sleeve: color pigment andpolyethylenePouch: Polyethylene & PETP/aluminum
PouchConfigurations	Single & double-loop (pocket-size)Dimension:Single: 249 mm L x 100mm WDouble: 186 mm L x 87 mm W	Single-loopDimension:216 mm L100 mm W
Biocompatibility	Per ISO 10993	Per ISO 10993
Friction	Per ASTM D 1894-14	Per ASTM D 1894-14
Flow rate	Per ASTM F 623-99	Per ASTM F 623-99
Tensile	Per EN 1616/1618	Per EN 1616/1618
Shelf life	2 years	2 years
Available sizes	Fr 10 - 16 single-loop Fr 10 – 14double-loop	Fr 10 – 16 single-loop

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Substantial Equivalence Conclusion:

Based on the intended use, technological characteristics, safety and performance testing included in this submission, Coloplast considers the Product to be substantially equivalent to the currently marketed SpeediCath Flex Coude' Pro.

The SpeediCath Flex Coudé Pro differs from the predicate device in regards to the protective sleeve, primary packaging pouch, wetting agent, and product size variants. The protective sleeve has been updated to a larger overall width to accommodate additional wetting agent. The primary packaging pouch length was increased to allow for additional space inside the pouch for the product, the pull-tab from the predicate product has been removed and replaced with a circular hole in order to provide ease of opening for users with limited dexterity, and the aluminum layer within the pouch has been replaced with a PET layer in order to improve the environmental impact. The wetting agent used within the protective sleeve was updated from PVP water to PEG water which is currently used within the predicate device. The product line has been updated to make available a double-loop (pocket-size) variation which is currently available in the predicate device.

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.