SpeediCath Flex Set 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 Set is a sterile, single use hydrophilic coated polyurethane catheter for men with an integrated collection bag (urine bag) which provides ease of use during collection and emptying of urine. The catheter is to be used for intermittent drainage of the bladder through the urethra by adult males with missing or reduced bladder control. The catheter has a protective sleeve which serves as protection from the user's touch and aids the user during insertion of the catheter into the urethra. The device is intended for use by prescription only. The device comes in FR size 10, 12, 14, and 16; corresponding to model numbers 28931, 28932, 28934, and 28936 respectively.

AI/ML Overview

The provided text describes the regulatory clearance for the SpeediCath Flex Set, a urological catheter. It does not contain information about an AI/ML powered device, therefore no information regarding acceptance criteria or performance of such a device can be extracted.

The document discusses the device's indications for use, technological characteristics, and non-clinical testing performed to demonstrate its safety and effectiveness compared to predicate devices. The listed tests are standard for medical devices like catheters and include standards for urine collection bags, sterile urinary catheters, material properties (coefficient of friction), usability, biocompatibility, packaging performance, and shelf life.

Here's the information that can be extracted, based on the provided text, heavily inferring from the context of a medical device submission:

A table of acceptance criteria and the reported device performance
The document states: "All tests met the pre-determined acceptance criteria." It lists the standards and internal requirements against which the device was tested, but does not provide specific numerical acceptance criteria or reported performance values for each test. For example, it lists "ISO 8669-2:1996 Urine collection bags - Part 2: Requirements and test methods" as a fulfilled requirement, but doesn't detail what those requirements are or the specific results.

Acceptance Criteria (Inferred from standards and internal requirements)	Reported Device Performance
Requirements of ISO 8669-2:1996 (Urine collection bags)	Met all requirements
Requirements of ISO 20696:2018 (Sterile urinary catheters and accessory devices)	Met all requirements
Requirements of ASTM F623-99:2013 (Foley Catheters - Flow rate only)	Met all requirements
Requirements of D1894:2014 (Coefficient of friction)	Met all requirements
Requirements of ISO 62366-1:2015, AAMI HE 75:2009, and FDA Guidance (Usability)	Met all requirements
Requirements of ISO 10993-1 (2018) and FDA Guidance (Biocompatibility)	Met all requirements
Requirements of ASTM D4169 (Performance Testing of Shipping Containers)	Met all requirements
Requirements of ASTM F1980-16 (Real Time and Accelerated Aging shelf life)	Met all requirements
Internal requirements for break-off tap force	Met all requirements
Internal requirements for cap/handle opening torque	Met all requirements
Internal requirements for drip-tight closure of handle and cap	Met all requirements
Internal requirements for pH and Osmolality of the wetting agent/hydrophilic coating	Met all requirements
Internal requirements for protective sleeve welding strength	Met all requirements

Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the non-clinical tests. It states "Performance testing for SpeediCath Flex Set was conducted..." but gives no details on the number of units tested. The data provenance is internal testing by Coloplast A/S. The text does not mention patient data, so neither retrospective nor prospective patient data is referenced.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is a non-clinical testing report for a physical medical device. Ground truth, in the context of expert review, is not relevant here. The "truth" is established by adherence to specified testing standards and internal requirements.
Adjudication method for the test set
Not applicable for non-clinical device performance testing.
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. The device is a urological catheter, not an AI/ML-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a urological catheter, not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the sense of clinical "ground truth." The "ground truth" for the non-clinical tests is defined by the requirements outlined in the referenced international standards, ASTM standards, relevant FDA guidances, and Coloplast's internal specifications.
The sample size for the training set
Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 21, 2022

Coloplast Preeti Jain Head of Regulatory Affairs 1601 West River Road North Minneapolis, MN 55411

Re: K222059

Trade/Device Name: SpeediCath Flex Set Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 12, 2022 Received: July 13, 2022

Dear Preeti Jain:

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.

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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 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

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Indications for Use

510(k) Number (if known) K222059

Device Name SpeediCath Flex Set

Indications for Use (Describe)

The product is for male patients only.

Type of Use (Select one or both, as applicable)
X 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 contains the logo for Coloplast. The logo consists of a blue circular graphic on the left, which is made up of several horizontal lines. To the right of the graphic is the word "Coloplast" in a bold, blue sans-serif font.

K222059
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5.0 TRADITIONAL 510(K) SUMMARY

Submitted by:	Coloplast A/SHoltedam13050 HumlebaekDenmark
Contact Person:	Preeti JainHead of Regulatory AffairsColoplast Corporation1601 West River Road NorthMinneapolis MN 55411Phone: +1 612-413-5614Email: uspj@coloplast.com
Date of Summary:Trade or ProprietaryName:	September 19, 2022SpeediCath Flex Set
Common or Usual Name:	Catheter, Urethral
Classification Name:	Urological Catheter and Accessories
Classification:	Class II
Regulation Number:	21 CFR 876.5130
Product Code:	EZD
Review Panel:	Gastroenterology/Urology
Predicate Device:	SpeediCath Flex Coudé Pro, K190620. The predicate devicehas not been subject to a design-related recall.
Reference Device:	SpeediCath Compact Set, K121458.
Device Description:	The SpeediCath Flex Set is a sterile, single use hydrophiliccoated polyurethane catheter for men with an integratedcollection bag (urine bag) which provides ease of use duringcollection and emptying of urine. The catheter is to be usedfor intermittent drainage of the bladder through the urethra byadult males with missing or reduced bladder control. Thecatheter has a protective sleeve which serves as protectionfrom the user's touch and aids the user during insertion of thecatheter into the urethra. The device is intended for use byprescription only. The device comes in FR size 10, 12, 14, and16; corresponding to model numbers 28931, 28932, 28934, and28936 respectively.

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SpeediCath Flex Set

Traditional 510(k) Notification Indications for Use:

Technological Characteristics:

Image /page/4/Picture/3 description: The image shows the Coloplast logo. The logo consists of a blue circular symbol on the left and the word "Coloplast" in blue on the right. The circular symbol is made up of several horizontal lines that are blue on the bottom and white on the top.

The product is for male patients only.

The subject device has the same intended use, indications for use, catheter sizes, technological characteristics, principles of operation, and performance specifications as the predicate device. The subject device shares the same catheter as previously cleared SpeediCath devices (K161671 and K190620). The subject device has the same hydrophilic coating, swelling medium (wetting agent), protective sleeve, and primary packaging as the predicate device.

The differences between the subject device and predicate device are in the following:

The subject device contains a 1,000 mL collection bag (urine bag) which is attached to the catheter connector via a bag connector.
A cap has been added to the subject device which connects to the handle and seals the catheter and wetting agent in the protective sleeve.
. The subject device outer connector is white, whereas the predicate device outer connector is turquoise.
. The subject device has a flexible, straight tip. The predicate device has a flexible, bended (Coudé) tip.

The difference in technological characteristics do not raise different questions of safety and effectiveness.

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Traditional 510(k) Notification

Image /page/5/Picture/2 description: The image shows the logo for Coloplast. The logo consists of a blue circular graphic on the left and the word "Coloplast" in blue on the right. The circular graphic is made up of several horizontal lines that create a sphere-like shape.

Summary of Non-Clinical Testing / Performance Data:

Performance testing for SpeediCath Flex Set was conducted according to the applicable sections of non-recognized and recognized voluntary consensus standards, as well as established internal methods.

The performance of SpeediCath Flex Set met the requirements of:

ISO 8669-2:1996 Urine collection bags - Part 2: Requirements and test methods
ISO 20696:2018: Sterile urinary catheters and accessory devices for single use
ASTM . F623-99:2013: Standard Performance Specification for Foley Catheters (Flow rate only)
D1894:2014: Coefficient of friction
Usability per ISO 62366-1:2015, AAMI HE 75:2009 ● and FDA Guidance "Applying Human Factors and Usability Engineering to Optimize Medical Device Design, February 3, 2016"
Biocompatibility according to ISO 10993-1 (2018) and . FDA Guidance "Use of International Standards ISO 10993-1" (2020)
. ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and Systems
Real Time and Accelerated Aging shelf life testing ● according to ASTM F1980-16
Internal requirements for break-off tap force, cap/handle opening torque, drip-tight closure of handle and cap, pH and Osmolality of the wetting agent/hydrophilic coating, and protective sleeve welding strength

All tests met the pre-determined acceptance criteria.

The performance testing demonstrates the subject device is as Conclusion: safe and effective as the predicate device.

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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.