SpeediCath Compact and SpeediCath Compact Plus is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is indicated for female patients only (adults and children of and above the age of 2 years). Choice of the catheter for the individual patient is made upon recommendation by the local health care professional.

Device Description

The SpeediCath Compact and SpeediCath Compact Plus are sterile, ready to use intermittent catheters for females. These are single use catheters. The subject catheters have a hollow polyurethane inner tube that facilitates drainage of urine from the bladder through the urethra. SpeediCath Compact is available in size FR/CH 8. FR/CH 12. and FR/CH 12. and FR/CH 14. SpeediCath Compact Plus is 2 cm longer than SpeediCath Compact and is available in FR/CH 10, FR/CH 12, and FR/CH 14. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside the inner tube, which together with a handle and plug make up the primary packaging and the sterile barrier.

After inserting the catheter through the urethra and into the bladder, urine flows through the polished evelets (holes) at the tip of the catheter, the handle, and the plug. The hydrophilic coating on the catheter, as well as the swelling medium, provide a lubricated surface for minimized friction through the urethra.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a urological catheter (SpeediCath Compact and SpeediCath Compact Plus). The document primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to a new AI/ML device requiring extensive standalone and comparative effectiveness studies.

Therefore, many of the requested details regarding acceptance criteria, study methodologies for AI performance, sample sizes for AI training/test sets, expert adjudication methods, and MRMC studies are not applicable or extractable from this specific document. This document is for a medical device (catheter), not an AI/ML diagnostic tool.

However, I can extract information related to the device's performance testing to meet its acceptance criteria for safety and effectiveness, focusing on what is available in the document.

Acceptance Criteria and Device Performance (as applicable to a physical medical device)

The document details performance testing conducted to ensure the device's safety and effectiveness, particularly in light of a change in its swelling medium compared to the predicate device. The acceptance criteria are implicitly that the device meets the standards of the listed tests.

Acceptance Criteria (Implicit from Tests Performed)	Reported Device Performance
Biocompatibility Testing:	Successfully completed (according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2016)) for cytotoxicity, irritation, sensitivity, pyrogenicity, and chemical characterization.
Coefficient of Friction:	Successfully completed (according to ASTM D1894:2014). Implicitly, the friction was within acceptable limits for safe and effective use.
Shelf Life (Accelerated and Real Time Aging):	Successfully completed (according to ASTM F1980-16). Implicitly, the device maintains its integrity and performance over its stated shelf life.
Sterilization Dose Setting:	Successfully completed (according to ISO 11137-1:2015 and ISO/TS 13004:2013). Implicitly, the device is effectively sterilized.
Impact of Swelling Medium Modification:	Successfully completed the following tests, demonstrating that the change in swelling medium (from PVP to PEG) does not raise different questions of safety or effectiveness: - Catheter coating - dry out in air - Catheters, objective friction measurement - pH of the swelling medium - Osmolality of the swelling medium

Study Details (as applicable to a physical medical device's performance testing):

Sample sizes used for the test set and the data provenance:
- The document does not specify the exact sample sizes (e.g., number of catheters) used for each performance test.
- Data provenance is not explicitly stated in terms of country of origin or retrospective/prospective, but these are in vitro and ex vivo laboratory tests on the device materials and performance, not clinical studies with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical medical device (catheter), and the "ground truth" for its performance is established by adherence to recognized international standards (ISO, ASTM) and internal test protocols for parameters like friction, biocompatibility, and sterility. There isn't a "ground truth" established by human experts in the context of diagnostic interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to human review of diagnostic outputs; here, performance is measured against objective engineering and biological standards.
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 not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device. The "standalone" performance here relates to the physical catheter meeting its specifications.
The type of ground truth used:
- The "ground truth" for this device's performance is derived from established scientific and engineering standards and validated test methodologies. For example, biocompatibility is assessed against ISO 10993, friction against ASTM D1894, and sterility against ISO 11137.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense.
How the ground truth for the training set was established:
- Not applicable.

Summary

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March 8, 2022

Coloplast Delaney McDougal Senior Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411

Re: K203637 Trade/Device Name: SpeediCath Compact SpeediCath Compact Plus Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: February 4, 2022 Received: February 8, 2022

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.

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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) K203637

Device Name

SpeediCath Compact and SpeediCath Compact Plus

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (k) Summary

1. Submitter Information

510 (k) submitter	Coloplast A/S
Address	Holtedam 13050 HumlebaekDenmark
Contact Person	Delaney McDougalSenior Regulatory Affairs SpecialistColoplast1601 West River Road North Minneapolis, MN 55411Telephone : 612-380-8034Email : usdel@coloplast.com

March 07, 2022 Preparation date

2. Device Name

Trade Name of the Device	SpeediCath CompactSpeediCath Compact Plus
Common Name	Catheter, Straight
Classification Name	Urological Catheter and Accessories
Classification Regulation	21 CFR 876.5130
Device Class	II
Panel	Gastroenterology/Urology
Product Code	EZD

3. Predicate Device

Owner	Coloplast Corp.
Trade Name of the Device	SpeediCath Compact
Classification Name	Urological Catheter and Accessories
Regulation Classification	21 CFR 876.5130
Device Class	II
Panel	Gastroenterology/Urology
Product Code	GBM
510(k) Number	K072808

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4. Device Description

5. Indication For Use

SpeediCath Compact and SpeediCath Compact Plus is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and nonneuroqenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is indicated for female patients only (adults and children of and above the age of 2 years). Choice of model and size of the individual patient is made upon recommendation by the local health care professional.

Device & PredicateDevice(s):	K203637	K072808
General DeviceCharacteristics
Device Name	SpeediCath Compact andSpeediCath Compact Plus	SpeediCath Compact
Device Type	Intermittent Urinary Drainagecatheter	Intermittent Urinary Drainagecatheter	same
Indication for Use	SpeediCath Compact and SpeediCathCompact Plus is indicated for use bypatients with chronic urine retentionand patients with a post void residualvolume (PVR) due to neurogenic andnon-neurogenic voiding dysfunction.The catheter is inserted into theurethra to reach the bladder allowingurine to drain. The product isindicated for female patients only(adults and children of and above theage of 2 years). Choice of model andsize of the catheter for the individualpatient is made upon recommendationby the local health care professional.	Speedicath compact is indicated for useby patients with chronic urine retentionand patients with a post void residualvolume (pvr) due to neurogenic andnon-neurogenic voiding dysfunction.The catheter is inserted into the urethrato reach the bladder allowing urine todrain.The catheter is for female patients only.	similar,clarificationpatientpopulationadded
Design	This catheter is a hollowpolyurethane inner tube with ahydrophilic coating.	This catheter is a disposablepolyurethane catheter for females.The catheter is pre-lubricated witha hydrophilic coating.	same

6. Comparison of the Technological Characteristics with Predicate Device

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Catheter Material	Polyurethane	Polyurethane	Same
Swelling Medium	Polyethylene Glycol (PEG)	Polyvinyl Pyrrolidone (PVP)	different
Catheter FrenchSize	SpeediCath Compact is availablein size FR/CH 8-14.SpeediCath Compact Plus isavailable in FR/CH 10-14.	SpeediCath Compact is availablein size FR/CH 8-14.	similar
Hydrophiliccoating	Polyvinylpyrrolidone	Polyvinylpyrrolidone	same
Storage	Exposure to extremetemperatures (-18°C and up to60°C) for up to 24 hours will notdamage the product.	Exposure to extreme temperatures(below 0°C and up to 60°C) for upto 24 hours will not damage theproduct.	similar
Provided Sterilized	Yes	Yes	same
User environment	In presence of healthcareprofessional or self (after gettingtrained by a healthcareprofessional)	In presence of healthcareprofessional or self (after gettingtrained by a healthcareprofessional)	same
Rx/OTC	Rx	Rx	same

The subject device has the same intended use as the predicate device. As evidenced from the above table, the only difference between the subject device and predicate device is that the swelling medium in the subject device contains polyethylene glycol (PEG); the predicate contains polyvinylpyrrolidone (PVP). The swelling medium resides between the catheter and the inner tube and activates the hydrophilic coating to create a lubricated surface. However, performance testing was conducted on the subject catheter, and it was established that the difference in swelling medium between the subject and the predicate does not raise different questions of safety or effectiveness.

7. Performance Data

Below is a list of the tests that have been performed and successfully completed for the subject catheter:

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 ●
Accelerated and Real Time aged shelf life testing according to ASTM F1980-16 ●
Sterilization dose setting according to ISO 11137-1:2015 and ISO/TS 13004:2013 .

The following tests were completed using established methods to determine the impact of the swelling medium modification based upon assessment of the risk documentation. The results showed that the subject catheter met all the requirements:

Catheter coating - dry out in air
Catheters, objective friction measurement ●
pH of the swelling medium
. Osmolality of the swelling medium

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8. Conclusion

Based on the information presented in this submission, it can be concluded that the subject
device is substantially equivalent to the predicate. .

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.