SpeediCath Compact Male 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 catheter is for male patients.

Device Description

The SpeediCath Compact Male is a sterile, single use, disposable polyurethane catheter for males. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. To prepare the catheter for use, the cover is removed and the catheter is pulled out of the packaging thereby extending and locking it to its full length. The catheter is then ready to use allowing easy drainage.

AI/ML Overview

This document is a 510(k) Summary for the SpeediCath Compact Male urinary catheter. It describes the device, its intended use, and substantial equivalence to a predicate device. It also summarizes the testing performed to demonstrate its safety and effectiveness.

However, the provided text does not contain acceptance criteria or a detailed study description that presents the device's performance against specific acceptance criteria.

The document states:

"SpeediCath Compact Male has been tested and complies with relevant sections of ASTM F 623-99, ASTM D1894-11, EN 1616, EN 1617 and EN 1618."
"Performance Testing included: Flow Rate, Coefficient of Friction, Tensile Strength."
"SpeediCath Compact Male has been tested and complies with relevant sections of ISO 10993, Biological Evaluation of Medical Devices."
"Biocompatibility Testing included: Cytotoxicity, Irritation, Sensitization, Colorant Leachable Study."

While these statements indicate that testing was performed and the device complied with standards, they do not provide the specific acceptance criteria (e.g., "flow rate must be > X mL/min") or the reported device performance values (e.g., "observed flow rate was Y mL/min"). Therefore, I cannot construct the requested table or answer the specific questions about sample size, ground truth, expert involvement, or MRMC studies for performance metrics.

Based on the provided text, the following information is either not available or cannot be fully extracted:

A table of acceptance criteria and the reported device performance: Information about specific acceptance criteria (e.g., numerical thresholds for flow rate, friction, tensile strength) and the actual performance values obtained is not provided. The document only states compliance with standards.
Sample sizes used for the test set and the data provenance: This information is not provided in the summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant for the type of device (urinary catheter) and the performance tests described (physical and biocompatibility). These tests do not involve expert interpretation of images or clinical data for ground truth establishment.
Adjudication method for the test set: Not applicable for empirical physical and biocompatibility 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: This is not applicable as this is a medical device (urinary catheter), not an AI/software as a medical device for interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical and biological tests, "ground truth" would typically be established by validated test methods and reference standards, not expert consensus or pathology in the context of this device.
The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device (urinary catheter) and focuses on demonstrating substantial equivalence through compliance with recognized standards for physical and biocompatibility properties. It does not contain the detailed performance study results, acceptance criteria, or ground truth establishment relevant for AI-based or diagnostic devices.

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, stacked on top of each other, representing the department's focus on health and human well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 20, 2015

Coloplast A/s Brian Schmidt Regulatory Affairs Manager 1601 West River Road North Minneapolis, MN 55411

Re: K143182

Trade/Device Name: Speedicath Compact Male Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: GBM Dated: January 7, 2015 Received: January 8, 2015

Dear Brian Schmidt,

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 yours,

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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Statement of Indications for Use

510(k) Number (if known): K143182

Device Name: SpeediCath Compact Male

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR (Per 21 CFR 801.109

Over-The-Counter Use_

(Optional Format 1-2-96)

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510(k) Summary

SpeediCath Compact Male

(as required per 21 CFR § 807.92)

The assigned 510(k) number is:
Submitter:	Coloplast Corp1601 West River Road NorthMinneapolis, MN 55411
Contact Person:	Brian E. SchmidtRegulatory Affairs ManagerColoplast Corp1601 West River RoadMinneapolis, MN 55411
	Office: (612) 302-4987Fax: (612) 287-4138e-mail: usbes@coloplast.com
Date Prepared:	January 9, 2015

Device Name and Classification

Trade Name:	SpeediCath Compact Male
Common Name:	Urinary Catheter for Intermittent Use
Classification Name:	Gastroenterology-Urology Devices
Product Code:	GBM

Legal Manufacturer

Coloplast A/S Holtedam 1 DK-3050 Humlebaek Denmark

Device Description

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Substantial Equivalence Claim

The proposed SpeediCath Compact Male is substantially equivalent in form and function to Coloplast's SpeediCath Compact Set Male, which was cleared under 510(k) K121458 on October 1, 2012.

SpeediCath Compact Male and the predicate device are sterile, single use catheters for intermittent use with hydrophilic coatings.

Both SpeediCath Compact Male and the predicate device are ready to use catheters with identical hydrophilic coatings immersed in identical saline solution. Furthermore, both SpeediCath Compact Male and the predicate device uses the same type of catheter design: telescope catheter.

The main difference between SpeediCath Compact Male and the predicate device is the packaging configuration and visual appearance. SpeediCath Compact Male does not have a pre-attached urine collection bag like the predicate device. The SpeediCath Compact Male packaging configuration has the same ready to use features as the predicate, and is packaged in a green discrete container instead of a turquoise colored. Equivalent to the predicate device, SpeediCath Compact Male is short in storage and is extended to its full length due to the telescopic extension of the catheter.

Indications for Use

Summary of Testing

SpeediCath Compact Male has been tested and complies with relevant sections of ASTM F 623-99, ASTM D1894-11, EN 1616, EN 1617 and EN 1618.

Performance Testing included:

. Flow Rate
Coefficient of Friction ●
. Tensile Strength

SpeediCath Compact Male has been tested and complies with relevant sections of ISO 10993, Biological Evaluation of Medical Devices.

Biocompatibility Testing included:

Cytotoxicity
Irritation ●
Sensitization ●
Colorant Leachable Study ●

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.