Urinary catheter for intermittent use.
The catheter is indicated for use by patients with chronic 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 the urine to drain.

Device Description

The SpeediCath Standard is a sterile single use hydrophilic coated polyurethane catheter. The catheter is placed in a swelling media, packed and sealed in a foil pouch and sterilized.

AI/ML Overview

The provided text is a 510(k) summary for the SpeediCath Standard urological catheter. It outlines the device's characteristics, indications for use, and a summary of non-clinical testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics. Instead, it indicates that "All tests met the pre-determined acceptance criteria." It lists the types of performance tests conducted.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met according to ISO 10993-1:2009 and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
Lubricity/Friction (Bench Tests)	Met per ASTM D1894:2014 and internal test methods.
Shelf Life	Met for Accelerated Aged shelf life testing (in compliance with ASTM F1980-16).
Sterilization	Met for sterilization dose confirmation according to ISO 11137-2:2013.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any of the tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) as the tests are non-clinical, benchtop, and accelerated aged studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. The studies described are non-clinical (biocompatibility, bench testing, shelf life, sterilization dose confirmation), which do not typically involve human expert interpretation for "ground truth" in the way clinical studies or AI algorithm evaluations do.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. As mentioned in point 3, the studies are non-clinical and do not involve human adjudication processes for a test set.

5. 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a urological catheter, and the studies described are non-clinical; thus, an MRMC study related to AI assistance for human readers would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. The device is a physical medical device (catheter) and does not involve an algorithm or AI.

7. The type of ground truth used

The concept of "ground truth" as typically defined in AI/clinical studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable to physical device performance testing as described. For the non-clinical tests, the "ground truth" would be established by the specifications and validated methodologies of the referenced standards (e.g., ISO, ASTM). For example:

Biocompatibility: Ground truth is defined by the criteria within ISO 10993-1 and FDA guidance.
Bench Testing: Ground truth is defined by the specified parameters and ranges within ASTM D1894 and internal test methods.
Shelf Life: Ground truth is established by the specified degradation limits and stability parameters within ASTM F1980-16.
Sterilization: Ground truth is defined by the validated sterilization dose (e.g., sterility assurance level) according to ISO 11137-2.

8. The sample size for the training set

This information is not applicable and not provided. As the device is a physical medical product and not an AI/software product, there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided. There is no training set for this type of device submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 25, 2018

Coloplast Troy Thome Senior Regulatory Affairs Specialist 1601 West River Road North Minneapolis, Minnesota 55411

Re: K180258

Trade/Device Name: SpeediCath Standard Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: GBM Dated: September 21, 2018 Received: September 24, 2018

Dear Troy Thome:

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Glenn B. Bell -S

for

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) K180258

Device Name SpeediCath Standard

Indications for Use (Describe)

Urinary catheter for intermittent use.

The catheter is indicated for use by patients with chronic urine retents with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the ureach the bladder allowing the urine to drain.

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 Standard 510(k) Summary

Submitted by:	Coloplast Corp1601 West River Road NorthMinneapolis, MN 55411 USA
Contact Person:	Troy ThomeColoplast CorpPhone : 612-704-9909Fax : 612-287-4138Email : ustthome@coloplast.com
Date of Summary:	October 24, 2018
Trade or Proprietary Name:	SpeediCath® Standard
Common or Usual Name:	Catheter, urethral
Classification Name:	Urological catheter and accessories21CFR 876.5130
Classification:	Class II
Product Code:	GBM
Predicate Device:	SpeediCath, K023254 (Manufacturer: Coloplast)
Device Description:	The SpeediCath Standard is a sterile single use hydrophilic coatedpolyurethane catheter. The catheter is placed in a swelling media,packed and sealed in a foil pouch and sterilized.
Indication for Use:	Urinary catheter for intermittent use.The catheter is indicated for use by patients with chronic urine retentionand patients with a post void residual volume (PVR) due to neurogenicand non-neurogenic voiding dysfunction. The catheter is inserted intothe urethra to reach the bladder allowing the urine to drain.
Technological Characteristics:	The subject device has the same indications for use, design, materials(with exception of the swelling media that lubricates the catheter) andprinciples of operations as the predicate device. The subject deviceincludes the same coating and packaging configuration.

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Summary of Non-Clinical Testing:

Performance testing for SpeediCath Standard was conducted according to applicable sections of voluntary standards:

. Biocompatibility testing according to ISO 10993-1:2009 and FDA Guidance "Use of International Standard ISO 10993-1" (2016) was completed.
Bench testing was completed per ASTM D1894:2014 and . internal test methods.
. Accelerated Aged (in compliance with ASTM F1980-16) shelf life testing was completed.
. Sterilization dose confirmation was completed according to ISO 11137-2: 2013.

All tests met the pre-determined acceptance criteria.

The SpeediCath Standard is as safe and effective and is substantially equivalent to the legally marketed predicate device as demonstrated by the same intended use, same principles of operation, similar technological characteristics and performance data, and does not raise different questions of safety and effectiveness.

Substantial Equivalence Conclusion:

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.