Self-Cath® CS Closed System is intended for use in male or female patients needing bladder drainage as determined by their physician. More specifically it is intended for use where drainage of the bladder into a suitable receptacle such as a commode or bedpan is not feasible or practical. The device can be used by either the patient, once appropriate training has taken place, or by a trained health care professional.

Device Description

The Coloplast Self-Cath® CS Closed System catheter (also referred to as "SCCS") is an extension of the existing Coloplast Self-Cath product line. The device is a modification of the Coloplast (Mentor) Self-Cath Closed System catheter, which was cleared under 510(k) K003873. It is available singly and as part of a kit.

The SCCS is intended to be used to drain urine from the bladder. The SCCS is a catheter and collection bag assembly for inserting a catheter from a closed, sterile bag through an insertion tip into the bladder. It consists of a sterile, pre-lubricated catheter with a pre-lubricated introducer tip on the proximal end, which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter and introducer tip are pre-lubricated with a water-soluble hydrophilic water-based lubricant. The catheter provides a conduit for draining the bladder into the pre-attached urine collection bag.

AI/ML Overview

This document is a 510(k) summary for the Coloplast Self-Cath® CS Closed Urinary Catheterization System, seeking clearance due to substantial equivalence to a previously cleared device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for diagnostic AI/ML products.

This 510(k) is for a physical medical device (a catheter system), not a software or AI-driven diagnostic device. Therefore, the questions about performance metrics (e.g., sensitivity, specificity), ground truth, expert readers, and training/test sets are largely incongruent with the information provided. The "acceptance criteria" for a device of this type would typically revolve around physical and biological compatibility, manufacturing quality, and functional performance relative to its predicate, rather than algorithmic accuracy.

However, I will extract relevant information and address the questions to the best of my ability based on the provided text, highlighting where the information is not applicable or available for this type of device submission.

Acceptance Criteria and Study Information for the Self-Cath® CS Closed Urinary Catheterization System

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

For this type of physical medical device, acceptance criteria are generally established against the functional, material, and safety characteristics of a legally marketed predicate device. The document states a claim of "Substantial Equivalence," which is the primary "acceptance criterion" for a 510(k) submission. Performance is assessed by demonstrating this equivalence through various tests (often mechanical, biological, and material compatibility), which are not detailed in this summary.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance (Implicit from Substantial Equivalence Claim)
Intended Use: Bladder drainage for male/female patients.	The device is intended for the same use as the predicate device.
Device Design: Catheter and collection bag assembly with a pre-lubricated catheter and introducer tip.	The device is a modification of the predicate, sharing core design elements.
Material Composition: (Not explicitly detailed, but implied to be equivalent or compatible)	(Implied to be equivalent or compatible with the predicate)
Performance Characteristics (e.g., flow rate, ease of insertion, sterility): (Not explicitly detailed, but implied to be equivalent)	(Implied to be equivalent to the predicate)
Safety and Effectiveness: No new questions of safety or effectiveness compared to the predicate.	The device is considered as safe and effective as the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. For a physical medical device, "test set" would typically refer to the samples used in engineering, biocompatibility, and sterility testing, not clinical data sets in the way AI/ML products require. The document states it is a "modification" of an existing device (K003873), implying that much of the foundational testing and validation was done for the predicate, and this submission focuses on demonstrating that the modifications do not alter the substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/provided. For a physical catheter system, "ground truth" and expert consensus in the diagnostic sense are not relevant. Clinical performance might be assessed via user feedback or clinical studies (which are not detailed here), but this is different from establishing ground truth for AI/ML evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not a part of the substantial equivalence process for a physical device like a catheter.

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

This information is not applicable/provided. MRMC studies are used to evaluate the performance of diagnostic imaging devices, often involving AI. This device is a catheter, not a diagnostic imaging or AI device, so such a study would not be performed.

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

This information is not applicable/provided. This is a physical medical device, not an algorithm, so standalone AI performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/provided. "Ground truth" in the context of diagnostic accuracy is not relevant for this physical device. The "truth" for a catheter would be its ability to correctly drain urine, its sterility, material safety, and physical properties, which are assessed through engineering and biological testing.

8. The sample size for the training set

This information is not applicable/provided. The concept of a "training set" is for AI/ML models. This document describes a physical medical device.

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

This information is not applicable/provided. Similar to point 8, this question is not relevant for the device described in the document.

Summary

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. Attachment I – 510(k) Summary

JUN - 1 2007

510(k) Summary

Self-Cath® CS Closed Urinary Catheterization System

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: K070939

Contact Person:
Rebeka A. Stoltman
Manager, Regulatory Affairs
Coloplast Corp
1601 West River Road North
Minneapolis, MN 55411

Telephone: (800) 788-0293, ext. 4997
Facsimile: (612) 287-4138
Email: usrst@coloplast.com

Date Prepared: April 3, 2007

Device Name and Classification

Trade Name:	Self-Cath® CS Closed Urinary Catheterization System
Common Name:	Intermittent Urethral Urinary Catheter
Classification Name:	Urological Catheter and Accessories
Product Code:	FCM and KOD

Legal Manufacturer

Coloplast A/S Holtedam 1 3050 Humlebaek, Denmark

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Manufacturing Site (Catheter)

Coloplast Manufacturing US, LLC 1601 West River Road Minneapolis, MN 55411 USA

Manufacturing Site (Assembly & Packaging)

Shanghai Amsino Medical Devices Co., Ltd. 668 Hua Jiang Road Shanghai, P.R. China 201803

Device Description

Substantial Equivalence Claim

Coloplast believes the proposed Self-Cath® CS Closed System is substantially equivalent in form and function to Coloplast's Self-Cath Closed System, which was cleared under 510(k) K003873.

Indications for Use

The Self-Cath® CS Closed System is intended for use in male or female patients needing bladder drainage as determined by their physician. More specifically it is intended for use where drainage of the bladder into a suitable receptacle such as a commode or bedpan is not feasible or practical. The device can be used by either the patient, once appropriate training has taken place, or by a trained health care professional.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rebeka Stoltman Manager, Regulatory Affairs Coloplast Corp. 1601 West River Road North MINNEAPOLIS MN 55411

JUN - 1 2007

Re: K070939

Trade/Device Name: Self-Cath® CS Closed Urinary Catheterization System Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Codes: FCM Dated: April 30, 2007 Received: May 4, 2007

Dear Ms. Stoltman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Rebeka Stoltman

In addition, we have determined that your device kit contains povidone iodine swabsticks and benzalkonium chloride towelettes, which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Nancy C Brogdon

ogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment C - Indications for Use Statement

Indications for Use Statement

070929

510(k) Number (if known):

Device Name: Self-Cath® CS Closed Urinary Catheterization System

Indications for Use:

Prescription Use X (21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive, Abdo minal. and Radiological Devices 510(k) Number.

Special 510(k): Device Modification

Confidential -

Self-Cath® CS Closed Urinary Catheterization System

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.