The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

Device Description

The Mentor Self-Cath® HydroGel™ catheter (hereafter referred to as SCHG) is an extension of the existing Mentor Self-Cath product line. The device is a modification of the Mentor Self-Cath® Plus catheter and the Mentor Self-Cath Closed System catheter.

The SCHG is intended to be used to drain urine from the bladder. It is provided sterile and is for single-use only. It consists of a prelubricated catheter with an 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 is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport.

The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.

AI/ML Overview

The provided text describes a medical device, the Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter, and its path to FDA clearance via a 510(k) submission (K050008). However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or similar measures typically used for diagnostic or AI-based devices.

This submission focuses on substantial equivalence to predicate devices and biocompatibility testing rather than performance in terms of diagnostic effectiveness or clinical outcome improvement through a P-value or specific statistical analysis commonly found in clinical trials. As such, many of the requested fields cannot be filled from the provided text.

Here's a breakdown based on the given information:

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

Acceptance Criteria	Reported Device Performance
Biocompatibility:
Cytotoxicity (ISO Method)	Catheter portion: Did not induce cytotoxicity. Introducer tip portion: Did introduce cytotoxicity, but reactivity was less than Grade 2 (mild reactivity).
Guinea Pig Maximization (Saline & Vegetable Oil Extracts)	No signs of sensitization observed.
Systemic Toxicity (Acute Systemic Injection with Saline & Vegetable Oil Extracts)	Met the requirements of the systemic injection test.
Acute Vaginal Irritation	Met the requirements of the vaginal irritation test.
Genotoxicity (Ames Test)	Extracts were not mutagenic for any tester strain, with or without S9 activation.
Substantial Equivalence:	The device is considered substantially equivalent in form and function to the Mentor's Self-Cath Plus Catheter (K003874) and the Self-Cath Closed System (K003873).

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

Sample Size for Test Set: Not specified for biocompatibility tests (e.g., number of units tested, number of animals). This information is usually detailed in the full test reports, which are not included in this summary.
Data Provenance: Not specified. The tests are general biocompatibility tests, not clinical studies in humans or specific geographical data.

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

Not applicable. This submission concerns the biocompatibility and substantial equivalence of a physical medical device, not a diagnostic algorithm requiring expert-established ground truth.

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

Not applicable. This type of adjudication is typically used for image-based diagnostics or clinical studies where subjective interpretation is involved.

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

No MRMC study was done. This is not an AI-assisted device.

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

Not applicable. This is not an algorithm.

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

For biocompatibility, the "ground truth" is established by the results of standardized biological tests (e.g., observation of cellular reactions, animal responses to extracts, genotoxicity assays) and comparison against acceptance criteria defined by relevant ISO standards or regulatory guidelines.
For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary

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Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter

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: K050008

Contact Person:	Donna A. CrawfordDirector, Domestic Regulatory SubmissionsMentor Corporation201 Mentor DriveSanta Barbara, CA 93111
Telephone:	805-879-6304
FAX:	805-879-6015
Date Prepared:	December 30, 2004

Device Name and Classification

Trade Name:	Mentor Self-Cath ® Hydrogel™ Intermittent Urethral Urinary Catheter
Common Name:	Urinary Catheter
Classification Name:	Urological Catheter and Accessories
Product Code:	78 EZD

Manufacturer

Mentor Minnesota 1601 West River Road North Minneapolis, MN 55411

Device Description

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potential contamination while advancing the catheter into the urethra. The catheter is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport.

The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.

Substantial Equivalence Claim

Mentor Corporation believes the proposed Mentor SCHG is substantially equivalent in form and function to Mentor's Self-Cath Plus Catheter and the Self-Cath Closed System, which were cleared under 510(k)s K003874 and K003873, respectively.

Indications for Use

Summary of Testing

Mentor has performed biocompatibility testing on the SCHG:

Cytotoxicity (Agar Diffusion - ISO Method): The catheter portion of the test article did not induce cytotoxicity. The introducer tip portion did introduce cytotoxicity; however, the reactivity was less that a Grade 2 (mild reactivity). Therefore, the test article does meet the criteria of this test.

Guinea Pig Maximization (Saline and Vegetable Oil Extracts): There were no signs of sensitization observed in guinea pigs treated with the test article. Therefore, the test article is not considered to elicit contact dermal allergenicity.

Systemic Toxicity (Acute Systemic Injection with Saline and Vegetable Oil Extracts: The test article met the requirements of the systemic injection test.

Acute Vaginal Irritation: The test article meets the requirements of the vaginal irritation test.

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Genotoxicity (Ames Test): The results of this test indicated that under the experimental conditions, the extracts of this test article were not mutagenic for any tester strain, with or without any S9 activation.

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Image /page/3/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" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three abstract figures or lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 - 2005

Ms. Donna A. Crawford Director, Domestic Regulatory Submissions Mentor Corporation 201 Mentor Drive SANTA BARBARA CA 93111

Re: K050008

Trade/Device Name: Mentor Self-Cath® HydroGel™ Intermittent Urinary Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD and FCM Dated: May 19, 2005 Received: May 20, 2005

Dear Ms. Crawford:

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 (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

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Page 2 - Ms. Donna Crawford

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.

In addition, we have determined that your device kit contains 3 Povidone-Iodine (PVP) swabs and a benzalkonium chloride (BZK) towellette, 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 (301) 443-6597, or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely vours.

Rate Phillips

1 Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Kog 0008

Device Name: Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter

Indications For Use:

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

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

11.188

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ra-C. Phillips

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050008

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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.