Medline silicone Foley catheters are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation.

Device Description

Medline silicone Foley catheters are two-way Foley catheters which are placed in the bladder through the urethra. The urine drains out through the catheter into a collection device attached to the catheter. Threeway Foley catheters offer the option of irrigating the bladder through a 3rd lumen. These catheters have various balloon volumes, shaft sizes and irrigation features.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device: Medline Silicone Foley Catheters (K142635).

This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove safety and effectiveness from scratch. Therefore, the information you're requesting regarding acceptance criteria and studies proving the device meets those criteria in the context of an AI/algorithm-driven device is largely not applicable to this document. This document describes a physical medical device, not an AI software.

Here's why and what can be extracted:

No AI/Algorithm: The Medline Silicone Foley Catheter is a physical device used for urine drainage and irrigation. It does not incorporate any AI or advanced algorithms with performance metrics like sensitivity, specificity, or ROC curves that would require the typical "acceptance criteria" you're inquiring about for AI-based medical devices.
Substantial Equivalence: The entire premise of a 510(k) is to demonstrate that the new device is "substantially equivalent" to an already legally marketed device (the predicate device) in terms of intended use, technological characteristics, and safety and effectiveness. This means it doesn't need to meet new acceptance criteria but rather demonstrate it performs similarly to an established device.
Non-Clinical Testing: The document explicitly states "Summary of Non-Clinical Testing: Functional performance testing of the Medline silicone Foley catheter demonstrated device effectiveness in accordance with relevant ASTM F623 test methods." This indicates that the device was tested against an existing standard for physical catheters. The acceptance criteria would be defined within the ASTM F623 standard for properties like balloon integrity, flow rates, material compatibility, etc. The document does not report the specific results or acceptance criteria from these ASTM tests, but rather states that it met them.
No Clinical Testing: The document explicitly states "Summary of Clinical Testing: Not applicable." This confirms that no clinical studies were performed to establish the device's efficacy or safety against new metrics.

Given this context, most of your requested information is not present or relevant to this 510(k) submission. However, I can fill in what is available from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments
Functional Performance	Demonstrated device effectiveness in accordance with relevant ASTM F623 test methods.	Specific criteria and numerical results are not detailed in this submission. Compliance with ASTM F623 implies meeting established engineering and material standards for Foley catheters.
Technological Characteristics	No significant differences in technological characteristics between Medline's silicone Foley catheters and the cited predicate device (Well Lead silicone and latex catheters, K082815).	This is the core of substantial equivalence. Details on specific characteristics compared are not provided in this summary.
Material Safety	Adequately supported by materials information and analysis data within this Premarket Notification.	Specific material tests and acceptance limits are not detailed.

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. Testing was non-clinical (functional performance tests according to ASTM F623).
Data Provenance: Not specified, but generally, non-clinical tests are conducted in laboratories and are prospective for the testing of the specific device.

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

Not Applicable. This is a physical medical device, not an AI/algorithm. Ground truth as typically understood for AI models (e.g., expert consensus on image interpretation) is not relevant here. The "ground truth" for non-clinical performance would be defined by the ASTM F623 standard itself.

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

Not Applicable. See point 3.

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. This is a physical medical device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

No. This is a physical medical device. No algorithm is involved.

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

Not Applicable. For the non-clinical testing described, the "ground truth" would be defined by the established parameters and performance requirements outlined in the ASTM F623 standard.

8. The sample size for the training set

Not Applicable. This is a physical medical device. No AI model was trained.

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

Not Applicable. See point 8.

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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

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

January 9, 2015

Medline Industries, Inc. Matt Clausen Sr. Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060

Re: K142635

Trade/Device Name: Medline Silicone Foley Catheters Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: December 10, 2014 Received: December 15, 2014

Dear Matt Clausen,

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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 -A

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) K142635

Device Name Medline silicone Foley catheters

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with the letters slightly spaced apart. Below the text is a stylized blue star shape with a curved line extending downwards from the center. The star and the text are both in the same shade of blue.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486

510(k) Summary (as required per 21 CFR 807.92)

Summary Preparation Date

September 10, 2014

Submitter / 510(k) Sponsor

Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060

Contact Person

Matt Clausen Sr. Regulatory Affairs specialist Phone: 847-643-4785 Fax: 847-643-4482

Device Name / Classification

Device Name: Silicone Foley Catheter Proprietary Name: Medline Silicone Foley Catheter Common Name: Foley Catheter Classification Name: Urological catheter and accessories (21 CRF 876.5130, product code - EZL)

Predicate Device

Well Lead silicone and latex catheters, K082815

Device Description

Indications for Use

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with the letters slightly slanted to the right. Below the text is a stylized blue symbol that resembles a compass or a stylized medical cross. The logo is simple and modern, and the blue color gives it a professional and trustworthy feel.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486

Summary of Technological Characteristics

Information within this Premarket Notification demonstrates that there are no significant differences in technological characteristics between Medline's silicone Foley catheters and the cited predicate device.

Summary of Non-Clinical Testing

The safety and effectiveness of Medline's silicone Foley catheters is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. Functional performance testing of the Medline silicone Foley catheter demonstrated device effectiveness in accordance with relevant ASTM F623 test methods.

Summary of Clinical Testing

Not applicable.

Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline silicone Foley catheter is safe, effective and substantially equivalent as described herein.

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.