Medline Poly-Cath Red Polymer Urethral Catheter is intended for use in the drainage of urine from the bladder, and it is indicated for the intermittent catheterization of male adults who are not capable of voluntary urination. This product is not designed for use as an indwelling catheter.

Device Description

Medline Poly-Cath™ Red Polymer Urethral Catheter is a single use, flexible, straight urinary catheter that is inserted through the urethra into the bladder allowing urine to drain. The proposed device is comprised of a polyvinyl chloride (PVC) compound that does not contain bis (2-ethylhexyl) phthalate (DEHP). The catheter has a rounded closed tip with two oval drainage eyes at one end, and a funnel bonded to the opposite end. Medline Poly-Cath™ Red Polymer Urethral Catheter is provided sterile.

AI/ML Overview

This document describes the regulatory submission for the Medline Poly-Cath™ Red Polymer Urethral Catheter, seeking substantial equivalence to a predicate device. It primarily focuses on the device's characteristics and performance relative to existing standards, rather than proving the performance of an AI/ML-based device against specific acceptance criteria using a clinical study.

Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and acceptance criteria based on AI/ML metrics, cannot be found in this document.

The document describes non-clinical testing to demonstrate performance and safety, primarily through bench testing and biocompatibility testing against established standards for urological catheters.

Here's the information that can be extracted or inferred from the document:

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

The document does not present acceptance criteria for an AI/ML device. Instead, it refers to industry standards for traditional medical devices.

Device Type: Medline Poly-Cath™ Red Polymer Urethral Catheter (a physical medical device, not an AI/ML diagnostic tool).
Acceptance Criteria (as implied by testing, not explicit thresholds): Conformance to relevant industry standards.
Reported Device Performance (from "Summary of Non-Clinical Testing" and "Performance Testing (Bench)" table):

Test Objective	Testing Standards	Performance Results
Catheter Surface Finish	BS EN 1616:1997	Meet BS EN 1616:1997 § 4.2 Requirements
Catheter Dimensional Analysis	BS EN 1616:1997	Meet BS EN 1616:1997 § 4.3 Requirements
Catheter Strength	BS EN 1616:1997	Meet BS EN 1616:1997 § 4.4 Requirements
Catheter Flow Rate	BS EN 1616:1997, BS EN 1618:1997	Meet BS EN 1616:1997 § 4.8 Requirements and BS EN 1618:1997 § Annex E
Connector Security	BS EN 1616:1997	Meet BS EN 1616:1997 § 4.5 Requirements

Biocompatibility Testing (Pass/Fail implied):
- Cytotoxicity: Per ISO 10993-5:2009
- Sensitization: Per ISO 10993-10:2010
- Irritation: Per ISO 10993-10:2010
- Acute Systemic Toxicity: Per ISO 10993-11:2006
- Results are implicitly "passed" or "met requirements" as the overall conclusion states "results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination."

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: Not specified for any test. The tests are bench tests of physical properties, not clinical data sets.
Data Provenance: Not applicable in the context of clinical data. The tests were likely conducted in a lab setting by or for Medline Industries, Inc. (Northfield, IL, USA).

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)

Not applicable. This is not a study requiring expert ground truth for image or clinical data interpretation. The ground truth is established by the specifications in the referenced standards (e.g., BS EN 1616:1997).

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

Not applicable. This is not a study requiring clinical or image data adjudication.

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

Not applicable. This document is for a physical medical device (catheter), not an AI/ML diagnostic or assistance tool.

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

Not applicable. This document is for a physical medical device (catheter).

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

For the performance testing, the "ground truth" (or "reference standard") is the specifications and methodology defined within the cited ISO and BS EN standards (e.g., BS EN 1616:1997). For biocompatibility, it's the pass/fail criteria outlined in the ISO 10993 series.

8. The sample size for the training set

Not applicable. This is not an AI/ML device being "trained."

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

Not applicable.

Summary

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June 12, 2019

Medline Industries, Inc. Dinah Rincones Regulatory Specialist Three Lakes Drive Northfield, IL 60093

Re: K183335

Trade/Device Name: Medline Poly-Cath Red Polymer Urethral Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: May 2, 2019 Received: May 6, 2019

Dear Dinah Rincones:

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. Although this letter refers to your product as a device, please be aware 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.

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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 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Glenn B. Bell, Ph.D. Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K183335

Device Name

Medline Poly-Cath Red Polymer Urethral Catheter

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)

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ledline Industries, Inc. Three Lakes Drive Northfield. IL 60093

SECTION 5 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592

Contact Person

Dinah Rincones Regulatory Affairs Specialist Phone: 847-949-2687 Email: DRincones@medline.com

Summary Preparation Date

November 30, 2018

Type of 510(k) Submission

Traditional

Device Name / Classification

Trade Name: ●
Device Common Name:
Regulation Name:
. Regulation Number :
Product Code:
Device Class:
. Review Panel:

Predicate Device DOVER ROB-NEL Catheter K040897

Device Description

Medline Poly-Cath™ Red Polymer Urethral Catheter Catheter, Urethral Urological Catheter and Accessories 21 CFR 8876.5130 GBM Class II Gastroenterology/Urology

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Image /page/4/Picture/1 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in white, stacked vertically, with a white starburst-like symbol to the right of the text. The background is a solid dark blue color. There is a gray bar on the right side of the image.

Aedline Industries. Inc Three Lakes Drive Northfield, IL 60093

(DEHP). The catheter has a rounded closed tip with two oval drainage eyes at one end, and a funnel bonded to the opposite end. Medline Poly-Cath™ Red Polymer Urethral Catheter is provided sterile.

Indications for Use

Summary of Technological Characteristics

The Medline Poly-Cath™ Red Polymer Urethral Catheter is similar in design, indications for use and technological characteristics to the predicate device cleared under K040897, DOVER® ROB-NEL Catheter.

Device Characteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Medline Poly-Cath™ RedPolymer Urethral Catheter	DOVER® ROB-NEL Catheter	N/A
510(k) Reference	N/A	K040897	N/A
Product Owner	Medline Industries, Inc.	Covidien	N/A
Intended Use	Medline Poly-Cath RedPolymer Urethral Catheter isintended for intermittentcatheterization to drain urinefrom the urinary bladder.The product is intended foruse on patients who are notcapable of voluntaryurination.	DOVER® ROB-NEL Catheteris intended for intermittentcatheterization to drain urinefrom the urinary bladder. Theproduct is intended for use onpatients who are not capable ofvoluntary urination.	Same
Indications for Use	Medline Poly-Cath RedPolymer Urethral Catheter isintended for use in thedrainage of urine from thebladder, and it is indicated forthe intermittent catheterizationof male and female adults whoare not capable of voluntaryurination. This product is notdesigned for use as anindwelling catheter.	The proposed device isintended for use in thedrainage of urine from theurinary bladder. The product isintended for intermittentcatheterization on patients whoare not capable of voluntaryurination. This product is notdesigned for use as anindwelling catheter.	Similar
Design Features	Flexible, straight catheter withtwo staggered eyes, a roundedclosed tip and a funnel end.	Flexible, straight catheter withtwo staggered holes, a roundedclosed tip and a funnel end.	Same

TABLE 1 - Comparison of Proposed and Predicate Devices

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Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

Device Characteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Design Configurations	One size: 16", 14 Fr	Various sizes, including 16", 14 Fr	Similar
Materials	PVC, colorants, adhesive	PVC, colorants	Similar
Prescription vs. OTC	Prescription	Prescription	Same
Biocompatibility, ContactDuration	ISO 10993-1,Limited Contact (<24h)	ISO 10993-1,Limited Contact (<24h)	Same
Performance Testing	Conforms to applicablestandard specification forurethral catheters	Conforms to applicablestandard specification forurethral catheters	Same
Sterile vs. Non-Sterile	Sterile	Sterile	Same
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Same
Single Use vs. Reusable	Single Use	Single Use	Same

Summary of Non-Clinical Testing

Non-clinical verification of The Medline Poly-Cath™ Red Polymer Urethral Catheter has been conducted to evaluate its safety, performance and functionality. The results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination. Specifically, the proposed device has been evaluated through the following tests:

Biocompatibility Testing

The biocompatibility evaluation was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA.

The following tests were performed to evaluate the biocompatibility of Medline Poly-Cath™ Red Polymer Urethral Catheter:

Cytotoxicity: ISO MEM Elution (GLP) in accordance with ISO 10993-5:2009 "Biological ● Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity".
Sensitization: ISO Guinea Pig Maximization Sensitization Test (GLP) in accordance with the ● test guidelines described in ISO 10993-10: 2010 Standard, "Biological Evaluation of Medical Devices, Part 10-Tests for Irritation and Sensitization".
Irritation: ISO Vaginal Irritation Study in Rabbits (GLP) in accordance with the test ● guidelines described in ISO 10993-10: 2010 Standard, "Biological Evaluation of Medical Devices, Part 10-Tests for Irritation and Sensitization".

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ledline Industries. Inc Three Lakes Drive Northfield, IL 60093

Acute Systemic Toxicity: ISO Systemic Toxicity Study in Mice (GLP) in accordance with the ● test guidelines described in ISO 10993-11: 2006 Standard, "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity".

Performance Testing (Bench)

Functional performance testing was carried out on the final finished form of the proposed device. The table below provides a summary of all functional testing performed.

Test Objective	Testing Standards	Performance Results
Catheter Surface Finish	BS EN 1616:1997	Meet BS EN 1616:1997 § 4.2Requirements
Catheter Dimensional Analysis	BS EN 1616:1997	Meet BS EN 1616:1997 § 4.3Requirements
Catheter Strength	BS EN 1616:1997	Meet BS EN 1616:1997 § 4.4Requirements
Catheter Flow Rate	BS EN 1616:1997BS EN 1618:1997	Meet BS EN 1616:1997 § 4.8Requirements and BS EN1618:1997 § Annex E
Connector Security	BS EN 1616:1997	Meet BS EN 1616:1997 § 4.5Requirements

TABLE 1 - Summary of Performance Testing

Additional Non-Clinical Evaluations

Stability (Shelf-Life) Testing. ●
Ethylene Oxide Sterilization Residuals Evaluation.
Bioburden Evaluation.
Simulated Shipping Testing.
Packaging Integrity Testing.

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Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

Conclusion

In accordance with 21 CFR Part 807, and based on a comparison of 'Indications for Use,' technological characteristics and performance data, Medline Industries, Inc. concludes that the proposed Medline Poly-Cath™ Red Polymer Urethral Catheter is substantially equivalent to the predicate device, DOVER ROB-NEL Catheter (K040897).

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.