Medline Catheter Specimen Collector is a tubular device that is inserted through the urethra and utilized for passage of fluids from the urinary tract.

Device Description

The Medline Catheter Specimen Collector is a sterile, single-use device consisting of a straight polyvinyl chloride (PVC) tube that is inserted through the urethra and utilized for passage of fluids from the urinary tract directly into a collection container. It is intended to be used in urinary collection procedures as a way to obtain a urine sample through a catheter inserted through the urethra into the bladder. The sample is obtained by this method to avoid contamination from the urethra, or if urine cannot be obtained from the patient using the clean catch method. The Medline Catheter Specimen Collector includes a straight urethral catheter, a sheath to protect the catheter during shipping, a pre-attached collection container, and a cap. The catheter is made of polyvinyl chloride (PVC) and features a closed rounded tip with four (4) drainage eyelets. It is available in a combination of French sizes (5FR and 8FR) and lengths ranging from 6.5 to 14 inches.

AI/ML Overview

Let's break down the information regarding the acceptance criteria and study for the Medline Catheter Specimen Collector (K172541), based on the provided text.

First, it's crucial to understand that this document describes a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device). This is not a clinical study where a new treatment or diagnostic is being evaluated for efficacy in humans. Therefore, many of the typical acceptance criteria and study design elements you'd expect for a clinical effectiveness study (like MRMC studies, specific expert consensus for ground truth on patient data, human-in-the-loop performance, etc.) are not applicable or are addressed differently in a 510(k) for a device like a catheter.

The "acceptance criteria" here relate to demonstrating that the new device is as safe and effective as the predicate device by showing similar performance characteristics and meeting relevant standards.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied from testing)	Reported Device Performance (Summary of Study Findings)
Biocompatibility	- Cytotoxicity (per ISO 10993-5)- Sensitization (Guinea Pig Maximization Test per ISO 10993-10)- Irritation (Intracutaneous Reactivity per ISO 10993-10)	The device passed all biocompatibility tests.Implied: No adverse biological reactions observed that would differentiate it from equivalent devices.
Functional Performance	- Catheter Surface Finish (per BS EN 1616:1997 §4.2)- Catheter Dimensions (per BS EN 1616:1997 §4.3)- Catheter Strength (per BS EN 1616:1997 §Annex A)- Catheter Flow Rate (per BS EN 1616:1997 §Annex E)	The device met the specified standards for surface finish, dimensions, strength, and flow rate.Implied: Performs as expected for a urethral catheter.
Sterility/Packaging	- Bioburden Testing- Package Seal Integrity (per ASTM F1929)- Stability (Shelf-Life) Testing- Ethylene Oxide and Ethylene Chlorohydrin Residual Evaluation Studies	The device met the requirements for bioburden, package integrity, shelf-life, and acceptable residuals from sterilization.Implied: Maintains sterility and safety over time.
Risk Management	- Internal Risk Analysis	An internal risk analysis was performed.Implied: Identified and mitigated potential risks to an acceptable level.
Technological Equivalence	- Same Product Code (EZD)- Same Intended Use- Same Description of use- Same Regulation Number (21 CFR 876.5130)- Same Catheter Material (Clear PVC)- Similar Catheter Sizes (5FR and 8FR)- Similar Drainage Eyes (4 vs. 2 or 3 in predicate)- Same Packaging- Conforms to recognized standard for urethral catheters (as predicate)- Same Prescription vs. OTC- Same Contact Duration (≤ 24 h)- Same Sterile vs. Non-Sterile- Same Disposable vs. Non-Disposable- Same Single Use vs. Reusable	The Medline Catheter Specimen Collector demonstrated substantial equivalence in technological characteristics and performance to the predicate device (Busse Hospital Disposable Urethral Catheter, K041464).

Study Details:

This submission relies on non-clinical testing to demonstrate substantial equivalence to its predicate device, primarily focusing on physical and material properties, and safety.

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "test set sample size" in terms of number of patients or images, as this is a non-clinical device submission. For the non-clinical tests (biocompatibility, functional, etc.), the sample sizes would be determined by the testing standards (e.g., number of catheters tested for flow rate, number of animals for biocompatibility). These specific quantities are not provided in this summary.
- Data Provenance: The data comes from non-clinical evaluations (laboratory testing) as opposed to patient data. The country of origin of the data is not specified but would typically be from accredited testing facilities. The studies are prospective in the sense that they were conducted for the purpose of this submission following defined protocols.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a 510(k) for a basic medical device like a catheter, "ground truth" in the clinical sense (e.g., expert consensus on medical images or pathology results) is not established. The "ground truth" for the non-clinical tests is adherence to recognized standards and objective measurements (e.g., a caliper measures "true" dimensions; a flow meter measures "true" flow rate).
Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in clinical studies to resolve disagreements. Since this is non-clinical testing against objective standards, no such adjudication method is relevant.
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. An MRMC study was not performed, nor is it applicable. This device is a physical medical device (catheter) used for fluid passage/specimen collection, not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
The type of ground truth used:
- Standards and Objective Measurements. The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards (e.g., ISO 10993, BS EN 1616, ASTM F1929) and the objective measurements derived from these tests. These standards represent accepted benchmarks for safety and performance for this type of device.
The sample size for the training set:
- Not Applicable. No "training set" is mentioned or implied for this device, as it is not an AI/machine learning product requiring data for model training.
How the ground truth for the training set was established:
- Not Applicable. As no training set was used, this question is not relevant.

In summary: The Medline Catheter Specimen Collector achieved FDA clearance via a 510(k) pathway by demonstrating substantial equivalence to a predicate device (Busse Hospital Disposable Urethral Catheter, K041464) through comprehensive non-clinical testing. This testing confirmed the device's biocompatibility, functional performance (surface finish, dimensions, strength, flow rate), sterility, and package integrity, all in accordance with recognized industry standards. The submission did not involve clinical studies or human-in-the-loop evaluations, as its purpose was to show equivalence to an already approved physical medical device.

Summary

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February 22, 2018

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

Re: K172541

Trade/Device Name: Medline Catheter Specimen Collector Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: December 28, 2017 Received: January 2, 2018

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. 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); 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.

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.

For comprehensive regulatory information about mediation-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,

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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) K172541

Device Name Medline Catheter Specimen Collector

Indications for Use (Describe)

Medline Catheter Specimen Collector is a tubular device that is inserted through the urethra and utilized for passage of fluids from the urinary tract.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image is a logo for Medline. The logo is set against a blue background. The word "MEDLINE" is written in white, bold, sans-serif font. Behind the word is a white, stylized starburst shape, with the points of the star extending above and below the word. The starburst is oriented vertically.

edline Industries. Inc Three Lakes Drive Northfield. IL 60093

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

Summary Preparation Date August 21, 2017

Submitter / 510(k) Sponsor

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

Submission Correspondent

Dinah Rincones Regulatory Specialist Phone: 847-949-2687 Fax: 224-931-1271 Email: DRincones@medline.com

Type of 510(k) Submission Traditional

Device Name / Classification

Device Common Name - Catheter, Straight Proprietary Name - Medline Catheter Specimen Collector Classification - Class II Panel - Gastroenterology / Urology Product Code - EZD Regulation # - 21 CFR 876.5130 Urological Catheter and Accessories

Predicate Device

Busse Hospital Disposable Urethral Catheter (K041464)

Indications for Use

Medline Catheter Specimen Collector is a tubular device that is inserted through the urethra and utilized for passage of fluids from the urinary tract.

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

ledline Industries. Inc Three Lakes Drive Northfield. II 60093

Device Description

The Medline Catheter Specimen Collector includes a straight urethral catheter, a sheath to protect the catheter during shipping, a pre-attached collection container, and a cap. The catheter is made of polyvinyl chloride (PVC) and features a closed rounded tip with four (4) drainage eyelets. It is available in a combination of French sizes (5FR and 8FR) and lengths ranging from 6.5 to 14 inches.

Summary of Technological Characteristics

The Medline Catheter Specimen Collector is similar in design, intended use, function and technological characteristics to the predicate device cleared under K041464. Busse Hospital Disposable Urethral Catheter.

Device Characteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Medline Catheter SpecimenCollector	Busse Hospital DisposableUrethral Catheter	Different
510(k) Reference	TBD	K041464	Different
Product Owner	Medline Industries, Inc.	Busse Hoapital Disposables,Inc.	Different
Product Code	EZD	EZD	Same
Intended Use	The Medline CatheterSpecimen Collector is a tubulardevice that is inserted throughthe urethra and utilized forpassage of fluids from theurinary tract.	The Busse Hospital DisposableUrethral Catheter is a tubulardevice that is inserted throughthe urethra and utilized forpassage of fluids from or to theurinary tract.	Same
Description	The device is used in urinarycollection procedures as a wayto obtain a urine sample. Theurine is obtained by this methodto avoid contamination fromthe urethra, or if urine cannotbe obtained from the patientusing the clean catch method.	The device is used in urinarycollection procedures as a wayto obtain a urine sample. Theurine is obtained by this methodto avoid contamination fromthe urethra, or if urine cannotbe obtained from the patientusing the clean catch method.	Same

TABLE 1: Comparison of proposed and predicate device

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Image /page/5/Picture/1 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points. A small gray square is visible in the upper right corner of the image.

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

Regulation Number	21 CFR 876.5130	21 CFR 876.5130	Same
Design Feature -Catheter Sizes	Available in 5FR and 8FRdesigns	Available in 5FR and 8FRdesigns	Same
Design Feature -Drainage Eyes	Tip features 4 drainage eyes	Tip features 2 or 3drainage eyes	Similar
Catheter Material	Clear PVC	Clear PVC	Same
Packaging	Heat-sealed in soft pouch withTyvek lid	Heat-sealed in soft pouch withTyvek lid	Same
PerformanceSpecifications	Conforms to recognizedstandard for urethral catheters	Conforms to recognizedstandard for urethral catheters	Same
Prescription vs. OTC	Prescription	Prescription	Same
Contact Duration	Limited ( ≤ 24 h)	Limited ( ≤ 24 h)	Same
Sterile vs. Non-Sterile	Sterile	Sterile	Same
Disposable vs. Non-Disposable	Disposable	Disposable	Same
Single Use vs. Reusable	Single Use	Single Use	Same

Summary of Non-Clinical Testing

Non-clinical verification of The Medline Catheter Specimen Collector 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:
- Cytotoxicity MEM Elution per ISO 10993-5
- Sensitization Guinea Pig Maximization Test per ISO 10993-10 A
- A Irritation - Intracutaneous Reactivity per ISO 10993-10
Functional Performance Testing: ●
- Catheter Surface Finish per BS EN 1616:1997 §4.2 A
- Catheter Dimensions per BS EN 1616:1997 §4.3 A
- Catheter Strength per BS EN 1616:1997 §Annex A A
- A Catheter Flow Rate per BS EN 1616:1997 §Annex E

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Image /page/6/Picture/1 description: The image features the Medline logo, set against a blue square background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a white, stylized starburst or cross-like symbol. The starburst is oriented vertically, with its apex pointing upwards and its base pointing downwards. A gray bar is visible on the right side of the blue square, adding a subtle design element to the composition.

edline Industries. Inc Three Lakes Drive Northfield. IL 60093

Additional Non-Clinical Evaluations: ●
- A Bioburden Testing
- Package Seal Integrity per ASTM F1929 A
- A Stability (Shelf-Life) Testing
- Ethylene Oxide and Ethylene Chlorohydrin Residual Evaluation Studies >
- A Internal Risk Analysis

Summary of Clinical Testing

Not applicable.

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 Catheter Specimen Collector is substantially equivalent to the predicate device, Busse Hospital Disposable Urethral Catheter (K041464).

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.