The Bard RiteCath Intermittent Urinary Catheter is intended for use by adult and pediatric, male and female patients for draining urine from the bladder. Pediatric patients include neonates, infants, children and adolescents.

Device Description

The Bard RiteCath Intermittent Urinary Catheter is a biocompatible, polyvinyl chloride (PVC) catheter used to drain urine from the bladder. The catheter consists of a funnel, shaft with two staggered eyelets and a tip. The tip is available in a straight or coude configuration. The tip of the catheter passes through the urethra into the bladder to allow urine to drain into the eyelets and then through the catheter shaft, exiting through the funnel. The catheter will be offered in multiple French sizes (6 – 18 Fr.), lengths (6", 10" and two tip designs (straight and coude). The product is ethylene oxide sterilized (per ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products – ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilized process for medical devices). The catheter is for single use.

AI/ML Overview

The provided document describes the Bard RiteCath Intermittent Urinary Catheter and its substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria for a specific performance metric directly related to the device's efficacy, nor does it present a study that measures the device's performance against such criteria in a quantitative manner with reported performance values.

Instead, the document focuses on:

Biocompatibility testing: Ensuring the materials used are safe for bodily contact.
Nonclinical functional performance testing: Confirming the device meets general standards for urethral catheters (e.g., flow rates, strength, ease of insertion, etc., as per BS EN 1616: 1997 + A1:1999).
Comparison to predicate devices: Demonstrating that its technological characteristics and intended use are similar to already approved catheter devices.

Therefore, many of the requested details about acceptance criteria and a study proving performance against them cannot be extracted from this document. The information available is presented below, and where specific requested details are not present, it is noted.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Biocompatibility	In accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1:2009 for Biological Evaluation of Medical Devices. The battery of testing included: Cytotoxicity, Sensitization, Vaginal Mucosal Irritation. A toxicological risk assessment for diisononyl phthalate (DINP) was performed per ISO 10993-17:2002.	All tests passed; subject device is considered mucosal contacting with limited exposure, and is safe for its intended use. (Implied acceptability based on "nonclinical test data demonstrates that the subject device is safe and effective.")
Functional Performance	"Nonclinical functional performance testing of the subject device was performed in accordance with BS EN 1616: 1997 + A1:1999, Sterile urethral catheters for single use." This standard specifies requirements for sterile urethral catheters, including physical, chemical, and biological tests for product design, materials, and performance (e.g., flow rates, integrity, strength, sterility, lubrication characteristics, etc.).	The subject device was found to be "substantially equivalent to the legally, marketed predicate devices and nonclinical test data demonstrates that the subject device is safe and effective." (Implied compliance with the standard).
Sterilization	Ethylene Oxide sterilization (per ANSI/AAMI/ISO 11135-1:2007)	Compliant with the standard for sterility.

Missing Information: The document does not provide specific numerical targets (e.g., "flow rate must be > X mL/min") or quantitative results (e.g., "average flow rate was Y mL/min") for functional performance. The assessment relies on compliance with an international standard for sterile urethral catheters and substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified for any of the performance tests.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests are described as "nonclinical functional performance testing" and "biocompatibility evaluation," implying laboratory-based testing rather than clinical data from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided. The testing described is primarily laboratory-based physical and biological evaluation against established standards, not interpretation by human experts to establish "ground truth" in terms of diagnosis or clinical outcome.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described does not involve expert 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

This information is not applicable and not provided. The device is a urinary catheter, not an AI-assisted diagnostic or assistive tool for human readers.

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

This information is not applicable and not provided. The device is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

For Biocompatibility: Compliant with ISO standards for materials, as determined by laboratory tests (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation).
For Functional Performance: Compliant with BS EN 1616: 1997 + A1:1999 (Sterile urethral catheters for single use), evaluated through specific physical and chemical tests defined by the standard. This represents an engineering standard as the "ground truth."

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical product, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as there is no training set for this type of device.

Summary

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

October 31, 2014

C.R. Bard, Inc. Michele Davis Regulatory Affairs Project Manager 8195 Industrial Blvd Covington, GA 30014

K142575 Trade/Device Name: Bard RiteCath Intermittent Urinary Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZD, EZC Dated: September 11, 2014 Received: September 12, 2014

Dear Michele Davis,

Re:

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

Herbert P.
Lerner -S

for

Benjamin 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K142575

Device Name

Bard RiteCath Intermittent Urinary 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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Bard Medical Division C.R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

Image /page/3/Picture/3 description: The image contains the word "BARD" in a stylized, green font. To the right of "BARD" is a vertical line, followed by the word "MEDICAL", also in green. The text appears to be a logo or brand name.

510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Bard RiteCath Intermittent Urinary Catheter 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Submitter:	BARD Medical DivisionC. R. BARD, Inc.8195 Industrial Blvd.Covington, GA 30014Establishment Registration Number: 1018233
Contact:	Michele Davis, RACRegulatory Affairs Project ManagerBard Medical DivisionTel: 770-784-6274Fax: 770-385-4706
Date:	September 11, 2014
Subject Device:	Trade Name: Bard® RiteCath TM Intermittent Urinary CatheterCommon Name: Urological CatheterClassification Name: Urological catheter and accessoriesRegulation: 21 CFR 876.5130Regulatory Class: IIPrimary Product Code: EZDSecondary Product Codes: EZC
Predicate Device:	Legally marketed device to which substantial equivalence is claimed• Bard RiteCath Intermittent Urinary Catheter, K133470• Coloplast A/S Self Cath Catheter, K100878

Coloplast A/S Self Cath Catheter, K100878

Device Description

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of health care products – ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilized process for medical devices). The catheter is for single use.

Intended Use

The indications for use statement for the Bard RiteCath Intermittent Urinary Catheter is not identical to the predicate device; however, the differences do no alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have intended use of urine drainage from the bladder (bladder drainage).

Comparison of Technological Characteristics with the Predicate Devices

The Bard RiteCath Intermittent Urinary Catheter has the same technological characteristics as the predicate devices. The subject and predicate devices are based on the following same technological elements:

Catheter material
Catheter length ●
Tip configuration
Drainage eye position
Condition of use
Sterilization

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility

The biocompatibility evaluation of the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993 'Biological Evaluation of Medical Devices Part 1: Evaluation of Testing''' May 1, 1995, and ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The battery of testing included the following tests:

Cytotoxicity
Sensitization
Vaginal Mucosal Irritation

In addition a toxicological risk assessment for diisononyl phthalate (DINP) was performed per ISO 10993-17:2002 "Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances."

The subject device is considered mucosal contacting with limited exposure.

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Nonclinical functional performance testing

Nonclinical functional performance testing of the subject device was performed in accordance with BS EN 1616: 1997 + A1:1999, Sterile urethral catheters for single use.

Conclusions

The Bard RiteCath Intermittent Urinary Catheter has the similar technological characteristics and is intended for the same use of draining urine from the bladder as the predicate devices. The subject device is substantially equivalent to the legally, marketed predicate devices and nonclinical test data demonstrates that the subject device is safe and effective.

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.