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 (8 – 18 Fr.), lengths (6" 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 ond routine control of a sterilized process for medical devices). The catheter is for single use.

AI/ML Overview

The provided text describes a 510(k) submission for the Bard RiteCath Intermittent Urinary Catheter and focuses on demonstrating substantial equivalence to a predicate device, not on a full clinical study with acceptance criteria and AI performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set details, AI performance) are not applicable or cannot be extracted from this document.

However, I can extract information related to the performance data presented within the scope of this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Standard/Test	Acceptance Criteria (Implicit)	Reported Device Performance
Functional Performance	BS EN 1616: 1997 + A1:1999 (Sterile urethral catheters for single use)	Adherence to standard's requirements for sterile urethral catheters.	"Nonclinical functional performance testing was performed per BS EN 1616: 1997 + A1:1999, Sterile urethral catheters for single use." (Implies compliance)
Biocompatibility	ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)	Adherence to standard's requirements for biological evaluation.	"Nonclinical biocompatibility testing was conducted in accordance with ISO 10993-1:2009..." (Implies compliance)
Biocompatibility	FDA Bluebook Memorandum G95-1 (Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing.")	Adherence to FDA guidance for biological evaluation.	"...and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 'Biological Evaluation of Medical Devices Part 1: Evaluation of Testing.'" (Implies compliance)
Sterilization	ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products – ethylene oxide – Part 1: Requirements for development, validation ond routine control of a sterilized process for medical devices)	Sterilization according to standard.	"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 ond routine control of a sterilized process for medical devices)." (Implies compliance)

2. Sample size used for the test set and the data provenance:

This document does not describe a clinical test set in the traditional sense. The "performance data" refers to nonclinical functional and biocompatibility testing against recognized standards. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

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

This information is not applicable as the evaluation is based on engineering and biological performance standards, not expert clinical assessment of images or outcomes.

4. Adjudication method for the test set:

This information is not applicable for the type of testing described (functional and biocompatibility).

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. The device is an intermittent urinary catheter and does not involve AI or human readers for diagnostic interpretation.

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

This information is not applicable. The device is an intermittent urinary catheter and does not involve an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by adherence to recognized international and national standards for medical device safety, functional performance, and biocompatibility (e.g., BS EN 1616, ISO 10993-1, ANSI/AAMI/ISO 11135-1).

8. The sample size for the training set:

This information is not applicable as there is no mention of a "training set" in the context of an AI/machine learning device. The performance data relates to physical device testing.

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

This information is not applicable as there is no mention of a "training set." The device performance is assessed against established engineering and biological standards.

Summary

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510(k) Summary

Traditional 510(k) | Bard RiteCath Intermittent Catheter

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

BARD | MEDICAL

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 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.

Sponsor:

BARD Medical Division C. R. BARD, Inc. 8195 Industrial Blvd. Covington, GA 30014 Establishment Registration Number: 1018233

Contact:

Michele Davis, RAC Regulatory Affairs Project Manager Bard Medical Division Tel: 770-784-6274 Fax: 770-385-4706

Date:

April 2, 2014

Subject Device:

Trade Name: Bard® RiteCath™ Intermittent Urinary Catheter Common Name: Urological Catheter Classification Name: Urological catheter and accessories Regulation: 21 CFR 876.5130 Classification: II Primary Product Code: EZD Secondary Product Codes: EZC

Legally marketed device to which substantial equivalence is claimed:

Coloplast A/S Self Cath Catheter, K100878 .

Device Description

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Intended Use

The Bard RiteCath Intermittent Urinary Catheter is intended for use by male and female patients for draining urine from the bladder.

Technological Characteristics

The Bard RiteCath Intermittent Urinary Catheter has the same technological characteristics as the predicate device. The subject and predicate device are made from the same catheter material, polyvinyl chloride (PVC) and have the same catheter design consisting of color-coded funnel, shaft, staggered eyelets, and straight or coude tip. The subject and predicate device are available in multiple French sizes and lengths.

Performance Data

Nonclinical functional performance testing was performed per BS EN 1616: 1997 + A1:1999, Sterile urethral catheters for single use. Nonclinical biocompatibility testing was conducted in accordance with ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing."

Substantial Equivalence

The Bard RiteCath Intermittent Urinary Catheter has the same design features and is indicated for the same use as the predicate device, Coloplast Self Cath Catheter, K100878. The subject device is substantially equivalent to the legally, marketed predicate device and nonclinical test data demonstrates that the subject device is safe and effective.

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Public Health Service

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

April 4, 2014

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

K133470 Re:

Trade/Device Name: Bard RiteCath Intermittent Urinary Catheter Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD, EZC Dated: March 4, 2013 Received: March 6, 2014

Dear Michele Davis,

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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Page 2 - Michele Davis, RAC

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

BenjaminFisher-S

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

Traditional 510(k) | Bard RiteCath Intermittent Catheter

Section 4 Indications for Use Statement

510(k) Number:

K133470

Bard RiteCath Intermittent Urinary Catheter Device Name:

INDICATIONS FOR USE:

The Bard RiteCath Intermittent Urinary Catheter is intended for use by male and female patients for draining urine from the bladder.

Prescription Use X (Part 21 CFR 801 Subpart D) and/or

Over-the-Counter Use (21 CFR 807 Subpart C)

-Counter Use
307 Subpart C) ☐

(Please do not write below this line – continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/15 description: The image shows the word "Benjamin" on the top left corner. Below it, the date "2014.04" is written. There are some graphical elements on the right side of the image, but they are not clear enough to describe.

Section 4

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.