(143 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a simple urinary catheter, with no mention of AI or ML technologies.
No.
The device is used for draining urine from the bladder, which is a diagnostic or management function, not a therapeutic one.
No
Explanation: The device is a catheter designed for draining urine from the bladder, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines a physical catheter made of PVC with a funnel, shaft, eyelets, and tip. It also mentions sterilization and physical dimensions (French sizes, lengths). There is no mention of software as the primary or sole component.
Based on the provided information, the Bard RiteCath Intermittent Urinary Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "drain urine from the bladder." This is a direct therapeutic or management action on the patient's body, not a test performed on a sample taken from the body to provide information about a physiological state or disease.
- Device Description: The description details a physical device (catheter) inserted into the body to facilitate drainage. It does not describe reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing urine for diagnostic purposes, detecting substances, or providing information about a patient's health status through testing of a sample.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to diagnose, monitor, or screen for diseases or conditions. The Bard RiteCath is a medical device used for a physical procedure (draining urine).
N/A
Intended Use / Indications for Use
The Bard RiteCath Intermittent Urinary Catheter is intended for use by male and female patients for draining urine from the bladder.
Product codes (comma separated list FDA assigned to the subject device)
EZD, EZC
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 (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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.
1
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.
2
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.
3
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
4
Indications for Use
Traditional 510(k) | Bard RiteCath Intermittent Catheter
Section 4
Indications for Use Statement
510(k) Number:
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