(49 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, biocompatibility, and functional performance of a simple mechanical catheter. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The primary purpose of this device is to drain urine from the bladder, which is a diagnostic or supportive function, not a therapeutic one that treats a disease or condition.
No
The device is a catheter used for draining urine, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical catheter made of PVC with a funnel, shaft, eyelets, and tip. It also mentions sterilization and physical dimensions (French sizes, lengths). This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Function: The Bard RiteCath Intermittent Urinary Catheter is a device that is inserted into the body to drain urine. It is a therapeutic and diagnostic tool used for direct intervention, not for analyzing samples in a lab setting.
- Intended Use: The intended use clearly states "for draining urine from the bladder," which is a direct physical action, not an in vitro diagnostic test.
- Device Description: The description details the physical components and how it functions to drain urine, not how it analyzes a sample.
Therefore, based on the provided information, the Bard RiteCath Intermittent Urinary Catheter is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
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 (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.
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
adult and pediatric, male and female patients. Pediatric patients include neonates, infants, children and adolescents.
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)
- Biocompatibility evaluation conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1:2009.
- Tests included: Cytotoxicity, Sensitization, Vaginal Mucosal Irritation.
- Toxicological risk assessment for diisononyl phthalate (DINP) performed per ISO 10993-17:2002.
- The subject device is considered mucosal contacting with limited exposure.
- Nonclinical functional performance testing performed in accordance with BS EN 1616: 1997 + A1:1999, Sterile urethral catheters for single use.
- Conclusion: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, layered on top of each other, with flowing lines suggesting movement or connection.
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
1
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)
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.
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.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 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: | September 11, 2014 |
| Subject Device: | Trade Name: Bard® RiteCath TM Intermittent Urinary Catheter
Common Name: Urological Catheter
Classification Name: Urological catheter and accessories
Regulation: 21 CFR 876.5130
Regulatory Class: II
Primary Product Code: EZD
Secondary 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
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
4
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 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.
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.
5
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.