(311 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a standard Foley catheter, with no mention of AI or ML.
No.
The device is a catheter for drainage, not for treating a disease or condition. While it aids in patient care, its primary function is to manage a symptom (bladder drainage) rather than provide therapy.
No
Explanation: The device, a Foley catheter, is indicated for transurethral drainage of the bladder, which is a therapeutic function, not a diagnostic one. The performance studies focus on physical characteristics and equivalence to a predicate drainage device.
No
The device description clearly describes a physical catheter with a balloon, lumens, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "routine transurethral drainage of the bladder." This is a direct intervention on the body for drainage, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical catheter designed for insertion into the bladder for drainage and retention. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device is a therapeutic/interventional device.
N/A
Intended Use / Indications for Use
The Rusch Brilliant Balloon Catheter is indicated for routine transurethral drainage of the bladder.
Product codes
EZL
Device Description
The Rusch Silicone Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The retention balloon is attached to the silicone two-lumen shaft. One lumen is used for drainage and the other lumen for inflation of the balloon. Sterile water is used to inflate and deflate the balloon. The distal end has two opposite eye holes which are used for drainage. On the opposing end of the shaft are a connective funnel and a Luer activated valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
Indicated Patient Age Range
Pediatric, Male and female
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)
The bench testing performed verifies that the performance of the subject Rusch Silicone Foley Catheter is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include Balloon Peel Strength, Balloon Security, Deflation Reliability, Shaft Pull Test, Tip Detachment, and Funnel Detachment.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring a series of overlapping human profiles facing to the right, creating a sense of depth and continuity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2017
Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709
Re: K161770
Trade/Device Name: Rusch Silicone Foley Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: April 6, 2017 Received: April 7, 2017
Dear Lori Pfohl:
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.
1
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 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,
Benjamin R. Fisher -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
510(k) Number (if known)
K161770
Device Name Rusch Silicone Foley Catheter
Indications for Use (Describe)
The Rusch Brilliant Balloon Catheter is indicated for routine transurethral drainage of the bladder.
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)
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510(k) SUMMARY
Rusch Silicone Foley Catheter
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-491-8960 919-433-4996 Fax:
Contact Person
Lori Pfohl Senior Regulatory Affairs Specialist
Date Prepared
4/5/2017
Device Name
Trade Name: Rusch Silicone Foley Catheter
Common Name: Disposable Balloon-Retention Catheter
Classification Name: Catheter, Retention Type, Balloon (Class II per 21 CFR 876.5130, Product Code EZL)
Predicate Device
Guangdong Baihe Medical Technology Co., Ltd. - K130908
Device Description
The Rusch Silicone Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The retention balloon is attached to the silicone two-lumen shaft. One lumen is used for drainage and the other lumen for inflation of the balloon. Sterile water is used to inflate and deflate the balloon. The distal end has two opposite eye holes which are used for drainage. On the opposing end of the shaft are a connective funnel and a Luer activated valve.
Indications for Use
The Rusch Brilliant Balloon Catheter is indicated for routine transurethral drainage of the bladder
Intended Population: Pediatric
Teleflex Medical
4
510(k) SUMMARY
Rusch Silicone Foley Catheter
Contraindications
-Insurmountable urethral passages -Excessive urethral stricture via falsa
Substantial Equivalence
The subject device is substantially equivalent to the predicate devices:
| Features | Teleflex Medical
Rusch Silicone Foley Catheter
(Subject Device) | Guangdong Baihe Medical Technology Co., Ltd.
(Predicate Device-K130908) |
|----------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Catheter, Retention Type,
Balloon | Same |
| Product Code | EZL | Same |
| Regulation
Number | 876.5130 | Same |
| Class | ll | Same |
| Indications for Use | The Rusch Brilliant Balloon
Catheter is indicated for
routine transurethral drainage
of the bladder | Two-way Disposable Silicone Foley Catheter: Urethral
catheterization for bladder drainage for urological
use only: indwelling time of the proposed device is no
more than 30 days
Three-way Disposable Silicone Foley Catheter: Urethral
catheterization for bladder drainage and bladder
irrigation for urological use only; indwelling time of the
proposed device is no more than 30 days |
| Population | Pediatric, Male and female | Same |
| Lumen | Two-Way | Two way and three way |
| Indwell Time | Maximum indwell time of
29 days | No more than 30 days |
| Single Use | Yes | Same |
| Size Range | 6Fr | 6-26Fr |
| Length | 300 ±10mm | 310mm and 400mm |
| Balloon | Yes | Same |
| Balloon size | 1.5ml | Same |
| Sterile | Yes | Same |
| Method of
Sterilization | Ethylene Oxide 106 SAL | Same |
| Biocompatibility | Materials have been tested
per ISO 10993 | Same |
| Main Shaft
Material | Silicone | Same |
| Eyes in Tip | Yes | Same |
| Standard Funnel | Yes | Same |
| Tip Shape | Rounded | Same |
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510(k) SUMMARY
Rusch Silicone Foley Catheter
The subject device is substantially equivalent to the subject device and nonclinical test data demonstrates substantial equivalence.
Non-clinical Performance testing
The bench testing performed verifies that the performance of the subject Rusch Silicone Foley Catheter is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include Balloon Peel Strength, Balloon Security, Deflation Reliability, Shaft Pull Test, Tip Detachment, and Funnel Detachment.
Conclusion
The Rusch Silicone Foley Catheter has the same indications for use, technological characteristics and construction as its predicates. Performance test results demonstrate that the subject device meets its intended use. It is for these reasons that the subject device can be found substantially equivalent.