(120 days)
No
The description focuses on the physical characteristics and intended use of a standard Foley catheter, with no mention of AI or ML. The performance studies are bench tests of physical properties.
Yes
The device is used for drainage and irrigation, which are therapeutic interventions aimed at maintaining or restoring health by managing bladder function.
No
Explanation: The device is a catheter for drainage and irrigation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical catheter made of PVC with lumens, a balloon, and other physical components, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "routine transurethral drainage of the bladder or for routine post-operative transurethral drainage and irrigation of the bladder." This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a physical catheter used for drainage and irrigation. It does not mention any components or processes related to analyzing samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing information about a patient's health status based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for a therapeutic/procedural purpose.
N/A
Intended Use / Indications for Use
These catheters are indicated for routine transurethral drainage of the bladder or for routine post-operative transurethral drainage and irrigation of the bladder.
Product codes
EZL
Device Description
The Rusch Simplastic Folev Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bladder (via transurethral drainage)
Indicated Patient Age Range
Adult and Pediatric
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
The bench testing performed verifies that the performance of the subject device 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, and Funnel Detachment.
Key Metrics
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2017
Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 3015 Carrington Mills Blvd Morrisville, North Carolina 27560
Re: K162989 Trade/Device Name: Rusch Simplastic Foley Catheters Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: EZL Dated: February 1, 2017 Received: February 6, 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. 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
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forth in 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/Resourcesfor You/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,
Charles Viviano -S
For 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) K162989
Device Name Rusch Simplastic Foley Catheters
Indications for Use (Describe)
These catheters are indicated for routine transurethral drainage of the bladder or for routine post-operative transurethral drainage and irrigation 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 Simplastic Foley Catheters
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-491-8960
Contact Person
Lori Pfohl Senior Regulatory Affairs Specialist
Date Prepared
1/23/2017
Device Name
Trade Name: Rusch Simplastic Foley Catheters
Common Name: Disposable Balloon-Retention Catheter
Classification Name: Catheter, Retention Type, Balloon (Class II per 21 CFR 876.5130, Product Code EZL)
Predicate Devices
Rusch Simplastic Foley Catheterization Set - K963996 Amsino International Amsure Hydrophilic Latex Foley Catheter (K091699)
Device Description
The Rusch Simplastic Folev Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.
Indications for Use
These catheters are indicated for routine transurethral drainage of the bladder or for routine postoperative transurethral drainage and irrigation of the bladder.
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Rusch Simplastic Foley Catheters
Substantial Equivalence
The subject device is substantially equivalent to the predicate devices:
| Features | Teleflex Medical
Rusch Simplastic Foley
Catheters
(Subject Device) | Rusch Simplastic Foley
Catheterization Set
(Predicate Device-
K963993) | Amsino International
Amsure Hydrophilic Latex
Foley Catheter (K091699) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Catheter, Retention Type,
Balloon | Tray, Catheterization,
Sterile urethral, With Or
Without Catheter | Catheter, Retention Type,
Balloon |
| Product Code | EZL | FCM | EZL |
| Regulation
Number | 876.5130 | Same | Same |
| Class | II | Same | Same |
| Indications for
Use | These catheters are
indicated for routine
transurethral drainage of the
bladder or for routine post-
operative transurethral
drainage and irrigation of the
bladder. | The Rusch Simplastic Foley
Catheter is intended to be
used to pass fluid to and
from the urinary tract. A
pack of lubricating jelly is
intended to assist insertion
of the catheter through the
urethra. | The Amsure Hydrophilic
Latex Foley Catheter, is
intended for use in the
drainage of fluids from,
and to the urinary
tract/bladder |
| Population | Adult and Pediatric | Not Specified | Adult and Pediatric |
| Lumen | Two way and three way | Same | Not specified |
| Single Use | Yes | Same | Same |
| Size Range | 12-28Fr | 12-26Fr | 12-28 |
| Radiopaque | Yes | Same | Not Specified |
| Balloon Sizes | 30 and 75 ml | 10, 30 and 75ml | 5 and 30 ml |
| Balloon
Material | Latex | same | Same |
| Shaft Material | PVC | PVC | Silicone coated natural
latex |
| Coated or
Uncoated | Uncoated | Uncoated | Coated |
| Connections | Luer Taper/Funnel | Same | Same |
| Biocompatibility | Materials have been tested
per ISO 10993 | Same | Not Specified |
| Sterile | Yes | Same | Same |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide or Gamma | Same |
The subject device is substantially equivalent to the subject device and nonclinical test data demonstrates substantial equivalence.
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510(k) SUMMARY
Rusch Simplastic Foley Catheters
Non-clinical Performance testing
The bench testing performed verifies that the performance of the subject device 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, and Funnel Detachment.
Conclusion
The Rusch Simplastic 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.