(303 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a standard intermittent catheter, with no mention of AI or ML.
No.
The device facilitates the passage of urine, which is a supportive function, not a therapeutic treatment of a disease or condition.
No
The device is described as a tubular device for passing urine from the bladder, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical, tubular device made of PVC with a hydrophilic coating, designed for insertion into the urethra. It also mentions a protective sleeve and a saline packet, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "pass urine from the bladder." This is a direct therapeutic or diagnostic procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device (a catheter) designed for insertion into the urethra. It does not describe reagents, test kits, or equipment used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine itself for diagnostic purposes), detecting specific substances, or providing diagnostic information based on in vitro testing.
The device is a medical device used for drainage, which is a common medical procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The subject device is a tubular device that is inserted through the urethra to pass urine from the bladder.
Product codes (comma separated list FDA assigned to the subject device)
GBM
Device Description
The Teleflex Rusch®FloCath Quick™ 18 French (Fr.) Coudé Hydrophilic Intermittent Catheter is single use, disposable and sterile. The catheter is made of clear polyvinylchloride (PVC) with vertically cut and softly rounded, polished eyes and has a hydrophilic coating. It is composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size is an 18 French gauge and is identified on the packaging. The funnel is color coded red to facilitate size identification. The catheter is 40 cm in overall length.
The FloCath Quick is an integrated package that contains the FloCath catheter with a blue protective catheter sleeve and a packet of sterile 0.9% saline. Before opening, the sterile saline pouch is broken to hydrate the catheter. The protective catheter sleeve allows for touchless insertion. The sleeve can also be pushed back and used as an extension to the catheter.
The FloCath Quick packaging has a packaging hole to facilitate opening the catheter. Either the packaging hole or the adhesive patch on the catheter pack can be used to hang up the catheter in an appropriate, convenient location while the catheter is hydrated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder
Indicated Patient Age Range
Adult
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 device FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include: Visual Inspection, Connector Security Test, Instron Pull Test, Flow Rate, Coating Presence, Friction Test, Biocompatibility Testing, Sterilization.
The proposed devices were tested to the requirements of EN 1616:1997, EN1617:1997, EN 1618:1997. In addition, testing was performed to ensure compliance to ASTM F623:2013.
Cytotoxicity, Sensitization, Irritation, were performed to demonstrate biocompatibility of the patient contacting materials.
The proposed device is sterilized using Ethylene Oxide method and the saline sachet is sterilized using Gamma Irradiation method. The respective sterilization validations performed are ETO overkill method and the dose audit study.
Overall, the results are comparable to the predicate and support a determination of substantial equivalence.
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 24, 2019
Teleflex Medical, Inc. Sirisha Kommana Regulatory Affairs Specialist 3015 Carrington Mill Blvd., Suite 600 North Morrisville, NC 27560
Re: K181979
Trade/Device Name: Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: April 24, 2019 Received: April 26, 2019
Dear Sirisha Kommana:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Glenn B. Bell, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
Indications for Use (Describe)
The subject device is a tubular device that is inserted through the urethra to pass urine from the bladder.
Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D)
ption Use (Part 21 CFR 601 Subpart D)
Over -- The -- Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
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
510(k) SUMMARY
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 Phone: 919-433-4831 919-361-3939 Fax:
B. Contact Person
Sirisha Kommana Requlatory Affairs Specialist, Respiratory Division
C. Date Prepared
May 23, 2019
D. Device Name
| Trade Name: | Rusch FloCath Quick™ 18 Fr. Coudé Hydrophilic Intermittent
Catheter |
|-----------------------|------------------------------------------------------------------------|
| Common Name: | Catheter, Urethral |
| Product Code: | GBM |
| Regulation Number: | CFR 876.5130 |
| Regulation Name: | Urological Catheter and Accessories |
| Classification: | II |
| Classification Panel: | Gastroenterology/Urology |
E. Predicate Device
This submission demonstrates substantial equivalence to the predicate device
Rusch® FloCath - K000070
F. Device Description
The Teleflex Rusch®FloCath Quick™ 18 French (Fr.) Coudé Hydrophilic Intermittent Catheter is single use, disposable and sterile. The catheter is made of clear polyvinylchloride (PVC) with vertically cut and softly rounded, polished eyes and has a hydrophilic coating. It is composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size is an 18 French gauge and is identified on the packaging. The funnel is color coded red to facilitate size identification. The catheter is 40 cm in overall length.
4
The FloCath Quick is an integrated package that contains the FloCath catheter with a blue protective catheter sleeve and a packet of sterile 0.9% saline. Before opening, the sterile saline pouch is broken to hydrate the catheter. The protective catheter sleeve allows for touchless insertion. The sleeve can also be pushed back and used as an extension to the catheter.
The FloCath Quick packaging has a packaging hole to facilitate opening the catheter. Either the packaging hole or the adhesive patch on the catheter pack can be used to hang up the catheter in an appropriate, convenient location while the catheter is hydrated.
G. Indications for Use
The Subject device is a tubular device that is inserted through the urethra to pass urine from the bladder.
H. Contraindications
- Insurmountable urethral obstructions
- Urethral injuries
- Urethral inflammation
l. Substantial Equivalence
The proposed Teleflex Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is substantially equivalent to the predicate devices with respect to intended use, technology and construction. The differences between the predicates and the proposed devices are minor and any risks have been mitigated through testing. Table 036-1 summarizes the differences between the proposed and predicate devices.
The proposed device is substantially equivalent to the predicate device:
5
| Features | Teleflex Medical
Rusch FloCath Quick
Urological Catheter
(Subject Device) | Rusch FloCath
(Predicate Device-
K000070) | |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Classification
Name | Catheter Urethral | Catheter Urological | |
| Product Code | GBM | KOD | |
| Class | II | II | |
| Regulation
Number | 876.5130 | 876.5130 | |
| Single Use | Yes | Yes | |
| Patient Population
for 18 Fr. | Adult | Adult | |
| Size Range | 18 Fr. | 5-30 Fr. | |
| 18 Fr. Overall
Length | 40 cm | 40 cm | |
| Color Indicating
Size for 18 Fr. | Red | Red | |
| Sterile | Yes | Yes | |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide or
Gamma irradiation. | |
| Device Description | The FloCath Quick is
a sterile, ready-to-use,
flexible PVC catheter
for intermittent
catheterization. The
catheter is hydrophilic
coated and has an
integrated pouch
containing a 0.9%
sterile saline solution
and a handling
sheath. The FloCath
Quick is a Coudé, 18
Fr. Catheter. | The Rusch FloCath
Catheter consists of
a tubular PVC shaft
with attached
drainage funnel.
The catheters is
designed with either
Nelaton, Olive or
Tiemann tip. This
device shaft may be
uncoated or
Hydrogel/ Hydrophilic
coated. | |
| | | | |
| Shaft | Tubular | Tubular | |
| Shaft Material | PVC | PVC | |
| Funnel Material | PVC | PVC | |
| Intended Use | The FloCath Quick
catheter is a tubular
device that is inserted
through the urethra
and is used to pass
fluids from urinary
tract. | FloCath catheter is a
tubular device that is
inserted through the
urethra and is used
to pass fluids to or
from urinary tracts. | |
| Indication for Use | The subject device is
a tubular device that is
inserted through the
urethra to pass urine
from the bladder. | FloCath catheter is a
tubular device that is
inserted through the
urethra and is used
to pass fluids to or
from urinary tracts. | |
| Contraindications | Insurmountable
urethral obstructions Urethral injuries Urethral
inflammation | None | |
| Coating | Hydrophilic | Uncoated or
Hydrogel/
Hydrophilic Coating | |
| Materials
Evaluation | The materials used in
the construction of | The materials used in
the construction of | |
| | Section 036 – Updated 510(k) Summary | | Hydrophilic Intermittent Catheter |
| | FloCath Quick were
evaluated per ISO
10993-1:2009 | predicate were
evaluated per ISO
10993-5:1993,
10993-10:1995 | |
| Principle of
Operation - Short
Description of Use | Squeeze saline
sachet.
Move packaging up
and down 2 or 3 times
to ensure coating of
the catheter.
Hang and let soak for
30 seconds.
Peel package open.
Insert catheter using
blue protective
catheter sleeve. | Tear peel back
wrapper about 5cm.
Pour water into
catheter funnel.
Takes about 30
seconds for catheter
to activate.
Remove catheter
from the package by
the funnel and insert
the catheter. | |
| Eyelets | Yes | Yes | |
| Liquid for Wetting | 0.9% Sterile saline
solution | Tap water | |
| Primary Packaging | Paper and film peel
back | Paper and film peel
back | |
| Secondary
Packaging | Corrugated board | Corrugated board | |
| Shipper Case | Corrugated board | Corrugated board | |
| Shelf-life | 5 Years | 5 Years | |
| Performance
Standards | ASTM F623:2013
EN 1616:1997,
EN 1617:1997, | ASTM F623-89 | |
Table 36-1. Comparison of Predicate vs. Proposed Device
6
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
Section 036 – Updated 510(k) Summary
7
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
8
J. Comparison to the Predicate
Table 36-1 illustrates the similarities and differences between the subject and predicate device (K000070). The basic technological and operating principles are the same for both devices. Both the predicate and subject device have same intended use.
Both the subject and predicate device are intended for similar patient populations, adult. Both the subject and predicate devices are disposable, sterile, single use devices. As evidenced by comparison Table 7-1, above, the proposed FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is substantially equivalent to the predicate device. There are no significant differences that would affect safety and efficacy.
K. Performance Data
The bench testing performed verifies that the performance of the subject device FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
| Testing Performed | Reference to Standard | Results |
|---|---|---|
| Visual Inspection | NA | Pass |
| Connector Security Test | EN 1616:1997 | Pass |
| Instron Pull Test | EN 1617:1997 | |
| EN 1618:1997 | Pass | |
| Flow Rate | EN 1618:1997 | |
| ASTM F623:2013 | Pass | |
| Coating Presence | NA | Pass |
| Friction Test | NA | Pass |
| Biocompatibility Testing | ISO 10993-1:2009 | |
| ISO 10993-5:2009 | ||
| ISO 10993-10:2010 | Pass | |
| Sterilization | ISO 11135-1: 2014 | |
| ISO 11137-1: 2006 | Pass |
The proposed devices were tested to the requirements of EN 1616:1997, EN1617:1997, EN 1618:1997. In addition, testing was performed to ensure compliance to ASTM F623:2013.
Cytotoxicity, Sensitization, Irritation, were performed to demonstrate biocompatibility of the patient contacting materials.
9
The proposed device is sterilized using Ethylene Oxide method and the saline sachet is sterilized using Gamma Irradiation method. The respective sterilization validations performed are ETO overkill method and the dose audit study.
Overall, the results are comparable to the predicate and support a determination of substantial equivalence.
L. Conclusion
The FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter has the same intended use and technological characteristics as its predicates. Test results demonstrate that the proposed device meets its intended use and is as safe, as effective, and performs as well as or better than the legally marketed predicate device. It is for these reasons that the subject device can be found substantially equivalent.