(145 days)
No
The device description and performance studies focus on the physical characteristics and basic functionality of a catheter, with no mention of AI/ML or data processing.
Yes.
The device facilitates the passage of urine from the bladder, which is a therapeutic function addressing a physiological need.
No
The device, a hydrophilic intermittent catheter, is used to pass urine from the bladder, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical, tubular device made of PVC with a hydrophilic coating, designed for insertion into the urethra. It is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that this device is a "tubular device that is inserted through the urethra to pass urine from the bladder." This is a physical intervention within the body to facilitate a physiological process (urination).
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze urine or any other bodily fluid for diagnostic purposes. Its sole function is to drain urine.
Therefore, based on the provided information, the Rusch Hydrophilic Intermittent catheters are not IVD devices. They are medical devices used for therapeutic or supportive purposes.
N/A
Intended Use / Indications for Use
The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder.
Product codes
GBM
Device Description
The Teleflex Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are single use, disposable and sterile. The catheters are made of clear polyvinylchloride (PVC) with vertically cut and softly rounded polished eyes and are coated with a hydrophilic coating. They are composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size ranges from 6-20 French gauge. The funnel is color coded to facilitate size identification. The Rusch® FloCath™ Quick is an "all-in-one catheter" that allows for convenience and the Rusch® MMG H2O™ is a closed system with integrated collection bag that allows for "no touch" catheterization due to an introducer tip that helps bypass the first 1.5" of the urethra.
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 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 devices are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include: Visual Inspection, Flow Rate, Friction Test, Coating Presence, Biocompatibility (ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process; ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity; ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization).
The subject devices were tested to the requirements of ASTM F623.
Cytotoxicity, Sensitization, Irritation, were performed to demonstrate biocompatibility of the patient contacting materials. Overall, the results are comparable to the predicate and support a determination of substantial equivalence.
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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May 8, 2019
Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd., Suite 600 North Morrisville, NC 27560
Re: K183461
Trade/Device Name: Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: April 5, 2019 Received: April 8, 2019
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. 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.
1
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 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.htm); 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 medical devices and radiation-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.
Purva Pandya Acting, Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183461
Device Name
Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles).
Indications for Use (Describe)
The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are 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) | ✖ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
Lori Pfohl Senior Regulatory Affairs Specialist
C. Date Prepared
May 7, 2019
D. Device Name
Trade Name: Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles)
| Common Name: | Catheter, Urethral |
|---|---|
| Product Code: | GBM |
| Regulation Number: | CFR 876.5130 |
| Classification 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 Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are single use, disposable and sterile. The catheters are made of clear
Teleflex Medical, Inc.
4
polyvinylchloride (PVC) with vertically cut and softly rounded polished eyes and are coated with a hydrophilic coating. They are composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size ranges from 6-20 French gauge. The funnel is color coded to facilitate size identification. The Rusch® FloCath™ Quick is an "all-in-one catheter" that allows for convenience and the Rusch® MMG H2O™ is a closed system with integrated collection bag that allows for "no touch" catheterization due to an introducer tip that helps bypass the first 1.5" of the urethra.
G. Indications for Use
The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder.
H. Contraindications
- Insurmountable urethral obstructions
- Urethral injuries
- Urethral inflammation
I. Substantial Equivalence
The subject device Teleflex Rusch FloCath Quick 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 subject devices are minor and any risks have been mitigated through testing. Table 07.1 summarizes the differences between the subject and predicate device.
The subject devices are substantially equivalent to the predicate device:
| Features | Teleflex Medical
Rusch FloCath Quick
Urological Catheter
(Subject Devices 1) | Teleflex Medical
Rusch MMG
Urological Catheter
(Subject Device 2) | Rusch FloCath - Uncoated or
Coated Urological Catheter
(Predicate Device-K000070) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Classification
Name | Urological Catheter
and Accessories | Same | Same |
| Regulation
Number | 876.5130 | 876.5130 | Same |
| FDA Procode | GBM | GBM | KOD |
| Class | II | II | Same |
| Indication for Use | The Rusch
Hydrophilic
Intermittent | The Rusch Hydrophilic
Intermittent
catheters (Rusch | The FloCath catheter is a
tubular device that is
inserted through the urethra |
| | | | |
| | catheters (Rusch
FloCath Quick, Rusch
FloCath Quick Kit,
Rusch FloCath
Intermittent
Catheter, Rusch
MMG H2O PVC
Catheter Kit, Rusch
MMG H2O Singles)
are tubular devices
that are inserted
through the urethra
to pass urine from
the bladder. | FloCath Quick, Rusch
FloCath Quick Kit,
Rusch FloCath
Intermittent Catheter,
Rusch MMG H2O PVC
Catheter Kit, Rusch
MMG H2O Singles)
are tubular devices
that are inserted
through the urethra
to pass urine from the
bladder. | and is used to pass fluids to
or from urinary tracts. |
| Contraindications | - Insurmountable
urethral
obstructions-
Urethral injuries-
Urethral
inflammation | None | None |
| Single Use | Yes | Yes | Same |
| Population | Adult and Pediatric,
Male and Female | Adult and Pediatric,
Male and Female | Same |
| Size Range | 6-20 Fr. | 6-20 Fr. | 5-30 Fr. |
| Overall Length | 40 cm | 40cm | Same |
| Shaft | Tubular | Tubular | Same |
| Shaft Material | PVC (Mucosal and
skin, limited contact