(69 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a simple, disposable medical device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an intermittent urethral catheter for routine drainage of fluids, which is a supportive rather than therapeutic function.
No
The device is indicated for "routine drainage of fluids from the bladder," which is a therapeutic function, not a diagnostic one. Diagnostic devices are used to identify a condition or disease.
No
The device description clearly outlines physical components made of PVC (tip, shaft, funnel) and describes manufacturing processes for these components. There is no mention of software as the primary or sole component.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is an "Intermittent Urethral Catheter" intended for "routine drainage of fluids from the bladder." This is a device used within the body (in vivo) to facilitate the removal of fluids.
- No Mention of Testing or Analysis of Samples: The text does not mention any function related to analyzing or testing bodily fluids or tissues for diagnostic purposes.
Therefore, the device described is a therapeutic medical device used for drainage, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Intermittent Urethral Catheters are indicated for routine drainage of fluids from the bladder. These catheters are not intended or designed for indwelling use.
Product codes (comma separated list FDA assigned to the subject device)
EZC, EZD
Device Description
The Rusch® Intermittent Urethral Catheters are single use, uncoated, disposable and sterile. The catheter is comprised of a tip, shaft, and funnel. The catheter tube is made of polovviny chiloride (PVC), the tip of a PVC/liquid colored PVC which is cured to the tube and a catheter funnel also made of PVC. The dimensions range from Charrièr (Ch.) Ch. 10 to Ch. 24 which is a range of 3.3 mm to 7.9 mm in Outer Diameter with a length 40 cm. The catheters are produced with two different tips - Tiemann and Nelaton-Robinson. Each catheter size has a color-coded tip.
The Nelaton-Robinson catheters have a size range from 10 Ch. to 24 Ch. and have two drainage holes. The Tiemann catheters have a size range from 12 Ch. and also have two drainage holes. Additionally the Tiemann and Nelaton-Robinson catheters also contain funnel adhesive solution to which the funnel is adhered to the shaft and hot embossing film or tint for printing text on the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder / urinary tracts
Indicated Patient Age Range
Not Found
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 Intermittent Urethral Catheters are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- Flow Rate
- Catheter Tensile properties
- . Break Strength
- Cytotoxicity ISO 10993-5
- Sensitization ISO 10993-10
- Skin Irritation ISO 10993-10
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 29, 2018
Teleflex Medical, Inc. Amanda Webb Manager, Regulatory Affairs 3015 Carrington Mill Blvd. Morrisville, NC 27560
Re: K173596
Trade/Device Name: Rusch® Intermittent Urethral Catheters Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZC, EZD Dated: November 28, 2017 Received: November 29, 2017
Dear Amanda Webb:
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 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.
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.
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,
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
2
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-491-8960 Fax: 919-443-4996
Contact Person
Amanda Webb Manager, Regulatory Affairs
Date Prepared
1/23/2018
Device Name
| Trade Name: | Rusch® Intermittent Urethral Catheter |
|---|---|
| Common/Usual Name: | Urological Catheter |
| Regulation Number: | 21 CFR 876.5130 |
| Regulation Name: | Urological catheter and accessories |
| Regulation Class: | II |
| Product Code: | EZC - catheter, coude |
| EZD - catheter, straight | |
| Panel: | Gastroenterology/Urology |
Predicate Device Rusch® Intermittent Urethral Catheters -K033023
Device Description
The Rusch® Intermittent Urethral Catheters are single use, uncoated, disposable and sterile. The catheter is comprised of a tip, shaft, and funnel. The catheter tube is made of polovviny chiloride (PVC), the tip of a PVC/liquid colored PVC which is cured to the tube and a catheter funnel also made of PVC. The dimensions range from Charrièr (Ch.) Ch. 10 to Ch. 24 which is a range of 3.3 mm to 7.9 mm in Outer Diameter with a length 40 cm. The catheters are produced with two different tips - Tiemann and Nelaton-Robinson. Each catheter size has a color-coded tip.
The Nelaton-Robinson catheters have a size range from 10 Ch. to 24 Ch. and have two drainage holes. The Tiemann catheters have a size range from 12 Ch. and also have two drainage holes. Additionally the Tiemann and Nelaton-Robinson catheters also contain funnel adhesive solution to which the funnel is adhered to the shaft and hot embossing film or tint for printing text on the catheter.
Indications for Use
The Intermittent Urethral Catheters are indicated for routine drainage of fluids from the bladder. These catheters are not intended or designed for indwelling use.
3
Contraindications
Insuperable obstruction of the urethra. However, the suitability of each patient must be individually assessed by a physician or other suitably qualified personnel.
Substantial Equivalence
The subject device is substantially equivalent to the predicate device:
| Features | Teleflex Medical
Rusch
Intermittent
Urethral
Catheters (Subject
Device) | Rusch Urethral
Intermittent
Catheters
(Predicate Device-
K033023) | Comparison | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Similarities | Differences |
| Classification
Name | Catheter,
Urological | Catheter,
Urological | Devices are the
same | None |
| Regulation
Number | 876.5130 | 876.5130 | Devices are the
same | None |
| Class | II | II | Devices are the
same | None |
| Device
Description | The Intermittent
Urethral Catheters
consists of a
tubular shaft with
attached funnel
as connecting
device. PVC
material used in
the catheter.
The product sizes
range from 10
Ch. to 24 Ch.
The device shaft is
uncoated. | The Intermittent
Urethral Catheters
consists of a
tubular shaft with
attached funnel
as connecting
device. The PVC
material used in
the catheter.
The product sizes
range from 6 Ch.
to 24 Ch.
The device shaft
may be uncoated
or hydrophilic
coated. | Both devices are
intended for
intermittent
catheterization. | The
predicate,
Intermittent
Urethral
Catheters,
are offered
with or
without
hydrophilic
coating and
have a wide
range of
sizes.
The subject
device shaft
does not
have a
hydrophilic
coating, it is
uncoated. |
| Indication for Use | The Intermittent
Urethral
Catheters are
indicated for
routine drainage
of fluids from the
bladder. These
catheters are not
intended or
designed for
indwelling use. | The Intermittent
Urethral Catheters
are sterile, single-
use, flexible tubular
devices that are
inserted through the
urethra and used to
pass fluids to or
from urinary tracts. | Both the
predicates and
subject catheters
are sterile, single-
use devices that
pass fluids from
the
bladder/urinary
tract. | The predicate
devices
intended use
includes
passage of
fluids to or
from the
urinary tract.
The subject
Intermittent
Urethral
Catheters do
not include
the intended
use of
administration
of fluids to the
urinary tract. |
| Contraindications | Insuperable
obstruction of the
urethra. However,
the suitability of
each patient must
be individually
assessed by a
physician or other
suitably qualified
personnel. | None known | There are no
known
contraindications
for the predicate
devices. | The subject
Intermittent
Urethral
Catheters has
a
contraindicatio
n. |
| Single Use | Yes | Yes | Devices are the
same | None |
| Size Range | 10 Ch. - 24 Ch. | 6 Ch. - 24 Ch. | The subject
Intermittent
Urethral catheters
sizes are included
within the range
of the predicate
devices. | The predicate
devices have a
larger size
range. |
| Overall Length | Nominal 40 cm | Nominal 40 cm | Devices are the
same | None |
| Shaft | Tubular | Tubular | Devices are the
same | None |
| Shaft Material | | | Both devices are | The subject |
| | PVC | PVC | made with PVC | device is made with different plasticizer |
| Funnel Material | PVC | PVC | Both devices are made with PVC | The subject device is made with different plasticizer |
| Coating | Uncoated | Uncoated or Hydrophilic Coated | Both the predicate and subject Intermittent Urethral Catheters have uncoated catheters. | The predicate, Intermittent Urethral Catheters, also has coated catheters. |
| Biocompatibility | Evaluation and testing within the risk management process ISO 10993-1 | Evaluation and testing within the risk management process ISO 10993-1 | Biocompatibility studies of the devices conclude that the materials are safe for the intended use | None |
| Principal of Operation - Short Description of Use | Peel package open Insert catheter Empty bladder Withdraw catheter Dispose device | Peel package open Insert catheter Empty bladder Withdraw catheter Dispose device | Devices are the same | None |
| Catheter Tip Configurations | Tiemann and Nelaton- Robinson | Tiemann, Nelaton-Robinson, and Olive | The Tiemann and Nelaton-Robison configurations are offered for the predicate and subject devices. | The Olive tip configuration is offered for the predicate device. |
| Eyelets | Yes | Yes | Devices are the same | None |
| Primary Packaging | Paper and film peel back | Paper and film peel back | Devices are the same | None |
| Secondary Packaging | Corrugated box, quantity 50 | Corrugated box, quantity 100 | | The unit quantities in the secondary |
| | | | Secondary
packaging
material is the
same | packaging are
different for
the predicate
than for the
subject device. |
| Shipper Case | Corrugated board | Corrugated board | Devices are the
same | None |
| Sterile | Yes | Yes | Devices are the
same | None |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Devices are the
same | None |
| Shelf-life | 5 Years | 3 Years | Both devices
have a shelf-life
of at least 3 years | The subject
device,
Intermittent
Urethral
Catheters,
have a shelf-
life of 5 years. |
4
5
6
Non-clinical Performance testing
The bench testing performed verifies that the performance of the subject Intermittent Urethral Catheters are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- Flow Rate
- Catheter Tensile properties
- . Break Strength
- Cytotoxicity ISO 10993-5 ●
- Sensitization ISO 10993-10
- Skin Irritation ISO 10993-10
Conclusion
The Intermittent Urethral Catheters have demonstrated through comparison of design features and performance testing that the proposed device and the predicate device are substantially equivalent. Performance test results demonstrate that the subject 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.
7
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