K Number

Device Name

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)

Manufacturer

Zhanjiang Star Enterprise Co., Ltd

Date Cleared

2017-10-13

(261 days)

Product Code

EZD

Regulation Number

876.5130

Intended Use

The PVC Urinary Catheter is launched for clean intermittent catheterization (CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract. It is indicated for use in male, female, and pediatric patients 2-12 years old. The Silicone Urinary Catheter is intended to be placed in the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old. The Latex Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Neleton catheters are launched for clean internittent catheterization (CIC). Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.

Device Description

Disposable urinary catheter is a kind of disposable product which is used for draining the bladder, for temporary or short term. Based on the materials, the disposable urinary catheter includes PVC Urinary Catheter, Silicone Urinary Catheter and Latex Urinary Catheter. PVC Urinary Catheter only has nelaton type structure, which is made of PVC and is intended for draining the bladder for short term. PVC Urinary Catheter consists of drainage funnel, drainage lumen, eyelets and tip. It is supplied in French size ranging from 8 to 20F. The catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old. Silicone Urinary Catheter is made of pure silicone. It is intended to be placed in the bladder, through the urethra, to drain urine into a collection device and has two-way type and three-way type. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eyes, balloon, inflating connector and valve. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old. Latex Foley Catheter is made of nature latex, which has nelaton type, two-way type and three-type. The nelaton Latex Urinary Catheter is intended for draining the bladder for short term and consists of drainage funnel, drainage lumen, eyelets and tip. The nelaton catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2-12 years old. The two-way type and three-way type are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eye. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K142575, K130908, K071423

Reference Devices

K142575, K130908, K071423

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on the physical characteristics, materials, and basic functionality of urinary catheters for drainage. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.

Therapeutic

Yes
The device is described as being used for "treatment" (e.g., "clean intermittent catheterization (CIC) treatment") and for "draining the bladder," which directly addresses a physiological function or condition. Therefore, it serves a therapeutic purpose.

Diagnostic

Explanation: The device is a urinary catheter, intended for the drainage of fluid from the urinary tract. Its function is to facilitate the flow of urine out of the body, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly outlines physical, disposable urinary catheters made of PVC, Silicone, and Latex, with various structural components and sizes. There is no mention of software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside the body (in vitro).
Device Function: The description clearly states that these urinary catheters are intended for the drainage of fluid from the urinary tract and to drain urine into a collection device. This is a physical intervention to remove fluid from the body, not to analyze a specimen for diagnostic purposes.
Intended Use: The intended use is for "clean intermittent catheterization (CIC) treatment," "urological bladder drainage," and "bladder irrigation." These are all therapeutic or procedural uses, not diagnostic ones.
Device Description: The description focuses on the physical components and materials of the catheters (PVC, silicone, latex, lumens, balloons, etc.), which are consistent with devices used for drainage and irrigation.
Performance Studies: The performance studies described are related to the physical and biological properties of the catheter itself (strength, flow rates, biocompatibility, balloon integrity, etc.), not the accuracy or reliability of a diagnostic test performed on a specimen.

In summary, the device is a medical device used for drainage and irrigation within the body, not for performing diagnostic tests on specimens outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The PVC Urinary Catheter is launched for clean intermittent catheterization (CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract. It is indicated for use in male, female, and pediatric patients 2-12 years old.
The Silicone Urinary Catheter is intended to be placed in the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.
The Latex Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Neleton catheters are launched for clean internittent catheterization (CIC). Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.

Product codes

EZD, EZL

Device Description

Disposable urinary catheter is a kind of disposable product which is used for draining the bladder, for temporary or short term. Based on the materials, the disposable urinary catheter includes PVC Urinary Catheter, Silicone Urinary Catheter and Latex Urinary Catheter.
PVC Urinary Catheter only has nelaton type structure, which is made of PVC and is intended for draining the bladder for short term. PVC Urinary Catheter consists of drainage funnel, drainage lumen, eyelets and tip. It is supplied in French size ranging from 8 to 20F. The catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.
Silicone Urinary Catheter is made of pure silicone. It is intended to be placed in the bladder, through the urethra, to drain urine into a collection device and has two-way type and three-way type. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eyes, balloon, inflating connector and valve. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.
Latex Foley Catheter is made of nature latex, which has nelaton type, two-way type and three-type.
The nelaton Latex Urinary Catheter is intended for draining the bladder for short term and consists of drainage funnel, drainage lumen, eyelets and tip. The nelaton catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2-12 years old.
The two-way type and three-way type are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eye. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urinary tract, bladder, urethra

Indicated Patient Age Range

pediatric patients 2-12 years old, male, female

Intended User / Care Setting

Prescription Use

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)

Non-clinical testing was performed to demonstrate substantial equivalence to predicate devices. Tests were conducted in accordance with applicable standards.
PVC Urinary Catheter: Tested for Surface finish, Dimensions, Strength, Connector security, Flow rates, Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic toxicity), and Sterility. All tests passed.
Silicone Urinary Catheter: Tested for Flow rate through drainage lumen, Balloon Integrity, Inflated Balloon Response to Traction, Balloon Volume Maintenance, Balloon Size and Shaft Size, Deflation Reliability (Failure to Deflate), Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Implantation), and Sterility. All tests passed.
Latex Urinary Catheter: Tested for Surface finish, Dimensions, Strength, Connector security, Flow rates, Balloon Integrity, Inflated Balloon Response to Traction, Balloon Volume Maintenance, Balloon Size and Shaft Size, Deflation Reliability (Failure to Deflate), Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Implantation), and Sterility. All tests passed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K142575, K130908, K071423

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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.

October 13, 2017

Zhanjiang Star Enterprise Co., Ltd % Elly Xu Consultant Manager Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, Guangdong GD755 CHINA

Re: K170233

Trade/Device Name: Disposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZD. EZL Dated: August 5, 2017 Received: September 1, 2017

Dear Elly Xu:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 (DICE) 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 (DICE) 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.

Joyce M. Whang -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

Indications for Use

510(k) Number (if known) K170233

Device Name Disposable Urinary Catheter

Indications for Use (Describe)

The Silicone Urinary Catheter is intended to be placed in the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.

The Latex Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Neleton catheters are launched for clean internittent catheterization (CIC). Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.

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)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Version: A/0

VOL 005_510(k) Summary

1. Submission Sponsor

Applicant Name	Zhanjiang Star Enterprise Co., Ltd
Address	NO.1, West Jinhua Rd. Zhanjiang, Guangdong, P. R.
CHINA
Post Code	524094
Phone No.	86-759-2701619
Fax No.	86-759-2706838
Contact Person	Rongsheng Tang
Email	Tangrs@starcompany.com.cn
Date Prepared	2017-08-19

2. Submission correspondent

Name	Shenzhen Joyantech Consulting Co., Ltd
Address	Room 1122, No.55 Shizhou Middle Road, Nanshan
District,
Shenzhen,
Guangdong,
P.R.China
	Image: logo
	卓远天成
Post Code	518000
Phone No.	86-755-86069197
Contact Person	Elly Xu; Field Fu
Email	elly@cefda.com; cefda13485@163.com

3. Devices Identification

Trade name	Disposable Urinary Catheter
Common name	Disposable Urinary Catheter
Model	PVC Urinary Catheter, Silicone Urinary Catheter,
Latex Catheter
Classification	II
Classification name	Urological catheter and accessories
Regulation number	876.5130
Product code	EZD, EZL
510(k) review panel	Gastroenterology/Urology
Performance standards	The performance and safety was evaluated in
accordance with EN 1616:1997(R2007) and ASTM
F623-99(2013).
Biocompatibility tests were done in conformance with
relevant requirements of ISO10993.

Version: A/0

Trade Name	Bard RiteCath Intermittent Urinary Catheter
Regulation number	876.5130
Regulation class	II
Regulation name	Urological catheter and accessories
510(k) Number	K142575
Product Code	EZD
Manufacturer	BARD Medical Division C. R. BARD, Inc.

Trade Name	Disposable Silicone Foley Catheter
Regulation number	876.5130
Regulation class	II
Regulation name	Urological catheter and accessories
510(k) Number	K130908
Product Code	EZL
Manufacturer	Guangdong Baihe Medical Technology Co., Ltd.

I egally Marketed Predicate Devices এ -

Trade Name	Medline Latex Foley Catheter
Regulation number	876.5130
Regulation class	II
Regulation name	Urological catheter and accessories
510(k) Number	K071423
Product Code	EZL
Manufacturer	Medline Industries, Inc.

5. Device Description

PVC Urinary Catheter

PVC Urinary Catheter only has nelaton type structure, which is made of PVC and is intended for draining the bladder for short term. PVC Urinary Catheter consists of drainage funnel, drainage lumen, eyelets and tip. It is supplied in French size ranging from 8 to 20F. The catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.

Silicone Urinary Catheter

Silicone Urinary Catheter is made of pure silicone. It is intended to be placed in the bladder, through the urethra, to drain urine into a collection device and has two-way type and three-way type. The two-way type consists of funnel, drainage lumen, drainage

eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eyes, balloon, inflating connector and valve. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.

Latex Urinary Catheter

Latex Foley Catheter is made of nature latex, which has nelaton type, two-way type and three-type.

The nelaton Latex Urinary Catheter is intended for draining the bladder for short term and consists of drainage funnel, drainage lumen, eyelets and tip. The nelaton catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2-12 years old.

The two-way type and three-way type are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eye. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.

6. Indications for Use Statement

The PVC Urinary Catheter is launched for clean intermittent catheterization (CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract. It is indicated for use in male, female, and pediatric patients 2-12 years old.
A The Silicone Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.
A The Latex Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Neleton catheters are launched for clean intermittent catheterization (CIC). Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.

7. Substantial Equivalence Discussion

7.1 Comparison between PVC Urinary Catheter and Bard RiteCath Intermittent Urinary Catheter

Version: A/0

| Item | Proposed Device:
PVC Urinary Catheter | Predicate Device:
Bard RiteCath
Intermittent Urinary
Catheter (K142575) | Comments | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Product Code | EZD | EZD | Same | |
| Intended Use | The PVC Urinary
Catheter is launched for
clean intermittent
catheterization (CIC)
treatment. It is intended
for use in the drainage of
fluid from the urinary
tract. It is indicated for
use in male, female, and
pediatric patients 2-12
years old. | The Bard RiteCath
Intermittent Urinary
Catheter is intended for use
by adult and pediatric, male
and female patients for
draining urine from the
bladder. Pediatric patients
include neonates, infants,
children and adolescents. | Same | |
| Device Structure | Color-coded funnel,
shaft, eyelets and tip | Color-coded funnel, shaft,
staggered eyelets and tip | Same | |
| Catheter
material | PVC | PVC | Same | |
| Size | Male: 12Fr-20Fr
Female: 12Fr-20Fr | Male: 12Fr-18Fr
Female: 12Fr-18Fr | Similar. Compared with the
predicate device, the
proposed device has 20Fr.
The 20Fr size for Urinary
Catheter is widely used in
the market and had been
approved in FDA (Such as
K142563, K130908 ). And
the sizes for pediatric is
covered in the scope of
predicate device. | |
| | Pediatric: 8Fr-10Fr | Pediatric: 6Fr-10Fr | | |
| Condition of use | It is used for clean
intermittent
catheterization (CIC)
treatment. | It is used for clean
intermittent catheterization
(CIC) treatment. | Same | |
| Sterilization | SAL: 10-6
Method: EO Sterilized | SAL: 10-6
Method: EO Sterilized | Same | |
| Performance | Complied with BS EN
1616: 1997(R2007) | Complied with BS EN
1616: 1997(R2007) | Same | |
| Shelf Life | 4 years | Unknown | The shelf life of 4 years
has been verified and the
test report is shown in
VOL 14 | |
| Item | Proposed Device:
PVC Urinary Catheter | Predicate Device:
Bard RiteCath
Intermittent Urinary
Catheter (K142575) | Comments | |
| Single Use | Yes | Yes | Same | |
| Biocompatibility | Cytotoxicity | ISO 10993-5:2009 | ISO 10993-5:2009 | Same |
| | Sensitization,
irritation | ISO 10993-10:2010 | ISO 10993-10:2010 | Same |
| | Systemic
toxicity | ISO 10993-11:2006 | ISO 10993-11:2006 | Same |
| | Implantation | ISO 10993-6:2007 | ISO 10993-6:2007 | Same |

Version: A/0

7.2 Comparison between Silicone Urinary Catheter and Bard RiteCath Intermittent Urinary Catheter

| Item | Proposed Device:
Silicone Urinary Catheter | Predicate Device:
Disposable Silicone Foley
Catheter (K130908) | Comments | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------|
| Product Code | EZL | EZL | Same | |
| Intended
Use/Indications
for Use | The Silicone Urinary Catheter
is intended to be placed in the
bladder, through the urethra, to
drain urine into a collection
device. Two-way catheters are
intended for urological bladder
drainage only. Three-way
catheters are intended for
urological bladder drainage
and bladder irrigation. It is
indicated for use in male,
female, and pediatric patients
2-12 years old. | Two-way Disposable Silicone
Foley Catheter: Urethral
catheterization for bladder
drainage for urological use
only; the indwell 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; the
indwell time of the proposed
device is no more than 30
days. | Same | |
| Item | Proposed Device:
Silicone Urinary Catheter | Predicate Device:
Disposable Silicone Foley
Catheter (K130908) | Comments | |
| Device Structure | Two-way: double lumen tube, a
double lumen hub, a balloon
and a tip
Three- way: a triple lumen
tube, a triple lumen hub, a
balloon and a tip | Two-way: double lumen tube, a
double lumen hub, a balloon
and a tip
Three- way: a triple lumen
tube, a triple lumen hub, a
balloon and a tip | Same | |
| Catheter
material | silicone | silicone | Same | |
| Size | Male: 12Fr-24Fr
Female: 12Fr-24Fr | Male: 12-26Fr
Female:12-26Fr | Similar. Similar.
The size of
proposed device
is included in the
scope of the
predicate device. | |
| | Pediatric: 8Fr,10Fr | Pediatric: 6Fr,8Fr, 10Fr | | |
| | | | | |
| Balloon size | 3 mL, 5 mL, 15 mL, 30 mL | 1.5 mL, 3 mL, 5 mL, 10 mL, 15
mL, 20 mL, 30 mL | Similar. The
balloon size of
proposed device
is included in the
scope of the
predicate device. | |
| Condition of use | Indwelling catheterization
treatment. | Indwelling catheterization
treatment. | Same | |
| Sterilization | SAL: 10-6
Method: EO Sterilized | SAL: 10-6
Method: EO Sterilized | Same | |
| Performance | Complied with ASTM
F623-99(2013) | Complied with ASTM
F623-99(2013) | Same | |
| Shelf Life | 4 years | Unknown | The shelf life of 4
years has been
verified and the
test report is
shown in
VOL_14. | |
| Single Use | Yes | Yes | Same | |
| Biocompatibility | Cytotoxicity | ISO 10993-5:2009 | ISO 10993-5:2009 | Same |
| | | | | |
| | Sensitization, | ISO 10993-10:2010 | ISO 10993-10:2010 | Same |
| Item | Proposed Device:
Silicone Urinary Catheter | Predicate Device:
Disposable Silicone Foley
Catheter (K130908) | Comments | |
| irritation | | | | |
| Systemi
c
toxicity | ISO 10993-11:2006 | ISO 10993-11:2006 | Same | |
| | Implant
ation | ISO 10993-6:2007 | ISO 10993-6:2007 | Same |

Version: A/0

7.3 Comparison between Latex Urinary Catheter and Bard RiteCath Intermittent Urinary Catheter

| Item | Proposed Device:
Latex Urinary Catheter | Predicate Device:
Medline Latex Foley
Catheter (K071423) | Comments | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Product Code | EZL | EZL | Same | |
| Intended Use/Indications for
Use | The Latex Urinary
Catheter is intended to be
placed in the bladder,
through the urethra, to
drain urine into a
collection device. Neleton
catheters are launched
for clean intermittent
catheterization (CIC).
Two-way catheters are
intended for urological
bladder drainage only.
Three-way catheters are
intended for urological
bladder drainage and
bladder irrigation. It is
indicated for use in male,
female, and pediatric
patients 2-12 years old. | The Medline Latex Foley
Catheter is intended to be
used as a urological
catheter inserted through
the Urethral for the
purpose of draining urine
and other fluids from the
urinary tract. | Similar. See
Issue 1. | |
| Device Structure | Neleton: funnel, shaft,
eyelets and tip | / | Different.
See Issue

                                                                                                                                                           |      |

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Issue 1: The proposed device has the Neleton type structure compared with the predicate device. As the neleton type has less dwell time compared with the Foley Catheter (two-way and three-way Urinary Catheter), it has less likely to cause a urinary-tract infection in these situations. Moreover, the biocompatibility test reports and the bench test reports for neleton type of the proposed device demonstrate that proposed device is biocompatible and the performance as intended.

Issue 2: Although the sterilization methods between the proposed device and the predicate device are different, but the EO sterilization effect of the proposed device is proved by the Sterilization report in VOL_014. The validation report showed that the sterilization effect of the proposed device can achieve a Sterility Assurance Level (SAL) of 10-6.

8. Non-clinical Testing

All nonclinical testing performed on new devices is to demonstrate the substantial

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equivalence to the predicate devices. Tests setup and execution are performed in accordance with applicable standards. Results of the testing are demonstrating the compliance to the standards and matching the performance of new devices to the predicate devices.

The following performance data were provided in support of the substantial equivalence determination.

Test	Requirements	Results
Surface finish	Meet the requirement of 4.2 of EN 1616:
1997(R2007).	Passed
Dimensions	Meet the requirement of 4.3 of EN 1616:
1997(R2007).	Passed
Strength	Meet the requirement of 4.4 of EN 1616:
1997(R2007).	Passed
Connector security	Meet the requirement of 4.5 of EN 1616:
1997(R2007).	Passed
Flow rates	Meet the requirement of 4.8 of EN 1616:
1997(R2007).	Passed
Biocompatibility	Cytotoxicity
ISO 10093-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity	Passed
	Sensitization
ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization	Passed
	Irritation
ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization	Passed
	Systemic toxicity
Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity	Passed
Sterility	SAL≤ 10-6	Passed

8.1 PVC Urinary Catheter

8.2 Silicone Urinary Catheter

Test	Requirements	Results
Flow rate through drainage
lumen	Meet the requirement of 4.1 of ASTM
F623-99(2013)	Passed
Balloon Integrity	Meet the requirement of 4.2 of ASTM
F623-99(2013)	Passed
Inflated Balloon Response to
Traction	Meet the requirement of 4.3 of ASTM
F623-99(2013)	Passed
Balloon Volume Maintenance	Meet the requirement of 4.4 of ASTM
F623-99(2013)	Passed
Balloon Size and Shaft Size	Meet the requirement of 4.5 of ASTM
F623-99(2013)	Passed

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| Deflation Reliability (Failure to Deflate) | Meet the requirement of 4.6 of ASTM
F623-99(2013) | Passed | |
|--------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------|
| Biocompatibility | Cytotoxicity | ISO 10093-5 Biological evaluation of medical
devices -Part 5: Tests for in vitro cytotoxicity | Passed |
| | Sensitization | ISO 10993-10 Biological evaluation of medical
devices -Part 10:Tests for irritation and skin
sensitization | Passed |
| | Irritation | ISO 10993-10 Biological evaluation of medical
devices -Part 10:Tests for irritation and skin
sensitization | Passed |
| | Systemic
toxicity | Biological Evaluation Of Medical Devices - Part 11:
Tests For Systemic Toxicity | Passed |
| | Implantation | Biological Evaluation Of Medical Devices - Part 6:
Tests For Local Effects After Implantation | Passed |
| Sterility | SAL shall be less than $10^{-6}$ . | | Passed |

8.3 Latex Urinary Catheter

Test	Requirements	Results
Surface finish	Meet the requirement of 4.2 of EN 1616:
1997(R2007).	Passed
Dimensions	Meet the requirement of 4.3 of EN 1616:
1997(R2007).	Passed
Strength	Meet the requirement of 4.4 of EN 1616:
1997(R2007).	Passed
Connector security	Meet the requirement of 4.5 of EN 1616:
1997(R2007).	Passed
Flow rates	Meet the requirement of 4.8 of EN 1616:
1997(R2007) and 4.1 of ASTM F623-99(2013).	Passed
Balloon Integrity	Meet the requirement of 4.2 of ASTM
F623-99(2013)	Passed
Inflated Balloon Response to
Traction	Meet the requirement of 4.3 of ASTM
F623-99(2013)	Passed
Balloon Volume Maintenance	Meet the requirement of 4.4 of ASTM
F623-99(2013)	Passed
Balloon Size and Shaft Size	Meet the requirement of 4.5 of ASTM
F623-99(2013)	Passed
Deflation Reliability (Failure to
Deflate)	Meet the requirement of 4.6 of ASTM
F623-99(2013)	Passed
Biocompatibility Cytotoxicity
Sensitization	ISO 10093-5 Biological evaluation of medical
devices -Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical
devices -Part 10:Tests for irritation and skin	Passed

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		sensitization
	Irritation	ISO 10993-10 Biological evaluation of medical
devices –Part 10:Tests for irritation and skin
sensitization	Passed
	Systemic
toxicity	Biological Evaluation Of Medical Devices - Part 11:
Tests For Systemic Toxicity	Passed
	Implantation	Biological Evaluation Of Medical Devices - Part 6:
Tests For Local Effects After Implantation	Passed
Sterility		SAL $ \leq $ 10-6.	Passed

9. Clinical Testing

Substantial equivalence does not depend on clinical test data.

10. Conclusions

Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed predicate devices.