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

K170233 · Zhanjiang Star Enterprise Co., Ltd. · EZD · Oct 13, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K170233
• Device Name: Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)
• Applicant: Zhanjiang Star Enterprise Co., Ltd.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Oct 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 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. 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.

Device Story

Disposable urinary catheters (PVC, silicone, or latex) facilitate bladder drainage; used for clean intermittent catheterization (CIC) or short-term indwelling catheterization. PVC catheters (Nelaton type) feature drainage funnel, lumen, eyelets, and tip. Silicone and latex catheters include two-way (drainage) or three-way (drainage and irrigation) configurations with inflatable balloons, valves, and connectors. Devices are inserted through the urethra into the bladder; urine drains into an external collection device. Operated by clinicians or patients (for CIC) in clinical or home settings. Output is the physical drainage of urine or irrigation fluid, enabling bladder management and relief of urinary retention. Benefits include effective fluid removal and reduced risk of urinary tract infection compared to long-term indwelling alternatives.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including surface finish, dimensions, strength, connector security, flow rates, balloon integrity, deflation reliability, and biocompatibility (ISO 10993).

Technological Characteristics

Materials: PVC, pure silicone, or natural rubber latex with silicone coating. Configurations: Nelaton, two-way, or three-way. Sizes: 8Fr-24Fr. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Performance standards: EN 1616:1997(R2007), ASTM F623-99(2013). Biocompatibility: ISO 10993 series.

Indications for Use

Indicated for male, female, and pediatric patients 2-12 years old requiring urinary tract fluid drainage, clean intermittent catheterization (CIC), or indwelling bladder drainage/irrigation.

Regulatory Classification

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).

Predicate Devices

• Bard RiteCath Intermittent Urinary Catheter (K142575)
• Disposable Silicone Foley Catheter (K130908)
• Medline Latex Foley Catheter (K071423)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known) K170233

Device Name Disposable Urinary Catheter

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

| <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 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.<br>CHINA |
| Post Code | 524094 |
| Phone No. | 86-759-2701619 |
| Fax No. | 86-759-2706838 |
| Contact Person | Rongsheng Tang |
| Email | [e-mail] |
| Date Prepared | 2017-08-19 |

# 2. Submission correspondent

| Name | Shenzhen Joyantech Consulting Co., Ltd |
|----------------|----------------------------------------------------------------------------------------------------|
| Address | Room 1122, No.55 Shizhou Middle Road, Nanshan<br>District,<br>Shenzhen,<br>Guangdong,<br>P.R.China |
| | Image: logo |
| | 卓远天成 |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Elly Xu; Field Fu |
| Email | [e-mail]; [e-mail] |

# 3. Devices Identification

| Trade name | Disposable Urinary Catheter |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name | Disposable Urinary Catheter |
| Model | PVC Urinary Catheter, Silicone Urinary Catheter,<br>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<br>accordance with EN 1616:1997(R2007) and ASTM<br>F623-99(2013).<br>Biocompatibility tests were done in conformance with<br>relevant requirements of ISO10993. |

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| 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

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

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

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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

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

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

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

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

| Item | Proposed Device:<br>Latex Urinary Catheter | Predicate Device:<br>Medline Latex Foley<br>Catheter (K071423) | Comments | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Product Code | EZL | EZL | Same | |
| Intended Use/Indications for<br>Use | The Latex Urinary<br>Catheter is intended to be<br>placed in the bladder,<br>through the urethra, to<br>drain urine into a<br>collection device. Neleton<br>catheters are launched<br>for clean intermittent<br>catheterization (CIC).<br>Two-way catheters are<br>intended for urological<br>bladder drainage only.<br>Three-way catheters are<br>intended for urological<br>bladder drainage and<br>bladder irrigation. It is<br>indicated for use in male,<br>female, and pediatric<br>patients 2-12 years old. | The Medline Latex Foley<br>Catheter is intended to be<br>used as a urological<br>catheter inserted through<br>the Urethral for the<br>purpose of draining urine<br>and other fluids from the<br>urinary tract. | Similar. See<br>Issue 1. | |
| Device Structure | Neleton: funnel, shaft,<br>eyelets and tip | / | Different.<br>See Issue<br>1. | |
| Item | Proposed Device:<br>Latex Urinary Catheter | Predicate Device:<br>Medline Latex Foley<br>Catheter (K071423) | Comments | |
| | Two-way: double lumen<br>tube, a double lumen hub,<br>a balloon and a tip<br>Three- way: a triple lumen<br>tube, a triple lumen hub, a<br>balloon and a tip | Two-way: double lumen<br>tube, a double lumen hub,<br>a balloon and a tip<br>Three-way: a triple lumen<br>tube, a triple lumen hub, a<br>balloon and a tip | Same | |
| Catheter material | Natural rubber latex,<br>Silicone coating | Natural rubber latex,<br>Silicone coating | Same | |
| Size | Male: 12Fr-24Fr<br>Female: 12Fr-24Fr | Male: 12-30Fr<br>Female:12-30Fr | Similar. The<br>size of<br>proposed<br>device is<br>included in<br>the scope of<br>the<br>predicate<br>device. | |
| | Pediatric: 8Fr,10Fr | Pediatric: 6Fr,8Fr, 10Fr | | |
| | | | | |
| Balloon size | 3 mL, 5 mL, 15 mL, 30<br>mL | 3 mL, 5 mL, 30 mL | Similar.<br>Both of the<br>proposed<br>device and<br>predicate<br>device have<br>the same<br>scope of<br>balloon<br>size. And<br>the<br>proposed<br>device has<br>more<br>optional<br>sizes. | |
| Condition of use | Neleton: CIC treatment<br>Two-way and three-way:<br>Indwelling catheterization<br>treatment. | /<br>Indwelling catheterization<br>treatment | Different.<br>See Issue 1<br>Same | |
| Sterilization | SAL: 10-6 | SAL: 10-6 | Same | |
| Item | Proposed Device:<br>Latex Urinary Catheter | Predicate Device:<br>Medline Latex Foley<br>Catheter (K071423) | Comments | |
| | Method: EO Sterilized | Method: Gamma<br>Irradiation | Different.<br>See Issue<br>2. | |
| Performance | Complied with BS EN<br>1616: 1997(R2007) and<br>ASTM F623-99(2013) | Complied with ASTM<br>F623-99(2013) | Same | |
| Shelf Life | 4 years | Unknown | The shelf<br>life of 4<br>years has<br>been<br>verified and<br>the test<br>report is<br>shown in<br>VOL_14. | |
| Single Use | Yes | Yes | Same | |
| Biocompatibility | Cytotoxicity | ISO 10993-5:2009 | ISO 10993-5:2009 | Same |
| | Sensitization,<br>irritation | ISO 10993-10:2010 | ISO 10993-10:2010 | Same |
| | Systemic<br>toxicity | ISO 10993-11:2006 | ISO 10993-11:2006 | Same |
| | Implantation | ISO 10993-6:2007 | ISO 10993-6:2007 | Same |

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#### Version: A/0

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 les…