Silicone Foley Catheter for single use

K172807 · Changzhou Rongxin Medicine Minimal Invasion Technology · EZL · Jun 4, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K172807
• Device Name: Silicone Foley Catheter for single use
• Applicant: Changzhou Rongxin Medicine Minimal Invasion Technology
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Jun 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Two-way Disposable Silicone Foley Catheterization for bladder drainage and urological use only; the indwelling time is no more than 30 days. Three-way Disposable Silicone Foley Catheterization for bladder drainage and bladder irrigation for urological use only; the indwelling time is no more than 30 days.

Device Story

Silicone Foley catheter designed for intermittent or indwelling bladder drainage and irrigation; available in two-way and three-way configurations. Device consists of a silicone shaft with an inflatable balloon for retention; includes pediatric models with internal steel wire. Used in clinical settings for urological procedures; operated by healthcare professionals. Device provides a pathway for fluid drainage or irrigation; balloon secures position within bladder. Benefits include effective bladder management and reduced risk of trauma due to silicone material. Sterile, single-use device.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including performance testing per ASTM F623-99 (2013) and EN 1616:1997, radiopacity testing per ASTM F640-2012, and comprehensive biocompatibility testing per ISO 10993-1.

Technological Characteristics

Material: Silicone. Design: Balloon-retention catheter, two-way or three-way. Sizes: 6Fr-24Fr. Sterilization: Ethylene Oxide (EO). Radiopaque. Complies with ASTM F623-99, EN 1616:1997, and ASTM F640-2012.

Indications for Use

Indicated for pediatric, male, and female patients requiring urethral catheterization for bladder drainage (two-way) or bladder drainage and irrigation (three-way). Indwelling time limited to 30 days.

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

• Disposable Balloon-retention Catheter (K130908)

Submission Summary (Full Text)

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June 4, 2018

Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No. 26 Qinglan Street Panyu District Guangzhou, 510006 CHINA

Re: K172807

Trade/Device Name: Silicone Foley Catheter for Single Use Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZL Dated: May 4, 2018 Received: May 4, 2018

# Dear Mike Gu:

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

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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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Benjamin R. Fisher -S

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)

### K172807

Device Name Silicone Foley Catheter for single use

### Indications for Use (Describe)

Two-way Disposable Silicone Foley Catheterization for bladder drainage and urological use only; the indwelling time is no more than 30 days.

Three-way Disposable Silicone Foley Catheterization for bladder drainage and bladder irrigation for urological use only; the indwelling time is no more than 30 days.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image shows a logo with a green leaf on the left and a blue wave on the right. The leaf and wave are arranged in a circular shape. The leaf is a bright green color, and the wave is a deep blue color. The logo is simple and modern, and it likely represents a company or organization that is focused on environmental sustainability or water conservation.

# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

# 1. SUBMITTER

CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION TECHNOLOGY CO., LTD. No. 8, Jianerkang Road, Industrial Concentration Area, Zhixi Town, Jintan City, Jiangsu Province, China Tel: [phone] Fax: [phone]

| Primary Contact | Mike Gu |
|-------------------|----------------------------------------------------|
| Person: | Regulatory Affairs Manager |
| | Guangzhou Osmunda Medical Device Technical Service |
| | Co., Ltd. |
| | Tel: [phone] |
| | Fax: (+86) -20-8633 0253 |
| Secondary Contact | Ping Liu |
| Person: | Quality Assurance Manager |
| | CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION |
| | TECHNOLOGY CO., LTD. |
| | Tel: [phone] |
| | Fax: [phone] |
| Date prepared | May 3, 2018 |
| 2. DEVICE | |
| Device Name: | Silicone Foley Catheter for single use |

| Common/Usual Name: | Silicone Foley Catheter for single use |
|---------------------|----------------------------------------|
| Regulation number | 21 CFR 876.5130 |
| Regulation Name | Urological catheter and accessories |
| Regulation Class: | II |
| Product Code: | EZL |
| Classification Name | Catheter, Retention Type, Balloon |
| | |

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Image /page/5/Picture/0 description: The image shows a logo with a green leaf-like shape on the upper left and a blue wave-like shape on the lower right. The two shapes are arranged in a circular fashion, creating a sense of balance and harmony. The green color of the leaf suggests nature and growth, while the blue color of the wave evokes water and fluidity. The logo is simple, clean, and visually appealing.

#### 3.
ന് PREDICATE DEVICES

Predicate device: K130908, Disposable Balloon-retention Catheter These predicates have not been subject to a design-related recall.

## 4. DEVICE DESCRIPTION

The Silicone Foley Catheter for single use is designed as an intermittent pathway for drainage and irrigation of the bladder. The device is made of silicone. The catheter is provided sterile in a variety of lengths and sizes.

### 5. Indications for USE

Two-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage for urological use only; the indwelling time 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 indwelling time is no more than 30 days.

| Specification | Predicate Device | Proposed Device | Discussion of<br>Differences |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Device name | Disposable Balloon-retention<br>Catheter | Silicone Foley Catheter for single<br>use | similar |
| K number | K130908 | -- | |
| Indications for<br>use | Two-way Disposable Silicone<br>Foley Catheter: Urethral<br>catheterization for bladder<br>drainage and urological use only;<br>the indwelling time 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>indwelling time is no more than<br>30 days. | Two-way Disposable Silicone<br>Foley Catheter: Urethral<br>catheterization for bladder<br>drainage and urological use only;<br>the indwelling time 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>indwelling time is no more than<br>30 days. | Identical |
| Specification | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Intended<br>population | Pediatric ,male and female | Pediatric ,male and female | Identical |
| Anatomical<br>Sites | Urethra, bladder | Urethra, bladder | Identical |
| Lumen | Two way, three way | Two way, three way | Identical |
| Size range | 6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr,<br>18Fr, 20Fr, 22Fr, 24Fr, 26Fr | 6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr,<br>18Fr, 20Fr, 22Fr, 24Fr | Identical |
| Tube Length | 6Fr, 8Fr ,10Fr: 310mm<br>12Fr-26Fr: 400mm | 6Fr, 8Fr ,10Fr: 310mm<br>12Fr-24Fr: 400mm | Identical |
| Balloon | Yes | Yes | Identical |
| Balloon size | 1.5ml, 3ml, 5ml, 10ml, 15ml,<br>20ml, 30ml | 3ml, 5ml, 10ml, 15ml, 30ml | Identical |
| Eyes in tip | Two-way: no<br>Three-way: yes | Two-way: no<br>Three-way: yes | Identical |
| Tip shape | circular | circular | Identical |
| Standard funnel | Yes | Yes | Identical |
| Steel wire in<br>pediatric models | yes | yes | Identical |
| Material of main<br>shaft | silicone | silicone | Identical |
| Single use | Yes | Yes | Identical |
| Shelf life | 3 years | 3 years | Identical |
| Sterility | EO | EO | Identical |

# 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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Image /page/6/Picture/0 description: The image shows a logo with a green leaf-like shape on the left and a blue wave-like shape on the right. The two shapes are intertwined, creating a circular design. The green color suggests nature or growth, while the blue color suggests water or sky. There is a trademark symbol in the upper right corner of the logo.

K172807

Silicone Foley Catheter for single use is substantially equivalent to the cleared predicate device, Disposable Balloon-retention Catheter (K130908) because it has same indications for use, is composed of the same materials, and has similar technological characteristics.

# 7. NON-CLINICAL DATA

The following non-clinical data were provided in support of the substantial equivalence determination.

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Image /page/7/Picture/0 description: The image shows a logo with a green leaf-like shape on the left and a blue wave-like shape on the right. The two shapes are intertwined. Below the logo, the words "Performance testing" are written in black text. The text is underlined.

The device were evaluated according to ASTM F623-99 (2013) and EN 1616:1997. Also, the device was evaluated to be radiopaque in accordance with ASTM F640-2012.

# Biocompatibility

According to the guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the following tests have been conducted. Sample preparation and reference materials were conducted based on ISO 10993-12:2012.

- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Subchronic Toxicity
- Genotoxicity
- Implantation

# Sterility

The device is designed for EO sterilization.

# Animal Study

The subject of this premarket submission, Silicone Foley Catheter for single use, does not require animal studies to support substantial equivalence.

# 8. CLINICAL DATA

The subject of this premarket submission, Silicone Foley Catheter for single use, did not require clinical studies to support substantial equivalence.

# 9. CONCLUSION

The differences between the Silicone Foley Catheter for single use and its predicate devices do not raise different questions of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the Silicone Foley Catheter for single use should perform as intended in the specified use conditions.

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Image /page/8/Picture/0 description: The image shows a logo with a green leaf on the left and a blue wave on the right. The leaf and wave are connected, forming a circular shape. The logo is simple and modern, and it likely represents a company or organization that is focused on environmental sustainability or water resources.

From the results of non-clinical data including the performance testing and comparative performance testing described, CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION TECHNOLOGY CO., LTD. concludes that the Silicone Foley Catheter for single use is as safe and as effective as the predicate devices.