Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter

K192468 · Hangzhou Bever Medical Devices Co., Ltd. · GBM · Nov 27, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K192468
• Device Name: Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter
• Applicant: Hangzhou Bever Medical Devices Co., Ltd.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Nov 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Ready-to-use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

Device Story

Single-use, disposable polyurethane catheter; pre-lubricated with polyvinylpyrrolidone (PVP) coating that binds water to create a smooth film. Available in Nelaton, Tapered (Tiemann), and Olive tip configurations; includes insertion aid (sleeve) for no-touch handling. Tiemann models feature guide stripes/ridges for orientation. Used by patients for intermittent bladder drainage; inserted into urethra to reach bladder. Device provides mechanical drainage of urine; benefits include reduced friction during insertion and simplified, hygienic handling via no-touch sleeve.

Clinical Evidence

Bench testing only. Performance validated per ISO 20696 (strength, connector security, flow rate, kink stability, peak tensile force), ASTM D 1894 (coefficient of friction), and internal methods (coating adhesion). Biocompatibility per ISO 10993-1. Sterilization validated per ISO 11137. Shelf life validated per ASTM F1980. All tests met acceptance criteria.

Technological Characteristics

Polyurethane catheter with PVP hydrophilic coating; sterile water hydration. Tip types: Nelaton, Tapered, Olive. Includes insertion sleeve. Sterilized per ISO 11137. Standards: ISO 20696 (performance), ASTM D 1894 (friction), ISO 10993-1 (biocompatibility), ASTM F1980 (shelf life).

Indications for Use

Indicated for intermittent urethral catheterization in patients unable to promote natural urine flow or those with significant residual urine volume following bladder voiding.

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

• SpeediCath (K023254)

Reference Devices

• LoFric® Primo™ (K122078)
• Self Cath (K100878)

Submission Summary (Full Text)

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November 27, 2019

Hangzhou Bever Medical Devices Co., Ltd. Ms. Allyson Zhou Management Representative Building 2, No. 1-1, Houmuqiao, Yongle Village, Cangqian St., Yuhang District Hangzhou, Zhejiang Province 311121 CHINA

Re: K192468

> Trade/Device Name: Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter Female, Nelaton-tip Ready-to-Use Hydrophilic Catheter Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM, EZD Dated: September 4, 2019 Received: September 9, 2019

Dear Ms. Zhou:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica K. Nguyen, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecological, and Urological Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K192468

#### Device Name

Ready-to-Use Hydrophilic Catheter

#### Indications for Use (Describe)

The Ready-to-use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

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

Z Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved:: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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#### Hangzhou Beve al Devices Co., Ltd.

Add: Building 2, No. 1-1, Houmuqiao, Yongle Village, Canggian Street, Yuhang District 311121, Hangzhou, China Tel: [phone] Fax: [phone]

# 510(k) Summary

Date of summary: November 22, 2019

### 1. Submitter (Owner) of 510 (k):

Hangzhou Bever Medical Devices Co., Ltd. Building 2, No. 1-1, Houmuqiao, Yongle Village, Cangqian Street, Yuhang District 311121, Hangzhou, China Tel: [phone] Fax: [phone] Registration Number: 3008729910

### 2. Contact person:

Allyson Zhou Management Representative Tel: [phone] Fax: [phone] Email: [e-mail]

#### 3. De vice Name :

Common Name: Catheter, Urethral Trade Name: Ready-to-use Hydrophilic Catheter Classification Name: Urological catheter and accessories (21 CFR 876.5130) Product Code: GBM Regulation Class: II

#### 4. Legally Marketed predicate(s):

Predicate Device: SpeediCath - K023254

Reference Device(s): LoFric® Primo™ - K122078 Self Cath - K100878

# 5. Device Description

The Ready-to-Use Hydrophilic Catheter is a single use, disposable polyurethane catheter. It is coated and placed in the water, packed and sealed in a foil bag and The catheter is prelubricated with a coating containing sterilized. polyvinylpyrrolidone, which binds the water molecules to the surface of the catheter creating a smooth and even lubricating film.

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#### K192468, pg. 2 of 4

The Ready-to-Use Hydrophilic Catheter is available for men, women and children, in three different tip configurations of Nelaton (straight and rounded), Tapered (curved and tapered) and Olive (curved and olive), in single or combination with an insertion aid (a sleeve) which provides an easy grip, allowing for insertion without touching. There are two polished drainage eyelets on the catheter in various configurations and types.

The Tiemann catheter has a bended tip along with a guide stripe (in the shaft) and/or aligned with a raised ridge (on the funnel), which will help ensure the catheter tip is still correctly oriented when approaching the bladder.

### 6. Indications for Use

The Ready-to-Use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder - voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

# 7. Technological Characteristics

| Characteristic | Subject device | Predicate device | Reference device | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ready-to-Use<br>Hydrophilic Catheter | SpeediCath<br>K023254 | LoFric® Primo™<br>K122078 | Self Cath<br>K100878 |
| Indication for<br>use | Indicated for<br>intermittent<br>catheterization of the<br>urethra for those<br>individuals who are<br>unable to promote a<br>natural urine flow or<br>for those individuals<br>who have a<br>significant volume of<br>residual urine<br>following a natural<br>bladder - voiding<br>episode. The catheter<br>is inserted into the<br>urethra to reach the<br>bladder allowing<br>urine to drain. | Indicated for use by<br>patients with<br>chronic urine<br>retention and<br>patients with a post<br>void residual<br>volume (PVR) due<br>to neurogenic and<br>non-neurogenic<br>voiding<br>dysfunction. The<br>catheter is inserted<br>into the urethra to<br>reach the bladder<br>allowing urine to<br>drain. | Intended for<br>Intermittent<br>catheterization<br>of the urethra. | Indicated for<br>those individuals<br>unable to<br>promote a natural<br>urine flow or for<br>those individuals<br>who have a<br>significant<br>volume of<br>residual urine<br>following a<br>natural bladder-<br>voiding episode. |

The table below summarizes the technological characteristics of Ready-to-Use Hydrophilic Catheter (subject device) as compared to the legally marketed predicates.

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| Size | Female Fr 6, 8, 10,<br>12, 14, 16, 18<br>Male Fr 6, 8, 10, 12,<br>14, 16, 18<br>Tiemann Fr 8, 10,<br>12, 14, 16, 18<br>Pediatric Fr 6, 8, 10 | Female Fr 6, 8, 10,<br>12, 14, 16<br>Male Fr 8, 10, 12,<br>14, 16, 18<br>Tiemann Fr 10, 12,<br>14<br>Pediatric Fr 6, 8, 10<br>Boy Fr 6, 8, 10, 12 | Nelaton 8in<br>Fr 8, 10, 12, 14,<br>16, 18<br>Nelaton 16in<br>Fr 8, 10, 12, 14,<br>16, 18<br>Tiemann 16in<br>Fr 10, 12, 14,<br>16, 18<br>Pediatric 8in<br>Fr 6, 8, 10 | Female Fr 8, 10,<br>12, 14,<br>Male Fr 8, 10, 12,<br>14, 16, 18<br>Tiemann Fr 6, 8,<br>10, 12, 14, 16, 18<br>Pediatric Fr 5, 6,<br>8, 10 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>composition | Polyurethane<br>catheter coated with<br>polyvinylpyrroli-<br>done, placed in<br>water, in single or<br>combination with an<br>insertion aid. | Polyurethane<br>catheter coated<br>with polyvinylpyr-<br>rolidone, placed in a<br>saline solution<br>containing poly-<br>vinylpyrrolidone. | Plastic catheter<br>coated with<br>polyvinylpyrro-<br>lidone, packed<br>with the sterile<br>water. | Polyvinyl<br>chloride catheter<br>(without coating) |
| Condition of<br>use | Singe Use | Singe Use | Singe Use | Singe Use |
| Coating | PVP(polyvinylpyr-<br>rolidone) Based<br>Coating | PVP(polyvinylpyr-<br>rolidone) Based<br>Coating | PVP(polyvi-<br>nylpyrrolidone)<br>Based Coating | No coating |
| Prelubricated | Yes-by water<br>hydration | Yes-by saline<br>solution hydration | Yes-by water<br>hydration | No |
| Lubricating<br>solution | Sterile water | Sterile saline<br>solution | Sterile water | No |
| Ready to use | Yes | Yes | Requires<br>bursting of<br>water packet<br>prior to use | No |
| No touch<br>design | Yes- contains an<br>insertion aid (sleeve) | No | Yes- by using<br>exterior<br>packaging | No |
| Tip<br>configuration | Nelaton tip, Tapered<br>tip and Olive tip | Nelaton tip and<br>Tapered tip | Nelaton tip and<br>Tapered tip | Nelaton tip,<br>Tapered tip and<br>Olive tip |
| Guide stripe<br>in the shaft | Yes-<br>Tiemann Catheter | No | No | Yes-<br>Tiemann Catheter |
| Drainage<br>Eyelets | Polished and<br>staggered | Polished and<br>staggered | Polished and<br>staggered | Polished and<br>staggered |
| End Design | Funnel | Funnel | Funnel | Funnel |
| Duration of<br>use | For intermittent use | For intermittent use | For intermittent use | For intermittent use |
| Sterile | Yes | Yes | Yes | Yes |
| Packaging | Peel Pack | Peel Pack | Peel Pack | Peel Pack |

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#### 8. Summary of Non-Clinical Testing

#### Performance testing for Ready-to-Use Hydrophilic Catheter was conducted according to applicable sections of voluntary standards:

a) Biocompatibility testing according to ISO 10993-1:2009 and FDA Guidance "Use of International Standard ISO 10993-1" (2016) was completed.

b) Bench testing was completed per ISO 20696, ASTM D 1894 and internal test methods.

Performance testing was conducted according to applicable sections of standards in order to document the following properties of the Ready-to-Use hydrophilic catheter:

- Strength was checked by the test method in Annex A of ISO 20696.
- Connector security was checked by the test method in Annex B of ISO 20696.
- Flow rate was checked by the test method in Annex E of ISO 20696.
- Kink stability was checked by the test method in Annex G of ISO 20696.
- Peak tensile force was checked by the test method in Annex H of ISO 20696.
- Coefficient of friction was checked by the test method in ASTM D 1894.
- Coating adhesion was checked by the test method in BEVER internal methods.

All tests passed.

c) Sterilization validation was conducted according to AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 11137-2 and AAMI/ANSI/ISO 11137-3.

d) Accelerated Aged (in compliance with ASTM F1980) Shelf life testing was completed.

All tests met the pre-determined acceptance criteria.

#### 9. Conclusions

The subject device has the same intended use and similar technological characteristics to the currently-marketed predicate devices. The subject device is substantially equivalent to the currently-marketed predicate devices. Laboratory and safety testing conducted on the product has provided scientific evidence that this subject device is as safe and effective as the predicate device for its intended use.