The BEVER™ intermittent 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 Description

BEVERTM Intermittent Catheter is sterile, single use device to be designed as an intermittent pathway for drainage of the bladder. It is available for men, women and children, in uncoated and coated variants and in two different tip configurations of Nelaton (straight and rounded) and Tiemann (curved and tapered) respectively. There are two polished drainage eyelets on the catheter in various configurations and types. The uncoated catheter consists of a tubular polyvinyl chloride catheter shaft with attached a drainage funnel. The catheter is available in sizes 6Fr ~ 22Fr in 2Fr increments for Nelaton-tip and sizes 8Fr ~ 22Fr in 2Fr increments for Tiemann-tip. The coated catheter consists of a tubular polyvinyl chloride catheter shaft, coated with a hydrophilic low-friction coating, with attached a drainage funnel, and a sterile water packet is placed in the package. The surface of coated catheter is hydrophilic and when the coated catheter is activated with the sterile water in the attached water packet, it becomes slippery and thus reduces friction against the urethra.

AI/ML Overview

The provided text describes the regulatory submission for the BEVER™ Intermittent Catheter, primarily focusing on demonstrating substantial equivalence to predicate devices rather than an efficacy study with specific acceptance criteria related to clinical performance. The "Device Performance" section refers to compliance with EN standards, and then details a series of biocompatibility tests.

Therefore, many of the requested elements for a study proving device meets acceptance criteria (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets) are not applicable or not provided in this regulatory submission document.

However, I can extract the information relevant to the acceptance criteria and performance as presented:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are based on compliance with established standards (EN and ISO) and the qualitative outcomes of the conducted tests (e.g., no cytotoxicity, non-irritant, no sensitization, no tearing). There are no specific quantitative performance metrics like sensitivity, specificity, or accuracy mentioned as this is a medical device (catheter) and not an AI/diagnostic device.

Acceptance Criteria Category	Specific Acceptance Criteria (Standard / Test Outcome)	Reported Device Performance
Physical/Material	Conformance to EN 1616:1997 and EN 1618:1997	"The dimension, design, material, sterility, packaging and labeling of BEVERTM Intermittent Catheter are conformed with EN 1616:1997." and "the device is compliance with EN 1616:1997, EN 1618:1997."
Biocompatibility - Cytotoxicity	Cell viability indicating no cytotoxic potential (per ISO 10993-5:2009, ISO 10993-12:2007)	"the viability of 100% extract of the test article was 86%, it had not a cytotoxic potential."
Biocompatibility - Irritation	Classified as non-irritant (per ISO 10993-10:2010, ISO 10993-12:2007)	"the extract of the test article was classified as a non- irritant as compared to the control."
Biocompatibility - Sensitization	No evidence of causing sensitization (per ISO 10993-10:2010, ISO 10993-12:2007)	"the SC and CSO extracts of the test article showed no evidence of causing sensitization in the guinea pig."
Packaging Integrity	No tearing observed after packaging shipment testing (per ISTA Procedure 2A)	"no tearing was observed on the inner packaging and outer packaging."
Sterility	Compliance with ISO 11135-1:2007, ISO 11137-1:2006, ISO 11137-2:2006, ISO 11137-3:2006	"The sterilization process is compliance with ISO11135-1: 2007, ISO11137-1: 2006, ISO11137-2: 2006, ISO11137-3: 2006."
Shelf Life (Coated)	Compliance with device specifications after accelerated and real-time aging for 3 years	"The shelf life of BEVER™ coated Intermittent Catheter could be considered as 3 years." and "the 3 years shelf life... has been validated."
Shelf Life (Uncoated)	Compliance with device specifications after accelerated and real-time aging for 4 years	"The shelf life of BEVER™ Uncoated Intermittent Catheter could be considered as 4 years." and "the 4 years shelf life... has been validated."

2. Sample Size Used for the Test Set and Data Provenance

Cytotoxicity Test: L-929 mouse fibroblast cells were used. The specific number of replicates or wells is not explicitly stated but implied by the use of "a 96-well microplate." Data provenance is laboratory testing.
Irritation Test: Test articles were contacted with vaginal tissue (animal model implied). The number of test subjects (animals) is not specified. Data provenance is laboratory testing.
Sensitization Test: Ten test guinea pigs (per extract) for the test group and five control guinea pigs (per vehicle) for the control group were used. Data provenance is laboratory testing (animal study).
Packaging Shipment Testing: 2 pieces of packaged-products were submitted for testing. Data provenance is laboratory testing.
Shelf Life Testing: The sample size for accelerated and real-time aging studies is not specified in the provided text. Data provenance is laboratory testing.

The country of origin for the data (tests) is not explicitly stated, but the submitter is based in Hangzhou, China, suggesting the testing was likely conducted there or overseen by the Chinese manufacturer. All studies appear to be prospective studies conducted for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The tests performed are laboratory-based assays (e.g., cell viability, tissue examination, animal skin reaction, physical integrity) whose "ground truth" is determined by the experimental results and established biological/physical standards, rather than expert consensus on complex diagnostic images or clinical scenarios. No human expert interpretation to establish a ground truth is mentioned beyond standard laboratory practice.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are laboratory-based with objective measurements (e.g., cell viability assays, macroscopic/microscopic tissue examination, visual inspection for tearing). There is no mention of a subjective "test set" requiring adjudication in the context of clinical or diagnostic performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This document describes a medical device (intermittent catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or human reader improvement with AI are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

Biocompatibility (Cytotoxicity, Irritation, Sensitization): Ground truth was established based on the results of standardized biological assays interpreted against pre-defined criteria in ISO 10993 standards and the control groups. For example, cell viability percentage for cytotoxicity, macroscopic and microscopic evaluation for irritation, and skin reaction scoring for sensitization.
Physical/Material/Packaging/Sterility/Shelf Life: Ground truth was established by demonstrating compliance with specific EN and ISO standards and by meeting the device specifications after various tests (e.g., physical inspection, sterility indicator, stability testing).

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context. The manufacturing processes and material selection might be informed by historical data or R&D, but not a formally defined "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned for this medical device.

Summary

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Hangzhou Bever N ical Devices Co., Ltd.

Add: No. 8-1, Longquan Rd., Cangqian Town, Yuhang District, Hangzhou, China Tel: +86-571-8861 6630 Fax: +86-0571-8861 6515

510(k) Summary

Date of summary: D December 30, 2011

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

Hangzhou Bever Medical Devices Co., Ltd. No. 8-1, Longquan Rd., Cangqian Town, Yuhang District 311121, Hangzhou, China Tel: +86-571-8861 6630 Fax: +86-0571-8861 6515 Registration Number: 3008729910

2. Contact person:

Allyson Zhou Management Representative Tel: +86-571-8861 6630 Fax: +86-0571-8861 6515 Email: zlshio1224@sina.com

3. Device Name:

Common Name: Intermittent Urethral Catheter Trade Name: BEVER™ Intermittent Catheter Classification name: Urological catheter and accessories (21 CFR 876.5130, Product Code GBM)

11:10:1

4. Predicate Device:

BEVER is claiming substantial equivalence to the following medical devices: Rüsch Intermittent Urethral Catheters - K033023 Astra Tech AB LoFric® Primo™ Single Use Urinary Catheter - K050874

5. Device Description

The uncoated catheter consists of a tubular polyvinyl chloride catheter shaft with attached a drainage funnel. The catheter is available in sizes 6Fr ~ 22Fr in 2Fr increments for Nelaton-tip and sizes 8Fr ~ 22Fr in 2Fr increments for Tiemann-tip.

The coated catheter consists of a tubular polyvinyl chloride catheter shaft, coated with a hydrophilic low-friction coating, with attached a drainage funnel, and a sterile water packet is placed in the package. The surface of coated catheter is hydrophilic and when the coated catheter is activated with the sterile water in the attached water

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packet, it becomes slippery and thus reduces friction against the urethra. This allows the coated catheter to slide in and out of the urethra in the most comfortable way, And, just as importantly, there's less risk of long-term complications from the repeated friction of self-catheterizing. The coated catheter is available in sizes 6Fr ~ 22Fr in 2Fr increments for Nelaton-tip and sizes 8Fr ~ 22Fr in 2Fr increments for Tiemann-tip.

6. Indications for Use

The BEVERTM Intermittent 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. Substantial Equivalence

The BEVERTM Intermittent Catheter maintains the same intended use as the predicate devices. It is a device that is inserted through the urethra and used to drain urine from the bladder.

The BEVERTM Intermittent Catheter is composed essentially of the same materials as the predicate devices. The material for both devices is PVC and PVP for coating.

The BEVER™ Intermittent Catheter has the same design and performance characteristic as the predicate devices.

8. Device Performance

The dimension, design, material, sterility, packaging and labeling of BEVERTM Intermittent Catheter are conformed with EN 1616:1997.

According to the device performance testing protocol, the device is compliance with EN 1616:1997, EN 1618:1997.

9. Summary of Testing

9.1 Biocompatibility testing was performed based on ISO 10993 requirements

The indwell time of BEVERTM Intermittent Catheter is about 1-3 minutes. And it contact mucosal membrane. According to 510(k) Memorandum - #G95-1 Table 1 Initial Evaluation Tests for Consideration, the biocompatibility testing show consider the following 3 items:

. Cytotoxicity
. Sensitization
Irritation .

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a) Test for in vitro cytotoxicity (MTT cytotoxicity test)

An in vitro cytotoxicity study was conducted to assess the potential for cytotoxicity of the test article, Intermittent Catheter, based on the International Organization for Standardization ISO 10993-5:2009: Biological evaluation of medical devices-Part 5:Tests for in vitro cytotoxicity; ISO 10993-12:2007; Biological evaluation of medical devices-Part 12: Sample preparation and reference materials.

Four concentrations (100%, 75%, and 25%) of the test article extracts, the blank control, 100% of the negative control and the positive control were prepared using Minimum Essential Medium (MEM) supplemented with 10% calf serum. The semi-confluent monolayers of L-929 mouse fibroblast cells were incubated with the test extract and other three controls, supplemented with 10% calf serum in a 96-well microplate respectively at 37℃ under the condition of 5% CO2.. At 24h, the MTT

colorimetric assay was employed and plate was read on a microplate reader at 570 and 650nm. The viability of the cells was calculated.

Under the conditions of this study, the viability of 100% extract of the test article was 86%, it had not a cytotoxic potential.

b) Test for irritation (vaginal irritation test)

The purpose of the study was to evaluate the potential irritation response of the extract of the test article, Intermittent Catheter contact with vaginal tissue. This study was conducted based on the requirements for the International Organization for Standardization ISO 10993-10:2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization: ISO 10993-12:2007: Biological evaluation of medical devices Part 12: Sample preparation and reference materials.

The test extract were contacted with vaginal tissue 1 time (once a day) directly for five consecutive days. At 24h after the final treatment, the tissues were examined macro- scopically and microscopically. The irritant effects on vaginal tissue were evaluated and scored.

Under the conditions of this study, the macroscopic reaction of test extract was relatively similar to that of the reagent control. Microscopically, the extract of the test article was classified as a non- irritant as compared to the control.

c) Test for skin sensitization (Maximization test)

A guinea pig maximization test of the test article, Intermittent Catheter, was conducted to evaluate the skin sensitizing potential. This study was based on the International Organization for Standardization ISO 10993-10:2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization; ISO 10993-12:2007: Biological evaluation of medical devices Part 12: Sample preparation and reference materials.

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Pg. Hoff

The test article was extracted in 0.9% sodium chloride solution (SC) and cotton seed oil (CSO). Each extract was injected intradermally and patched occlusively to ten test guinea pigs (per extract) in an attempt to induce sensitization. The vehicle was similarly injected and patched occlusively to five control guinea pigs (per vehicle). Following a recovery period, the test and control animals were received a challenge patch of the appropriated test article extract and the reagent control. All sites were scored at 24h and 48h after patch removal,

Under the conditions of this study, the SC and CSO extracts of the test article showed no evidence of causing sensitization in the guinea pig.

9.2 Packaging Shipment Testing was performed based on ISTA Procedure 2A

2 pieces of packaged-products were submitted for the packaging shipment testing in accordance with ISTA Procedure 2A. After all tests completed, no tearing was observed on the inner packaging and outer packaging.

10. sterility and shelf life

The device is sterilized by EO. The water packet in coated Intermittent Catheter is sterilized by radiation. The sterilization process is compliance with ISO11135-1: 2007, ISO11137-1: 2006, ISO11137-2: 2006, ISO11137-3: 2006.

Regarding the accelerated aging testing result, after 137 days accelerated aging, BEVER " coated Intermittent Catheter is still compliance the requirements of device specification. The shelf life of BEVER™ coated Intermittent Catheter could be considered as 3 years. And, according to the real time stability study, the 3 years shelf life of BEVER"10 Coated Intermittent Catheter has been validated. Herewith we declare that the shelf life of BEVERTM Coated Intermittent Catheter is 3 years.

Regarding the accelerated aging testing result, after 183 days accelerated aging, BEVER™ uncoated Intermittent Catheter is still compliance the requirements of device specification. The shelf life of BEVER™ Uncoated Intermittent Catheter could be considered as 4 years. And, according to the real time stability study, the 4 years shelf life of BEVER™ Coated Intermittent Catheter has been validated. Herewith we declare that the shelf life of BEVER 110 Coated Intermittent Catheter is 4 years.

11. Conclusions

These proposed devices have the same intended use and technological characteristics to the currently-marketed predicate devices. No new issues of safety or effectiveness are introduced by using these devices. Therefore we believe the proposed devices are substantially equivalent to the currently-marketed predicate devices.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple, yet recognizable, representing the department's role in promoting the health and well-being of the nation.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Allyson Zhou Management Representative Hangzhou Bever Medical Devices Co., Ltd. No. 8-1, Longquan Rd., Cangqian Town, Yuhang District HANGZHOU ZHEJIANG 311121 CHINA

FEB 1 3 2012

Re: K111405

Trade/Device Name: BEVER™ Intermittent Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: May 16, 2011 Received: January 11, 2012

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. 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 (reporting of medical

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Twichell

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): Device Name: BEVERTM Intermittent Catheter Indications For Use:

Over-The-Counter Use Prescription Use _ Yes AND/OR No (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and Urological Devices
510(k) Number	K111405

Section 1, Page 1 of 1 Page

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.