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 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 sterilized. The catheter is prelubricated with a coating containing polyvinylpyrrolidone, which binds the water molecules to the surface of the catheter creating a smooth and even lubricating film. 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a "Ready-to-Use Hydrophilic Catheter." The acceptance criteria and the study that proves the device meets them are outlined in the "Summary of Non-Clinical Testing" section (page 6).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All tests met the pre-determined acceptance criteria." It does not provide specific numerical acceptance criteria or detailed numerical performance results for each test. Instead, it lists the properties tested and the standards used.

Property Tested	Standard/Method Used	Reported Device Performance
Biocompatibility	ISO 10993-1:2009 and FDA Guidance "Use of International Standard ISO 10993-1" (2016)	Completed, implying conformity.
Strength	Annex A of ISO 20696	Passed
Connector Security	Annex B of ISO 20696	Passed
Flow Rate	Annex E of ISO 20696	Passed
Kink Stability	Annex G of ISO 20696	Passed
Peak Tensile Force	Annex H of ISO 20696	Passed
Coefficient of Friction	ASTM D 1894	Passed
Coating Adhesion	BEVER internal methods	Passed
Sterilization	AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 11137-2, AAMI/ANSI/ISO 11137-3	Validation conducted according to standards, implying conformity.
Accelerated Aged Shelf Life	ASTM F1980	Completed, implying conformity.

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

The document does not explicitly state the sample sizes used for the non-clinical bench testing. It also does not discuss data provenance in terms of country of origin or whether studies were retrospective or prospective, as these are non-clinical bench tests, not clinical studies involving human subjects.

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

This information is not applicable. The tests conducted were non-clinical bench tests (e.g., strength, flow rate, biocompatibility) based on international and internal standards, which do not involve expert consensus for ground truth determination in the same way clinical studies with human subjects or image analysis algorithms would. The "ground truth" for these tests is defined by the objective pass/fail criteria established within the cited standards.

4. Adjudication Method for the Test Set:

This information is not applicable for non-clinical bench tests. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert reviews where there's a need to resolve discrepancies among multiple human readers or observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance testing of the device itself, not a study evaluating human readers' performance with or without AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable as the device is a physical medical catheter, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to report.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is based on objective measurements and established pass/fail criteria defined by the relevant international standards (e.g., ISO 20696, ASTM D 1894, ISO 10993-1, AAMI/ANSI/ISO 11137, ASTM F1980) and the manufacturer's internal methods for coating adhesion.

8. The Sample Size for the Training Set:

This question is not applicable as the device is a physical medical catheter and does not involve a "training set" in the context of machine learning.

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

This question is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

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FORM FDA 3881 (7/17)

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Image /page/3/Picture/1 description: The image shows the logo for B. Ever. The logo consists of two vertical lines followed by a stylized letter B. The word "EVER" is written in capital letters to the right of the B. The logo is in black and white.

Hangzhou Beve al Devices Co., Ltd.

Add: Building 2, No. 1-1, Houmuqiao, Yongle Village, Canggian Street, Yuhang District 311121, Hangzhou, China Tel: +86-571-8861 6630 Fax: +86-0571-8861 6515

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: +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: allyson@bevermedical.com

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-UseHydrophilic Catheter	SpeediCathK023254	LoFric® Primo™K122078	Self CathK100878
Indication foruse	Indicated forintermittentcatheterization of theurethra for thoseindividuals who areunable to promote anatural urine flow orfor those individualswho have asignificant volume ofresidual urinefollowing a naturalbladder - voidingepisode. The catheteris inserted into theurethra to reach thebladder allowingurine to drain.	Indicated for use bypatients withchronic urineretention andpatients with a postvoid residualvolume (PVR) dueto neurogenic andnon-neurogenicvoidingdysfunction. Thecatheter is insertedinto the urethra toreach the bladderallowing urine todrain.	Intended forIntermittentcatheterizationof the urethra.	Indicated forthose individualsunable topromote a naturalurine flow or forthose individualswho have asignificantvolume ofresidual urinefollowing anatural bladder-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, 10,12, 14, 16, 18Male Fr 6, 8, 10, 12,14, 16, 18Tiemann Fr 8, 10,12, 14, 16, 18Pediatric Fr 6, 8, 10	Female Fr 6, 8, 10,12, 14, 16Male Fr 8, 10, 12,14, 16, 18Tiemann Fr 10, 12,14Pediatric Fr 6, 8, 10Boy Fr 6, 8, 10, 12	Nelaton 8inFr 8, 10, 12, 14,16, 18Nelaton 16inFr 8, 10, 12, 14,16, 18Tiemann 16inFr 10, 12, 14,16, 18Pediatric 8inFr 6, 8, 10	Female Fr 8, 10,12, 14,Male Fr 8, 10, 12,14, 16, 18Tiemann Fr 6, 8,10, 12, 14, 16, 18Pediatric Fr 5, 6,8, 10
Devicecomposition	Polyurethanecatheter coated withpolyvinylpyrroli-done, placed inwater, in single orcombination with aninsertion aid.	Polyurethanecatheter coatedwith polyvinylpyr-rolidone, placed in asaline solutioncontaining poly-vinylpyrrolidone.	Plastic cathetercoated withpolyvinylpyrro-lidone, packedwith the sterilewater.	Polyvinylchloride catheter(without coating)
Condition ofuse	Singe Use	Singe Use	Singe Use	Singe Use
Coating	PVP(polyvinylpyr-rolidone) BasedCoating	PVP(polyvinylpyr-rolidone) BasedCoating	PVP(polyvi-nylpyrrolidone)Based Coating	No coating
Prelubricated	Yes-by waterhydration	Yes-by salinesolution hydration	Yes-by waterhydration	No
Lubricatingsolution	Sterile water	Sterile salinesolution	Sterile water	No
Ready to use	Yes	Yes	Requiresbursting ofwater packetprior to use	No
No touchdesign	Yes- contains aninsertion aid (sleeve)	No	Yes- by usingexteriorpackaging	No
Tipconfiguration	Nelaton tip, Taperedtip and Olive tip	Nelaton tip andTapered tip	Nelaton tip andTapered tip	Nelaton tip,Tapered tip andOlive tip
Guide stripein the shaft	Yes-Tiemann Catheter	No	No	Yes-Tiemann Catheter
DrainageEyelets	Polished andstaggered	Polished andstaggered	Polished andstaggered	Polished andstaggered
End Design	Funnel	Funnel	Funnel	Funnel
Duration ofuse	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.

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.