Disposable Ureteral Access Sheath

K203165 · Suzhou Beyo Medical Technology Co., Ltd. · FED · Apr 30, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K203165
• Device Name: Disposable Ureteral Access Sheath
• Applicant: Suzhou Beyo Medical Technology Co., Ltd.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Apr 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Ureteral Access Sheath is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.

Device Story

Disposable Ureteral Access Sheath facilitates urologic endoscopic procedures by providing a conduit for endoscopes and instruments into the urinary tract. Device consists of a sheath assembly and a dilator assembly with a hydrophilic coating to reduce tissue trauma. Physician advances dilator over a 0.038" guidewire to guide sheath into body orifice; placement confirmed via fluoroscopy. Dilator and sheath are radiopaque. Device accepts urological instruments with 10, 12, or 14 Fr outer diameters. Used in clinical settings by physicians to protect the ureter during device exchanges and instrument passage.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, irritation, sensitization per ISO 10993-1:2009), tensile strength, dynamic friction force, bending resistance, and guidewire compatibility testing per EN 1618:1997 and internal requirements.

Technological Characteristics

Materials: PEBAX, SUS, PTFE (sheath); LDPE (dilator); Polyurethane/Polyacrylamide (hydrophilic coating). Energy: None (mechanical). Dimensions: 10Fr, 12Fr, 14Fr; lengths 25-55cm. Connectivity: None. Sterilization: Ethylene Oxide (EO). Single-use. Radiopaque.

Indications for Use

Indicated for use in urologic endoscopic procedures to facilitate the passage of endoscopes into the urinary tract for patients requiring such procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Well Lead Ureteral Access Sheath (K151084)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.

April 30. 2021

Suzhou Beyo Medical Technology Co., Ltd. Aline Oin Supervisor of Quality Department No. 38 Beiguandu Road Suzhou, Jiangsu 215000 China

Re: K203165

> Trade/Device Name: Disposable Ureteral Access Sheath Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: March 29, 2021 Received: April 5, 2021

Dear Aline Qin:

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.

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.

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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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,

for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

### 510(k) Number (if known)

### K203165

### Device Name Disposable Ureteral Access Sheath

Indications for Use (Describe)

The Ureteral Access Sheath is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

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011 Annex 1 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K203165

#### SUBMITTER 1.

Suzhou Beyo Medical Technology Co., Ltd.

2nd Floor, 5th Building, No.38 Beiguandu Road, Wuzhong District, 215000 Suzhou,

P.R.China

Phone: [phone]

Contact Person: Aline Qin

Contact title: Supervisor of Quality Department

Mail: [e-mail]

Date Prepared: March 29, 2021

#### 2. DEVICE

Name of Device: Disposable Ureteral Access Sheath Common or Usual Name: Disposable Ureteral Access Sheath Classification Name: Endoscope and accessories Regulatory Class: II Product Code: FED Model Number: BY-AS-1025, BY-AS-1035, BY-AS-1040, BY-AS-1045, BY-AS-1055, BY-AS-1225, BY-AS-1235, BY-AS-1240, BY-AS-1245, BY-AS-1255, BY-AS-1425, BY-AS-1435, BY-AS-1440, BY-AS-1445, BY-AS-1455.

#### PREDICATE DEVICE 3.

Product Name: Well Lead Ureteral Access Sheath

510(k) Number: K151084

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

#### DEVICE DESCRIPTION 4.

The Disposable Ureteral Access Sheath is one single use device, which is provided after EO sterilization. The shelf life of Disposable Ureteral Access Sheath is 3(three) years.

The Disposable Ureteral Access Sheath consists of two major components: sheath assembly

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| Image: Beyomed logo | 011_Annex 1 510(k) Summary | Page: | 011-2 |
|---------------------|----------------------------|-------|-------|
|---------------------|----------------------------|-------|-------|

and dilator assembly. Sheath assembly consists of sheath hub, the dilator assembly consists of dilator, dilator hub and dilator clip. And there is a hydrophilic coating on the surface of the sheath and dilator.

The Disposable Ureteral Access Sheath is designed to provide the physician with reliable access to the urinary tract, the ability to inject fluids, and act as a conduit for device changes. Like all ureteral access sheath sets, Beyo's Disposable Ureteral Access Sheath also protects the ureter during device exchanges, thus helping reduce tissue trauma. Both the dilator and sheath are radiopaque and have a lubricous hydrophilic coating.

To guide the access sheath into the body orifice, the dilator is advanced over up to a 0.038" guidewire. The device can be visualized under X-ray(fluoroscopy) during placement to confirm location. The device can accept other urological instruments with OD's compatible with the sheath's OD of 10,12 and 14 Fr.

The device has two assemblies, sheath assembly and dilator assembly, the two assemblies are combined through dilator clip, the dilator can insert and withdrawn easily from sheath, The dilator assembly can be fixed on the sheath assembly.

#### 5. INDICATIONS FOR USE

The Ureteral Access Sheath is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.

#### PERFORMANCE DATA 6.

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility testing

According to ISO 10993-1:2009 Table A.1 -Evaluation tests for consideration and the intended use, the Disposable Ureteral Access Sheath is categorized as a surface device that contacts with mucosal membrane only, limited exposure. The biological safety tests recommended in ISO 10993-1:2009 for this category of devices are: cytotoxicity; irritation and sensitization.

The biological safety of the Disposable Ureteral Access Sheath has been evaluated in accordance with the requirements of ISO 10993-1:2009. The Disposable Ureteral Access Sheath contacts the human body component is sheath, dilator and hydrophilic coating and the material is summarized as below table 1.

Table 1 Patient Contact Material Identification

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| Image: Beyomed logo | 011_Annex 1 510(k) Summary | Page: | 011-3 |
|---------------------|----------------------------|-------|-------|
|---------------------|----------------------------|-------|-------|

| NO. | Contact human<br>body<br>component<br>name | Material | Duration of<br>contact | Nature of<br>body<br>contact | |
|-----|--------------------------------------------|-------------------|-----------------------------------------------------------------|------------------------------|--------|
| 1 | Sheath | PEBAX+SUS+PTFE | <24hrs | Ureter | |
| 2 | Dilator | LDPE | <24hrs | Ureter | |
| 3 | Hydrophilic<br>coating | Primer<br>Coating | Polyurethane +<br>deionized water<br>mixture | <24hrs | Ureter |
| | | Top<br>Coating | Polyacrylamide +<br>isopropanol +<br>deionized water<br>mixture | | |

# Animal Study

This section is not applicable to the proposed device, because there is no animal testing of this device.

## Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

| The test results demonstrated that the proposed device complies with the following standards: |
|-----------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------|

| No. | Standard Name | Title of Standard |
|-----|---------------|-------------------------------------------------------------------------------------|
| 1 | EN 1618:1997 | Catheters other than intravascular catheters-Test<br>methods for common properties. |

## Clinical Test Conclusion

No clinical study is included in this submission.

#### 7. Substantially Equivalent (SE) Comparison

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| Image: Beyomed logo | 011_Annex 1 510(k) Summary | Page: | 011-4 |
|---------------------|----------------------------|-------|-------|
|---------------------|----------------------------|-------|-------|

| Item | Proposed Device | Predicate Device | Substantial Equivalence |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | Disposable Ureteral Access Sheath | Well Lead Ureteral Access Sheath (K151084) | |
| Product Code | FED | FED | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| Class | II | II | Same |
| Supplied Sterile | Yes | Yes | Same |
| Sheath ID | 10Fr, 12 Fr, 14Fr | 10Fr, 12 Fr, 14Fr | Same |
| Sheath Effective Length | 25cm, 35cm, 40cm, 45cm, 55cm, | 13cm, 20cm, 28cm, 35cm, 45cm, 55cm | Similar |
| Indications for Use | The Ureteral Access Sheath is intended to use in<br>urologic endoscopic procedures to facilitate the<br>passage of endoscopes. | The Well Lead Ureteral Access Sheath is used to<br>establish a conduit during endoscopic urological<br>procedures facilitating the passage of endoscopes and<br>other instruments into the urinary tract. | Similar |
| Configuration | Sheath, sheath hub, dilator, dilator hub, dilator clip,<br>hydrophilic coating | sheath, dilator, connector,<br>hydrophilic coating | Similar |
| Single Use | Yes | Yes | Same |
| Packaging | Single-use EO sterilized pouch with one device per<br>pouch | Single-use EO sterilized pouch with one device per pouch | Same |
| Shelf Life | Three years (36 months) | Three years (36 months) | Same |

# Table 1 Comparison of Technology Characteristics

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Image /page/7/Picture/1 description: The image shows the logo for Beyomed. The logo consists of an orange abstract shape on the left, followed by the text "Beyomed" in blue. Above the word "Beyomed" are three Chinese characters, also in blue. The logo is simple and modern, with a focus on the company name.

| NO. | Characteristics | Specifications | Test method | Standard | Comparison<br>Result |
|-----|--------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------|
| 1 | Dimensions | Dimension of ureteral access sheath shall<br>comply with the requirements of Table 3<br>Dimensions. | Using a universal gage. | Internal<br>requirement | SE |
| 2 | Dilator & Sheath<br>Compatibility | The dilator should be able to enter and<br>withdraw smoothly and unobstructed<br>within the sheath. | Pull the dilator out of the sheath, then insert it into<br>the sheath cavity, repeat three times, the results<br>should meet the requirements. | Internal<br>requirement | SE |
| 3 | Hub security | Dilator hub can lock onto the sheath hub,<br>dilator can be fixed on the sheath hub, no<br>relative slip. | The dilator hub is screwed off from the sheath hub<br>and then inserted into the sheath in the same<br>direction. The results should meet the<br>requirements. | Internal<br>requirement | SE |
| 4 | Sheath<br>Inner<br>Lumen Passability | The dilator should be able to pass<br>through the sheath with a minimum<br>bending radius of 55 mm. | The sheath is bent under the condition that the<br>marking length is 55 mm, the dilator pass through<br>the sheath inner cavity, the results should meet the<br>requirements. | Internal<br>Requirement | SE |
| 5 | Dynamic Friction<br>Force | The surface dynamic friction of the<br>sheath after water contact should be<br><0.5N. | Soaking the samples with the distilled water, use<br>the Automatic friction tester, set the grip force<br>200g force, speed 200mm/min, distance<br>15mm.Back and forth 10 times, the results should<br>meet the requirements. | Internal<br>requirement<br>and clinical<br>requirement. | SE |

# Table 2 Comparison of Performance testing

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| Image: Beyomed logo | 011_Annex 1 510(k) Summary | Page: | 011-6 |
|---------------------|----------------------------|-------|-------|
|---------------------|----------------------------|-------|-------|

| 6 | Dilator to Hub<br>Tensile Strength | The Dilator to Hub<br>Strength≥15N. | Cut out a 5cm sample from the dilator (with hub<br>part) ; place the sample on the clamp of the<br>tension machine and clamp it. Set the standard<br>distance as 20mm and the tensile speed as<br>400mm/min. Run the tension machine to test and<br>record the maximum force value when the<br>product breaks. | EN1618:1997 | SE |
|---|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----|
| 7 | Sheath to Hub<br>Tensile Strength | The Sheath to Hub<br>Strength≥15N. | Cut out a 5cm sample from the sheath (with hub<br>part); place the sample on the clamp of the tension<br>machine and clamp it. Set the standard distance as<br>20mm and the tensile speed as 400mm/min. Run<br>the tension machine to test and record the<br>maximum force value when the product breaks. | EN1618:1997 | SE |
| 8 | Guidewire<br>compatibility | 0.038" (0.97mm) guidewire can<br>smoothly enter and exit the inner cavity<br>of the dilator. | Inject liquid and simulate the medical guidewire<br>lumen to verify that it can pass smoothly. | Internal<br>requirement | SE |
| 9 | Sheath Flexibility | Sheath &Dilator should be flexible,<br>when the tip bending 90°, the sheath and<br>dilator can recover, when bending 10<br>times with a minimum bending radius of<br>55 mm, the sheath and dilator can not<br>kink or broken. | Fix the sheath and dilator tip, rotate the hub 90°,<br>the sheath and dilator should not permanent<br>deformation, after the sheath and dilator recover,<br>bending 10 times with a minimum bending radius<br>of 55 mm, the results should meet the<br>requirements. | Internal<br>Requirement | SE |

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| Image: Beyomed logo | 011_Annex 1 510(k) Summary | Page: | 011-7 |
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| 10 | Sheath<br>Bending<br>Resistance | The bending force should more than<br>2.1N, less than 7.6N. | Cutting 25cm samples from the distal end of<br>sheath, set the sample into the tensile machine<br>fixture with vertical direction, set the speed<br>10mm/min, fix the samples, compressed down<br>3cm. The results should meet the requirements | Internal<br>Requirement | SE |
|----|---------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----|
|----|---------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----|

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#### Substantially Equivalent (SE) Conclusion 8.

Based on the comparison and analysis from the nonclinical tests, the proposed devices is safe and effective, the performance is as well as the predicate devices. It is determined to be Substantially Equivalent (SE) to the predicate devices.