(189 days)
No reference devices were used in this submission.
No
The device description focuses on mechanical components and materials, with no mention of AI or ML capabilities. The performance studies are related to physical properties and biocompatibility, not algorithmic performance.
No.
The device facilitates the passage of endoscopes and protects the ureter, but it does not directly treat a disease or condition.
No
Explanation: The device is an access sheath designed to facilitate the passage of endoscopes and instruments into the urinary tract. Its function is to provide a conduit for other devices and protect the ureter during exchanges, not to diagnose medical conditions.
No
The device description clearly outlines physical components (sheath assembly, dilator assembly, hydrophilic coating, radiopaque materials) and their mechanical functions, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the passage of endoscopes" in urologic endoscopic procedures. This is a procedural aid, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical device used for accessing the urinary tract and facilitating instrument passage. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample analysis, or any other typical characteristics of an IVD.
The device is a surgical tool used during a medical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Ureteral Access Sheath is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.
Product codes
FED
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray(fluoroscopy)
Anatomical Site
urinary tract, ureter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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:
EN 1618:1997 Catheters other than intravascular catheters-Test methods for common properties.
Clinical Test Conclusion
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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 PRAStaff@fda.hhs.gov
"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)
3
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: +86-512-67269209
Contact Person: Aline Qin
Contact title: Supervisor of Quality Department
Mail: qinling@beyomed.com
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
4
| 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
body
component
name | Material | Duration of
contact | Nature of
body
contact | |
|-----|--------------------------------------------|-------------------|-----------------------------------------------------------------|------------------------------|--------|
| 1 | Sheath | PEBAX+SUS+PTFE |