(268 days)
No
The summary describes standard image processing for display and recording, but does not mention any AI/ML capabilities or algorithms.
No
Explanation: The device is described as an imaging and diagnostic tool that allows for the insertion of therapeutic accessories but does not perform therapeutic functions itself. Its primary functions are imaging, processing images, and providing power.
Yes
Explanation: The device is used to process images collected by video endoscopes, which are then displayed in real-time. This visual information aids in the observation and recognition of features within the urinary tract and kidney, thereby assisting in diagnosis. The "Intended Use" explicitly states its use for "endoscopy and endoscopic surgery within urinary tract and interior of the kidney," and the "Device Description" mentions "operating diagnostic and therapeutic accessories."
No
The device description clearly outlines both a hardware component (Single use flexible ureteroscope) and an Image processor, which includes hardware like an LCD screen and image processing motherboard. The 510(k) summary details performance studies related to the physical ureteroscope and the image processor hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopy and endoscopic surgery within urinary tract and interior of the kidney." This involves direct visualization and intervention within the body.
- Device Description: The description details a flexible ureteroscope and an image processor. The ureteroscope is inserted into the body to capture images, and the image processor displays these images. This is a system for in vivo (within the living body) imaging and intervention.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on such specimens. It is a tool for direct visualization and access within the body.
- Anatomical Site: The device is used within the "urinary tract and interior of the kidney," which are internal anatomical sites. IVDs typically analyze samples taken from these sites, not directly visualize them internally.
In summary, the device is an endoscopic system used for direct visualization and intervention within the body, which is characteristic of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Single use flexible ureteroscope has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
The Image processor is used in conjunction with the video endoscopes produced by BESDATA to process the images collected by the video endoscopes and send it to the display, and provide power for the endoscope.
Product codes
FGB
Device Description
The Single use flexible ureteroscope system consists of a sterile Single use flexible ureteroscope and an Image processor.
Description of the ureteroscope
Name: Single use flexible ureteroscope
Model: UR-D1, UR-D2, UR-F1, UR-F2
There are four models of the Single use flexible ureteroscope. Different models are the same except for size and handle appearance. The ' D ' and ' F ' indicate that the appearance of different handles is different, ' 1 ' and ' 2 'represent different Maximum widths of insulation portion.
The only difference in the appearance of the handle is to cater to the grip habits of different doctors.
Single use flexible ureteroscope is a sterile product for single use, and repeated use is prohibited.The Single use flexible ureteroscope is a portable equipment. The Single use flexible ureteroscope mainly consists of the distal, insertion portion, handle,connection cable and LEMO plug:
- The distal including LED lighting, optical lens, CMOS imaging module.
- The insertion portion includes the instrument channel and insertion tube.
- The handle includes instrument channel ports, hand push rods, imaging control button switches and connecting the cable (with LEMO plug ).
Single use flexible ureteroscope is connected to the image processor through the LEMO plug on the connecting cable, and the patient's area is illuminated and imaged by the LED and camera of the insertion tube Distal. The CMOS sensor of the insertion tube Distal collects optical signals in imaging and converts them into electrical signals, which are transmitted to the image processor for display. There is an instrument channel in the insertion tube for operating diagnostic and therapeutic accessories (not configured on this device) through the instrument channel. The instrument channel can also provide water/air supply facilities for water/air supply through the instrument channel. Water supply is used to remove mucus attached to the surface of the camera, while air supply is used to remove residual water droplets on the camera. The handles each have two imaging button, and a push rod. The imaging button can control imaging (One button controls taking photos and one button controls recording), and the push rod can control the curvature of the insertion tube Distal.
The materials used in construction of the insertion of ureteroscope are Polytetrafluoroethylene (PTFE), Polyether-polyamide block copolymers (PEBAX), and polycarbonate (PC). The insertion portion is considered to contact a breached or compromised surface for a duration of less than 24 hours. The biocompatibility evaluation was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
The handle does not contact the patient.
Description of the Image processor
Name: Image processor
Model: MIP1001, MIP1002
The model MIP1001 and MIP1002 were identical except for position of button and different appearance size.
Image processor is a lightweight endoscope video display, This device is composed of image processor, power adapter(power supply), LCD screen(image display) and image processing motherboard(function).
The endoscopic video image processor can process the image collected by the endoscope and display the image in real time through the LCD module. Users can use the LCD module for humanmachine interaction.
The principle of optical imaging: the light source illuminates the inspected site of the patient, which is imaged by the photosensitive surface of endoscope's CMOS camera module. The optical signal received by the CMOS sensor is converted into electrical signal after processing. The electrical signal is then transmitted by the cable to the signal processing chip embedded on the Image processor where it is restored after processing and finally displayed on the screen of Image processor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical imaging with CMOS sensor
Anatomical Site
Urinary tract and interior of the kidney
Indicated Patient Age Range
Adult
Intended User / Care Setting
Physicians in Hospitals
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)
Summary of Non-clinical Performance
All non-clinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate device and reference device. Tests setup and execution were performed in accordance with applicable standards. Results of the testing demonstrate compliance to the standards and matching the performance of subject device to the reference device.
- Biocompatibility: Evaluation in accordance with FDA guidance, tests passed for Cytotoxicity, Skin sensitization, Vaginal irritation, Acute Systemic Toxicity, and Pyrogen.
- Electrical Safety and Electromagnetic Compatibility: Compliance with IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, and IEC TR 60601-4-2.
- Photobiological safety: Compliance with IEC 62471:2006.
- Sterilization Validation: Validated according to ISO11135:2014, ISO 11737-2:2019, ISO 10993-7:2008, and USP .
- Shelf Life and Sterile Barrier System (Packaging): Validated according to ASTM F1980-16, ASTM D4169-22, ISO11607-1:2020, ISO11607-2:2020, ASTM F 1929-15, ASTM F88/F88M-15, DIN 58953-6:2016, ASTM F1886/F1886M-16, and ASTM F1608-16.
- Performance Data - Bench: Optical performance testing according to ISO 8600-1:2015, ISO 8600-3:2019, ISO 12233-2017, ISO15739-2017, ISO/CIE 11664-4 and mechanical performance testing according to ISO 8600-1:2015, ISO 8600-4:2014, YY/T 1028-2023. Field of view and geometric distortion measured according to specified articles.
- Test items include: Resolution, Direction of view, Depth of Field, Field of view, Geometric Distortion, Signal-To-Noise Ratio, Dynamic Range, Image Intensity Uniformity (IIU), Color Performance, Basic Size, Bending angle(degree).
- Performance Data - Animal: N/A, no animal studies are available for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
October 4, 2024
Shenzhen Besdata Technology Co., Ltd. Xiaohong Lu General Manager 503, Building #2, Xinnantian Industrial Park, No. 3179 Laokeng Community, Longtian Street, Pingshan District Shenzhen, Guangdong 518128 CHINA
Re: K240074
Trade/Device Name: Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: September 4, 2024 Received: September 4, 2024
Dear Xiaohong Lu:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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,
Mark R. Kreitz -S
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Single use flexible ureteroscope (UR-D1/UR-D2/UR-F1/UR-F2); Image processor (MIP1001/MIP1002)
Indications for Use (Describe)
The Single use flexible ureteroscope has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
The Image processor is used in conjunction with the video endoscopes produced by BESDATA to process the images collected by the video endoscopes and send it to the display, and provide power for the endoscope.
Type of Use (Select one or both, as applicable)
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."
4
510(k) SUMMARY
510(k) Number: K240074
I.SUBMITTER
Name: Shenzhen Besdata Technology Co.,Ltd.
Address: 503, Building #2, Xinnantian Industrial Park, No. 3179, Danzi Avenue, Laokeng
Community, Longtian Street, Pingshan District, Shenzhen
Name of contact person: Xiaohong Lu
Tel: +86 755 84416070
Fax: +86 755 23039200
E-mail: regulation(@besdatatech.com
Date prepared: October 2, 2024
Proposed Device II.
Submission Number: K240074
Trade/Device name: Single use flexible ureteroscope system
Regulation number: 21CFR 876.1500
Classification Name: Ureteroscope and accessories, flexible/rigid
Regulation class: II
Review Panel: Gastroenterology/Urology
Product code: FGB
Common Name: Ureteroscope and accessories
III. Predicate Device
510(k) Number: K172098 Trade/Device Name: Medical Video Endoscope System
Applicant: Zhuhai Pusen Medical Technology Co, Ltd.
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulation class: II
Review Panel: Gastroenterology/Urology
Product code: FGB
Note: This predicate device has not been subject to a design-related recall.
5
IV.Reference Device
510(k) Number: K210579 Device name: WiScope® OM Endoscope System Applicant: OTU Medical Inc. Regulation number:21 CFR 876.1500 Common/Usual Name: Endoscope and Accessories Regulation class: II Review Panel: Gastroenterology/Urology Product code: FBN, FGB Note: This reference device has not been subject to a design-related recall.
V. Indications for use
Single use flexible ureteroscope has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
The image processor is used in conjunction with the video endoscopes produced by BESDATA to process the images collected by the video endoscopes and send it to the display, and provide power for the endoscope.
VI. Description of the Device
The Single use flexible ureteroscope system consists of a sterile Single use flexible ureteroscope and an Image processor.
>Description of the ureteroscope
Name: Single use flexible ureteroscope
Model: UR-D1, UR-D2, UR-F1, UR-F2
There are four models of the Single use flexible ureteroscope. Different models are the same except for size and handle appearance. The ' D ' and ' F ' indicate that the appearance of different handles is different, ' 1 ' and ' 2 'represent different Maximum widths of insulation portion.
As shown in the table below:
| Model | Maximum widths of insulation portion | handle appearance |
|---|---|---|
| UR-D1 | 2.8mm | Image: handle appearance |
| UR-D2 | 2.5mm | Image: handle appearance |
| UR-F1 | 2.8mm | Image: handle appearance |
| UR-F2 | 2.5mm | Image: handle appearance |
6
The only difference in the appearance of the handle is to cater to the grip habits of different doctors.
Single use flexible ureteroscope is a sterile product for single use, and repeated use is prohibited.The Single use flexible ureteroscope is a portable equipment. The Single use flexible ureteroscope mainly consists of the distal, insertion portion, handle,connection cable and LEMO plug:
1)The distal including LED lighting, optical lens, CMOS imaging module.
-
The insertion portion includes the instrument channel and insertion tube.
-
The handle includes instrument channel ports, hand push rods, imaging control button switches and connecting the cable (with LEMO plug ).
Single use flexible ureteroscope is connected to the image processor through the LEMO plug on the connecting cable, and the patient's area is illuminated and imaged by the LED and camera of the insertion tube Distal. The CMOS sensor of the insertion tube Distal collects optical signals in imaging and converts them into electrical signals, which are transmitted to the image processor for display. There is an instrument channel in the insertion tube for operating diagnostic and therapeutic accessories (not configured on this device) through the instrument channel. The instrument channel can also provide water/air supply facilities for water/air supply through the instrument channel. Water supply is used to remove mucus attached to the surface of the camera, while air supply is used to remove residual water droplets on the camera. The handles each have two imaging button, and a push rod. The imaging button can control imaging (One button controls taking photos and one button controls recording), and the push rod can control the curvature of the insertion tube Distal.
The materials used in construction of the insertion of ureteroscope are Polytetrafluoroethylene (PTFE), Polyether-polyamide block copolymers (PEBAX), and polycarbonate (PC). The insertion portion is considered to contact a breached or compromised surface for a duration of less than 24 hours. The biocompatibility evaluation was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
The handle does not contact the patient.
Description of the Image processor
7
Name: Image processor
Model: MIP1001, MIP1002
The model MIP1001 and MIP1002 were identical except for position of button and different appearance size. As shown in the table below:
| Model | Size | position of button |
|---|---|---|
| MIP1001 | 259 mm x 206 mm x 50 mm | The button is located at the top of the |
| device | ||
| MIP1002 | 252 mm x 278 mm x 55 mm | The button is located at the bottom of the |
| device |
Image processor is a lightweight endoscope video display, This device is composed of image processor, power adapter(power supply), LCD screen(image display) and image processing motherboard(function).
The endoscopic video image processor can process the image collected by the endoscope and display the image in real time through the LCD module. Users can use the LCD module for humanmachine interaction.
The principle of optical imaging: the light source illuminates the inspected site of the patient, which is imaged by the photosensitive surface of endoscope's CMOS camera module. The optical signal received by the CMOS sensor is converted into electrical signal after processing. The electrical signal is then transmitted by the cable to the signal processing chip embedded on the Image processor where it is restored after processing and finally displayed on the screen of Image processor.
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VIII.Comparison with the Predicate Devices
>Comparison of Indications with the Predicate Devices
Regarding the indications for use, although the subject device lacks integrated biopsy functionality compared to the predicate device, the intended use of both of them are the same.
>Comparison of Technological Characteristics with the Predicate Devices
Subjective device and the predicate device have intended use. The subject and predicate device have similar technological characteristics as evidenced by the table below. All differences have been discussed in detail and chat these differences in technological characteristics do not raise new questions regarding safety or effectiveness of the subject device.
a. The following basic technological elements are the same or similar for the subject and predicate devices :
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Table 1 General Comparison
| Item | Proposed Device
Single use flexible
ureteroscope | Predicate Device
Pusen Single Use Flexible
Video Ureteroscope | Reference Device
WiScope® OM
Endoscope System | Remark |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) number | K240073 | K172098 | K210579 | |
| Product Code | FGB | FGB | FBN, FGB | Same |
| Regulation
Number | 21CFR 876.1500 | 21CFR 876.1500 | 21CFR 876.1500 | Same |
| Indications for
Use | Single use flexible ureteroscope has
been designed to be used with endo
therapy accessories such as a biopsy
forceps and other ancillary equipment
for endoscopy and endoscopic surgery
within urinary tract and interior of the
kidney. | This instrument has been
designed to be used with endo
therapy accessories such as a
biopsy forceps and other ancillary
equipment for endoscopy and
endoscopic surgery within urinary
tract and interior of the kidney. | WiScope® OM Endoscope
System is intended to be
used by physicians to access,
visualize, and perform
procedures in the urinary
tract and the kidney.
WiScope® OM Endoscope
System is also intended to be
used by physicians through
percutaneous insertion to
access, visualize, and | Note1 |
| Item | Proposed Device | Predicate Device | Reference Device | Remark |
| 510(k) number | Single use flexible
ureteroscope | Pusen Single Use Flexible
Video Ureteroscope | WiScope® OM
Endoscope System | |
| | K240073 | K172098 | K210579 | |
| | perform procedures in the
pancreaticobiliary system
including the hepatic ducts
and the common bile duct.
The instrument enables
delivery and use of
accessories such as biopsy
forceps, laser fibers, graspers
and retrieval baskets at a
surgical site. | | | |
| Patient
Population | Adult | Adult | Adult | Same |
| where used | Hospitals | Hospitals | Hospitals | Same |
| Item | Proposed Device
Single use flexible
ureteroscope | Predicate Device
Pusen Single Use Flexible
Video Ureteroscope | Reference Device
WiScope® OM
Endoscope System | Remark |
| 510(k) number | K240073 | K172098 | K210579 | |
| Digital video technology | CMOS | CMOS | CMOS | Same |
| Light source | LED | LED | LED | Same |
| Field of view(degree) | 120° | 120° | 100° | Same as the Predicate Device |
| Direction of view(degree) | 0° | 0° | 0° | Same |
| Resolution ratio | $400×400$ | Unknow | 16.0 million pixels | Note 2 |
| Depth of field | 3-50mm | 3-50mm | 2-50mm | Same as the Predicate Device |
| Instrument channel width | UR-D1: Φ1.2mm
UR-D2: Φ1.2mm
UR-F1: Φ1.2mm
UR-F2: Φ1.2mm | 1.0 mm | 3.6Fr | Note 3 |
| | Maximum width of
insertion tube | UR-D1: Φ2.8mm
UR-D2: Φ2.5mm
UR-F1: Φ2.8mm
UR-F2: Φ2.5mm | 3.2 mm | 8.6Fr |
| Working length of the | | 650mm | 650 mm | 670mm |
| Item | Proposed Device
Single use flexible
ureteroscope | Predicate Device
Pusen Single Use Flexible
Video Ureteroscope | Reference Device
WiScope® OM
Endoscope System | Remark |
| 510(k) number | K240073 | K172098 | K210579 | |
| insertion section | | | | |
| Bending angle(degree) | Upper: 275°
Down: 275° | Upper: 270°
Down: 270° | Upper: 275°
Down: 275° | Same as the Reference Device |
| Ureteroscope | Single-Use | Single-Use | Single-Use | Same |
| Sterilization | EO
SAL: 10-6 | EO
SAL: 10-6 | EO
SAL: 10-6 | Same |
| White balance | Yes | Yes | Yes | Same |
| Brightness Control | Yes | Yes | Yes | Same |
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K240074
Page 7 / 14
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Table 2 Performance Comparison
12
K240074
Page 9 / 14
b. Discussion on differences between the subject and the predicate device
| Regarding the indications for use, compared to the predicate device, the intended use of both of them are the same. | |
|---|---|
| Note 1 | The intended use of the subject device is the same as that of the reference device in the urinary tract and the kidney, with only |
| Indications for | slight differences in description. The indications of reference device contain two aspects, to performing various diagnostic and |
| therapeutic procedures within the urinary tract (code "FGB") and to examining and performing procedures within the bile ducts. | |
| Use | |
| (code "FBN"). The aspect compared with the proposed device is to performing various diagnostic and therapeutic procedures |
13
| 1 |
|---|
| C |
| | within the urinary tract (code “FGB”). The indications which represented by code “FBN” are not in the scope of comparison. So
the product codes and the indications of use can be judged as equal. |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 2 | Same as the reference Device. |
| Resolution ratio | The different with Predicate Device does not adversely impact safety and effectiveness of proposed device. |
| Note 3 | The instrument channel width of the subject device is the same as the reference device, but larger than the predicate device. The
larger the indicator, the more advantageous it is for clinical application.
Therefore, the different does not adversely impact safety and effectiveness of subject device. |
| Instrument
channel width | |
| Note 4 | The Maximum width of insertion tube of the subject device is smaller than the predicate devices, The smaller of the Maximum
width of insertion tube, the more advantageous it is for clinical application. Therefore, the different does not adversely impact
safety and effectiveness of subject device. |
| Maximum width
of insertion tube | The subject device offers a variety of sizes for flexible selection. |
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IX.Summary of Non-clinical Performance
All non-clinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate device and reference device. Tests setup and execution were performed in accordance with applicable standards. Results of the testing demonstrate compliance to the standards and matching the performance of subject device to the reference device. The following performance data were provided in support of the substantial equivalence determination.
> Biocompatibility
The biocompatibility evaluation for the Single use flexible ureteroscope was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The insertion portion of Single use flexible ureteroscope is considered to contact a breached or compromised surface for a duration of less than 24 hours; therefore, the following tests are considered and passed:
| Biocompatibility testing summary | |
|---|---|
| Test | Testing Summary |
| Cytotoxicity test (ISO 10993-5:2009 “Biological evaluation of | |
| medical devices – Part 5: Tests for in vitro cytotoxicity) | No Cytotoxicity |
| Skin sensitization test (ISO 10993-10:2010 “Biological evaluation | |
| of medical devices – Part 10: Tests for irritation and sensitization) | No evidence of skin |
| sensitization | |
| Vaginal irritation Test (ISO 10993-23:2021 | |
| Biological evaluation of medical devices-Part 10: Tests for irritation | |
| and vaginal irritation) | No evidence of |
| irritation | |
| Acute Systemic Toxicity Test(ISO 10993-11:2017 “Biological | |
| evaluation of medical devices – Part 11: Tests for systemic | |
| toxicity” ) | No evidence of Acute |
| Systemic Toxicity |
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| Pyrogen Test(ISO 10993-11:2017 “Biological evaluation of | No evidence of |
|---|---|
| medical devices - Part 11: Tests for systemic toxicity” ) | Pyrogen |
A Electrical Safety and Electromagnetic Compatibility
Electrical safety and EMC testing were conducted on the Single use flexible ureteroscope and image processor, and the device complies with the following standards:
- · IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
• IEC 60601-2-18: 2009 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment.
• IEC 60601-1-2: 2014 + A1: 2020 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests.
• IEC TR 60601-4-2:2016 Medical electrical equipment- Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
A Photobiological safety
The subject device was tested according to the following FDA recognized standards: • IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems.
> Sterilization Validation
The EO sterilization of the Single use flexible ureteroscope has been validated according to the following applicable standards:
• ISO11135:2014: Sterilization of medical device- validation and routine control of ethylene oxide sterilization
· ISO 11737-2:2019 Sterilization of Medical Device-Microbiological methods part 2: Tests of sterility performed in the validation of a sterilization process
• ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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• USP Bacterial endotoxins test
A Shelf Life and Sterile Barrier System (Packaging)
Shelf Life and Sterile Barrier System of the Single use flexible ureteroscope has been validated according to the following applicable standards:
• ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
• ISO11607-1:2020 Packaging for terminally sterilized Medical Device Part 1:
Requirement for materials, sterile barrier systems and packaging systems
• ISO11607-2:2020 Packaging for terminally sterilized Medical Device Part 2:
Validation Requirement for forming, sealing and assembly process
• ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks in Porous
Medical Packaging by Dye Penetration
• ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
• DIN 58953-6:2016 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
• ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
• ASTM F1608-16 Standard Test Method for Microbial Ranking of Porous
Packaging Materials (Exposure Chamber Method)
A Performance Data - Bench
The following performance data were provided in support of the substantial equivalence, as shown in the table below.
The optical performance testing was conducted in accordance with applicable parts of ISO 8600-1:2015, ISO 8600-3:2019, ISO 12233-2017, ISO15739-2017 and ISO/CIE 11664-4 standards, and the mechanical performance testing was conducted in accordance with applicable parts of ISO 8600-1:2015, ISO 8600-4:2014, YY/T 1028-2023 standards. The field of view was measured according to the test method in the article: Wang et al.,
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"Endoscope field of view measurement." Biomedical Optics Express 8, no. 3 (2017): 1441-1454, and geometric distortion was measured according to section 3 of the article: Wang, et al., "Development of the local magnification method for quantitative evaluation of endoscope geometric distortion." Journal of Biomedical Optics 21, no. 5 (2016): 056003.
| Test category | Test item |
|---|---|
| Optical | |
| performance | Resolution |
| Direction of view | |
| Depth of Field | |
| Field of view | |
| Geometric Distortion | |
| Signal-To-Noise Ratio | |
| Dynamic Range | |
| Image Intensity Uniformity (IIU) | |
| Color Performance | |
| Mechanical | |
| performance | Basic Size |
| Bending angle(degree) |
A Performance Data - Animal
N/A, no animal studies are available for the subject device.
X.Clinical Evidence
N/A.
XI.Conclusion
In conclusion, the technological characteristics, features, specifications, and intended use of the subject device are substantially equivalent to the predicate device quoted above. The differences between the subjective device and the predicate device do not raise new questions of safety and effectiveness. Performance testing demonstrated that the subject device is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate device.