(271 days)
Not Found
No
The description focuses on standard video processing and display, with no mention of AI/ML terms or functionalities like image analysis for diagnosis or treatment guidance.
Yes.
The device description explicitly states its use for "endoscopic diagnosis, treatment and video observation" within the urinary tract and kidney. The mention of "endotherapy accessories" further supports its role in therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Digital Video Monitor is designed for "endoscopic diagnosis." The device description further elaborates on how images are captured and displayed for observation, which is fundamental to diagnosis.
No
The device description clearly outlines hardware components: a Single-use Flexible Ureteroscope with an image sensor (CMOS) and a Digital Video Monitor. The system relies on the interaction and function of these physical components to capture and display images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopy and endoscopic surgery within urinary tract and kidney in adults." This describes a procedure performed on the patient's body to visualize and potentially treat internal structures.
- Device Description: The description details how the device captures images of the urinary tract and displays them. This is a direct visualization tool.
- Lack of In Vitro Activity: An IVD device is designed to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not perform any analysis on such specimens.
The device is a medical endoscope system used for direct visualization and intervention within the body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.
The Digital Video Monitor is specially designed to be used with medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
Product codes (comma separated list FDA assigned to the subject device)
FGB
Device Description
The Video Ureteroscope System consists of Single-use Flexible Ureteroscope (Model:US-S2600, US-E2600) and Digital Video Monitor(Model:DVM-B1) . During diagnosis and treatment with the Video Ureteroscope System, the Single-use Flexible Ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible Ureteroscope converts the received mucosal reflected light signals into electrical signals , transmitted to the Digital Video Monitor through the cable, the Digital Video Monitor receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display.
The Single-use Flexible Ureteroscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.The Single-use Flexible Ureteroscope is provided sterile (sterilized by EO) and intended to be single-use.
There are 2 models of Single-Use Flexible Ureteroscope, the difference between US-S2600 and US-E2600 lies in the US-S2600 with self-lock,US-E2600 does not come with self-lock, the rest is exactly the same.
The Digital Video Monitor contains touch monitor with data processing center and provide energy to Single-Use Flexible Ureteroscope, The Digital Video Monitor can be powered by the main line or lithium.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract and kidney
Indicated Patient Age Range
adults
Intended User / Care Setting
The device is only to be used by skilled medical staff trained in clinical endoscopic techniques and procedures. The device is for use in a hospital or qualified medical institution.
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)
The non-clinical testing demonstrates that the device is as effective and performs as well as the legally marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2024
Hunan Vathin Medical Instrument Co., Ltd. Du Jing RA Manager 1/F, Building 12, Innovation and Entrepreneurship Service Center No 9 Chuangi west road. Jiuhua Economic Development Xiangtan, Hunan 411100 China
K231135 Re:
Trade/Device Name: Video Ureteroscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: December 18, 2023 Received: December 20, 2023
Dear Du Jing:
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 (QS) 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.
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.
2
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,
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
510(k) Number (if known) K231135
Device Name Video Ureteroscope System
Indications for Use (Describe)
The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.
The Digital Video Monitor is specially designed to be used with medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
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) |
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4
Section 5 510(k) summary
I Submitter
| Device submitter: | Hunan Vathin Medical Instrument Co., Ltd. |
|---|---|
| Address: | 1/F, Building 12, Innovation and Entrepreneurship Service |
| Center, No 9 Chuanqi west road, Jiuhua Economic Development | |
| Zone, 411100 Xiangtan, Hunan, China | |
| Contact person: | Du Jing |
| Title: RA Manager | |
| Phone: +86-18915069265 | |
| E-mail: charlene@vathin.com |
II Device
| Trade name: | Video Ureteroscope System |
|---|---|
| Regulation number: | 21 CFR 876.1500 |
| Classification name: | Endoscope and Accessories |
| Common name: | Ureteroscope and Accessories |
| Regulatory class: | Class II |
| Product code: | FGB |
| Review Panel: | Gastroenterology/Urology |
| Date prepared: | April 13, 2023 |
III Predicate Device
| Trade name: | Video Endoscope system. |
|---|---|
| Regulation number: | 21 CFR 876.1500 |
| Classification name: | Endoscope and Accessories |
| Common name: | Ureteroscope and Accessories |
| Regulatory class: | Class II |
| Product code: | FGB |
| Submitter: | Zhuhai Pusen Medical Technology Co., Ltd. |
| 510(k) number: | K172098 |
IV Device description
The Video Ureteroscope System consists of Single-use Flexible Ureteroscope (Model:US-S2600, US-E2600) and Digital Video Monitor(Model:DVM-B1) . During diagnosis and treatment with the Video Ureteroscope System, the Single-use Flexible Ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible Ureteroscope converts the received mucosal reflected light signals into electrical signals , transmitted to the Digital Video Monitor through the cable, the Digital Video Monitor receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display.
5
The Single-use Flexible Ureteroscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.The Single-use Flexible Ureteroscope is provided sterile (sterilized by EO) and intended to be single-use.
There are 2 models of Single-Use Flexible Ureteroscope, the difference between US-S2600 and US-E2600 lies in the US-S2600 with self-lock,US-E2600 does not come with self-lock, the rest is exactly the same.
The Digital Video Monitor contains touch monitor with data processing center and provide energy to Single-Use Flexible Ureteroscope, The Digital Video Monitor can be powered by the main line or lithium.
V Indications for use
The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.
The Digital Video Monitor is specially designed to be used with medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
VI Comparison of technological characteristics with the predicate devices
The Single-Use Flexible Ureteroscope is similar to the predicate device in the following areas:
- Intended use (including application field, intended user and patient population) .
- Principal operation ●
- Design and performance specifications .
- Digital video technology and illumination source .
- It allows for irrigation .
- It is single-use and delivered sterile .
The Single-Use Flexible Ureteroscope is different to the predicate device in the following areas:
- The bending angle is larger than the predicate .
- . Working length is 700mm while working length of predicate device is 650mm
The differences between the Single-Use Flexible Ureteroscope and predicate device do not alter suitability of the subject device for its intended use.
6
| Device
| feature | Subject Device | Predicate Device |
|---|---|---|
| Trade Name | Single-Use Flexible Ureteroscope | Uscope |
| Classification | ||
| Name | Endoscope and accessories | Endoscope and accessories |
| Product Code | FGB | FGB |
| Regulation | ||
| Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Indications for | ||
| use | The Single-use Flexible | |
| Ureteroscope is designed for use | ||
| with Vathin Display Units, | ||
| endotherapy accessories and other | ||
| ancillary devices for the endoscopy | ||
| and endoscopic surgery within | ||
| urinary tract and kidney in adults. | 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. | ||
| Application | ||
| field | The device is for use in a hospital | |
| or qualified medical institution. | The Medical Video Endoscope | |
| system is for use in a hospital or | ||
| qualified medical institution. | ||
| Intended user | The device is only to be used by | |
| skilled medical staff trained in | ||
| clinical endoscopic techniques and | ||
| procedures. | The system is only to be used by | |
| skilled physicians trained in clinical | ||
| endoscopic techniques and | ||
| procedures. | ||
| Patient | ||
| population | Adults | Adults |
| Scope type | Flexible | Flexible |
| Field of view | ||
| (degree) | 120° | 120° |
| Direction | ||
| of | ||
| view (degree) | 0° | 0° |
| Bending | Up: 285° | Up: 270° |
| angle | ||
| (degree) | Down: 285° | Down: 270° |
| Maximum | ||
| insertion | ||
| portion | ||
| width(mm) | US-S2600、US-E2600: 2.7 | 3.2 |
| Minimum | ||
| insertion | ||
| channel | ||
| width(mm) | US-S2600、US-E2600: 1.2 | 1.0 |
| Device | ||
| feature | Subject Device | Predicate Device |
| Working | ||
| length (mm) | 700 | 650 |
| Digital video | ||
| technology | CMOS | CMOS |
| Illumination | ||
| source | LED | LED |
| Single-use | Yes | Yes |
| Biocompatibili | ||
| ty | No Cytotoxicity | |
| No Irritation to Skin | ||
| No significant evidence of | ||
| sensitization | No Cytotoxicity | |
| No Irritation to Skin | ||
| No significant evidence of | ||
| sensitization | ||
| Sterilization | EO | EO |
7
The Digital Video Monitor and its predicate device have the following same technical characteristics:
- . Both are video monitors displaying live video-imaging data from the connected endoscope.
- . Both provide video output format, recording and data storage and data transport functions.
- . Both reusable device.
VII Summary of Non-clinical tests:
Biocompatibility testing
Biocompatibility of the Single-Use Flexible Ureteroscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "breached or compromised surface" with a contact duration of "Limited (