(113 days)
Not Found
No
The description focuses on standard image processing for display and does not mention any AI/ML techniques for analysis, interpretation, or decision support.
No.
The device is described as being for endoscopy and endoscopic surgery, which are diagnostic and interventional procedures rather than therapeutic in themselves. It is used with "endotherapy accessories" but is not a therapeutic device on its own.
Yes
The "Intended Use / Indications for Use" states the device is for "endoscopy and endoscopic surgery" within the urinary tract and kidney. The "Device Description" further elaborates that during "diagnosis and treatment," an image sensor converts light signals to electrical signals, which are then processed and displayed. This explicit mention of "diagnosis" and the detailed process of image acquisition and display for visualization during procedures directly supports its use as a diagnostic tool.
No
The device description clearly details physical hardware components like the ureteroscope itself (insertion part, control part, connection part, sheath, bending section, distal end with sensor and LED), the Display Unit, and cables. While there is image processing software involved, the device is fundamentally a hardware system with integrated software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of this device is for direct visualization and surgical procedures within the urinary tract and kidney of adults. It is used in vivo (within the living body), not in vitro (in a test tube or other artificial environment).
- The device's function is to provide visual information and facilitate surgical intervention. It does not perform tests on biological samples to diagnose conditions.
The device is a medical endoscope system used for diagnostic and therapeutic procedures within the body.
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.
Product codes (comma separated list FDA assigned to the subject device)
FGB
Device Description
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 singleuse.
The compatible Digital Video Monitor: Model: DVM-A1
The Single-use Flexible ureteroscope and Display Unit make up the video ureteroscope system. 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 Display Unit through the cable, the Display Unit 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.
There are 4 models of Single-Use Flexible Ureteroscope, the difference between US-S170 and US-E170,US-S180 and US-E180 lies in the US-SXXX series with self-lock and suction function, US-EXXX series does not come with self-lock and suction functions, the rest is exactly the same. The difference between the 2 models of US-EXXX series lies in work channel ID, head OD and outer diameter of main hose OD, while the rest are exactly the same. The difference between the 2 models of US-SXXX series also lies in work channel ID, head OD and outer diameter of main hose OD, and the rest are the same.
The Single-use Flexible Ureteroscope includes insertion part, control part, connection part. The control part is made with ABS, contacted with users. The insertion part, as the part connected with patients, includes the sheath which is braided tube made with PEBAX tube, the bending section and the distal end. The bending section is made of snake bone, covered with snake bend eraser. The distal end is made of sensor and LED.
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)
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 (
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
May 18, 2023
Hunan Vathin Medical Instrument Co., Ltd. Du Jing RA Manager 1/F, Building 12, Innovation Entrepreneurship Service Center No.9 Chuangi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 China
Re: K230200
Trade/Device Name: Single-use Flexible Ureteroscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: April 18, 2023 Received: April 19, 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 (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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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 J. Antonino -S
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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Indications for Use
510(k) Number (if known) K230200
Device Name Single-use Flexible Ureteroscope
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.
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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3
Section 5 510(k) summary
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 |
Device
Trade Name of Device: Single-use Flexible Ureteroscope Common name: Ureteroscope and Accessories, Flexible/rigid Classification name: Endoscope and accessories Classification: Class II, 21 CFR 876.1500 Product Code: FGB Review Panel: Gastroenterology/Urology Date prepared: January 18, 2023
Predicate Device
| Trade name: | Medical Video Endoscope system. |
|---|---|
| Regulation number: | 21 CFR 876.1500 |
| Regulation name: | Ureteroscope and Accessories, Flexible/rigid |
| Regulatory class: | Class II |
| Product code: | FGB |
| Submitter: | Zhuhai Pusen Medical Technology Co., Ltd. |
| 510(k) number: | K172098 |
Device description
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 singleuse.
The compatible Digital Video Monitor: Model: DVM-A1
The Single-use Flexible ureteroscope and Display Unit make up the video ureteroscope system. 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
4
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 Display Unit through the cable, the Display Unit 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.
There are 4 models of Single-Use Flexible Ureteroscope, the difference between US-S170 and US-E170,US-S180 and US-E180 lies in the US-SXXX series with self-lock and suction function, US-EXXX series does not come with self-lock and suction functions, the rest is exactly the same. The difference between the 2 models of US-EXXX series lies in work channel ID, head OD and outer diameter of main hose OD, while the rest are exactly the same. The difference between the 2 models of US-SXXX series also lies in work channel ID, head OD and outer diameter of main hose OD, and the rest are the same.
The Single-use Flexible Ureteroscope includes insertion part, control part, connection part. The control part is made with ABS, contacted with users. The insertion part, as the part connected with patients, includes the sheath which is braided tube made with PEBAX tube, the bending section and the distal end. The bending section is made of snake bone, covered with snake bend eraser. The distal end is made of sensor and LED.
Indications for use
The indications for use of subject and predicate device are the same. Both of the subject and predicate device are indicated for endoscopy and endoscopic surgery within urinary tract and kidney. The indications for use of subject device: 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 indications for use of predicate device: 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.
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Comparison of technological characteristics with the predicate devices
The Single-Use Flexible Ureteroscope is like 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 .
- There are 4 specifications while predicate device has 2 specifications .
- 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 proposed device for its intended use.
| Device feature | Proposed Device | Predicate Device |
|---|---|---|
| Trade Name | Single-Use Flexible Ureteroscope | Medical Video Endoscope |
| system(K172098) | ||
| 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. |
6
| Device feature | Proposed Device | Predicate Device |
|---|---|---|
| Trade Name | Single-Use Flexible Ureteroscope | Medical Video Endoscope |
| system(K172098) | ||
| Patient | ||
| population | Adults | Adults |
| Scope type | Flexible | Flexible |
| Field of view | ||
| (degree) | 110° | 120° |
| Direction | ||
| of | ||
| view (degree) | 0° | 0° |
| Bending angle | ||
| (degree) | Up: 285° | |
| Down: 285° | Up: 270° | |
| Down: 270° | ||
| Maximum | ||
| insertion | ||
| portion | ||
| width(mm) | US-S170、US-E170: 3.15 | |
| US-S180、US-E180: 3.25 | 3.2 | |
| Minimum | ||
| insertion | ||
| channel | ||
| width(mm) | US-S170、US-E170: 1.2 | |
| US-S180、US-E180: 1.4 | 1.0 | |
| 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 |
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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 (