(170 days)
Not Found
No
The document describes a standard flexible cystoscope and its performance characteristics, with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" states that the device is for "endoscopy and treatment of adult bladder," indicating a therapeutic purpose.
Yes
Explanation: The device is described as being used for "endoscopy and treatment of adult bladder," indicating both observational (diagnostic) and interventional (treatment) capabilities. Endoscopy itself is a diagnostic procedure.
No
The device description and performance studies clearly indicate a physical, hardware-based device (Single-Use Flexible Cystoscope) with associated components and functionalities, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopy and treatment of adult bladder." This involves directly visualizing and potentially treating the bladder within the body.
- Device Description: The description reinforces its use for "endoscopy and treatment of adult bladder."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device is used inside the body for direct observation and intervention.
The device is a medical device used for diagnostic and therapeutic procedures performed in vivo (within the living body), not in vitro (in glass, or outside the body).
N/A
Intended Use / Indications for Use
The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.
Product codes (comma separated list FDA assigned to the subject device)
FAJ
Device Description
The Single-use Flexible Cystoscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and treatment of adult bladder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
adult bladder
Indicated Patient Age Range
adult
Intended User / Care Setting
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)
Non-clinical tests were conducted:
Biocompatibility testing: evaluated in accordance with ISO 10993-1:2018 for "Surface – Mucosal Membrane" contact of "
§ 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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November 17, 2022
Hunan Vathin Medical Instrument Co., Ltd. Du Jing RA Manager, RA Department 1/F, Building 12, Innovation and Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan, Hunan 411100 CHINA
Re: K221580
Trade/Device Name: Single-Use Flexible Cystoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: October 19, 2022 Received: October 19, 2022
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 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 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) K221580
Device Name Single-use Flexible Cystoscope
Indications for Use (Describe)
The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 510(k) summary
ll 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: +86-731-55558558 | |
| E-mail: charlene@vathin.com |
II Device
Trade Name of Device: Single-Use Flexible Cystoscope Common name: Cystoscope and Accessories, Flexible/rigid Classification: Class II, 21 CFR 876.1500 Product Code: FAJ Review Panel: Gastroenterology/Urology
III Predicate Device
| Trade name: | Ambu AScope 4 Cysto |
|---|---|
| Regulation number: | 21 CFR 876.1500 |
| Regulation name: | Cystoscope and Accessories, Flexible/rigid |
| Regulatory class: | Class II |
| Product code: | FAJ |
| Submitter: | Ambu A/S |
| 510(k) number: | K193095 |
IV Device description
The Single-use Flexible Cystoscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and treatment of adult bladder.
V Indications for use
The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.
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VI Comparison of technological characteristics with the predicate devices
The Single-Use Flexible Cystoscope 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 Cystoscope is different to the predicate device in the following areas:
- The bending angle is larger than the predicate .
- There are 10 specifications while predicate device has 1 specification .
- Working length is 450mm while working length of predicate device is 390mm .
The differences between the Single-Use Flexible Cystoscope and predicate device do not alter suitability of the proposed device for its intended use.
VII Summary of Non-clinical tests:
Biocompatibility testing
Biocompatibility of the Single-Use Flexible Cystoscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (