(114 days)
No
The summary describes standard endoscopic image processing and display, with no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is used for "treatment of adult bladder," indicating a therapeutic purpose in addition to diagnosis and observation.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Digital Video Monitor is designed for "endoscopic diagnosis".
No
The device description explicitly states it consists of a "Single-use Flexible Cystoscope and a Digital Video Monitor," which are hardware components. The summary also includes non-clinical performance tests for hardware aspects like biocompatibility, electrical safety, sterilization, and mechanical/optical performance.
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" and "endoscopic diagnosis, treatment and video observation." This involves directly visualizing and potentially treating the inside of the body.
- Device Description: The device consists of a cystoscope and a monitor for image processing and displaying. This is consistent with an endoscopic system used for direct visualization.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs typically involve reagents, assays, or other methods for analyzing samples.
The device is clearly designed for in vivo (within the body) procedures for visualization and treatment, which falls outside the definition of an In Vitro Diagnostic device.
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.
The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The devices are for use in professional Healthcare Facility Environment.
Product codes (comma separated list FDA assigned to the subject device)
FAJ
Device Description
The device consists of a Single-use Flexible Cystoscope and a Digital Video Monitor for endoscopic image processing and displaying. They are used in conjunction with other accessories for the endoscopy and treatment of adult bladder.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
adult bladder
Indicated Patient Age Range
Adults
Intended User / Care Setting
The device is for use in professional Healthcare Facility Environment.
The device is only to be used by skilled medical staff trained in clinical endoscopic techniques and procedures.
For use by trained clinicians/physicians only.
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 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 (
§ 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 contains 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, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 18, 2024
Hunan Vathin Medical Instrument Co. Ltd Charlene Du RA Manager 1/F, Bldg 12, Innovation and Entrepreneurship Service Center No 9 Chuangi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 CHINA
Re: K242535
Trade/Device Name: Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01. CY-E2F01R. CY-E2G01. CY-E2G01R. CY-S2E01. CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: November 25, 2024 Received: November 25, 2024
Dear Charlene Du:
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/ofdocs/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.
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
Submission Number (if known)
Device Name
Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R);
Digital Video Monitor (DVM-D1, DVM-D2)
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.
The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The devices are for use in professional Healthcare Facility Environment.
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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K242535 Page 1 of 7
Image /page/4/Picture/1 description: The image shows the word "VATHIN" in blue. The "VA" portion of the word is stylized with three parallel lines that form the shape of the letters. The "THIN" portion of the word is in a solid blue font, and there is a small blue circle above the "I".
Premarket Notification 510(k) Submission
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: Regulatory Affairs Manager | |
| Phone: +86-731-5558558 | |
| E-mail: charlene@vathin.com | |
| Date of prepared: | December 18, 2024 |
II Device
| Trade Name of | Single-use Flexible Cystoscope |
|---|---|
| Device: | Digital Video Monitor |
| Common name: | Endoscope and Accessories |
| Classification name: | Cystoscope and Accessories, Flexible/rigid |
| Regulation number: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product Code: | FAJ |
| Review Panel: | Gastroenterology/Urology |
III Predicate device and reference device
| Predicate device | Reference device | |
|---|---|---|
| Trade name: | Ambu AScope 4 Cysto | Ambu aView™ 2 Advance |
| Regulation number: | 21 CFR 876.1500 | 21 CFR 874.4680 |
| Regulation name: | Endoscope and accessories | Bronchoscope (Flexible Or Rigid) |
| Regulatory class: | Class II | Class II |
| Product code: | FAJ | EOQ |
| Submitter: | Ambu A/S | Ambu A/S |
| 510(k) number: | K193095 | K223299 |
5
K242535 Page 2 of 7
Image /page/5/Picture/1 description: The image shows the logo for Vathin. The logo is blue and features the word "VATHIN" in a stylized font. The "VA" portion of the logo is made up of three lines, while the "THIN" portion is in a solid blue font. There is a blue dot above the "I" in "THIN".
Premarket Notification 510(k) Submission
IV Device description
The device consists of a Single-use Flexible Cystoscope and a Digital Video Monitor for endoscopic image processing and displaying. They are used in conjunction with 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.
The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The device is for use in professional Healthcare Facility Environment.
VI Comparison of technological characteristics with the predicate devices
The device is similar to the predicate device in the following areas:
- Intended use (including intended use, intended user and patient population) ●
- Operation principle ●
- Design and performance specifications
- Digital video technology and illumination source
- It allows for irrigation
- It is single-use and delivered sterile
The device is different to the predicate device in the following areas:
- The field of view is slightly smaller than that of the predicate device
- The bending angle is larger than that of the predicate device
- There are 8 specifications while predicate device has 2 specification
- Working length is 400mm while working length of predicate device is 390mm
The differences between the device 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 Cystoscope | Ambu AScope 4 Cysto (K193095) |
| Classification | ||
| Name | Cystoscope and Accessories, | |
| Flexible/rigid | Cystoscope and Accessories, | |
| Flexible/rigid | ||
| Product Code | FAJ | FAJ |
| Device feature | Proposed Device | Predicate Device |
| Trade Name | Single-Use Flexible Cystoscope | Ambu AScope 4 Cysto (K193095) |
| Regulation | ||
| Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Intended 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. | The aScope 4 Cysto is a sterile, single- | |
| use, flexible cystoscope intended to be | ||
| used for endoscopic access to and | ||
| examination of the lower urinary tract. | ||
| The aScope 4 Cysto is intended to provide | ||
| visualisation via Ambu displaying units | ||
| and can be used with endoscopic | ||
| accessories. | ||
| The aScope 4 Cysto is intended for use in | ||
| a hospital environment or medical office | ||
| environment. | ||
| The aScope 4 Cysto is designed for use in | ||
| adults. | ||
| The compatible | ||
| Display Unit | Device Name: Digital Video Monitor | |
| Models:DVM-D1, DVM-D2 | Ambu aView 2 Advance | |
| Application field | The device is for use in a hospital or | |
| qualified medical institution. | The aScope 4 Cysto is intended for use in | |
| a hospital environment or medical office | ||
| environment. | ||
| Intended user | The device is only to be used by skilled | |
| medical staff trained in clinical | ||
| endoscopic techniques and procedures. | Before initial use of the aScope 4 Cysto, it | |
| is essential for operators to have received | ||
| sufficient training in clinical endoscopic | ||
| techniques and to be familiar with the | ||
| intended use, warnings and cautions | ||
| described in these instructions. | ||
| Patient population | Adults | Adults |
| Scope type | Flexible | Flexible |
| Field of view | 110° | 120° |
| Bending angle | Up: 210° | |
| Down: 210° | Up: 210° | |
| Down: ≥120° | ||
| Instrument | ||
| Channel ID(mm) | CY-E2E01, CY-E2E01R, | |
| CY-S2E01, CY-S2E01R: | ||
| 2 | ||
| CY-E2F01, CY-E2F01R: | ||
| 2.2 | ||
| CY-E2G01, CY-E2G01R: | ||
| 2.4 | 2.2 | |
| Device feature | Proposed Device | Predicate Device |
| Trade Name | Single-Use Flexible Cystoscope | Ambu AScope 4 Cysto (K193095) |
| Maximum outer | ||
| diameter of | ||
| insertion part (mm) | CY-E2E01, CY-E2E01R, | |
| CY-S2E01, CY-S2E01R: | ||
| 5.25 | ||
| CY-E2F01, CY-E2F01R: | ||
| 5.45 | ||
| CY-E2G01, CY-E2G01R: | ||
| 5.65 | 6.0 | |
| Outer diameter of | ||
| main hose (mm) | CY-E2E01, CY-E2E01R, | |
| CY-S2E01, CY-S2E01R: | ||
| 4.9 | ||
| CY-E2F01, CY-E2F01R: | ||
| 5.1 | ||
| CY-E2G01, CY-E2G01R | ||
| 5.3 | 5.4 | |
| Distal end | ||
| OD(mm) | CY-E2E01, CY-E2E01R, | |
| CY-S2E01, CY-S2E01R: | ||
| 5.1 | ||
| CY-E2F01, CY-E2F01R: | ||
| 5.3 | ||
| CY-E2G01, CY-E2G01R: | ||
| 5.5 | 5.4 | |
| Working length | ||
| (mm) | 400 | 390 |
| Digital video | ||
| technology | CMOS | CMOS |
| Illumination source | LED | LED |
| Single-use | Yes | Yes |
| Biocompatibility | 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 |
Table 1 Substantial Comparison (Single-use Flexible Cystoscope)
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Image /page/6/Picture/1 description: The image shows the word "VATHIN" in blue letters. The "VA" portion of the word is stylized with three parallel lines that are light blue. The rest of the word is in a darker blue color. There is a small light blue circle above the "I" in the word.
Premarket Notification 510(k) Submission
7
K242535
Page 4 of 7
Image /page/7/Picture/1 description: The image shows the logo for Vathin. The logo is blue and white. The word "Vathin" is written in a stylized font, with the "V" and "A" being made up of three parallel lines. There is a blue dot above the "i" in "Vathin".
Premarket Notification 510(k) Submission
Table 2 Substantial Comparison (Digital Video Monitor)
| Device feature | Proposed Device | Reference Device |
|---|---|---|
| Trade Name | Digital Video Monitor | Ambu® aView™ 2 Advance (K223299) |
| Classification | Cystoscope and Accessories, | Bronchoscope (Flexible or Rigid) and |
| Name | Flexible/rigid | Accessories |
| Product Code | FAJ | EOQ |
| Regulation | 21 CFR 876.1500 | 21 CFR 874.4680 |
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K242535 Page 5 of 7
Image /page/8/Picture/1 description: The image shows the word "VATHIN" in blue font. The "VA" portion of the word is stylized with three parallel lines that are light blue. The rest of the word is in a darker blue font. There is a light blue circle above the "I" in the word.
Premarket Notification 510(k) Submission
| Device feature | Proposed Device | Reference Device |
|---|---|---|
| Number | ||
| Models | Digital Video Monitor: | |
| DVM-D1, DVM-D2 | Ambu® aView™ 2 Advance | |
| Intended use | The Digital Video Monitor is specially | |
| designed to be used with Vathin medical | ||
| endoscopes and other auxiliary equipment | ||
| for the purposes of endoscopic diagnosis, | ||
| treatment and video observation. | The Ambu® aView™ 2 Advance is | |
| intended to display live imaging data from | ||
| compatible Ambu visualization devices. | ||
| Application field | The device is for use in a hospital or | |
| qualified medical institution. | For in-hospital use. | |
| Intended user | For use by trained clinicians/physicians | |
| only. | For use by trained clinicians/physicians | |
| only. | ||
| Max. resolution | 1920 * 1080 | 1920 * 1080 |
| Display type | 15.6" touch screen | 12.8" colour TFT LCD |
| USB connection | A-type | Type A |
| Video output | HDMI, SDI | HDMI, 3G-SDI |
| Image/Video | ||
| capture | Yes | Yes |
VII Summary of Non-clinical performance 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 (