(280 days)
Not Found
No
The summary describes a standard endoscopic device for visualization and basic image manipulation (flip, snapshot). There is no mention of AI, ML, or advanced image analysis beyond simple display functions.
Yes
The device is described as assisting with "surgical treatment within the lower urinary tract" and having a "working channel provide access for accessories to conduct surgical process," indicating it plays a role in active medical intervention.
Yes
The device "provides visualization via displaying unit" and its function is to "provide live imaging of the lower urinary tract, including tissue appearance recording, snapshot, vertical flip and horizontal flip," which are diagnostic functions.
No
The device description clearly outlines hardware components like the flexible cystoscope with an illumination LED, bending section, control lever, and a cable-connected display system (Tablet or Video Box). The performance studies also include tests for electrical safety, electromagnetic compatibility, and optical performance, which are relevant to hardware.
Based on the provided information, the VersaVue™ Single-Use Flexible Cystoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- VersaVue™ Function: The VersaVue™ Cystoscope is used for direct visualization inside the lower urinary tract ("in vivo"). It provides live imaging and allows for surgical procedures. It does not analyze samples taken from the body.
The device is an endoscopic device used for direct visualization and intervention within the body, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system (VersaVue™ Tablet OR VersaVue™ Video Box). The device provides endoscopic procedure and surgical treatment within the lower urinary tract.
The Cystoscope is intended to provide visualization via displaying unit.
The Cystoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.
Product codes
FAJ
Device Description
VersaVue™ Single-Use Flexible Cystoscope is a single-use, flexible, sterile cystoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected display system (VersaVue™ Tablet OR VersaVue™ Video Box). The working channel provide access for accessories to conduct surgical process.
VersaVue™ Tablet is a tablet. The live imaging or snapshot will present directly on the tablet.
VersaVue™ Video Box is a standalone imaging transfer system, it can be connected to computer to project live imaging. The function of VersaVueTM Single-Use Flexible Cystoscope is to provide live imaging of the lower urinary tract, including tissue appearance recording, snapshot, vertical flip and horizontal flip. Table 1 below includes a summary of the technical information used in the substantial equivalence comparison.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower urinary tract
Indicated Patient Age Range
adults
Intended User / Care Setting
hospital environment or medical office environment
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)
Nonclinical Tests
The following tests have been performed in support of the substantial equivalence determination:
- Electrical safety per IEC/EN 60601-1:2005/2006+A1:2012/2013+A2:2020/2021. -
- Electromagnetic Compatibility per IEC/EN 60601-1-2:2014/2015+A1:2020/2021
- Sterilization Validation per ISO 11135:2014 and ISO 11737-1:2019 -
- Package Integrity per ISO 11607-1:2019
- EO/ECH Residue per ISO 10993-7:2008 -
- Transportation test per ASTM D4169-22 -
- Aging test per ASTM F1980-16 -
- ISO 14971:2019, EN ISO 14971:2019 and MDR 2017/745 for risk management. -
- Light hazards per IEC 62471:2006 -
- Biocompatibility:
. Cytotoxicity test per ISO 10993-5:2009
. Sensitization and Irritation test per ISO 10993-10:2021
. Material mediated pyrogenicity and systemic toxicity test per ISO 10993-11:2017 - Optical and Color performance testing: -
. Field of view and direction of view .
. Resolution
. Depth of field
. Geometric distortion
. Image intensity uniformity (IIU)
. Noise and dynamic range
. Color performance
Clinical Tests
No clinical studies were performed.
Optical Radiation Safety Assessment
The VersaVue™ Single-Use Flexible Cystoscope was tested according to ISO 62471:2006 to determine acceptable light safety limits for both the illumination. The test results demonstrate the VersaVue™ Single-Use Flexible Cystoscope meets the requirements of the standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
October 6, 2023
Medimaging Integrated Solution Inc. (MiiS) Luu Hsu Official Correspondent 3F., No. 24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu, Taiwan 30077 China
Re: K223926
Trade/Device Name: Cystoscope: VersaVue™ Single-Use Flexible Cystoscope Tablet: VersaVue™ Tablet Video Box: VersaVue™ Video Box Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: September 8, 2023 Received: September 8, 2023
Dear Luu Hsu:
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/cdrb/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) K223926
Device Name
Cystoscope: VersaVue™ Single-Use Flexible Cystoscope Tablet: VersaVue™ Tablet Video Box: VersaVue™ Video Box
Indications for Use (Describe)
The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system (VersaVue™ Tablet OR VersaVue™ Video Box). The device provides endoscopic procedure and surgical treatment within the lower urinary tract.
The Cystoscope is intended to provide visualization via displaying unit.
The Cystoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.
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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Image /page/4/Picture/0 description: The image is a logo with a circular target-like design at the top and the text "MiiS" at the bottom. The target design consists of concentric circles divided into quadrants, with alternating shades of gray and black. The text "MiiS" is in a bold, blue font and is underlined with a blue line. The entire logo is set against a white background with rounded corners.
K223926 Page 1 of 6
510(k) Summary
| Prepared: | September 27, 2023 |
|---|---|
| Submitter/Owner's | |
| Name/ Address | Medimaging Integrated Solution Inc. (MiiS) |
| 3F., No.24-2, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu, Taiwan | |
| 30077, R.O.C. | |
| Contact Person: | Guan-Yuan Liu |
| Telephone: | +886-3-5798860 Ext: 1707 |
| Fax: | +886-3-5798011 |
| Email Address: | ra@miis.com.tw |
5
K223926 Page 2 of 6
Image /page/5/Picture/2 description: The image is a logo with a circular target-like design at the top and the text "MiiS" at the bottom. The target design consists of concentric circles divided into quadrants, with alternating shades of gray and white. The text "MiiS" is written in blue, with a line underneath it. The logo has a white background and a rounded blue border.
Device Identification:
Trade/Device Name: Cystoscope: VersaVue™ Single-Use Flexible Cystoscope Tablet: VersaVue™ Tablet Video Box: VersaVue™ Video Box Common Name: Cystoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FAJ
Predicate Device:
Trade/Device Name: Ambu aScope 4 Cysto Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FAJ
Description of Device:
VersaVue™ Single-Use Flexible Cystoscope is a single-use, flexible, sterile cystoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected display system (VersaVue™ Tablet OR VersaVue™ Video Box). The working channel provide access for accessories to conduct surgical process.
VersaVue™ Tablet is a tablet. The live imaging or snapshot will present directly on the tablet.
VersaVue™ Video Box is a standalone imaging transfer system, it can be connected to computer to project live imaging. The function of VersaVueTM Single-Use Flexible Cystoscope is to provide live imaging of the lower urinary tract, including tissue appearance recording, snapshot, vertical flip and horizontal flip. Table 1 below includes a summary of the technical information used in the substantial equivalence comparison.
6
Image /page/6/Picture/0 description: The image is a logo with a white background and a blue border. The logo features a circular target-like design in the upper half, composed of concentric rings in alternating shades of gray. The lower half of the logo contains the text "MiiS" in bold, blue letters. The overall design is simple and clean, with a focus on the target symbol and the acronym.
Indications for Use (IFU):
The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system (VersaVue™ Tablet OR VersaVue™ Video Box). The device provides endoscopic procedure and surgical treatment within the lower urinary tract.
The Cystoscope is intended to provide visualization via displaying unit.
The Cystoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.
Substantial Equivalence Summary
Below is a summary table comparing the IFUs and key technological characteristics between the subject and the predicate devices.
| Device | K223926 | K193095 |
|---|---|---|
| Model name | Cystoscope: VersaVue™ Single- | |
| Use Flexible Cystoscope | ||
| Tablet: VersaVue™ Tablet | ||
| Video Box: VersaVue™ Video | ||
| Box | Ambu aScope 4 Cysto | |
| Product code & | ||
| Classification | 21 CFR 876.1500, | |
| FAJ Class II | 21 CFR 876.1500, | |
| FAJ Class II | ||
| Intended use | The VersaVue™ Single-Use | |
| Flexible Cystoscope is a sterile, | ||
| single-use, and flexible device | ||
| intended to be operated with its | ||
| compatible display system | ||
| (VersaVue™ Tablet OR | ||
| VersaVue™ Video Box). The | ||
| device provides endoscopic | ||
| procedure and surgical treatment | ||
| within the lower urinary tract. | ||
| The Cystoscope is intended to | ||
| provide visualization via | ||
| displaying unit. | 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 visualization | ||
| via the reusable Ambu Displaying | ||
| Unit and can be used with | ||
| endoscopic accessories and | ||
| instruments. | ||
| The aScope 4 Cysto is intended | ||
| for use in a hospital environment | ||
| Image: MHS logo | The Cystoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults. | or medical office environment. |
| The aScope 4 Cysto is designed for use for adult patients requiring cystoscopy. | ||
| Lens Specification | FOV: 120° | |
| DOV: 0° | ||
| DOF: 3-50 mm | FOV: 120° | |
| DOV: 0° | ||
| DOF: 3-100 mm | ||
| Mechanical | ||
| Specification | Bending angle: | |
| Up: 220°/Down: 130° | ||
| Working length: | ||
| 380 mm | ||
| Distal end diameter: | ||
| 5.5 mm | ||
| Working channel diameter: | ||
| 2.33 mm | Bending angle: | |
| Up: 210°/Down: 120° | ||
| Working length: | ||
| 390 mm | ||
| Distal end diameter: | ||
| 5.4 mm | ||
| Working channel diameter: | ||
| 2.2 mm | ||
| EMC | IEC 60601-1-2 | IEC 60601-1-2 |
| Safety | IEC 60601-1 | |
| IEC 60601-2-18 | IEC 60601-1 | |
| IEC 60601-2-18 | ||
| Bench test | ISO 8600-1 | |
| ISO 8600-3 | ||
| ISO 8600-4 | ISO 8600-1 | |
| ISO 8600-3 | ||
| ISO 8600-4 | ||
| Sterilization | EO Sterilization | EO Sterilization |
| Materials | Acroylonitrile butadiene styrene | |
| (ABS), Polyurethane, | ||
| polycarbonate, polyethylene, | ||
| silicon rubber, UV-curing resin, | ||
| thermoplastic elastomer (Pebax) | Methyl Acrylonitrile Butadiene | |
| Styrene (MABS), Polyurethane, | ||
| polypropylene, Polycarbonate, | ||
| Polyoxymethylene, | ||
| Polyvinylchloride | ||
| LED Light source | At distal tip | At distal tip |
7
Image /page/7/Picture/0 description: The image is a logo with a circular target-like design at the top and the word "MiiS" in blue at the bottom. The circular design consists of concentric rings divided into quadrants, with alternating black, white, and gray segments. The word "MiiS" is written in a bold, sans-serif font, with a horizontal line underlining it. The background of the logo is white.
8
Image /page/8/Picture/1 description: The image shows a logo with the word "Meis" written in black letters. To the left of the word is a circular graphic with concentric circles in shades of gray and white. The word "is" is written in blue letters below the circular graphic.
Image /page/8/Picture/3 description: The image shows two different medical devices. The device on the left has a white handle with a blue accent, a black cord, and a connector. The device on the right has a white handle with a green button, a clear tube, and a black tube.
Substantial Equivalence Discussion
Similarities:
- VersaVue™ Single-Use Flexible Cystoscope and the predicate device, Ambu aScope 4 Cysto (K193095), have the same intended use and similar specifications in field of view, direction of view, depth of field, bending angle, working length, outer diameter, working channel diameter, sterilization method, light source location and appearance.
Differences:
- The differences lie in the optical specification (depth of field), bending angle, outer diameter of the insertion tube, working length and working channel diameter. Differences about most of these features are not more than 10%. Although the difference becomes bigger in the feature of depth of field, the usability test proves that image performance and the usability of the device are both acceptable during clinical use. Additionally, the materials of the subject device are different. The materials were tested. Thus, it is considered that there is no significance difference occurs between VersaVue™ Single-Use Flexible Cystoscope with its predicate devices.
Nonclinical Tests
The following tests have been performed in support of the substantial equivalence determination:
- Electrical safety per IEC/EN 60601-1:2005/2006+A1:2012/2013+A2:2020/2021. -
- Electromagnetic Compatibility per IEC/EN 60601-1-2:2014/2015+A1:2020/2021 ၊
9
Image /page/9/Picture/2 description: The image is a logo with a white background and a rounded rectangular border. At the top of the logo is a circular target-like design with alternating black, white, and gray concentric rings. Below the target design, the text "MiiS" is written in large, bold, blue letters. The logo appears to represent an organization or company, possibly related to targeting, precision, or data analysis, given the target symbol and the acronym.
- Sterilization Validation per ISO 11135:2014 and ISO 11737-1:2019 -
- Package Integrity per ISO 11607-1:2019 ।
- EO/ECH Residue per ISO 10993-7:2008 -
- Transportation test per ASTM D4169-22 -
- Aging test per ASTM F1980-16 -
- ISO 14971:2019, EN ISO 14971:2019 and MDR 2017/745 for risk management. -
- Light hazards per IEC 62471:2006 -
- Biocompatibility: ।
- . Cytotoxicity test per ISO 10993-5:2009
- . Sensitization and Irritation test per ISO 10993-10:2021
- . Material mediated pyrogenicity and systemic toxicity test per ISO 10993-11:2017
- Optical and Color performance testing: -
- Field of view and direction of view .
- Resolution
- Depth of field
- Geometric distortion ●
- . Image intensity uniformity (IIU)
- . Noise and dynamic range
- . Color performance
Clinical Tests
No clinical studies were performed.
Optical Radiation Safety Assessment
The VersaVue™ Single-Use Flexible Cystoscope was tested according to ISO 62471:2006 to determine acceptable light safety limits for both the illumination. The test results demonstrate the VersaVue™ Single-Use Flexible Cystoscope meets the requirements of the standard.
Conclusion
Substantial equivalence comparison and bench performance tests support the conclusion of substantial equivalence of VersaVue™ Single-Use Flexible Cystoscope to the predicate devices Ambu aScope 4 Cysto (K193095).