WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System

K212202 · OTU Medical, Inc. · FAJ · Apr 13, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K212202
• Device Name: WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
• Applicant: OTU Medical, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Apr 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

Device Story

Single-use flexible digital cystoscope system; includes control body with articulation controls/accessory ports and insertion tube with distal CMOS camera and LED light source. Used by physicians in hospital or medical office settings to access/visualize bladder and lower ureter. Enables delivery of accessories (biopsy forceps, laser fibers, graspers, retrieval baskets) for diagnostic and therapeutic procedures. Operates with OTU-A image system (K181977) to display real-time video. Provides visual guidance for clinical decision-making during urological procedures; benefits include single-use design to eliminate cross-contamination risks associated with reusable endoscopes.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-18), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-5, ISO 10993-10), sterilization validation (ISO 11135), and performance testing per ISO 8600 and ISO 12233 (resolution, illumination, angulation, flow rate, etc.).

Technological Characteristics

Flexible cystoscope; CMOS sensor (1mm x 1mm, 400x400 pixels); LED light source (54 mW). Materials: Polycarbonate (distal tip/sleeve), TPU (deflection sheath), PEBAX (shaft), Stainless steel 304 (working channel/deflection section). Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: Connects to OTU-A image system. Standards: ISO 10993, ISO 8600, IEC 60601 series, ASTM F1980.

Indications for Use

Indicated for physicians to access, visualize, and perform procedures in the bladder and lower ureter in adult patients. Enables use of endoscopic accessories.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Ambu® aScope™ 4 Cysto (K193095)

Submission Summary (Full Text)

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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, 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.

April 13, 2022

OTU Medical, Inc. % Mingzi Hussey Principal Regulatory Consultant Zi-medical, Inc. 93 Springs Rd Bedford, MA 01730

Re: K212202

> Trade/Device Name: WiScope® Digital Cystoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: June 29, 2021 Received: March 10, 2022

Dear Mingzi Hussey:

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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# Indications for Use

510(k) Number (if known) K212202

Device Name WiScope® Digital Cystoscope System

#### Indications for Use (Describe)

WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## Section 5 510(k) Summary

[As required by 21 CFR 807.92]

## 1. Submission Sponsor

OTU Medical Inc. 2231A Fortune Drive, San Jose, CA 95131 Phone: [phone] Contact: Geping Liu Email: info@@otumed.com

## 2. Submission Correspondent

Mingzi Hussey Zi-medical, Inc. Address: 93 Springs Rd, Bedford, MA 01730 US Phone: [phone] Email: [e-mail]

## 3. Date Prepared

Feb 28th, 2022

### 4. Device Identification

Trade/Proprietary Name: WiScope® Digital Cystoscope System Common Name: Cystoscope and Accessories, Flexible/rigid Classification Name: Endoscope and Accessories Product Code: FAJ Regulation Number: 21 CFR 876.1500 Regulation Class: Class II Review Panel: Gastroenterology/Urology

### 5. Predicate Devices

The proposed devices are substantially equivalent to the following predicate

| Applicant | Device name | 510(k) Number | Product code |
|-----------|-----------------------|---------------|--------------|
| Ambu Inc. | Ambu® aScope™ 4 Cysto | K193095 | FAJ |

### 6. Device Description

WiScope® Digital Cystoscope System is designed for physicians to access, visualize, and perform procedures in the bladder and lower ureter for diagnosis and treatment. This system includes a single-use digital cystoscope and an image system OTU-A.

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- The Image system OTU-A is currently marketed in the United States by OTU Medical Inc. ● under 510(k) # K181977.
- The single-use cystoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source.

● WiScope® Single-Use Digital Flexible Cystoscope has the following 4 models: OTU-C300S: Standard Deflection Model for OTU-C300 series OTU-C300R: Reverse Deflection Model for OTU-C300 series OTU-C310S: Standard Deflection Model for OTU-C310 series OTU-C310R: Reverse Deflection Model for OTU-C310 series Note:

* Standard Deflection Models: Pushing the deflection lever forward articulates the distal tip "up" and pushing the lever back articulates the distal tip "down", as shown in Figure 1.

* Reverse Deflection Models: Pushing the deflection lever forward articulates the distal tip "down" and pushing the lever back articulates the distal tip "up", as shown in Figure 1.

Image /page/4/Picture/7 description: The image shows a collection of line drawings, arranged in a grid-like format. Each drawing features a tool with a handle and a different type of end. Some ends are curved, while others are straight and have small markings. The drawings appear to be technical illustrations or diagrams of some sort of medical or surgical instrument.

Standard Deflection Models

Reverse Deflection Models

Figure 1. Illustration of standard deflection models vs. reverse deflection models.

The structure design and parts of the standard deflection models are the same as those of the reverse deflection model, i.e., OTU-C300S vs. OTU-C300R, OTU-C310S vs. OTU-C310R.

| 6.1 Specifications of the WiScope® Single-Use Digital Flexible Cystoscope | | | |
|---------------------------------------------------------------------------|--|--|--|
| | | | |

| Item | OTU-C300S/<br>OTU-C300R | OTU-C310S/<br>OTU-C310R |
|------------------------------|-------------------------|-------------------------|
| Size of CMOS image sensor | 1mm×1mm | 1mm×1mm |
| Optical format of CMOS image | 1/18" | 1/18" |

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| OTU Medical Inc. |
|-----------------------------------------|
| 2231A Fortune Drive, San Jose, CA 95131 |

| 2231A Fortune Drive, San Jose, CA 95131 | | | |
|-----------------------------------------|---------------------------------------------------------------------|-------------------------|-------------------------|
| Video<br>Camera | sensor | 400(H)×400(V)<br>pixels | 400(H)×400(V)<br>pixels |
| | Resolution of CMOS image sensor | | |
| | Optical Resolution | 4lp/mm | 4lp/mm |
| | Field of view | 100° | 100° |
| | Direction of view | Forward | Forward |
| | Depth of field | 2 – 50 mm | 2 – 50 mm |
| Light<br>Source | Power rating and component<br>specification of the LED light source | 54 mW | 54 mW |
| | Ratio of luminous energy<br>transmitted to energy delivered | 100 lm/W | 100 lm/W |
| Shaft | Insertion tube type | Flexible | Flexible |
| | Distal tip diameter | 10Fr | 9Fr |
| | Maximum outer diameter of<br>insertion portion | 16Fr | 15Fr |
| | Insertion tube outer diameter | 15.3Fr | 13.8Fr |
| | Working length of shaft | 380 mm | 380 mm |
| | Angulation range | 210° Up / 210°<br>Down | 210° Up / 210°<br>Down |
| Working<br>Channel | Working channel diameter | 6.6 Fr | 6.6 Fr |
| | Flow rate | ≥100 ml/min | ≥100 ml/min |
| | Compatible fluids | Normal Saline | Normal Saline |

# Patient Contacting Materials:

Image /page/5/Picture/4 description: The image shows two views of a medical instrument, possibly an endoscope. The left image is a close-up of the tip, labeled with 'A', 'B', and 'C', likely indicating different components or features. The right image shows a longer section of the instrument, labeled 'B, C', 'D', and 'E', suggesting the shaft and other parts of the device.

Figure 2. Photos of patient contacting materials

| S/N | Components | Material |
|-----|------------------------------|-----------------------------------|
| A | Lens of camera module | Glass |
| B | Distal tip | Polycarbonate (PC) |
| C | Rigid distal sleeve | Polycarbonate (PC) |
| D | Sheath of deflection section | Thermoplastic polyurethanes (TPU) |
| E | Shaft | PEBAX |

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| S/N | Components | Material |
|-----|---------------------------|------------------------------------|
| 1 | Camera system | LED, Sensor, PCB, electrical wires |
| 2 | Working channel connecter | Stainless steel 304 |
| 3 | Working channel | PU |
| 4 | Deflection section | Stainless steel 304 |
| 5 | Shaft | PEBAX, Stainless steel 304 |

## 6.2 Non-patient contacting materials on shaft:

### 7. Indication for Use Statement

The subject device: WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

The predicate device: Ambu® 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 Ambu® aScope™ 4 Cysto is intended to provide visualization via Ambu® displaying unit and can be used with endoscopic accessories. Ambu® aScope™ 4 Cysto is intended for use in a hospital environment or medical office environment. Ambu® aScope™ 4 Cysto is designed for use in adults.

WiScope® Digital Cystoscope System and the primary predicate device are similar in terms of indication for use. WiScope® Digital Cystoscope System is used in the bladder and lower ureter, while predicate device is used in the lower urinary tract. They are all for endoscopic examinations/diagnoses and therapeutic procedures with endoscopic accessories.

### 8. Comparison of Technological Characteristics

The following table compares the proposed device with the predicate devices in terms of intended use, technological characteristics and principles of operation, and it provides detailed information for determining substantial equivalences.

| ITEM | Proposed Device | Primary Predicate Device |
|------------------------------|------------------------------------|-----------------------------|
| Trade name | WiScope® Digital Cystoscope System | Ambu® aScope™ 4 Cysto |
| 510(K)<br>Submitter | OTU Medical Inc. | Ambu Inc. |
| 510(K) Number | / | K193095 |
| Classification<br>Regulation | 21CRF 876.1500 | 21CRF 876.1500 |
| Classification<br>and Code | Class II,<br>FAJ | Class II,<br>FAJ |
| Common name | Cystoscope and Accessories, | Cystoscope and Accessories, |

| | Table 5A - General Comparison | |
|--|-------------------------------|--|

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## OTU Medical Inc. 2231A Fortune Drive, San Jose, CA 95131

| | Flexible/rigid | Flexible/rigid |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ureteroscope | Single-Use | Single-Use |
| Intended Use | WiScope® Digital Cystoscope System is<br>intended to be used by physicians to<br>access, visualize, and perform<br>procedures in the bladder and lower<br>ureter. The instrument enables delivery<br>and use of accessories such as biopsy<br>forceps, laser fibers, graspers and<br>retrieval baskets at a surgical site. | Ambu® aScope™ 4 Cysto is a<br>sterile, single-use, flexible<br>cystoscope intended to be used<br>for endoscopic access to and<br>examination of the<br>lower urinary tract. The Ambu®<br>aScope™ 4 Cysto is intended to<br>provide visualization via Ambu®<br>displaying unit and can be used<br>with endoscopic accessories.<br>Ambu® aScope™ 4 Cysto is<br>intended for use in a hospital<br>environment or medical office<br>environment.<br>Ambu® aScope™ 4 Cysto is<br>designed for use in adults. |
| Digital video<br>technology | CMOS | CMOS |
| Illumination | LED | LED |
| Field of View | 100° | 120° |
| Working<br>Length (mm) | 380 | 390 |
| Insertion tube<br>outer diameter | OTU-C300 series: 15.3Fr<br>OTU-C310 series: 13.8Fr | 16.2Fr |
| Working<br>Channel<br>Diameter (Fr) | 6.6Fr | 6.6Fr |
| Up/Down<br>Deflection | UP: 210°<br>DOWN: 210° | UP: 210°<br>DOWN: 120° |
| Sterilization | EO<br>SAL: 10-6 | EO<br>SAL: 10-6 |
| Packaging | OTU-C300 series: packaged by<br>paper-plastic bag.<br>OTU-C310 series: packaged in a tray<br>which is sealed by sterile barrier. | Cystoscope is packaged by<br>paper-plastic bag. |
| Label and<br>Labeling | Meet FDA's Requirements | Meet FDA's Requirements |
| Cytotoxicity | Comply with ISO 10993-5, no<br>cytotoxicity effect | Comply with ISO 10993-5, no<br>cytotoxicity effect |
| Irritation | Comply with ISO 10993-10, not an<br>irritant | Comply with ISO 10993-10, not<br>an irritant |
| Sensitization | Comply with ISO 10993-10, not a | Comply with ISO 10993-10, not a |
| sensitizer. | a sensitizer. | |

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WiScope® Single-Use Digital Flexible Cystoscope has two series, OTU-C300 series and OTU-C310 series.

The differences between WiScope® Single-Use Digital Flexible Cystoscope OTU-C300 series and WiScope® Single-Use Digital Flexible Cystoscope OTU-C310 series have been described in 012 Section 10 Device Description in this 510K submission.

The proposed device shares the similar indications for use, same device operation, and overall technical and functional capabilities as the predicate device. It also has the same standards and requirements as the predicate device.

## 9. Description of Non-clinical Testing

The non-clinical tests of the subject device and predicate device are in compliance with the following standards and guidances.

| ITEM | Proposed Device | Primary Predicate Device |
|----------------|-----------------------------------|--------------------------|
| Trade name | WiScope® Digital Cystoscope | Ambu® aScope™ 4 Cysto |
| | System | |
| Safety Testing | *AAMI / ANSI ES60601-1:2012 | *IEC 60601-2-18:2009 |
| | *AAMI / ANSI / IEC 60601-1-2:2014 | *ISO 10993-5:2009 |
| | *IEC 60601-2-18:2009 | *ISO 10993-10:2010 |
| | *IEC IEC62471:2006 | *ISO 11135:2014 |
| | *AAMI / ANSI / ISO 10993-5:2009 | *ISO 8600-1-2015 |
| | *ISO 10993-10:2010 | *ISO 8600-3-2019 |
| | *ISO 11135:2014 | *ISO 8600-4-2014 |
| | *ISO 10993-7:2008 | |
| | *ISO 11607-1:2019 | |
| | *ASTM F1980-16 | |
| | *ISO 11737-2:2019 | |
| | *ASTM D3078-2013 | |
| | *ASTM F1929-15 | |
| | *DIN 58953-6:2016 | |
| | *ASTM F88/F88M-15 | |
| | *ISO 8600-1-2015 | |
| | *ISO 8600-3-2019 | |
| | *ISO 8600-4-2014 | |
| | *ISO 8600-6-2005 | |
| | *ASTM D4169-16 | |

WiScope® Digital Cystoscope System has been verified for its safety and effectivity based on the following performance data. These tests only used to evaluate non-clinical testing of the subject device.

Electrical safety of the system was evaluated in accordance with IEC 60601-1and IEC 60601-2-18. Electromagnetic compatibility was evaluated in accordance with IEC 60601-1-2.

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### All evaluation acceptance criteria were met.

The biocompatibility evaluation for WiScope® Single-Use Digital Flexible Cystoscope was conducted in accordance with ISO 10993-1.

- · Cytotoxicity (ISO 10993-5)
- · Sensitization (ISO 10993-10)
- · Intracutaneous reactivity test (ISO 10993-10)

Result: All tests were passed.

Shelf life test is conducted based on ASTM F1980:

- Performance test
- · Sterile Packaging Integrity

Result: All tests were passed.

Sterile barrier systems were evaluated in accordance with ISO 11607-1:2019.

Sterilization Process has been validated accordance with ISO 11135:2014. Result: The WiScope® Single-Use Digital Flexible Cystoscope is sterile with a determination of lethal rate of the sterilization process to demonstrate achievement of the required SAL of 10® is in accordance to half cycle overkill approach as described in Section 14 Sterilization and Shelf Life.

Technological characteristics have been tested for its functions as intended including verification of performance characteristics per ISO8600, ISO 12233 and performances characteristics relevant to functions as intended:

- · Appearance
- Working length of the shaft
- Minimum bending radius
- Working channel diameter
- Outer Shaft Diameter
- · Depth of field
- Field of view
- Direction of view
- Rigid Distal Tip Temperature
- · Tensile Force Testing
- Resolution
- Illumination
- Angulation range
- Working channel free from leakage
- Waterproof
- Flow rate of water

Result: All tests were passed.

Noise and dynamic range test were conducted based on ISO 15739. Result: All evaluation acceptance criteria were met.

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Simulated shipping distribution on aged devices test were conducted based on ASTM D4169-16. Result: All tests were passed.

Photobiological safety test were conducted based on IEC 62471:2006. Result: All tests were passed.

The results of Non-Clinical Performance testing demonstrate that the WiScope® Digital Cystoscope System is considered safe and effective for its intended use.

## 10. Performance Data - Clinical

No clinical study is included in this submission.

## 11. Conclusion

lt has been shown in this 510(k) submission that the differences between the proposed device and the predicate device do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed are substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.

Therefore, the proposed devices are determined to be substantially equivalent to the referenced predicate device.