← Product Code [FAJ](/productcode/FAJ) · K231702
# WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet (K231702)
_OTU Medical, Inc. · FAJ · Sep 29, 2023 · Gastroenterology, Urology · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K231702
## Device Facts
- **Applicant:** OTU Medical, Inc.
- **Product Code:** [FAJ](/productcode/FAJ.md)
- **Decision Date:** Sep 29, 2023
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **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 digital flexible cystoscope; used by physicians for bladder/lower ureter visualization and procedures. Device captures images via distal tip CMOS sensor; LED illumination; transmits video to back-end processing system via cable. Features handle with deflection control; two-way deflectable insertion tube. Enables use of accessories (biopsy forceps, laser fibers, graspers, retrieval baskets). Used in clinical settings. Output viewed by physician on display for diagnostic/therapeutic guidance. Benefits include single-use sterility, reducing cross-contamination risk.
## Clinical Evidence
No clinical data. Bench testing only. Performance verified via biocompatibility (ISO 10993-1), sterilization validation (ISO 11135), EO/ECH residuals (ISO 10993-7), shelf life (ASTM F1980), packaging integrity (ISO 11607-1), photobiological safety (IEC 62471), electrical safety (IEC 60601-1, IEC 60601-2-18), EMC (IEC 60601-1-2), and optical/color performance testing.
## Technological Characteristics
Single-use flexible cystoscope; CMOS image sensor; LED illumination; 2-way deflection; 9Fr-10Fr distal tip; 13.8Fr-15.3Fr insertion tube; 380mm working length; 6.6Fr working channel. Sterilized via Ethylene Oxide (EO) to SAL 10^-6. Complies with IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, ISO 10993, ISO 11135, ISO 11607, and ASTM F1980.
## Regulatory 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
- WiScope® Digital Cystoscope System ([K212202](/device/K212202.md))
## Submission Summary (Full Text)
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September 29, 2023
OTU Medical, Inc. % Mingzi Hussey Regulatory Consultant Zi-medical, Inc. 93 Springs Road Bedford, MA 01730
Re: K231702 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: September 1, 2023 Received: September 1, 2023
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 (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/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.
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).
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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.
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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## Indications for Use
510(k) Number (if known)
K231702
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)
|
|
CONTINUE ON A SEPARATE PAGE IF NEEDED
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## Section 5 510(k) Summary
[As required by 21 CFR 807.92]
#### 1. Submission Sponsor
OTU Medical Inc. 2847A Whipple Rd, Union City, CA 94587 Phone: (408) 797-7313 Contact: Geping Liu Email: geping.liu@otumed.com
#### 2. Submission Correspondent
Mingzi Hussey Zi-medical, Inc. Address: 93 Springs Rd, Bedford, MA 01730 US Phone: 206-981-0675 Email: mingzi@zi-medical.com
#### 3. Date Prepared
September 28, 2023
#### 4. Device Identification
Trade/Proprietary Name: WiScope® Digital Cystoscope System Common Name: Cystoscope and Accessories, Flexible/rigid Product Code: FAJ Regulation Number: 21 CFR 876.1500 Requlation Name: Endoscope and Accessories Requlatory Class: Class II
#### 5. Predicate Devices
The proposed devices are substantially equivalent to the following predicate devices:
| Applicant | Device name | 510(k) Number | Product code |
|------------------|------------------------------------|---------------|--------------|
| OTU Medical Inc. | WiScope® Digital Cystoscope System | K212202 | 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.
WiScope®Digital Cystoscope System has the same intended use to the predicate device. Both devices use the same CMOS image sensor technology, i.e., an CMOS image sensor at the scope tip, a back-end image/video processing system, and a cable connecting the CMOS sensor to the processing system. In addition, they have same mechanical functions, e.g., a handle with a
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deflection control and a two-way deflectable insertion tube.
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
Detail device description please refer to Device Description in this submission.
#### 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: WiScope® Digital Cystoscope System 510(k) #K212202 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.
#### 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 single-use cystoscope: OTU-C300S; OTU-C300R OTU-C310S; OTU-C310R Note: The WiScope® single-use cystoscope is currently marketed in the United States by OTU Medical Inc. under 510(k) # K212202. | WiScope®Digital Cystoscope System single-use cystoscope: OTU- C300S; OTU-C300R OTU-C310S; OTU-C310R |
| 510(K)Submitter | OTU Medical Inc. | OTU Medical Inc. |
| 510(K)Number | / | K212202 |
| Classification Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Classification and Code | Class II, FAJ | Class II, FAJ |
| Digital video technology | CMOS | CMOS |
| Illumination | LED | LED |
| Common name | Cystoscope and Accessories, Flexible/rigid | Cystoscope and Accessories, Flexible/rigid |
#### Table 5A - General Comparison
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| 2847A Whipple Rd, Union City, CA 94587 | | |
|----------------------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Item | OTU-C300S/ OTU-C300R | OTU-C310S/ OTU-C310R |
| Field of view | 100° | 100° |
| Direction of view | Forward | Forward |
| Depth of Field | 2-50mm | 2-50mm |
| Distal tip diameter | 10Fr | 9Fr |
| Insertion tube outer diameter | 15.3Fr | 13.8Fr |
| Working length of shaft | 380mm | 380mm |
| Angulation range | 210° Up / 210°Down | 210° Up / 210°Down |
| Working channel diameter | 6.6 Fr | 6.6 Fr |
| Compatible fluids | Normal saline | Normal saline |
| Sterilization | EO SAL: 10-6 | EO SAL: 10-6 |
| Packaging | Packaged by paper-plastic bag | OTU-C300 series: packaged by paperplastic bag. OTU-C310 series: packaged in a tray which is sealed by sterile barrier |
The proposed device shares the same indications for use, same device operation, and overall technical and functional capabilities as the predicate device. The subject image system differs from the predicate in regard to the packaging of the WiScope® Single-Use Digital Flexible Cystoscope, shelf life, and camera module parameters. These differences do not raise different questions of safety and effectiveness as compared to the predicate, and can be evaluated through performance testing.
### 9. Description of Non-clinical Testing
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.
The biocompatibility evaluation for WiScope®Single-UseDigital Flexible Cystoscope was conducted in accordance with ISO 10993-1.
Sterilization Process for WiScope®Single-Use Digital Flexible Cystoscope has been validated accordance with ISO 11135:2014.
EO/ECH residual test for WiScope®Single-Use Digital Flexible Cystoscope was performed according to ISO 10993-7:2008.
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Shelf life test for WiScope®Single-Use Digital Flexible Cystoscope is conducted based on ASTMF1980; Sterile barrier systems for WiScope®Single-Use Digital Flexible Cystoscope were evaluated in accordance with ISO 11607-1:2019.
Packaging Integrity Testing based on ISO 11607-1 and ASTM F1980-16
Photobiological safety testing based on IEC 62471:2006 and stay the same as K212202.
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.
Optical and Color Performance Testing:
- Resolution
- Depth of field ●
- Distortion ●
- Signal to noise ratio ●
- Dynamic Range ●
- Image/Brightness Uniformity ●
- Color performance ●
#### 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 different 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 device is determined to be substantially equivalent to the predicate device.
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**Source:** [https://fda-staging.innolitics.com/device/K231702](https://fda-staging.innolitics.com/device/K231702)
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