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 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 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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:

Based on the provided text, the submission is a 510(k) for the WiScope® Digital Cystoscope System. The core of this submission is to demonstrate substantial equivalence to a previously cleared device (K212202) rather than proving novel performance against specific clinical acceptance criteria. Therefore, the information typically found in a clinical study seeking to establish performance against acceptance criteria for a new device is largely absent.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria for clinical performance with reported results in the same way a de novo device might. Instead, it relies on demonstrating that the proposed device is substantially equivalent to a predicate device (K212202). The "acceptance criteria" are implicitly met by showing that the differences between the proposed device and the predicate do not raise new questions of safety or effectiveness, which is supported by non-clinical testing.

The non-clinical testing performed includes evaluations of:

Acceptance Criteria Category (Implicit)	Reported Device Performance / Evaluation Type
Biocompatibility	Evaluated in accordance with ISO 10993-1
Sterilization	Validated in accordance with ISO 11135:2014
EO/ECH Residuals	Performed according to ISO 10993-7:2008
Shelf Life	Conducted based on ASTM F1980
Packaging Integrity	Evaluated in accordance with ISO 11607-1:2019 and ASTM F1980-16
Photobiological Safety	Performed based on IEC 62471:2006 (and stayed the same as K212202)
Electrical Safety	Evaluated in accordance with IEC 60601-1 and IEC 60601-2-18
Electromagnetic Compatibility	Evaluated in accordance with IEC 60601-1-2
Optical and Color Performance	Resolution, Depth of Field, Distortion, Signal-to-Noise Ratio, Dynamic Range, Image/Brightness Uniformity, Color performance

Note: For the Optical and Color Performance, the document lists the parameters tested but does not provide specific numerical acceptance criteria or reported performance values (e.g., "Resolution > X lp/mm" or "Distortion < Y%"). The implicit acceptance is that these performances are comparable to or meet the requirements for the intended use and are at least as good as the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in the context of a clinical performance study. The testing revolves around non-clinical engineering and biological safety tests. For these non-clinical tests, the "sample size" would refer to the number of device units tested according to the respective standards. This specific number is not provided in the text; only the type of test and the standard followed are mentioned.
Data Provenance: Not applicable for clinical data, as "No clinical study is included in this submission." The non-clinical data provenance is internal to the manufacturer (OTU Medical Inc.) and conducted according to international standards (ISO, ASTM, IEC).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Since no clinical study or expert-adjudicated ground truth for a test set was performed, there's no mention of experts for this purpose. The non-clinical tests rely on established scientific methods and adherence to standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical study with a test set requiring adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study or AI assistance is mentioned in the context of this device. The device is a digital cystoscope system, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable as the device is a medical instrument (digital cystoscope), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical ground truth. The "ground truth" for the non-clinical tests is defined by the objective pass/fail criteria of the referenced international standards (e.g., ISO for biocompatibility and sterilization, IEC for electrical safety, ASTM for shelf life).

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device submission.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a training set.

Summary

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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, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, followed by 'ADMINISTRATION' in a smaller font size.

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)

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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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

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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 Systemsingle-use cystoscope:OTU-C300S; OTU-C300ROTU-C310S; OTU-C310RNote: The WiScope® single-use cystoscope is currently marketed inthe United States by OTU Medical Inc. under 510(k) # K212202.	WiScope®Digital Cystoscope Systemsingle-use cystoscope: OTU-C300S; OTU-C300ROTU-C310S; OTU-C310R
510(K)Submitter	OTU Medical Inc.	OTU Medical Inc.
510(K)Number	/	K212202
ClassificationRegulation	21 CFR 876.1500	21 CFR 876.1500
Classificationand Code	Class II,FAJ	Class II,FAJ
Digital videotechnology	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	EOSAL: 10-6	EOSAL: 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.

Regulation Number and Section

§ 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.