WiScope® OM Endoscope System is also intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct. 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® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney, and the pancreaticobiliary system including the hepatic ducts and the common bile duct. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

This system includes a single-use digital ureteroscope/choledochoscope and an image system.

WiScope® Single-Use Digital Flexible Ureteroscope/Choledochoscope is a modified version of the currently marketed WiScope Single-Use Digital Flexible Ureteroscope device that widen its application area from urinary system to bile ducts. Other than that, nothing has changed. The image system stays the same.

AI/ML Overview

The provided FDA 510(k) summary for the "WiScope OM Endoscope System" focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and intended use, rather than on performance against specific acceptance criteria derived from clinical study results of an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study details for proving device performance (such as sample size, expert ground truth establishment, MRMC studies, standalone performance, and training set information) is not present in the provided document.

The document states:

"No clinical study is included in this submission." (Page 7, Section 10. Clinical Test Conclusion)
The comparison focuses on "intended use, technological characteristics, and performance characteristics" relative to predicate devices, and claims the device is "as safe and effective as the predicate devices." (Page 4, Section 8. Comparison of Technological Characteristics)
"Non-Clinical Test Conclusion" (Page 7, Section 9) refers to previous 510(k) submission K181977 and explicitly states: "There is no change on product design, materials and packaging. The no-clinical performance test stays the same as K181977." This implies that the current submission relies on previously established non-clinical performance, not new studies proving performance against acceptance criteria for an AI/ML component.

This 510(k) submission is for an endoscope system (a medical device), not an AI/ML algorithm that identifies or performs automated tasks. Hence, the questions related to AI/ML specific performance metrics (like sensitivity, specificity, clinical outcome improvement via AI, ground truth establishment for AI, etc.) are not applicable to the content provided.

Summary

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July 22, 2021

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

Re: K210579

Trade/Device Name: WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope. Choledochoscope, WiScope Image System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBN, FGB Dated: June 15, 2021 Received: June 23, 2021

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant 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) K210579

Device Name WiScope® OM Endoscope System

Indications for Use (Describe)

WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.

Type of Use (Select one or both, as applicable)
☑ Research Use (per 21 CFR 201.122 Subject to)
□ Compounding Use (per 21 CFR 201.115)

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. 2231A Fortune Drive, San Jose, CA 95131 Phone: (408) 797-7313 Contact: Geping Liu Email: info@@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

Feb. 1th, 2021

4. Device Identification

Trade/Proprietary Name: WiScope® OM Endoscope System Common Name/Classification Name: Endoscope and Accessories Product Code: FBN, FGB 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 devices:

Applicant	Device name	510(k) Number	Product code
OTU Medical Inc.	WiScope™ Digital Endoscope System	K181977	FGB
ACMI Corporation	ACMI® DUR-Digital Ureteroscope andCholedochoscope System (DUR®-D)	K060269	FBN, FGB

6. Device Description

This system includes a single-use digital ureteroscope/choledochoscope and an image system.

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

7. Indication For Use Statement

WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.

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

A direct comparison of key characteristics demonstrates that the WiScope®OM Endoscope System is substantially equivalent to the predicate devices in terms of intended use, technological characteristics, and performance characteristics. The WiScope®OM Endoscope System is as safe and effective as the predicate devices.

ITEM	Proposed Device	Reference device	Predicate Device
Trade name	WiScope®OM EndoscopeSystem	WiScope™ DigitalEndoscope System	ACMI® DUR-DigitalUreteroscope andCholedochoscopeSystem (DUR®-D)
510(K)Submitter	OTU Medical Inc.	OTU Medical Inc.	ACMI Corporation
510(K)Number	/	K181977	K060269
ClassificationRegulation	21CRF 876.1500	21CRF 876.1500	21CRF 876.1500
Classificationand Code	Class II,FGB, FBN	Class II,FGB	Class II,FGB, FBN
Commonname	Choledochoscope andAccessories, Flexible/rigid	Ureteroscope andAccessories,Flexible/rigid	Choledochoscope andAccessories,Flexible/rigid
Ureteroscope	Single-Use	Single-Use	Reuse
Intended Use	WiScope® OM EndoscopeSystem is intended to beused by physicians to access,visualize, and performprocedures in the urinarytract and the kidney.	WiScope™ DigitalEndoscope System isintended to be used byphysicians to access,visualize, and performprocedures in the urinary	The ACMI instrumentsystem (which includesthe DUR-Digital InvisioFlexible Ureteroscope,Choledochoscope, andIDC Invisio Digital

	WiScope® OM EndoscopeSystem is also intended to beused by physicians throughpercutaneous insertion toaccess, visualize, andperform procedures in thepancreaticobiliary systemincluding the hepatic ductsand the common bile duct.The instrument enablesdelivery and use ofaccessories such as biopsyforceps, laser fibers, graspersand retrieval baskets at asurgical site.	tract and the kidney. Theinstrument enablesdelivery and use ofaccessories such asbiopsy forceps, laserfibers, graspers andretrieval baskets at asurgical site.	Controller) is intendedfor use to examinebody cavities, holloworgans and canals inthe body, in the urinarytract, and can be usedpercutaneously toexamine the interior ofthe kidney; and usingadditional accessories,can be used to performvarious diagnosticand therapeuticprocedures.The DUR-D System isalso indicated for theexamination of bileducts, and usingadditional accessories,to perform variousdiagnostic andtherapeutic proceduresduringcholecystectomy.
Digital videotechnology	CMOS	CMOS	CMOS
Illumination	LED	LED	LED
Field of View(Diagonal)	100°	100°	80°
WorkingLength (mm)	670	670	650
Outer ShaftDiameter	8.6Fr	8.6Fr	9.3Fr
WorkingChannelDiameter(Fr)	3.6Fr	3.6Fr	3.6Fr
Up/DownDeflection	UP: 275°DOWN: 275°	UP: 275°DOWN: 275°	UP: 250°DOWN: 250°
Direction ofView	0°	0°	9°
BrightnessControl	Yes	Yes	Yes
White	Yes	Yes	No
	USB/AV/HDMI	USB/AV/HDMI	USB/AV
Balance
OutputFormats	USB/AV/HDMI	USB/AV/HDMI	USB/AV
Image/VideoCapture	No	No	Yes
Camera HeadConfigurable	Yes	Yes	Yes
Sterilization	EOSAL: 10-6	EOSAL: 10-6	EO;SAL: 10-6
Packaging	Ureteroscope/Choledochoscope is packaged in a tray which is sealed by sterile barrier.	Ureteroscope is packaged in a tray which is sealed by sterile barrier.	Ureteroscope is packaged in a storage container.
Label andLabeling	Meet FDA's Requirements	Meet FDA's Requirements	Meet FDA's Requirements
SafetyTesting	AAMI / ANSIES60601-1:2012AAMI / ANSI / IEC 60601-1-2:2014IEC 60601-2-18:2009AAMI / ANSI / ISO 10993-5:2009ISO 10993-10:2010ISO 11135:2014ISO 10993-7:2008ISO 11607-1:2019ASTM F1980-16ISO 11737-2:2019ASTM D3078-2013ASTM F1929-15DIN 58953-6:2010ASTM F88/F88M-15ISO 8600-1-2015ISO 8600-3-2019ISO 8600-4-2014ISO 8600-6-2005	AAMI / ANSIES60601-1:2012AAMI / ANSI / IEC 60601-1-2:2014IEC 60601-2-18:2009AAMI / ANSI / ISO 10993-5:2009ISO 10993-10:2010ISO 11135:2014ISO 10993-7:2008ISO 11607-1:2006ASTM F1980-16ISO 11737-2:2009ASTM D3078-2013ASTM F1929-15DIN 58953-6:2010ASTM F88/F88M-15ISO 8600-1-2015ISO 8600-3-1997ISO 8600-4-2014ISO 8600-6-2005	IEC 60601:1995IEC 60601-1-2:2004IEC 60601-2-18:2000UL 60601-1:2003*CSA C22.2.125:1999
Cytotoxicity	Comply with ISO 10993-5, no cytotoxicity effect	Comply with ISO 10993-5, no cytotoxicity effect	Comply with ISO 10993-5
Irritation	Comply with ISO 10993-10, not an irritant	Comply with ISO 10993-10, not an irritant	Comply with ISO 10993-5
Sensitization	Comply with ISO 10993-10, not a	Comply with ISO 10993-10, not a	Comply with ISO 10993-10

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

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

	sensitizer.	sensitizer.

Conclusion:

Usability Engineering was performed in accordance with IEC 62366 and stay the same as previous 510k submission.

Biocompatibility test was conducted in accordance with ISO 10993-5, ISO 10993-10, ISO 10993-11and the same as previous 510k submission.

The proposed devices share the same indications for use, device operation, overall technical and functional capabilities, meets the same standards and requirements and therefore are substantially equivalent to the predicate devices.

9. Non-Clinical Test Conclusion

Refer to the document of WiScope™ Digital Endoscope System which has been marketed in the United States by OTU Medical Inc. under 510(k) # K181977. There is no change on product design, materials and packaging. The no-clinical performance test stays the same as K181977.

10. Clinical Test Conclusion

No clinical study is included in this submission.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device.

It has been shown in this 510(k) submission that the difference between the proposed device and the predicate devices 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 devices 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 devices.

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.