(21 days)
Not Found
No
The summary describes a digital endoscope system with image processing capabilities but does not mention AI, ML, or any related terms. The performance studies focus on traditional device characteristics rather than AI/ML performance metrics.
No
The device is primarily for visualization and access, enabling physicians to perform procedures and deliver accessories. While it aids in treatment, it does not directly apply therapy itself.
Yes
The Device Description explicitly states: "WiScope™ Digital Endoscope System is designed for physicians to access, visualize, and perform procedures in the urinary tract for diagnosis and treatment."
No
The device description explicitly states that the system includes a "single-use digital ureteroscope" which is a physical hardware component with an on-tip camera module and LED lighting source. The performance studies also include testing for hardware characteristics like electrical safety, biocompatibility, and mechanical properties.
Based on the provided information, the WiScope™ Digital Endoscope System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "access, visualize, and perform procedures in the urinary tract and the kidney." This describes a device used in vivo (within the body) for direct visualization and intervention.
- Device Description: The description details a flexible endoscope with an on-tip camera and lighting, designed for insertion into the urinary tract. This is consistent with an in vivo imaging and procedural device.
- Anatomical Site: The anatomical site is the "Urinary tract and the kidney," which are internal organs.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body), such as blood, urine, tissue, or other bodily fluids, for diagnostic purposes. IVDs are typically used to test these types of samples.
The device is clearly designed for direct visualization and intervention within the patient's body, which falls under the category of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
WiScope™M Digital 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.
Product codes
FGB
Device Description
WiScope™ Digital Endoscope System is designed for physicians to access, visualize, and perform procedures in the urinary tract for diagnosis and treatment. This system includes a single-use digital ureteroscope and an image system.
The single-use ureteroscope 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. The image system processes the images from the ureteroscope and outputs video signals to a display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract and the kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians / operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Conclusion:
The WiScope™ Digital Endoscope System has been verified for its safety and effectivity based on the following performance data.
Electrical safety of the system was evaluated in accordance with IEC 60601-1:2012, and AAMI/ANSIES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 and IEC 60601-2-18:2009. Electromagnetic compatibility was evaluated in accordance with IEC 60601-1-2:2014. All evaluation acceptance criteria were met.
The biocompatibility evaluation for the Medical Video Endoscopy system was conducted in accordance with the Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA.
Biocompatibility of the patient contacting materials were evaluated safe in accordance with ISO 10993-1:2009/(R)2013.
Sterile barrier systems were evaluated in accordance with ISO 11607-1:2006. Sterilization Process has been validated accordance with ISO 11135:2014.
Technological characteristics has been tested for its functions as intended including verification of performance characteristics per ISO8600 (Appearance, The minimum bending radius, The Working length of shaft, Perimeter, Depth of field, Field of view, Direction of view) and performances characteristics relevant to functions as intended(Resolution, Rigid distal tip temperature, Illumination, Articulation, Working channel freedom from leakage, Waterproof, Flow rate of water, Function keys, OLED display).
The results of Non-Clinical Performance testing demonstrate that the WiScope™ Digital Endoscope System is considered safe and effective for its intended use.
Clinical Test Conclusion:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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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.
August 14, 2018
OTU Medical Inc. % David Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, NJ 07041
Re: K181977
Trade/Device Name: WiScope™ Digital Endoscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: July 20, 2018 Received: July 24, 2018
Dear David Yungvirt:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181977
Device Name WiScope™M Digital Endoscope System
Indications for Use (Describe)
WiScope™ Digital 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.
| 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. 2231A Fortune Drive, San Jose, CA 95131 Phone: (408) 797-7313 Contact: Geping Liu Email: info@otumed.com
2. Submission Correspondent
Shanghai CV Technology Co., Ltd. Room 903 of Dongbao Building, No. 19 Dongbao Road, Songjiang Area, Shanghai, China 201613 Phone: 86 21-31261348 Fax: 86 21-57712250 Contact: Doris Dong(Consultant) Email: doris_d@126.com
3. Date Prepared
May 14, 2018
4. Device Identification
Trade/Proprietary Name: WiScope™ Digital Endoscope System Common Name/Classification Name: Ureteroscope and Accessories, Flexible/rigid Product Code: FGB Regulation Number: 21 CFR 876.1500 Endoscope and Accessories 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 |
|---|---|---|---|
| Zhuhai Pusen Medical | |||
| Technology Co., Ltd. | Medical Video | ||
| Endoscope System | K171076 | FGB |
6. Device Description
WiScope™ Digital Endoscope System is designed for physicians to access, visualize, and perform
4
procedures in the urinary tract for diagnosis and treatment. This system includes a single-use digital ureteroscope and an image system.
The single-use ureteroscope 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. The image system processes the images from the ureteroscope and outputs video signals to a display.
7. Indication For Use Statement
WiScope™ Digital 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
The following table compares the proposed device with the predicate device in terms of intended use, technological characteristics and principles of operation, and it provides detailed information for determining substantial equivalences.
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Trade name | WiScope™ Digital | ||
| Endoscope System | Medical Video Endoscope | ||
| System | |||
| 510(K) | |||
| Submitter | OTU Medical Inc. | Zhuhai Pusen Medical | |
| Technology Co., Ltd. | |||
| 510(K) Number | K171076 | ||
| Classification | |||
| Regulation | 21CRF 876.1500 | 21CRF 876.1500 | SE |
| Classification | |||
| and Code | Class II, | ||
| FGB | Class II, | ||
| FGB | SE | ||
| Common name | Ureteroscope and | ||
| Accessories, Flexible/rigid | Ureteroscope and | ||
| Accessories, Flexible/rigid | SE | ||
| Ureteroscope | Single-Use | Single-Use | SE |
| Image System | Not including OS, monitor, | ||
| and battery | Including a touch PC and | ||
| battery | Analysis 1 | ||
| 2231A Fortune Drive, San Jose, CA 95131 | |||
| Intended Use | WiScope™ Digital | ||
| 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. | This instrument has been | ||
| designed to be used with | |||
| endo-therapy accessories | |||
| such as a biopsy forceps and | |||
| other ancillary equipment for | |||
| endoscopy and endoscopic | |||
| surgery within urinary tract | |||
| and interior of the kidney. | Note 1 | ||
| Digital video | |||
| technology | CMOS | CMOS | Note 2 |
| Illumination | LED | Optical fiber | Analysis 2 |
| Field of View | |||
| (Diagonal) | 100° | 120° | Note 3 |
| Outer Shaft | |||
| Diameter | 8.6Fr | 9.0Fr | Note 4 |
| Working Length | |||
| (mm) | 670 | 630 | Note 4 |
| Working | |||
| Channel | |||
| Diameter | |||
| (Fr) | 3.6Fr | 3.6Fr | SE |
| Up/Down | |||
| Deflection | UP: 275° | ||
| DOWN: 275° | UP: 270° | ||
| DOWN: 270° | SE | ||
| Direction of | |||
| View | 0° | 0° | SE |
| Brightness | |||
| Control | Yes | Yes | SE |
| White Balance | Yes | Yes | SE |
| Output Formats | USB/AV/HDMI | USB/AV/HDMI | SE |
| Image/Video | |||
| Capture | No | Yes | Analysis 3 |
| Camera Head | |||
| Configurable | Yes | Yes | SE |
| Sterilization | EO | ||
| SAL: 10-6 | EO | ||
| SAL: 10-6 | SE | ||
| Packaging | Ureteroscope is packaged in a | ||
| tray which is sealed by sterile | |||
| barrier | Ureteroscope is packaged in | ||
| a tray which is sealed by | |||
| sterile barrier | SE | ||
| Label and | |||
| Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SE |
| Safety Testing | *AAMI / ANSI ES60601-1:2012 | *AAMI / ANSI ES60601-1:2012 | Performed |
| *AAMI / ANSI / IEC | *IEC 60601-1-2:2007 | more | |
| 60601-1-2:2014 | *IEC 60601-2-18:2009 | testing than | |
| *IEC 60601-2-18:2009 | *ISO 10993-5:2009 | the | |
| *AAMI / ANSI / ISO | *ISO 10993-10:2010 | predicate to | |
| 10993-5:2009 | *ISO 11135:2014 | show safety | |
| *ISO 10993-10:2010 | *ISO 11607:2006 | ||
| *ISO 11135:2014 | *ISO 8600 | ||
| *ISO 10993-7:2008 | |||
| *ISO 11607-1:2006 | |||
| *ASTM F1980-16 | |||
| *ISO 11737-2:2009 | |||
| *ASTM D3078-2013 | |||
| *ASTM F1929-15 | |||
| *DIN 58953-6:2010 | |||
| *ASTM F88/F88M-15 | |||
| *ISO 8600-1-2015 | |||
| *ISO 8600-3-1997 | |||
| *ISO 08600-4-2014 | |||
| *ISO 8600-6-2005 |
Table 5A - General Comparison
5
6
Note 1:
WiScope™ Digital Endoscope System and the predicate device are similar in terms of indication for use. They are all used in the urinary tract and the kidney. They are both for endoscopic examinations/diagnoses and therapeutic procedures with endoscopic accessories.
Note 2:
WiScope™ Digital Endoscope System and the predicate device use the similar CMOS image sensor technology, i.e., an CMOS image sensor at the ureteroscope tip, a back-end image/video processing system, and a cable connecting the CMOS sensor to the processing system.
Note 3:
WiScope™ ureteroscope has a field of view (FOV) of 100°, and the predicate device claimed a field of view of 120°. However, a comparison study between the proposed and the predicate device by physicians demonstrates that the optical parameter is similar and it does not affect safety and effectiveness.
Note 4:
WiScope™ ureteroscope's outer shaft diameter (8.6Fr) is smaller than the predicate device's 9.0Fr. The shaft working length (670mm) is longer than the predicate device's 630mm.
The longer working length allows for better operating flexibility of the proposed device than the predicate.
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The smaller outer shaft diameter is even better, which allows for better performance of the proposed device than the predicate, because it facilitates passage of the ureter and into the kidney.
Analysis1:
OTU's image system does not include the Operating System (OS), the monitor, and the battery, while the predicate does include a PC with a touch screen, and a battery. OTU's image system is connected to a single-use ureteroscope and an existing monitor in the operating room via a standard video connector, i.e., CVBS or HDMI, and is AC powered up for a clinical procedure. As compared to the predicate device, using the external monitor offers better flexibility to use the proposed device. In addition, the proposed image system has passed all safety and EMC testing. Therefore, we consider both devices are substantially equivalent.
Analysis 2:
The proposed device has an LED lighting source directly installed at the distal-end, while the predicate device has the optical fibers at the distal-end and the LED source at the proximal-end. The LED lighting sources ensure high image quality of the ureteroscope. In addition, the proposed device has passed all distal tip temperature tests, and it meets the requirements of IEC 60601-1. Thus we consider that both devices are substantially equivalent.
Analysis 3:
The proposed device doesn't have integrated image/video capture function in the system. However, this feature can be implemented by using legally marketed video recorder or software. The implementations also comply with cybersecurity requirements, and more detailed analysis is described in the report of Cybersecurity Risk Assessment. Therefore, both devices are the same in this aspect.
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Cytotoxicity | Comply with ISO | ||
| 10993-5, no | |||
| cytotoxicity effect | Comply with ISO | ||
| 10993-5 | SE | ||
| Irritation | Comply with ISO | ||
| 10993-10, not an | |||
| irritant | Comply with ISO | ||
| 10993-10 | SE | ||
| Sensitization | Comply with ISO | ||
| 10993-10, not a | |||
| sensitizer. | SE | ||
Table 5B - Biocompatibility Comparison
Conclusion:
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
8
equivalent to the predicate device.
9. Non-Clinical Test Conclusion
The WiScope™ Digital Endoscope System has been verified for its safety and effectivity based on the following performance data.
Electrical safety of the system was evaluated in accordance with IEC 60601-1:2012, and AAMI/ANSIES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 and IEC 60601-2-18:2009. Electromagnetic compatibility was evaluated in accordance with IEC 60601-1-2:2014. All evaluation acceptance criteria were met.
The biocompatibility evaluation for the Medical Video Endoscopy system was conducted in accordance with the Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA.
Biocompatibility of the patient contacting materials were evaluated safe in accordance with ISO 10993-1:2009/(R)2013.
Sterile barrier systems were evaluated in accordance with ISO 11607-1:2006. Sterilization Process has been validated accordance with ISO 11135:2014.
Technological characteristics has been tested for its functions as intended including verification of performance characteristics per ISO8600 (Appearance, The minimum bending radius, The Working length of shaft, Perimeter, Depth of field, Field of view, Direction of view) and performances characteristics relevant to functions as intended(Resolution, Rigid distal tip temperature, Illumination, Articulation, Working channel freedom from leakage, Waterproof, Flow rate of water, Function keys, OLED display).
The results of Non-Clinical Performance testing demonstrate that the WiScope™ Digital Endoscope System is considered safe and effective for its intended use.
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 devices and
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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.