(146 days)
No
The summary does not mention AI, ML, or any related concepts like image processing beyond basic digital video technology. The focus is on the device's intended use, physical description, and comparison to predicate devices.
No
Explanation: The device is primarily for visualization and access, enabling the delivery and use of accessories for therapeutic procedures, rather than performing therapy itself.
No
The device is described as an endoscope system used to "access, visualize, and perform procedures," enabling the "delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site." This functionality points towards interventional and procedural uses, not primarily diagnostic interpretation or disease detection. While it allows visualization, its primary function is for performing procedures and facilitating interventional tools, making it an interventional device rather than a diagnostic one.
No
The device description explicitly states that the system includes a "single-use digital ureteroscope/choledochoscope and an image system," indicating the presence of hardware components beyond just software.
Based on the provided information, the WiScope® OM Endoscope System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- WiScope® OM Endoscope System Function: The description clearly states that the WiScope® OM Endoscope System is used by physicians to access, visualize, and perform procedures directly within the urinary tract, kidney, and pancreaticobiliary system. It is an endoscopic system that allows for direct observation and intervention within the body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to provide visual access and facilitate procedures within the body itself.
Therefore, the WiScope® OM Endoscope System falls under the category of a surgical or procedural device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.
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.
Product codes (comma separated list FDA assigned to the subject device)
FBN, FGB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS
Anatomical Site
urinary tract and the kidney, and the pancreaticobiliary system including the hepatic ducts and the common bile duct.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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: 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.
Clinical Test Conclusion: No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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
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/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
2
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.
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.
| 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 and | ||
| Choledochoscope System (DUR®-D) | K060269 | FBN, FGB |
6. 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.
4
OTU Medical Inc. 2231A Fortune Drive, San Jose, CA 95131
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.
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.
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.
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 Endoscope | ||
| System | WiScope™ Digital | ||
| Endoscope System | ACMI® DUR-Digital | ||
| Ureteroscope and | |||
| Choledochoscope | |||
| System (DUR®-D) | |||
| 510(K) | |||
| Submitter | OTU Medical Inc. | OTU Medical Inc. | ACMI Corporation |
| 510(K) | |||
| Number | / | K181977 | K060269 |
| Classification | |||
| Regulation | 21CRF 876.1500 | 21CRF 876.1500 | 21CRF 876.1500 |
| Classification | |||
| and Code | Class II, | ||
| FGB, FBN | Class II, | ||
| FGB | Class II, | ||
| FGB, FBN | |||
| Common | |||
| name | Choledochoscope and | ||
| Accessories, Flexible/rigid | Ureteroscope and | ||
| Accessories, | |||
| Flexible/rigid | Choledochoscope and | ||
| Accessories, | |||
| Flexible/rigid | |||
| Ureteroscope | Single-Use | Single-Use | Reuse |
| Intended Use | WiScope® OM Endoscope | ||
| System is intended to be | |||
| used by physicians to access, | |||
| visualize, and perform | |||
| procedures in the urinary | |||
| tract and the kidney. | WiScope™ Digital | ||
| Endoscope System is | |||
| intended to be used by | |||
| physicians to access, | |||
| visualize, and perform | |||
| procedures in the urinary | The ACMI instrument | ||
| system (which includes | |||
| the DUR-Digital Invisio | |||
| Flexible Ureteroscope, | |||
| Choledochoscope, and | |||
| IDC Invisio Digital | |||
| 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. | 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. | Controller) is intended | ||
| for use to examine | |||
| body cavities, hollow | |||
| organs and canals in | |||
| the body, in the urinary | |||
| tract, and can be used | |||
| percutaneously to | |||
| examine the interior of | |||
| the kidney; and using | |||
| additional accessories, | |||
| can be used to perform | |||
| various diagnostic | |||
| and therapeutic | |||
| procedures. | |||
| The DUR-D System is | |||
| also indicated for the | |||
| examination of bile | |||
| ducts, and using | |||
| additional accessories, | |||
| to perform various | |||
| diagnostic and | |||
| therapeutic procedures | |||
| during | |||
| cholecystectomy. | |||
| Digital video | |||
| technology | CMOS | CMOS | CMOS |
| Illumination | LED | LED | LED |
| Field of View | |||
| (Diagonal) | 100° | 100° | 80° |
| Working | |||
| Length (mm) | 670 | 670 | 650 |
| Outer Shaft | |||
| Diameter | 8.6Fr | 8.6Fr | 9.3Fr |
| Working | |||
| Channel | |||
| Diameter | |||
| (Fr) | 3.6Fr | 3.6Fr | 3.6Fr |
| Up/Down | |||
| Deflection | UP: 275° | ||
| DOWN: 275° | UP: 275° | ||
| DOWN: 275° | UP: 250° | ||
| DOWN: 250° | |||
| Direction of | |||
| View | 0° | 0° | 9° |
| Brightness | |||
| Control | Yes | Yes | Yes |
| White | Yes | Yes | No |
| USB/AV/HDMI | USB/AV/HDMI | USB/AV | |
| Balance | |||
| Output | |||
| Formats | USB/AV/HDMI | USB/AV/HDMI | USB/AV |
| Image/Video | |||
| Capture | No | No | Yes |
| Camera Head | |||
| Configurable | Yes | Yes | Yes |
| Sterilization | EO | ||
| SAL: 10-6 | EO | ||
| SAL: 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 and | |||
| Labeling | Meet FDA's Requirements | Meet FDA's Requirements | Meet FDA's Requirements |
| Safety | |||
| Testing | *AAMI / ANSI | ||
| ES60601-1:2012 | |||
| *AAMI / ANSI / IEC 60601-1-2:2014 | |||
| *IEC 60601-2-18:2009 | |||
| *AAMI / ANSI / ISO 10993-5:2009 | |||
| *ISO 10993-10:2010 | |||
| *ISO 11135:2014 | |||
| *ISO 10993-7:2008 | |||
| *ISO 11607-1:2019 | |||
| *ASTM F1980-16 | |||
| *ISO 11737-2:2019 | |||
| *ASTM D3078-2013 | |||
| *ASTM F1929-15 | |||
| *DIN 58953-6:2010 | |||
| *ASTM F88/F88M-15 | |||
| *ISO 8600-1-2015 | |||
| *ISO 8600-3-2019 | |||
| *ISO 8600-4-2014 | |||
| *ISO 8600-6-2005 | *AAMI / ANSI | ||
| ES60601-1:2012 | |||
| *AAMI / ANSI / IEC 60601-1-2:2014 | |||
| *IEC 60601-2-18:2009 | |||
| *AAMI / ANSI / ISO 10993-5:2009 | |||
| *ISO 10993-10:2010 | |||
| *ISO 11135:2014 | |||
| *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 8600-4-2014 | |||
| *ISO 8600-6-2005 | *IEC 60601:1995 | ||
| *IEC 60601-1-2:2004 | |||
| *IEC 60601-2-18:2000 | |||
| *UL 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 |
5
6
OTU Medical Inc. 2231A Fortune Drive, San Jose, CA 95131
7
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.