The HD-550 video endoscope system, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract. The EG-550 Series Video Gastroscope has been designed to be used with the image processor. Iight source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum). The EC-550 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment). The HD-550 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording. The VLS-55 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.
Device Story
HD-550 Video Endoscope System is a flexible, direct-viewing endoscopic imaging system. It captures visual data from the upper and lower GI tract via a video gastroscope or colonoscope. The system includes an image processor, light source, and monitor. The processor transforms raw sensor data into video output for real-time observation, diagnosis, and treatment by physicians. It features image enhancement modes (WL, EWL, SFI, VIST) and auto-white balance. The device is used in clinical settings by trained medical professionals. Output is displayed on a monitor to assist in clinical decision-making during endoscopic procedures. The system supports video recording to memory cards. The current submission adds an automatic sterilization method to the previously cleared components.
Clinical Evidence
No clinical data included. Bench testing only.
Technological Characteristics
System comprises flexible video endoscopes (EG-550/EC-550 series), image processor, and LED light source. Materials include PU, fluoroelastomer, PEEK, sapphire crystal, SUS 304, and epoxy resin. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 8600-1, and ISO 8600-7. Biocompatibility per ISO 10993-5 and ISO 10993-10. Imaging modes: WL, EWL, SFI, VIST.
Indications for Use
Indicated for endoscopic examination, diagnosis, and treatment of the upper and lower gastrointestinal tract in patients requiring such procedures.
Regulatory Classification
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 8, 2022
Sonoscape Medical Corp. Toki Wu Regulatory Affairs Manager Room 201 & 202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nansha Shenzhen, Guangdong 51857 CHINA
Re: K222020
> Trade/Device Name: HD-550 Video Endoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NWB, FDF, FDS Dated: July 1, 2022 Received: July 8, 2022
Dear Toki Wu:
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 medical devices and radiation-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)
K222020
Device Name HD-550 Video Endoscope System
## Indications for Use (Describe)
### HD-550 Video Endoscope System
The HD-550 video endoscope system, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract.
### EG-550 Series Video Gastroscope
The EG-550 Series Video Gastroscope has been designed to be used with the image processor. Iight source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).
### EC-550 Series Video Colonoscope
The EC-550 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).
### HD-550 Series Image Processor
The HD-550 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.
## VLS-55 Series Light Source
The VLS-55 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# Tab #6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
- 1. Date of Preparation: 09/07/2022
- 2. Sponsor Identification
#### SONOSCAPE MEDICAL CORP.
Room 201 & 202, 12 th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2 nd Road, Yuehai Subdistrict, Nanshan District, Shenzhen, 518057, Guangdong, China Establishment Registration Number: 3004705634
Contact Person: Toki Wu Position: Regulatory Affairs Manager Tel: +86-755-26722890 Fax: +86-755-26722850 Email: ra@sonoscape.net
- 3. Identification of Proposed Device
Trade Name: HD-550 Video Endoscope System Common Name: Endoscopic Video Imaging System Primary Components and Component Models:
| HD-550<br>Video<br>Endoscope System | EG-550 Series Video Gastroscope | EG-550, EG-550L |
|-------------------------------------|---------------------------------|--------------------------------------------------------------|
| | EC-550 Series Video Colonoscope | EC-550, EC-550T,<br>EC-550L, EC-550L/T |
| | HD-550 Series Image Processor | HD-550Exp, HD-550, HD-550Pro,<br>HD-550S, HD-510, HD-500Plus |
| | VLS-55 Series Light Source | VLS-55Q, VLS-55T,<br>VLS-51T, VLS-51D |
Regulatory Information
Classification Name: Endoscope and accessories
Classification: II
Product Code: NWB, FDF and FDS
Regulation Number: 21 CFR 876.1500
Review Panel: Gastroenterology/Urology
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Indications for Use:
#### HD-550 Video Endoscope System
The HD-550 video endoscope system, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract.
#### EG-550 Series Video Gastroscope
The EG-550 Series Video Gastroscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).
#### EC-550 Series Video Colonoscope
The EC-550 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).
#### HD-550 Series Image Processor
The HD-550 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.
#### VLS-55 Series Light Source
The VLS-55 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.
#### Device Description 4.
The proposed device, HD-550 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices.
HD-550 Video Endoscope System can be offered in several configurations with the options of different models of primary components.
The EG-550 Series Video Gastroscope/ EC-550 Series Video Colonoscope is the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract.
The HD-550 Series Image Processor is a video processing system which is designed to be used with endoscopes, light source, monitor of the proposed system. Apart from the image processing functions, it also provides power supply for the endoscopes.
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The VLS-55 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.
- Identification of Predicate Device ડ.
510(k) Number: K211882
Product Name: HD-550 Video Endoscope System.
Primary Components and Component Models:
| EG-550 Series Video Gastroscope | EG-550, EG-550L |
|---------------------------------|--------------------------------------------------------------|
| EC-550 Series Video Colonoscope | EC-550, EC-550T,<br>EC-550L, EC-550L/T |
| HD-550 Series Image Processor | HD-550Exp, HD-550, HD-550Pro,<br>HD-550S, HD-510, HD-500Plus |
| VLS-55 Series Light Source | VLS-55Q, VLS-55T,<br>VLS-51T, VLS-51D |
#### 6. Non-Clinical Test Conclusion
The proposed device (HD-550 Video Endoscope System) is the same as the predicate device (K211882), including HD-550 Series Image Processor, VLS-55 Series Light Source, EG-550 Series Video Gastroscope and EC-550 Series Video Colonoscope.
The modification, adding an automatic sterilization method to the cleared EG-550 Series Video Gastroscope (K211882) and EC-550 Series Video Colonoscope (K211882), doesn't affect the electrical safety and performance of proposed device, so the tests about electrical safety and performance of proposed device weren't conducted repeatedly. Liquid chemical sterilization test reports were submitted to support the reprocessing change in the labeling.
- Clinical Test Conclusion 7.
No clinical study is included in this submission.
- 8. Substantially Equivalent (SE) Comparison
The whole system and components of the proposed device is the same as its predicate device in indication for use and specification. Comparisons between the proposed device and predicate device are shown in Table 1 to Table 6.
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| ITEM | Proposed Device | Predicate Device<br>K211882 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | NWB, FDF and FDS | NWB, FDF and FDS |
| Regulation<br>Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Class | II | II |
| Indications for<br>Use | HD-550 Video Endoscope System<br>The HD-550 video endoscope system,<br>which includes a video gastroscope<br>/video colonoscope, image processor,<br>light source, monitor, accessories and<br>other peripheral devices, is intended for<br>endoscopic examination, diagnosis and<br>treatment of the upper and lower<br>gastrointestinal tract. | HD-550 Video Endoscope System<br>The HD-550 video endoscope system,<br>which includes a video gastroscope<br>/video colonoscope, image processor,<br>light source, monitor, accessories and<br>other peripheral devices, is intended for<br>endoscopic examination, diagnosis and<br>treatment of the upper and lower<br>gastrointestinal tract. |
| | VLS-55 Series Light Source,<br>The VLS-55 Series Light Source has<br>been designed to be used with the<br>endoscope, image processor and other<br>peripheral devices for endoscopic<br>observation, diagnosis and treatment. | VLS-55 Series Light Source,<br>The VLS-55 Series Light Source has<br>been designed to be used with the<br>endoscope, image processor and other<br>peripheral devices for endoscopic<br>observation, diagnosis and treatment. |
| | HD-550 Series Image Processor,<br>The HD-550 Series Image Processor<br>has been designed to be used with the<br>endoscope, light source, monitor and<br>other peripheral devices for endoscopic<br>observation, diagnosis, treatment, and<br>video recording. | HD-550 Series Image Processor,<br>The HD-550 Series Image Processor<br>has been designed to be used with the<br>endoscope, light source, monitor and<br>other peripheral devices for endoscopic<br>observation, diagnosis, treatment, and<br>video recording. |
| | EG-550 Series Video Gastroscope<br>The EG-550 Series Video Gastroscope<br>has been designed to be used with the<br>image processor, light source, monitor<br>and other peripheral devices for<br>endoscopic observation, diagnosis and<br>treatment of the upper digestive tract<br>(including the esophagus stomach and | EG-550 Series Video Gastroscope<br>The EG-550 Series Video Gastroscope<br>has been designed to be used with the<br>image processor, light source, monitor<br>and other peripheral devices for<br>endoscopic observation, diagnosis and<br>treatment of the upper digestive tract<br>(including the esophagus stomach and |
| | duodenum). | duodenum). |
| | EC-550 Series Video Colonoscope<br>The EC-550 Series Video Colonoscope<br>has been designed to be used with the<br>image processor, light source, monitor<br>and other peripheral devices for<br>endoscopic observation, diagnosis and<br>treatment of the lower digestive tract<br>(including the anus, rectum, colon and<br>ileocecal segment). | EC-550 Series Video Colonoscope<br>The EC-550 Series Video Colonoscope<br>has been designed to be used with the<br>image processor, light source, monitor<br>and other peripheral devices for<br>endoscopic observation, diagnosis and<br>treatment of the lower digestive tract<br>(including the anus, rectum, colon and<br>ileocecal segment). |
| Configuration<br>(primary<br>components) | Light Source | Light Source |
| | Image processor | Image processor |
| | Video Gastroscope | Video Gastroscope |
| | Video Colonoscope | Video Colonoscope |
| | Accessories and peripheral devices | Accessories and peripheral devices |
Table 1 General Comparison
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| | Proposed Device | | | | | | Predicate device (K211882) | | | | | | Remark | |
|---------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------|----------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------|----------------------------|----------------------------|----------------------------|--------|
| ITEM | Model | HD-550Exp | HD-550 | HD-550Pro | HD-550S | HD-510 | HD-500Plus | HD-550Exp | HD-550 | HD-550Pro | HD-550S | HD-510 | HD-500Plus | / |
| | Power supply | 100-240V AC, 50/60Hz | | | | | 100-240V AC, 50/60Hz | | | | | | SE | |
| | Over-current protection | Fuse type | | | | | Fuse type | | | | | | SE | |
| | Size | 370(W)×124(H)<br>×500(D)mm | | 370(W)×124(H)<br>×500(D)mm | 370(W)×124(H)<br>×500(D)mm | 370(W)×124(H)<br>×500(D)mm | 370(W)×124(H)<br>×500(D)mm | 370(W)×124(H)<br>×500(D)mm | | 370(W)×124(H)<br>×500(D)mm | 370(W)×124(H)<br>×500(D)mm | 370(W)×124(H)<br>×500(D)mm | 370(W)×124(H)<br>×500(D)mm | SE |
| | Weight | 11.1 Kg | | | | | 11.1 Kg | | | | | | SE | |
| | compatible endoscope | Videoscope | | | | | Videoscope | | | | | | SE | |
| | Video signal<br>output | DVI (high definition) | | | | | DVI (high definition) | | | | | | SE | |
| | | VGA (high definition) | | | | | VGA (high definition) | | | | | | | |
| | | SDI (high definition) | | | | | SDI (high definition) | | | | | | | |
| | | CVBS (standard definition) | | | | | CVBS (standard definition) | | | | | | | |
| | | S-Video (standard definition) | | | | | S-Video (standard definition) | | | | | | | |
| | Auto white<br>balance | Automatically adjusted using the white balance switch. At the time of<br>connection with the scope in which the scope ID is provide,<br>compensation is performed automatically | | | | | Automatically adjusted using the white balance switch. At the time of<br>connection with the scope in which the scope ID is provide,<br>compensation is performed automatically | | | | | | SE | |
| | | Observation | Standard<br>color<br>char<br>output | Color bar image | | | | | Color bar image | | | | | |
| color tone<br>adjustment | Red: ±15 steps, Blue: ±15 steps, chroma: ±15 steps | | | | | Red: ±15 steps, Blue: ±15 steps, chroma: ±15 steps | | | | | | SE | | |
| automatic<br>gain control | Provided | | | | | Provided | | | | | SE | | | |
| | Image<br>enhancement | Edge enhancement<br>Structure enhancement | | | | | Edge enhancement<br>Structure enhancement | | | | | SE | | |
| ITEM | | Proposed Device | | | | | | Predicate device (K211882) | | | | | | Remark |
| | Model | HD-550Exp | HD-550 | HD-550Pro | HD-550S | HD-510 | HD-500Plus | HD-550Exp | HD-550 | HD-550Pro | HD-550S | HD-510 | HD-500Plus | / |
| | | Contrast enhancement<br>Color enhancement | | | | | | Contrast enhancement<br>Color enhancement | | | | | | |
| | IRIS mode<br>selection | Peak/AVE/Auto photometry mode | | | | | | Peak/AVE/Auto photometry mode | | | | | | SE |
| | Zoom | 1.0 - 4.0 | | | | | | 1.0 - 4.0 | | | | | | SE |
| | Imaging<br>modes | White light (WL) imaging mode, Enhanced white light (EWL) imaging<br>mode, Spectral focused (SFI mode) imaging mode and Intelligent<br>staining technology mode (VIST mode)NOTE | | | | | | White light (WL) imaging mode, Enhanced white light (EWL) imaging<br>mode, Spectral focused (SFI mode) imaging mode and Intelligent<br>staining technology mode (VIST mode)NOTE | | | | | | SE |
| | | Foot switch connector | Provided | | | | | | Provided | | | | | |
| | record to memory card | Provided | | | | | | Provided | | | | | | SE |
Table 2 Specifications Comparison of Image Processor
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NOTE:
The prospective clinical value of the enhanced imaging modes has not been demonstrated, and no clinical claims are made.
| ITEM | Proposed device | | | | Predicate device (K211882) | | | | Remark |
|-------------------|-----------------|------------|------------|------------|----------------------------|------------|------------|------------|--------|
| Model | EC-550 | EC-550T | EC-550L | EC-550L/T | EC-550 | EC-550T | EC-550L | EC-550L/T | / |
| Field of<br>view | 140° | 140° | 140° | 140° | 140° | 140° | 140° | 140° | SE |
| Depth of<br>focus | 3-100mm | 3-100mm | 3-100mm | 3-100mm | 3-100mm | 3-100mm | 3-100mm | 3-100mm | SE |
| Front<br>view | 0° | 0° | 0° | 0° | 0° | 0° | 0° | 0° | SE |
| Sensor<br>type | color CMOS | color CMOS | color CMOS | color CMOS | color CMOS | color CMOS | color CMOS | color CMOS | SE |
Table 3 Specifications Comparison of Video Colonoscope
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| ITEM | Proposed device | | | | Predicate device (K211882) | | | | Remark |
|----------------------------------------|--------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|--------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|--------|
| Model | EC-550 | EC-550T | EC-550L | EC-550L/T | EC-550 | EC-550T | EC-550L | EC-550L/T | |
| Distal<br>end outer<br>diameter | 12mm | 12mm | 12.9mm | 12.9mm | 12mm | 12mm | 12.9mm | 12.9mm | SE |
| Insert<br>section<br>outer<br>diameter | 12.5mm | 12.5mm | 12.9mm | 12.9mm | 12.5mm | 12.5mm | 12.9mm | 12.9mm | SE |
| Bend<br>angle | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160°" | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160° | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160° | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160° | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160°" | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160° | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160° | UP:180°<br>DOWN:180°<br>RIGHT:160°<br>LEFT:160° | SE |
| Insertion<br>section<br>length | 1350mm | 1700mm | 1350mm | 1700mm | 1350mm | 1700mm | 1350mm | 1700mm | SE |
| Total<br>length | 1700mm | 2050mm | 1700mm | 2050mm | 1700mm | 2050mm | 1700mm | 2050mm | SE |
| Biopsy<br>channel<br>inner<br>diameter | \$\geq\$ 3.8mm | \$\geq\$ 3.8mm | \$\geq\$ 4.2mm | \$\geq\$ 4.2mm | \$\geq\$ 3.8mm | \$\geq\$ 3.8mm | \$\geq\$ 4.2mm | \$\geq\$ 4.2mm | SE |
{11}------------------------------------------------
| ITEM | Proposed device | | Predicate device (K211882) | | Remark |
|----------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|--------|
| Model | EG-550 | EG-550L | EG-550 | EG-550L | / |
| Field of view | 140° | 140° | 140° | 140° | SE |
| Depth of<br>focus | 3-100mm | 3-100mm | 3-100mm | 3-100mm | SE |
| Front view | 0° | 0° | 0° | 0° | SE |
| Sensor type | color CMOS | color CMOS | color CMOS | color CMOS | SE |
| Distal end<br>outer<br>diameter | 9.3mm | 9.8mm | 9.3mm | 9.8mm | SE |
| Insertion<br>section outer<br>diameter | 9.3mm | 9.8mm | 9.3mm | 9.8mm | SE |
| Bend angle | UP:210°<br>DOWN:90°<br>RIGHT:100°<br>LEFT:100° | UP:210°<br>DOWN:90°<br>RIGHT:100°<br>LEFT:100° | UP:210°<br>DOWN:90°<br>RIGHT:100°<br>LEFT:100° | UP:210°<br>DOWN:90°<br>RIGHT:100°<br>LEFT:100° | SE |
| Insertion<br>section length | 1050mm | 1050mm | 1050mm | 1050mm | SE |
| Total length | 1400mm | 1400mm | 1400mm | 1400mm | SE |
| Biopsy<br>channel inner<br>diameter | 2.8mm | 3.2mm | 2.8mm | 3.2mm | SE |
Table 4 Specifications Comparison of Video Gastroscope
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| ITEM | VLS-55 Series Light<br>Source | VLS-55 Series Light<br>Source (K211882) | Remark |
|--------------------------------|-------------------------------|-----------------------------------------|--------|
| Power supply | AC 100-240V<br>50Hz/60Hz | AC 100-240V<br>50Hz/60Hz | SE |
| Over-current protection | Fuse type | Fuse type | SE |
| Input current | 300VA | 300VA | SE |
| Examination lamp | 50W LED | 50W LED | SE |
| Average lamp life | 50000 hours | 50000 hours | SE |
| Emergency lamp | 14W LED | 14W LED | SE |
| Average emergency<br>lamp life | 50000 hours | 50000 hours | SE |
| Brightness control | Automatic and manual | Automatic and manual | SE |
| Automatic exposure | 19 steps | 19 steps | SE |
| System connector | Provided | Provided | SE |
| Foot switch connector | Provided | Provided | SE |
| CV connector | Provided | Provided | SE |
Table 5 Specifications Comparison of Light Source
Table 6 Safety Comparison
| ITEM | Proposed Device<br>HD-550 Video Endoscope System | Predicate Device<br>HD-550 Video Endoscope System (K211882) | Remark | | |
|----------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------|--------------------------------|----|
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE | | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE | | |
| Particular<br>requirements | Comply with IEC 60601-2-18 | Comply with IEC 60601-2-18 | SE | | |
| Product<br>Performance | Comply with ISO 8600-1 and ISO 8600-7 | Comply with ISO 8600-1 and ISO 8600-7 | SE | | |
| Patient-contact<br>component and<br>material | Insertion<br>section | PU, fluoroelastomer | Insertion<br>section | PU, fluoroelastomer | SE |
| | Distal end | PEEK, Sapphire crystal SUS 304 | Distal end | PEEK, Sapphire crystal SUS 304 | |
| | Adhesive | Epoxy resin | Adhesive | Epoxy resin | |
| Biocompatibility | Cytotoxicity, ISO 10993-5<br>Sensitization, ISO 10993-10<br>Irritation, ISO 10993-10 | Cytotoxicity, ISO 10993-5<br>Sensitization, ISO 10993-10<br>Irritation, ISO 10993-10 | SE | | |
#### 9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis in section 8, the proposed device and the predicate device have the same intended use, product specification and optical performance. Therefore, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
