(62 days)
Not Found
No
The document describes a standard video endoscope system with image processing capabilities, but there is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on the hardware components and basic image processing for visualization.
Yes
The device is described as being for "diagnosis and treatment" of the gastrointestinal tract, which indicates therapeutic intent.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for endoscopic examination, diagnosis and treatment".
No
The device description explicitly lists multiple hardware components including a video colonoscope, image processor, light source, and monitor, in addition to software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the system is for "endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract." This involves direct visualization and intervention within the body.
- Device Description: The description details a system for capturing and processing images from within the body using an endoscope.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. This device does not perform such analysis on specimens.
The device is a medical device used for in vivo (within the body) examination and procedures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NWB, FDF, FDS
Device Description
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.
The VLS-55 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper and lower gastrointestinal tract (including the esophagus, stomach, duodenum, anus, rectum, colon and ileocecal segment)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Not Found
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.
0
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
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 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
2
Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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.
-
- Date of Preparation: 09/07/2022
-
- 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
-
- Identification of Proposed Device
Trade Name: HD-550 Video Endoscope System Common Name: Endoscopic Video Imaging System Primary Components and Component Models:
- Identification of Proposed Device
| HD-550
Video
| Endoscope System | EG-550 Series Video Gastroscope | EG-550, EG-550L |
|---|---|---|
| EC-550 Series Video Colonoscope | EC-550, EC-550T, | |
| EC-550L, EC-550L/T | ||
| HD-550 Series Image Processor | HD-550Exp, HD-550, HD-550Pro, | |
| HD-550S, HD-510, HD-500Plus | ||
| VLS-55 Series Light Source | VLS-55Q, VLS-55T, | |
| 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
4
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.
5
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, |
| EC-550L, EC-550L/T | |
| HD-550 Series Image Processor | HD-550Exp, HD-550, HD-550Pro, |
| HD-550S, HD-510, HD-500Plus | |
| VLS-55 Series Light Source | VLS-55Q, VLS-55T, |
| 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. -
- 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.
- Substantially Equivalent (SE) Comparison
6
| ITEM | Proposed Device | Predicate Device
K211882 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | NWB, FDF and FDS | NWB, FDF and FDS |
| Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Class | II | II |
| 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. | 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. |
| | 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. | 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. |
| | 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. | 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. |
| | 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 | 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). | 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). | 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). |
| Configuration
(primary
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
7
8
| 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) | |||||||||||||
| ×500(D)mm | 370(W)×124(H) | |||||||||||||
| ×500(D)mm | 370(W)×124(H) | |||||||||||||
| ×500(D)mm | 370(W)×124(H) | |||||||||||||
| ×500(D)mm | 370(W)×124(H) | |||||||||||||
| ×500(D)mm | 370(W)×124(H) | |||||||||||||
| ×500(D)mm | 370(W)×124(H) | |||||||||||||
| ×500(D)mm | 370(W)×124(H) | |||||||||||||
| ×500(D)mm | 370(W)×124(H) | |||||||||||||
| ×500(D)mm | 370(W)×124(H) | |||||||||||||
| ×500(D)mm | SE | |||||||||||||
| Weight | 11.1 Kg | 11.1 Kg | SE | |||||||||||
| compatible endoscope | Videoscope | Videoscope | SE | |||||||||||
| Video signal | ||||||||||||||
| 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 | ||||||||||||||
| balance | Automatically adjusted using the white balance switch. At the time of | |||||||||||||
| connection with the scope in which the scope ID is provide, | ||||||||||||||
| compensation is performed automatically | Automatically adjusted using the white balance switch. At the time of | |||||||||||||
| connection with the scope in which the scope ID is provide, | ||||||||||||||
| compensation is performed automatically | SE | |||||||||||||
| Observation | Standard | |||||||||||||
| color | ||||||||||||||
| char | ||||||||||||||
| output | Color bar image | Color bar image | ||||||||||||
| color tone | ||||||||||||||
| adjustment | Red: ±15 steps, Blue: ±15 steps, chroma: ±15 steps | Red: ±15 steps, Blue: ±15 steps, chroma: ±15 steps | SE | |||||||||||
| automatic | ||||||||||||||
| gain control | Provided | Provided | SE | |||||||||||
| Image | ||||||||||||||
| enhancement | Edge enhancement | |||||||||||||
| Structure enhancement | Edge enhancement | |||||||||||||
| 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 | ||||||||||||||
| Color enhancement | Contrast enhancement | |||||||||||||
| Color enhancement | ||||||||||||||
| IRIS mode | ||||||||||||||
| selection | Peak/AVE/Auto photometry mode | Peak/AVE/Auto photometry mode | SE | |||||||||||
| Zoom | 1.0 - 4.0 | 1.0 - 4.0 | SE | |||||||||||
| Imaging | ||||||||||||||
| modes | White light (WL) imaging mode, Enhanced white light (EWL) imaging | |||||||||||||
| mode, Spectral focused (SFI mode) imaging mode and Intelligent | ||||||||||||||
| staining technology mode (VIST mode)NOTE | White light (WL) imaging mode, Enhanced white light (EWL) imaging | |||||||||||||
| mode, Spectral focused (SFI mode) imaging mode and Intelligent | ||||||||||||||
| 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
9
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 | |||||||||
| view | 140° | 140° | 140° | 140° | 140° | 140° | 140° | 140° | SE |
| Depth of | |||||||||
| focus | 3-100mm | 3-100mm | 3-100mm | 3-100mm | 3-100mm | 3-100mm | 3-100mm | 3-100mm | SE |
| Front | |||||||||
| view | 0° | 0° | 0° | 0° | 0° | 0° | 0° | 0° | SE |
| Sensor | |||||||||
| 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
10
| 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 | |||||||||
| end outer | |||||||||
| diameter | 12mm | 12mm | 12.9mm | 12.9mm | 12mm | 12mm | 12.9mm | 12.9mm | SE |
| Insert | |||||||||
| section | |||||||||
| outer | |||||||||
| diameter | 12.5mm | 12.5mm | 12.9mm | 12.9mm | 12.5mm | 12.5mm | 12.9mm | 12.9mm | SE |
| Bend | |||||||||
| angle | UP:180° | ||||||||
| DOWN:180° | |||||||||
| RIGHT:160° | |||||||||
| LEFT:160°" | UP:180° | ||||||||
| DOWN:180° | |||||||||
| RIGHT:160° | |||||||||
| LEFT:160° | UP:180° | ||||||||
| DOWN:180° | |||||||||
| RIGHT:160° | |||||||||
| LEFT:160° | UP:180° | ||||||||
| DOWN:180° | |||||||||
| RIGHT:160° | |||||||||
| LEFT:160° | UP:180° | ||||||||
| DOWN:180° | |||||||||
| RIGHT:160° | |||||||||
| LEFT:160°" | UP:180° | ||||||||
| DOWN:180° | |||||||||
| RIGHT:160° | |||||||||
| LEFT:160° | UP:180° | ||||||||
| DOWN:180° | |||||||||
| RIGHT:160° | |||||||||
| LEFT:160° | UP:180° | ||||||||
| DOWN:180° | |||||||||
| RIGHT:160° | |||||||||
| LEFT:160° | SE | ||||||||
| Insertion | |||||||||
| section | |||||||||
| length | 1350mm | 1700mm | 1350mm | 1700mm | 1350mm | 1700mm | 1350mm | 1700mm | SE |
| Total | |||||||||
| length | 1700mm | 2050mm | 1700mm | 2050mm | 1700mm | 2050mm | 1700mm | 2050mm | SE |
| Biopsy | |||||||||
| channel | |||||||||
| inner | |||||||||
| 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 | |||||
| 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 | |||||
| outer | |||||
| diameter | 9.3mm | 9.8mm | 9.3mm | 9.8mm | SE |
| Insertion | |||||
| section outer | |||||
| diameter | 9.3mm | 9.8mm | 9.3mm | 9.8mm | SE |
| Bend angle | UP:210° | ||||
| DOWN:90° | |||||
| RIGHT:100° | |||||
| LEFT:100° | UP:210° | ||||
| DOWN:90° | |||||
| RIGHT:100° | |||||
| LEFT:100° | UP:210° | ||||
| DOWN:90° | |||||
| RIGHT:100° | |||||
| LEFT:100° | UP:210° | ||||
| DOWN:90° | |||||
| RIGHT:100° | |||||
| LEFT:100° | SE | ||||
| Insertion | |||||
| section length | 1050mm | 1050mm | 1050mm | 1050mm | SE |
| Total length | 1400mm | 1400mm | 1400mm | 1400mm | SE |
| Biopsy | |||||
| channel inner | |||||
| diameter | 2.8mm | 3.2mm | 2.8mm | 3.2mm | SE |
Table 4 Specifications Comparison of Video Gastroscope
12
| ITEM | VLS-55 Series Light
Source | VLS-55 Series Light
Source (K211882) | Remark |
|--------------------------------|-------------------------------|-----------------------------------------|--------|
| Power supply | AC 100-240V
50Hz/60Hz | AC 100-240V
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
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
HD-550 Video Endoscope System | Predicate Device
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
requirements | Comply with IEC 60601-2-18 | Comply with IEC 60601-2-18 | SE | | |
| Product
Performance | Comply with ISO 8600-1 and ISO 8600-7 | Comply with ISO 8600-1 and ISO 8600-7 | SE | | |
| Patient-contact
component and
material | Insertion
section | PU, fluoroelastomer | Insertion
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
Sensitization, ISO 10993-10
Irritation, ISO 10993-10 | Cytotoxicity, ISO 10993-5
Sensitization, ISO 10993-10
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.