(253 days)
HD-500 Video Endoscope System
The HD-500 Video Endoscope System, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopies examination, diagnosis and treatment of the disease of the upper and lower gastrointestinal tract.
HDL-500 Series Light Source, HDL-500E, HDL-500X
The HDL-500 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-500 Series Image Processor, HD-500, HD-500S, HD-330Plus
The HD-500 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-500 Series Video Gastroscope, EG-500, EG-500L
The EG-500 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-500 Series Video Colonoscope, EC-500, EC-500T, EC-500L, EC-500L/T
The EC-500 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 proposed device, HD-500 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices.
HD-500 Video Endoscope System can be offered in several configurations with the options of different models of primary components
The EG-500 Series Video Gastroscope/ EC-500 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-500 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 HDL-500 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.
The provided text is a 510(k) summary for the HD-500 Video Endoscope System. It describes the device, its intended use, and a comparison to a predicate device (EVIS EXERA II 180 System) to demonstrate substantial equivalence.
However, this document does not describe a study that proves the device meets specific acceptance criteria related to AI or a "human-in-the-loop" performance study. The entire document focuses on non-clinical tests and a comparison to a predicate device to establish substantial equivalence for a medical endoscope system, which is a hardware device, not an AI/software as a medical device (SaMD).
Here's a breakdown of why the requested information cannot be fully provided from the given document:
- No AI Component: The document clearly describes a traditional video endoscope system, including gastroscopes, colonoscopes, image processors, and light sources. There is no mention of any artificial intelligence, machine learning, or software for diagnosis/analysis.
- No Clinical Study for Performance Benchmarking: The document explicitly states: "No clinical study is included in this submission." (Page 6, Section 7). This means there is no data on human-in-the-loop performance, MRMC studies, or standalone algorithm performance.
- Focus on Substantial Equivalence: The entire submission is built around demonstrating that the new device is "substantially equivalent" to an existing, legally marketed predicate device. This is primarily done through feature-by-feature comparison and non-clinical engineering tests (electrical safety, EMC, optical performance, physical/functional performance, imaging performance) against established standards (IEC, ISO).
Therefore, I cannot populate the table or answer most of your specific questions related to AI acceptance criteria, data provenance, expert ground truth establishment, MRMC studies, or training sets. The document simply doesn't contain that information.
What the document does provide in terms of "acceptance criteria" and "performance" (though not AI-related):
The "acceptance criteria" in this context are the standards and benchmarks the device needs to meet to be considered safe and effective and "substantially equivalent" to predicate devices. These are primarily engineering and technical specifications.
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Traditional Device Focus)
| Acceptance Criteria (Standards/Benchmarks) | Reported Device Performance (Compliance/Comparison) |
|---|---|
| Safety Standards (General) | |
| IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012 (Medical Electrical Equipment - Basic Safety & Essential Performance), including US National Differences | Complies (Page 5, Section 6) |
| IEC 60601-1-2:2007 (EMC - Electromagnetic compatibility) | Complies (Page 5, Section 6) |
| IEC 60601-2-18:2009 (Particular requirements for endoscopic equipment) | Complies (Page 6, Section 6) |
| Biocompatibility Standards | |
| ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Complies (Page 6, Section 6); Proposed device is biocompatible and conforms to ISO 10993 series standards (Page 18, SE Analysis 19). |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Complies (Page 6, Section 6); Proposed device is biocompatible and conforms to ISO 10993 series standards (Page 18, SE Analysis 19). |
| Product Performance Standards | |
| ISO 8600-1:2015 (Endoscopes - General requirements) | Complies (Page 6, Section 6); Field of view for video colonoscope meets requirements (Page 15, SE Analysis 12). |
| ISO 8600-7:2012 (Endoscopes - Water-resistant type) | Complies (Page 6, Section 6) |
| Optical Performance (Comparison to Predicate) | |
| Resolution (vs. Predicate) | Test results satisfactory and "Substantially Equivalent" (Page 6, Section 6) |
| Depth of field (vs. Predicate) | Test results satisfactory and "Substantially Equivalent" (Page 6, Section 6) |
| Optical magnification and distortion (vs. Predicate) | Test results satisfactory and "Substantially Equivalent" (Page 6, Section 6) |
| Image intensity uniformity (vs. Predicate) | Test results satisfactory and "Substantially Equivalent" (Page 6, Section 6) |
| Physical/Functional Performance (Overall System) | |
| Angulation/Deflection maintenance | Demonstrated ability to maintain maximum angulation/deflection (Page 6, Section 6) |
| Appearance visual inspection and handle strength inspection | Testing conducted, results satisfactory (Page 6, Section 6) |
| Image function visual inspection | Testing conducted, results satisfactory (Page 6, Section 6) |
| Sealing performance | Testing conducted, results satisfactory (Page 6, Section 6) |
| Maximum bending angle measurement and body model testing | Testing conducted, results satisfactory (Page 6, Section 6) |
| Imaging Performance (Lifetime Use) | |
| Degradation of imaging performance over lifetime | Degradations are "very little which will not affect the normal use of the endoscope" (Page 6, Section 6) |
| Functional Equivalence (Comparison with Predicate Device Features) | |
| Indications for Use | Identical to predicate device (Page 7, Table 1; Page 8, SE Analysis 1) |
| Input Current (Image Processor) | Similar to predicate; complies with IEC 60601-1 (Page 9, Table 2; Page 10, SE Analysis 2) |
| Size and Weight (Image Processor) | Different from predicate, but "will not affect the safety and effectiveness" (Page 9, Table 2; Page 11, SE Analysis 3) |
| Video Signal Output (Image Processor) | Different types, but both offer standard and high-definition interfaces and versatility; "will not affect the safety and effectiveness" (Page 9, Table 2; Page 11, SE Analysis 4) |
| Image Enhancement (Image Processor) | More selection than predicate, offers physician more adjustment; "will not affect the safety and effectiveness" (Page 9, Table 2; Page 11, SE Analysis 5) |
| IRIS mode selection (Image Processor) | More selection than predicate; "will not affect the safety and effectiveness" (Page 9, Table 2; Page 11, SE Analysis 6) |
| Zoom (Image Processor) | Similar to predicate; "will not affect the safety and effectiveness" (Page 9, Table 2; Page 11, SE Analysis 7) |
| Imaging Modes (Image Processor) | "VIST observation mode" is substantially equivalent to predicate's "NBI modes" for clinical application purposes (Page 9, Table 2; Page 12, SE Analysis 8) |
| Sensor Type (Gastroscope/Colonoscope) | CMOS vs. predicate's CCD, but both provide high-quality images; CMOS commonly used; "does not affect the safety and effectiveness" (Page 13, Table 3; Page 15, Table 4; Page 13, SE Analysis 9) |
| Diameters (Gastroscope/Colonoscope) | Similar to predicate and meet industrial standard (Page 13, Table 3; Page 15, Table 4; Page 14, SE Analysis 10) |
| Insertion Section Length (Gastroscope/Colonoscope) | Similar to predicate (Page 13, Table 3; Page 15, Table 4; Page 14, SE Analysis 11) |
| Field of View (Colonoscope) | Different from predicate, but meets ISO 8600-1 requirements; "does not affect the safety and effectiveness" (Page 15, Table 4; Page 15, SE Analysis 12) |
| Power Supply (Light Source) | Different from predicate, but electrical safety testing demonstrates compliance with IEC 60601-1; "does not affect the safety and effectiveness" (Page 16, Table 5; Page 16, SE Analysis 13) |
| Input Current (Light Source) | HDL-500X is same as predicate; HDL-500E is different but complies with IEC 60601-1; "considered not affectiveness" (presumably 'not affecting effectiveness') (Page 16, Table 5; Page 17, SE Analysis 14) |
| Examination Lamp & Emergency Lamp (Light Source) | HDL-500X same as predicate; HDL-500E uses different common LED light source; "does not affect the safety and effectiveness" (Page 16, Table 5; Page 17, SE Analysis 15) |
| Average Lamp Life (Light Source) | HDL-500X same as predicate; HDL-500E has longer life; "does not affect the safety and effectiveness" (Page 16, Table 5; Page 17, SE Analysis 16) |
| Average Emergency Lamp Life (Light Source) | Longer than predicate; "does not affect the safety and effectiveness" (Page 16, Table 5; Page 17, SE Analysis 17) |
| Automatic Exposure (Light Source) | Both provide function; adjustable levels differ but achieve same purpose; "considered as substantial equivalence" (Page 16, Table 5; Page 17, SE Analysis 18) |
2. Sample size used for the test set and the data provenance: Not applicable. This is a non-clinical submission. The "test set" refers to the specific units of the device that underwent engineering tests (e.g., optical performance, physical performance). The data provenance is these lab tests themselves, conducted by the manufacturer (Sonoscape Medical Corp.) likely in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the AI/clinical context, is not established for this type of non-clinical device test. The "ground truth" for these tests would be the established engineering standards and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a clinical study involving human readers or interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, explicitly stated "No clinical study is included in this submission." (Page 6, Section 7). No AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, explicitly stated "No clinical study is included in this submission." (Page 6, Section 7). No AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/clinical sense. The "ground truth" for engineering tests are the industry standards (IEC, ISO) and the specifications of the predicate device for comparison.
8. The sample size for the training set: Not applicable. No AI/ML model.
9. How the ground truth for the training set was established: Not applicable. No AI/ML model.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 5, 2018
Sonoscape Medical Corp. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K173921
Trade/Device Name: HD-500 Video Endoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NWB, FDF, FDS Dated: July 13, 2018 Received: July 24, 2018
Dear Diana Hong:
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.
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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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173921
Device Name HD-500 Video Endoscope System
Indications for Use (Describe)
HD-500 Video Endoscope System
The HD-500 Video Endoscope System, which includes a video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopies examination, diagnosis and treatment of the disease of the upper and lower gastrointestinal tract.
HDL-500 Series Light Source, HDL-500E, HDL-500X
The HDL-500 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-500 Series Image Processor, HD-500, HD-500S, HD-330Plus
The HD-500 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-500 Series Video Gastroscope, EG-500, EG-500L
The EG-500 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-500 Series Video Colonoscope, EC-500, EC-500T, EC-500L, EC-500L/T
The EC-500 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).
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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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K173921
-
- Date of Preparation: 11/30/2017
-
- Sponsor Identification
SONOSCAPE MEDICAL CORP.
4/F, 5/F, 8/F, 9/F & 10/F, Yizhe Building, Yuquan Road, Nanshan, Shenzhen, 518051, Guangdong, China
Establishment Registration Number: 3004705634
Contact Person: Toki Wu Position: Regulatory Affairs Manager Tel: 0755-26722890 Fax: 0755-26722850 Email: ra@sonoscape.net
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 001-3609253199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: HD-500 Video Endoscope System
Common Name: Endoscopic Video Imaging System
Components and Component Models:
| EG-500 Series Video Gastroscope: | EG-500, EG-500L |
|---|---|
| EC-500 Series Video Colonoscope: | EC-500, EC-500T, EC-500L, EC-500L/T |
| HD-500 Series Image Processor: | HD-500, HD-500S, HD-330Plus |
| HDL-500 Series Light Source: | HDL-500E, HDL-500X |
Regulatory Information
Classification Name: Endoscope and accessories Classification: II Product Code: NWB, FDF and FDS Regulation Number: 21 CFR 876.1500 Endoscope and accessories Review Panel: Gastroenterology/Urology
Intended Use Statement:
HD-500 Video Endoscope System
The HD-500 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopies examination, diagnosis and treatment of the disease of the upper and lower gastrointestinal tract.
EG-500 Series Video Gastroscope, EG-500, EG-500L
The EG-500 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-500 Series Video Colonoscope, EC-500, EC-500T, EC-500L, EC-500L/T
The EC-500 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-500 Series Image Processor, HD-500, HD-500S, HD-330Plus
The HD-500 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.
HDL-500 Series Light Source, HDL-500E, HDL-500X
The HDL-500 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.
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Device Description
The proposed device, HD-500 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices.
HD-500 Video Endoscope System can be offered in several configurations with the options of different models of primary components
The EG-500 Series Video Gastroscope/ EC-500 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-500 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 HDL-500 Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation.
- Identification of Predicate Device న.
510(k) Number: K100584 Product Name: EVIS EXERA II 180 System Primary components and Component Models:
| EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE | OLYMPUS GIF TYPE Q180,OLYMPUS GIF TYPE H180 |
|---|---|
| EVIS EXERA II COLONOVIDEOSCOPE | OLYMPUS CF TYPE Q180ALOLYMPUS CF TYPE Q180AI |
| EVIS EXERA II VIDEO SYSTEM CENTER | OLYMPUS CV-180 |
| EVIS EXERA II XENON LIGHT SOURCE | OLYMPUS CLV-180 |
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance, including the US National Differences
-
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests
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-
IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
-
ISO 8600-1:2015 Endoscopes--Medical endoscopes and endotherapy devices - part 1: General requirements
-
ISO 8600-7:2012 Endoscopes --Medical endoscopes and endotherapy devices - part 7: Basic requirements for medical endoscopes of water-resistant type
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
Optical performance testing
The following testing was conducted to evaluate the optical performance characteristics for each endoscopic system mode.
- A Photobiological safety
- A Resolution (test results comparison between the proposed device and predicate device)
- A Depth of field (test results comparison between the proposed device and predicate device)
-
Optical magnification and distortion (test results comparison between the proposed device and predicate device)
-
Image intensity uniformity (test results comparison between the proposed device and predicate device)
Physical/functional performance testing
The endoscope performance test was conducted to evaluate the ability of proposed endoscope to maintain the maximum angulation/deflection when in use, the physical/functional performance of the proposed device, including a) Appearance visual inspection and handle strength inspection, b) Image function visual inspection, c) Sealing performance, and d) Maximum bending angle measurement and body model testing.
Imaging performance testing
The imaging performance testing was conducted to demonstrate that the imaging quality of the proposed device is still in a better condition when the device is over its lifetime of clinical use. The degradations of imaging performance are very little which will not affect the normal use of the endoscope.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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Substantially Equivalent (SE) Comparison 8.
The whole system and components of the proposed device is basically identical to its predicate device in indication for use, and similar in specification. Comparisons between the proposed device and predicate device are shown in Table 1 to Table 6.
| Table 1 General Comparison |
|---|
| Proposed device: HD-500 Video Endoscope System |
| ITEM | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | NWB, FDF and FDS | K100584 |
| RegulationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Class | II | II |
| Indicationsfor Use(SE Analysis 1) | HD-500 Video Endoscope SystemThe HD-500 Video Endoscope System, whichincludes a video gastroscope /videocolonoscope, image processor, light source,monitor, accessories and other peripheral /devices, is intended for endoscopiesexamination, diagnosis and treatment of thedisease of the upper and lower gastrointestinaltract. | EVIS EXERA II XENON LIGHTSOURCE OLYMPUS CLV-180This light source has been designedto be used with Olympusendoscopes, video system center, andother ancillary equipment forendoscopic diagnosis, treatment andvideo observation. |
| HDL-500 Series Light Source, HDL-500E,HDL-500XThe HDL-500 Series Light Source has beendesigned to be used with the endoscope,image processor and other peripheral devicesfor endoscopic observation, diagnosis andtreatment. | ||
| HD-500 Series Image Processor, HD-500,HD-500S, HD-330PlusThe HD-500 Series Image Processor has beendesigned to be used with the endoscope, lightsource, monitor and other peripheral devicesfor endoscopic observation, diagnosis,treatment, and video recording. | EVIS EXERA II VIDEO SYSTEMCENTER OLYMPUS CV-180This video system center has beendesigned to be used with OLYMPUScamera heads, endoscopes, lightsources, monitors, endo-therapyaccessories and other ancillaryequipment for endoscopic diagnosis,treatment and video observation. | |
| EG-500 Series Video Gastroscope, EG-500,EG-500I | EVIS EXERA IIGASTROINTESTINAL | |
| Configuration(primarycomponents) | The EG-500 Series Video Gastroscope hasbeen designed to be used with the imageprocessor, light source, monitor and otherperipheral devices for endoscopicobservation, diagnosis and treatment of theupper digestive tract (including theesophagus, stomach and duodenum). | VIDEOSCOPE OLYMPUS GIFTYPE Q180, OLYMPUS GIF TYPEH180These instruments have beendesigned to be used with an Olympusvideo system center, light source,documentation equipment, monitor,EndoTherapy accessories (such as abiopsy) and other ancillaryequipment for endoscopy andendoscopic surgery within the upperdigestive tract (including theesophagus, stomach, and duodenum). |
| EC-500 Series Video Colonoscope, EC-500,EC-500T, EC-500L, EC-500L/T | EVIS EXERA IICOLONOVIDEOSCOPEOLYMPUS CF TYPE Q180AL.OLYMPUS CF TYPE Q180AI. | |
| The EC-500 Series Video Colonoscope hasbeen designed to be used with the imageprocessor, light source, monitor and otherperipheral devices for endoscopicobservation, diagnosis and treatment of thelower digestive tract (including the anus,rectum, colon and ileocecal segment). | These instruments have beendesigned to be used with an Olympusvideo system center, light source,documentation equipment, monitor,EndoTherapy accessories (such as abiopsy forceps), and other ancillaryequipment for endoscopy andendoscopic surgery within the lowerdigestive tract (including the anus,rectum, sigmoid colon, colon, andileocecal valve). | |
| Light Source | Light Source | |
| Image processor | Image processor | |
| Video Gastroscope | Video Gastroscope | |
| Video Colonoscope | Video Colonoscope | |
| Accessories and peripheral devices | Accessories and peripheral devices |
Predicate device: EVIS EXERA II 180 SYSTEM
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SE Analysis 1-Indications for Use
The indications for use of proposed device is summarized for the whole video endoscope system and the primary components, the indications for use of predicate device is only summarized for the primary components. It is only the different expressions on indications for use, actually the proposed device and the predicate device have the same primary components, each of the primary component has the same intended use. Therefore, this item is considered as substantial equivalence.
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Table 2 Specifications Comparison of Image Processor Proposed device: HD-500 Series Image Processor (HD-500, HD-500S, HD-330Plus)
Predicate device: EVIS EXERA II VIDEO SYSTEM CENTER (OLYMPUS CV-180)
| ITEM | Proposed Device | Predicate Device | |||
|---|---|---|---|---|---|
| Model | HD-330Plus | HD-500 | HD-500S | OLYMPUS CV-180 | |
| Power supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz | |
| Over-current protection | Fuse type | Fuse type | Fuse type | Fuse type | |
| Input current(SE Analysis 2) | 160VA | 160VA | 160VA | 150VA | |
| Size(SE Analysis 3) | 370(W)×124(H)×455(D)mm | 370(W)×124(H)×455(D)mm | 370(W)×124(H)×455(D)mm | 383(W)×162(H)×536(D)mm | |
| Weight(SE Analysis 3) | 9.5 Kg | 9.5 Kg | 9.5 Kg | 15.4kg | |
| compatible endoscope | Videoscope | Videoscope | Videoscope | Fiber/rigid scope with camera headVideoscope | |
| Video signaloutput(SE Analysis 4) | DVI:1VGA:1Y/C:1VBS:1 | DVI:1VGA:1SDI:1Y/C:1VBS:1 | DVI:1VGA:1SDI:1Y/C:1VBS:1 | RGB:3Y/C:4VBS:4HDTV:1 | |
| Observation | Autowhitebalance | Automatically adjusted usingthe white balance switch. At thetime of connection with thescope in which the scope ID isprovide, compensation isperformed automatically | Automatically adjusted usingthe white balance switch. At thetime of connection with thescope in which the scope ID isprovide, compensation isperformed automatically | Automatically adjusted usingthe white balance switch. At thetime of connection with thescope in which the scope ID isprovide, compensation isperformed automatically | |
| Standard colorchar output | Color bar image | Color bar image | Color bar image | Color bar image | |
| Colortoneadjustment | R: ±8 steps B:±8 stepsChroma:±8 steps | R: ±8 stepsB:±8 stepsChroma:±8 steps | R: ±8 stepsB:±8 stepsChroma:±8 steps | R:±8 stepsB:±8 stepsChroma:±8 steps | |
| Automaticgain control | Provided | Provided | Provided | Provided | |
| Imageenhancement(SE Analysis 5) | Edge enhancement: [1][2][3] 3-mode selectable and each mode have 9 levels adjustable by the userStructure enhancement: [1][2][3] 3-mode selectable and each mode have 9 levels adjustable by theuserContrast enhancement: [low][med][high] 3 levels availableColor enhancement: [1][2][3] 3-mode selectable and each mode have 9 levels adjustable by the user | Edge enhancement:[off][low][med][high] 4 levelsavailablestructure enhancement:[off][low][med][high] 4 levelsavailable | |||
| IRIS modeselection(SE Analysis 6) | Peak/AVE/Autophotometry mode | Peak/AVE/Autophotometry mode | Peak/AVE/Autophotometry mode | Peak/Auto photometry mode | |
| Zoom(SE Analysis 7) | ×1.4 /×1.6/×1.8 | ×1.4 /×1.6/×1.8 | ×1.4 /×1.6/×1.8 | ×1/×1.2/×1.5 3-mode | |
| Imagingmodes(SE Analysis 8) | Common observation mode;VIST observation mode | Common observation mode;VIST observation mode | Common observation mode;VIST observation mode | White-light imaging modeNarrow Band Imaging (NBI) modes | |
| Foot switch connector | Provided | Provided | Provided | Provided | |
| record to memory card | Provided | Provided | Provided | Provided |
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SE Analysis 2-Input Current
The input current of proposed devices is similar as that of the input current proposed device comples with IEC 60601-1 standard. Therefore, this difference on input current is considered not effectiveness of the proposed device.
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SE Analysis 3-Size and Weight
The physical specifications are different between the proposed device; the difference on physical specification will not affect the safety and effectiveness of the proposed device.
SE Analysis 4-Video Signal Output
The types of video signal output are different between the difference on video signal output will not affect the safety and effectiveness of the proposed device based on the following reasons:
- a. Both the proposed system and predicate system are the high-definition endoscope system; they all have the standard -definition interface and high-definition interface. The proposed system has of the predicate system, these interfaces improve the system's versatility.
- Standard -definition interface: Y/C interface and VBC interface belong to the standard -definition interface. b.
- High-definition interface DVI interface is substantially equivalent to the HDTV interface is substantially equivalent to the RGB C. interface.
- d. SDI interface belongs to the direct output interface. The display of the monitor can be switched to SDI signal output in case of the image processor suddenly doesn't work or the system suddenly crashes.
SE Analysis 5- Image enhancement
The proposed devices provide more selection about the image enhancement; it will offer the physician to adjust the observation. This difference will not affect the safety and effectiveness of the proposed device.
SE Analysis 6- IRIS mode selection
The proposed devices provide more selection about the IRIS mode; it will offer the physician more selection. This difference will not affect the safety and effectiveness of the proposed device.
SE Analysis 7- Zoom
The zoom of image processor is similar as that of the processor. This difference will not affect the safety and effectiveness of the proposed device.
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SE Analysis 8- Imaging modes
The predicate device has both white-light inaging (NB), modes. The NBI mode selectively processes green and blue light images by filtering the white light spectum with an optical filter, and thus enhances visualization of superficial vacce also has two modes, the common observation modes. In the VIST observation mode, a dedicated light filter is insetted into the light path to filter out the light of a specific color, theress. The common observation mode of proposed device is same as the white-light imaging mode of the predicate device) and NBI technology (proposed device) and NBI technology (predicate device) are special light imaging technologies taking advantage of the extinction spectra between mucosal vessels and mucosa. Both of them utilize optical filtering and digital image processing to enhance the visibility of mucosal vesses. Although there are digital filtering parameters, leading to slight difference in the corresponding images, they are not the essential differences. VIST can still achieve the same clinical application purposes as NBI does. Therefore, the VIST observation mode of proposed device is substantially equivalent to the NBI imaging mode of the predicate device.
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Table 3 Specifications Comparison of Video Gastroscope
Proposed device: EG-500 Series Video Gastroscope
| Predicate device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS | |
|---|---|
| --------------------------------------------------------------------- | -- |
| ITEM | Proposed device | Predicate device | ||
|---|---|---|---|---|
| Model | EG-500 | EG-500L | GIF-Q180 | GIF-H180 |
| Field of view | 140° | 140° | 140° | 140° |
| Depth of focus | 3-100mm | 3-100mm | 3-100mm | 2-100mm |
| Front view | 0° | 0° | 0° | \ |
| Sensor type(SE Analysis 9) | color CMOS | color CMOS | color CCD | color CCD |
| Distal end outer diameter(SE Analysis 10) | 9.3mm | 9.8mm | 8.8mm | 9.8mm |
| Insertion section outer diameter(SE Analysis 10) | 9.3mm | 9.8mm | 8.8mm | 9.8mm |
| 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° |
| Insertion section length(SE Analysis 11) | 1050mm | 1050mm | 1030mm | 1030mm |
| Biopsy channel inner diameter(SE Analysis 10) | 2.8mm | 3.2mm | 2.8mm | 2.8mm |
SE Analysis 9- Sensor type
Although the CMOS sensor and CCD sensor have logic, but both they can provide high quality image. And the CMOS sensor has been commonly used in the endoscope systems. This difference on sensor type does not affect the safety and effectiveness of the proposed device.
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SE Analysis 10- Diameters
The Distal end outer diameter, Insertion outer diameter and Biopsy chamel inner diameter of proposed device are similar as those of the predicate device. Those diameters meet the industrial standard. Therefore, this item is considered as substantial equivalence.
SE Analysis 11- Insertion section length
The insertion length of proposed device is similar as that of the predicate device. Therefore this item is considered as substantial equivalence.
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Table 4 Specifications Comparison of Video Colonoscope
Proposed device: EC-500 Series Video Colonoscope
Predicate device: EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE
| ITEM | Proposed device | Predicate device | |||
|---|---|---|---|---|---|
| Model | EC-500 | EC-500T | EC-500L | EC-500L/T | CF-Q180AL/ CF-Q180AI |
| Field of view (SE Analysis 12) | 140° | 140° | 140° | 140° | 170° |
| Depth of focus | 3-100mm | 3-100mm | 3-100mm | 3-100mm | 3-100mm |
| Front view | 0° | 0° | 0° | 0° | 0° |
| Sensor type (SE Analysis 9) | color CMOS | color CMOS | color CMOS | color CMOS | color CCD |
| Distal end outer diameter (SE Analysis 10) | 12mm | 12mm | 12.9mm | 12.9mm | 13.2mm |
| Insertion section outer diameter(SE Analysis 10) | 12.5mm | 12.5mm | 12.9mm | 12.9mm | 12.8mm |
| 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° |
| Insertion section length (SE Analysis 11) | 1350mm | 1700mm | 1350mm | 1700mm | 1680mm |
SE Analysis 12- Field of view
Although the field of view of the proposed video colonoscope is different than that of the predicate video colonoscope, the field of view of the proposed video colonoscope meets the requirements of ISO 8600-1 standard. Therefore, this difference on field of view does not affect the safety and effectiveness of the proposed device.
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Table 5 Specifications Comparison of Light Source Proposed device: HDL-500E Light Source/ HDL-500X Light Source Predicate device: EVIS EXERA II XENON LIGHT SOURCE (OLYMPUS CLV-180)
| ITEM | HDL-500E Light Source | HDL-500X Light Source | Predicate device |
|---|---|---|---|
| Power supply (SE Analysis 13) | AC 100-240V50Hz/60Hz | AC 100-240V50Hz/60Hz | AC 100-120V,50/60HZ ±1Hz |
| Over-current protection | Fuse type | Fuse type | Fuse type |
| Input current (SE Analysis 14) | 160VA | 500VA | 500VA |
| Examination lamp (SE Analysis 15) | 50W LED | 300W xenon lamp | 300W Xenon lamp |
| Average lamp life (SE Analysis 16) | 50000 hours | 500 hours | Approximately 500 hours ofcontinuous use |
| Emergency lamp (SE Analysis 15) | 14W LED | 12V 60W halogen lamp | 12V 35W Halogen lamp |
| Average emergency lamp life (SE Analysis 17) | 50000 hours | 4000 hours | Approximately 500 hours |
| Brightness control | Automatic and manual | Automatic and manual | Automatic and manual |
| Automatic exposure (SE Analysis 18) | 19 steps | 19 steps | 17 steps |
| Air feeding | 4 levels available (off, low,mid, high) | 4 levels available (off, low,mid, high) | 4 levels available (off, low,mid, high) |
| System connector | Provided | Provided | Provided |
| Foot switch connector | Provided | Provided | Provided |
| CV connector | Provided | Provided | Provided |
SE Analysis 13-Power supply
Although the power supply of proposed light source is different from that of the electrical safety testing of proposed device demonstrates that the power supply of the proposed device meets the requirements of IEC 60601-1 Standard. Therefore, on power supply does not affect the safety and effectiveness of the proposed device.
SE Analysis 14-Input current
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The input current of proposed HDL-500X Light Source is same as that of the input current of proposed HDL-500E Light Source is different from that of the predicate device, the input current of proposed HDL-500E Light Standard), Therefore this difference on input current is considered not affectiveness of the proposed device.
SE Analysis 15- Examination lamp and Emergency lamp
The proposed HDL-500X Light Source has that of the predicate device. The proposed HDL-500E has different light source from that of the predicate device. The LED light source of HDL-500E is also a common light source used in endoscope system, therefore this difference on examination lamp and emergency lamp does not affect the safety and effectiveness of the proposed device.
SE Analysis 16- Average lamp life
The proposed HDL-500X Light Source has that of the predicate device. The proposed HDL-500E has longer lamp life than that of the predicate device. The LED ight source of HDL-500E is also a common light source used in endoxope system. Therefore on lamp life does not affect the safety and effectiveness of the proposed device.
SE Analysis 17- Average emergency lamp life
The proposed Light Sources have longency lamp life than that of the predicate device. This difference on average emergency lamp life does not affect the safety and effectiveness of the proposed device.
SE Analysis 18- Automatic exposure
Both the proposed device and predicate device provide the fination of automatic exposure. Although the adjustable levels the proposed device and predicate device, the purpose of image brightness adjustment. Therefore this item is considered as substantial equivalence.
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| Predicate device: EVIS EXERA II 180 SYSTEM | ||
|---|---|---|
| ITEM | Proposed Device | Predicate Device |
| HD-500 Video Endoscope System | K100584 | |
| EVIS EXERA II 180 SYSTEM | ||
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Particularrequirements | Comply with IEC 60601-2-18 | Comply with IEC 60601-2-18 |
| ProductPerformance | Comply with ISO 8600-1 and ISO8600-7 | Comply with ISO 8600-1 and ISO8600-7 |
| Patient-contactcomponent andmaterial(SE Analysis 19) | Insertion section | Unknown |
| Distal end | Unknown | |
| Adhesive | Unknown | |
| Biocompatibility(SE Analysis 19) | Cytotoxicity, ISO 10993-5 | |
| Sensitization, ISO 10993-10 | ||
| Irritation, ISO 10993-10 |
Table 6 Safety Comparison Proposed device: HD-500 Video Endoscope System
SE Analysis 19- Patient-contact component and material /Biocompatibility
The patient-contact components of the proposed device are same as those of the predicate device. Although the patient-contacting materials of the predicated device are unknown, the proposed device is biocompatible and conforms to ISO 10993 series standards. Therefore, the proposed device is claimed to be substantially equivalent to the predicate devices.
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis in section 8 and the side-by-side optical performance tests, the proposed device and the predicate device have the same intended use, comparable product specification and optical performance. Therefore, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
§ 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.