(62 days)
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.
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.
The SonoScape Medical Corp. HD-550 Video Endoscope System (K222020) is found to be substantially equivalent to its predicate device (K211882) based on non-clinical performance data. No clinical study was performed.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence determination based on an identical predicate device, the "acceptance criteria" are effectively the specifications and performance of the predicate device, and the "reported device performance" is the claim that the proposed device is identical to the predicate device in these aspects.
| Feature / Performance Metric | Acceptance Criteria (Predicate Device K211882) | Reported Device Performance (Proposed Device K222020) |
|---|---|---|
| General | ||
| 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 | Identical for all components | Identical for all components |
| Configuration (primary components) | Light Source, Image Processor, Video Gastroscope, Video Colonoscope, Accessories and peripheral devices | Identical |
| HD-550 Series Image Processor | (Specifications found in Table 2) | Identical |
| Power supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz |
| Over-current protection | Fuse type | Fuse type |
| Size | 370(W)×124(H)×500(D)mm (varies by model) | Identical (varies by model) |
| Weight | 11.1 Kg | 11.1 Kg |
| Compatible endoscope | Videoscope | Videoscope |
| Video signal output | DVI, VGA, SDI, CVBS, S-Video | Identical |
| Auto white balance | Automatically adjusted | Automatically adjusted |
| Color tone adjustment | Red: ±15 steps, Blue: ±15 steps, chroma: ±15 steps | Identical |
| Automatic gain control | Provided | Provided |
| Image enhancement | Edge, Structure, Contrast, Color enhancement | Identical |
| IRIS mode selection | Peak/AVE/Auto photometry mode | Peak/AVE/Auto photometry mode |
| Zoom | 1.0 - 4.0 | 1.0 - 4.0 |
| Imaging modes | White light (WL), Enhanced white light (EWL), Spectral focused (SFI), Intelligent staining technology (VIST) | Identical |
| Foot switch connector | Provided | Provided |
| Record to memory card | Provided | Provided |
| EC-550 Series Video Colonoscope | (Specifications found in Table 3 and 4 for Gastroscopes) | Identical for all models (EC-550, EC-550T, EC-550L, EC-550L/T) |
| Field of view | 140° | 140° |
| Depth of focus | 3-100mm | 3-100mm |
| Front view | 0° | 0° |
| Sensor type | color CMOS | color CMOS |
| Distal end outer diameter | 12mm - 12.9mm (varies by model) | Identical (varies by model) |
| Insert section outer diameter | 12.5mm - 12.9mm (varies by model) | Identical (varies by model) |
| Bend angle | UP:180°, DOWN:180°, RIGHT:160°, LEFT:160° | Identical |
| Insertion section length | 1350mm - 1700mm (varies by model) | Identical (varies by model) |
| Total length | 1700mm - 2050mm (varies by model) | Identical (varies by model) |
| Biopsy channel inner diameter | ≥ 3.8mm - ≥ 4.2mm (varies by model) | Identical (varies by model) |
| EG-550 Series Video Gastroscope | (Specifications found in Table 4) | Identical for all models (EG-550, EG-550L) |
| Field of view | 140° | 140° |
| Depth of focus | 3-100mm | 3-100mm |
| Front view | 0° | 0° |
| Sensor type | color CMOS | color CMOS |
| Distal end outer diameter | 9.3mm - 9.8mm (varies by model) | Identical (varies by model) |
| Insertion section outer diameter | 9.3mm - 9.8mm (varies by model) | Identical (varies by model) |
| Bend angle | UP:210°, DOWN:90°, RIGHT:100°, LEFT:100° | Identical |
| Insertion section length | 1050mm | 1050mm |
| Total length | 1400mm | 1400mm |
| Biopsy channel inner diameter | 2.8mm - 3.2mm (varies by model) | Identical (varies by model) |
| VLS-55 Series Light Source | (Specifications found in Table 5) | Identical |
| Power supply | AC 100-240V, 50Hz/60Hz | AC 100-240V, 50Hz/60Hz |
| Over-current protection | Fuse type | Fuse type |
| Input current | 300VA | 300VA |
| Examination lamp | 50W LED | 50W LED |
| Average lamp life | 50000 hours | 50000 hours |
| Emergency lamp | 14W LED | 14W LED |
| Average emergency lamp life | 50000 hours | 50000 hours |
| Brightness control | Automatic and manual | Automatic and manual |
| Automatic exposure | 19 steps | 19 steps |
| System connector | Provided | Provided |
| Foot switch connector | Provided | Provided |
| CV connector | Provided | Provided |
| Safety and Biocompatibility | (Standards found in Table 6) | Identical |
| 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 |
| Particular requirements | Comply with IEC 60601-2-18 | Comply with IEC 60601-2-18 |
| Product Performance | Comply with ISO 8600-1 and ISO 8600-7 | Comply with ISO 8600-1 and ISO 8600-7 |
| Patient-contact component material | PU, fluoroelastomer (Insertion section); PEEK, Sapphire crystal SUS 304 (Distal end); Epoxy resin (Adhesive) | Identical |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation (ISO 10993 standards) | Identical |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable. The submission states, "No clinical study is included in this submission." The evaluation relies on the equivalence of the proposed device to the predicate device, which itself would have had its performance demonstrated through testing. The current submission focuses on non-clinical tests to demonstrate that the proposed device is identical to the predicate device in all relevant aspects, except for a reprocessing change.
- Data provenance: Not explicitly stated for the non-clinical tests. However, the manufacturer is Sonoscape Medical Corp. in Shenzhen, Guangdong, China. The non-clinical tests (electrical safety, EMC, performance, biocompatibility) are typically performed by the manufacturer or accredited labs on their behalf. The liquid chemical sterilization test reports were submitted to support the reprocessing change.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical study with a "test set" requiring expert ground truth was conducted for this specific submission. The submission is based on substantial equivalence to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical study requiring adjudication of a test set was conducted for this submission.
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
Not applicable. This device is an endoscope system, not an AI-assisted diagnostic tool for interpretation of images by human readers. The document makes a note that "The prospective clinical value of the enhanced imaging modes has not been demonstrated, and no clinical claims are made" regarding the enhanced imaging modes (EWL, SFI, VIST).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. It is a medical device system (endoscope, image processor, light source) used by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical study with a "ground truth" was conducted for this submission. The demonstration of performance relies on compliance with recognized standards (IEC, ISO) and comparison of specifications with a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven submission that would involve a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used.
§ 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.