(261 days)
The ultrasonic gastrovideoscope (hereinafter called endoscope) is intended to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs.
The endoscope should be used in the medical institution. The operator of the endoscope should be a physician or a medical staff supervised by a physician, both of whom have received sufficient training in clinical endoscopy technology.
The subject device, Ultrasonic Gastrovideoscope, is consisting of insertion, control section and connector section. The insertion is consisting of a distal end, a bending section and an insertion tube. This Ultrasonic Gastrovideoscope is intended to use in conjunction with Endoscopic Image Processor (HD-550Exp, HD-550, HD-550Pro, HD-550S, HD-510 and HD-500Plus), light source (VLS-55Q, VLS-55T, VLS-51D and VLS-51T), ultrasound system (P60 Exp, P60, P60 Pro, P60 CV, P60S and P60 VO) and monitor to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs.
The Ultrasonic Gastrovideoscope is a reusable device. The Ultrasonic Gastrovideoscope has only one model EG-UR5.
The prospective clinical value of the enhanced imaging modes (EWL, SFI, and VIST) has not been demonstrated, and no clinical claims are made.
The provided text describes the acceptance criteria and the study conducted for the Sonoscape Medical Corp. Ultrasonic Gastrovideoscope (EG-UR5).
Here's the information broken down as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by testing against recognized standards and comparing performance to a predicate device. The document repeatedly states that the device's performance is "similar" to or "meets the requirements" of the predicate device and relevant standards.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit from Standard/Predicate Comparison) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | No cytotoxicity, no sensitization, no irritation (comply with ISO 10993 series) | Met: "No Cytotoxicity, No Sensitization, No Irritation." |
| Optical Performance | Color reproduction, depth of field, intensity uniformity, optical magnification and distortion, resolution, dynamic range similar to predicate. | Met: "same or similar optical performance" compared to predicate. |
| Ultrasonic Performance | Similar performance indexes of ultrasonic quantization imaging compared to predicate. | Met: Performance indexes of ultrasonic quantization imaging are "similar" to predicate; no clinically significant difference. |
| Irrigation Performance | Air/Water-feeding and Suction Performance similar to predicate. | Met: "similar irrigation performance" compared to predicate. |
| Backflow Prevention | Effectively prevent contaminated liquid backflow to the proximal irrigation system (per FDA guidance). | Met: "effective and reliable" prevention of backflow. |
| Performance Stability | Mechanical fatigue from long-period use does not decrease endoscope performance; appearance, handle strength, image function, sealing, and bending angle meet clinical requirements after simulated fatigue. | Met: Components mechanically fatigue will "not lead to the decrease of endoscope performance...still meet the clinical requirements." |
| Imaging Performance Attenuation | Degradations in imaging performance (noisy point, color reducibility, resolution, bad point) are detected before leading to misdiagnosis over the device's lifetime. | Met: Image performance is "still in a better condition" over lifetime; degradations are "very little" and "will not affect the normal use." |
| Dimensions | Performance meets ISO 8600 requirements despite similar but not identical dimensions to predicate. | Met: ISO 8600 testing conducted; performance "meets the requirements." |
| Acoustic Frequency | Clinical safety and effectiveness not affected by similar acoustic frequency range compared to predicate. | Met: Acoustic performance comparison showed "basically the same" results; differences within measurement error and "will not affect the safety and effectiveness." |
| Depth of Field | Clinical safety and effectiveness not affected by similar depth of field compared to predicate. | Met: No statistical difference in performance compared to predicate; "will not affect the safety and effectiveness." |
| Bend Angulation | Performance meets ISO 8600 requirements and provides sufficient operating space despite being different from predicate. | Met: ISO 8600 testing conducted; performance "meets the requirements." Angulation is greater, offering "more operating space." |
| Electrical Safety | Comply with IEC 60601-1. | Met: "Comply with IEC 60601-1." |
| EMC | Comply with IEC 60601-1-2. | Met: "Comply with IEC 60601-1-2." |
| Particular Requirements | Comply with IEC 60601-2-18 and IEC 60601-2-37. | Met: "Comply with IEC 60601-2-18, Comply with IEC 60601-2-37." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for test sets (e.g., number of devices tested for each non-clinical test). The studies appear to be non-clinical bench testing rather than clinical studies on human subjects.
- Data Provenance: The tests were conducted by the manufacturer, Sonoscape Medical Corp., in China, as indicated by their address. The data is retrospective in the sense that it was collected as part of the device development and verification process before submission for FDA clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. As this was a non-clinical submission, the "test set" refers to physical device testing against standards and predicate devices, not clinical data requiring expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
- None. Since there was no clinical test set requiring human interpretation, no adjudication method was used. The evaluation involved technical measurements and comparisons to established standards and the predicate device's specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was performed.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
- Not Applicable. The device is an endoscope, a hardware medical device that directly captures images and performs ultrasound. It is not an AI algorithm or software-only device, so the concept of "standalone algorithm performance" does not apply in this context. Its performance is intrinsically tied to human operation and interpretation.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests was established by:
- Technical Specifications and Performance of the Predicate Device (K130206): The subject device's performance was compared directly to that of the PENTAX EG-3670URK Ultrasound Video Gastroscope.
- International Standards: Compliance with standards such as ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-18, IEC 60601-2-37 (particular requirements), and ISO 8600 (endoscope performance).
- FDA Guidance Documents: For example, "Mitigating the risk of Cross-Contamination from valves and Accessories Used for irrigation through Flexible Gastrointestinal Endoscopes" for backflow prevention.
8. The Sample Size for the Training Set
- Not Applicable. This device is a hardware endoscope, not an AI or machine learning system. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 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.