(261 days)
The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The VISERA ELITE III Surgical Imaging System is intended to be used with ancillary equipment for endoscopic diagnosis, treatment, and observation and supports the function of high definition (HD) videoscopes and is Camera Head (CH) compatible.
The following devices of the VISERA ELITE III Surgical Imaging System are the subject of this premarket notification submission:
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VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model: OLYMPUS OTV-S700) - A video system center that processes electronic signals transmitted from a video endoscope or a camera head and outputs the image signal to a monitor.
- VISERA ELITE III 3D Upgrade Pack (Model: MAJ-2511) - A function activation portable memory key accessory that unlocks the 3D software function when connected with OTV-S700 to enable the observation of 3D mode.
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VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 (Model: OLYMPUS CLL-S700) - A LED light source provides examination light to a video endoscope and a camera head.
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4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA (Model: OLYMPUS CH-S700-XZ-EA) - A 4K Inline camera head is intended to be used with Olympus endoscopes, the video system center, and other ancillary equipment for the visualization of internal organs (endoscopic diagnosis), treatment and observation.
Based on the provided FDA 510(k) clearance letter and documentation for the Olympus VISERA ELITE III Surgical Imaging System, here's a description of the acceptance criteria and the study proving the device meets them:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and exhaustive study results as might be found in a full clinical trial report or a PMA submission. For a device like this (endoscopic video imaging system), performance is typically evaluated through a combination of internationally recognized standards, bench testing, and comparison to predicate devices, rather than clinical efficacy studies in the way you might see for an AI diagnostic tool. Therefore, some of the requested information (especially regarding statistical metrics like sensitivity/specificity, sample sizes for training/test sets, expert adjudication, or MRMC studies) is not explicitly stated or applicable in the context of this 510(k) summary for an imaging system that primarily focuses on image quality and safety.
The summary emphasizes "substantial equivalence" based on similar intended use and technological characteristics, and that the differences do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
For an endoscopic video imaging system, acceptance criteria are primarily related to image quality, safety (electrical, EMC, photobiological, laser), and functional performance in accordance with recognized industry standards. The reported "performance" is generally that the device meets these standards and functions as intended, with specific measurements taken during bench testing.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (Summary) |
|---|---|---|
| Image Quality & Function | Field of View and Direction of View | Tested and functions as intended (Specific values provided in comparison tables for FoV for the camera head). |
| Resolution | Tested and functions as intended (4K compatible, higher pixel count compared to predicate). | |
| Image Noise and Dynamic Range | Tested and functions as intended (HDR Function available for OTV-S700). | |
| Brightness | Tested and functions as intended. | |
| Image Intensity Uniformity | Tested and functions as intended. | |
| Color Performance | Tested and functions as intended. | |
| Latency | Tested and functions as intended. | |
| Iris Area Observation | Tested and functions as intended. | |
| Laser Mode Observation | Tested and functions as intended. | |
| Magnification | Tested and functions as intended. | |
| Distortion | Tested and functions as intended. | |
| Depth of Field | Tested and functions as intended. | |
| Auto Focus Function (CH-S700-XZ-EA) | Tested and functions as intended (New feature: Electrical automatically focus with one-touch auto focus/Continuous auto focus). | |
| Electrical Safety | Compliance with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012 | Confirmed in compliance. |
| Compliance with IEC 60601-2-18 Ed. 3.0 2009-08 (Endoscopic equipment) | Confirmed in compliance. | |
| Degree of protection against electric shock (CH-S700-XZ-EA) | Type CF (improved from predicate's Type BF). | |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Ed. 4.1 2020-09 | Confirmed in compliance. |
| Usability | Compliance with IEC 60601-1-6 Ed. 3.2 2020-07 | Confirmed in compliance. |
| Human Factors Validation (for CH-S700-XZ-EA reprocessing) | Performed; risks mitigated effectively. | |
| Reprocessing/Sterilization | Validation for 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | Validated for Manual Cleaning, Delayed Manual Cleaning (Endozime AW), Sterilization (V-PRO maX, Autoclave), Drying time. |
| Software | Compliance with "Guidance for the Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices" | Verification and validation performed and documented. |
| Risk Management | Established in-house acceptance criteria based on ISO 14971:2019 | Risk analysis conducted; design verification tests identified and performed. |
| Photobiological Safety | Compliance with IEC 62471:2006-07 | Tested and functions as intended. |
| Laser Product Safety | Compliance with IEC 60825-1 Edition 2.0 2007-03 | Tested and functions as intended. |
| Durability | Tested and functions as intended. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not provide details on specific "sample sizes" in terms of number of patients or images for the performance tests. The testing described (bench testing, electrical safety, EMC, software V&V, reprocessing validation) typically involves testing of the physical devices themselves and their components, rather than a dataset of patient images.
- Data Provenance: The testing was conducted in support of a 510(k) submission from Olympus, with manufacturing in Japan. The testing described is bench testing and laboratory validation, not human clinical data. Therefore, the concept of "country of origin of the data" or "retrospective/prospective" does not apply in the typical sense of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Ground Truth Experts: Not applicable in this context. The "ground truth" for an imaging system like this is its ability to accurately capture and display images according to objective physical and electrical parameters, as measured through engineering and quality control tests (e.g., resolution targets, color charts, electrical signal analysis). It's not about expert interpretation of medical images.
- Qualifications of Experts: The testing would be performed by qualified engineers, technicians, and quality assurance personnel with expertise in electrical engineering, optics, software testing, and medical device regulations.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no human rating or judgment that requires adjudication for the types of tests described (bench tests, safety, EMC). The results are objective measurements against predefined engineering specifications and regulatory standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for AI-driven diagnostic tools to assess how human reader performance (e.g., diagnostic accuracy) changes with and without AI assistance. This device is a foundational imaging system, not an AI diagnostic tool, so such a study would not be relevant for its clearance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a hardware imaging system, not an algorithm, so the concept of "standalone performance" of an AI algorithm does not apply. Its "performance" is inherently tied to its function as a tool for human use.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's performance relies on objective engineering specifications, standardized test targets (e.g., resolution charts, color references), and regulatory safety standards. It's not based on expert consensus, pathology, or outcomes data in a clinical sense. For example, to test resolution, a known resolution target is imaged, and the system's ability to resolve details is measured.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a hardware imaging system and does not involve machine learning or AI models that require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
In summary, the 510(k) process for a device like the VISERA ELITE III Surgical Imaging System primarily relies on demonstrating technical performance, safety, and substantial equivalence to legally marketed predicate devices through rigorous engineering testing (bench testing, electrical safety, EMC, software validation) against established standards, rather than clinical studies or AI model validation studies. The "acceptance criteria" are compliance with these standards and the "proof" is the successful completion of these tests.
§ 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.