(83 days)
The device is intended for use in all types of endoscopic and endoscopic assisted procedures, including general thoracic and as an aid in visualization of the evacuated cardiac chamber.
The 3D Video Endoscope System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures, including general thoracic and as an aid in visualization of the evacuated cardiac chamber. The product is an integrated endoscope and video camera. The system will be supplied as a 3D Video Endoscope and Camera Control Unit. The device is designed to work with commercially available light sources, and video monitors or head mounted displays (HMD). Additionally the device can be mounted in a rack and used as one module of a rack mounted system.
Here's an analysis of the acceptance criteria and study information based on the provided text:
Acceptance Criteria and Device Performance
The provided 510(k) summary does not explicitly state quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific imaging metrics) related to the "3D Video Endoscope". Instead, the "Performance Data" section lists compliance with a set of international and U.S. safety and compatibility standards.
Therefore, the table below reflects the stated performance criteria (standards compliance) and the implicit claim of meeting these standards for the device.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 601-1: "General Safety Requirements for Medical Electrical Equipment" | The device is implied to meet this standard. |
| Electromagnetic Compatibility (EMC) | IEC 601-1-2: "Electrical Magnetic Compatibility" | The device is implied to meet this standard. |
| Endoscopic Equipment Safety | IEC 601-2-18: "Safety of Endoscopic Equipment" | The device is implied to meet this standard. |
| Biocompatibility | ISO 10993: "Biological Evaluation of Medical Devices" | The device is implied to meet this standard. |
| U.S. Electrical Safety | UL 544: "Standard for Safety Medical and Dental Equipment" | The device is implied to meet this standard. |
| Optical Performance | Optical Test Data | "Optical Test Data" is listed, implying the device underwent optical performance testing relevant to its function as a video endoscope. No specific metrics or results are provided. |
Study Information
Based on the provided K970214 510(k) Notification, the nature of the "study" conducted for this device is primarily focused on bench testing and compliance with recognized standards, rather than clinical performance (e.g., diagnostic accuracy, reader studies).
Here's a breakdown of the requested information, where available:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable in the context of a clinical test set. The testing involved compliance with various standards, which would typically involve testing of device units/components, not patient data sets.
- Data Provenance: Not applicable. The "data" refers to engineering test results and compliance documentation, not patient data.
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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. Ground truth, in the sense of expert consensus on medical findings, is not mentioned as part of this submission. Compliance with standards is typically verified by engineers and quality assurance personnel against defined test protocols.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for interpretation of clinical results, which are not described here.
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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. The document presents a 510(k) for a 3D Video Endoscope. This device predates the widespread use of AI in medical imaging interpretation and does not involve AI assistance for human readers. No MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a video endoscope, not an algorithm. Its function is to provide images for human interpretation and surgical guidance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the clinical sense. The "ground truth" for the performance studies listed is adherence to the specifications within the cited safety, EMC, biocompatibility, and optical standards. For example, for an electrical safety test, the "ground truth" is that the device passes specific voltage, current, or insulation resistance thresholds as defined by IEC 601-1.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
Summary of Device Evaluation Approach:
The 510(k) submission for the Vista Medical Technologies 3D Video Endoscope primarily demonstrates substantial equivalence to predicate devices and adherence to established electrical, safety, biocompatibility, and optical performance standards. The "study" data mentioned are technical compliance documents and test reports, not clinical trials or reader studies in the modern sense of demonstrating diagnostic accuracy or efficacy.
§ 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.