(73 days)
The device is intended for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber.
The Vista Mini Camera System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orificies. It is designed for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber. The product is a video camera. The system will be supplied as a Vista Mini Camera, intended to be used with a Vista camera control unit (CCU). The device is designed to work with commercially available light sources and video monitors or head mounted displays.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vista Mini Camera System:
1. Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating compliance with established safety and electromagnetic compatibility (EMC) standards. It does not provide specific performance metrics (e.g., resolution, field of view, illumination intensity) that are typically associated with "acceptance criteria" for image quality or clinical efficacy in the way modern AI/ML devices do.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| General Safety | IEC 601-1: General Safety requirements for Medical Electronic Equipment | Designed and tested in compliance. |
| Electromagnetic Compatibility (EMC) | IEC 601-1-2: Electromagnetic Compatibility Requirements and Tests | Designed and tested in compliance. |
| Endoscopic Equipment Safety | IEC 601-2-18: Safety of Endoscopic Equipment | Designed and tested in compliance. |
| Biocompatibility | ISO 10993: Biological Evaluation of Medical Devices | Designed and tested in compliance. |
| Electrical Safety (US Specific) | UL544: Standard for Safety, Medical and Dental Equipment | Designed and tested in compliance. |
| Optical Performance | (Implicit, but no specific metrics provided) | "Optical Test Data" (details not provided in the excerpt). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of this device and study. The document describes compliance with standards (safety, EMC, biocompatibility) through design and testing. It doesn't involve a "test set" of medical images or patient data to evaluate algorithmic performance.
- Data Provenance: Not applicable. The testing relates to engineering and material properties, not medical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The ground truth for compliance with safety and EMC standards is established by the specifications within those standards, and testing is performed by engineers/technicians according to defined protocols, often by accredited testing labs. There's no "ground truth" derived from expert medical review for performance claims in this document.
4. Adjudication Method for the Test Set:
- Not applicable. There is no "test set" of medical cases requiring adjudication. Compliance with standards is typically confirmed through objective measurements and verification against specified criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the subject of this 510(k) summary.
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not performed. This device is a camera system, not an AI or algorithmic diagnostic tool.
7. Type of Ground Truth Used:
- The "ground truth" for the device's acceptable performance is defined by the requirements and specifications within the cited industry and safety standards (IEC 601-1, IEC 601-1-2, IEC 601-2-18, ISO 10993, UL544). These standards specify acceptable levels for electrical current leakage, electromagnetic emissions/immunity, biocompatibility, and mechanical safety, among others.
8. Sample Size for the Training Set:
- Not applicable. This device is a hardware camera system, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.
Summary of the Study and Device Purpose:
This 1997 510(k) submission for the Vista Mini Camera System focuses entirely on demonstrating the device's safety and effectiveness by showing compliance with well-established international and national standards for medical electrical equipment, endoscopic equipment, and biocompatibility. The "study" described is a series of engineering tests and evaluations against these technical standards. It is crucial to understand that this submission predates the widespread use of AI/ML in medical devices, and therefore, the document does not contain the types of performance metrics or study designs (e.g., MRMC, standalone algorithm performance, clinical ground truth from experts) that would be expected for a modern AI-powered diagnostic or assistive tool. The acceptance criteria are primarily related to the physical and electrical integrity and safety of the device for its intended use.
§ 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.