(87 days)
The ER150/M2 is a video monitor intended to display viewable images transmitted by standard video signals during surgical or diagnostic procedures, particularly in endoscopy.
The ER150/M2 is a color video monitor intended to display viewable medical images transmitted by standard video signals. In particular, the device is intended for use as part of a visualisation system in endoscopic surgery. The monitor accepts and processes composite=FBAS, Y-UV, analog RGB, digital RGB, Y/C signals and NTSC, PAL and SECAM standard video signals. The ER150/M2 is designed with a digital microprocessor and offers an automatic input selection. The received signal is displayed on a 20" screen. The images can be adjusted by the user for color, contrast, hue, brightness, enhanced sharpness and color temperature (6500K or 9300K). Additional output sockets of the ER150/M2 allow the connection to further equipment including a second monitor or recording device.
This 510(k) summary describes a medical video monitor, the ER150/M2, which is an accessory to an endoscope. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for novel acceptance criteria.
Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not applicable or available in the provided text. The device is a monitor, and its "performance" is primarily defined by its ability to display signals effectively, conforming to established standards for medical monitors.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Regulatory Compliance: | |
| 21 C.F.R. § 81020.10 (Performance Standard) | Meets the requirements of 21 C.F.R. § 81020.10. |
| IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety) | Complies with IEC 60601-1. |
| IEC 60601-1-2 (Medical Electrical Equipment - General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility) | Complies with IEC 60601-1-2. |
| Medical Device Directive 93/42/EEC | Conforms to Medical Device Directive 93/42/EEC. |
| UL2601-1 (Underwriters Laboratories Standard for Medical Electrical Equipment) | Meets the requirements of UL2601-1. |
| Functional Equivalence to Predicate: | |
| Ability to display viewable medical images transmitted by standard video signals during surgical/diagnostic procedures, particularly in endoscopy. | Intended use, design, and technological characteristics are similar to the Sony Trinitron Color Video Monitor PVM-1343 MD (K885042). |
| Ability to process various standard video signals (composite=FBAS, Y-UV, analog RGB, digital RGB, Y/C, NTSC, PAL, SECAM). | Accepts and processes these signals. |
| Automatic input selection. | Designed with a digital microprocessor and offers automatic input selection. |
| Display on a 20" screen. | Received signal is displayed on a 20" screen. |
| User-adjustable image parameters (color, contrast, hue, brightness, enhanced sharpness, color temperature). | Images can be adjusted by the user for these parameters. |
| Additional output sockets for connection to other equipment (e.g., second monitor, recording device). | Offers additional output sockets. |
| Differences from predicate limited to picture quality and handling convenience, not raising new safety/effectiveness questions. | Stated that differences are limited to picture quality and handling convenience and do not raise new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission is for product clearance based on substantial equivalence to a predicate device and compliance with general performance and safety standards, not a clinical study involving a "test set" of patient data. The "test" in this context refers to engineering and quality assurance testing against the listed standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this isn't a clinical study, there was no ground truth for a test set established by medical experts in the way that would be done for an AI diagnostic device. The "ground truth" for a medical monitor is its adherence to technical specifications and regulatory standards, which are evaluated through engineering tests and regulatory review.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical ground truth requiring adjudication. Compliance with technical standards would be determined by testing procedures outlined within those standards and reviewed by the manufacturer's quality control and ultimately by the FDA.
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 is a medical monitor, not an AI-powered diagnostic tool. No MRMC study was performed, and there is no AI component described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. As described, this is a hardware device (a monitor) with no standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established technical and safety standards for medical monitors (e.g., IEC 60601-1, UL2601-1, 21 C.F.R. § 81020.10) and general device requirements for substantial equivalence. The device's performance is measured against these objective, predefined criteria through engineering and compliance testing. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device; there is no "training set" in the machine learning sense. The design and development process would involve iterative engineering and testing, but not training data for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set.
§ 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.