(10 days)
The CardioVations Portable Video System is intended to be used as an accessory in any endoscopic procedures that require a viewing distance up to 2 inches (5cm), when used with many rigid B-Style (32mm diameter eyecup) endoscopes.
The CardioVations Portable Video System is designed to be used as an accessory in any endoscopic procedures that require a viewing distance up to 2 inches (5cm), when used with many rigid B-Style (32mm diameter eyecup) endoscopes.
The CardioVations Portable Video System is a self contained system that is used as an endoscopic accessory to provide visualization during any endoscopic procedure that requires a viewing distance up to 2 inches (5 cm), when used with many B-style eyecup rigid endoscopes. The system consists of the following components:
• Video System Controller (Pack)
• Camera Heads (PAL, NTSC) with Light Source and Cable (Umbilical)- as one unit
• Heads-up Display (serves as a monitor or can be connected to a monitor).
• Battery Charger and Universal Power Supply
There are three main components of the Cardio Vations Portable Video System. These components are the Video System Controller (camera control unit) that is powered by a lithium ion rechargeable battery pack and worn by the user under the sterile gown, a Video Display (Heads-Up Video Display or standard monitor display) description and camera head (two, NTSC or PAL) and compact light source and cable. Only the camera head, light source and connection cable can be sterilized.
The Video System Controller provides power to the camera head and light source through the umbilical cable. The camera and light source is connected to an endoscope for visualization. In use, the camera, light source and cable are brought to the sterile field after being sterilized. The user connects them to a sterile endoscope and passes the cable off to a circulating nurse using appropriate sterile technique. The circulating nurse connects the cable to the control unit and turns the power on. The user then focuses the camera and white balances the unit by pressing the push and lock white balance button. The camera control unit and batteries are designed to be reused indefinitely, while the camera head can be reused 34 times before it needs to be replaced.
The provided text describes the CardioVations Portable Video System, an endoscopic accessory. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with electrical standards IEC 60601-1-2 and IEC 60601-2-18. | The device will be tested for compliance with these standards (indicating testing was planned or ongoing, not explicitly stated as concluded and met in this summary). |
| Ability to produce a quality video image (color, clarity, brightness, contrast) comparable to the predicate device. | Pre-clinical testing concluded that the video image quality of the new device is comparable to the predicate device in terms of color, clarity, brightness, and contrast. This implies the device met the implicit acceptance criteria of being "comparable." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the pre-clinical evaluation. It refers to a "pre-clinical evaluation" without specifying the number of tests performed or the number of units tested. The data provenance is not mentioned (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The pre-clinical evaluation focused on comparing the new device's video image quality to a predicate device, but it doesn't detail the method of assessment for "comparability," nor does it mention the use of experts for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC study was conducted or mentioned. The device is an endoscopic camera system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a video system, not an algorithm. Performance is intrinsically tied to human use for visualization.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the pre-clinical evaluation was based on comparison to a predicate device's video image quality in terms of color, clarity, brightness, and contrast. It was not based on expert consensus, pathology, or outcomes data in the traditional sense, but rather a direct comparative assessment of visual output.
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is not an AI/ML algorithm that requires a 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.