(48 days)
The Endohub-1.0 Endoscopic Video Camera with Video Capture is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to; orthopedic, laparoscopic, urologic, sinuscopic and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.
The Endohub-1.0 Endoscopic Video Camera System is a video camera system which consists of a Camera Control Unit [CCU] and Camera Head. The Endohub-1.0 Camera System is used in conjunction with an endoscope to allow for visualization during minimally invasive surgical procedures. Sterilization of the camera head may be required prior to use. The camera head may be steam sterilized. The camera head may utilize 1CCD or 3CCD image sensors, and employ either fixed or variable focal length optics. The Endohub-1.0 Camera System incorporates an image capture system which allows for the capture of streaming video or still video images.
The provided text describes a 510(k) summary for the Endohub-1.0 Endoscopic Video Camera System. This type of regulatory submission establishes substantial equivalence to a predicate device and does not typically include detailed performance studies with acceptance criteria, sample sizes, expert-adjudicated ground truth, or multi-reader multi-case studies as would be seen for AI/ML device submissions.
Based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or provide a table of performance metrics. The claim for the Endohub-1.0 is based on substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
No test set with a specific sample size or data provenance is mentioned. The device's performance is assumed to be equivalent to the predicate device based on its design and intended use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. The submission does not describe a study involving human experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic or AI-powered devices, not for basic endoscopic video camera systems demonstrating substantial equivalence to existing technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a video camera system, not an algorithm. Its function is to capture and display images for human interpretation during surgical procedures.
7. The Type of Ground Truth Used:
Not applicable. The submission does not define a "ground truth" as would be relevant for a diagnostic or AI device. The equivalence is based on the functional aspects of the video camera system.
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI/ML model, no ground truth establishment is described.
Summary of Device Acceptance Criteria and Study Information from the Provided Text:
The Endohub-1.0 Endoscopic Video Camera System’s acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (Linvatec Corporation's Autoclavable 3-CCD Digital Camera System, K031098). The study supporting this acceptance is a comparative analysis against the predicate, focusing on:
- Indications for Use: The Endohub-1.0 is intended for use as an endoscopic video camera in various surgical procedures (orthopedic, urologic, sinuscopic, plastic, and microscopic surgery) and allows for presentation of endoscopic images onto video monitors. This is stated to be equivalent to the predicate.
- Basic Design: The system consists of a Camera Control Unit (CCU) and Camera Head, similar to the predicate.
- Energy Delivered: Not specified, but implied to be equivalent.
- Biocompatibility: Implied to be equivalent.
- Performance: Implied to be equivalent, meaning it performs its function of capturing and displaying video for endoscopic procedures to a similar standard as the predicate. No specific quantitative performance metrics are provided.
- Standards Used: Compliance with IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2 for safety and electromagnetic compatibility forms part of the acceptance criteria.
- Materials: Implied to be equivalent.
- Safety and Effectiveness: No significant differences that would raise concerns regarding safety or effectiveness compared to the predicate.
- Labeling: Implied to be equivalent.
The submission concludes that there are "no significant differences in the new device which raise issues of safety or effectiveness," leading to the FDA's determination of substantial equivalence. This regulatory pathway does not require the extensive performance studies typically associated with novel or AI-powered devices.
§ 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.