(121 days)
The EnView™ camera controller is intended for use by surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemicolectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.
The EnView™ camera controller is a manually operated mechanical surgical device. It is designed to hold an endoscope during diagnostic and therapeutic surgical procedures. A surgeon can, with one hand, position and reposition the placement of an endoscope during a surgical procedure by simple movements of a control handle. This camera controller eliminates the need for the surgeon to continually hold the endoscope during a surgical procedure.
This document, K102179, describes the 510(k) summary for the CareFusion EnView™ Camera Controller, a mechanical surgical device intended to hold rigid endoscopes.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing specific performance metrics or acceptance criteria for the EnView™ camera controller itself.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Operational Performance & Conformance to Design Specifications | Testing was performed under various conditions to assess design performance and conformance to design specifications. (Specific details or quantitative results are not provided.) |
| Biocompatibility Standards | The EnView™ camera controller met ISO 10993:2003 (Biological evaluation of medical devices) standards. |
| Sterilization & Reprocessing Standards | The EnView™ camera controller met ISO 17664:2004 (Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices) standards. |
| Electrical Safety Standards | IEC 60601 testing was not required due to the mechanical and hydraulic mode of operation, similar to the predicate device (V.Mueller Camera Controller). |
| Substantial Equivalence (Operation, Design, Materials, Mfg.) | Substantially equivalent in operation, design, materials, and manufacturing characteristics as the V.Mueller Camera Controller and Storage Cart (K093616). |
| Substantial Equivalence (Indications for Use) | Substantially equivalent with respect to indications for use as the Prosurgics Freehand (K090340). |
| Safety and Efficacy | Equivalent in safety and efficacy to the legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. The document states, "Clinical studies were not required." The non-clinical testing mentioned does not specify a "test set" in the context of clinical data. It refers to various conditions for design performance and conformance.
- Data Provenance: Not applicable, as no clinical studies were performed. The non-clinical testing would have been conducted by the manufacturer, CareFusion.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No clinical studies or human expert evaluations for ground truth are mentioned.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical trials or expert adjudication processes were described.
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 device is a mechanical camera controller, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI improvement effect sizes are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a mechanical tool operated by a surgeon, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- Not applicable. The approval is based on substantial equivalence to predicate devices and non-clinical engineering/materials testing against ISO standards, not clinical ground truth.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set or ground truth in that context is relevant for this device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" in this context is the non-clinical testing performed by CareFusion. The primary method for proving the device meets acceptance criteria (which are largely implicit based on substantial equivalence) is through:
- Design Performance and Conformance to Design Specifications Testing: This would involve engineering tests to ensure the mechanical parts function as intended, can hold endoscopes of specified diameters, and allow for proper manipulation. Details such as specific forces, movements, or durability tests are not provided in this summary.
- Adherence to International Standards: The device was tested and met:
- ISO 10993:2003: This series of standards deals with the biological evaluation of medical devices, ensuring the materials used are biocompatible and do not pose a toxicological risk when in contact with tissues.
- ISO 17664:2004: This standard provides information for the processing (cleaning, disinfection, sterilization) of re-usable medical devices. This confirms the device can be properly sterilized for safe re-use.
- Substantial Equivalence Argument: The core of the 510(k) submission is the demonstration that the EnView™ camera controller is "substantially equivalent" to two legally marketed predicate devices:
- V.Mueller Camera Controller with Storage Cart (K093616): Substantially equivalent in operation, design, materials, and manufacturing characteristics. This implies that the engineering and material science aspects are comparable.
- Prosurgics Freehand (K090340): Substantially equivalent with respect to indications for use. This means it can be used for the same surgical procedures and purposes.
Conclusion:
The K102179 submission for the CareFusion EnView™ Camera Controller relies on non-clinical testing against design specifications and international standards (ISO 10993, ISO 17664), alongside a robust argument for substantial equivalence to existing predicate devices. No clinical studies, expert consensus, or AI-related performance metrics were involved or required for its 510(k) clearance due to its nature as a mechanical surgical accessory.
§ 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.