(269 days)
The C-cam camera head is designed for general endoscopic procedures in an operating room or a doctor's office. The camera head is suitable for attachment to all standard KARL STORZ Endoscopes and must be used with a C-MAC monitor or C-HUB for observation purposes in general endoscopic procedures.
The KSEA CMOS Camera System is a camera system designed for use in the operating room for general endoscopic procedures. The camera head is suitable for attachment to all standard KARL STORZ Endoscopes and Fiberscopes and must be used with a C-MAC™ monitor or C-HUB for observation purposes in general endoscopic procedures.
The KSEA CMOS Camera System (C-CAM) consists of a camera head, a cable and a monitor. The camera head must be connected to the C-MAC monitor, 8403ZX. The KSEA CMOS Camera System is compatible for use with all standard KARL STORZ Endoscopes and Fiberscopes for endoscopic observation in general endoscopic procedures.
The provided text describes a 510(k) premarket notification for the KARL STORZ Endoscopy America Incorporated KSEA CMOS Camera System (C-cam). This document focuses on demonstrating substantial equivalence to a predicate device (Tricam) rather than proving the device meets acceptance criteria through a specific study with detailed performance metrics.
However, based on the information provided, I can infer the "acceptance criteria" through the comparison to the predicate device and the "study" appears to be internal bench testing.
Here's the breakdown of the requested information based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Compatibility with KARL STORZ Endoscopes and Fiberscopes | Compatible for use with all standard KARL STORZ Endoscopes and Fiberscopes |
| Used with C-MAC monitor or C-HUB | Must be connected to the C-MAC monitor, 8403ZX, or C-HUB |
| Suitable for general endoscopic procedures in an operating room or doctor's office | Designed for general endoscopic procedures in an operating room or a doctor's office |
| Resolution (compared to predicate) | Slightly lower than the predicate (350 TVL [H]) |
| Meeting design specifications | Met all its design specifications |
| Safety and Effectiveness (compared to predicate) | Does not raise new issues of safety and effectiveness; substantially equivalent to the predicate |
| Compliance with standards | Tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 |
| Performance verification for Resolution, Field Flatness, White Balance | Bench testing performed verified and validated these aspects |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical or performance data from a specific number of samples. The evaluation primarily relies on bench testing and comparison to a predicate device. Therefore, a sample size for a test set and data provenance (country of origin, retrospective/prospective) are not explicitly mentioned for evaluation of the device's performance against defined acceptance criteria, but rather for validation against design specifications and regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The document does not describe a study involving expert readers or ground truth establishment in a clinical setting. The evaluation is based on engineering and regulatory standards and a comparison with a predicate device.
4. Adjudication Method for the Test Set
Not applicable. As there is no "test set" with expert assessment described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical information is required for this submission." This indicates that no MRMC comparative effectiveness study was conducted or presented.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The performance evaluation described is for the device operating on its own through bench testing. The results "show that the subject device has met all its specifications" and its performance for resolution, field flatness, and white balance was verified and validated through this testing. This can be considered a standalone assessment of the device's technical performance.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through its design specifications and compliance with international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18). The device's performance (e.g., resolution, field flatness, white balance) is measured and compared against these predefined technical specifications and functional requirements.
8. The Sample Size for the Training Set
Not applicable. This is a medical device approval, not an AI/machine learning algorithm, so there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set, there's no ground truth established for it.
§ 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.