(70 days)
The Karl Storz Imaging (KSI) Endovision XL System is a color, television camera head designed for use with any flexible or rigid endoscope. The camera head may be attached to any rigid or flexible endoscope, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera is connected to the video processor via a ten foot cable. The endoscopic image can be displayed on any standard operating room video monitor.
The Endovision XL is a state-of-the-art endoscopic camera. The head of the camera is equipped with a V-mount thread, allowing the head to couple to Karl Storz V-mount optical adapters. Three adapters, 15 mm, 20 mm and 25 mm, are available with the system. These couplers allow easy attachment of the XL head to any standard endoscope. Microprocessor controlled automatic exposure adjusts image brightness. The image sensor is a 1/4" CCD-chip. The processor weighs 1.77 pounds and the camera .6 pounds. Dimensions of the processor and camera in width, height and depth are: 8.29 x 2.16 x 6.07 inches and 1.96 x 2.4 x 3.9 inches respectively.
This 510(k) summary (K974391) describes an endoscopic camera system. It does not contain the detailed performance study information typically associated with establishing acceptance criteria and proving a device meets them through clinical or technical studies.
Here's an analysis based on the provided text, highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or specific reported device performance metrics. The submission focuses on substantial equivalence to previously cleared devices rather than new performance claims that would require specific acceptance criteria and detailed quantitative results.
2. Sample size used for the test set and the data provenance:
Not applicable. The document does not describe a test set or explicit performance data from a study. The basis for clearance is substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment is described for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done or described in this document. The focus is on the device's physical characteristics being "smaller, lighter, more portable" compared to its predicates.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a camera system, not an algorithm. Its performance is inherent in its image capture capabilities, which are established by equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth is described.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/algorithm-based device.
Summary of the Study per the Provided Document:
The provided document (a 510(k) summary) does not describe a formal study with acceptance criteria and a detailed performance evaluation. Instead, the "study" (or rather, the justification for marketing) is based on the concept of Substantial Equivalence.
- Substantial Equivalence Claim: Karl Storz Imaging (KSI) states that its "Endovision XL endoscopic camera system is substantially equivalent to several other systems currently on the market including the KSI Tricam Color Endoscopic Television System (K950862) and the KSI Telecam Color Endoscopic Television System (K883943)."
- Basis for Equivalence: The document explicitly states, "The proposed new KSI Endovision XL is unique only in that it is a smaller, lighter, more portable camera system." This implies that its core functional performance (e.g., image quality, illumination, compatibility with endoscopes) is considered comparable or identical to the predicate devices, with the primary difference being size and weight for improved portability.
- FDA Response: The FDA's letter confirms their review and determination that "the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified..." This indicates the FDA agreed with the substantial equivalence claim based on the information provided, without requiring a new, specific performance study with acceptance criteria for this particular submission.
§ 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.