(63 days)
The Karl Storz Imaging (KSI) Autoclavable camera head is a color, television camera. suitable for use with any rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope. The camera head may be used with any current, compatible KSI camera control unit (CCU). The endoscopic image can then be displayed on any standard operating room video monitor.
The new autoclavable camera heads are identical to previous single chip and three chip models with the exception that these units are hermetically sealed and use a magnetic switch for operating the integral hand-held camera controls.
The provided text is a 510(k) summary for the Karl Storz Autoclavable Camera Head. It outlines the device's intended use, description, and claims of substantial equivalence to previously reviewed devices. However, it does not contain any information regarding specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria.
The submission focuses primarily on demonstrating substantial equivalence based on the device's design (hermetically sealed, magnetic switch) and sterilization capability, rather than presenting a performance study with detailed metrics.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be stated based on the provided text:
- Acceptance Criteria and Reported Device Performance: Not provided in the document. The submission focuses on substantial equivalence to predicate devices rather than meeting specific performance metrics.
- Sample size used for the test set and data provenance: Not mentioned. No specific test set or clinical study data is presented.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no test set or ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a camera head, not an AI algorithm.
- The type of ground truth used: Not applicable, as no ground truth is described.
- The sample size for the training set: Not applicable, as no training set for an algorithm is described.
- How the ground truth for the training set was established: Not applicable.
Summary of available information:
The 510(k) summary addresses the regulatory requirements for showing substantial equivalence. It highlights:
- Device Name: Karl Storz Autoclavable Camera Head
- Intended Use: A color, television camera suitable for use with various rigid or flexible endoscopes, coupled to the endoscope, and used with compatible KSI camera control units (CCUs) to display endoscopic images on standard operating room video monitors.
- Device Description: Identical to previous single-chip and three-chip models, but hermetically sealed and uses a magnetic switch for integral handheld camera controls.
- Substantial Equivalence: Claimed to be substantially equivalent to previously reviewed KSI single CCD (K883943) and triple CCD (K950862) camera heads, and in pressurized steam sterilization capability, to M.P. Video's "Autoclaveable Medicam 900 Digicon Camera" (K942358).
The document's purpose is to demonstrate that the new autoclavable camera head is safe and effective because its technological characteristics and intended use are comparable to legally marketed predicate devices, not through a detailed performance study with specific acceptance criteria and outcome data.
§ 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.