(28 days)
The 1788 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope is indicated for use. The 1788 Video Camera is indicated for use in adults and pediatric patients.
The 1788 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1788 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.
The Stryker 1788 4K Camera System with Advanced Imaging Modality (K230605) is an endoscopic camera system.
Here's an analysis of its acceptance criteria and supporting studies based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Method) | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility | IEC 60601-1-2:2014 | Pass |
| Electrical Safety | ANSI/AAMI ES60601-1:2005 + A1:2012, IEC 60601-1-6:2010 + A1:2013, IEC 60601-2-18:2009 | Pass |
| Software | IEC 62304:2015 | Pass |
| Performance Testing - Bench: | ||
| • Camera Head Soaker Cap Tether Pull Force | (Method not explicitly detailed but implied by "Pass") | Pass |
| • Camera Head to Camera Control Unit Connector Insertion/Removal Force | (Method not explicitly detailed but implied by "Pass") | Pass |
| • Camera Head Button to Camera Control Unit Activation Timing | (Method not explicitly detailed but implied by "Pass") | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information about sample sizes for a 'test set' in the context of clinical or image-based evaluation. The performance data presented consists of engineering and software compliance testing. The data provenance is not specified beyond being generated by Stryker for its 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable as the provided documentation details engineering and software performance testing for a camera system, not the evaluation of a diagnostic or interpretive algorithm that would require expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons mentioned in point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size:
No, an MRMC comparative effectiveness study was not explicitly conducted or referenced in the provided document. The device is a camera system providing visual input, not an AI-assisted diagnostic tool that would typically be evaluated with MRMC studies to measure human reader improvement. The document explicitly states: "The 1788 4K Camera System does not require clinical studies to support the determination of substantial equivalence."
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device described is an endoscopic camera system, which provides visual information to a human user in a clinical setting; it is not a standalone algorithm performing a diagnostic task.
7. The Type of Ground Truth Used:
For the performance tests conducted, the "ground truth" refers to the established standards or specifications being tested against (e.g., IEC 60601-1-2:2014 for EMC, product design specifications for bench tests). It's not an expert consensus, pathology, or outcomes data in the sense of clinical decision-making.
8. The Sample Size for the Training Set:
This information is not applicable. The document describes a medical device (camera system), not an AI/ML algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reasons mentioned in point 8.
§ 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.