(54 days)
The TELE PACK X LED is an all-in-one Imaging System, which comprises a light source for illumination, Camera Control Unit (CCU) for use with compatible camera heads or video endoscopes for image processing, as well as a monitor for image display, intended for the visualization of endoscopic and microscopic procedures.
The Telepack X LED is a portable and compact all-in-one imaging system that includes a 15 inch screen display, a camera control unit and internal LED light source, that is intended to be connected to a compatible device (camera head or videonendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy.
The Telepack X LED includes a LED illumination light source to illuminate the intended area and a 15 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack X LED is a non-patient contacting and require only wipe down as needed.
The provided document describes a 510(k) submission for the KARL STORZ Endoscopy-America, Inc. Telepack X LED, an all-in-one imaging system for endoscopic and microscopic procedures. It is a traditional 510(k) submission, demonstrating substantial equivalence to a predicate device.
The study presented focuses primarily on non-clinical performance and bench testing to demonstrate substantial equivalence, rather than a clinical study involving human readers or AI. Therefore, many of the requested elements for an AI study (e.g., acceptance criteria for AI performance, MRMC study, expert ground truth for test sets) are not applicable to this submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with numerical targets against which performance of an AI algorithm is measured. Instead, it relies on comparison to a predicate device and adherence to recognized consensus standards for its non-AI related functions.
However, it lists various performance testing conducted to ensure the device met its design specifications and is substantially equivalent to its predicate. These can be considered the "acceptance criteria" for the device's fundamental image capture and display capabilities in a non-AI context.
| Acceptance Criteria Category | Reported Device Performance / Evaluation Method |
|---|---|
| Electrical Safety & EMC | Tested and passed: |
| - IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) | |
| - IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests) | |
| - IEC 60601-2-18 (Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment) | |
| - IEC 62471 (Photobiological safety of lamps and lamp systems) - Compliance due to internal light source | |
| - Certified to be Class I protection against electrical shock. | |
| - Type BF protection against electrical shock from stroboscopy and camera applied parts. | |
| - Type CF protection against electrical shock from light. | |
| - Drip-water protection against moisture per IPX1. | |
| Software V&V | - Followed "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device." |
| - Software level of concern: Moderate. | |
| Performance Testing | Additional bench testing performed and results verified the device met all design specifications. This included: |
| - Minimum Illumination | |
| - Spatial Resolution | |
| - Color Performance | |
| - Latency | |
| - White Balance | |
| - AE Step Response (Auto Exposure) | |
| - Head Button Functionality | |
| Image Quality Evaluation | Substantial equivalence on the effectiveness is supported by comparison of images and standard image quality characteristics (resolution, latency, white balance, AE step response) between the subject and predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The submission primarily relies on bench testing and comparison to a predicate device's technical specifications and previously cleared performance, rather than a "test set" of clinical cases for an AI algorithm.
- Data Provenance: Not applicable for an AI test set. Bench testing data is typically generated internally by the manufacturer. If any clinical "data" were used for comparison (e.g., images), the provenance is not specified. The document mentions "Clinical published literatures were provided to support the effectiveness of NIR imaging," but this is for reference, not a direct clinical test of this specific device's AI capabilities.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable as this is not an AI device validation requiring ground truth established by clinical experts on a test set. This device is an imaging system, not an AI diagnostic algorithm.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is typically performed to evaluate the diagnostic performance of an AI system, often in comparison to or in assistance of human readers. This submission is for an imaging system hardware, not an AI diagnostic algorithm.
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done
Not applicable. There is no AI algorithm being evaluated for standalone performance.
7. The Type of Ground Truth Used
Not applicable for an AI algorithm. The "ground truth" for this device's performance is its ability to meet engineering specifications and produce images comparable to the predicate device, as verified through bench testing.
8. The Sample Size for the Training Set
Not applicable. This document pertains to the submission of an imaging system, not the training of an AI algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the study that proves the device meets acceptance criteria (as per this 510(k) submission):
The KARL STORZ Telepack X LED demonstrated that it meets acceptance criteria, primarily through non-clinical bench testing and comparison to its predicate device (Image 1 Video Imaging System K070716).
The studies performed included:
- Electrical Safety and EMC Testing: Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and IEC 62471. The device was certified for various classes of electrical shock protection and drip-water protection (IPX1).
- Software Verification and Validation (V&V) Testing: Conducted in accordance with FDA guidance for software in medical devices, with a "Moderate" level of concern.
- Performance Testing: Bench tests were conducted to verify parameters such as minimum illumination, spatial resolution, color performance, latency, white balance, AE step response, and head button functionality. These tests aimed to ensure the device met its design specifications and performed comparably to the predicate device in terms of image quality characteristics.
The conclusion drawn was that the Telepack X LED's intended use, operating principles, technological characteristics, and features are similar, if not identical, to the predicate device. Differences identified (e.g., integrated light source, storage methods, absence of interoperability/split screen enhancement) were determined not to raise new or different questions of safety and effectiveness, as the underlying principles, functions, and compliance to standards were maintained. Clinical performance data was not required or provided to establish substantial equivalence for this type of device, as non-clinical bench testing was deemed sufficient.
§ 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.