(18 days)
The TELE PACK + 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 + is a portable and compact all-in-one imaging system that includes a 18.5 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 videoendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy. The Telepack + includes a LED illumination light source to illuminate the intended area and a 18.5 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack + is a non-patient contacting and require only wipe down as needed.
The KARL STORZ TELEPACK+ is an all-in-one imaging system for endoscopic and microscopic procedures. This submission (K221174) is a modification of a previously cleared device (K193235). The key modifications include:
- Swapping of two camera types (X-link and Office Link) via touchscreen.
- Addition of capacitors to the Office Link front end.
- Mechanical changes: added isolation to the microphone, an additional cover for the power supply, and a mechanical metal part as a protective earth.
- Addition of video playback and image review functionality.
- Additional cybersecurity features.
- Additional camera and videoscope compatibility.
The device's non-clinical performance data and bench testing were deemed sufficient to demonstrate substantial equivalence to its predicate device. This implies that the device meets its design specifications and is as safe and effective as the legally marketed predicate devices.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Electrical Safety and EMC | |
| IEC 60601-1 (General medical electrical equipment) | Passed |
| IEC 60601-1-2 (Electromagnetic compatibility) | Passed |
| IEC 60601-2-18 (Endoscopic equipment) | Passed |
| IEC 62471 (Photobiological safety) | Passed |
| Software Verification and Validation | |
| Guidance for the Content of Premarket Submissions | Met (Level of concern: Moderate) |
| Performance Testing | |
| Minimum Illumination | Met design specifications |
| Spatial Resolution | Met design specifications |
| Color Performance | Met design specifications |
| Latency | Met design specifications |
| White Balance | Met design specifications |
| AE (Automatic Exposure) Step Response | Met design specifications |
| Head Button Functionality | Met design specifications |
| Protection against electrical shock | Class I protection, Type BF protection (stroboscopy & camera), Type CF protection (light) |
| Moisture protection | Drip-water protection per IPX1 |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" and its sample size in the context of a clinical study, as no clinical performance data was required. The "test set" for demonstrating substantial equivalence primarily involved bench testing and electrical, EMC, and software validation tests. The data provenance is internal to KARL STORZ Endoscopy America, Inc., as these were laboratory and engineering tests conducted on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For this type of device (an imaging system, not an AI diagnostic tool), "ground truth" established by medical experts for a test set is typically not germane to the substantial equivalence pathway, especially when no clinical data is required. The ground truth for engineering and performance measurements is established by standard measurement techniques and reference equipment.
4. Adjudication method for the test set
Not applicable. Since no clinical study or expert review for diagnostic accuracy was performed or required, an adjudication method for a test set is not relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The TELEPACK+ is an imaging system and not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The TELEPACK+ is a medical imaging system, not a standalone algorithm. Its performance is evaluated on its ability to produce high-quality images and manage endoscopic/microscopic procedures, not on an algorithm's diagnostic capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing (e.g., minimum illumination, spatial resolution, color performance) was established through objective engineering measurements using calibrated equipment and standard test methods against the device's design specifications. For electrical safety and EMC, the "ground truth" is compliance with recognized international standards (e.g., IEC 60601 series).
8. The sample size for the training set
Not applicable. The TELEPACK+ relies on traditional imaging processing and control technologies, not machine learning or artificial intelligence that would require a "training set" in the context of algorithm development.
9. How the ground truth for the training set was established
Not applicable. As no training set for an AI algorithm was used, this question is not relevant.
§ 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.