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.

Device Description

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.

AI/ML Overview

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.

Summary

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November 20, 2018

KARL STORZ Endoscopy-America, Inc. Winkie Wong Manager, Regulatory Affairs 2151 E. Grand Avenue EI Segundo, CA 90245

Re: K182696 Trade/Device Name: Telepack X LED Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FET Dated: September 25, 2018 Received: September 27, 2018

Dear Winkie Wong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeffrey W. Cooper -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182696

Device Name Telepack X LED

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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K182696

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

Applicant:	KARL STORZ Endoscopy-America, Inc2151 E. Grand AvenueEl Segundo, CA 90245
Contact:	Winkie WongRegulatory Affairs Manager424-218-8379 (phone)
Date of Preparation:	September 24th, 2018
Type of 510(k)Submission:	Traditional
Device Identification:	Trade Name: Telepack X LEDClassification Name: Endoscopic Video ImagingSystem/Component
Product Code:	FET
Regulation:	21 CFR 876.1500 (Endoscope and Accessories)
Predicate Device(s):	Image 1 Video Imaging System (K070716) – PrimaryKARL STORZ ICG Imaging System (K180146) – ReferenceThe above predicate and reference device have not been subject to any recall
Device Description:	The Telepack X LED is a portable and compact all-in-one imagingsystem that includes a 15 inch screen display, a camera controlunit and internal LED light source, that is intended to beconnected to a compatible device (camera head orvideonendoscope) for the purpose of visualization anddocumentation of endoscopic and microscopic procedures as wellas stroboscopy.
	The Telepack X LED includes a LED illumination light source toilluminate the intended area and a 15 inch monitor for display. Italso allows the users to redefine the functions that take placewhen a button is pressed. The Telepack X LED is a non-patientcontacting and require only wipe down as needed.
Intended Use andIndications for use:	The TELE PACK X LED is an all-in-one Imaging System, whichcomprises a light source for illumination, Camera Control Unit(CCU) for use with compatible camera heads or video endoscopesfor image processing, as well as a monitor for image display,intended for the visualization of endoscopic and microscopicprocedures.
TechnologicalCharacteristics:	The Telepack X LED is a portable and compact all-in-one imagingsystem that includes a 15 inch screen display, a camera controlunit and internal LED light source, that is intended to beconnected to a compatible device (camera head orvideonendoscope) for the purpose of visualization anddocumentation of endoscopic and microscopic procedures as wellas stroboscopy.The Telepack X LED includes, but not limited to, the followingfeatures:Image capture Flip or mirror image Zoom Brightness control Light source control White Balance The dimension of the subject device is 450 x 350 x 150 mm andweighs 7kg. It is not intended to be soiled and is non-patientcontacting. It includes moderate level of concern software. Thedevice has been tested and passed the electrical safety and EMCtesting, which is certified to be Class I protection againstelectrical shock, Type BF protection against electrical shock fromstroboscopy and camera applied parts, Type CF protectionagainst electrical shock from light and lastly drip-waterprotection against moisture per IPX1.
Non-ClinicalPerformance Data:	There are no performance standards or special controlsdeveloped under Section 514 of the FD&C Act for endoscopes.However, the KARL STORZ ICG Imaging System follows the FDArecognized consensus standards and is tested according to thefollowing standards and FDA Guidance:Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 IEC 52471 Software Verification and Validation Testing Guidance for the Content of PremarketSubmissions for Software Contained in MedicalDevice Level of concern: Moderate Performance Testing Minimum Illumination Spatial Resolution Color Performance Latency White Balance AE Step Response Head Button Functionality Additional bench testing was performed to ensure the device metits design specifications. The bench testing performed verifiedand validated that the Telepack X LED has met all its designspecification and is substantially equivalent to its predicatedevices.
ClinicalPerformance Data:	Clinical published literatures were provided to support theeffectiveness of NIR imaging in the neuro- and endonasal skullbase surgeries as well as the use of the KARL STORZ ICG ImagingSystem in pediatrics.
SubstantialEquivalence:	The intended use, operating principles, technologicalcharacteristics and features are similar, if not identical, betweenthat subject device and the Image 1 Video Imaging System(K070716). The minor difference between the subject andpredicate devices that does not raise new or different questionsor safety and effectiveness are:
	The subject device seeks clearance on the CCU, internal light source and internal display to be used with compatible camera heads and videoendoscopes, whereas the predicate device sought clearance on the CCU and camera heads with use of an external standard light source and external display as part of the submission. The subject device allows image, video and audio files to be stored via an external SD memory card or the hospital's/office's network server, whereas the predicate allows image, video and audio files to be stored via an external device. (Function not under review as this function is 510k exempt per product code, LMD, and does not have impact on the performance of the device) The subject device does not offer interoperability (the ability to control external devices), whereas the predicate does. The subject device does not offer split screen enhancement, whereas the predicate does. The subject device is slightly larger and heavier than the predicate device Due to the internal light source the subject device offer, the subject device is compliant to IEC 62471, whereas for the predicate, the compliance to IEC 62471 is achieved by the external light source. As proven by the comparisons, the above differences do not raise different questions of safety and effectiveness because the intended use, operating principles, technological characteristics, and features are similar, if not identical. Both systems also comply with identical standards and safety testing, where applicable.Substantial equivalence on the effectiveness of the subject device is supported by the comparison of the images and standard image quality characteristics including, but not limited to, resolution, latency, white balance and AE step response between subject and predicate devices.
Clinical PerformanceData:	Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence.
Conclusion:	The Telepack X LED is substantially equivalent to its predicate device. The non-clinical bench and comparative testing demonstrate that the device is as safe and effective as the legally marketed devices.

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Regulation Number and Section

§ 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.