K182696 · KARL STORZ Endoscopy-America, Inc. · FET · Nov 20, 2018 · Gastroenterology, Urology
Device Facts
Record ID
K182696
Device Name
Telepack X LED
Applicant
KARL STORZ Endoscopy-America, Inc.
Product Code
FET · Gastroenterology, Urology
Decision Date
Nov 20, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
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 Story
Portable, all-in-one imaging system; includes 15-inch monitor, camera control unit (CCU), and internal LED light source. Connects to compatible camera heads or video endoscopes. Used for visualization and documentation of endoscopic/microscopic procedures and stroboscopy. Operated by clinicians in clinical settings. Inputs: optical signals from endoscopes. Processing: image processing (capture, flip/mirror, zoom, brightness control, white balance). Outputs: visual display on integrated monitor; storage of image/video/audio files to SD card or network server. Benefits: provides integrated illumination and visualization for surgical/diagnostic procedures.
Clinical Evidence
No clinical data required for substantial equivalence. Evidence based on non-clinical bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-18), EMC (IEC 60601-1-2), and photobiological safety (IEC 62471). Performance testing verified minimum illumination, spatial resolution, color performance, latency, white balance, and AE step response.
Technological Characteristics
Portable all-in-one system (450x350x150 mm, 7kg). Features: LED light source, 15-inch display, CCU. Connectivity: SD card, network server. Electrical safety: Class I, Type BF (stroboscopy/camera), Type CF (light). Moisture protection: IPX1. Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 62471.
Indications for Use
Indicated for visualization of endoscopic and microscopic procedures in patients requiring such interventions.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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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)
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.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="font-size: 12px;"></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 12px;"></span> |
| | 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, Inc<br>2151 E. Grand Avenue<br>El Segundo, CA 90245 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong<br>Regulatory Affairs Manager<br>424-218-8379 (phone) |
| Date of Preparation: | September 24th, 2018 |
| Type of 510(k)<br>Submission: | Traditional |
| Device Identification: | Trade Name: Telepack X LED<br>Classification Name: Endoscopic Video Imaging<br>System/Component |
| Product Code: | FET |
| Regulation: | 21 CFR 876.1500 (Endoscope and Accessories) |
| Predicate Device(s): | Image 1 Video Imaging System (K070716) – Primary<br>KARL STORZ ICG Imaging System (K180146) – Reference<br>**The 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 imaging<br>system that includes a 15 inch screen display, a camera control<br>unit and internal LED light source, that is intended to be<br>connected to a compatible device (camera head or<br>videonendoscope) for the purpose of visualization and<br>documentation of endoscopic and microscopic procedures as well<br>as stroboscopy. |
| | The Telepack X LED includes a LED illumination light source to<br>illuminate the intended area and a 15 inch monitor for display. It<br>also allows the users to redefine the functions that take place<br>when a button is pressed. The Telepack X LED is a non-patient<br>contacting and require only wipe down as needed. |
| Intended Use and<br>Indications for use: | The TELE PACK X LED is an all-in-one Imaging System, which<br>comprises a light source for illumination, Camera Control Unit<br>(CCU) for use with compatible camera heads or video endoscopes<br>for image processing, as well as a monitor for image display,<br>intended for the visualization of endoscopic and microscopic<br>procedures. |
| Technological<br>Characteristics: | The Telepack X LED is a portable and compact all-in-one imaging<br>system that includes a 15 inch screen display, a camera control<br>unit and internal LED light source, that is intended to be<br>connected to a compatible device (camera head or<br>videonendoscope) for the purpose of visualization and<br>documentation of endoscopic and microscopic procedures as well<br>as stroboscopy.<br>The Telepack X LED includes, but not limited to, the following<br>features:<br>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 and<br>weighs 7kg. It is not intended to be soiled and is non-patient<br>contacting. It includes moderate level of concern software. The<br>device has been tested and passed the electrical safety and EMC<br>testing, which is certified to be Class I protection against<br>electrical shock, Type BF protection against electrical shock from<br>stroboscopy and camera applied parts, Type CF protection<br>against electrical shock from light and lastly drip-water<br>protection against moisture per IPX1. |
| Non-Clinical<br>Performance Data: | There are no performance standards or special controls<br>developed under Section 514 of the FD&C Act for endoscopes.<br>However, the KARL STORZ ICG Imaging System follows the FDA<br>recognized consensus standards and is tested according to the<br>following standards and FDA Guidance:<br>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 Premarket<br>Submissions for Software Contained in Medical<br>Device 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 met<br>its design specifications. The bench testing performed verified<br>and validated that the Telepack X LED has met all its design<br>specification and is substantially equivalent to its predicate<br>devices. |
| Clinical<br>Performance Data: | Clinical published literatures were provided to support the<br>effectiveness of NIR imaging in the neuro- and endonasal skull<br>base surgeries as well as the use of the KARL STORZ ICG Imaging<br>System in pediatrics. |
| Substantial<br>Equivalence: | The intended use, operating principles, technological<br>characteristics and features are similar, if not identical, between<br>that subject device and the Image 1 Video Imaging System<br>(K070716). The minor difference between the subject and<br>predicate devices that does not raise new or different questions<br>or 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.<br>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 Performance<br>Data: | 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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