(54 days)
No
The summary describes a standard imaging system with image processing capabilities, but there is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No.
The device is described as an "all-in-one Imaging System" for "visualization of endoscopic and microscopic procedures," which indicates it is for diagnostic or visualization purposes, not for treating a condition.
No
The device is an imaging system for "visualization of endoscopic and microscopic procedures," which focuses on displaying images rather than providing a medical diagnosis.
No
The device description explicitly states it 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," indicating it is a hardware device with integrated software.
Based on the provided information, the TELE PACK X LED is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for the "visualization of endoscopic and microscopic procedures." This involves imaging within the body or of microscopic samples, not testing biological samples outside the body.
- Device Description: The description reinforces its function as an imaging system for visualization and documentation during procedures. It mentions connecting to camera heads or video endoscopes, which are used for direct observation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to perform tests on these types of samples to diagnose conditions.
The device is an imaging system used to assist in medical procedures by providing visual information, which is distinct from the function of an IVD.
N/A
Intended Use / 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.
Product codes
FET
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes. However, the KARL STORZ ICG Imaging System follows the FDA recognized consensus standards and is tested according to the following 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 Premarket Submissions for Software Contained in Medical 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 its design specifications. The bench testing performed verified and validated that the Telepack X LED has met all its design specification and is substantially equivalent to its predicate devices.
Clinical Performance Data: Clinical published literatures were provided to support the effectiveness of NIR imaging in the neuro- and endonasal skull base surgeries as well as the use of the KARL STORZ ICG Imaging System in pediatrics. Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.
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
2151 E. Grand Avenue
El Segundo, CA 90245 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong
Regulatory Affairs Manager
424-218-8379 (phone) |
| Date of Preparation: | September 24th, 2018 |
| Type of 510(k)
Submission: | Traditional |
| Device Identification: | Trade Name: Telepack X LED
Classification Name: Endoscopic Video Imaging
System/Component |
| Product Code: | FET |
| Regulation: | 21 CFR 876.1500 (Endoscope and Accessories) |
| Predicate Device(s): | Image 1 Video Imaging System (K070716) – Primary
KARL STORZ ICG Imaging System (K180146) – Reference
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
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. |
| Intended Use and
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. |
| Technological
Characteristics: | 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, but not limited to, the following
features:
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
weighs 7kg. It is not intended to be soiled and is non-patient
contacting. It includes moderate level of concern software. The
device has been tested and passed the electrical safety and EMC
testing, which is 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 and lastly drip-water
protection against moisture per IPX1. |
| Non-Clinical
Performance Data: | There are no performance standards or special controls
developed under Section 514 of the FD&C Act for endoscopes.
However, the KARL STORZ ICG Imaging System follows the FDA
recognized consensus standards and is tested according to the
following 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 Premarket
Submissions for Software Contained in Medical
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
its design specifications. The bench testing performed verified
and validated that the Telepack X LED has met all its design
specification and is substantially equivalent to its predicate
devices. |
| Clinical
Performance Data: | Clinical published literatures were provided to support the
effectiveness of NIR imaging in the neuro- and endonasal skull
base surgeries as well as the use of the KARL STORZ ICG Imaging
System in pediatrics. |
| Substantial
Equivalence: | The intended use, operating principles, technological
characteristics and features are similar, if not identical, between
that subject device and the Image 1 Video Imaging System
(K070716). The minor difference between the subject and
predicate devices that does not raise new or different questions
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.
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
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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