(25 days)
No
The summary describes a standard imaging system with image processing capabilities, but there is no mention of AI, ML, or related technologies in the intended use, device description, or performance studies. The focus is on basic image processing, illumination, and display.
No
Explanation: The device is described as an all-in-one imaging system for visualization of endoscopic and microscopic procedures. Its function is to display images, not to treat any medical condition.
No
The device is an imaging system intended for visualization and documentation of endoscopic and microscopic procedures. It does not provide any analysis or interpretation of the images to diagnose a condition.
No
The device description explicitly states it is a portable and compact all-in-one imaging system that includes hardware components such as an 18.5-inch screen display, a camera control unit, and an internal LED light source. It also mentions connections to compatible hardware devices (camera head or videoendoscope).
Based on the provided information, the TELE PACK + is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "visualization of endoscopic and microscopic procedures." This involves directly viewing internal structures or microscopic samples in situ or through a camera, not analyzing samples in vitro (outside the body).
- Device Description: The description focuses on components for illumination, image capture (via compatible devices), image processing, and display. These are all related to visualization, not laboratory analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Reagents or assays
- Sample preparation or analysis of biological specimens (blood, urine, tissue, etc.)
- Measurement of analytes or biomarkers
- Diagnostic testing performed on samples outside the body
The TELE PACK + is an imaging system designed to support endoscopic and microscopic procedures by providing illumination, image processing, and display capabilities. This falls under the category of medical devices used for visualization and procedural support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
FET
Device Description
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 videonendoscope) 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 dimension of the subject device is 450 x 350 x 150 mm and weighs 9kg. 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.
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 Telepack + 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 62471). 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 + has met all its design specification and is substantially equivalent to its 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Telepack X LED (K182696)
Reference Device(s)
Flexible Video Cytoscope HD-View (K191357); Image1 SPIES System (K160044); IMAGE1 SPIES (K131953)
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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December 20, 2019
Karl Storz Endoscopy America, Inc. Winkie Wong Manager, Regulatory Affairs 2151 E. Grand Ave El Segundo, CA 90245
Re: K193235 Trade/Device Name: Telepack + Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: November 22, 2019 Received: November 25, 2019
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 may, 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 aware 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. 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193235
Device Name
Telepack +
Indications for Use (Describe)
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.
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: | December 10th, 2019 |
| Type of
510(k)
Submission: | Special |
| Device
Identification: | Trade Name: Telepack +
Classification Name: Endoscope and accessories |
| Product
Code: | FET |
| Regulation: | 21 CFR 876.1500 (Endoscope and Accessories) |
| Predicate
Device(s): | Telepack X LED (K182696) – Primary |
| Reference
Device(s): | Flexible Video Cytoscope HD-View (K191357); Image1 SPIES System
(K160044); IMAGE1 SPIES (K131953) |
| Device
Description: | 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 videonendoscope) for the purpose of visualization and
documentation of endoscopic and microscopic procedures as well as
stroboscopy. |
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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.
TELEPACK + is compatible with the following devices that are either 510(k) exempt and FDA cleared:
| Model
Number | Description | Product
Code | Clearance status |
|-----------------|------------------------------------------|-----------------|------------------|
| TH110 | IMAGE1 HX | FET | K160044 |
| TH111 | IMAGE1 HX-P | FET | K160044 |
| TH115/TH116 | IMAGE1 D1 S | FET | K131953 |
| 11101VN | Video rhino-laryngoscope | EOB | K072387 |
| 11101VNS | Strobo video rhino-larygoscope | EOB | K072387 |
| 11102CM | CMOS Video-Rhino- | EOB | K182186 |
| 11900BN | Video bronchoscope | EOQ | K071530 |
| 11272VN/VNU | Video cysto-urethroscope | FBO | K062918 |
| 11272VH/VHU | Flexible Video Cystoscope HD-
View | FAJ, FBO | K191357 |
| 8403AXC | Video Laryngoscope | CCW | 510k exempt |
| 8403BXC | Video Laryngoscope | CCW | 510k exempt |
| 8403DXC | Video Laryngoscope | CCW | 510k exempt |
| 8403XSI | C-MAC® S Imager with Office
Interface | CCW | 510k exempt |
| 11301ABX | FIVE Intubation video | CAL | 510k exempt |
| 11302BDX | FIVE Intubation video | CAL | 510k exempt |
| 11303BNX | FIVE Intubation video | CAL | 510k exempt |
| 11304BCX | FIVE Intubation video | CAL | 510k exempt |
| TC001/TC010 | Video connection cable | FGB, FET | K141250, K160044 |
| 20140030 | Microphone | EQL | 510k exempt |
| 20140030T | Adaptor for structure-borne | EQL | 510k exempt |
| Intended Use
and
Indications
for use: | 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. |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological | 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 |
| Characteristics: | 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, but not limited to, the following features:
• Image capture
• Zoom
• Brightness control
• Light source control
• White Balance |
| | The dimension of the subject device is 450 x 350 x 150 mm and weighs 9kg.
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 Telepack +
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 62471
• 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 + has met all its design specification and is substantially equivalent to its predicate devices. |
| Substantial
Equivalence: | The intended use, operating principles, technological characteristics and features are similar, if not identical, between that subject device and the Telepack X LED (K182696). 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 only offers automatic shutter speed, whereas the predicate device offers both automatic and manual shutter speed options. The display resolution is increased from XGA 1204 x 768p to HD 1920 x 1080p to meet market demands. Fuse replacement, Audio Capture, Video input and video playback features are removed for the subject device. Camera head interface has changed; thus the compatible camera head models are different than the predicates User interface has changed from Telepack X LED's own interface to a KARL STORZ unified user interface so all KARL STORZ devices can have the same look and feel. Change in input technology (button to touchscreen). All other inputs (i.e. keyboard, mouse, head buttons, footswitches) remain the same. The subject utilizes internal storage while predicate device allows connection to an external storage device. Screen size is increased from 15" to 18.5" to meet market demands. The weight has increased from 7kg to 9 kg, respectively to accommodate minor change in technology and screen size. 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 + 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 predicate device. |
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