(18 days)
Not Found
No
The summary describes a standard imaging system with basic image processing capabilities and does not mention any AI or ML components or functionalities.
No
The device is described as an "all-in-one Imaging System" intended for "visualization of endoscopic and microscopic procedures," which points to a diagnostic rather than therapeutic function.
No
The device is described as an "all-in-one Imaging System" for "visualization of endoscopic and microscopic procedures," but it does not claim to interpret or analyze images to provide a medical diagnosis.
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.
Based on the provided information, the TELE PACK + is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "visualization of endoscopic and microscopic procedures." This involves imaging within the body or of microscopic samples, but it does not involve testing samples in vitro (outside the living body) to diagnose diseases or conditions.
- Device Description: The description reinforces its function as an imaging system for visualization and documentation of endoscopic and microscopic procedures. It focuses on light source, camera control, and display.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to provide diagnostic information. IVD devices are specifically designed for such purposes.
The device is an imaging system used in conjunction with other medical devices (camera heads, video endoscopes) to aid in medical procedures, but it does not perform diagnostic tests itself.
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 (comma separated list FDA assigned to the subject device)
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 videoendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy. The Telepack + includes a LED illumination light source to illuminate the intended area and a 18.5 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack + is a non-patient contacting and require only wipe down as needed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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May 13, 2022
KARL STORZ Endoscopy America, Inc. Mario Trujillo Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K221174 Trade/Device Name: TELEPACK+ Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FET Dated: April 22, 2022 Received: April 25, 2022
Dear Mario Trujillo:
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.
1
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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,
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221174
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 with a ring around the "O". Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
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: | Mario Trujillo
Regulatory Affairs Specialist
Tel.: (424) 218-8184
Email: Mario.Trujillo@karlstorz.com |
| Date of Preparation: | April 22, 2022 |
| Type of 510(k) Submission: | Special |
| Device Identification: | Trade Name:TELEPACK +
Common Name: Endoscopic Video Imaging System/Component
Classification Name: Endoscope and Accessories |
| Product Code: | FET |
| Regulation: | 21 CFR 876.1500 (Endoscope and Accessories) |
| Predicate Device(s): | Trade Name: Telepack + (K193235) |
| 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. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
Characteristics: | The Telepack + is a portable and compact all-in-one
imaging system that includes a 18.5 inch screen
display, a camera control unit and internal LED light
source, that is intended to be connected to a
compatible device (camera head or videoendoscope)
for the purpose of visualization and documentation of
endoscopic and microscopic procedures as well as
stroboscopy. |
| | The Telepack + includes, 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 subject device, Telepack +, marketed by KARL
STORZ Endoscopy America, Inc., is a modification of
the previous clearance of the same device in
K193235.
Predicate Comparison Summary |
| The intended use, operating principles, technological
characteristics and features are identical to those
originally cleared in K193235. The minor differences
between the originally cleared device and the modified
device that do not raise new or different questions of
safety and effectiveness are:
Swapping of two cameras types (X-link and
office link) via touchscreen. Capacitors were added to the office link front
end Mechanical changes: Isolation is added to microphone Additional cover for power supply Mechanical metal part added as a
protective earth Addition of video playback and image review
functionality. Additional cybersecurity features Additional camera and videoscope compatibility 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. The modified system also
complies with identical standards and safety testing as
the originally cleared device. | |
| 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 modified Telepack + is substantially equivalent to
the originally cleared 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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