(18 days)
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.
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.
The KARL STORZ TELEPACK+ is an all-in-one imaging system for endoscopic and microscopic procedures. This submission (K221174) is a modification of a previously cleared device (K193235). The key modifications include:
- Swapping of two camera types (X-link and Office Link) via touchscreen.
- Addition of capacitors to the Office Link front end.
- Mechanical changes: added isolation to the microphone, an additional cover for the power supply, and a mechanical metal part as a protective earth.
- Addition of video playback and image review functionality.
- Additional cybersecurity features.
- Additional camera and videoscope compatibility.
The device's non-clinical performance data and bench testing were deemed sufficient to demonstrate substantial equivalence to its predicate device. This implies that the device meets its design specifications and is as safe and effective as the legally marketed predicate devices.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Electrical Safety and EMC | |
| IEC 60601-1 (General medical electrical equipment) | Passed |
| IEC 60601-1-2 (Electromagnetic compatibility) | Passed |
| IEC 60601-2-18 (Endoscopic equipment) | Passed |
| IEC 62471 (Photobiological safety) | Passed |
| Software Verification and Validation | |
| Guidance for the Content of Premarket Submissions | Met (Level of concern: Moderate) |
| Performance Testing | |
| Minimum Illumination | Met design specifications |
| Spatial Resolution | Met design specifications |
| Color Performance | Met design specifications |
| Latency | Met design specifications |
| White Balance | Met design specifications |
| AE (Automatic Exposure) Step Response | Met design specifications |
| Head Button Functionality | Met design specifications |
| Protection against electrical shock | Class I protection, Type BF protection (stroboscopy & camera), Type CF protection (light) |
| Moisture protection | Drip-water protection per IPX1 |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" and its sample size in the context of a clinical study, as no clinical performance data was required. The "test set" for demonstrating substantial equivalence primarily involved bench testing and electrical, EMC, and software validation tests. The data provenance is internal to KARL STORZ Endoscopy America, Inc., as these were laboratory and engineering tests conducted on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For this type of device (an imaging system, not an AI diagnostic tool), "ground truth" established by medical experts for a test set is typically not germane to the substantial equivalence pathway, especially when no clinical data is required. The ground truth for engineering and performance measurements is established by standard measurement techniques and reference equipment.
4. Adjudication method for the test set
Not applicable. Since no clinical study or expert review for diagnostic accuracy was performed or required, an adjudication method for a test set is not relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The TELEPACK+ is an imaging system and not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The TELEPACK+ is a medical imaging system, not a standalone algorithm. Its performance is evaluated on its ability to produce high-quality images and manage endoscopic/microscopic procedures, not on an algorithm's diagnostic capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing (e.g., minimum illumination, spatial resolution, color performance) was established through objective engineering measurements using calibrated equipment and standard test methods against the device's design specifications. For electrical safety and EMC, the "ground truth" is compliance with recognized international standards (e.g., IEC 60601 series).
8. The sample size for the training set
Not applicable. The TELEPACK+ relies on traditional imaging processing and control technologies, not machine learning or artificial intelligence that would require a "training set" in the context of algorithm development.
9. How the ground truth for the training set was established
Not applicable. As no training set for an AI algorithm was used, this question is not relevant.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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.
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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/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, Inc2151 E. Grand AvenueEl Segundo, CA 90245 |
|---|---|
| Contact: | Mario TrujilloRegulatory Affairs SpecialistTel.: (424) 218-8184Email: 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/ComponentClassification 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-oneimaging system that includes a 18.5 inch screendisplay, a camera control unit and internal LED lightsource, that is intended to be connected to acompatible device (camera head or videonendoscope)for the purpose of visualization and documentation ofendoscopic and microscopic procedures as well asstroboscopy. |
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| The Telepack + includes a LED illumination lightsource to illuminate the intended area and a 18.5 inchmonitor for display. It also allows the users to redefinethe functions that take place when a button is pressed.The Telepack + is a non-patient contacting and requireonly wipe down as needed. | |
|---|---|
| Intended Use andIndications 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 compatiblecamera heads or video endoscopes for imageprocessing, as well as a monitor for image display,intended for the visualization of endoscopic andmicroscopic procedures. |
| TechnologicalCharacteristics: | The Telepack + is a portable and compact all-in-oneimaging system that includes a 18.5 inch screendisplay, a camera control unit and internal LED lightsource, that is intended to be connected to acompatible device (camera head or videoendoscope)for the purpose of visualization and documentation ofendoscopic and microscopic procedures as well asstroboscopy. |
| The Telepack + includes, but not limited to, thefollowing features:● Image capture● Zoom● Brightness control● Light source control● White Balance | |
| The dimension of the subject device is 450 x 350 x150 mm and weighs 9kg. It is not intended to besoiled and is non-patient contacting. It includesmoderate level of concern software. The device hasbeen tested and passed the electrical safety and EMCtesting, which is certified to be Class I protectionagainst electrical shock, Type BF protection againstelectrical shock from stroboscopy and camera applied | |
| parts, Type CF protection against electrical shock fromlight and lastly drip-water protection against moistureper IPX1. | |
| Non-ClinicalPerformance Data: | There are no performance standards or specialcontrols developed under Section 514 of the FD&C Actfor endoscopes. However, the Telepack + follows theFDA recognized consensus standards and is testedaccording to the following standards and FDAGuidance: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 PremarketSubmissions for Software Contained inMedical 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 thedevice met its design specifications. The benchtesting performed verified and validated that theTelepack + has met all its design specification and issubstantially equivalent to its predicate devices. |
| Substantial Equivalence: | The subject device, Telepack +, marketed by KARLSTORZ Endoscopy America, Inc., is a modification ofthe previous clearance of the same device inK193235.Predicate Comparison Summary |
| The intended use, operating principles, technologicalcharacteristics and features are identical to thoseoriginally cleared in K193235. The minor differencesbetween the originally cleared device and the modifieddevice that do not raise new or different questions ofsafety and effectiveness are:Swapping of two cameras types (X-link andoffice link) via touchscreen. Capacitors were added to the office link frontend Mechanical changes: Isolation is added to microphone Additional cover for power supply Mechanical metal part added as aprotective earth Addition of video playback and image reviewfunctionality. Additional cybersecurity features Additional camera and videoscope compatibility As proven by the comparisons, the above differencesdo not raise different questions of safety andeffectiveness because the intended use, operatingprinciples, technological characteristics, and featuresare similar, if not identical. The modified system alsocomplies with identical standards and safety testing asthe originally cleared device. | |
| Clinical Performance Data: | Clinical performance is not required to demonstratesubstantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establishsubstantial equivalence. |
| Conclusion: | The modified Telepack + is substantially equivalent tothe originally cleared device. The non-clinical benchand comparative testing demonstrate that the device isas safe and effective as the legally marketed devices. |
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§ 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.