(81 days)
The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
The KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
The KARL STORZ VITOM II ICG System is intended for capturing fluorescent mages for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.
The modified KARL STORZ ICG Imaging System includes the following components:
i) Modified 10mm and 5mm HOPKINS ICG/NIR Rigid Endoscopes (0°, 30°, 45°): have an improved optical design with the white light and NIR images in good focus simultaneously.
ii) Power LED Rubina Light Source and Footswitch: The light source has two LEDs, white light and NIR.
iii) Image1 S 4U Rubina Camera Head: uses a 2 chip 4K camera head that houses 2 CMOS sensors: one for white light and the other for NIR.
iv) Camera Control Unit: Image1 S Connect II (TC201US) and Image1 S 4U- Link (TC304US): is used with the Image1 S 4U Rubina Camera Head to output a 4K image to the monitor.
The provided text describes a 510(k) submission for the KARL STORZ ICG Imaging System. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. Therefore, there is no information provided regarding acceptance criteria for device performance related to a clinical study, or details about such a study.
The document details various non-clinical performance data and validation tests conducted to ensure the device meets its design specifications and complies with relevant standards. Here's a breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria with reported device performance in a format typically used for clinical endpoints. Instead, it lists various non-clinical tests that were performed to demonstrate that the device met its design specifications and complied with standards.
Here's a summary of the non-clinical performance data categories mentioned:
| Acceptance Criteria Category (Non-Clinical) | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety and EMC | Device follows IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 standards. |
| ISO Endoscopic Standards | Device follows ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 8600-5, ISO 8600-6 standards. |
| Software Verification and Validation | Testing conducted according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device" (Level of concern: Moderate). |
| Cleaning and Sterilization Validations | Validations conducted for the Image1 S 4U Rubina camera head. |
| Bench Testing (Optical/Imaging) | Testing performed to ensure device met design specifications for: - Depth of Field - Distortion - Latency - Dynamic Range - Signal to Noise Ratio (SNR) & Sensitivity - Spatial Resolution - Color Reproduction and Color Contrast Enhancement - Illumination Detection Uniformity - Detection Linearity - Direction of View - Field of View - Zoom Characterization - Penetration Depth - ICG Contrast Concentration Sensitivity - Color Rendering - Coregistration - Photobiological Safety (UV Exposure and Distal Irradiance) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." Therefore, there is no information about a test set sample size or data provenance from a clinical study.
The "test set" in this context refers to the methods and components used in the described non-clinical bench tests and validations (e.g., specific endoscopes, camera heads, light sources, etc., as detailed in the "Device Description" and "Technological Characteristics" sections). These are not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical study was performed or required, there is no mention of experts establishing a ground truth for a test set, nor their qualifications. The ground truth for the non-clinical tests would be defined by the technical specifications and standards against which the device's performance was measured.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study or expert adjudication for a test set is mentioned.
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 device is an imaging system (endoscope and related components), not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a medical imaging system intended for use by surgeons during procedures, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" would be the engineering specifications and established performance parameters of the device, as evaluated through bench testing against recognized standards (e.g., IEC, ISO). No clinical ground truth (like pathology or outcomes data) was used.
8. The sample size for the training set
Not applicable. The document describes a medical imaging hardware system and its components. It does not mention any machine learning or AI components that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Karl Storz-Endoscopy-America, Inc. Alita McElroy Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245
August 17, 2020
Re: K201399
Trade/Device Name: HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0, 30, 45, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0. 30. 45. HOPKIN ICG/NIR 4mm Ridgid Endoscope 0, 30, 45, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN, GWG Dated: May 27, 2020 Received: May 28, 2020
Dear Alita McElroy:
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.
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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 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.
Neil R.P. Ogden Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K201399
Device Name KARL STORZ ICG Imaging System
Indications for Use (Describe)
The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
The KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
The KARL STORZ VITOM II ICG System is intended for capturing fluorescent mages for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.
| 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 is 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 phrase "KARL STORZ - ENDOSKOPE" in smaller letters. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.
510(k) Summary
This 510(k) Summary 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.
| Submitter: | KARL STORZ Endoscopy-America, Inc.2151 E. Grand AvenueEI Segundo, CA 90245 |
|---|---|
| Contact: | Alita McElroyRegulatory Affairs SpecialistPhone: (424) 218-8376Fax: (424) 218-8519 |
| Date ofPreparation: | May 27, 2020 |
| Type of 510(k)Submission: | Traditional |
| 510(k) Number: | K201399 |
| DeviceIdentification: | Trade Name: KARL STORZ ICG Imaging SystemClassification Name: Confocal Optical Imaging |
| RegulatoryClass: | II |
| Product Code: | OWN, GWG |
| Regulation: | 21 CFR 876.1500 (Endoscope and Accessories)21 CFR 882.1480 (Neurological Endoscopes) |
| PredicateDevice(s): | KARL STORZ ICG Imaging System (K180146) |
| DeviceDescription: | The modified KARL STORZ ICG Imaging System includes thefollowing components:Modified 10mm and 5mm HOPKINS ICG/NIR Rigidi)Endoscopes (0°, 30°, 45°): have an improved opticaldesign with the white light and NIR images in goodfocus simultaneously.ii)Power LED Rubina Light Source and Footswitch: Thelight source has two LEDs, white light and NIR.iii)Image1 S 4U Rubina Camera Head: uses a 2 chip 4Kcamera head that houses 2 CMOS sensors: one forwhite light and the other for NIR.Camera Control Unit: Image1 S Connect II (TC201US)iv)and Image1 S 4U- Link (TC304US): is used with the |
| Image1 S 4U Rubina Camera Head to output a 4Kimage to the monitor. | |
| Intended Use | The KARL STORZ ICG Imaging System is intended to provide real-time visible and near-infrared fluorescence imaging. |
| Indications forUse: | The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. |
| The KARL STORZ Endoscopic ICG System enables surgeons toperform minimally invasive surgery using standard endoscopic visiblelight as well as visual assessment of vessels, blood flow and relatedtissue perfusion, and at least one of the major extra-hepatic bile ducts(cystic duct, common bile duct and common hepatic duct), using nearinfrared imaging. Fluorescence imaging of biliary ducts with theKARL STORZ Endoscopic ICG System is intended for use withstandard of care white light and, when indicated, intraoperativecholangiography. The device is not intended for standalone use forbiliary duct visualization. | |
| Additionally, the KARL STORZ Endoscopic ICG System enablessurgeon to perform minimally invasive cranial neurosurgery in adultsand pediatrics and endonasal skull base surgery in adults andpediatrics > 6 years of age using standard endoscopic visible light aswell as visual assessment of vessels, blood flow and related tissueperfusion using near infrared imaging. | |
| The KARL STORZ VITOM II ICG System is intended for capturingand viewing fluorescent images for the visual assessment of bloodflow, as an adjunctive method for the evaluation of tissue perfusion,and related tissue-transfer circulation in tissue and free flaps used inplastic, micro- and reconstructive surgical procedures. The VITOM IIICG System is intended to provide a magnified view of the surgicalfield in standard white light. | |
| TechnologicalCharacteristics: | The clinical application for the subject KARL STORZ ICG ImagingSystem is identical to the cleared KARL STORZ ICG ImagingSystem, K180146. |
| The 4mm, 5mm & 10mm Endoscopes and VITOM ICG telescopesconnected to the optical coupler of the Image1 S 4U Rubina camerahead, which connects to the Image1 S Camera Control Unit for imageprocessing, as well as to the Power LED Rubina light source light |
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Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters on the second line.
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Image /page/5/Picture/0 description: The image is a logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
| Technological Characteristics | KARL STORZ ICGImaging SystemSubject Device | KARL STORZICG SystemPredicate DeviceK180146 | |
|---|---|---|---|
| Endoscopes(5mm and10mm) | Direction ofView | 0°, 30°, 45° | 0°, 30° |
| WorkingLength | 29cm (5mm, 0°,30°, 45°)31cm (10mm, 0°,30°, 45°)42cm (10mm 45°) | 29cm (5mm, 0°,30°)31cm (10mm,0°, 30°) | |
| CameraHead | Imager Type | 2-chip CMOS (onefor WLi and one forICG) | 3- chip CCDsensors (one foreach red, greenand blue) |
| Number ofPixels | 3840 x 2160p | 1920 x 1080p | |
| CameraControlUnit | Zoom | 1x, 1.2x, 1.5x,1.75x, 2x, 2.25x,2.5x | 1x, 1.2x, 1.5x,1.75x, 2x |
| Adaptive Zoom | Yes | No | |
| Digital Outputs | 12G/3G-SDIDisplayPortDVI-D | 3G-SDIDVI-D | |
| CommunicationInterface | KS HIVE | SCB | |
| LightSource | Light SourceType | Dual LEDs | Xenon 300Wlamp |
| NIR Light | Filtered LEDOutput: 720-810 nm | Filtered XenonlampOutput: 690-790nm | |
| Image Presentation | Displayed image iseither the VIS lightimage or the NIRimage.For the NIR image,the user has threepresentations of theICG imagery tochoose from:a. Overlay: Thewhite light image isoverlaid with theNIR image. TheNIR image couldeither by blue orgreenb. Intensity Map:The white lightimage is overlaidwith colortransformed NIRimage.c. Monochromatic:The NIR image isindicated by thecolor white againsta dark background. | Displayed imageis either the VISlight image orthe NIR image.The blue NIRimage is overlaidover remnantred-greenbackground. | |
| Non-ClinicalPerformanceData: | There are no performance standards or special controls developedunder Section 514 of the FD&C Act for endoscopes.However, the KARL STORZ ICG Imaging System follows the FDArecognized consensus standards and is tested according to thefollowing standards and FDA Guidance: |
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Image /page/6/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 phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
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Image /page/7/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 phrase "KARL STORZ - ENDOSKOPE" in a smaller font.
| Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 ISO Endoscopic Standards ISO 8600-1 ISO 8600-3 ISO 8600-4 ISO 8600-5 ISO 8600-6 Software Verification and Validation Testing Guidance for the Content of Premarket Submissions for Software Contained in Medical Device Level of concern: Moderate Cleaning and sterilization validations were conducted for the Image1 S 4U Rubina camera head.Additional bench testing listed below was performed to ensure the device met its design specifications. Depth of Field Distortion Latency Dynamic Range Signal to Noise Ratio (SNR) & Sensitivity Spatial Resolution Color Reproduction and Color Contrast Enhancement Illumination Detection Uniformity Detection Linearity Direction of View Field of View Zoom Characterization Penetration Depth ICG Contrast Concentration Sensitivity Color Rendering Coregisteration Photobiological Safety (UV Exposure and Distal Irradiance) | |
|---|---|
| ClinicalPerformanceData: | Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications. |
| SubstantialEquivalence: | The conclusions drawn from the cleaning and sterilization data(Section 17), Software Data (Section 19), Electrical Safety and EMCdata (Section 20), as well as the Bench Top Performance Data (Section21) demonstrated that the subject device is as safe and as effective asthe predicate device. |
| As such, we concluded that the substantial equivalence of the subjectand the predicate device has been met, and the differences between thesubject and predicate do not raise new questions of safety andeffectiveness. |
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Image /page/8/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 circle in the middle of the "O". Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller, sans-serif font.
§ 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.