(126 days)
The Image 1 S is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization, image recording and documentation during general endoscopic and microscopic procedures.
The Image 1 S 4U camera head is intended to the Image1 S Camera Control Unit (CCU) and compatible endoscope for visualization, image recording and documentation during general endoscopic and microscopic procedure.
The Image1 S camera control unit is a medical device which consists of the Image1 S Connect (TC200US), Image1 S Connect II (TC201US) modules and the link modules. The link modules are Image1 S H3-Link (TC300US), Image1 S X-Link (TC301US), Image1 S D3-Link (TC302US) and Image1 S 4U-Link (TC304US).
The Image1 S Connect (TC200US) and the Image1 S Connect II (TC201US) modules can be connected to a minimum of one and a maximum of three links modules. The modularity enables customers to customize their Image1 S system to their specific current and future video needs.
The Image1 S includes, but not limited to, the following features:
• Brightness control
• Enhancement Control
• Automatic Light Source Control
• Shutter Control
• Image/Video Capture
When the Image1 S Connect II module is used with the 4U-Link and the Image1 S 4U camera head, it can output a 4K image to the monitor and also offers 7 increments of zoom ranging from 1x to 2.5x.
The software version of the Image1 S camera control is upgraded to version 4.0. Software version 4.0 introduces the KS HIVE, an Ethernet based interface that allows for communication between the Image 1 S camera control unit and certain KARL STORZ devices.
This is a premarket notification (510(k)) for an endoscopic video imaging system, the Image1 S CCU and Image1 S 4U Camera Head. The primary purpose of this 510(k) is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device (Image1 S, K160044). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the testing and analysis performed to demonstrate this substantial equivalence, rather than a clinical outcome-based performance study typically associated with AI/ML devices.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for an imaging system rather than an AI/ML diagnostic or prognostic device, the "acceptance criteria" are related to safety, effectiveness, and technological characteristics compared to the predicate device. The "reported device performance" are the results of the non-clinical tests demonstrating these aspects.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance / Outcome |
|---|---|---|
| Optical Performance | Comparative testing of optical parameters (e.g., imager type, sensor resolution, zoom capabilities) | Both subject and predicate use CMOS for imager type. Sensor resolution increased from 1920x1080p (predicate) to 3840x2160p (subject). Zoom capabilities expanded from 1x, 1.2x, 1.5x, 1.75x, 2x (predicate) to include 2.25x, 2.5x, and "Adaptive Zoom" (subject). |
| Software Performance | Software verification and validation testing, including compliance with FDA Guidance for "Software Contained in Medical Device" | Software version upgraded from 2.4 (predicate) to 4.0 (subject), introducing KS HIVE (Ethernet-based interface). Testing demonstrated the software functions as intended and is safe. (Level of concern: Moderate) |
| Electrical Safety & EMC | Compliance with international standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 | Device complies with all listed electrical safety and electromagnetic compatibility standards. |
| Reprocessing (Cleaning & Sterilization) | Validation of cleaning and sterilization for the Image1 S 4U camera head against specified standards (e.g., ANSI/AAMI/ISO 14937, AAMI TIR 12, ANSI/AAMI ST81, ST79, ST58, ISO 14161). | Reprocessing data submitted is in compliance with all relevant standards. |
| Design Specifications | Bench testing to ensure the device meets all its design specifications | Bench testing performed verified and validated that the Image1 S has met all its design specifications. |
| Substantial Equivalence | Demonstrated through differences that do not raise new questions of safety and effectiveness, compared to the predicate device. | Conclusions from all technical and performance tests demonstrated the subject device is as safe and effective as the predicate, and differences do not raise new questions of safety and effectiveness. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify a "test set" in the context of clinical images or patient data that would typically be used for AI/ML performance evaluation. The testing primarily involved non-clinical bench testing, software verification/validation, and compliance with standards. Therefore, the "sample size" would refer to the various components and systems tested, but no numerical count is provided for this.
- Data Provenance: Not applicable as no clinical patient data was used for performance evaluation in this 510(k). The testing is primarily engineering and regulatory compliance based.
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)
- Number of Experts & Qualifications: Not applicable. Ground truth, in the sense of clinical annotations by experts for AI/ML performance, was not established as this is not an AI/ML diagnostic device with a clinical performance study. The "ground truth" here is compliance with engineering standards, design specifications, and the functionality of the device as tested by engineers and technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There was no clinical ground truth established requiring expert adjudication.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an endoscopic video imaging system, not an AI/ML diagnostic assistant, so such a study is not relevant to this submission. 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."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an AI/ML algorithm. The "standalone performance" refers to the device's functional operation (imaging, brightness control, zoom, etc.) as detailed in the non-clinical performance data and bench testing, which was indeed performed without human-in-the-loop diagnostic interpretations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For this device, the "ground truth" used is primarily engineering specifications, compliance with recognized international standards (e.g., IEC 60601 series, ANSI/AAMI reprocessing standards), and the functional design requirements of the imaging system. It's not clinical ground truth like pathology or expert consensus on disease.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not involve an AI/ML algorithm that would require a "training set" of clinical data.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable, as there is no AI/ML training set.
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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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 1, 2020
Karl Storz Endoscopy-America, Inc. Alita McElroy Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K201135
Trade/Device Name: Image1 S CCU (TC200US, TC201US, TC300US, TC301US, TC302US, TC304US); Image1 S 4U Camera Head (TH120) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: July 31, 2020 Received: August 3, 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.
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
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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 medical devices and radiation-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,
For Shanil P. Haugen, Ph.D. 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
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Indications for Use
510(k) Number (if known) K201135
Device Name Image1 S CCU (TC200US, TC201US, TC300US, TC301US, TC302US, TC304US) Image1 S 4U Camera Head (TH120)
Indications for Use (Describe)
The Image 1 S is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization, image recording and documentation during general endoscopic and microscopic procedures.
The Image 1 S 4U camera head is intended to the Image1 S Camera Control Unit (CCU) and compatible endoscope for visualization, image recording and documentation during general endoscopic and microscopic procedure.
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.
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: | September 1, 2020 |
| Type of 510(k)Submission: | Traditional |
| Device Name:(Model numbers) | Image1 S CCU (TC200US, TC201US, TC300US, TC301US,TC302US, TC304US)Image1 S 4U Camera Head (TH120) |
| Common Name: | Endoscopic Video Imaging System/Component |
| RegulationNumber: | 21CFR 876.1500 |
| RegulationName: | Endoscope and Accessories |
| RegulatoryClass: | II |
| Product Code: | FET |
| Product CodeName | Endoscopic Video Imaging System/Component |
| Device Panel: | Gastroenterology/Urology |
| PredicateDevice(s): | Image1 S (K160044) |
| DeviceDescription: | The Image1 S camera control unit is a medical device which consistsof the Image1 S Connect (TC200US), Image1 S Connect II(TC201US) modules and the link modules. The link modules areImage1 S H3-Link (TC300US), Image1 S X-Link (TC301US), Image1S D3-Link (TC302US) and Image1 S 4U-Link (TC304US). |
| The Image1 S Connect (TC200US) and the Image1 S Connect II(TC201US) modules can be connected to a minimum of one and amaximum of three links modules. The modularity enables customers tocustomize their Image1 S system to their specific current and futurevideo needs. | |
| The Image1 S includes, but not limited to, the following features:• Brightness control• Enhancement Control• Automatic Light Source Control• Shutter Control• Image/Video Capture | |
| When the Image1 S Connect II module is used with the 4U-Link andthe Image1 S 4U camera head, it can output a 4K image to the monitorand also offers 7 increments of zoom ranging from 1x to 2.5x. | |
| The software version of the Image1 S camera control is upgraded toversion 4.0. Software version 4.0 introduces the KS HIVE, an Ethernetbased interface that allows for communication between the Image 1 Scamera control unit and certain KARL STORZ devices. | |
| Intended Use andIndications forUse: | The Image1 S is a camera control unit (CCU) for use with cameraheads or video endoscopes for visualization, image recording anddocumentation during general endoscopic and microscopic procedures.The Image1 S 4U camera head is intended to be attached to theImage1 S Camera Control Unit (CCU) and compatible endoscope forvisualization, image recording and documentation during generalendoscopic and microscopic procedure. |
| TechnologicalCharacteristics: | The Image1 S camera control unit consists of the Image1 S Connect(TC200US), Image1 S H3-Link (TC300US), Image1 S X-Link(TC301US) cleared in K131953 and the Image1 S D3-Link(TC302US) cleared in K150525 |
| The modified Image1 S now includes following additionalcomponents:• Image1 S Connect II (TC201US)• Image1 S 4U-Link (TC304US)• Image1 S 4U Camera Head (TH120) | |
| The following comparison table summarizes the technologicalcharacteristics between the subject and predicate devices: |
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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. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.
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Image /page/5/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.
| Technological Characteristics | Image1 S | Image1 S | ||
|---|---|---|---|---|
| Subject Device | Predicate DeviceK160044 | |||
| CameraHead | Imager Type | CMOS | CMOS | |
| SensorResolution | 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 | ||
| Softwareversion | 4.0 | 2.4 | ||
| CommunicationInterface | KS HIVE | SCB | ||
| Non-ClinicalPerformanceData: | Comparative testing of optical parameters and software verificationand validation testing demonstrated that the subject device is as safeand as effective as the predicate device. | |||
| There are no performance standards or special controls developedunder Section 514 of the FD&C Act for endoscopes.However, the Image1 S follows the FDA recognized consensusstandards and is tested according to the following standards and FDAGuidance:● Electrical Safety and EMCo IEC 60601-1:2012 (3rd Edition)- Medical ElectricalEquipment - Part 1: General Requirements for basic safetyand essential performanceo IEC 60601-1-2:2014 (4th Edition)- Medical ElectricalEquipment - Part 1- 2: General Requirements for BasicSafety and Essential Performance - Collateral Standard: |
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Image /page/6/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.
| Electromagnetic Compatibility - Requirements and Testso IEC 60601-2-18:2009 (3rd Edition) – Medical ElectricalEquipment Part 2-18:Particular requirements for the basicsafety and essential performance of endoscopic equipment | |
|---|---|
| • Software Verification and Validation Testingo Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Deviceo Level of concern: Moderate | |
| Cleaning and sterilization validations were conducted for the Image1 S4U camera head. The reprocessing data submitted is in compliancewith the following standards:• ANSI/AAMI/ISO 14937:2009/(R) 2013• AAMI TIR 12:2010• ANSI/AAMI ST81:2004/(R) 2010• ANSI/AAMI ST79: 2010/A4:2013• ANSI/AAMI ST 58:2005• ANSI/AAMI/ISO 14161:2000 | |
| Additional bench testing was performed to ensure the device met itsdesign specifications. The bench testing performed verified andvalidated that the Image1 S has met all its design specification and is | |
| substantially equivalent to its predicate device. | |
| ClinicalPerformanceData: | Clinical testing was not required to demonstrate the substantialequivalence to the predicate devices. Non-clinical bench testing wassufficient to establish the substantial equivalence of the modifications. |
| SubstantialEquivalence: | The conclusions drawn from the cleaning and sterilization, software,electrical safety and EMC as well as bench top performance testsdemonstrated that the subject device is as safe and as effective as thepredicate 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. |
§ 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.