KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit

K233333 · Karl Storz SE & CO. KG · OWN · Nov 21, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K233333
• Device Name: KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
• Applicant: Karl Storz SE & CO. KG
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Nov 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, 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 in adults and pediatric patients ≥1 month of age, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients ≥ 12 years of age, using near infrared imaging in accordance with the appropriately indicated endoscope. 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. Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. 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 Imagel S camera control unit (CU) in combination with either a compatible camera head or an appropriately indicated video endoscope is intended for real-time visualization, image recording and documentation during general endoscopic and microscopic procedures in adults and pediatrics.

Device Story

System provides real-time visible (VIS) and near-infrared (NIR) fluorescence imaging for surgical guidance. Inputs: optical signals from endoscopic/microscopic procedures using ICG contrast agent. Components: rigid rod-lens endoscopes, dual-LED light source (VIS 400-700nm, NIR 720-810nm), Image1 S camera control unit (CCU), and camera heads. CCU processes video signals for display, recording, and documentation; features include brightness/enhancement control, automatic light/shutter control, and digital zoom. Used in OR by surgeons for intraoperative assessment of blood flow, tissue perfusion, biliary ducts, and lymphatic structures. Output: visual display of surgical field in white light or fluorescence overlay. Benefits: real-time visual feedback for tissue perfusion and anatomical structure identification during minimally invasive procedures.

Clinical Evidence

No clinical data provided; substantial equivalence demonstrated through bench testing, including electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) testing, and software verification/validation.

Technological Characteristics

Rigid rod-lens endoscopes (5mm diameter); dual-LED light source (VIS 400-700nm, NIR 720-810nm); modular CCU (Image1 S Connect/Link modules); digital outputs (12G/3G-SDI, DisplayPort, DVI-D); connectivity via SCB and Ethernet (KS HIVE); software-controlled image processing (zoom, enhancement, auto-light).

Indications for Use

Indicated for minimally invasive surgery, cranial neurosurgery, endonasal skull base surgery, and plastic/micro/reconstructive surgery. Patient population: adults and pediatrics (≥1 month for general/vessels/perfusion; ≥12 years for biliary ducts; >6 years for neuro/skull base). Used with ICG for visualization of vessels, blood flow, tissue perfusion, biliary ducts, and lymphatic system.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• KARL STORZ ICG Imaging System (K212695)
• HOPKINS Telescopes (K221004)
• Image1 S CCU (TC200US, TC201US, TC300US, TC301US, TC302US, TC304US)
• Image1 S 4U Camera Head (TH120) (K201135)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

November 21, 2023

Karl Storz Se & Co. Kg Emily Rhiel Specialist, Regulatory Affairs Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg Tuttlingen, 78532 Germany

Re: K233333

Trade/Device Name: KARL STORZ ICG Imaging System, KARL STORZ Image 1S Camera Control Unit Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN. GWG. FET Dated: September 28, 2023 Received: September 29, 2023

Dear Emily Rhiel:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Jessica Carr -S

Jessica Carr, Ph.D. Assistant Director 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

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## Indications for Use

510(k) Number (if known) K233333

#### Device Name KARL STORZ ICG Imaging System KARL STORZ Image1 S Camera Control Unit

Indications for Use (Describe) KARL STORZ ICG Imaging System The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.

#### Endoscopic ICG System

Upon intravenous administration and use of ICG consistent with its approved label, 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 in adults and pediatric patients ≥1 month of age, and at least one of the major extrahepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients ≥ 12 years of age, using near infrared imaging in accordance with the appropriately indicated endoscope. 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.

Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

### VITOM II ICG System

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. KARL STORZ Image1 S CCU

The Imagel S camera control unit (CU) in combination with either a compatible camera head or an appropriately indicated video endoscope is intended for real-time visualization, image recording and documentation during general endoscopic and microscopic procedures in adults and pediatrics.

| Type of Use (Select one or both, as applicable) | |
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| <span></span> | <span></span> |
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| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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 at the top. Below that, in smaller blue letters, is the phrase "KARL STORZ - ENDOSKOPE."

# 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 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.

| Submitter: | KARL STORZ SE & Co. KG<br>Dr.-Karl-Storz-Straße 34<br>78532 Tuttlingen, Germany |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Emily Rhiel<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Email: [e-mail] |
| Date of<br>Preparation: | November 6, 2023 |
| Type of 510(k)<br>Submission: | Traditional |
| Device<br>Identification: | KARL STORZ ICG Imaging System<br>KARL STORZ IMAGE1 S Camera Control Unit |
| Regulatory Class: | II |
| Product Code: | OWN: Confocal Optical Imaging<br>GWG: Endoscope, Neurological<br>FET: Endoscopic Video Imaging System/Component |
| Classification<br>Name: | 21 CFR 876.1500 (Endoscope and Accessories)<br>21 CFR 882.1480 (Neurological Endoscopes) |
| Common Name: | Confocal Optical Imaging |
| Device Panel: | Gastroenterology/Urology |
| Predicate Device(s): | KARL STORZ ICG Imaging System (K212695)<br>HOPKINS Telescopes (K221004)<br>Image1 S CCU (TC200US, TC201US, TC300US, TC301US, TC302US, TC304US);<br>Image1 S 4U Camera Head (TH120) (K201135)<br>Predicate devices are manufactured by KARL STORZ SE & Co. KG |
| Device Description: | KARL STORZ ICG Imaging System |
| | The KARL STORZ ICG Imaging System is intended to provide real-time visible<br>(VIS) and near-infrared (NIR) fluorescence imaging for general surgical sites<br>including the abdomen, bile ducts, brain/skull base, and the lymph<br>nodes/lymphatic vessels. Components of the system include: |
| | Scopes:<br>3D TIPCAM®1 Rubina videoendoscope<br>26006ACA/BCA, 26616ACA/BCA Rigid Endoscope<br>26003ACA/ARA/BCA/BRA/FCA/FRA/FCEA/FREA<br>26046ACA/ARA/BCA/BRA/FCA/FRA<br>28164AC/BC/FC VITOM II ICG/NIR Telescope<br>20916025AGA |
| | Light Source:<br>Power LED Rubina (TL400) Foot Switch (UF101) Fiber Optic Light Cable (495TIP/NCSC/NAC) |
| | Camera Head:<br>Image1 S 4U Rubina (TH121) |
| | Camera Control Unit (CCU):<br>Image1 S Connect II (TC201US) Image1 S 4U-Link (TC304US) |
| | KARL STORZ Image1 S CCU |
| | The KARL STORZ IMAGE1 S Camera Control Unit (CCU) is a modular CCU that<br>consists of Image1 S Connect and Connect II modules and the link modules.<br>The Connect modules can be connected to minimum of one and a maximum<br>of three links modules. The modularity enables customers to customize their<br>Image1 S system to their specific 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 |
| | Seven increments of zoom from 1-2.5x and adaptive zoom<br>Modules of the Image1 S CCU include: Image1 S Connect (TC200US) Image1 S Connect II (TC201US) Image1 S H3-Link (TC300US) Image1 S X-Link (TC301US) Image1 S D3-Link (TC302US) Image1 S 4U-Link (TC304US) Accessories to the Image1 S CCU include: Microscope Footswitch (TC019) Image1 S Pilot (TC014) LINK Cable (TC011, TC012) |
| Indications for Use: | KARL STORZ ICG Imaging System<br>The KARL STORZ ICG Imaging System is intended to provide real-time visible<br>(VIS) and near-infrared (NIR) fluorescence imaging.<br><br>Endoscopic ICG System<br>Upon intravenous administration and use of ICG consistent with its approved label, 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 in adults and pediatric patients ≥1 month of age, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients ≥ 12 years of age, using near infrared imaging in accordance with the appropriately indicated endoscope. 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.<br><br>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. |

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Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

## VITOM II ICG System

The KARL STORZ VITOM II ICG System is intended for capturing and viewing fluorescent images 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.

## KARL STORZ Image1 S CCU

The Image1 S camera control unit (CCU) in combination with either a compatible camera head or an appropriately indicated video endoscope is intended for real-time visualization, image recording and documentation during general endoscopic and microscopic procedures in adults and pediatrics.

| Technological<br>Characteristics: | 5mm HOPKINS Rigid Telescope | | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| | Technological<br>Characteristic | Subject Device:<br>KARL STORZ ICG<br>Imaging System | Primary Predicate:<br>K212695<br>KARL STORZ ICG<br>Imaging System | Secondary<br>Predicate: K221004<br>KARL STORZ<br>HOPKINS Telescopes |
| | Endoscope<br>Type | Rigid, rod lens | Same as subject | Same as subject |
| | Outer Diameter | 5mm | Same as subject | Same as subject |
| | Direction of<br>View | 0°<br>30°<br>45° | Same as subject | 0°<br>25°<br>45° |
| | Working Length | 29cm | Same as subject | Same as subject |
| | Depth of Field | 30 – 80 mm | Same as subject | 15.1 – 200mm |
| | Field of View | 68° | Same as subject | Same as subject |
| | Light Source | External | Same as subject | Same as subject |
| | Camera Control Unit (CCU) | | | |
| | Technological<br>Characteristic | Subject Device:<br>KARL STORZ Image1 S CCU | Primary Predicate: K201135<br>KARL STORZ Image1 S CCU<br>(TC200US, TC201US, TC300US,<br>TC301US, TC302US, TC304US) | |
| | Brightness<br>Control | Yes | Yes | |
| | Enhancement<br>Control | Yes | Yes | |
| | Light Source<br>Control | Automatic | Same as subject | |
| | Shutter Control | Automatic | Same as subject | |
| | Image/Video<br>Capture | Yes | Yes | |
| | Zoom | 1x, 1.2x, 1.5x, 1.75x, 2x, 2.25x, 2.5x | Same as subject | |
| | Adaptive Zoom | Yes | Yes | |
| | Digital Outputs | 12G/3G-SDI<br>DisplayPort<br>DVI-D | Same as subject | |
| | Communication<br>Interface | SCB, KS HIVE (Ethernet) | Same as subject | |
| | Control Panel | Microscope Footswitch<br>Pilot | None | |
| | Remote Service | Yes | No | |
| | Software<br>Revision | 4.5 | 4.0 | |
| Light Source | | | | |
| | Technological<br>Characteristic | Subject Device:<br>KARL STORZ ICG Imaging System | Primary Predicate: K212695<br>KARL STORZ ICG Imaging System | |
| | Light Source | Dual LEDs | Same as subject | |
| | Light Source<br>Power | 100-240 VAC | Same as subject | |
| | VIS Light | LED<br>Output: 400-700 nm | Same as subject | |
| | NIR Light | Filtered LED<br>Output: 720-810 nm | Same as subject | |
| | Software<br>Revision | 1.11.01 | 1.08 | |
| Non-Clinical<br>Performance Data: | Electrical Safety and Electromagnetic Compatibility<br>Electrical Safety and Electromagnetic Compatibility testing was conducted in<br>accordance with the following standards:<br>• IEC 60601-1:2005 + A1:2012 + A2:2021 Medical electrical equipment<br>- Part 1: General requirements for basic safety and essential | | | |

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| | • IEC 60601-1-2 : 2014 + A1:2020, Medical Electrical Equipment – Part<br>1-2: General requirements for basic safety and essential<br>performance - Electromagnetic Compatibility |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Software Verification and Validation<br>Software verification and validation testing was conducted and<br>documentation was provided as recommended by FDA's Guidance for<br>Industry and FDA Staff, "Content of Premarket Submissions for Device<br>Software Functions" issued June 14, 2023. The software documentation<br>level conforms to the Basic Level of documentation as there are no risks<br>identified in which a failure or flaw of any device software function(s) could<br>present a hazardous situation with a probable risk of death or serious injury,<br>either to a patient, user of the device, or others in the environment of use. |
| Clinical<br>Performance Data: | Clinical testing was not required to demonstrate substantial equivalence to<br>the predicate devices. |
| Conclusion: | The conclusions drawn from the substantial equivalence comparison<br>demonstrate that the subject device is as safe and effective as the<br>predicates. |