Cellvizio 100 series system with confocal Miniprobes
Applicant
Mauna Kea Technologies
Product Code
OWN · Gastroenterology, Urology
Decision Date
Apr 11, 2022
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The Cellvizio® 100 series system with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture. The Cellvizio® 100 Series System F400 is indicated for in vascular areas, including microvasculature and capillaries. Upon intravenous administration and use of an ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence angiography. Upon interstitial administration and use of ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging of tissues that have taken up the drug. The GastroFlex™ (UHD, UHD-C) and ColoFlex™ (UHD, UHD-C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscopic accessories. The AlveoFlex™ (-. -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e. respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories. The AQ-Flex™ 19 (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, EBUS-TBNA and TBNA). The CystoFlex™ (F. F-C. and UHD, UHD-C) and UroFlex™ B (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories. The CelioFlex™ (UHD 5, UHD 5-C) Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic surgical procedures, including robot-assisted procedures. The CranioFlex™ (-, -C) Confocal Miniprobes™ are indication within the central nervous system during cranial diagnostic and therapeutic procedures such as turnor biopsy and resection.
Device Story
Confocal laser endomicroscopy system; utilizes fiber optic Confocal Miniprobes™ to image internal tissue microstructure. System emits 785nm laser light to excite fluorescent components (ICG or pafolacianine) in tissue; collects emitted fluorescence (800-905 nm) via same fiber optics. Laser Scanning Unit (LSU) digitizes signal; Confocal Processor™ generates real-time images for display on monitor. Used in OR/clinic by physicians during endoscopic/laparoscopic/robot-assisted procedures. Provides high-resolution, real-time visualization of cells, vessels, and tissue architecture; assists in identifying structures or drug uptake. Benefits include improved intraoperative tissue characterization and guidance for diagnostic/therapeutic procedures like biopsies or resections.
Clinical Evidence
Five clinical studies reported; evaluated Cellvizio 100 F800 for tissue characterization using ICG. Demonstrated clear visualization of cellular cytoarchitecture in brain, liver, peritoneum, lymph nodes, diaphragm, colon, stomach, and adrenal gland. Bench testing validated imaging of ICG and pafolacianine at various concentrations and in human cervical carcinoma cell lines. Animal study confirmed real-time, high-quality microscopic imaging of pafolacianine-targeted cells in tumor-bearing mice.
Technological Characteristics
Confocal laser imaging system; 785nm laser source; 800-905 nm detection bandwidth. Components: Laser Scanning Unit (LSU), Confocal Processor™, and fiber optic Confocal Miniprobes™ (rigid objective lens, flexible fibers). Lateral resolution 1-3.5 μm; depth of observation 0-65 μm. Connectivity: Standalone system with monitor output. Sterilization: Miniprobes are endoscopic accessories.
Indications for Use
Indicated for patients undergoing endoscopic, laparoscopic, or surgical procedures requiring visualization of internal tissue microstructure, blood flow, or lymphatic systems. Used in conjunction with ICG or pafolacianine contrast agents for fluorescence imaging in vascular, lymphatic, gastrointestinal, respiratory, urinary, and central nervous system applications.
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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Mauna Kea Technologies % Michael Daniel President Daniel & Daniel Consulting 340 Jones Lane Gardnerville, Nevada 89460
April 11, 2022
## Re: K220477
Trade/Device Name: Cellvizio 100 series system with confocal Miniprobes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OWN, GCJ, GWG Dated: February 16, 2022 Received: February 18, 2022
Dear Michael Daniel:
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. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
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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, M.S. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K220477
Device Name Cellvizio® 100 series system with Confocal Miniprobes™
### Indications for Use (Describe)
The Cellvizio@ 100 series system with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.
The Cellvizio® 100 Series System F400 is indicated for in vascular areas, including microvasculature and capillaries.
Upon intravenous administration and use of an ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence angiography.
Upon interstitial administration and use of ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging of tissues that have taken up the drug.
The GastroFlex™ (UHD, UHD-C) and ColoFlex™ (UHD, UHD-C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscopic accessories.
The AlveoFlex™ (-. -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e. respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
The AQ-Flex™ 19 (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, EBUS-TBNA and TBNA).
The CystoFlex™ (F. F-C. and UHD, UHD-C) and UroFlex™ B (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
The CelioFlex™ (UHD 5, UHD 5-C) Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic surgical procedures, including robot-assisted procedures.
The CranioFlex™ (-, -C) Confocal Miniprobes™ are indication within the central nervous system during cranial diagnostic and therapeutic procedures such as turnor biopsy and resection.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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#### Premarket Notification 510(k) Summary 1
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
## 510(k) Number: K220477
## Applicant Information:
Date Prepared: March 28, 2022
| Name: | Mauna Kea Technologies |
|-----------------|------------------------------------------|
| Contact Person: | Aline Criton, Ph.D. |
| Address: | 9 rue d'Enghien<br>F-75010 Paris, France |
| Phone: | +33 1 48 24 03 45 |
| Fax: | +33 1 48 24 12 18 |
| Contact Person: | Michael A Daniel, Consultant |
| e-mail: | madaniel@clinregconsult.com |
| Phone Number: | (415) 407-0223 |
## Subject Device Information:
| Device Trade Name: | Cellvizio® 100 series system with Confocal Miniprobes™ |
|---------------------------|--------------------------------------------------------|
| Common Name: | Confocal Optical Imaging |
| Classification Name(s): | Endoscope and Accessories |
| Product Code/ Regulation: | OWN / GCJ / GWG 21 CFR 876.1500, 21 CFR 882.1480 |
Classification:
Class II
## Predicate Device:
VS3 Iridium System, Visionsense Ltd., K210265.
## Reference Device:
Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies, K191144.
### Indications for Use:
The Cellvizio® 100 series system with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.
The Cellvizio® 100 Series System F400 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.
Upon intravenous administration and use of an ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence angiography.
Upon interstitial administration and use of ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging of tissues that have taken up the drug.
The GastroFlex™ (UHD, UHD-C) and ColoFlex™ (UHD, UHD-C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.
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The AlveoFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ (-. -C) Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscopic accessories.
The AQ-Flex™ 19 (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, and TBNA).
The CystoFlex™ (F, F-C, and UHD, UHD-C) and UroFlex™ B (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
The CelioFlex™ (UHD 5, UHD 5-C) Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robotassisted procedures.
The CranioFlex™ (-, -C) Confocal Miniprobes™ are indicated to provide visualization within the central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.
## Subject Device Description:
Confocal Miniprobes™ are used with Cellvizio® 100 series (F800) system, which is a confocal imaging system with fiber optic probes which allows visualization of internal microstructure of tissues and blood flow including, but not limited to, the identification of cells, vessels and their orqanization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
To achieve this function, the Cellvizio® 100 series system F800 with its Confocal Miniprobes™ has been designed:
- . To excite fluorescent components within the human tissue with the laser light emitted by the Cellvizio® at 785nm.
- To receive fluorescence signal emitted from tissue microstructures within the spectral detection . bandwidth of the Cellvizio® 800-905 nm.
ICG absorbs light in the near-infrared (NIR) region within a range of 780 nm to 805 nm with a peak absorption of 805 nm and emits fluorescence within a range of 810 nm to 850 nm with a peak emission of 820 nm (cf. ICG labeling).
Therefore, the Cellvizio® 100 series system F800 can excite ICG circulating in the vascular and lymphatic systems and image signal emitted by ICG in these two systems.
Pafolacianine absorbs light in the near-infrared (NIR) region within a range of 760 nm to 785 nm with a peak absorption of 776 nm and emits fluorescence within a range of 790 nm to 815 nm with a peak emission of 796 nm (cf. Pafolacianine Sodium labeling).
Therefore, the Cellvizio® 100 series F800 model can:
- A excite ICG in the vascular system or the Ivmphatic system and image signal emitted by ICG in the vascular system or the lymphatic system after ICG has been administered to the patient according to its approved labeling.
- A excite pafolacianine or tissues that have taken up pafolacianine and image signal emitted by pafolacianine or tissues that have taken up pafolacianine after pafolacianine has been administered to the patient according to its approved labeling.
### Comparison to Predicate and Reference Devices:
The table below details the Indications for Use between the subject device, the predicate device and the reference device.
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| Device<br>&<br>Predicate<br>Device(s): | K220477 | K210265 | K191144 |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device Characteristics | | | |
| Device Name | Cellvizio® 100 Series<br>System with Confocal<br>Miniprobes | VS3 Iridium system | Cellvizio® 100 Series<br>System with Confocal<br>Miniprobes |
| Operating<br>mechanism | The tissue is illuminated by<br>the laser light transmitted by<br>the fibers of the Confocal<br>Miniprobe™ through its<br>distal objective lens. The<br>optical signal from the<br>tissue is collected back by<br>the same objective and<br>fibers. The fibers are<br>connected to the Laser<br>Scanning Unit (LSU) that<br>integrates the illumination<br>source and the optical<br>detector. Once digitized, the<br>signal is transmitted to the<br>Confocal Processor™ that<br>processes the image to be<br>displayed on a monitor. | IR laser/LED is integrated in<br>VS3- 785 nm Iridium<br>System endoscope /<br>microscope, and it is used<br>to provide illumination of the<br>anatomy under<br>examination. The light is<br>transmitted from the IR<br>laser/LED to the distal tip<br>via two glass fiber light<br>bundles. The raw data<br>captured at the distal tip<br>Silicon Image Sensor in the<br>Camera is converted to a<br>video signal by the printed<br>circuit board (PCB). It<br>allows the image to be<br>displayed on a monitor. | The tissue is illuminated by<br>the laser light transmitted by<br>the fibers of the Confocal<br>Miniprobe™ through its<br>distal objective lens. The<br>optical signal from the<br>tissue is collected back by<br>the same objective and<br>fibers. The fibers are<br>connected to the Laser<br>Scanning Unit (LSU) that<br>integrates the illumination<br>source and the optical<br>detector. Once digitized, the<br>signal is transmitted to the<br>Confocal Processor™ that<br>processes the image to be<br>displayed on a monitor. |
| Light Source | Laser | Laser | Laser |
| Maximum<br>output<br>power | 40 mW | 500 mW | 15 mW |
| Excitation<br>wavelength | 785 nm | 785 nm | 488 nm |
| Detection<br>bandwidth | 800 - 905 nm | 800 - 850 nm | 500 - 650 nm |
| Optical<br>components | Rigid section including<br>objective lens, flexible<br>optical fibers to transmit<br>visible light to and from the<br>tissue. | Rigid section including<br>objective lens, flexible<br>optical fibers to transmit<br>NIR light to and from the<br>tissue. | Rigid section including<br>objective lens, flexible<br>optical fibers to transmit<br>visible light to and from the<br>tissue. |
| Angle of view | 0 degrees | 0 and 30 degrees | 0 degrees |
| Field of view | Circular, diameters of 240,<br>325, and 600 μm | 70 - 95 degrees to provide<br>visualization at a<br>macroscopic level | Circular, diameters of 240,<br>325, and 600 μm |
| Depth<br>of<br>observation | 0 – 65 μm | 0 μm | 0 – 65 μm |
| Lateral resolution | 1 - 3.5 μm | 50 – 250 μm | 1 – 3.5 μm |
| Visualization<br>of<br>Real-Time Images | 9 - 12 FPS | 45 FPS | 9 - 12 FPS |
| Use<br>of<br>contrast<br>agent | ICG, pafolacianine | ICG, pafolacianine | Sodium Fluorescein |
Table: Comparison the subject device and previously cleared predicate and reference devices
Materials, design, and intended use of the aforementioned Cellvizio® 100 series F800 system Confocal laser imaging systems and its Confocal Miniprobes™ remain exactly the same as previously cleared in K191144. The F800 system is similar to the VS3 Iridium System (cleared via K210265) including the use of the system with the approved infrared contrast agents, ICG or pafolacianine sodium injection (or Pafolacianine).
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The subject device, the Cellvizio® 100 series F800 with Confocal Miniprobes™ operates in an identical way as the reference device, the Cellvizio® 100 F400 series with Confocal Miniprobes™ (cleared via K191144) in order to provide confocal images of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.
No change is being made in terms of design, fundamental technology, and operating principle of the previously cleared CholangioFlex™, AQ-Flex™ 19, CystoFlex™ F, and UroFlex™ B Confocal Miniprobes™ (cleared via K172844 and K183640). The commercial name of these Confocal Miniprobes™ has been changed when they are used with a Cellvizio 100 Series F800 model. Indications for use of the CholangioFlex™ -C, AQ-Flex™ 19 -C, CystoFlex™ F-C, and UroFlex™ B-C Confocal Miniprobes™ are the same as the reference device (K191144).
The subject device, the Cellvizio® 100 (F800) series with its Confocal Miniprobes™ and the reference device, the Cellvizio® 100 (F400) series with its Confocal Miniprobes™ (cleared via K191144) are similar as they have the identical indications for use, material, design, fundamental technology, and operating principle.
## Performance Testing - Bench Completed:
Bench testing has been performed to validate the capability of the Cellvizio® 100 series F800 model with Confocal Miniprobes™ to image ICG and pafolacianine. These tests consisted of the following:
- In vitro imaging of ICG with different concentrations,
In vitro imaging of pafolacianine with different concentrations,
- In vitro imaging of human cervical carcinoma cell line with known overexpression of FRa, stained with different concentrations of pafolacianine.
These tests showed that the Cellvizio 100 series F800 model with Confocal Miniprobes™ is capable of imaging ICG at different concentrations and pafolacianine-labeled cells.
## Performance Testing - Animal Completed:
The objective of this animal study was to assess the capability of the Cellvizio® 100 series F800 model with its Confocal Miniprobes™, also called Confocal Laser Endomicroscopy (CLE), to image cells targeted by pafolacianine sodium in tumor cell culture, and in tumor-bearing mice in vivo.
This animal study demonstrated that Cellvizio® 100 series F800 model with its Confocal Miniprobes™ can provide high quality images at microscopic level, in real-time, pafolacianine sodium targeted cells and tissues. Endomicroscopic images demonstrated adequate resolution and sensitivity to identify different cell types in different tissues and visualize distinct cell architectures based on pafolacianine sodium biodistribution in the tumor and normal organs.
### Performance Testing - Clinical:
Five (5) studies have been reported on the use of the Cellvizio® 100 series F800 confocal laser endomicroscopy for tissue characterization using ICG as a contrast agent.
All studies reported clear visualization of the cellular cytoarchitecture with the Cellvizio® 100 series F800 after intravenous injection of ICG in different tissues, such as the brain, liver, peritoneum, lymph node, diaphragm, colon, stomach, and adrenal gland.
### Summary:
The subject device, the Cellvizio® 100 series F800 model with Confocal Miniprobes™ and the predicate device Medtronic VS3-785 nm Iridium System (K210265) have the same intended use and the same operating procedure and are made of the same, main components (optical fibers and optical lenses) that allow imaging of tissues, the vascular system or the lymphatic system.
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The subject device, the Cellvizio® 100 series F800 model with Confocal Miniprobes™ and the predicate device Medtronic VS3-785 nm Iridium System (K210265) are comparable when used in conjunction with ICG or pafolacianine as:
- A The concentration, rate of administration, or route of administration for the use of ICG or pafolacianine are the same for both devices and as those described in the approved labeling of the contrast agents.
- A Body systems imaged with the Cellvizio® 100 series F800 model and the predicate device in conjunction with pafolacianine (tissues that have taken up pafolacianine) and ICG (vascular system or lymphatic system) are the same as those described in the approved labeling of the contrast agent, pafolacianine and ICG.
- A The patient population for which the subject device will be used is the same as the predicate, the VS3 Iridium System. Indeed, the predicate system is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The subject device is used to perform fluorescence imaging of tissues that have taken up the drug during endoscopic, laparoscopic surgical, and surgical procedures.
- A The imaging modality performed by both the predicate and the subject devices is comparable. Both devices achieve fluorescence imaging by:
- を exciting fluorescent components within the human tissue that have taken up pafolacianine with the laser light emitted at 785nm
- ゃ receiving fluorescence signal emitted from tissues that have taken up pafolacianine within the spectral detection bandwidth (800-850 nm for the VS3 Iridium System and 800-905 nm for the Cellvizio®).
In both cases. ICG and Pafolacianine are administered to the patient according to their approved labeling, excitation light is shown onto the tissue and emitted fluorescent light is used to observe the blood flow in vascular areas or visualize the lymphatic system for ICG (depending on the route of administration or ICG), or perform fluorescence imaging of tissues that have taken up the Pafolacianine. While the systems have specific technological differences, they each have the functions for viewing and recording fluorescent images. The technological differences do not raise different questions of safety or effectiveness.
Both devices use ICG and Pafolacianine as contrast agents to perform fluorescent imaging without changes to the formulation, mode of action, approved dose or route of administration.
ICG and Pafolacianine are used in an identical manner for both devices.
Additionally, the Confocal Miniprobes™ of the subject device have technical characteristics (maximum field of view, depth of observation, lateral resolution) as Confocal Miniprobes™ of the reference device.
The subject device, the Cellvizio® 100 (F800) series system with Confocal Miniprobes™ and the reference device, Cellvizio® 100 (F400) series system with Confocal Miniprobes™ (cleared via K191144), have the same indications for use. The resolution and optical characteristics of the Confocal Miniprobes™ on both the reference and subject devices are identical.
Therefore, Mauna Kea respectfully asserts that the Cellvizio® 100 series system with its Confocal Miniprobes™ described in this submission is as safe, as effective, and performs as well as the VS3-785 nm Iridium System (K210265) and is identical to the previously cleared Cellvizio® 100 Series system with Confocal Miniprobes reference device (cleared via K191144).
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
