Who is the manufacturer of Cellvizio 100 Series System with Confocal Miniprobes?

Mauna Kea Technologies filed the 510(k) submission for Cellvizio 100 Series System with Confocal Miniprobes (K191144).

What is the FDA product code for Cellvizio 100 Series System with Confocal Miniprobes?

OWN. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Cellvizio 100 Series System with Confocal Miniprobes?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Cellvizio 100 Series System with Confocal Miniprobes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cellvizio 100 Series System with Confocal Miniprobes

K191144 · Mauna Kea Technologies · OWN · Jan 24, 2020 · Gastroenterology, Urology

Device Facts

Record ID	K191144
Device Name	Cellvizio 100 Series System with Confocal Miniprobes
Applicant	Mauna Kea Technologies
Product Code	OWN · Gastroenterology, Urology
Decision Date	Jan 24, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

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-v2 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. The GastroFlex™ UHD and ColoFlex™ UHD Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e. respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ series of Confocal Miniprobe™ is 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 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories (e.g. aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA needles). The CystoFlex™ (F, UHD-R) and UroFlex™ B of 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 of Confocal Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures. The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

Device Story

Cellvizio 100 Series is a confocal laser endomicroscopy system using fiber optic probes to provide real-time, high-magnification in-vivo imaging of tissue microstructure. The system utilizes a 488 nm blue laser to excite tissue autofluorescence or Fluorescein Sodium contrast agent. The fiber scanner probe is placed in direct contact with target tissue; the system reconstructs the reflected/emitted light into images displayed on a monitor. Used in OR or clinical settings by physicians (endoscopists, surgeons, neurosurgeons) during diagnostic and therapeutic procedures (e.g., biopsy, resection). Output provides visual information on cellular organization and blood flow, assisting clinicians in real-time decision-making during procedures. Benefits include enhanced visualization of microvasculature and tissue architecture, potentially improving diagnostic accuracy and surgical guidance.

Clinical Evidence

No new clinical trials conducted. Substantial equivalence supported by literature review, Real World Evidence (RWE), and independent clinical findings from researchers and Health Technology Assessment organizations. Previous bench testing from cited predicates (K111047, K122042, K123676, K133466, K150831, K151593, K160416, K171345, K172844, K180270, K183640) remains applicable.

Technological Characteristics

Confocal laser scanning system; 488 nm continuous blue laser source (Class 2M). Fiber optic probe sensing/actuation. Real-time imaging (9-12 Hz). Connectivity via DICOM PACS, shared drive, and USB. Software controls laser emission, scanning, image reconstruction, and display. No changes to materials or design from predicates.

Indications for Use

Indicated for imaging internal tissue microstructure, cells, and vessels in gastrointestinal, respiratory, urinary, and central nervous system tracts, as well as body cavities and organs during endoscopic, laparoscopic, or robot-assisted procedures. Also indicated for imaging blood flow in microvasculature and capillaries using Fluorescein Sodium contrast agent.

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

Cellvizio® 100 Series Confocal laser imaging system with Confocal Miniprobe™ (K172844, K180270, K183640)

Reference Devices

Zeiss CONVIVO (K181116)

Related Devices

K220477 — Cellvizio 100 series system with confocal Miniprobes · Mauna Kea Technologies · Apr 11, 2022
K193416 — Cellvizio I.V.E. with Confocal Miniprobes · Mauna Kea Technologies · Feb 28, 2020
K180270 — Cellvizio 100 Series Systems with Confocal Miniprobes · Mauna Kea Technologies · May 22, 2018
K111047 — CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES · Mauna Kea Technologies, Inc. · Aug 8, 2011
K212322 — Cellvizio I.V.E. system with Confocal Miniprobes · Mauna Kea Technologies · Aug 18, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Mauna Kea Technologies % Michael Daniel President Daniel & Daniel Consulting 340 Jones Lane Gardnerville, Nevada 89460 January 24, 2020 Re: K191144 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: December 19, 2019 Received: December 20, 2019 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Neil R.P. Ogden Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT5: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191144 Device Name Cellvizio® 100 Series system with Confocal Miniprobes™ ### Indications for Use (Describe) 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-v2 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. The GastroFlex™ UHD and ColoFlex™ UHD Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e. respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ series of Confocal Miniprobe™ is 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 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories (e.g. aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA needles). The CystoFlex™ (F, UHD-R) and UroFlex™ B of 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 of Confocal Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures. The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D)</div> | Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # K191144 # 2 Premarket Notification 510(k) Summary 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: K191144 ## Applicant Information: Date Prepared: January 24, 2020 | Manufacturer Contact Person: | Aline Criton | |------------------------------|-------------------------------------------------------------| | Name: | Mauna Kea Technologies | | Address: | 9 rue d'Enghien F-75010 Paris, France | | Phone: | +33 1 48 24 03 45 | | Fax: | +33 1 48 24 12 18 | | Contact Person: | Michael A Daniel, Consultant madaniel@clinregconsult.com | | Phone Number: | (415) 407-0223 | | Office: | (775) 392-2970 | | Facsimile Number: | (610) 545-0799 | ## Device Information: | Device Trade Name: | Cellvizio® 100 Series Confocal laser imaging systems with Confocal Miniprobes™ | |-------------------------------------------|-----------------------------------------------------------------------------------| | Common Name: | Endoscope and Accessories Neurological Endoscope | | Classification Name(s): | Confocal Optical Imaging | | Primary regulation and Product Code: | OWN / GCJ 21 CFR 876.1500 | | Secondary regulation and Product Code: | GWG 21 CFR 882.1480 | | Classification: | Class II | # Classification: Predicate Devices: - Previously cleared versions of Cellvizio® 100 Series Confocal laser imaging system with ● Confocal Miniprobe™ (K172844, K180270 and K183640). ## Reference Devices: - . The Zeiss CONVIVO (K181116). {5}------------------------------------------------ ## Indications for Use: 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-v2 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. The GastroFlex™ UHD and ColoFlex™ UHD Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ series of Confocal Miniprobe™ is 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 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories (e.g. aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA needles). The CystoFlex™ (F, UHD-R) and UroFlex™ B of Confocal Miniprobe™ 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 of Confocal Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures. The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection. ## Device Description: Confocal Miniprobes™ are used with Cellvizio® 100 Series System (F400-v2), 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 organization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures and during neurosurgical procedures. Fluorescein Sodium is used as a fluorescence contrast agent to allow imaging of microvasculature and visualization of blood flow. Fluorescein Sodium can be used as a contrast agent with Cellvizio® 100 Series system with Confocal Miniprobes™ without change of formulation, mode of action, approved dose or route of administration; it is delivered independent of Cellvizio® 100 Series system in accordance with Fluorescein Sodium instruction for use. {6}------------------------------------------------ Materials, design and intended use of the aforementioned Cellvizio® 100 Series Confocal laser imaging systems and their Confocal Miniprobes™ remain exactly the same as what were previously cleared in K172844, K180270 and K183640. ## Comparison to Predicate Device: The table below details the difference in Indications for Use between the subject device and the previously cleared predicate device (See Table 7-1). {7}------------------------------------------------ | Aspect | Subject Device Cellvizio® 100 Series System F400-V2 with Confocal Miniprobes™ with Fluorescein | Predicate Device Cellvizio® 100 Series System F400-V2 with Confocal Miniprobes™ | Comparison to predicate | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Cellvizio® 100 Series System with Confocal Miniprobes™ | Cellvizio® 100 Series System with Confocal Miniprobes™ | Unchanged | | Manufacturer | Mauna Kea Technologies 9 Rue d'Enghien F-75010 Paris, France | Mauna Kea Technologies 9 Rue d'Enghien F-75010 Paris, France | Unchanged | | Model | Cellvizio® 100 Series F400-V2 with Confocal Miniprobes™ | Cellvizio® 100 Series F400-V2 with Confocal Miniprobes™ | Unchanged | | 510 (k)# | Not Assigned | K172844, K180270, and K183640 | / | | Regulation Number | 21 CFR 876.1500 21 CFR 882.1480 | 21 CFR 876.1500 21 CFR 882.1480 | Unchanged | | Class | II | II | Unchanged | | Classification Advisory Committee | General & Plastic Surgery and Neurological Devices Panel | General & Plastic Surgery and Neurological Devices Panel | Unchanged | | Device Class / Name | Confocal Optical Imaging | Confocal Optical Imaging | Unchanged | | Product Code | OWN/GCJ/GWG | OWN/GCJ/GWG | Unchanged | | Combination Device | Yes | No | Extension of the Indications for Use with Fluorescein Sodium dye | | Indication For Use | The Cellvizio® 100 Series system with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that is 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-V2 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection. The GastroFlex™ UHD and ColoFlex™ UHD Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ (or GastroFlex™ M) series of Confocal Miniprobes™ is 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 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts and respiratory tracts accessed by an endoscope or endoscopic accessories, including through endoscopic needles. The CystoFlex™ (F, UHD R) and UroFlex™ B 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 Confocal Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures. | 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 and vessels and their organization or architecture. The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection. The GastroFlex™ UHD and ColoFlex™ UHD Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ (or GastroFlex™ M) series of Confocal Miniprobes™ is 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 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts and respiratory tracts accessed by an endoscope or endoscopic accessories, including through endoscopic needles. The CystoFlex™ (F, UHD R) and UroFlex™ B Confocal Miniprobe™ 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 Confocal Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures. | There is an extension of the Indication For Use of the Cellvizio® 100 series system F400-V2 to visualize blood flow with Fluorescein Sodium contrast agent. The indications for use of the different Confocal Miniprobes ™ do not change. | {8}------------------------------------------------ Table 7-1: Comparison of Indication for Use between the Subject Device and Previously Cleared Predicate Device The table below further demonstrates the substantial equivalence of the subject device to the predicate device. {9}------------------------------------------------ | Aspect | Comparison of Predicate Device to Cellvizio® 100 Series system with Confocal Miniprobes™, with extended Indications for Use with Fluorescein Sodium contrast agent | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technical equivalence | No change of design and performances Same technical design Same operating principle Same safety profile and risk level Identical technological characteristics Same reprocessing methods Same device packaging | | Biological equivalence | Same biocompatible patient-contacting materials and same biocompatibility test requirements Same target tissues to image | | Application and usage equivalence | Same intended use of the device Same environment of use and same intended user Same instructions for use and operating procedure Same precautions and safety instructions | Table 7-2: Comparison of Predicate Device to Cellvizio® 100 Series system with Confocal Miniprobes™, with new Indications for Use. # Comparison to Reference Device: The table below provides the comparison between the subject device and the reference device (Zeiss CONVIVO Confocal Endomicroscopy system K181116). | Attribute | Subject Device Cellvizio® 100 Series System F400-V2 with Confocal Miniprobes™ with Fluorescein | Reference Device CONVIVO K181116 | Comparison to Reference | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Device name | Cellvizio® 100 Series System with Confocal Miniprobes™ | CONVIVO | / | | Manufacturer | Mauna Kea Technologies 9 Rue d'Enghien F-75010 Paris, France | Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 D-07745 Jena, Germany | / | | 510(k) | Not Assigned | K181116 | / | | Classification Product Code | GWG (primary product code) OWN (secondary product code) | GWG (primary product code) OWN (secondary product code) | Same | | Regulation No. | 21 CFR 882.1480 21 CFR 876.1500 | 21 CFR 882.1480 21 CFR 876.1500 | Same | | Class | II | II | Same | | Classification Adv. Committee | General & Plastic Surgery and Neurological Devices Panel | General & Plastic Surgery and Neurological Devices Panel | Same | | Device Class / Name | Confocal Optical Imaging | Confocal Optical Imaging | Same | | Product Code | OWN/GCJ/GWG | OWN/GCJ/GWG | Same | | Combination Device | Yes | Yes | Both devices can be used with Fluorescein Sodium as a contrast agent to image blood flow. | | Indications for use | The Cellvizio® 100 Series system with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that is | The ZEISS CONVIVO is a surgical endomicroscope intended for viewing intra- operative blood flow in the cerebral | Similar Indication for Use for blood | {10}------------------------------------------------ | | 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. Cellvizio® 100 series F400- V2 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection. The GastroFlex™ UHD and ColoFlex™ UHD Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ (or GastroFlex™ M) series of Confocal Miniprobes™ is 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 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts and respiratory tracts accessed by an endoscope or endoscopic accessories, including through endoscopic needles. The CystoFlex™ (F, UHD R) and UroFlex™ B Confocal Min…