(269 days)
No
The summary describes a confocal laser imaging system and its probes, focusing on visualization and image reconstruction. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies sections.
No.
The device is intended for imaging and visualization, not for treating or curing medical conditions.
Yes
The device 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" and for "imaging blood flow in vascular areas". This information is used by physicians for "cranial diagnostic and therapeutic procedures". Therefore, the device provides information that aids in diagnosis.
No
The device description explicitly states it is a "confocal laser system with fiber optic probes" and a "confocal imaging system with fiber optic probes," indicating significant hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD definition: IVDs are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue samples) to provide information for diagnostic purposes.
- Device's intended use: The Cellvizio® 100 Series System and its Confocal Miniprobes™ are intended for direct imaging of internal tissues and structures within the living body. They are used during endoscopic, laparoscopic, and neurosurgical procedures to visualize the microstructure of tissues, blood flow, and anatomical tracts.
- No specimen analysis: The device does not analyze samples taken from the body. It directly images the tissues within the body.
Therefore, the device falls under the category of in vivo imaging devices rather than in vitro diagnostic devices.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OWN, GCJ, GWG
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal laser scanning
Anatomical Site
Tissues, vascular areas, microvasculature, capillaries, gastrointestinal systems, respiratory systems, upper gastrointestinal tract, biliary ducts, pancreatic ducts, urinary tract (urethra, bladder, ureter), body cavities, organs, canals, central nervous system, cerebral vascular area.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical demonstration based on literature review has been carried out to support this submission, as described in section 13.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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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 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 | vascular area, including microvasculature
and capillaries.
The CONVIVO's fiber optic scanner probe
is placed in direct contact with tissue
during cranial diagnostic and therapeutic
procedures, such as tumor biopsy and
resection, to create in-vivo confocal laser
scanning images of the internal
microstructure of tissues. | flow
visualization
with
Fluorescein
Sodium | | | | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------|------|------|
| Device
Description | Standalone confocal endomicroscope for
intraoperative imaging with high
magnification. | Standalone confocal endomicroscope for
intraoperative imaging with high
magnification. | Same | | | | |
| Basic System
Function | Imaging
System | Create in-vivo confocal laser scanning
images of the internal microstructure of
tissue. | Confocal laser scanning system with fiber
optic probe | Create in-vivo confocal laser scanning
images of the internal microstructure of
tissue. | Confocal laser scanning system with fiber
optic probe | Same | Same |
| Optical
Visualization | Fiber scanner Photo detector | Fiber scanner Photo detector | Same | | | | |
| Display | Monitor | Monitor | Same | | | | |
11
| Fluorescent
Agent | Tissue autofluorescence and Fluorescence
imaging system used with Fluorescein
Sodium yields fluorescent image with very
high magnification of the distribution of the
fluorescein sodium dye in the imaged tissue
during the
operation. | Fluorescence imaging system used with
Fluorescein Sodium yields fluorescent
image with very high magnification of the
distribution of the fluorescein Sodium dye
in the imaged tissue during the
operation. | Same |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Visualization
of Real-Time
images | 9 to 12Hz | 1 to 3 Hz | Similar/ Real
time imaging |
| Fluorescence
Excitation | 488 nm | 488 nm | Same |
| Physical
Method of
Illumination | Laser source (continuous blue light of 488
nm wavelength); Fluorescence | Laser source (continuous blue light of 488
nm wavelength); Fluorescence | Same |
| Physical
Method of
Imaging | Confocal Laser Scanning system | Confocal Laser Scanning system | Same |
| Actions
ensured by the
software | Control of the laser-scanning unit and of
the laser emission, reconstruction of images
process, display of images on a screen. | Control of the laser-scanning unit and of
the laser emission, reconstruction of images
process, display of images on a screen. | Same |
| Export | Via DICOM PACS, Shared Drive and USB
thumb drives. | Via DICOM PACS, Shared Drive and USB
thumb drives | Same |
| Laser | Class 2M laser product | Class 3R laser product | Similar with
lower laser
power for the
subject
device |
Table 7-3: Comparison of Indication for Use between the Subject Device and Previously Cleared Reference Device
The Cellvizio® 100 series system F400-V2 with the CranioFlex™ Confocal Miniprobe and the reference device. CONVIVO (K181116), have the same indication for use. They are both used to examine blood flow in the cerebral vascular area. In both cases, Fluorescein Sodium is injected into the patient, excitation light is shined onto the tissue and emitted fluorescent light is used to observe the blood flow and the vasculature within the brain. While the systems have differences, they each have the functions for viewing and recording fluorescent images. Both devices use Fluorescein Sodium as a contrast agent to visualize vascular structures without changes to the formulation, mode of action, approved dose or route of administration. Fluorescein Sodium is used in an identical manner for both devices.
The resolution and optical characteristics of the Confocal Miniprobes™ are identical or similar to the resolution and optical characteristics of the CranioFlex™ Confocal Miniprobes™. Therefore, blood flow can be image with all Confocal MiniprobesTM.
The Cellvizio® 100 series system with F400-V2 with all Confocal Miniprobes™ device, also enables visualization of blood flow with Fluorescein Sodium for a different Indication for Use (imaging of gastrointestinal, respiratory ad urinary tracts, body cavities, organs and canals accessed by an endoscope, or endoscopic accessories, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures) but a generally equivalent intended use (tissue microstructures imaging).
12
Testing Completed:
As no change is being made to the devices, all testing required has been provided in previous submissions (K111047, K122042, K123676, K133466, K150831, K151593, K160416, K171345, K172844, K180270 and K183640).
Clinical demonstration based on literature review has been carried out to support this submission, as described in section 13.
Summary:
The Cellvizio® 100 Series system F400-v2 with its Confocal Miniprobes™ used with Fluorescein Sodium contrast agent remains exactly the same device in terms of design, performance and general intended use (allow imaging of the internal microstructure) as the previously cleared devices.
The subject device (the Cellvizio® 100 Series system (F400-v2) (with Confocal Miniprobes™) used with Fluorescein Sodium Contrast Agent) has the same indications for use as the predicate device (the Cellvizio® 100 Series system (F400-v2) (with Confocal Miniprobes™)) since both devices are intended to be used to image the tissue microstructures.
The objective of this submission is to extend the previously cleared Indications for Use with the visualization of blood flow when using Fluorescein Sodium as a contrast agent with the proven optical resolution and real time imaging capabilities of the system, corresponding anatomical sizes of cells and vessels, Real World Evidence (RWE) and independent clinical findings from well-respected clinical researchers and international independent Health Technology Assessment organizations.
The subject device and the reference CONVIVO device are intended to visualize both internal microvascularization and microstructure of tissues. The devices are tools that are used to provide imaging information to the physician.
Both devices are intended to be brought into direct contact with the tissue to be examined to create in-vivo confocal laser scanning images of the internal microstructure of tissue.
Furthermore, both devices are confocal laser systems with fiber optic probes and have the identical operation principle. Both devices use a laser source which emits a continuous blue light of 488 nm wavelength. With both devices, a monitor is used to view the images generated with the scanner probe are displayed on the monitor. Both devices can be used in realtime during procedures.
The subject device, Cellvizio® 100 Series system (F400-v2) with Confocal Miniprobes™ used with Fluorescein Sodium, and the reference device, CONVIVO used with Fluorescein Sodium, have the same Indication for Use. They are both used to examine blood flow in vascular areas.