The CranioFlex™ (-,-C) Confocal Miniprobes™ are indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

Device Description

The Cellvizio® 100 Series systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues. Confocal Miniprobes™ are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures and during neurosurgical procedures.

CranioFlex™ (-,-C) Confocal Miniprobes™ are used with Cellvizio® 100 Series systems to provide imaging of the brain through contact of their distal tip with the tissue. They are designed to be used and manually handled during neurosurgical procedures.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Cellvizio 100 Series Systems with Confocal Miniprobes, specifically the CranioFlex™ (-,-C) Confocal Miniprobes, for use in neurosurgical procedures.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not present a study with specific acceptance criteria or performance metrics for an AI/algorithm-based device. The device described (Cellvizio with CranioFlex™ Miniprobes) appears to be an optical imaging system that provides direct visualization, not an AI or algorithm that interprets images or assists human readers. Therefore, many of the requested elements for AI acceptance criteria and studies (like MRMC studies, standalone algorithm performance, training set details, ground truth establishment for AI) are not applicable to this type of medical device submission.

The document primarily focuses on comparing the subject device's technological characteristics and intended use to a predicate neuro-endoscope and previously cleared reference devices from the same manufacturer.

Based on the provided text, here's an attempt to address the requested information, highlighting where the information is not applicable (N/A) due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or performance metrics in the format typically seen for AI/algorithm-based devices (e.g., sensitivity, specificity, accuracy thresholds). The "acceptance" for this 510(k) relies on demonstrating substantial equivalence to a predicate device. This is achieved through qualitative comparisons of design, materials, indications for use, and technological characteristics, along with verification that risks are acceptable and don't raise new questions of safety or effectiveness.

Characteristic / "Acceptance Criterion" (Implied from equivalence claim)	Reported Device Performance (from comparison tables)
Primary Indication for Use Equivalence	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. This aligns with the predicate device (KARL STORZ Flexible Video-Neuro-Endoscope System) which also provides visualization during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection, hydrocephalus treatment, etc. The document asserts "equivalent Indications for Use to Karl Storz's Flexible Video-Neuro-Endoscope System."
Operating Mechanism for Imaging	Subject Device: Tissue illuminated by laser light transmitted by fibers of the Confocal Miniprobe™ through its distal objective lens. Optical signal collected back by same objective and fibers. Fibers connected to Laser Scanning Unit (LSU) which integrates illumination source and optical detector. Signal digitized and transmitted to Confocal Processor™ for display. Predicate Device: LED in handpiece provides illumination via two glass fiber light bundles. Raw data from distal tip CMOS imaging sensor converted to NTSC video signal by PCB for display. Comparison/Conclusion: "Equivalent because: Fibers to provide illumination in each case; a source of light and a means to see what is illuminated in each case; a video source processor in each case."
Device Design / Optical Components	Both subject and predicate devices have a rigid section including objective lens and flexible optical fibers to transmit visible light to and from the tissue. Conclusion: "Same as predicate device."
Distal Tip Diameter	Subject Device: 2.6 mm Predicate Device: 3.2 mm x 2.4 mm (elliptical shaped distal tip) Conclusion: "Equivalent."
Distal Tip Cross-Sectional Surface	Subject Device: 5.31 mm2 Predicate Device: 6.03 mm2 Conclusion: "Equivalent."
Outer Shaft Diameter	Subject Device: 1.4 mm Predicate Device: 2.9 mm Conclusion: "Equivalent."
Working Channel Diameter	Subject Device: No working channel/lumen Predicate Device: 1.2 mm Conclusion: "Not having a working channel does not raise different questions of safety or effectiveness."
Distal Tip Type	Both subject and predicate devices have an Atraumatic Tip. Conclusion: "Same as predicate device."
Biocompatibility	Both subject and predicate devices use Standard, Proven Inert Materials. Conclusion: "Same as predicate device."
Sterilization	Previously cleared reference devices (GastroFlex™) validated for high-level disinfection/sterilization. For neurosurgery, CranioFlex™ will be sterilized similarly to the predicate device (KARL STORZ). The document implies this is sufficient for safety.
Risk Analysis	"All risks reviewed during the risk analysis of the subject devices were confirmed to be acceptable. Moreover, they do not change safety, performances nor increase residual risks, compared to the risk level of the reference devices... The global risk is therefore unchanged and remains acceptable and does not change performance, safety and effectiveness."

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of an algorithm evaluation with a specific number of cases or data provenance. The assessment for this 510(k) is based on technical comparison and risk analysis, not a prospective clinical study with a defined test set.

Sample Size for Test Set: N/A (Not an algorithm evaluation study requiring a test set of cases).
Data Provenance: N/A (The submission primarily relies on design specifications, materials, and comparison to predicate/reference devices, along with in-house testing for sterilization and biocompatibility). There is a mention of a "clinical feasibility study published in a peer reviewed journal" being used to confirm risk assessment, but no details on size, type, or provenance of that dataset are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. As this is not an AI/algorithm-based device being validated against a ground truth dataset, this information is not relevant or provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Not applicable to this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is not an AI-assisted diagnostic device; it's an imaging tool that provides direct visualization. Therefore, an MRMC study assessing AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is a direct visualization device, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

N/A. The "ground truth" for this submission is implicitly the safety and effectiveness of the legally marketed predicate device (KARL STORZ Flexible Video-Neuro-Endoscope System) and the established safety and performance of the manufacturer's own reference devices (GastroFlex™ Confocal Miniprobes). The CranioFlex™ Miniprobe is asserted to be fundamentally the same device as the GastroFlex™ but with an expanded indication for use into neurosurgery, hence the comparison to a neuro-endoscope predicate.

8. The sample size for the training set

N/A. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

N/A. This is not an AI/machine learning device.

Summary

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May 22, 2018

Mauna Kea Technologies % Michael Daniel President Daniel & Daniel Consulting 340 Jones Lane Gardnerville, Nevada 89460

Re: K180270

Trade/Device Name: Cellvizio 100 Series Systems with Confocal Miniprobes™ Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG, OWN Dated: January 30, 2018 Received: January 31, 2018

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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K180270

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS Director

for

Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180270

Device Name

Cellvizio® 100 Series systems with Confocal Miniprobes™

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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7. 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: K180270

Applicant Information:

Date Prepared:	January 30, 2018
Date Revised:	May 14, 2018
Name:Address:	Mauna Kea Technologies9 Rue d'EnghienF-75010 Paris, France
Phone:Fax:	+33 1 48 24 03 45+33 1 48 24 12 18
Contact Person:	Michael A. Daniel, Consultantmadaniel@clinregconsult.com
Phone Number:	(415) 407-0223
Office:	(775) 392-2970
Facsimile Number:	(610) 545-0799

Device Information:

Device Trade Name:	CranioFlex™ (-,-C) type Confocal Miniprobes™used with Cellvizio® 100 Series Systems
Common Name:	Neurological Endoscope
Primary Regulation and Product Code:	21 CFR 882.1480 – GWG
Secondary Product Code:	OWN
Classification Name(s):	Neurological Endoscope
Classification:	Class II

Predicate Device:

. KARL STORZ Flexible Video-Neuro-Endoscope System (K161112).

Reference devices:

. The Cellvizio® 100 Series System with Confocal Miniprobes™ cleared via K172844
The GastroFlexTM UHD has been cleared with K111047 and K150831
The GastroFlex™ UHD-C has been cleared with K133466 ●

Device Description:

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surgical procedures, including robot-assisted procedures and during neurosurgical procedures.

Indications for Use:

Comparison to Predicate and Reference Devices:

The CranioFlex™ (-,-C) Confocal Miniprobes™ are identical in terms of design and materials to the previously cleared GastroFlexTM (UHD, UHD-C) Confocal MiniprobesTM (K111047, K150831, K133466). It is in fact the same device. The only change being made is to the Indications.

The Indications for Use and Intended Use of CranioFlexTM (-,-C) are substantially equivalent to the KARL STORZ's Flexible Video-Neuro-Endoscope System (K161112) predicate and GastroFlex™ (UHD, UHD-C) (K111047, K150831, K133466, K172844) reference devices, respectively.

The CranioFlex™ (-,-C) are designed to be handled manually. Please reference comparison tables below:

Characteristics	Subject device	Reference devices	Predicate device	Comparison topredicate and referencedevices
Device Name	Cellvizio® 100 SeriesSystem with ConfocalMiniprobes	Cellvizio® 100 SeriesSystem with ConfocalMiniprobes	Neuro-endoscopeConfocal	Same as referencedevice
Manufacturer	Mauna Kea Technologies	Mauna Kea Technologies	Karl Storz GmbH & Co. KG	Same as referencedevice
Model	CranioFlexTM,CranioFlexTM-C	GastroFlexTM UHD,GastroFlexTM UHD-C	Flexible Video-Neuro-Endoscope System	N/A
510(k)	K180270	K111047, K150831,K133466 and K172844	K161112	N/A
Regulation Number	21 CFR 876.150021 CFR 882.1480	21 CFR 876.1500	21 CFR 882.1480	Same as predicatedevice and referencedevice
Class	II	II	II	Unchanged
ClassificationAdvisoryCommittee	General & PlasticSurgery andNeurological DevicesPanel	General & Plastic Surgery	Neurological Devices Panel	Same as predicatedevice and referencedevice

General Comparison Table

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Characteristics	Subject device	Reference devices	Predicate device	Comparison topredicate and referencedevices
Device Class/Name	Confocal OpticalImaging	Confocal Optical Imaging	Endoscope, Neurological	Same as referencedevice
Product Code	GWG/OWN	OWN	GWG	Same as referencedevice and predicatedevice
Indications for Use	The Cellvizio® 100Series systems withConfocal Miniprobes™are confocal lasersystems with fiber opticprobes that are intendedto allow imaging of theinternal microstructure oftissues including, but notlimited to, theidentification of cells andvessels and theirorganization orarchitecture.The CranioFlex™ (-,-C)Confocal Miniprobes™are indicated to providevisualization withincentral nervous systemduring cranial diagnosticand therapeuticprocedures such as tumorbiopsy and resection.	The Cellvizio® 100 Seriessystems with ConfocalMiniprobes™ are confocallaser systems with fiberoptic probes that areintended to allow imagingof the internalmicrostructure of tissuesincluding, but not limitedto, the identification ofcells and vessels and theirorganization orarchitecture.The GastroFlex™ (UHD,UHD-C) and ColoFlex™(UHD, UHD-C) ConfocalMiniprobes™ are intendedto allow imaging ofanatomical tracts, i.e.,gastrointestinal systems,accessed by an endoscopeor endoscopic accessories.	The KARL STORZFlexible Video-Neuro-Endoscope System isindicated to providevisualization and accessduring cranial diagnosticand therapeutic proceduressuch as tumor biopsy andresection, hydrocephalustreatment, endoscopic thirdventriculostomy withchoroid plexuscauterization (ETV/CPC),endoscopic thirdventriculostomy, cystfenestration, and aqueductexploration.	Same intended use asGastroFlex™ (UHD-UHD-C) and equivalentIndications for Use toKarl Storz's FlexibleVideo-Neuro-Endoscope System

Technological Comparison Table

	Subject DevicesCranioFlexTM(-,-C)	Predicate DeviceFlexible Video-Neuro-EndoscopeSystem	Comparison to predicate device
510(k) #	TBD	K161112	N/A
Operatingmechanism forimaging	The tissue is illuminated bythe laser light transmitted bythe fibers of the ConfocalMiniprobeTM through itsdistal objective lens. Theoptical signal from the tissueis collected back by the sameobjective and fibers. Thefibers are connected to theLaser Scanning Unit (LSU)that integrates theillumination source and theoptical detector. Oncedigitized, the signal istransmitted to the ConfocalProcessorTM that processesthe image to be displayed ona monitor. See section 12 ofsubmission.	LED is integrated in thehandpiece of the KARL STORZFlexible Neuro-endoscope, and itis used to provide illumination ofthe anatomy under examination.The light is transmitted from theLED to the distal tip via two glassfiber light bundles. The raw datacaptured at the distal tip CMOS(complementary metal oxidesemiconductor) imaging sensor isconverted to a standard NTSC(National Television SystemCommittee) video signal by theprinted circuit board (PCB), alsohoused in the handpiece. It allowsthe image to be displayed on amonitor.	Equivalent because:Fibers to provideillumination in each case(Confocal MiniprobeTM /fiber light bundle) A source of light and amean to see what isilluminated in each case(LSU / LED + CMOS) A video source processor in each case(Confocal ProcessorTM / PCB)
Device Design /Opticalcomponents	Rigid section includingobjective lens, flexible opticalfibers to transmit visible lightto and from the tissue. Seesection 12 of submission	Rigid section including objectivelens, flexible optical fibers totransmit visible light to and fromthe tissue.	Same as predicate device
	Subject DevicesCranioFlexTM(-,-C)	Predicate DeviceFlexible Video-Neuro-EndoscopeSystem	Comparison to predicate device
Working ShaftLength	3 m	350 mm	The difference in length does notraise different questions of safety andeffectiveness.
Distal TipDiameter	2.6 mm	3.2 mm x 2.4 mm (ellipticalshaped distal tip)	Equivalent
Distal Tip Cross-Sectional Surface	5.31 mm2	6.03 mm2	Equivalent
Outer ShaftDiameter	1.4 mm	2.9 mm	Equivalent
WorkingChannelDiameter	No working channel/lumen	1.2 mm	Not having a working channel doesnot raise different questions of safetyor effectiveness.
Angle of view	0 degree, enface imaging ofthe surface in contact with theConfocal MiniprobeTM	Deflection:● Up: 270 degrees● Down: 270 degrees	In the handpiece of the KARLSTORZ Flexible Neuro-endoscope,the user has a deflection lever, whichallows the distal tip to deflect 270degrees in the up/down direction.Manipulation of the CranioFlexTM (-,-C) is manual (the physician has tohandle the device with one hand).The minimal radius of curvature ofthe CranioFlexTM (-,-C) is 35 mm.The way the device is handled doesnot introduce new or differentquestions of safety or effectiveness.
Field of view	Microscopic imaging bycontact of the distal tip of theConfocal MiniprobeTM on adiameter 240 µm	Standard neuro-endoscope have afield of view of several tens ofdegrees to provide enlargedvisualization at a macroscopiclevel	The optical characteristics of thesubject device are different fromthose of the predicate device and ofany neuro-endoscope. This is due tothe fact that the subject devicesprovide microscopic imaging withhigh resolution and a reduced field ofview, whereas a neuro-endoscopeprovides a macroscopic view of alarger surgical area with a lowerresolution. These differences do notraise different questions of safety andeffectiveness.
Depth ofobservation	55 - 65 µm from the tissuesurface in contact with the tipof the Confocal MiniprobeTM	0 µm
Lateralresolution	1 µm	from 250 µm down to 50 µm
Distal Tip	Atraumatic Tip	Atraumatic Tip	Same as predicate device
Biocompatibility	Standard, Proven InertMaterials	Standard, Proven Inert Materials	Same as predicate device

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Sterilization and biocompatibility testing have been previously provided for the cleared reference devices in K150831. The GastroFlex™ (UHD, UHD-C) Confocal Miniprobes™ have been tested and validated to be high level disinfected or sterilized, whereas the use of the CranioFlex™ (-, -C) Confocal Miniprobes™ during neurosurgery will require this device to be sterilized similarly to the KARL STORZ's Flexible Video-Neuro-Endoscope System (K161112) predicate.

The differences in technological characteristics between the subject devices and the predicate device do not raise different questions of safety or effectiveness. Further, there

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are no different technological characteristics between the reference devices and the subject devices as described in the K111047. K150831 and K133466.

The potential risks associated with the use of CranioFlex™ (-,-C) Confocal Miniprobes™ during neurosurgical procedures have been assessed. All risks reviewed during the risk analysis of the subject devices were confirmed to be acceptable. Moreover, they do not change safety, performances nor increase residual risks, compared to the risk level of the reference devices as also reported in clinical feasibility study published in a peer reviewed journal. The global risk is therefore unchanged and remains acceptable and does not change performance, safety and effectiveness.

Summarv:

Based upon the Intended Use, Indications for Use, product technical information, risk analysis, and additional biocompatibility validation provided in this premarket notification, the CranioFlex™ (-,-C) Confocal Miniprobes™, when used as part of the Cellvizio® 100 Series, have been shown to be substantially equivalent to the KARL STORZ's Flexible Video-Neuro-Endoscope System, and are identical in technological characteristics to the GastroFlex™ (UHD, UHD-C) Confocal Miniprobes™ reference devices. The differences in technological characteristics' between the subject devices and the predicate device do not raise different questions of safety or effectiveness. Thus, the subject devices can safely and effectively be used to provide visualization within the central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

Regulation Number and Section

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).