Cellvizio 100 Series Systems with Confocal Miniprobes

K180270 · Mauna Kea Technologies · GWG · May 22, 2018 · Neurology

Device Facts

• Record ID: K180270
• Device Name: Cellvizio 100 Series Systems with Confocal Miniprobes
• Applicant: Mauna Kea Technologies
• Product Code: GWG · Neurology
• Decision Date: May 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K180270 · May 22, 2018	Cellvizio 100 Series Systems with Confocal Miniprobes	Mauna Kea Technologies	Peer-reviewed clinical feasibility study	The sponsor utilized a published clinical feasibility study to support the risk analysis and confirm that the safety and performance profile of the device in neurosurgical applications is acceptable.	Clinical feasibility study; Risk analysis; Neurosurgery

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical feasibility study (referenced in peer-reviewed journal); Clinical feasibility study	Patients undergoing neurosurgical procedures	Not applicable for this study	Safety and performance assessment

Indications for Use

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 including, but not limited to, the identification of cells and vessels and their organization or architecture. 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 Story

Cellvizio 100 Series with CranioFlex Confocal Miniprobes provides real-time, microscopic imaging of internal tissue microstructure. System uses laser light transmitted through fiber optic probes to illuminate tissue; reflected optical signal is collected by the same probe, digitized by a Laser Scanning Unit (LSU), and processed by a Confocal Processor for display on a monitor. Operated by physicians during neurosurgical procedures (e.g., biopsy, resection). Device tip contacts tissue directly to provide enface imaging (1 µm lateral resolution, 55-65 µm depth). Provides high-resolution microscopic visualization to assist surgeons in identifying cells, vessels, and tissue architecture, potentially aiding in surgical decision-making.

Clinical Evidence

No new clinical data provided. Substantial equivalence is supported by technological identity to previously cleared reference devices (GastroFlex) and risk analysis. Clinical feasibility previously reported in peer-reviewed literature.

Technological Characteristics

Confocal laser imaging system; fiber optic probe with distal objective lens. Laser Scanning Unit (LSU) integrates illumination source and optical detector. Confocal Processor handles image digitization and display. Atraumatic distal tip. Biocompatible materials. Manual handling. No working channel. Sterilization required for neurosurgical use.

Indications for Use

Indicated for visualization within the central nervous system during cranial diagnostic and therapeutic procedures, including tumor biopsy and resection.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

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

Reference Devices

• Cellvizio® 100 Series System with Confocal Miniprobes (K172844)
• GastroFlexTM UHD (K111047, K150831)
• GastroFlex™ UHD-C (K133466)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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 including, but not limited to, the identification of cells and vessels and their organization or architecture.

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.

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

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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:<br>Address: | Mauna Kea Technologies<br>9 Rue d'Enghien<br>F-75010 Paris, France |
| Phone:<br>Fax: | [phone]<br>[phone] |
| Contact Person: | Michael A. Daniel, Consultant<br>[e-mail] |
| Phone Number: | [phone] |
| Office: | [phone] |
| Facsimile Number: | [phone] |

#### Device Information:

| Device Trade Name: | CranioFlex™ (-,-C) type Confocal Miniprobes™<br>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:

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

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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.

#### Indications for Use:

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 including, but not limited to, the identification of cells and vessels and their organization or architecture.

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.

#### 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 to<br>predicate and reference<br>devices |
|-----------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------|-----------------------------------------------------|
| Device Name | Cellvizio® 100 Series<br>System with Confocal<br>Miniprobes | Cellvizio® 100 Series<br>System with Confocal<br>Miniprobes | Neuro-endoscope<br>Confocal | Same as reference<br>device |
| Manufacturer | Mauna Kea Technologies | Mauna Kea Technologies | Karl Storz GmbH & Co. KG | Same as reference<br>device |
| Model | CranioFlexTM,<br>CranioFlexTM-C | GastroFlexTM UHD,<br>GastroFlexTM UHD-C | Flexible Video-Neuro-<br>Endoscope System | N/A |
| 510(k) | K180270 | K111047, K150831,<br>K133466 and K172844 | K161112 | N/A |
| Regulation Number | 21 CFR 876.1500<br>21 CFR 882.1480 | 21 CFR 876.1500 | 21 CFR 882.1480 | Same as predicate<br>device and reference<br>device |
| Class | II | II | II | Unchanged |
| Classification<br>Advisory<br>Committee | General & Plastic<br>Surgery and<br>Neurological Devices<br>Panel | General & Plastic Surgery | Neurological Devices Panel | Same as predicate<br>device and reference<br>device |

#### General Comparison Table

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| Characteristics | Subject device | Reference devices | Predicate device | Comparison to<br>predicate and reference<br>devices |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class/Name | Confocal Optical<br>Imaging | Confocal Optical Imaging | Endoscope, Neurological | Same as reference<br>device |
| Product Code | GWG/OWN | OWN | GWG | Same as reference<br>device and predicate<br>device |
| Indications for Use | The Cellvizio® 100<br>Series systems with<br>Confocal Miniprobes™<br>are confocal laser<br>systems with fiber optic<br>probes that are intended<br>to allow imaging of the<br>internal microstructure of<br>tissues including, but not<br>limited to, the<br>identification of cells and<br>vessels and their<br>organization or<br>architecture.<br>The CranioFlex™ (-,-C)<br>Confocal Miniprobes™<br>are indicated to provide<br>visualization within<br>central nervous system<br>during cranial diagnostic<br>and therapeutic<br>procedures such as tumor<br>biopsy and resection. | The Cellvizio® 100 Series<br>systems with Confocal<br>Miniprobes™ are confocal<br>laser systems with fiber<br>optic probes that are<br>intended to allow imaging<br>of the internal<br>microstructure of tissues<br>including, but not limited<br>to, the identification of<br>cells and vessels and their<br>organization or<br>architecture.<br>The GastroFlex™ (UHD,<br>UHD-C) and ColoFlex™<br>(UHD, UHD-C) Confocal<br>Miniprobes™ are intended<br>to allow imaging of<br>anatomical tracts, i.e.,<br>gastrointestinal systems,<br>accessed by an endoscope<br>or endoscopic accessories. | The KARL STORZ<br>Flexible Video-Neuro-<br>Endoscope System is<br>indicated to provide<br>visualization and access<br>during cranial diagnostic<br>and therapeutic procedures<br>such as tumor biopsy and<br>resection, hydrocephalus<br>treatment, endoscopic third<br>ventriculostomy with<br>choroid plexus<br>cauterization (ETV/CPC),<br>endoscopic third<br>ventriculostomy, cyst<br>fenestration, and aqueduct<br>exploration. | Same intended use as<br>GastroFlex™ (UHD-<br>UHD-C) and equivalent<br>Indications for Use to<br>Karl Storz's Flexible<br>Video-Neuro-<br>Endoscope System |

# Technological Comparison Table

| | Subject Devices<br>CranioFlexTM(-,-C) | Predicate Device<br>Flexible Video-Neuro-Endoscope<br>System | Comparison to predicate device |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | TBD | K161112 | N/A |
| Operating<br>mechanism for<br>imaging | The tissue is illuminated by<br>the laser light transmitted by<br>the fibers of the Confocal<br>MiniprobeTM through its<br>distal objective lens. The<br>optical signal from the tissue<br>is collected back by the same<br>objective and fibers. The<br>fibers are connected to the<br>Laser Scanning Unit (LSU)<br>that integrates the<br>illumination source and the<br>optical detector. Once<br>digitized, the signal is<br>transmitted to the Confocal<br>ProcessorTM that processes<br>the image to be displayed on<br>a monitor. See section 12 of<br>submission. | LED is integrated in the<br>handpiece of the KARL STORZ<br>Flexible Neuro-endoscope, and it<br>is used to provide illumination of<br>the anatomy under examination.<br>The light is transmitted from the<br>LED to the distal tip via two glass<br>fiber light bundles. The raw data<br>captured at the distal tip CMOS<br>(complementary metal oxide<br>semiconductor) imaging sensor is<br>converted to a standard NTSC<br>(National Television System<br>Committee) video signal by the<br>printed circuit board (PCB), also<br>housed in the handpiece. It allows<br>the image to be displayed on a<br>monitor. | Equivalent because:<br>Fibers to provide<br>illumination in each case<br>(Confocal MiniprobeTM /<br>fiber light bundle) A source of light and a<br>mean to see what is<br>illuminated in each case<br>(LSU / LED + CMOS) A video source processor in each case<br>(Confocal ProcessorTM / PCB) |
| Device Design /<br>Optical<br>components | Rigid section including<br>objective lens, flexible optical<br>fibers to transmit visible light<br>to and from the tissue. See<br>section 12 of submission | Rigid section including objective<br>lens, flexible optical fibers to<br>transmit visible light to and from<br>the tissue. | Same as predicate device |
| | Subject Devices<br>CranioFlexTM(-,-C) | Predicate Device<br>Flexible Video-Neuro-Endoscope<br>System | Comparison to predicate device |
| Working Shaft<br>Length | 3 m | 350 mm | The difference in length does not<br>raise different questions of safety and<br>effectiveness. |
| Distal Tip<br>Diameter | 2.6 mm | 3.2 mm x 2.4 mm (elliptical<br>shaped distal tip) | Equivalent |
| Distal Tip Cross-<br>Sectional Surface | 5.31 mm2 | 6.03 mm2 | Equivalent |
| Outer Shaft<br>Diameter | 1.4 mm | 2.9 mm | Equivalent |
| Working<br>Channel<br>Diameter | No working channel/lumen | 1.2 mm | Not having a working channel does<br>not raise different questions of safety<br>or effectiveness. |
| Angle of view | 0 degree, enface imaging of<br>the surface in contact with the<br>Confocal MiniprobeTM | Deflection:<br>● Up: 270 degrees<br>● Down: 270 degrees | In the handpiece of the KARL<br>STORZ Flexible Neuro-endoscope,<br>the user has a deflection lever, which<br>allows the distal tip to deflect 270<br>degrees in the up/down direction.<br>Manipulation of the CranioFlexTM (-,-<br>C) is manual (the physician has to<br>handle the device with one hand).<br>The minimal radius of curvature of<br>the CranioFlexTM (-,-C) is 35 mm.<br>The way the device is handled does<br>not introduce new or different<br>questions of safety or effectiveness. |
| Field of view | Microscopic imaging by<br>contact of the distal tip of the<br>Confocal MiniprobeTM on a<br>diameter 240 µm | Standard neuro-endoscope have a<br>field of view of several tens of<br>degrees to provide enlarged<br>visualization at a macroscopic<br>level | The optical characteristics of the<br>subject device are different from<br>those of the predicate device and of<br>any neuro-endoscope. This is due to<br>the fact that the subject devices<br>provide microscopic imaging with<br>high resolution and a reduced field of<br>view, whereas a neuro-endoscope<br>provides a macroscopic view of a<br>larger surgical area with a lower<br>resolution. These differences do not<br>raise different questions of safety and<br>effectiveness. |
| Depth of<br>observation | 55 - 65 µm from the tissue<br>surface in contact with the tip<br>of the Confocal MiniprobeTM | 0 µm | |
| Lateral<br>resolution | 1 µm | from 250 µm down to 50 µm | |
| Distal Tip | Atraumatic Tip | Atraumatic Tip | Same as predicate device |
| Biocompatibility | Standard, Proven Inert<br>Materials | 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.