(111 days)
No
The document describes image processing but does not mention AI, ML, or related terms like deep learning or neural networks. The focus is on the hardware and basic image processing for display.
No
The device is described as an imaging system intended for visualization and diagnostic purposes, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "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" and "to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures". "Identification of cells and vessels and their organization or architecture" and "visualization within central nervous system during cranial diagnostic procedures" are inherently diagnostic activities.
No
The device description clearly states it is a "confocal laser system with fiber optic probes" and includes physical components like "Confocal Miniprobes™" and a "Confocal ProcessorTM". This indicates it is a hardware-based system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for imaging the internal microstructure of tissues and providing visualization during surgical procedures. This is a diagnostic imaging tool used in vivo (within the living body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description reinforces its use as an imaging system with probes for direct contact with tissue during procedures.
- Input Imaging Modality: Confocal laser systems with fiber optic probes are imaging modalities, not methods for analyzing biological samples.
- Anatomical Site: The device is used to image tissues within the body.
- Predicate and Reference Devices: The listed predicate and reference devices are also imaging systems (endoscopes and similar Cellvizio systems), further supporting its classification as an imaging device rather than an IVD.
IVD devices typically involve the analysis of biological samples (blood, urine, tissue biopsies, etc.) outside the body to detect or measure specific substances or characteristics related to a disease or condition. This device is used for direct visualization of tissue structure in situ.
N/A
Intended Use / 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.
Product codes
GWG, OWN
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.
Mentions image processing
Once digitized, the signal is transmitted to the Confocal ProcessorTM that processes the image to be displayed on a monitor.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal laser systems with fiber optic probes
Anatomical Site
central nervous system, brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians / during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures and during neurosurgical procedures.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KARL STORZ Flexible Video-Neuro-Endoscope System (K161112).
Reference Device(s)
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
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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);
1
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)
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) | |
|---|---|
| ☑ 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 Technologies |
| 9 Rue d'Enghien | |
| F-75010 Paris, France | |
| Phone: | |
| Fax: | +33 1 48 24 03 45 |
| +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: | 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:
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
4
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
predicate and reference
devices |
|-----------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------|-----------------------------------------------------|
| Device Name | Cellvizio® 100 Series
System with Confocal
Miniprobes | Cellvizio® 100 Series
System with Confocal
Miniprobes | Neuro-endoscope
Confocal | Same as reference
device |
| Manufacturer | Mauna Kea Technologies | Mauna Kea Technologies | Karl Storz GmbH & Co. KG | Same as reference
device |
| 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 876.1500
21 CFR 882.1480 | 21 CFR 876.1500 | 21 CFR 882.1480 | Same as predicate
device and reference
device |
| Class | II | II | II | Unchanged |
| Classification
Advisory
Committee | General & Plastic
Surgery and
Neurological Devices
Panel | General & Plastic Surgery | Neurological Devices Panel | Same as predicate
device and reference
device |
General Comparison Table
5
| Characteristics | Subject device | Reference devices | Predicate device | Comparison to
predicate and reference
devices |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class/Name | Confocal Optical
Imaging | Confocal Optical Imaging | Endoscope, Neurological | Same as reference
device |
| Product Code | GWG/OWN | OWN | GWG | Same as reference
device and predicate
device |
| 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. | 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 GastroFlex™ (UHD,
UHD-C) and ColoFlex™
(UHD, UHD-C) Confocal
Miniprobes™ are intended
to allow imaging of
anatomical tracts, i.e.,
gastrointestinal systems,
accessed by an endoscope
or endoscopic accessories. | The KARL STORZ
Flexible Video-Neuro-
Endoscope System is
indicated to provide
visualization and access
during cranial diagnostic
and therapeutic procedures
such as tumor biopsy and
resection, hydrocephalus
treatment, endoscopic third
ventriculostomy with
choroid plexus
cauterization (ETV/CPC),
endoscopic third
ventriculostomy, cyst
fenestration, and aqueduct
exploration. | Same intended use as
GastroFlex™ (UHD-
UHD-C) and equivalent
Indications for Use to
Karl Storz's Flexible
Video-Neuro-
Endoscope System |
Technological Comparison Table
| | Subject Devices
CranioFlexTM(-,-C) | Predicate Device
Flexible Video-Neuro-Endoscope
System | Comparison to predicate device |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | TBD | K161112 | N/A |
| Operating
mechanism for
imaging | The tissue is illuminated by
the laser light transmitted by
the fibers of the Confocal
MiniprobeTM through its
distal objective lens. The
optical signal from the tissue
is collected back by the same
objective and fibers. The
fibers are connected to the
Laser Scanning Unit (LSU)
that integrates the
illumination source and the
optical detector. Once
digitized, the signal is
transmitted to the Confocal
ProcessorTM that processes
the image to be displayed on
a monitor. See section 12 of
submission. | LED is integrated in the
handpiece of the KARL STORZ
Flexible Neuro-endoscope, and it
is used to provide illumination of
the anatomy under examination.
The light is transmitted from the
LED to the distal tip via two glass
fiber light bundles. The raw data
captured at the distal tip CMOS
(complementary metal oxide
semiconductor) imaging sensor is
converted to a standard NTSC
(National Television System
Committee) video signal by the
printed circuit board (PCB), also
housed in the handpiece. It allows
the image to be displayed on a
monitor. | Equivalent because:
Fibers to provide
illumination in each case
(Confocal MiniprobeTM /
fiber light bundle) A source of light and a
mean to see what is
illuminated in each case
(LSU / LED + CMOS) A video source processor in each case
(Confocal ProcessorTM / PCB) |
| Device Design /
Optical
components | Rigid section including
objective lens, flexible optical
fibers to transmit visible light
to and from the tissue. See
section 12 of submission | Rigid section including objective
lens, flexible optical fibers to
transmit visible light to and from
the tissue. | Same as predicate device |
| | Subject Devices
CranioFlexTM(-,-C) | Predicate Device
Flexible Video-Neuro-Endoscope
System | Comparison to predicate device |
| Working Shaft
Length | 3 m | 350 mm | The difference in length does not
raise different questions of safety and
effectiveness. |
| Distal Tip
Diameter | 2.6 mm | 3.2 mm x 2.4 mm (elliptical
shaped distal tip) | Equivalent |
| Distal Tip Cross-
Sectional Surface | 5.31 mm2 | 6.03 mm2 | Equivalent |
| Outer Shaft
Diameter | 1.4 mm | 2.9 mm | Equivalent |
| Working
Channel
Diameter | No working channel/lumen | 1.2 mm | Not having a working channel does
not raise different questions of safety
or effectiveness. |
| Angle of view | 0 degree, enface imaging of
the surface in contact with the
Confocal MiniprobeTM | Deflection:
● Up: 270 degrees
● Down: 270 degrees | In the handpiece of the KARL
STORZ Flexible Neuro-endoscope,
the user has a deflection lever, which
allows the distal tip to deflect 270
degrees in the up/down direction.
Manipulation of the CranioFlexTM (-,-
C) is manual (the physician has to
handle the device with one hand).
The minimal radius of curvature of
the CranioFlexTM (-,-C) is 35 mm.
The way the device is handled does
not introduce new or different
questions of safety or effectiveness. |
| Field of view | Microscopic imaging by
contact of the distal tip of the
Confocal MiniprobeTM on a
diameter 240 µm | Standard neuro-endoscope have a
field of view of several tens of
degrees to provide enlarged
visualization at a macroscopic
level | The optical characteristics of the
subject device are different from
those of the predicate device and of
any neuro-endoscope. This is due to
the fact that the subject devices
provide microscopic imaging with
high resolution and a reduced field of
view, whereas a neuro-endoscope
provides a macroscopic view of a
larger surgical area with a lower
resolution. These differences do not
raise different questions of safety and
effectiveness. |
| Depth of
observation | 55 - 65 µm from the tissue
surface in contact with the tip
of the Confocal MiniprobeTM | 0 µm | |
| Lateral
resolution | 1 µm | from 250 µm down to 50 µm | |
| Distal Tip | Atraumatic Tip | Atraumatic Tip | Same as predicate device |
| Biocompatibility | Standard, Proven Inert
Materials | Standard, Proven Inert Materials | Same as predicate device |
6
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
7
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.