(23 days)
No
The document describes a confocal laser imaging system and its probes. There is no mention of AI or ML in the intended use, device description, or any other section. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No
The device is described as a confocal laser system intended for imaging tissues and blood flow, not for treating any condition or disease.
Yes
Explanation: The device is intended to allow imaging of the internal microstructure of tissues for the identification of cells and vessels and their organization or architecture, and imaging blood flow in vascular areas. This information is used by physicians to gain insights into the tissues to make clinical decisions and understand the state of disease, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "confocal laser system with fiber optic probes" and a "confocal imaging system," indicating the presence of hardware components beyond just software.
Based on the provided information, the Cellvizio® I.V.E. system with Confocal Miniprobes™ is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the Cellvizio system is used for in vivo imaging of internal tissues, blood flow, and anatomical structures within the body.
- The system is used for direct visualization of tissues and structures. It is a confocal laser system with fiber optic probes that are inserted into the body to capture images. This is a form of in vivo imaging, not in vitro testing of samples.
- The use of Fluorescein Sodium as a contrast agent is for enhancing in vivo visualization. While contrast agents can be used in some IVD tests, in this context, it's used to improve the imaging of blood flow within the patient.
The device is clearly intended for direct imaging and visualization of internal structures within a living patient, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The Cellvizio® I.V.E. 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 Cellvizio® I.V.E. system is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.
The GastroFlex™ N and ColoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.
The AlveoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ N Confocal Miniprobes™ are 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 N Confocal Miniprobes™ are 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 but not limited to EUS-FNA, EBUS-TBNA and TBNA).
The CystoFlex™F N, CystoFlex™ R N and UroFlex™ N 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™ 5 N Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
Product codes
OWN, GCJ
Device Description
Confocal Miniprobes™ are used with Cellyizio® I.V.E. system. 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.
Fluorescein Sodium is used as a fluorescence contrast agent to allow imaging of microvasculature and visualization of blood flow in vascular areas, including microvasculature and capillaries. Fluorescein Sodium can be used as a contrast agent with Cellvizio® I.V.E. system with Confocal Miniprobes™ without change of formulation, mode of action, approved dose or route of administration: it is delivered independent of Cellyizio® I.V.E. 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 system
Anatomical Site
Internal microstructure of tissues; vascular areas, including microvasculature and capillaries; gastrointestinal systems; respiratory systems; upper gastrointestinal tract including biliary and pancreatic ducts; urinary, including, but not limited to, urethra, bladder, and ureter; body cavities, organs, and canals.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
As no technical change is being made to the subject/reference device, all testing required has been provided in the previous submission (K193416).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 for the U.S. Food & 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
August 18, 2021
Re: K212322
Trade/Device Name: Cellvizio I.V.E. system with Confocal Miniprobes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN. GCJ Dated: July 23, 2021 Received: July 26, 2021
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/ofdocs/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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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, M.S. Assistant Director DHT4A: Division of General Surgery Devices OHT4: 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) K212322
Device Name
Cellvizio® I.V.E. system with Confocal Miniprobes™
Indications for Use (Describe)
The Cellvizio® I.V.E. 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 Cellvizio® I.V.E. system is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.
The GastroFlex™ N and ColoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.
The AlveoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ N Confocal Miniprobes™ are 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 N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, EBUS-TBNA and TBNA).
The CystoFlex™F N, CystoFlex™ R N and UroFlex™ N 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™ 5 N Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
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
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: K212322
Applicant Information:
Date Prepared: August 6, 2021
| 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® I.V.E. system with Confocal Miniprobes™ |
|---|---|
| Common Name: | Confocal Optical Imaging |
| Classification Name(s): | Endoscope and Accessories |
| Primary regulation and Product Code: | OWN 21 CFR 876.1500 |
| Secondary regulation and Product Code: | GCJ 21 CFR 876.1500 |
|---|---|
| Classification: | Class II |
Predicate Device:
The Cellvizio® 100 Series system with Confocal Miniprobes™ cleared as a drug-device combination with Fluorescein Sodium via 510(k) K191144 serves as the predicate device.
Reference Device:
The Cellvizio® I.V.E. system with Confocal Miniprobes™ is the reference device via 510(k) K193416.
5
Indications for Use:
Cellvizio® I.V.E. 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® I.V.E. system is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.
The GastroFlex™ N and ColoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.
The AlveoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ N Confocal Miniprobes™ are 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 N Confocal Miniprobes™ are 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 but not limited to EUS-FNA, EBUS-TBNA and TBNA).
The CystoFlex™ F N, CystoFlex™ R N and UroFlex™ N 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™ 5 N Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
Device Description:
Confocal Miniprobes™ are used with Cellyizio® I.V.E. system. 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.
Fluorescein Sodium is used as a fluorescence contrast agent to allow imaging of microvasculature and visualization of blood flow in vascular areas, including microvasculature and capillaries. Fluorescein Sodium can be used as a contrast agent with Cellvizio® I.V.E. system with Confocal Miniprobes™ without change of formulation, mode of action, approved dose or route of administration: it is delivered independent of Cellyizio® I.V.E. system in accordance with Fluorescein Sodium instruction for use.
6
Materials, design and intended use of the aforementioned Cellvizio® I.V.E. system Confocal laser imaging systems and its Confocal Miniprobes™ remain exactly the same as what were previously cleared in K193416 and were found to be substantially equivalent to the Cellvizio® 100 series system Confocal laser imaging system and its Confocal Miniprobes™ (cleared via K172844) without Fluorescein Sodium. A reference to the use of Sodium Fluorescein was added to the Cellvizio 100 Series System with Confocal Miniprobes (K172844) via K191144 on 01/24/2020. The sole purpose of this submission is to extend the previously cleared Indications for Use of Cellvizio® I.V.E. system Confocal laser imaging systems and its Confocal Miniprobes™ with the visualization of blood flow in vascular areas, including microvasculature and capillaries when using Sodium Fluorescein as a contrast agent.
Comparison to Predicate Device:
The table below details the differences between the subject device and the previously cleared predicate device (See Table 1-1).
| Subject Device | Predicate Device | Comparison to Predicate | ||
|---|---|---|---|---|
| Attribute | Cellvizio® I.V.E. System with Confocal Miniprobes™ | |||
| with Fluorescein | Cellvizio® 100 Series System with Confocal Miniprobes™ with Fluorescein | |||
| Device name | Cellvizio® I.V.E. System with Confocal Miniprobes™ | Cellvizio® 100 Series System with Confocal Miniprobes™ | / | |
| Model | I.V.E. | 100 series F400-v2 | / | |
| Confocal | ||||
| MiniProbe™ Names | ColoFlex™ N, | |||
| GastroFlex™ N, | ||||
| CystoFlex™ R N, | ||||
| CelioFlex™ 5 N, | ||||
| AlveoFlex™ N, | ||||
| AQ-Flex™ 19 N, | ||||
| CystoFlex™ F N, | ||||
| UroFlex™ N, | ||||
| CholangioFlex™ N | ColoFlex™ UHD, | |||
| GastroFlex™ UHD, | ||||
| CystoFlex™ UHD R, | ||||
| CelioFlex™ UHD 5, | ||||
| AlveoFlex™, | ||||
| AQ-Flex™ 19, | ||||
| CystoFlex™ F, | ||||
| UroFlex™ B, | ||||
| CholangioFlex™ | / | |||
| Manufacturer | Mauna Kea Technologies | |||
| 9 Rue d'Enghien | ||||
| F-75010 Paris, France | Mauna Kea Technologies | |||
| 9 Rue d'Enghien | ||||
| F-75010 Paris, France | Same | |||
| 510(k) | ||||
| Classification | ||||
| Product Code | K212322 | |||
| OWN (primary product code) GCJ (secondary product code) | K191144 | |||
| OWN (primary product code) GWG (secondary product code) | / | |||
| Regulation No. | 21 CFR 876.1500 | 21 CFR 882.1480 | ||
| 21 CFR 876.1500 | Same | |||
| Class | II | II | Same | |
| Classification Adv. | ||||
| Committee | General & Plastic Surgery 1 | General & Plastic Surgery | Same | |
| Device Class / Name | ||||
| Product Code | Confocal Optical Imaging | |||
| OWN/GCJ | Confocal Optical Imaging | |||
| OWN/GCJ | Same | |||
| Combination Device | Yes | Yes | Both systems have co-packaging with Sodium Fluorescein | |
| Indications for use | The Cellvizio® I.V.E. 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 Cellvizio® I.V.E. system is indicated for imaging | ||||
| blood flow in vascular areas, including microvasculature | ||||
| and capillaries. | The 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 Cellvizio® 100 series system F400-V2 is indicated | ||||
| for imaging blood flow in vascular areas, including | ||||
| microvasculature and capillaries. | Identical | |||
| Indications for Use | ||||
| including blood | ||||
| flow visualization | ||||
| in vascular areas, | ||||
| including | ||||
| microvasculature | ||||
| and capillaries with | ||||
| Fluorescein Sodium | ||||
| The GastroFlex™ N and ColoFlex™ N Confocal | ||||
| Miniprobes™ are intended to allow imaging of | 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 AlveoFlexTM N Confocal MiniprobesTM are intended | ||||
| to allow imaging of anatomical tracts, i.e., respiratory | ||||
| systems, accessed by an endoscope or endoscopic | ||||
| accessories. | ||||
| The CholangioFlexTM N Confocal MiniprobesTM are | ||||
| intended to allow imaging of the upper gastrointestinal | ||||
| tract including biliary and pancreatic ducts, accessed by | ||||
| an endoscope or endoscopic accessories. | ||||
| The AQ-FlexTM 19 N Confocal MiniprobesTM are | ||||
| 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 but not limited | ||||
| to EUS-FNA, EBUS-TBNA and TBNA). | ||||
| The CystoFlexTM F N, CystoFlexTM R N and UroFlexTM | ||||
| N Confocal MiniprobesTM 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 CelioFlexTM 5 N Confocal MiniprobesTM are | ||||
| intended to provide visualization of body cavities, | ||||
| organs, and canals during endoscopic and laparoscopic | ||||
| surgical procedures, including robot-assisted procedures. | anatomical tracts, i.e., gastrointestinal systems, accessed | |||
| by an endoscope or endoscopic accessories. | ||||
| The AlveoFlexTM Confocal MiniprobeTM is intended to | ||||
| allow imaging of anatomical tracts, i.e., respiratory | ||||
| systems, accessed by an endoscope or endoscopic | ||||
| accessories. | ||||
| The CholangioFlexTM (or GastroFlexTM M) series of | ||||
| Confocal MiniprobesTM is intended to allow imaging of | ||||
| the upper gastrointestinal tract including biliary and | ||||
| pancreatic ducts, accessed by an endoscope or | ||||
| endoscopic accessories. | ||||
| The AQ-FlexTM 19 Confocal MiniprobeTM 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 CystoFlexTM (F, UHD R) and UroFlexTM B Confocal | ||||
| MiniprobeTM 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 CelioFlexTM UHD 5 Confocal MiniprobeTM is | ||||
| intended to provide visualization of body cavities, | ||||
| organs, and canals during endoscopic and laparoscopic | ||||
| surgical procedures, including robot-assisted procedures. | ||||
| Device Description | Standalone confocal endomicroscope for intraoperative | |||
| imaging with high magnification. | Standalone confocal endomicroscope for intraoperative | |||
| imaging with high magnification. | Same | |||
| Basic System | ||||
| Function | Create in-vivo confocal laser scanning images of the | |||
| internal microstructure of tissue. | Create in-vivo confocal laser scanning images of the | |||
| internal microstructure of tissue. | Same | |||
| Imaging System | Confocal laser scanning system with fiber optic probe | Confocal laser scanning system with fiber optic probe | Same | |
| Optical | ||||
| Visualization | ||||
| Display | Fiber scanner Photo detector | |||
| Monitor | Fiber scanner Photo detector | |||
| Monitor | Same | |||
| 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. | 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. | Same | |||
| Fluorescence | ||||
| Excitation | 488 nm | 488 nm | Same | |
| Physical Method of | ||||
| Illumination | Laser source (continuous blue light of 488 nm | |||
| wavelength); Fluorescence. | ||||
| Maximum output power: 15 mW | Laser source (continuous blue light of 488 nm | |||
| wavelength); Fluorescence | ||||
| Maximum output power: 15 mW | Same | |||
| Physical Method of | ||||
| Imaging | Confocal Laser Scanning system. | Confocal Laser Scanning system | Same | |
| Laser classification | Class 2M laser product | |||
| Proximal (in the OSU) | Class 2M laser product | |||
| Proximal (in the LSU) | Same | |||
| Scanning system | Same mirrors types and manufacturer with a lower | |||
| footprint for the scanning boards | 4 kHz horizontal scanning with resonant mirror vertical | |||
| scanning with galvanometric mirror | Same technology | |||
| (cleared via | ||||
| K193416) | ||||
| Illumination output | Class 2M visible laser light at 488 nm when a N model | |||
| Confocal Miniprobe is connected | Class 2M visible laser light at 488 nm when a Confocal | |||
| Miniprobe is connected | Same | |||
| Detection | ||||
| Bandwidth | 500-650 nm | 500 - 650 nm | Same | |
| Location of Single | ||||
| Point Optical Signal | ||||
| Detector | In the eBox that receives the optical signal from the OSU | |||
| electronic BOX connected to the scanner body through | ||||
| an optical fiber | In the Laser Scanning Unit connected to the Confocal | |||
| MiniprobeTM | Found substantially | |||
| equivalent (cleared | ||||
| via K193416) | ||||
| Location of signal | ||||
| analog to digital | ||||
| conversion | On eBox motherboard | On specific CSU board in LSU | Found substantially | |
| equivalent (cleared | ||||
| via K193416) | ||||
| Location of signal | ||||
| processing | On eBox motherboard | On computer motherboard after digital signal is | ||
| transferred from LSU through Firewire cable | Found substantially | |||
| equivalent (cleared | ||||
| via K193416) | ||||
| Firmware algorithm | Same functions with equivalent algorithm except for the | |||
| autofocus | Mirror scanning control, Digitization of the laser signal, | |||
| Interlock laser (laser safety mechanisms de-activating the | ||||
| laser power), EEPROM read/write | Found substantially | |||
| equivalent (cleared | ||||
| via K193416) | ||||
| Image processing | ||||
| algorithm | Same algorithm with addition of automatic adjustment of | |||
| laser focus in the fiber bundle | Proprietary algorithm including fiber bundle calibration, | |||
| and image reconstruction | Found substantially | |||
| equivalent (cleared | ||||
| via K193416) | ||||
| Output video format | SDI, DVI and other numerical video format / conversion | |||
| performed in eBox | SDI, DVI and other numerical format, through video | |||
| converters | Found substantially | |||
| equivalent (cleared | ||||
| via K193416) | ||||
| Dimensions of | ||||
| imaging system | Footprint |