(87 days)
No
The summary describes a confocal laser imaging system and its probes, focusing on visualization and imaging capabilities. There is no mention of AI, ML, or any related technologies for image analysis, interpretation, or other functions. The device description explicitly states that the materials, design, and intended use remain the same as previously cleared devices, none of which are indicated to use AI/ML.
No
The device is described as an "imaging" system intended to "allow imaging of the internal microstructure of tissues" and "provide visualization," which are diagnostic rather than therapeutic functions.
Yes
The device's intended use explicitly states "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." This information is clearly used for diagnostic purposes.
No
The device description explicitly states it is a "confocal laser systems with fiber optic probes," which are hardware components. The submission also references previous clearances for the "Cellvizio® 100 Series confocal laser imaging systems and their Confocal Miniprobes™," further indicating a hardware-based system.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "imaging of the internal microstructure of tissues" and "visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures." This describes a device used in vivo (within a living organism) for direct visualization.
- Device Description: The description reinforces that it's a "confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues." This is consistent with an in vivo imaging device.
- Lack of IVD characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention the analysis of any biological specimens outside the body.
Therefore, the Cellvizio® 100 Series systems with Confocal Miniprobes™ are an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Cellvizio® 100 Series systems (400 and/or 800) 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 AlveoFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ (or GastroFlex™ M) series of Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscopic accessories.
The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.
The CystoFlex™ (F, UHD R, UHD R-C) and Uroflex™ B of Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
The CelioFlex™ (UHD 5, UHD 5-C) of 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
Device Description
The Cellvizio® 100 Series systems with Confocal Miniprobes™ are a 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.
Materials, design and intended use of the aforementioned Cellvizio® 100 Series confocal laser imaging systems and their Confocal Miniprobes™ remain exactly the same as what were previously cleared in K111047, K122042, K123676, K133466, K150831, K151593, K160416 and K171345 respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
confocal laser systems
Anatomical Site
internal microstructure of tissues, gastrointestinal tracts, respiratory systems, upper gastrointestinal tract including biliary and pancreatic ducts, urinary tracts (urethra, bladder, and ureter), body cavities, organs, and canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians / endoscopic and laparoscopic surgical 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
Clinical demonstration based on literature review has been carried out to support this submission, as described in section 14.
Key Metrics
Not Found
Predicate Device(s)
K111047, K122042, K123676, K133466, K150831, K151593, K160416, K171345
Reference Device(s)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2017
Mauna Kea Technologies % Michael Daniel President Daniel & Daniel Consulting 340 Jones Lane Cardnerville, Nevada 89460
Re: K172844
Trade/Device Name: Cellvizio 100 Series System with Confocal Miniprobes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN Dated: September 18, 2017 Received: September 19, 2017
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,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172844
Device Name
Cellvizio® 100 Series systems (400 and/or 800) with Confocal Miniprobes™
Indications for Use (Describe)
The Cellvizio® 100 Series systems (400 and/or 800) 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 AlveoFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ (or GastroFlex™ M) series of Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscopic accessories.
The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.
The CystoFlex™ (F, UHD R, UHD R-C) and Uroflex™ B of Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
The CelioFlex™ (UHD 5, UHD 5-C) of 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) | |
|---|---|
| ------------------------------------------------- | -- |
区 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:
Applicant Information:
| Date Prepared: | September 18, 2017 |
|---|---|
| Date Revised: | November 16, 2017 |
| 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: | |
| Phone Number: | |
| Office: | |
| Facsimile Number: | Michael A. Daniel, Consultant |
| madaniel@clinregconsult.com | |
| (415) 407-0223 | |
| (775) 392-2970 | |
| (610) 545-0799 |
Device Information:
| Device Trade Name: | Cellvizio® 100 Series Confocal laser imaging systems and
their Confocal Miniprobes™ |
|--------------------------|----------------------------------------------------------------------------------------|
| Common Name: | Endoscope and Accessories |
| Classification Name(s): | Confocal Optical Imaging |
| Product Code/Regulation: | OWN/GCJ 21 CFR876.1500 |
| Classification: | Class II |
Predicate devices:
Previously cleared versions of Cellvizio® 100 Series Confocal laser imaging systems and their Confocal Miniprobes™ (K111047, K122042, K123676, K133466, K150831, K151593, K160416, K171345).
Device Description:
The Cellvizio® 100 Series systems with Confocal Miniprobes™ are a 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.
Materials, design and intended use of the aforementioned Cellvizio® 100 Series confocal laser imaging systems and their Confocal Miniprobes™ remain exactly the same as what were previously cleared in K111047, K122042, K123676, K133466, K150831, K151593, K160416 and K171345 respectively.
4
Intended 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 their organization or architecture.
The individual Confocal Miniprobes™ have been previously cleared as summarized in the following table:
| Application | Mode of Operation | |
|---|---|---|
| 400 | 800 | |
| Gastrointestinal | ||
| Endoscopy, | GastroFlex™ UHD (K111047, K150831) | |
| ColoFlex™ UHD (K111047, K150831) | ||
| GastroFlex™ UHD-C (K133466) | ||
| ColoFlex™UHD-C (K133466) | GastroFlex™ UHD-C (K133466) | |
| ColoFlex™UHD-C (K133466) | ||
| Gastrointestinal | ||
| Endoscopy, including | ||
| biliary and pancreatic | ||
| ducts | CholangioFlex™ (or GastroFlex™ M) | |
| (K122042, K150831) | ||
| Gastrointestinal | ||
| Endoscopy, Needle | ||
| Endoscopy, including | ||
| biliary and pancreatic | ||
| ducts | AQ-Flex™ 19 (K123676, K150831) | |
| Lung Endoscopy | AlveoFlex™ (K111047, K150831) | |
| AlveoFlex™-C (K133466) | AlveoFlex™-C (K133466) | |
| Urinary Endoscopy | CystoFlex™ UHD R (K150831) | |
| CystoFlex™ F (K150831) | ||
| UroFlex™ B (K150831) | ||
| CystoFlex™ UHD R-C (K160416) | CystoFlex™ UHD R-C (K160416) | |
| Laparoscopy, Manual | ||
| and robot-assisted | ||
| laparoscopic surgery | CelioFlex™ UHD 5 (manual laparoscopy: | |
| K151593, robot-assisted laparoscopy: | ||
| K171345) | ||
| CelioFlex™ UHD 5-C (manual laparoscopy: | ||
| K160416, robot-assisted laparoscopy: K171345) | CelioFlex™ UHD 5-C (manual laparoscopy: | |
| K160416, robot-assisted laparoscopy: K171345) |
Table 1 Table summarizing cleared Confocal Miniprobe™ with models Cellvizio® 100 Series systems with K numbers.
The fundamental system capabilities in terms of optical resolution, field of view, etc. as compared to the size of cells and vessels are independent of anatomical location and for this reason, we are requesting the additional intended use wording be associated with the laser imaging system itself separate from the individual Confocal Miniprobes™. There are relatively small differences in Confocal Miniprobe™ image resolution as described below in Section 14, however all of these Confocal Miniprobe™ capabilities are well above what is required to image cells, vessels, and their organization or architecture as described in Section 14.
5
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 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 AlveoFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ (or GastroFlex™ M) series of Confocal Miniprobes™ 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 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.
The CystoFlexTM (F, UHD-R, UHD-C) and UroflexTM B of Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
The CelioFlex™ (UHD 5, UHD 5-C) of Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
Comparison to previous Devices:
The Cellvizio® 100 Series systems and its Confocal Miniprobes™ remain exactly the same devices in terms of design, performance and general intended use (allow imaging of the internal microstructure) as the previously cleared devices.
Testing Completed:
As no change is being made to the devices, all testing required has been provided in previous submissions (K111047, K122042, K123676, K133466, K150831, K151593, K160416, K171345).
Clinical demonstration based on literature review has been carried out to support this submission, as described in section 14.
Summary:
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
6
cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
There are two models of the Cellvizio® 100 Series systems cleared by the F400 (K111047) and the F800 [K160416, formerly cleared as F700-v2 system (K133466)]. All cleared Cellvizio® 100 Series Confocal Miniprobes™ are compatible with the Cellvizio® 100 Series system (400) - F400 (K111047) but not all are compatible with the Cellvizio® 100 Series system (800) - F800 (K133466, K160416) as shown in the following table (Table 2).
| Cellvizio 100 Series
Confocal Miniprobe™ | Clearance
K number | Cellvizio® 100 Series
system (400) - F400
(K111047) | Cellvizio® 100 Series system
(800) - F800 (K133466,
K160416) |
|---------------------------------------------|-----------------------|-----------------------------------------------------------|--------------------------------------------------------------------|
| AlveoFlex™ | K111047
K150831 | Compatible | Not Compatible |
| AlveoFlex-C™ | K133466 | Compatible | Compatible |
| ColoFlex™ UHD | K111047
K150831 | Compatible | Not Compatible |
| ColoFlex™ UHD-C | K133466 | Compatible | Compatible |
| GastroFlex™ UHD | K111047
K150831 | Compatible | Not Compatible |
| GastroFlex™ UHD-C | K133466 | Compatible | Compatible |
| CystoFlex™ F | K150831 | Compatible | Not Compatible |
| CystoFlex™ UHD R | K150831 | Compatible | Not Compatible |
| CystoFlex™ UHD R-C | K160416 | Compatible | Compatible |
| CelioFlex™ UHD 5 | K151593,
K171345 | Compatible | Not Compatible |
| CelioFlex™ UHD 5-C | K160416,
K171345 | Compatible | Compatible |
| CholangioFlex™ (or
GastroFlex™ M) | K150831,
K123676 | Compatible | Not Compatible |
| AQ-Flex™ 19 | K150831,
K122042 | Compatible | Not Compatible |
| UroFlex™ B | K150831 | Compatible | Not Compatible |
Table 2 Compatibility of Cleared Confocal Miniprobe™ with models Cellvizio® 100 Series systems. F400 and F800.
Please note: A "-C" suffix has been added to the commercial name of Confocal Miniprobes™ to distinguish probes compatible with both Cellvizio® 100 Series systems F400 and F800 from probes compatible only with the Cellvizio® 100 Series system F400.
The objective of this submission is to clarify the previously cleared Indications for Use consistent with the proven optical resolution capabilities of the system, corresponding anatomical sizes of cells and vessels, Real World Evidence (RWE) and independent clinical findings from wellrespected clinical researchers and medical societies.