(125 days)
Not Found
No
The summary describes a confocal laser imaging system and a fiber optic probe. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies. The performance studies focus on verification, validation, and biocompatibility, not algorithmic performance.
No
The device is described as a "confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues," implying a diagnostic rather than therapeutic purpose.
Yes
The device is intended to "allow imaging of the internal microstructure of tissues" to be "accessed through an endoscope or endoscopic accessories." This imaging ability suggests its use in examining and identifying medical conditions or diseases, which aligns with the definition of a diagnostic device.
No
The device description explicitly mentions hardware components like a confocal laser system, fiber optic probes, and a miniprobe with a distal optical head, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "allow imaging of the internal microstructure of tissues" within anatomical tracts. This is a direct imaging technique performed in vivo (within the living body).
- Device Description: The device is a "confocal laser system with fiber optic probes" used for "confocal laser imaging of the internal microstructure of tissues." This describes an imaging system, not a device that analyzes samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue biopsies) outside the body, which is the defining characteristic of an IVD. The device is used to visualize tissue in situ.
Therefore, the Cellvizio® 100 Series System with Confocal Miniprobes™ and the CystoFlex™ UHD R Confocal Miniprobe are considered imaging devices used for direct visualization of tissue microstructure, not IVDs.
N/A
Intended Use / Indications for Use
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.
The CystoFlex UHD R Confocal Miniprobe can be used within anatomical tracts. i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
Product codes
OWN
Device Description
The CystoFlex UHD R Confocal Miniprobe, when used as part of the Cellvizio 100 Series system and the Cellvizio system, is intended to allow confocal laser imaging of the internal microstructure of tissues in anatomical tracts, i.e., urinary, including, but not limited to, urethra and bladder, accessed through an endoscope or endoscopic accessories.
The CystoFlex UHD R Confocal Miniprobe is similar in design to the UroFlex B Confocal Miniprobe, except for its distal optical head, which is a UHD-type distal head. The CystoFlex UHD R Confocal Miniprobe can be inserted into endoscope lumens with inner diameter equal to or higher than 2.8mm, allowing them to work in currently used rigid cystoscopes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
confocal laser imaging
Anatomical Site
internal microstructure of tissues in anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter
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
Verification and validation testing provides proof that the modifications meet the design specifications and user needs, and biocompatibility testing provides evidence that there are no changes to the biocompatibility of the device.
Key Metrics
Not Found
Predicate Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2014
Mauna Kea Technologies % Mr. Michael A. Daniel Daniel and Daniel Consulting 340 Jones Lane Gardnerville, Nevada 89460
Re: K141358
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: August 27, 2014 Received: August 29, 2014
Dear Mr. 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 (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K141358
Device Name
Cellvizio 100 Series System with Confocal Miniprobes
Indications for Use (Describe)
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.
The CystoFlex UHD R Confocal Miniprobe can be used within anatomical tracts. i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 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: | K141358 |
|---|---|
| ---------------- | --------- |
Applicant Information:
| Date Prepared: | May 6, 2014 |
|---|---|
| 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
| Phone Number: | (415) 407-0223 |
|---|---|
| Office: | (775) 392-2970 |
| Facsimile Number: | (775) 392-2972 |
Device Information:
| Device Trade Name: | Cellvizio® 100 Series System with Confocal
Miniprobes™ |
|---------------------------|-----------------------------------------------------------|
| Common Name: | Endoscope and Accessories |
| Classification Name(s): | Confocal Optical Imaging |
| Product Code/ Regulation: | OWN / 21 CFR 876.1500 |
Predicate Device:
Classification:
-
Regarding the Cellvizio Confocal Imaging System, the Cellvizio 100 . Series System has been cleared in K111047.
Class II -
. Regarding the compatibility of the access during urological procedures in rigid cystoscopes and the visualization and examination of the urinary tract, the CystoFlex UHD R Confocal Miniprobe is substantially equivalent to the previously cleared UroFlex B Confocal Miniprobe (K132389).
4
Device Description:
The CystoFlex UHD R Confocal Miniprobe, when used as part of the Cellvizio 100 Series system and the Cellvizio system, is intended to allow confocal laser imaging of the internal microstructure of tissues in anatomical tracts, i.e., urinary, including, but not limited to, urethra and bladder, accessed through an endoscope or endoscopic accessories.
The CystoFlex UHD R Confocal Miniprobe is similar in design to the UroFlex B Confocal Miniprobe, except for its distal optical head, which is a UHD-type distal head. The CystoFlex UHD R Confocal Miniprobe can be inserted into endoscope lumens with inner diameter equal to or higher than 2.8mm, allowing them to work in currently used rigid cystoscopes.
Indications for Use:
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.
The CystoFlex™ UHD R Confocal Miniprobe can be used within anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
Comparison to Predicate Device:
No change is being made to the fundamental technology and operating principle of the previously cleared UroFlex™ B Confocal Miniprobe used in this submission as a predicate device (K132389). The CystoFlex UHD R is identical to this predicate device, only differing by the design of its distal optical head ("UHD-type" for the CystoFlex™ UHD R instead of "Z-type" for the UroFlex™ B). The indications for use is unchanged and remains to image the urinary tract during endoscopic procedures.
Due to this UHD-type distal optical head, the CystoFlex™ UHD R is designed to fit into rigid cystoscopes with working channel ≥ 2.8 mm.
Verification and validation testing provides proof that the modifications meet the design specifications and user needs, and biocompatibility testing provides evidence that there are no changes to the biocompatibility of the device.
Summary:
Based upon the intended use, indications for use, product technical information, performance testing and biocompatibility information provided in this premarket notification, the CystoFlex™ UHD R Confocal Miniprobe, when used as part of the Cellvizio 100 Series and the Cellvizio Systems, has been shown to be substantially equivalent to the UroFlex™ B Confocal Miniprobe, and can be used as intended to image the internal microstructure
5
Mauna Kea Technologies
of tissues in the urinary tract during endoscopic procedures. This Confocal Miniprobe has been verified to be compatible with cystoscopes that are designed to be used in these applications.