(133 days)
No
The summary describes a confocal laser imaging system and a modified fiber optic probe. There is no mention of any software features, image analysis, or algorithms that would suggest the use of AI or ML. The modifications described are purely mechanical (addition of a "Grabule").
No
The device is described as an imaging system intended for visualization, not for treatment or therapy.
No
The device is intended for "imaging of the internal microstructure of tissues" and to "provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures," which describes an imaging and visualization tool, not a device that provides a diagnosis.
No
The device description explicitly details hardware components including a confocal laser system, fiber optic probes, and a metallic "Grabule" component. It is not solely software.
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" and "provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures." This describes a device used for direct visualization and imaging within the body, not for testing samples in vitro (outside the body).
- Device Description: The description details a confocal laser system with fiber optic probes designed for insertion into the body for imaging. It also describes a specific probe (CelioFlex™ UHD 5) used with laparoscopic forceps for positioning within the body. This aligns with an in vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue biopsies, etc.) in vitro. The device is used to image tissue in situ.
Therefore, the Cellvizio® 100 Series System with Confocal Miniprobes™ and the CelioFlex™ UHD 5 Confocal Miniprobe are in vivo imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
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.
CelioFlex™ UHD 5 Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.
Product codes
OWN, GCJ
Device Description
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.
CelioFlex™ UHD 5 Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures. The CelioFlex™ UHD 5 confocal Miniprobe is a CystoFlex™ UHD R Confocal Miniprobe with an additional "Grabule" component and with an optical fiber of 3 meters vs. 2 meters. The Grabule is a metallic part glued to the distal tip and the adjacent part of the sheath of the CelioFlex™ UHD 5 Confocal Miniprobe. The Grabule has been designed as a grip for laparoscopic forceps, facilitating user control of the Miniprobe distal tip during laparoscopic procedures. Both the stainless steel 316L metal comprising the Grabule and the epoxy glue (Epotek 301) used to cement the Grabule to the Miniprobe are currently used in the CystoFlex™ UHD R Miniprobe reference device. The Grabule shields the Miniprobe tip from potential wear that repeated handling by forceps might cause.
During standard laparoscopic procedures, CelioFlex™ UHD 5 Confocal Miniprobe is inserted through a pre-installed trocar. When the CelioFlex™ UHD 5 appears on the laparoscope monitor, the surgeon grasps the distal tipped Grabule with the laparoscopic fenestrated forceps to position the Confocal Miniprobe facing the tissue to be imaged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal Laser
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing demonstrates that the modifications meet the design specifications and user needs. Sterilization and biocompatibility testing provides evidence that there are no changes to the biocompatibility of the device and no changes to the efficacy and compatibility of the subject device with sterilization processes.
Testing Completed:
Sterilization Efficacy Verification: All requirements met, Test Passed
Reprocessing Sterilization Validation: All requirements met, Test Passed
Biocompatibility (Cytotox)Validation: All requirements met, Test Passed
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2015
Mauna Kea Technologies Mr. Michael A. Daniel Daniel & Daniel Consulting 340 Jones Lane Gardnerville, Nevada 89460
Re: K151593
Trade/Device Name: CelioFlex " UHD 5 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OWN, GCJ Dated: September 24, 2015 Received: September 25, 2015
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
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6. Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(K) Number (if known)
Device Name
CelioFlex™ UHD 5
· Indications for Use (Describe)
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.
CelioFlex™ UHD 5 Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.
Type of Use (Select one or both, as applicable) X 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)
FORM FDA 3881 (1/14)
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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: | June 9, 2015 |
|---|---|
| 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: | CelioFlex™ UHD 5 Confocal Miniprobe to be used with
Cellvizio® 100 Series System |
|---------------------------|-------------------------------------------------------------------------------------|
| Common Name: | Endoscope and Accessories |
| Classification Name(s): | Confocal Optical Imaging |
| Product Code/ Regulation: | OWN / GCJ 21 CFR 876.1500 |
| Classification: | Class II |
Predicate Device:
- Circon's USA Series™ Laparoscope has been cleared with K013165
Reference Devices:
- The Cellvizio 100 Series System with Confocal Miniprobes cleared via K111047.
- . The CystoFlex™ UHD R has been cleared with K141358
Device Description:
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.
CelioFlex™ UHD 5 Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures. The CelioFlex™ UHD 5 confocal Miniprobe is a CystoFlex™ UHD R Confocal Miniprobe with an additional "Grabule" component and with an optical fiber of 3 meters vs. 2 meters. The Grabule is a metallic part glued to the distal tip and the adjacent part of the sheath of the CelioFlex™ UHD 5 Confocal Miniprobe. The
4
Grabule has been designed as a grip for laparoscopic forceps, facilitating user control of the Miniprobe distal tip during laparoscopic procedures. Both the stainless steel 316L metal comprising the Grabule and the epoxy glue (Epotek 301) used to cement the Grabule to the Miniprobe are currently used in the CystoFlex™ UHD R Miniprobe reference device. The Grabule shields the Miniprobe tip from potential wear that repeated handling by forceps might cause.
During standard laparoscopic procedures, CelioFlex™ UHD 5 Confocal Miniprobe is inserted through a pre-installed trocar. When the CelioFlex™ UHD 5 appears on the laparoscope monitor, the surgeon grasps the distal tipped Grabule with the laparoscopic fenestrated forceps to position the Confocal Miniprobe facing the tissue to be imaged.
Indications for Use:
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.
CelioFlex™ UHD 5 Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.
Comparison to Previous Devices:
No change is being made to the fundamental technology and operating principle of the previously cleared CystoFlexTM UHD R Confocal Miniprobe (K141358). The CelioFlex™ UHD 5 is identical to this reference device, only differing by the addition of the Grabule on its distal tip and by the fiber length (2m for CystoFlex™ UHD R and 3m for CelioFlex™ UHD 5).
The Indications for Use and Intended Use of CelioFlex™ UHD R are the same as Circon's USA Series™ Laparoscopes (K013165) predicate and CystoFlex™ UHD R (K141358) reference devices, respectively.
Due to the addition of the Grabule on its distal tip, the CelioFlex™ UHD 5 is designed to fit into trocars of 4.95mm or greater.
Attached verification and validation testing demonstrates that the modifications meet the design specifications and user needs. Sterilization and biocompatibility testing provides evidence that there are no changes to the biocompatibility of the device and no changes to the efficacy and compatibility of the subject device with sterilization processes.
Testing Completed:
| Sterilization Efficacy Verification: | All requirements met, Test Passed |
|---|---|
| Reprocessing Sterilization Validation: | All requirements met, Test Passed |
| Biocompatibility (Cytotox)Validation: | All requirements met, Test Passed |
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Summary:
Based upon the Intended Use, Indications for Use, product technical information, performance, sterilization testing, and biocompatibility validation provided in this premarket notification, the CelioFlex™ UHD 5 Confocal Miniprobe, when used as part of the Cellvizio 100 Series, has been shown to be substantially equivalent to the Circon's USA Series™ Laparoscopes, and is basically identical in technological characteristics to the CystoFlexTM UHD R Confocal Miniprobe reference device. The subject device can safely and effectively be used to visualize and image the internal microstructure of tissues during endoscopic and laparoscopic surgical procedures.