(88 days)
Not Found
No
The summary describes a confocal laser imaging system with fiber optic probes and a mechanical "grabule" for manipulation. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the optical imaging technology and mechanical handling features.
No.
The device is intended for imaging and visualization of tissues, not for providing therapy.
Yes
This device is intended to allow imaging of the internal microstructure of tissues and provide visualization of body cavities, organs, and canals during surgical procedures. While it doesn't explicitly state diagnostic intent, the act of visualizing internal structures to inform medical decisions inherently involves diagnostic capabilities.
No
The device description clearly details physical components like fiber optic probes, a "grabule", and compatibility with laparoscopic and robotic hardware, indicating it is a hardware device, 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" and "provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic and laparoscopic surgical procedures". This describes a device used in vivo (within the living body) for direct visualization.
- Device Description: The description details a system with fiber optic probes used for imaging through contact of their distal tip with the tissues during surgical procedures. This further confirms its in vivo application.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze biological specimens in vitro.
The device is clearly designed for direct visualization of internal tissues and structures during surgical procedures, which is an in vivo application, not an in vitro diagnostic one.
N/A
Intended Use / Indications for Use
Intended Use: 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.
Indications for Use: CelioFlex™ UHD Confocal Miniprobes™ are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic and laparoscopic surgical procedures, including robotic-assisted procedures.
Product codes (comma separated list FDA assigned to the subject device)
OWN, GCJ
Device Description
CelioFlex™ UHD Confocal Miniprobes™ are used with Cellvizio® 100 Series systems to provide imaging of the internal microstructure of body cavities, organs, and canals through contact of their distal tip with the tissues. They are designed for use during laparoscopic surgical procedures, including robot-assisted procedures.
CelioFlex™ UHD Confocal Miniprobes™ have a "grabule" (previously cleared in K151593 and K160416) on their distal tip. The "grabule" has been designed as a grip for laparoscopic grasping accessories, facilitating user control of the miniprobe distal tip during conventional laparoscopic procedures while preventing potential wear to the Miniprobe tip that repeated handling by forceps might cause. The diameter of the "grabule" is fitted for insertion of CelioFlex™ UHD Confocal Miniprobes™ through trocars with diameter larger or equal to 5 mm.
CelioFlex™ UHD Confocal Miniprobes are also compatible with laparoscopy robot-assisted procedures. Robotic arm graspers can be used to manipulate CelioFlex™ UHD Confocal Miniprobes.
During robotic-asisted procedures, CelioFlex™ UHD Confocal Miniprobes™ are inserted through a pre-installed trocar. When the CelioFlex™ UHD distal end appears on the monitor. the surgeon uses the robotic accessory to grasp the distal part of the Confocal Miniprobe™ or "grabule", with the laparoscopic grasper to position the Confocal Miniprobe-TM facing the tissue to be imaged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal imaging
Anatomical Site
body cavities, organs, and canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians / during endoscopic and laparoscopic and laparoscopic surgical procedures, including robotic-assisted 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 CelioFlex™ UHD Confocal Miniprobes™ during robot-assisted laparoscopy procedures have been assessed and additional testing with representative worst case robot grasping tools was performed to validate that the CelioFlex™ UHD Confocal Miniprobes™ can be used during robot-assisted laparoscopic procedures without change of safety, performances and increase of residual risks. The result from these tests, summarized in the table below, have demonstrated that the use of CelioFlexI™ UHD Confocal Miniprobes™ during robot-assisted laparoscopic procedures does not change performance or safety and effectiveness, and does not affect image quality and does not change the global residual risk.
Test performed: Grasp and Release Test with grasping robotic accessory (100 handling cycles with 8 samples)
Acceptance Criteria: The CelioFlexTM UHD Confocal Miniprobes must complete the testing without loss of imaging performance or broken and/or loose components
Result: Pass
Test performed: Bend and Flexibility Test with grasping robotic accessory (40 handling cycles with 8 samples)
Acceptance Criteria: The CelioFlexTM UHD Confocal Miniprobes must complete the testing without loss of imaging performance or broken and/or loose components
Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: | May 5, 2017 |
|---|---|
| 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 Confocal Miniprobes to be used with |
|---|---|
| Cellvizio® 100 Series Systems | |
| Common Name: | Endoscope and Accessories |
| Classification Name(s): | Confocal Optical Imaging |
| Product Code/Regulation: | OWN/GCJ 21 CFR876.1500 |
| Classification: | Class II |
Predicate devices:
The CelioFlex™ UHD 5 has been cleared with K151593
The CelioFlex™ UHD 5-C has been cleared with K160416
Device Description:
CelioFlex™ UHD Confocal Miniprobes™ are used with Cellvizio® 100 Series systems to provide imaging of the internal microstructure of body cavities, organs, and canals through contact of their distal tip with the tissues. They are designed for use during laparoscopic surgical procedures, including robot-assisted procedures.
CelioFlex™ UHD Confocal Miniprobes™ have a "grabule" (previously cleared in K151593 and K160416) on their distal tip. The "grabule" has been designed as a grip for laparoscopic grasping accessories, facilitating user control of the miniprobe distal tip during conventional laparoscopic procedures while preventing potential wear to the Miniprobe tip that repeated handling by forceps might cause. The diameter of the "grabule" is fitted for insertion of
1
CelioFlex™ UHD Confocal Miniprobes™ through trocars with diameter larger or equal to 5 mm.
CelioFlex™ UHD Confocal Miniprobes are also compatible with laparoscopy robot-assisted procedures. Robotic arm graspers can be used to manipulate CelioFlex™ UHD Confocal Miniprobes.
During robotic-asisted procedures, CelioFlex™ UHD Confocal Miniprobes™ are inserted through a pre-installed trocar. When the CelioFlex™ UHD distal end appears on the monitor. the surgeon uses the robotic accessory to grasp the distal part of the Confocal Miniprobe™ or "grabule", with the laparoscopic grasper to position the Confocal Miniprobe-TM facing the tissue to be imaged.
Intended Use:
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.
Indications for Use:
CelioFlex™ UHD Confocal Miniprobes™ are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic and laparoscopic surgical procedures, including robotic-assisted procedures.
Comparison to previous Devices:
CelioFlex™M UHD Confocal Miniprobes™ are already cleared for conventional laparoscopic procedures and have been thoroughly tested for this indication (K151593).
The subject devices are strictly identical to the predicate devices in terms of design, technological characteristics, and operating principle. The performances of the subject devices are thus unchanged in terms of imaging performances, biocompatibility, reprocessing, and laser safety, electrical safety and EMC when used with the Cellvizio® 100 Series systems. The Intended Use of the subject devices also remains the same as that of predicate devices.
Robotic accessories are more and more commonly used during laparoscopic procedures and the only difference in robot-assisted procedures is that the Confocal Miniprobe is handled by robotic grasping accessories instead of hand-held grasping accessories.
Testing Completed:
The table below summarizes the verification and validation testing performed on predicate devices (CelioFlex™ UHD 5 and CelioFlex™ UHD 5-C Confocal Miniprobes™) that have been provided in previous submissions K151593 and K160416 respectively.
2
| Test performed | Acceptance Criteria | Test Results |
|---|---|---|
| Biocompatibility (Cytotoxicity, Sensitization, Irritation or | ||
| Intracutaneous reactivity & Systemic toxicity) | All requirements met | Pass |
| Resistance to reprocessing methods: mechanical resistance, | ||
| tensile strength assessment, functional testing, image quality | ||
| etc. | All requirements met | Pass |
| Efficacy of reprocessing methods | All requirements met | Pass |
| Laser safety | All requirements met | Pass |
| Imaging quality | All requirements met | Pass |
| Compatibility of the CelioFlex™ UHD Confocal Miniprobes with | ||
| Trocars commonly used during laparoscopic procedures. | All requirements met | Pass |
The potential risks associated with the use of CelioFlex™ UHD Confocal Miniprobes™ during robot-assisted laparoscopy procedures have been assessed and additional testing with representative worst case robot grasping tools was performed to validate that the CelioFlex™ UHD Confocal Miniprobes™ can be used during robot-assisted laparoscopic procedures without change of safety, performances and increase of residual risks. The result from these tests, summarized in the table below, have demonstrated that the use of CelioFlexI™ UHD Confocal Miniprobes™ during robot-assisted laparoscopic procedures does not change performance or safety and effectiveness, and does not affect image quality and does not change the global residual risk.
| Test performed | Acceptance Criteria | Result |
|---|---|---|
| Grasp and Release Test with grasping | ||
| robotic accessory (100 handling cycles with | ||
| 8 samples) | The CelioFlexTM UHD Confocal Miniprobes must complete the | |
| testing without loss of imaging performance or broken and/or | ||
| loose components | Pass | |
| Bend and Flexibility Test with grasping | ||
| robotic accessory (40 handling cycles with 8 | ||
| samples) | The CelioFlexTM UHD Confocal Miniprobes must complete the | |
| testing without loss of imaging performance or broken and/or | ||
| loose components | Pass |
Summary:
Based upon the Intended Use, Indications for Use, product technical information, performances, safety and effectiveness, and biocompatibility provided in this submission and in the submissions of the previously cleared CelioFlex UHD 5 (K151593) and CelioFlex UHD 5-C (K160416), CelioFlex™ UHD Confocal Miniprobes™ used in robotic-assisted surgery procedures are substantially equivalent to predicate devices. The subject devices can safely and effectively be used to visualize and image the internal microstructure of tissues during endoscopic and laparoscopic surgical procedures, including robotic-assisted procedures.
3
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" 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
August 4, 2017
Mauna Kea Technologies % Michael Daniel President Daniel &Daniel Consulting 340 Jones Lane Gardnerville. Nevada 89460
Re: K171345
Trade/Device Name: Cellvizio 100 Series Systems with Confocal Miniprobes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN, GCJ Dated: May 5, 2017 Received: May 8, 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
5
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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.
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.
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