(88 days)
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.
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CelioFlex™ UHD Confocal Miniprobes™:
Acceptance Criteria and Device Performance
The provided documentation describes the acceptance criteria and performance for the CelioFlex™ UHD Confocal Miniprobes™ used with Cellvizio® 100 Series Systems, specifically focusing on their use during robot-assisted laparoscopic procedures.
Table 1: Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 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 |
| For Robot-Assisted Procedures: | ||
| Grasp and Release Test with grasping robotic accessory (100 handling cycles) | The CelioFlex™ 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) | The CelioFlex™ UHD Confocal Miniprobes must complete the testing without loss of imaging performance or broken and/or loose components | Pass |
Study Information
The document describes verifications and validations performed, primarily to demonstrate the substantial equivalence of the device for robot-assisted procedures, building upon previous clearances for conventional laparoscopic use.
-
Sample Size, Test Set, and Data Provenance:
- Test Set Sample Size:
- For the "Grasp and Release Test with grasping robotic accessory," 8 samples were used.
- For the "Bend and Flexibility Test with grasping robotic accessory," 8 samples were used.
- For the other tests (Biocompatibility, Reprocessing, Laser Safety, Imaging Quality, Trocar Compatibility), the specific sample sizes are not explicitly stated in this summary, but they are implied to be part of the predicate device submissions (K151593 and K160416).
- Data Provenance: The studies described are prospective in nature, as they involve performing specific tests on the devices to assess their performance under defined conditions. The country of origin of the data is not specified, but the applicant's address is Paris, France.
- Test Set Sample Size:
-
Number and Qualifications of Experts for Ground Truth:
- This document focuses on device performance and safety testing rather than diagnostic accuracy involving human experts. Therefore, the concept of "experts used to establish the ground truth" in a clinical diagnostic sense is not directly applicable here. The "Pass" results are based on meeting predefined engineering and safety requirements.
-
Adjudication Method for Test Set:
- Again, this is not a clinical study involving human interpretation of results requiring adjudication. The tests have clear pass/fail criteria based on objective measurements and observations (e.g., "no loss of imaging performance or broken and/or loose components").
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This document pertains to the physical and functional performance of a medical device (endoscopic probe) and its safety for a specific surgical procedure, not the diagnostic accuracy or interpretative performance of a reading algorithm or human readers.
-
Standalone (Algorithm Only) Performance Study:
- No, a standalone (algorithm only) performance study was not done. This device is a physical diagnostic tool (a confocal miniprobe) used by a surgeon, not an AI algorithm. The performance being evaluated is the physical integrity and imaging capability of the probe itself during manipulation.
-
Type of Ground Truth Used:
- The "ground truth" used for these tests is based on engineering specifications, safety standards, and functional performance criteria. For example, the criteria dictate that the device must maintain imaging performance and not break or loosen components after specific manipulation cycles. This is not clinical pathology, expert consensus on diagnostic findings, or outcomes data in the usual sense for an AI diagnostic device.
-
Sample Size for Training Set:
- There is no training set mentioned or implied, as this is not an artificial intelligence or machine learning device. The "training" in this context refers to the development and previous testing of the predicate devices.
-
How Ground Truth for Training Set was Established:
- Since there is no training set, this question is not applicable.
§ 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.