(94 days)
Cellvizio® 100 Series Systems with Confocal Miniprobes™ are systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.
CelioFlex™ UHD 5-C 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.
CystoFlex™ UHD R-C 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.
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 cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.
Both CystoFlex UHD R-C and CelioFlex™ UHD 5-C have an achromatic UHD optical distal head that provide high resolution imaging for 488 to 785nm laser emission.
A "-C" suffix has been added to the commercial name of these Confocal Miniprobes compared to the predicate devices when used with a Cellvizio 100 Series (800) which has been previously cleared as Cellvizio 100 Series with F700-v2 system (K133466).
Here's an analysis of the provided text regarding the acceptance criteria and study information:
This document is a 510(k) summary for the Cellvizio® 100 Series Systems with Confocal Miniprobes™ (CystoFlex™ UHD R-C and CelioFlex™ UHD 5-C). The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, specifically CystoFlex UHD R (K141358) and CelioFlex UHD 5 (K151593), and the reference device Cellvizio 100 Series F700-V2 system (K133466), which has been re-named to Cellvizio 100 Series (800) with F800-V2.
Key takeaway: The document states that "No change is being made to the fundamental technology and operating principle of the previously cleared CystoFlex™ UHD R & CelioFlex™ UHD 5 Confocal Miniprobes." The suffix "-C" was added for commercial reasons when used with the Cellvizio 100 Series (800). Therefore, the acceptance criteria and performance data primarily refer to the studies previously conducted for the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this submission is for a device that has "no change... to the fundamental technology and operating principle" of its predicate, the acceptance criteria and reported performance mirror those established for the original predicate devices (K141358 and K151593). The document explicitly states: "All the verification and validation testing were performed on predicate devices... and have shown that subject devices... meet the design specification and user needs." and "The result from these performance evaluations demonstrated that the CystoFlex™ UHD R-C and CelioFlex™ UHD 5-C met the acceptance criteria defined in the product specification and performed comparably to the predicate device."
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | - ISO 10993-1:2009 (Evaluation and testing within a risk management process) | Met requirements; assessed for cytotoxicity, sensitization, irritation/intracutaneous reactivity, and systemic toxicity. |
| - ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Met requirements. | |
| - ISO 10993-10:2010 (Tests for irritation and delayed-type hypersensitivity) | Met requirements. | |
| - ISO 10993-11:2009 (Tests for systemic toxicity) | Met requirements. | |
| Resistance to Reprocessing Methods | - Internal specifications for number of uses | Met requirements. |
| - AAMI TIR 12:2010 (Designing, testing and labeling reusable medical devices for reprocessing) | Met requirements (mechanical resistance, tensile strength, functional testing, image quality). | |
| Efficacy of Reprocessing Methods | - AAMI TIR 12:2010 | Met requirements. |
| - AAMI TIR 30:2011 (Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices) | Met requirements. | |
| Laser Safety | - IEC 60825-1:2007 | Compliant. |
| - 21 CFR 1040.10 and 1040.11 with Laser Notice N°50 | Compliant. | |
| Imaging Quality | - ISO 8600-1:2005 (General requirements for medical endoscopes) | Compliant. |
| - ISO 8600-3:1997 & Amendment 1, 2003 (Determination of field of view and direction of view) | Compliant. | |
| - ISO 8600-4:1997 (Determination of maximum width of insertion portion) | Compliant. | |
| - Internal standards using 1951 USAF resolution test chart (MIL-STD-150A) for resolution | Met standards. | |
| Compatibility (CystoFlex™ UHD R-C) | - With rigid cystoscopes according to specifications and IEC 60601-1-6:2010 & IEC 62366:2007 | Tested and validated. |
| Compatibility (CelioFlex™ UHD 5-C) | - With Trocars according to specifications and IEC 60601-1-6:2010 & IEC 62366:2007 | Tested and validated. |
| Electrical Safety (System) | - IEC 60601-1:2005 and applicable collateral standards | Compliant. |
Study Information:
Since "all verification and validation testing were performed on predicate devices," the following answers refer to the studies for the predicate devices as implied by this submission. The provided document is a 510(k) summary, which generally summarizes existing data rather than providing full study protocols or detailed results. As such, specific details for some points are not explicitly stated in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in this summary for each test. Testing would involve multiple units/samples for each specific test (e.g., multiple probes for reprocessing, multiple runs for biocompatibility tests).
- Data Provenance: Not explicitly stated, but typically these tests are conducted in controlled lab environments or testing facilities, often within the manufacturer's R&D or by certified third-party testing labs. The product is manufactured in France (Mauna Kea Technologies, 9 rue d'Enghien F-75010 Paris, France). It is reasonable to assume the testing was conducted in Europe or by international standards-compliant labs, but specific country of origin for the data is not given.
- Retrospective or Prospective: These are predominantly prospective verification and validation tests conducted to demonstrate compliance with standards and specifications for the initial clearance of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. The tests described are primarily engineering, electrical, optical, and biological safety tests against established international and national standards (ISO, AAMI, IEC, CFR). The "ground truth" is adherence to these quantifiable technical and safety standards, rather than expert interpretation of medical images. For functional tests, "qualified physicians" are mentioned for the intended use, but not for establishing ground truth of the technical performance tests themselves.
4. Adjudication method for the test set:
- Not applicable. These are technical and safety tests, not clinical performance studies requiring adjudication of medical diagnoses. The results are typically pass/fail against predetermined acceptance criteria based on industry standards and device specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an imaging system (confocal miniprobes), not an AI-powered diagnostic or assistive tool. It provides images of the "internal microstructure of tissues." The document describes technical performance and safety, not diagnostic efficacy or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is an imaging hardware system. It does not contain an "algorithm only" component for standalone performance evaluation in the context of AI.
7. The type of ground truth used:
- Established Technical and Safety Standards: The ground truth for this device's performance is adherence to recognized international and national standards for medical devices, optics, laser safety, biocompatibility, and reprocessing (e.g., ISO, AAMI, IEC, 21 CFR).
- Internal Specifications: Company-defined specifications regarding device functionality, image quality (e.g., resolution using USAF test chart), and durability (e.g., number of uses) also serve as ground truth for acceptance.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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.