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510(k) Data Aggregation
(267 days)
The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal or respiratory, accessed by an endoscope or endloscopic accessories.
The GastroFlex M series of Confocal Miniprobes are intended to allow imaging of the internal microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endloscopic accessories.
The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal.
The AQ-Flex 19 member of the GastroFlex M series of Confocal Miniprobes can be used within anatomical tracts, i.e., gastrointestinal, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.
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 Uroflex™B and CystoFlex™F Confocal Miniprobes can be used within anatomical tracts, i.e. Urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscopic accessories.
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.
AlveoFlex™. ColoFlex™ UHD, GastroFlex™ UHD, CholangioFlex™, AQ-Flex™. UroFlex™ B and CystoFlex™ UHD R are Confocal Miniprobes which are compatible with specific high level disinfection and low temperature sterilization methods as described in the reprocessing instructions.
Materials, design and intended use of the aforementioned Confocal Miniprobes remain exactly the same as what were previously cleared in K111047. K122042. K123676. K132389 and K141358 respectively.
Low temperature sterilization methods will be added to the reprocessing instructions. Compatibility and efficacy of these methods with Confocal Miniprobes have been validated. The extent of validation testing relevant to this submission is provided below
Verification and validation testing confirm that GastroFlex™ UHD, ColoFlex™ UHD, AlveoFlex™ and CholangioFlex™ Confocal Miniprobes™ can be reprocessed safely using STERRAD® sterilization systems 100S and 100NX (EXPRESS) according to reprocessing instructions.
The provided text describes a 510(k) premarket notification for a medical device family (Cellvizio 100 Series System with Confocal Miniprobes), specifically focusing on the addition of low-temperature sterilization methods to their reprocessing instructions. The primary study presented is a performance evaluation to confirm the compatibility and efficacy of these sterilization methods.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Device Family: Cellvizio 100 Series System with Confocal Miniprobes
(Including AQ-Flex™, UroFlex™ B, CystoFlex™ UHD R, ColoFlex™ UHD, GastroFlex™ UHD, CholangioFlex™, and AlveoFlex™)
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Achieve a Sterility Assurance Level (SAL) of $10^{-6}$ | Confirmed: "Sterilization validation was performed on the products to confirm sterility assurance levels (SAL) of $10^{-6}$." |
| Material Compatibility | Components remain visually intact & functional | Confirmed: "Functional testing post sterilization validation included visual assessment of component condition, insertion and removal tests, tensile strength and optical performance assessment. These tests also confirmed material compatibility." |
Specific Device Performance:
- AQ-Flex™ 19, UroFlex™ B, and CystoFlex™ UHD R: "can safely and efficiently be reprocessed using STERRAD® 50, 200, 100S, 100NX EXPRESS and 100NX Duo cycles according to reprocessing instructions. Chemical resistance [material compatibility implied] as well as a sterility assurance level (SAL) of 10-$^6$ has been demonstrated."
- GastroFlex™ UHD, ColoFlex™ UHD, AlveoFlex™ and CholangioFlex™: "Can be reprocessed using STERRAD® sterilization systems 100S, 100NX EXPRESS according to reprocessing instructions... The compatibility with these sterilization methods has been demonstrated." |
| Functional Performance | Maintain mechanical (insertion/removal/tensile) & optical performance after reprocessing | Confirmed: "Functional testing post sterilization validation included visual assessment of component condition, insertion and removal tests, tensile strength and optical performance assessment." |
| Biocompatibility | No unacceptable biological response after contact with reprocessed device | Confirmed: "Biocompatibility per relevant portions of ISO 10993-1" was tested for Cytotoxicity, Sensitization, and Irritation. The summary implies these tests were met as part of demonstrating safe reprocessing. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the numerical sample size for the "test set" (i.e., the number of miniprobes subjected to the full battery of sterilization and functional tests). It refers to "the products" and specific models (AQ-Flex™ 19, UroFlex™ B, CystoFlex™ UHD R, GastroFlex™ UHD, ColoFlex™ UHD, AlveoFlex™, CholangioFlex™). Typically, for sterilization validation, multiple units of each device type and/or material are tested.
- Data Provenance: The data is likely prospective as it involves specific validation testing for the new sterilization methods. There's no information about the country of origin of the data beyond the applicant being "Mauna Kea Technologies, F-75010 Paris, France."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study focuses on validating physical and functional properties (sterilization efficacy, material compatibility, functional performance, biocompatibility) rather than a diagnostic performance where expert ground truth would be required. The "ground truth" here is objective measurements against established engineering and biological standards (e.g., SAL of $10^{-6}$, ISO 10993-1).
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving reader interpretations of images or data where a consensus among experts is needed to establish ground truth. This study involves laboratory validation.
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
Not applicable. This is not a study assessing AI performance or human reader performance. It's a technical validation study for reprocessing instructions of an endoscope accessory.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device is not an AI algorithm. It is a medical device (confocal miniprobe) that requires human operation with an endoscope, and the study focuses on its physical properties after reprocessing.
7. The type of ground truth used
The ground truth used for this study is based on objective engineering and biological standards.
- Sterilization Efficacy: Sterility Assurance Level (SAL) of $10^{-6}$ as per industry standards and regulatory requirements. This is typically verified through biological indicator testing.
- Material Compatibility & Functional Performance: Performance against predefined specifications for visual integrity, mechanical function (e.g., tensile strength, insertion/removal forces), and optical performance after a specified number of reprocessing cycles.
- Biocompatibility: Conformance to relevant portions of ISO 10993-1 (e.g., passing tests for cytotoxicity, sensitization, irritation).
8. The sample size for the training set
Not applicable. This is a validation study for physical device properties, not a machine learning study that would involve training data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this type of validation, there is no ground truth established for it.
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(133 days)
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.
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.
The provided text is a 510(k) summary for the CelioFlex™ UHD 5 Confocal Miniprobe. It describes the device, its intended use, and its comparison to predicate and reference devices. However, it does not contain a study that demonstrates the device meets specific performance acceptance criteria related to its imaging capabilities or a comparison to a gold standard of truth for diagnostic accuracy.
The "Testing Completed" section lists engineering and manufacturing verification and validation tests, not clinical performance studies with acceptance criteria for diagnostic accuracy. These include:
- Sterilization Efficacy Verification: "All requirements met, Test Passed"
- Reprocessing Sterilization Validation: "All requirements met, Test Passed"
- Biocompatibility (Cytotox) Validation: "All requirements met, Test Passed"
These tests confirm that the device is safe and functions as intended from a manufacturing and material perspective, and that additions like the "Grabule" and increased fiber length do not compromise these aspects. They are not performance metrics for diagnostic accuracy or imaging quality in a clinical context that would typically involve acceptance criteria like sensitivity, specificity, or image resolution compared to a "ground truth".
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of diagnostic performance, as such a study is not present in the provided document.
To directly answer your numbered points based on the provided text's limitations:
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A table of acceptance criteria and the reported device performance:
- No acceptance criteria for diagnostic accuracy/imaging performance are provided.
- The reported device performance relates to manufacturing and safety conformity:
- 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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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as detailed clinical performance studies for diagnostic accuracy are not described in this summary. The "tests" mentioned are likely lab-based engineering/manufacturing verification.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the diagnostic sense is not established in the described testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. This device is an endoscope component, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable, as this summary does not describe an AI/ML device or its training.
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How the ground truth for the training set was established: Not applicable.
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