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510(k) Data Aggregation
(87 days)
The Cellvizio® 100 Series systems (400 and/or 800) with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture.
The GastroFlex™ (UHD, UHD-C) and ColoFlex™ (UHD, UHD-C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.
The AlveoFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ (or GastroFlex™ M) series of Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscopic accessories.
The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.
The CystoFlex™ (F, UHD R, UHD R-C) and Uroflex™ B of Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
The CelioFlex™ (UHD 5, UHD 5-C) of Confocal Miniprobes™ are intended to provide visualization of body cavities. organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
The Cellvizio® 100 Series systems with Confocal Miniprobes™ are a 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.
Materials, design and intended use of the aforementioned Cellvizio® 100 Series confocal laser imaging systems and their Confocal Miniprobes™ remain exactly the same as what were previously cleared in K111047, K122042, K123676, K133466, K150831, K151593, K160416 and K171345 respectively.
The provided document is a 510(k) premarket notification for the "Cellvizio 100 Series System with Confocal Miniprobes™". It describes the device, its intended use, and argues for substantial equivalence to previously cleared devices.
Crucially, this document states that "As no change is being made to the devices, all testing required has been provided in previous submissions." It also notes that "Clinical demonstration based on literature review has been carried out to support this submission, as described in section 14."
This K172844 clearance is an update to the Indications for Use based on existing data and literature, rather than presenting new primary study data for the device's performance against acceptance criteria. Therefore, the information typically found in a clinical study report proving device performance against acceptance criteria for a new device or significant modification is not explicitly present in this document.
The document discusses the capabilities of the device in terms of optical resolution for imaging cells and vessels, referencing it as "proven optical resolution capabilities" and citing "Real World Evidence (RWE) and independent clinical findings from well-respected clinical researchers and medical societies." However, it does not provide the specifics of the studies that generated this evidence within this submission.
Therefore, many of your requested points about acceptance criteria and a study proving their achievement cannot be directly extracted from this particular 510(k) summary. This document is a re-submission leveraging prior clearances and general scientific understanding.
Based on the provided text, here's what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new study in this document. The device's "proven optical resolution capabilities" and ability to "image cells, vessels, and their organization or architecture" serve as implicit performance expectations, derived from prior clearances (K111047, K122042, K123676, K133466, K150831, K151593, K160416, K171345).
- Reported Device Performance: The document states that the device's "fundamental system capabilities in terms of optical resolution, field of view, etc. as compared to the size of cells and vessels are independent of anatomical location" and that "all of these Confocal Miniprobe™ capabilities are well above what is required to image cells, vessels, and their organization or architecture as described in Section 14." No specific numerical performance metrics are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. The submission relies on "Real World Evidence (RWE) and independent clinical findings from well-respected clinical researchers and medical societies" and previous clearance data, rather than a new, specific test set for this particular submission.
3. 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 explicitly stated in this document. The "independent clinical findings" mentioned imply expert input, but details on the number or qualifications of experts involved in prior studies or literature review are absent from this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
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 device is an imaging system, not an AI-assisted diagnostic tool designed to improve human reader performance in the way an AI algorithm for image interpretation would. The document does not describe an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a direct visualization device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The implicit ground truth for the device's performance relates to its ability to image the "internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture." This would typically be confirmed via a comparison to histology/pathology, or by expert observation using the device itself, but the specific studies and their ground truth methodology are not detailed in this summary. The mention of "Real World Evidence" and "clinical findings" suggests real-world diagnostic outcomes and expert interpretations.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
In summary, the provided document (K172844) is a regulatory submission focused on clarifying and expanding the Indications for Use of a previously cleared device. It relies on the substantial equivalence principle and existing evidence (prior clearances, literature review, and "Real World Evidence") rather than presenting new, detailed study results for acceptance criteria. Therefore, specific details about sample sizes, expert qualifications, and study methodologies for proving the device's performance against defined acceptance criteria are not contained within this specific document. These details would presumably be in the support documentation for the original clearances (e.g., K111047, K122042, etc.) or the referenced scientific literature.
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(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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