(23 days)
The Cellvizio® I.V.E. 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 including, but not limited to, the identification of cells and vessels and their organization or architecture.
The Cellvizio® I.V.E. system is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.
The GastroFlex™ N and ColoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.
The AlveoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ N Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
The AQ-Flex™ 19 N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, EBUS-TBNA and TBNA).
The CystoFlex™F N, CystoFlex™ R N and UroFlex™ N 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™ 5 N Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
Confocal Miniprobes™ are used with Cellyizio® I.V.E. system. which is a confocal imaging system with fiber optic probes which allows visualization of internal microstructure of tissues and blood flow including, but not limited to, the identification of cells, vessels and their organization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
Fluorescein Sodium is used as a fluorescence contrast agent to allow imaging of microvasculature and visualization of blood flow in vascular areas, including microvasculature and capillaries. Fluorescein Sodium can be used as a contrast agent with Cellvizio® I.V.E. system with Confocal Miniprobes™ without change of formulation, mode of action, approved dose or route of administration: it is delivered independent of Cellyizio® I.V.E. system in accordance with Fluorescein Sodium instruction for use.
The provided text is a 510(k) Premarket Notification summary for the Cellvizio® I.V.E. system with Confocal Miniprobes™. This submission is primarily to extend the device's Indications for Use to include imaging blood flow in vascular areas when used with Fluorescein Sodium as a contrast agent.
Based on the document, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance metrics in a quantitative manner (e.g., sensitivity, specificity, accuracy thresholds). Instead, the submission relies on demonstrating substantial equivalence to previously cleared devices. The "performance" assessment is based on the device having the "same intended use," "same operating principle," "same technological characteristics," "same design," and "same biocompatible materials" as predicate and reference devices, especially in the context of the new expanded indication.
Therefore, the "acceptance criteria" are implied to be equivalence to the performance of the predicate and reference devices under the expanded use case (imaging blood flow with Fluorescein Sodium), as the core technology and hardware are unchanged.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance and Justification |
|---|---|
| Similar Intended Use and Indications for Use (especially with Fluorescein Sodium) | Subject Device: The Cellvizio® I.V.E. system with Confocal Miniprobes™ is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries when used with Fluorescein Sodium. Predicate Device (K191144): The Cellvizio® 100 Series system with Confocal Miniprobes™ with Fluorescein also has identical Indications for Use including blood flow visualization in vascular areas, including microvasculature and capillaries with Fluorescein Sodium. Justification: "Identical Indications for Use... including blood flow visualization in vascular areas, including microvasculature and capillaries with Fluorescein Sodium." |
| Similar Operating Principle & Technological Characteristics | Subject Device: Confocal laser scanning system with fiber optic probe. Predicate and Reference Devices: Also confocal laser scanning system with fiber optic probe. Justification: "has the same operating principle, the same technological characteristics, and the same design." |
| Similar Hardware Design (Laser, Detection, Scanning, Display, etc.) | All key hardware attributes (Laser source, Physical Method of Illumination, Physical Method of Imaging, Laser classification, Scanning system technology, Illumination output, Detection Bandwidth, Location of Signal Detection/Conversion/Processing, Fluorescence Excitation) are stated to be "Same" or "Same technology" as the predicate and reference devices. Justification: "The subject device... is exactly the same device in terms of design and performance as the previously cleared device (K193416)." |
| Similar Software/Firmware (Image Processing, Control) | Firmware algorithm and Image processing algorithm are stated to be "Same functions with equivalent algorithm" or "Same algorithm with addition of automatic adjustment of laser focus in the fiber bundle" (which is a refinement, not a fundamental change). Justification: Found substantially equivalent (cleared via K193416). |
| Safety Data (Biocompatibility, Laser Safety) | Justification: "constructed with the same biocompatible materials and meets the same biocompatibility tests requirements"; "Same maximum laser output and therefore no additional testing was performed to ensure safety." |
| Co-packaging (with Fluorescein Sodium) | Justification: "Confocal Miniprobes™ model will be delivered co-packaged with Sodium Fluorescein vials in an identical way as the one described and cleared in K191144." "No additional testing was performed for the co-packaging of Sodium Fluorescein with Cellvizio® I.V.E the Confocal Miniprobes™." |
2. Sample sizes used for the test set and the data provenance
The document explicitly states: "As no technical change is being made to the subject/reference device, all testing required has been provided in the previous submission (K193416)." And further, regarding co-packaging: "Therefore, no additional testing was performed for the co-packaging of Sodium Fluorescein with Cellvizio® I.V.E the Confocal Miniprobes™."
This indicates that no new clinical study or test set data was generated for this specific 510(k) submission (K212322). The basis for substantial equivalence is the prior clearance of the Cellvizio® I.V.E. system (K193416 as a reference device) and the Cellvizio® 100 Series system with Fluorescein (K191144 as a predicate device). The document does not provide details about the sample sizes or data provenance (e.g., country of origin, retrospective/prospective) of the studies that supported those previous clearances.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since no new human reading study or clinical test set was conducted for this submission (K212322), this information is not provided. The substantial equivalence argument relies on the inherent capabilities of the device, which were previously established and deemed safe and effective in earlier clearances.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study or human reading test set was conducted for this submission.
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 for human readers, and no MRMC study was performed for this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the device itself as an imaging system. The "performance" is demonstrated through its physical and optical characteristics (e.g., field of view, depth of observation, lateral resolution, real-time image visualization frequency), which are stated to be "Same" as previously cleared devices. The document essentially argues that the device's technical specifications and resulting image quality are equivalent to the predicate and reference devices, implying equivalent "standalone" performance. No new quantitative performance metrics (like accuracy against a ground truth for a specific disease) are presented as part of this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this specific 510(k), since the submission is based on substantial equivalence to existing devices and expanding an indication for an existing capability (blood flow imaging with a contrast agent), no new ground truth establishment is detailed. The performance of confocal endomicroscopy in general (the technology this device uses) is inherently about visualizing microstructures and blood flow. The "truth" would logically be the real-time images themselves, and in a clinical context, a physician's interpretation of those images in conjunction with other diagnostic information. For the original clearances of the predicate and reference devices, ground truth for imaging capabilities would typically involve:
- Physical/Optical Measurements: Demonstrating adherence to specifications for resolution, field of view, depth of observation.
- Bench Testing/Phantom Studies: Using known physical models to assess image quality.
- Pre-clinical (animal) and Clinical Studies: Demonstrating the ability to visualize the intended structures (cells, vessels, blood flow) in vivo, often compared to histological confirmation or other established imaging modalities if applicable to the initial clearances.
8. The sample size for the training set
Not applicable. This submission is for an imaging device, not an AI/machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no AI algorithm being trained for this submission.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Mauna Kea Technologies % Michael Daniel President Daniel & Daniel Consulting 340 Jones Lane Gardnerville, Nevada 89460
August 18, 2021
Re: K212322
Trade/Device Name: Cellvizio I.V.E. system with Confocal Miniprobes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN. GCJ Dated: July 23, 2021 Received: July 26, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part
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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Neil R.P. Ogden, M.S. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212322
Device Name
Cellvizio® I.V.E. system with Confocal Miniprobes™
Indications for Use (Describe)
The Cellvizio® I.V.E. 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 including, but not limited to, the identification of cells and vessels and their organization or architecture.
The Cellvizio® I.V.E. system is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.
The GastroFlex™ N and ColoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.
The AlveoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ N Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
The AQ-Flex™ 19 N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, EBUS-TBNA and TBNA).
The CystoFlex™F N, CystoFlex™ R N and UroFlex™ N 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™ 5 N Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: K212322
Applicant Information:
Date Prepared: August 6, 2021
| Manufacturer Contact Person: | Aline Criton |
|---|---|
| Name: | Mauna Kea Technologies |
| Address: | 9 rue d'EnghienF-75010 Paris, France |
| Phone: | +33 1 48 24 03 45 |
| Fax: | +33 1 48 24 12 18 |
| Contact Person: | Michael A Daniel, Consultantmadaniel@clinregconsult.com |
| Phone Number: | (415) 407-0223 |
| Office: | (775) 392-2970 |
| Facsimile Number: | (610) 545-0799 |
Device Information:
| Device Trade Name: | Cellvizio® I.V.E. system with Confocal Miniprobes™ |
|---|---|
| Common Name: | Confocal Optical Imaging |
| Classification Name(s): | Endoscope and Accessories |
| Primary regulation and Product Code: | OWN 21 CFR 876.1500 |
| Secondary regulation and Product Code: | GCJ 21 CFR 876.1500 |
|---|---|
| Classification: | Class II |
Predicate Device:
The Cellvizio® 100 Series system with Confocal Miniprobes™ cleared as a drug-device combination with Fluorescein Sodium via 510(k) K191144 serves as the predicate device.
Reference Device:
The Cellvizio® I.V.E. system with Confocal Miniprobes™ is the reference device via 510(k) K193416.
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Indications for Use:
Cellvizio® I.V.E. 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 including, but not limited to, the identification of cells, vessels and their organization or architecture.
The Cellvizio® I.V.E. system is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.
The GastroFlex™ N and ColoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.
The AlveoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ N Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
The AQ-Flex™ 19 N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope or endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, EBUS-TBNA and TBNA).
The CystoFlex™ F N, CystoFlex™ R N and UroFlex™ N 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™ 5 N Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
Device Description:
Confocal Miniprobes™ are used with Cellyizio® I.V.E. system. which is a confocal imaging system with fiber optic probes which allows visualization of internal microstructure of tissues and blood flow including, but not limited to, the identification of cells, vessels and their organization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
Fluorescein Sodium is used as a fluorescence contrast agent to allow imaging of microvasculature and visualization of blood flow in vascular areas, including microvasculature and capillaries. Fluorescein Sodium can be used as a contrast agent with Cellvizio® I.V.E. system with Confocal Miniprobes™ without change of formulation, mode of action, approved dose or route of administration: it is delivered independent of Cellyizio® I.V.E. system in accordance with Fluorescein Sodium instruction for use.
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Materials, design and intended use of the aforementioned Cellvizio® I.V.E. system Confocal laser imaging systems and its Confocal Miniprobes™ remain exactly the same as what were previously cleared in K193416 and were found to be substantially equivalent to the Cellvizio® 100 series system Confocal laser imaging system and its Confocal Miniprobes™ (cleared via K172844) without Fluorescein Sodium. A reference to the use of Sodium Fluorescein was added to the Cellvizio 100 Series System with Confocal Miniprobes (K172844) via K191144 on 01/24/2020. The sole purpose of this submission is to extend the previously cleared Indications for Use of Cellvizio® I.V.E. system Confocal laser imaging systems and its Confocal Miniprobes™ with the visualization of blood flow in vascular areas, including microvasculature and capillaries when using Sodium Fluorescein as a contrast agent.
Comparison to Predicate Device:
The table below details the differences between the subject device and the previously cleared predicate device (See Table 1-1).
| Subject Device | Predicate Device | Comparison to Predicate | ||
|---|---|---|---|---|
| Attribute | Cellvizio® I.V.E. System with Confocal Miniprobes™with Fluorescein | Cellvizio® 100 Series System with Confocal Miniprobes™ with Fluorescein | ||
| Device name | Cellvizio® I.V.E. System with Confocal Miniprobes™ | Cellvizio® 100 Series System with Confocal Miniprobes™ | / | |
| Model | I.V.E. | 100 series F400-v2 | / | |
| ConfocalMiniProbe™ Names | ColoFlex™ N,GastroFlex™ N,CystoFlex™ R N,CelioFlex™ 5 N,AlveoFlex™ N,AQ-Flex™ 19 N,CystoFlex™ F N,UroFlex™ N,CholangioFlex™ N | ColoFlex™ UHD,GastroFlex™ UHD,CystoFlex™ UHD R,CelioFlex™ UHD 5,AlveoFlex™,AQ-Flex™ 19,CystoFlex™ F,UroFlex™ B,CholangioFlex™ | / | |
| Manufacturer | Mauna Kea Technologies9 Rue d'EnghienF-75010 Paris, France | Mauna Kea Technologies9 Rue d'EnghienF-75010 Paris, France | Same | |
| 510(k)ClassificationProduct Code | K212322OWN (primary product code) GCJ (secondary product code) | K191144OWN (primary product code) GWG (secondary product code) | / | |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 882.148021 CFR 876.1500 | Same | |
| Class | II | II | Same | |
| Classification Adv.Committee | General & Plastic Surgery 1 | General & Plastic Surgery | Same | |
| Device Class / NameProduct Code | Confocal Optical ImagingOWN/GCJ | Confocal Optical ImagingOWN/GCJ | Same | |
| Combination Device | Yes | Yes | Both systems have co-packaging with Sodium Fluorescein | |
| Indications for use | The Cellvizio® I.V.E. System with ConfocalMiniprobes™ is a confocal laser system with fiber opticprobes that are intended to allow imaging of the internalmicrostructure of tissues including, but not limited to, theidentification of cells and vessels and their organizationor architecture.The Cellvizio® I.V.E. system is indicated for imagingblood flow in vascular areas, including microvasculatureand capillaries. | The Cellvizio® 100 Series System with ConfocalMiniprobes™ is a confocal laser system with fiber opticprobes that are intended to allow imaging of the internalmicrostructure of tissues, including, but not limited to,the identification of cells and vessels and theirorganization or architecture.The Cellvizio® 100 series system F400-V2 is indicatedfor imaging blood flow in vascular areas, includingmicrovasculature and capillaries. | IdenticalIndications for Useincluding bloodflow visualizationin vascular areas,includingmicrovasculatureand capillaries withFluorescein Sodium | |
| The GastroFlex™ N and ColoFlex™ N ConfocalMiniprobes™ are intended to allow imaging of | The GastroFlex™ UHD and ColoFlex™ UHD ConfocalMiniprobes™ are intended to allow imaging of | |||
| anatomical tracts, i.e., gastrointestinal systems, accessedby an endoscope or endoscopic accessories.The AlveoFlexTM N Confocal MiniprobesTM are intendedto allow imaging of anatomical tracts, i.e., respiratorysystems, accessed by an endoscope or endoscopicaccessories.The CholangioFlexTM N Confocal MiniprobesTM areintended to allow imaging of the upper gastrointestinaltract including biliary and pancreatic ducts, accessed byan endoscope or endoscopic accessories.The AQ-FlexTM 19 N Confocal MiniprobesTM areintended to allow imaging of anatomical tracts, i.e.,gastrointestinal and respiratory tracts, accessed by anendoscope or endoscopic accessories (e.g. aspirationneedles used during procedures including but not limitedto EUS-FNA, EBUS-TBNA and TBNA).The CystoFlexTM F N, CystoFlexTM R N and UroFlexTMN Confocal MiniprobesTM are intended to allow imagingof anatomical tracts, i.e., urinary, including, but notlimited to, urethra, bladder, and ureter, accessed throughan endoscope or endoscopic accessories.The CelioFlexTM 5 N Confocal MiniprobesTM areintended to provide visualization of body cavities,organs, and canals during endoscopic and laparoscopicsurgical procedures, including robot-assisted procedures. | anatomical tracts, i.e., gastrointestinal systems, accessedby an endoscope or endoscopic accessories.The AlveoFlexTM Confocal MiniprobeTM is intended toallow imaging of anatomical tracts, i.e., respiratorysystems, accessed by an endoscope or endoscopicaccessories.The CholangioFlexTM (or GastroFlexTM M) series ofConfocal MiniprobesTM is intended to allow imaging ofthe upper gastrointestinal tract including biliary andpancreatic ducts, accessed by an endoscope orendoscopic accessories.The AQ-FlexTM 19 Confocal MiniprobeTM is intended toallow imaging of anatomical tracts, i.e., gastrointestinaltracts and respiratory tracts accessed by an endoscope orendoscopic accessories, including through endoscopicneedles.The CystoFlexTM (F, UHD R) and UroFlexTM B ConfocalMiniprobeTM are intended to allow imaging of anatomicaltracts, i.e., urinary, including, but not limited to, urethra,bladder, and ureter, accessed through an endoscope orendoscopic accessories.The CelioFlexTM UHD 5 Confocal MiniprobeTM isintended to provide visualization of body cavities,organs, and canals during endoscopic and laparoscopicsurgical procedures, including robot-assisted procedures. | |||
| Device Description | Standalone confocal endomicroscope for intraoperativeimaging with high magnification. | Standalone confocal endomicroscope for intraoperativeimaging with high magnification. | Same | |
| Basic SystemFunction | Create in-vivo confocal laser scanning images of theinternal microstructure of tissue. | Create in-vivo confocal laser scanning images of theinternal microstructure of tissue. | Same | |
| Imaging System | Confocal laser scanning system with fiber optic probe | Confocal laser scanning system with fiber optic probe | Same | |
| OpticalVisualizationDisplay | Fiber scanner Photo detectorMonitor | Fiber scanner Photo detectorMonitor | Same | |
| Fluorescent Agent | Tissue autofluorescence and Fluorescence imagingsystem used with Fluorescein Sodium yields fluorescentimage with very high magnification of the distribution ofthe fluorescein sodium dye in the imaged tissue duringthe operation. | Tissue autofluorescence and Fluorescence imagingsystem used with Fluorescein Sodium yields fluorescentimage with very high magnification of the distribution ofthe fluorescein sodium dye in the imaged tissue duringthe operation. | Same | |
| FluorescenceExcitation | 488 nm | 488 nm | Same | |
| Physical Method ofIllumination | Laser source (continuous blue light of 488 nmwavelength); Fluorescence.Maximum output power: 15 mW | Laser source (continuous blue light of 488 nmwavelength); FluorescenceMaximum output power: 15 mW | Same | |
| Physical Method ofImaging | Confocal Laser Scanning system. | Confocal Laser Scanning system | Same | |
| Laser classification | Class 2M laser productProximal (in the OSU) | Class 2M laser productProximal (in the LSU) | Same | |
| Scanning system | Same mirrors types and manufacturer with a lowerfootprint for the scanning boards | 4 kHz horizontal scanning with resonant mirror verticalscanning with galvanometric mirror | Same technology(cleared viaK193416) | |
| Illumination output | Class 2M visible laser light at 488 nm when a N modelConfocal Miniprobe is connected | Class 2M visible laser light at 488 nm when a ConfocalMiniprobe is connected | Same | |
| DetectionBandwidth | 500-650 nm | 500 - 650 nm | Same | |
| Location of SinglePoint Optical SignalDetector | In the eBox that receives the optical signal from the OSUelectronic BOX connected to the scanner body throughan optical fiber | In the Laser Scanning Unit connected to the ConfocalMiniprobeTM | Found substantiallyequivalent (clearedvia K193416) | |
| Location of signalanalog to digitalconversion | On eBox motherboard | On specific CSU board in LSU | Found substantiallyequivalent (clearedvia K193416) | |
| Location of signalprocessing | On eBox motherboard | On computer motherboard after digital signal istransferred from LSU through Firewire cable | Found substantiallyequivalent (clearedvia K193416) | |
| Firmware algorithm | Same functions with equivalent algorithm except for theautofocus | Mirror scanning control, Digitization of the laser signal,Interlock laser (laser safety mechanisms de-activating thelaser power), EEPROM read/write | Found substantiallyequivalent (clearedvia K193416) | |
| Image processingalgorithm | Same algorithm with addition of automatic adjustment oflaser focus in the fiber bundle | Proprietary algorithm including fiber bundle calibration,and image reconstruction | Found substantiallyequivalent (clearedvia K193416) | |
| Output video format | SDI, DVI and other numerical video format / conversionperformed in eBox | SDI, DVI and other numerical format, through videoconverters | Found substantiallyequivalent (clearedvia K193416) | |
| Dimensions ofimaging system | Footprint < 70cmx70cm (wheels) / <35cm*40cm(body)Weight: <40 kg | Footprint < 80cmx80cm (wheels and body)Weight: 131 kg | Found substantiallyequivalent (clearedvia K193416) | |
| Field of view | Circular, 240 µm, 325 µm or 600 µm diameter dependingon the Confocal Miniprobe model | Circular, 240 µm, 325 µm or 600 µm diameter dependingon the Confocal Miniprobe model | Same | |
| Depth of observation | Fixed, 0 µm, 40-70 µm or 55-65 µm with axial resolution5 or 15 µm depending on the Confocal Miniprobe model | Fixed, 0 µm, 40-70 µm or 55-65 µm with axial resolution5 or 15 µm depending on the Confocal Miniprobe model | Same | |
| Lateral resolution | 1 µm or 3.5 µm depending on the model of ConfocalMiniprobe | 1 µm or 3.5 µm depending on the model of ConfocalMiniprobe | Same | |
| Visualization ofReal-Time images | 9 to 12Hz | 9 to 12Hz | Same | |
| Actions ensured bythe software | Control of the laser-scanning unit and of the laseremission, reconstruction of images process, display ofimages on a screen, time stamping and review of imagesacquired. | Control of the laser-scanning unit and of the laseremission, reconstruction of images process, display ofimages on a screen, time stamping and review of imagesacquired. | Same | |
| Export | Via DICOM PACS, Shared Drive and USB thumbdrives. | Via DICOM PACS, Shared Drive and USB thumbdrives. | Same |
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Table 1-1: Comparison of the subject device with previously cleared predicate device
As described in K193416, the cleared Cellvizio® I.V.E. system and its Confocal Miniprobes™ represent a refinement to Cellvizio® 100 series system and its Confocal Miniprobes™ (K172844). Design modifications and refinements included:
- Improving the integration of the system in endoscopy, interventional, or surgical operating 1. suites by reducing the global footprint of the system.
- Improving the user interface and ease-of-use of the system by replacing the keyboard and 2. the trackball of the Cellvizio® 100 series with a touchscreen for review and interaction with the software and the addition of a separate remote (external) display screen for live imaging. This configuration allows better positioning of the physician's line of site during procedures.
-
- Simplifying the connection of the Miniprobes to the system. This improvement has no impact on other parts of the Confocal Miniprobe design, in particular the sheathed fiber and the distal head that are the patient-contacting parts are unchanged.
-
- The addition of "autofocus," allowing automatic positioning of the laser focal point for optimal optical injection from the Optical Scanning Unit into the fibers.
The subject device. the Cellvizio® I.V.E. system (with Confocal Miniprobes™) used with Fluorescein Sodium Contrast Agent) has the same intended use and indication for uses than the predicate device (the Cellvizio® 100 Series system (with Confocal Miniprobes™) since both devices are intended to be used to image the tissue microstructures and blood flow in vascular areas, including microvasculature and capillaries when used in combination with Fluorescein Sodium dye. The subject device is similar in terms of design to the cleared predicate device as it:
- . has the same operating principle, the same technological characteristics, and the same design:
- is constructed with the same biocompatible materials and meets the same ● biocompatibility tests requirements;
- is reprocessed with the same methods; ●
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- . has the same device packaging with a co-packaging with Sodium Fluorescein.
The subject and predicate devices, when used in combination with Sodium Fluorescein dye, have the same intended use and indications for use. The differences between subject device, the Cellvizio® I.V.E. system with Confocal Miniprobes™ and the predicate device (K191144), including revisions to the User Interface, System footprint and Connector can have no effect upon the system's ability to be used with Sodium Fluorescein and the imaging of blood flow indication. The Cellvizio® I.V.E. system, in the exact same manner as K191144, can be used to examine blood flow in vascular areas, including microvasculature and capillaries.
Comparison to Reference Device:
The table below details the Indications for Use between the subject device and the previously cleared reference device (See Table 1-2).
| Attribute | Subject DeviceCellvizio® I.V.E. System with Confocal Miniprobes™with Fluorescein | Reference DeviceCellvizio® I.V.E. System with Confocal Miniprobes™ | Comparison toReference |
|---|---|---|---|
| Device name | Cellvizio® I.V.E. System with Confocal Miniprobes™ | Cellvizio® I.V.E. System with Confocal Miniprobes™ | Same |
| Model | I.V.E. | I.V.E. | Same |
| ConfocalMiniProbe™ Names | ColoFlex™ N, | ColoFlex™ N, | Same |
| GastroFlex™ N, | GastroFlex™ N, | ||
| CystoFlex™ R N, | CystoFlex™ R N, | ||
| CelioFlex™ 5 N, | CelioFlex™ 5 N, | ||
| AlveoFlex™ N, | AlveoFlex™ N, | ||
| AQ-Flex™ 19 N, | AQ-Flex™ 19 N, | ||
| CystoFlex™ F N, | CystoFlex™ F N, | ||
| UroFlex™ N, | UroFlex™ N, | ||
| CholangioFlex™ N | CholangioFlex™ N | ||
| Manufacturer | Mauna Kea Technologies | Mauna Kea Technologies | Same |
| 9 Rue d'Enghien | 9 Rue d'Enghien | ||
| F-75010 Paris, France | F-75010 Paris, France | ||
| 510(k) | K212322 | K193416 | / |
| ClassificationProduct Code | OWN (primary product code) GCJ (secondary productcode) | OWN (primary product code) GCJ (secondary productcode) | Same |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Class | II | II | Same |
| Classification Adv.Committee | General & Plastic Surgery 1 | General & Plastic Surgery 1 | Same |
| Device Class / Name | Confocal Optical Imaging | Confocal Optical Imaging | Same |
| Product Code | OWN/GCJ | OWN/GCJ | Same |
| Combination Device | Yes | No | Subject devicenow includes co-packaging withSodiumFluorescein |
| Indications for use | The Cellvizio® I.V.E. System with ConfocalMiniprobes™ is a confocal laser system with fiber opticprobes that are intended to allow imaging of the internalmicrostructure of tissues including, but not limited to, theidentification of cells and vessels and their organizationor architecture.The Cellvizio® I.V.E. system is indicated for imagingblood flow in vascular areas, including microvasculatureand capillaries.The GastroFlex™ N and ColoFlex™ N ConfocalMiniprobes™ are intended to allow imaging ofanatomical tracts, i.e., gastrointestinal systems, accessedby an endoscope or endoscopic accessories. | The Cellvizio® I.V.E. System with ConfocalMiniprobes™ is a confocal laser system with fiber opticprobes that are intended to allow imaging of the internalmicrostructure of tissues including, but not limited to, theidentification of cells and vessels and their organizationor architectureThe GastroFlex™ N and ColoFlex™ N ConfocalMiniprobes™ are intended to allow imaging ofanatomical tracts, i.e., gastrointestinal systems, accessedby an endoscope or endoscopic accessories.The AlveoFlex™ N Confocal Miniprobes™ are intendedto allow imaging of anatomical tracts, i.e., respiratorysystems, accessed by an endoscope or endoscopicaccessories. | Indications forUse of thesubject devicehas beenextended forblood flowvisualizationwhen used withSodiumFluorescein as acontrast agent |
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| The AlveoFlex™ N Confocal Miniprobes™ are intendedto allow imaging of anatomical tracts, i.e., respiratorysystems, accessed by an endoscope or endoscopicaccessories.The CholangioFlex™ N Confocal Miniprobes™ areintended to allow imaging of the upper gastrointestinaltract including biliary and pancreatic ducts, accessed byan endoscope or endoscopic accessories.The AQ-Flex™ 19 N Confocal Miniprobes™ areintended to allow imaging of anatomical tracts, i.e.,gastrointestinal and respiratory tracts, accessed by anendoscope or endoscopic accessories (e.g. aspirationneedles used during procedures including but not limitedto EUS-FNA, EBUS-TBNA and TBNA).The CystoFlex™ F N, CystoFlex™ R N and UroFlex™N Confocal Miniprobes™ are intended to allow imagingof anatomical tracts, i.e., urinary, including, but notlimited to, urethra, bladder, and ureter, accessed throughan endoscope or endoscopic accessories.The CelioFlex™ 5 N Confocal Miniprobes™ areintended to provide visualization of body cavities,organs, and canals during endoscopic and laparoscopicsurgical procedures, including robot-assisted procedures. | The CholangioFlex™ N Confocal Miniprobes™ areintended to allow imaging of the upper gastrointestinaltract including biliary and pancreatic ducts, accessed byan endoscope or endoscopic accessories.The AQ-Flex™ 19 N Confocal Miniprobes™ areintended to allow imaging of anatomical tracts, i.e.,gastrointestinal and respiratory tracts, accessed by anendoscope or endoscopic accessories (e.g. aspirationneedles used during procedures including but not limitedto EUS-FNA, EBUS-TBNA and TBNA).The CystoFlex™ F N, CystoFlex™ R N and UroFlex™N Confocal Miniprobes™ are intended to allow imagingof anatomical tracts, i.e., urinary, including, but notlimited to, urethra, bladder, and ureter, accessed throughan endoscope or endoscopic accessories.The CelioFlex™ 5 N Confocal Miniprobes™ areintended to provide visualization of body cavities,organs, and canals during endoscopic and laparoscopicsurgical procedures, including robot-assisted procedures. | ||||||
|---|---|---|---|---|---|---|---|
| Device Description | Standalone confocal endomicroscope for intraoperativeimaging with high magnification. | Standalone confocal endomicroscope for intraoperativeimaging with high magnification. | Same | ||||
| Basic SystemFunction | Create in-vivo confocal laser scanning images of theinternal microstructure of tissue. | Create in-vivo confocal laser scanning images of theinternal microstructure of tissue. | Same | ||||
| Imaging System | Confocal laser scanning system with fiber optic probe | Confocal laser scanning system with fiber optic probe | Same | ||||
| OpticalVisualization | Fiber scanner Photo detector | Fiber scanner Photo detector | Same | ||||
| Display | Monitor | Monitor | Same | ||||
| Fluorescent Agent | Tissue autofluorescence and Fluorescence imagingsystem used with Fluorescein Sodium yields fluorescentimage with very high magnification of the distribution ofthe fluorescein sodium dye in the imaged tissue duringthe operation. | Tissue autofluorescence and Fluorescence imagingsystem used with Fluorescein Sodium yields fluorescentimage with very high magnification of the distribution ofthe fluorescein sodium dye in the imaged tissue duringthe operation. | Same | ||||
| FluorescenceExcitation | 488 nm | 488 nm | Same | ||||
| Physical Method ofIllumination | Laser source (continuous blue light of 488 nmwavelength); Fluorescence.Maximum output power: 15 mW | Laser source (continuous blue light of 488 nmwavelength); Fluorescence.Maximum output power: 15 mW | Same | ||||
| Physical Method ofImaging | Confocal Laser Scanning system. | Confocal Laser Scanning system. | Same | ||||
| Laser classification | Class 2M laser productProximal (in the OSU) | Class 2M laser productProximal (in the OSU) | Same | ||||
| Scanning system | Same mirrors types and manufacturer with a lowerfootprint for the scanning boards | Same mirrors types and manufacturer with a lowerfootprint for the scanning boards | Same | ||||
| Illumination output | Class 2M visible laser light at 488 nm when a N modelConfocal Miniprobe is connected | Class 2M visible laser light at 488 nm when a N modelConfocal Miniprobe is connected | Same | ||||
| DetectionBandwidth | 500-650 nm | 500-650 nm | Same | ||||
| Location of SinglePoint Optical SignalDetector | In the eBox that receives the optical signal from the OSUelectronic BOX connected to the scanner body throughan optical fiber | In the eBox that receives the optical signal from the OSUelectronic BOX connected to the scanner body throughan optical fiber | Same | ||||
| Location of signalanalog to digitalconversion | On eBox motherboard | On eBox motherboard | Same | ||||
| Location of signalprocessing | On eBox motherboard | On eBox motherboard | Same | ||||
| FluorescenceExcitation | Same functions with equivalent algorithm except for the | Same functions with equivalent algorithm except for the | Same | ||||
| Physical Method ofIllumination | Laser source (continuous blue light of 488 nmwavelength); Fluorescence.Maximum output power: 15 mW | Laser source (continuous blue light of 488 nmwavelength); Fluorescence.Maximum output power: 15 mW | Same | ||||
| Physical Method ofImaging | Confocal Laser Scanning system. | Confocal Laser Scanning system. | Same | ||||
| Laser classification | Class 2M laser product | Class 2M laser product | Same | ||||
| Scanning system | Proximal (in the OSU)Same mirrors types and manufacturer with a lowerfootprint for the scanning boards | Proximal (in the OSU)Same mirrors types and manufacturer with a lowerfootprint for the scanning boards | Same | ||||
| Illumination output | Class 2M visible laser light at 488 nm when a N modelConfocal Miniprobe is connected | Class 2M visible laser light at 488 nm when a N modelConfocal Miniprobe is connected | Same | ||||
| DetectionBandwidth | 500-650 nm | 500-650 nm | Same | ||||
| Location of SinglePoint Optical SignalDetector | In the eBox that receives the optical signal from the OSUelectronic BOX connected to the scanner body throughan optical fiber | In the eBox that receives the optical signal from the OSUelectronic BOX connected to the scanner body throughan optical fiber | Same | ||||
| Location of signalanalog to digitalconversion | On eBox motherboard | On eBox motherboard | Same | ||||
| Location of signalprocessing | On eBox motherboard | On eBox motherboard | Same | ||||
| Firmware algorithm | Same functions with equivalent algorithm except for theautofocus | Same functions with equivalent algorithm except for theautofocus | Same | ||||
| Image processingalgorithm | Same algorithm with addition of automatic adjustment oflaser focus in the fiber bundle | Same algorithm with addition of automatic adjustment oflaser focus in the fiber bundle | Same | ||||
| Output video format | SDI, DVI and other numerical video format / conversionperformed in eBox | SDI, DVI and other numerical video format / conversionperformed in eBox | Same |
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| Dimensions ofimaging system | Footprint < 70cmx70cm (wheels) / <35cm*40cm(body)Weight: <40 kg | Footprint < 70cmx70cm (wheels) / <35cm*40cm(body)Weight: <40 kg | Same |
|---|---|---|---|
| Field of view | Circular, 240 µm, 325 µm or 600 µm diameter dependingon the Confocal Miniprobe model | Circular, 240 µm, 325 µm or 600 µm diameter dependingon the Confocal Miniprobe model | Same |
| Depth of observation | Fixed, 0 µm, 40-70 µm or 55-65 µm with axial resolution5 or 15 µm depending on the Confocal Miniprobe model | Fixed, 0 µm, 40-70 µm or 55-65 µm with axial resolution5 or 15 µm depending on the Confocal Miniprobe model | Same |
| Lateral resolution | 1 µm or 3.5 µm depending on the model of ConfocalMiniprobe | 1 µm or 3.5 µm depending on the model of ConfocalMiniprobe | Same |
| Visualization ofReal-Time images | 9 to 12Hz | 9 to 12Hz | Same |
| Actions ensured bythe software | Control of the laser-scanning unit and of the laseremission, reconstruction of images process, display ofimages on a screen, time stamping and review of imagesacquired. | Control of the laser-scanning unit and of the laseremission, reconstruction of images process, display ofimages on a screen, time stamping and review of imagesacquired. | Same |
| Export | Via DICOM PACS, Shared Drive and USB thumbdrives. | Via DICOM PACS, Shared Drive and USB thumbdrives. | Same |
Table 1-2: Comparison the subject device and previously cleared reference device
The Cellvizio® I.V.E. system with its Confocal Miniprobes™ used with Sodium Fluorescein contrast agent remains exactly the same device in terms of design, technology, performance and general intended use (allow imaging of the internal microstructure) as the previously cleared reference device (K193416).
The subject device is identical in terms of design to the cleared reference device as it:
- has identical operating principle, identical technological characteristics, and identical ● design;
- . is constructed with identical biocompatible materials and meets the same biocompatibility tests requirements;
- is reprocessed with the same methods; ●
- has the same device packaging except for the co-packaging with Sodium Fluorescein. ●
The objective of this submission is to extend the previously cleared Indications for Use with the visualization of blood flow in vascular areas, including microvasculature and capillaries when using Fluorescein Sodium.
Testing Completed:
As no technical change is being made to the subject/reference device, all testing required has been provided in the previous submission (K193416).
The subject device, Cellvizio® I.V.E. system with Confocal Miniprobes™ used with Fluorescein Sodium, and the previously cleared predicate device, Cellvizio® 100 Series system with Confocal Miniprobes"" used with Fluorescein Sodium, have the same Indications for Use. They are both used to examine blood flow in the tissue vascular area.
The subject device, the Cellvizio® I.V.E. system with Confocal Miniprobes™ and the previously cleared predicate device, the Cellvizio® 100 series system with Confocal Miniprobes™, are used in the same way in combination with Sodium Fluorescein.
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The subiect device, the Cellyizio® I.V.E. svstem with Confocal Miniprobes™ and the previously cleared predicate device, the Cellvizio® 100 series system with Confocal Miniprobes™, have the same maximum laser output and therefore no additional testing was performed to ensure safety when the subject device is used in combination with Sodium Fluorescein.
Co-packaging testing
The design of the Cellvizio® I.V.E product and the Confocal Miniprobes™ model is unchanged with respect to K193416. For Cellvizio® I.V.E. to be used as a combination product. Confocal Miniprobes™ model will be delivered co-packaged with Sodium Fluorescein vials in an identical way as the one described and cleared in K191144. The components of the co-package will be assembled into the same shipper box that can fit all configurations that has been validated in K191144. Empty spaces due to differences in size of package between the different Confocal Miniprobe models will be filled by folded paper or cardboard fillers in an identical fashion to the cleared predicate device. Therefore, no additional testing was performed for the co-packaging of Sodium Fluorescein with Cellvizio® I.V.E the Confocal Miniprobes™.
Summary:
The subject/modified device Cellvizio® I.V.E. system with its Confocal Miniprobes™ used with Fluorescein Sodium contrast agent is exactly the same device in terms of design and performance as the previously cleared device (K193416).
The objective of this submission is to extend the previously cleared Indications for Use with the visualization of blood flow in vascular areas, including microvasculature and capillaries when using Fluorescein Sodium as a contrast agent.
The device is brought into direct contact with tissue to be examined to create in-vivo confocal laser scanning images of the internal microstructure of tissue.
The subject device is a confocal laser system with fiber optic probes and has the identical operation principle as the previously cleared co-packaged combination predicate device (K191144). Both devices use a laser source which emits a continuous blue light of 488 nm wavelength with the same maximum output power. With both devices, a monitor is used to view the images - the images generated with the scanner probe are displayed on the monitor. Both devices can be used in real-time during procedures.
The subject device, Cellvizio® I.V.E. system with Confocal Miniprobes™ used with Sodium Fluorescein, and the previously cleared predicate device, Cellvizio® 100 Series system with Confocal Miniprobes " used with Sodium Fluorescein, have the same Indications for Use. They are both used to examine blood flow in the tissue vascular area.
§ 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.