K193416 · Mauna Kea Technologies · OWN · Feb 28, 2020 · Gastroenterology, Urology
Device Facts
Record ID
K193416
Device Name
Cellvizio I.V.E. with Confocal Miniprobes
Applicant
Mauna Kea Technologies
Product Code
OWN · Gastroenterology, Urology
Decision Date
Feb 28, 2020
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
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 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 Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ N Confocal Miniprobe™ is 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 Miniprobe™ is 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 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 Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
Device Story
Confocal laser endomicroscopy system using fiber optic probes for real-time, in vivo imaging of internal tissue microstructure. System consists of an optical scanning unit and interchangeable Confocal Miniprobes™; probes contact tissue directly during endoscopic or surgical procedures. Device transforms laser light reflections into high-resolution images of cellular/vascular architecture. Used in OR or endoscopy suites by physicians to provide immediate visual feedback, aiding clinical decision-making during diagnostic or surgical interventions. Refinements include reduced footprint, touchscreen interface, external display for live imaging, and automated laser focal point positioning (autofocus).
Clinical Evidence
Bench testing only. Verification and validation included biocompatibility (ISO 10993), reprocessing effectiveness (AAMI TIR 12/30), laser safety (IEC 60825-1), imaging quality (ISO 8600-1), electrical safety/EMC (IEC 60601 series), and usability (IEC 62366-1). No clinical data presented.
Indicated for patients requiring real-time imaging of internal tissue microstructure, including cells and vessels, within gastrointestinal, respiratory, and urinary tracts, or during endoscopic/laparoscopic surgical procedures (including robot-assisted).
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
Cellvizio 100 Series System with Confocal Miniprobes (K172844)
Reference Devices
Cellvizio 100 Series Confocal Laser Imaging systems and their Confocal Miniprobes (K183640)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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
February 28, 2020
Re: K193416
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 Dated: December 7, 2019 Received: December 9, 2019
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/cfdocs/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 Assistant Director, THT4A4 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) K193416
Device Name
Cellvizio® I.V.E. system with Confocal MiniprobesTM
#### Indications for Use (Describe)
The Cellvizio® I.V.E. 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 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 Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ N Confocal Miniprobe™ is 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 Miniprobe™ is 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 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 Miniprobe™ is 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) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> |
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# 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
### 510(k) Number: K193416
#### Applicant Information:
Date Prepared: February 26, 2020
| Name: | Mauna Kea Technologies<br>Manufacturer Contact Person: Aline Criton |
|-------------------|---------------------------------------------------------------------|
| Address: | 9 rue d'Enghien<br>F-75010 Paris, France |
| Phone: | +33 1 48 24 03 45 |
| Fax: | +33 1 48 24 12 18 |
| Contact Person: | Michael A Daniel, Consultant |
| e-mail: | madaniel@clinregconsult.com |
| Phone Number: | (415) 407-0223 |
| Facsimile Number: | (610) 545-0799 |
#### Device Information:
| Device Trade Name: | Cellvizio® I.V.E. system with Confocal Miniprobes™ |
|--------------------------|----------------------------------------------------|
| Common Name: | Endoscope and Accessories |
| Classification Name(s): | Confocal Optical Imaging |
| Product Code/Regulation: | OWN / GCJ 21 CFR 876.1500 |
| Classification: | Class II |
#### Primary Predicate Device:
Cellvizio 100 Series System with Confocal Miniprobes (K172844).
#### Reference Predicate Device:
Cellvizio 100 Series Confocal Laser Imaging systems and their Confocal Miniprobes (K183640)
#### Device Description:
The subject device Cellvizio® I.V.E. system with Confocal Miniprobes™ is a confocal laser imaging system that can be used with a variety of Confocal Miniprobe™ (fiber optic probes) to allow real-time imaging of the internal microstructure of tissues by direct contact with the tip of the Confocal Miniprobe™ during existing medical procedures, such as endoscopy or endoscopic or open surgical procedures. The technology provides the physician with additional information in the form of real-time images during these open or minimally invasive procedures.
The Cellvizio® I.V.E. system with Confocal Miniprobes™ represents a refinement of the currently cleared and marketed predicate device, the Cellvizio® 100 Series System with Confocal Miniprobes™ (K172844). Design modifications and refinements include:
- 1. Improving the integration of the system in endoscopy, interventional, or surgical operating suites by reducing the global footprint of the system.
- 2. lmproving the user interface and ease-of-use of the system by replacing the keyboard and the trackball of the Cellvizio® 100 series with a touchscreen for review and interaction with the software and the addition of a
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separate remote (external) display screen for live imaging. This configuration allows better positioning of the physician's line of site during procedures.
- 3. 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 that are the patientcontacting parts are unchanged.
- 4. 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 intended use, indications for use, and mechanism of the subject device are unchanged as compared to the 510(k) cleared Cellvizio® 100 Series System with Confocal Miniprobes™ (K172844).
# Indications for Use:
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 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 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 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.
#### Comparison to Predicate Device:
The Cellvizio® I.V.E. and the Cellvizio® 100 Series systems are based on the same technology and have virtually identical Confocal Miniprobes™. The two devices are substantially equivalent as:
- 1. Both devices have the same Intended use and indications for use. The Cellvizio® 100 Series System with Confocal Miniprobes™ (K172844) (predicate device) and the Cellvizio® I.V.E. system with Confocal Miniprobes™ (subject device) are based on the same technology of confocal laser endomicroscopy.
- 2. Both devices rely on an optical scanning unit and a fiber probe to propagate light between the observation area and the system in order to provide real-time imaging. The Cellvizio® I.V.E. system with confocal Miniprobes™ is basically a miniaturized version of the predicate Cellvizio® 100 Series System with Confocal
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Miniprobes™ (K172844). Both systems use Confocal Miniprobes™ with identical optical design and properties (only the connector differs). Both systems are intended to be used by the same users and on the same intended patient populations.
- ဒေ There are no significant technological characteristic differences between the predicate devices. The design of the Cellvizio® I.V.E. system is based on the Cellvizio® 100 Series system and has evolved in order to reduce the system footprint and to improve the usability of the device. These design changes are not significant changes and raise no new or different questions of safety and effectiveness.
Therefore, technologically the Cellvizio® I.V.E. system with Confocal Miniprobes™ is substantially equivalent to the predicate Cellvizio® 100 series system with Confocal Miniprobes™.
# Testing Completed:
.
The following verification and validation tests were performed on the subject device:
- Biocompatibility (Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity & Systemic toxicity) according to:
- ISO 10993-1:2009 "Biological evaluation of medical devices Part 1: Evaluation and testing within a O risk management process".
- ISO 10993-5:2009 "Biological evaluation of medical devices Part 5: Tests for in vitro cytoxicity", O
- o ISO 10993-10:2010 "Biological evaluation of medical devices - Part 10: Tests for irritation and delayedtype hypersensitivity",
- ISO 10993-11:2017 "Biological evaluation of medical devices Part 11: Tests for systemic toxicity" O
- . Effectiveness of reprocessing methods has been tested according to:
- AAMI TIR 12:2010 "Designing, testing and labeling reusable medical devices for reprocessing in health o care facilities: A quide for medical device manufacturers" and
- AAMI TIR 30:2011 "A compendium of processes, materials, test methods, and acceptance criteria for O cleaning reusable medical devices"
- . Laser safety has been tested compliant with:
- IEC 60825-1:2007 and 2014 and o
- 21 CFR 1040.10 and 21 CFR 1040.11 with Laser Notice No. 50 and No. 56. O
- . Imaging quality has been tested in compliance with the following standards:
- o ISO 8600-1:2015 "Optics and photonics -- Medical endoscopes and endotherapy devices -- Part 1: General requirements",
- o The resolution is measured according to our internal standards using 1951 USAF resolution test chart as a resolution test pattern.
- . Software Verification and Validation:
- Software verification and validation testing were conducted and documentation was provided as o recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The Cellvizio® I.V.E. software is considered as a "minor" level of concern.
- The Cellvizio® I.V.E. software was developed in accordance with the IEC 62304:2006 standard o (amendment 2015).
- Electrical safety and electromagnetic compatibility (EMC):
- Electrical safety and EMC testing were conducted on the Cellvizio® I.V.E system with Confocal o Miniprobes™. The system complies with the IEC 60601-1:2005/Amendment 2012, IEC 60601-2-18:2009 and 60601-1-6:2010/A1:2013 (Ed 3.1) standards for safety and the IEC 60601-1-2:2014 standard for EMC.
- Usability
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- Mauna Kea Technologies has implemented a usability engineering process compliant with the IEC 62366 о 1:2015 standards. Compliance to this standard relies on the design control process and on the risk management process and is validated with an external laboratory (LNE).:
The results from these performance evaluations demonstrated that the Cellvizio® I.V.E system with Confocal Miniprobes™ met the acceptance criteria defined in the product specification and the performance is equivalent to the predicate device.
# Conclusions:
The subject device, the Cellvizio® I.V.E system with Confocal Miniprobes™, is substantially equivalent to the predicate device Cellvizio® 100 Series System with Confocal Miniprobes™ (K172844) in terms of technological characteristics, with minor design modifications implemented. The subject device has the same principle of operation, critical performance requirements, biocompatibility, reprocessing, intended use, indications for use, and product technical information as the cleared predicate device, the Cellvizio® 100 series system with Confocal Miniprobes™.
Based upon performance testing, reprocessing parameters, biocompatibility, electromagnetic compatibility, and usability testing provided in this subject device Cellvizio® I.V.E system with Confocal Miniprobes™ can be used as safely and effectively to image the internal microstructure of tissues including, and not limited to, the identification of cells and their organization or architecture as the predicate. The differences in technological characteristics do not raise any different questions of safety and effectiveness. The Cellvizio® I.V.E. system with Confocal Miniprobes™ was determined to be substantially equivalent to the Cellvizio® 100 series system with Confocal Miniprobes™.
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Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
