K254180 · LIMIS Development B.V. · OWN · Jul 24, 2026 · Gastroenterology, Urology
Device Facts
Record ID
K254180
Device Name
PerfusiX-Imaging
Applicant
LIMIS Development B.V.
Product Code
OWN · Gastroenterology, Urology
Decision Date
Jul 24, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
PerfusiX-Imaging device is intended to be used only in combination with third party camera heads, rigid surgical endoscopes, monitors, accessories, and other ancillary equipment employed for surgical endoscopic diagnosis, treatment and video observation. PerfusiX-Imaging device enables real-time visual assessment of vessels, blood flow and related tissue perfusion by means of laser speckle contrast imaging (LSCI), during minimally invasive surgery (laparoscopy) of the gastrointestinal tract, using the device incorporated laser light illumination and video processor. The device is not intended for standalone use.
Device Story
PerfusiX-Imaging is an accessory to existing surgical laparoscope systems; provides real-time Laser Speckle Contrast Imaging (LSCI) for intraoperative assessment of vessels, blood flow, and tissue perfusion. Input: laser light illumination (639 nm) directed through a rigid endoscope; reflected light captured by third-party RGB camera. Processing: device video processor transforms speckle contrast data into a viridis color heatmap; output: heatmap signal overlayed on standard white light video signal displayed on OR monitor. Operation: surgeon-controlled via device switch; used in surgical environment during laparoscopy. Benefit: enables real-time visualization of perfusion without contrast agents, aiding surgical decision-making regarding tissue viability.
Clinical Evidence
Bench testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 62366-1), software lifecycle (IEC 62304), and laser safety (IEC 60825-1). Animal study performed to validate blood flow/perfusion visualization against reference device (Karl Storz ICG Imaging System). Clinical evaluation conducted to support gastrointestinal tract use.
Technological Characteristics
Accessory to third-party laparoscopic systems. Employs 639 nm coherent laser for LSCI. Class 3B laser (cable), Class 2 (scope). Full HD (1080p) resolution at 60 fps. Output via SDI. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 62304, IEC 60825-1, IEC 60601-2-18. Standalone video processor/light source unit.
Indications for Use
Indicated for real-time visual assessment of vessels, blood flow, and tissue perfusion during minimally invasive gastrointestinal tract surgery. Used in combination with third-party endoscopic equipment. No specific age or gender restrictions noted.
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
ActivSight Intraoperative Imaging System (K203550)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
July 24, 2026
LIMIS Development B.V.
Kelsey Van Abbema
QA/RA Manager
Henri Dunantweg 2
Leeuwarden, 8934AD
Netherlands
Re: K254180
Trade/Device Name: PerfusiX-Imaging
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: OWN
Dated: June 24, 2026
Received: June 24, 2026
Dear Kelsey Van Abbema:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K254180 - Kelsey Van Abbema
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K254180 - Kelsey Van Abbema
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Sincerely,
# SHANIL P. HAUGEN -S
Shanil P. Haugen, Ph.D.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254180 | ? |
| Please provide the device trade name(s). | | ? |
| PerfusiX-Imaging | | |
| Please provide your Indications for Use below. | | ? |
| PerfusiX-Imaging device is intended to be used only in combination with third party camera heads, rigid surgical endoscopes, monitors, accessories, and other ancillary equipment employed for surgical endoscopic diagnosis, treatment and video observation. PerfusiX-Imaging device enables real-time visual assessment of vessels, blood flow and related tissue perfusion by means of laser speckle contrast imaging (LSCI), during minimally invasive surgery (laparoscopy) of the gastrointestinal tract, using the device incorporated laser light illumination and video processor. The device is not intended for standalone use. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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LIMIS
K254180
# 510(k) SUMMARY (21 CFR 807.92)
## 1. General Information
| Submitter Name: | LIMIS Development B.V. |
| --- | --- |
| Submitter Address: | Henri Dunantweg 2, 8934AD, Leeuwarden, The Netherlands |
| Contact Person: | Kelsey van Abbema Manager, Quality Assurance and Regulatory Affairs |
| Contact Information: | Email: kelsey.vanabbema@limis.com Phone: +31 58 2866971 |
| Submission Type: | Traditional 510(k) |
| Date Prepared: | December 18^{th}, 2025 |
## 2. Subject Device
| Proprietary Name | PerfusiX-Imaging |
| --- | --- |
| Device Common Name | Light Source, Imaging Module, Light Cable |
| Device Model Number | 904.000 |
| Device Classification Name | Endoscopic Video Imaging System / Component, Gastroenterology-Urology |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | OWN |
| Device Classification | II |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3) |
## 3. Predicate Device and Reference Device
| | Predicate Device | Reference Device |
| --- | --- | --- |
| Proprietary Name | ActivSight Intraoperative Imaging System | Karl Storz ICG Imaging System |
| 510(k) Number | K203550 | K232857 |
| Device Classification Name | Confocal Optical Imaging | Confocal Optical Imaging |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Product Code | OWN | OWN, GWG |
| Device Classification | II | II |
Confidential
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LIMIS
K254180
#### 4. Device Description
PerfusiX-Imaging is an accessory to existing commercial surgical laparoscope systems, including cameras and video processor units. PerfusiX-Imaging provides real-time endoscopic laser speckle contrast imaging (LSCI). These imaging features allow surgeons to visually assess vessels, blood flow, and tissue perfusion (using Laser Speckle Contrast Imaging). Laser Speckle Contrast Imaging is enabled through a switch on the device. These visualization features are available for surgeons to use during minimally invasive surgery. PerfusiX-Imaging is intended to be used in a surgical environment.
PerfusiX-Imaging consists of the following:
- PerfusiX-Imaging Video Processor and Light Source, which is placed in the light path between the laparoscope video processor, enabling surgeons to switch between white light imaging (WLI) and laser speckle contrast imaging (LSCI). PerfusiX-Imaging is furthermore looped into the video signal path to process and display the LSCI image on the Operating Room screen.
#### 5. Indications for Use
PerfusiX-Imaging is intended to be used only in combination with third party camera heads, rigid surgical endoscopes, monitors, accessories, and other ancillary equipment employed for surgical endoscopic diagnosis, treatment and video observation.
PerfusiX-Imaging enables real-time visual assessment of vessels, blood flow and related tissue perfusion by means of laser speckle contrast imaging (LSCI), during minimally invasive surgery (laparoscopy) of the gastrointestinal tract, using the device incorporated laser light illumination and video processor. The device is not intended for standalone use.
#### 6. Substantial Equivalence
PerfusiX-Imaging (subject) is substantially equivalent to ActivSight's capability to visualize blood flow and perfusion through speckle laser illumination (predicate).
The subject device and predicate device have nearly identical Indications for Use. Both devices provide real-time endoscopic Laser Speckle Contrast Imaging during minimally invasive surgery. Both are indicated to enable surgeons to visually assess blood flow and tissue perfusion in the abdominal cavity.
Differences between the two devices are that PerfusiX-Imaging operates on a different light wavelength, 639nm for PerfusiX-Imaging versus 852nm for ActivSight. Furthermore, ActivSight provides a separate camera with the system whereas PerfusiX-Imaging uses the 3rd party camera of the laparoscopic tower.
Confidential
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LIMIS
K254180
Table 6.1: Comparison to Predicate
| | PerfusiX-Imaging | ActivSight Intraoperative Imaging System (K K203550) - Predicate | Karl Storz ICG Imaging System (K232857) - Reference |
| --- | --- | --- | --- |
| Intended Use | Confocal Optical Imaging (OWN) | Confocal Optical Imaging (OWN) | Confocal Optical Imaging (OWN) |
| Indications for Use | PerfusiX-Imaging is intended to be used only in combination with third party camera heads, endoscopes, monitors, accessories, and other ancillary equipment employed for endoscopic diagnosis, treatment and video observation. PerfusiX-Imaging enables real-time visual assessment of vessels, blood flow and related tissue perfusion by means of laser speckle contrast imaging (LSCI), during minimally invasive surgery (laparoscopy) of the gastrointestinal tract, using the device incorporated laser light illumination and video processor. The device is not intended for standalone use. | The ActivSight Intraoperative Imaging System (ActivSight) is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence, all during minimally invasive surgery. Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization. | Upon intravenous administration and use of ICG consistent with its approved label, the Karl Storz Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the Karl Storz Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light |
Confidential
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| | | | as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. The Karl Storz VITOM ICG System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures in adults and pediatrics. |
| --- | --- | --- | --- |
Confidential
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LIMIS
K254180
| Technical Specifications | | | |
| --- | --- | --- | --- |
| | PerfusiX-Imaging | ActivSight Perfusion (K203550) - Predicate | Karl Storz ICG Imaging System (K232857) - Reference |
| Mode of Action | Laser Speckle | Laser Speckle / Fluorescence | Fluorescence |
| Contrast Agent | None | None / ICG | ICG |
| Information Presentation Format | Viridis color heatmap signal overlayed on black/white video signal | Laser Speckle: Heatmap signal overlayed on red/green/blue (RGB) or heatmap signal only For ICG: Green Signal overlayed on red/green/blue (RGB) | Displayed image is either the VIS light image or the NIR image. For the NIR image, the user has three presentations of the ICG imagery to choose from: a. Overlay: The white light image is overlaid with the NIR image. The NIR image could either by blue or green b. Intensity Map: The white light image is overlaid with color transformed NIR image. c. Monochromatic: The NIR image is indicated by the color white against a dark background. |
| White light source | Third party light source | Third party light source | Karl Storz Power LED RUBINA® light source (TL400) |
| White light camera | Third party camera | Third party camera | Karl Storz Image1 S™ |
| White light image processing | Third party processing unit | Third party processing unit | Karl Storz Image1 S™ |
| LSCI/ICG Light Source(s) | Coherent 639 nm laser | Coherent 852 nm laser | NIR Filtered LED Output: 720-810 nm |
| Laser Power Rating | Class 3B out of light cable, class 2 out of scope. | Class 3R out of Light Cable, class 1 out of scope | N/A |
| Light Capture | 3rd party laparoscopic system with RGB camera | IR sensitive camera | IR sensitive camera |
| Resolution | Full HD (1080p) | Full HD (1080p) | Ultra HD (4k) |
| Framerate | 60 fps | 60 fps | 60 fps |
| Power requirements | AC mains powered | AC mains powered | AC mains powered |
| Data output | SDI | DVI | 12G/3G-SDI, DisplayPort, DVI-D |
| User interface | Touchscreen and monitor | Touchscreen and monitor | Touchscreen and monitor |
Confidential
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LIMIS
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## 7. Performance Data
Safety and performance of PerfusiX-Imaging have been evaluated and verified in accordance with design specifications and applicable performance standards, including risk management, basic safety and essential performance, electromagnetic disturbances, human factors and usability, software lifecycle processes, and safety of laser products.
LIMIS Development has performed design validation in animal study, comparatively visualizing blood flow and perfusion in specific structures against the reference device ICG mode (Karl Storz ICG Imaging System). In a similar way to the validation study performed by the predicate device (ActivSight) on their respective reference device ICG mode. A clinical evaluation of PerfusiX-Imaging was conducted to support use of the device in the gastrointestinal tract.
The following performance testing has also been conducted:
Basic safety and essential performance testing completed in accordance with
- IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020: Medical Electrical Equipment- Part 1: General Requirements for Basic Safety and Essential Performance. Testing indicates that the proposed device conforms to this standard.
- Electrical safety and electromagnetic compatibility testing completed in accordance with IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances: Requirements and tests. Testing indicates that the proposed device conforms to this standard.
- Human factors and usability testing completed in accordance with IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-6:2010/AMD2:2020 for use in conjunction with IEC 62366-1:2015, IEC 62366-1:2015/AMD1:2020, and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 Medical Devices -Application of Usability Engineering to Medical Devices- Evaluation and reporting. Testing indicates that the proposed device presents no unacceptable risk to the user during its intended use, and that the device conforms to this standard.
- Software development and software life cycle processes competed in accordance with IEC 62304:2006+AMD1:2015 Medical Device Software - Software Life Cycle Processes, Evaluation, Testing, and Reporting. Testing indicates that the proposed device conforms to this standard.
- Laser safety testing completed in accordance with IEC 60825-1 Ed. 3.0 b:2014 Safety of Laser Products- Part 1: Equipment Classification and Requirements. Testing indicates that the proposed device conforms to this standard.
- Safety of endoscopic equipment testing completed in accordance with IEC 60601-2-18:2009 for use in conjunction with IEC 60601-1:2005 Medical Electrical Equipment- Part 2-18: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment. Testing indicates that the proposed device conforms to this standard.
The results of these studies demonstrate that the proposed device is as safe and effective as the predicate.
Confidential
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### 8. Conclusion
Based on the information provided in this premarket notification and based on a comparison to the indications for use, performance testing, and technological characteristics of the predicate, PerfusiX-Imaging is shown to raise no new questions of safety and efficacy, and is substantially equivalent to the ActivSight Intraoperative Imaging System.
Confidential
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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.
