(88 days)
Not Found
No
The document describes an imaging system with advanced imaging modalities (near-infrared and visible light) and image processing capabilities, but it does not mention or imply the use of AI or ML for image analysis, interpretation, or any other function.
No
The device is described as an illumination and imaging system used for visualization during surgical procedures, not for direct treatment or therapy.
No
The device is described as an imaging system used during surgical procedures to provide visualization (visible and near-infrared) to assist surgeons. While it aids in visualization of anatomy and certain physiological processes (like blood flow or bile ducts using ICG), its stated "Intended Use / Indications for Use" and "Device Description" focus on providing real-time endoscopic imaging and illumination for surgical guidance, not on making a diagnosis of a disease or condition. It is a surgical visualization tool, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a Camera System, Light Source and SafeLight Cable, Laparoscope, and IRIS Ureteral Kit. While it mentions image processing (software functionality), it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is an endoscopic imaging system that uses visible and near-infrared light to visualize internal structures during surgical procedures. It provides real-time images to assist surgeons.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly images the internal anatomy.
- Intended Use: The intended use is for surgical visualization and guidance, not for analyzing biological samples for diagnostic purposes.
While the system uses an imaging agent (ICG), this agent is administered to the patient and then visualized in vivo by the device, rather than being used to test a sample in vitro.
Therefore, the 1688 4K Camera System with Advance Imaging Modality and the L11 LED Light Source with Advanced Imaging Modality are surgical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
1688 4K Camera System with Advance Imaging Modality:
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality:
The L11 AIM Light Source and SafeLightTM Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 L1 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
The L11 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, OWN, FCS, FCW
Device Description
The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using indocyanine green (ICG) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing near-infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) Imaging Agent Kits containing ICG used for fluorescence imaging.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic visible and near-infrared fluorescence imaging, near-infrared imaging, white light
Anatomical Site
vessels, blood flow, related tissue perfusion, major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), ureter, evacuated cardiac chamber
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. Minimally invasive surgery, open surgical procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance studies included Electrical Safety, EMC Testing, Laser Safety, Sterilization, Software Validation & Verification, Usability, Performance - Bench, and Performance - Animal. All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K173866, K151243, K142310, K132785, K150956, K161792
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 5, 2018
Stryker April Malmborg Director, Regulatory Affairs 5900 Optical Court San Jose, California 95138
Re: K182160
Trade/Device Name: 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, OWN, FCS, FCW Dated: August 7, 2018 Received: August 9, 2018
Dear April Malmborg:
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/cfpmr/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.
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -53
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182160
Device Name
1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM
Indications for Use (Describe)
1688 4K Camera System with Advance Imaging Modality:
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality:
The L11 AIM Light Source and SafeLightTM Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 L1 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
The L11 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92(c).
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | April Malmborg, RAC
Director, Regulatory Affairs
Phone: (408) 754-2473
Facsimile: (408) 754-2598
Email: april.malmborg(a)stryker.com |
| Date Prepared: | October 29, 2018 |
Subject Device:
The subject device is the AIM (Advanced Imaging Modality) System, and specifically the following system components:
| Name of Device: | 1688 4K Camera System with Advance Imaging Modality |
|---|---|
| Common or | |
| Usual Name | 3-chip Video Camera |
| Classification | |
| Name: | Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500) |
| Regulatory Class: | II |
| Product Code: | GCJ |
| 510(k) Review | |
| Panel: | General & Plastic Surgery |
| Name of Device: | L11 LED Light Source with Advanced Imaging Modality |
|---|---|
| Common or | |
| Usual Name | Light Source, Illuminator |
| Classification | |
| Name: | Confocal Optical Imaging1 (21 C.F.R. §876.1500) |
| Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020) | |
| Light Source, Fiberoptic, Routine3 (21 C.F.R. §876.4020) | |
| Regulatory Class: | II |
| Product Code: | OWN1 |
| FSC2 | |
| FCW3 | |
| 510(k) Review | |
| Panel: | General & Plastic Surgery1 |
| Gastroenterology/ Urology2,3 |
1When used for 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
2When used to transilluminate the ureter during open or laparoscopic surgical procedures
3When used to provide standard endoscopic visible light to support real-time endoscopic visible imaging.
4
Predicate Device(s):
| Stryker® Infrared Fluorescence Imaging (IRF) System | K173866, K151243,
K142310, K132785 |
|-----------------------------------------------------|---------------------------------------|
| PINPOINT Endoscopic Fluorescence Imaging System | K150956, K161792 |
NOTE: The predicate devices have not been subject to a design-related recall.
Device Description:
The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using indocyanine green (ICG) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing near-infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) Imaging Agent Kits containing ICG used for fluorescence imaging.
Indications for Use:
1688 4K Camera System with Advance Imaging Modality:
The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ arthroscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion. Anterior cruciate ligament reconstruction. Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality:
The L11 AIM Light Source and SafeLight™ Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual 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.
5
Fluorescence imaging of biliary ducts with the L11 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
The L11 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
| Item | Subject Device | Predicate Devices | ||
|---|---|---|---|---|
| AIM (Advanced Imaging Modality) System | Stryker Infrared Fluorescence (IRF) Imaging System | PINPOINT Endoscopic Fluorescence Imaging System | ||
| Manufacturer | Stryker | Same as subject device | Novadaq Technologies (now a part of Stryker) | |
| Submission Reference | Current Submission | K173866, K151243, K142310, K132785 | K150956 | |
| Intended Use | Endoscopic visible and near-infrared light illumination and imaging during surgical endoscopic procedures | Same as subject device | Same as subject device | |
| Indications for Use | NOTE 1 | Same as subject device | NOTE 2 (same as L11 LED Light Source) | |
| Imaging Modes | White Light | |||
| Near-infrared – fluorescence | ||||
| Near-infrared - transillumination | Same as subject device | White Light | ||
| Near -infrared - fluorescence | ||||
| Safety Standards | IEC 60601-1 | |||
| IEC 60601-2-18 | ||||
| IEC 60601-1-2 | ||||
| IEC 60825-1 | Same as subject device | Same as subject device | ||
| System Components | Camera System | |||
| Light Source and SafeLight Cable | ||||
| Laparoscopes | ||||
| IRIS Ureteral Kits | ||||
| Imaging Agent Kits | Same as subject device | Video Processor/ Illuminator | ||
| Camera Head | ||||
| Light Guide Cable | ||||
| Laparoscopes | ||||
| Imaging Agent Kits | ||||
| Camera System | Principles of Operation | Via an optical scope and coupler, light is projected onto one or more complementary metal oxide semiconductor image sensors which acquire a continuous stream of image data. The image data is processed to provide a video stream that is then sent to a display for viewing. | Same as subject device | Same as subject device |
| Image Sensor | CMOS image sensor | Same as subject device | Same as subject device | |
| Image Processing/ Video Output | Digital | Same as subject device | Same as subject device | |
| Resolution | 4K (up to3840 x 2160) | Up to 1920 x 1080 | Up to 1920 x 1080 | |
| Light Source | Principles of Operation | An electronic driver controls Red/Green/Blue LEDs & a near-infrared | Same as subject device | Same as subject device |
| Item | Subject Device | Predicate Devices | ||
| AIM (Advanced Imaging Modality) | ||||
| System | Stryker Infrared | |||
| Fluorescence (IRF) | ||||
| Imaging System | PINPOINT Endoscopic | |||
| Fluorescence Imaging | ||||
| System | ||||
| dichroic mirrors and projected onto an | ||||
| output light collimator. A fiber output | ||||
| bundle can be inserted into the light | ||||
| source to couple light to the distal end | ||||
| and into an endoscope. | ||||
| Light | ||||
| Source/ | ||||
| Laser | RGB LEDs | |||
| Infrared Laser | Same as subject | |||
| device | Same as subject device |
Comparison of Technological Characteristics with the Predicate Device:
6
NOTE 1: The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small ioint arthroscopy. Decompression fixation. Wedge resection. Lung biopsy. Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general surgeons, gynecologists. cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
The L11 AIM Light Source and SafeLight™ Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 L11 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. The L1 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
NOTE 2: The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The PINPOINT 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 or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the PINPOINT 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.
Performance Data:
| Test | Method | Result |
|---|---|---|
| Electrical Safety | ANSI IEC 60601-1:2005 + A1:2012; | |
| IEC 60601-2-18:2009 | ||
| IEC 60601-1-6:2013 | PASS | |
| EMC Testing | IEC 60601-1-2:2010 | PASS |
| Laser Safety | IEC 60825-1:2014 | PASS |
| Sterilization | ISO 14937:2009 | PASS |
Testing was completed in accordance with the following:
7
| Test | Method | Result |
|---|---|---|
| Software Validation & | ||
| Verification | IEC 62304:2006 | PASS |
| Usability | IEC 62366-1:2015 | PASS |
| Performance - Bench | In accordance with device performance | |
| specifications | PASS | |
| Performance - Animal | In accordance with user needs; | |
| Comparative testing to currently legally marketed | ||
| device in compliance | PASS |
NOTE: The AIM (Advanced Imaging Modality) System does not require clinical studies to support the determination of substantial equivalence.
Conclusions:
The AIM (Advanced Imaging Modality) System is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. There are no new issues of safety and/or effectiveness introduced by the 1688 4K Camera System or L11 LED Light Source when used as instructed.