(88 days)
Not Found
No
The summary describes a light source and cable for real-time visible and near-infrared fluorescence imaging and transillumination. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the illumination and imaging capabilities, not on automated analysis or interpretation of the images using AI/ML.
No.
The document describes a diagnostic imaging system that aids surgeons in visualizing anatomical structures during surgery, not a device that directly treats or prevents disease.
No
The device is described as an illumination and imaging system used during surgery to provide real-time visible and near-infrared fluorescence imaging, and transillumination. Its purpose is to help surgeons visualize structures like vessels, bile ducts, and the lymphatic system, and assess blood flow, which are intraoperative guidance functions rather than diagnostic ones (leading to a diagnosis or identifying disease).
No
The device description explicitly states it includes a "Light Source" and a "SafeLight Cable," which are hardware components used for illumination and light transmission.
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 outside of the living organism.
- Device Function: The AIM Light Source and SafeLight Cable are used during surgical procedures to provide real-time imaging within the patient's body. They illuminate tissues and structures to aid the surgeon's visualization.
- Intended Use: The intended use clearly describes the device's application in surgical settings for visualizing vessels, bile ducts, the lymphatic system, and the ureter in vivo.
The device is a surgical imaging system used to enhance visualization during procedures, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The 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 AIM Light Source and SafeLight Cable is intended for use with standardof-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Upon interstitial administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLightTM Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The 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)
OWN, FSC, FCW
Device Description
The AIM Light Source (L10 and L11 LED Light Source) and SafeLight™ Cable are part of the AIM (Advanced Imaging Modality) System. The AIM System is an endoscopic real-time 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 using the IRIS Ureteral Kit during minimally invasive and open surgical procedures, respectively. The AIM Light Source is a light-generating unit designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination. The SafeLight Cable transmits light from the light source to an endoscope during endoscopic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic visible light, near-infrared fluorescence imaging, near-infrared transillumination
Anatomical Site
vessels, blood flow, related tissue perfusion, major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), lymphatic system (lymphatic vessels and lymph nodes), ureter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons, 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 - Bench: In accordance with device input specifications, Result: PASS
Performance - Animal: In accordance with device user needs; Comparative testing to currently legally marketed device in accordance with 21CFR58, Result: PASS; Equivalent
The nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legal marketed predicate device, the PINPOINT System. There are no new issues of safety and/or effectiveness introduced by the AIM Light Source and SafeLight Cable for intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes using SPY AGENT™ GREEN the when used as instructed.
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.
K150956, K161792, K182606, K142310, K151243, K173866, K191046, K182160, K191046
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 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.
Stryker April Malmborg Director, Regulatory Affairs 5900 Optical Court San Jose. California 95138
November 19, 2019
Re: K192292
Trade/Device Name: L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN, GCJ Dated: August 22, 2019 Received: August 23, 2019
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/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
1
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, MS 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
2
Indications for Use
510(k) Number (if known) K192292
Device Name
Stryker L10 and L11 LED Light Source with AIM (Advanced Imaging Modality)
Indications for Use (Describe)
Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The 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 AIM Light Source and SafeLight Cable is intended for use with standardof-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Upon interstitial administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLightTM Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | |||
| Prescription Use (Part 21 CFR 801 Subpart D) | ||||||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K192292
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@stryker.com |
| Date Prepared: | August 22, 2019 |
Subject Device:
| Name of Device: | AIM Light Source and SafeLight™ Cable |
|---|---|
| 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), and lymphatic system, including lymphatic vessels and lymph nodes, 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.
Predicate Device(s):
| PINPOINT Endoscopic Fluorescence Imaging System (primary predicate) | K150956, K161792,
K182606 |
|---------------------------------------------------------------------|---------------------------------------|
| L10 LED Light Source and SafeLight Cable (secondary predicate) | K142310, K151243,
K173866, K191046 |
| L11 LED Light Source and SafeLight Cable (secondary predicate) | K182160, K191046 |
NOTE: The predicate devices have not been subject to a design-related recall.
4
K192292
Device Description:
The AIM Light Source (L10 and L11 LED Light Source) and SafeLight™ Cable are part of the AIM (Advanced Imaging Modality) System. The AIM System is an endoscopic real-time 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 using the IRIS Ureteral Kit during minimally invasive and open surgical procedures, respectively. The AIM Light Source is a light-generating unit designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination. The SafeLight Cable transmits light from the light source to an endoscope during endoscopic procedures.
Indications for Use:
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight™ Cable is used with SPY AGENT™ GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The 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 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.
Upon interstitial administration of SPY AGENT™ GREEN (ICG drug product), the AIM Light Source and SafeLight™ Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system. including lymphatic vessels and lymph nodes.
The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
| Item | Subject Device | Predicate Devices | ||
|---|---|---|---|---|
| AIM Light Source and Safe | ||||
| Light Cable | PINPONT Endoscopic | |||
| Fluorescence Imaging | ||||
| System (primary | ||||
| predicate) | AIM Light Source and | |||
| Safe Light Cable | ||||
| (secondary predicate) | ||||
| Manufacturer | Stryker | Novadaq Technologies | ||
| ULC (now a part of | ||||
| Stryker) | Same as subject device | |||
| Submission Reference | Current submission | K150956, K161792, | ||
| K182606 | K142310, K151243, | |||
| K173866, K182160, | ||||
| K191046 | ||||
| Item | Subject Device | Predicate Devices | ||
| AIM Light Source and Safe | ||||
| Light Cable | PINPONT Endoscopic | |||
| Fluorescence Imaging | ||||
| System (primary | ||||
| predicate) | AIM Light Source and | |||
| Safe Light Cable | ||||
| (secondary predicate) | ||||
| Intended Use | Endoscopic white light and | |||
| near-infrared illumination andimaging during endoscopic | ||||
| procedures. | Same as subject device. | Same as subject device | ||
| Indications for Use | NOTE 1 | Same as subject device. | ||
| NOTE 2 | NOTE 3 | |||
| Principles of Operation | An electronic driver controls | |||
| Red/Green/Blue LEDs and a | ||||
| near-infrared laser diode which | ||||
| are combined through 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. | Same as subject device. | Same as subject device. | ||
| Components | Light Source and SafeLight | |||
| Cable | ||||
| Camera System | ||||
| Laparoscopes | ||||
| IRIS Ureteral Kit | ||||
| Imaging Agent | Video Processor/ | |||
| Illuminator (VPI) | ||||
| Light Guide Cable | ||||
| Camera Head | ||||
| Laparoscopes | ||||
| Imaging Agent | Same as subject device | |||
| Safety Standards | IEC 60601-1 | |||
| IEC 60601-2-18 | ||||
| IEC 60601-1-2 | ||||
| IEC 60825-1 | Same as subject device | Same as subject device | ||
| Light Source/ Laser | RGB LEDs | |||
| Infrared Laser | Same as subject device | Same as subject device | ||
| Infrared Wavelengths | 806nm (used for NIR | |||
| fluorescence) | ||||
| 830nm (used for NIR | ||||
| transillumination) | 805nm (used for NIR | |||
| fluorescence) | Same as subject | |||
| device | ||||
| L10 | ||||
| Imaging | ||||
| Modes | White Light | Manual | Same as subject device | Same as subject device |
| NIR | ||||
| Fluorescence | ENV | Contrast | ||
| Overlay | ||||
| Color Segmented | ||||
| Fluorescence | Same as subject device | |||
| NIR Trans- | ||||
| illumination | IRIS | None | Same as subject device | |
| L11 | ||||
| Imaging | ||||
| Modes | White Light | Manual | ||
| Autolight | Manual | Same as subject device | ||
| NIR | ||||
| Fluorescence | ENV | |||
| Contrast | ||||
| Overlay | Contrast | |||
| Overlay | ||||
| Color Segmented | ||||
| Fluorescence | Same as subject device | |||
| Item | Subject Device | Predicate Devices | ||
| AIM Light Source and Safe | ||||
| Light Cable | PINPONT Endoscopic | |||
| Fluorescence Imaging | ||||
| System (primary | ||||
| predicate) | AIM Light Source and | |||
| Safe Light Cable | ||||
| (secondary predicate) | ||||
| NIR Trans- | ||||
| illumination | IRIS | None | Same as subject device | |
| SafeLight | ||||
| Cable | Single-Use/ | |||
| Reusable | Reusable | Same as subject device | Same as subject device |
Comparison of Technological Characteristics with the Predicate Device:
5
6
NOTE 1: Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight™ Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the 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 biliary duct visualization. Upon interstital administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
NOTE 2: Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the PINPOINT Endoscopic Fluorescence Imaging System is used with SPY AGENT GREEN to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when intraoperative cholangiography. 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 endoscope 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 duct, common bile duct or common hepatic duct), using near-infraging. Fluorescence imaging of biliary ducts with the PINPOINT System in intended for use with standard of care white light, and when indicated intraoperative cholangiography. The device is not intended for biliary duct visualization. Upon interstital administration of SPY AGENT GREEN (ICG drug product), the PINPOINT System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
NOTE 3: Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight™ Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperaphy. The devices are not intended for standalone use for biliary duct visualization. The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
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 60601-1-2:2014 | 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 input specifications | PASS |
| Performance - Animal | In accordance with device user needs; | |
| Comparative testing to currently legally | ||
| marketed device in accordance with 21CFR58 | PASS; | |
| Equivalent |
NOTE: The AIM Light Source and SafeLight Cable do not require clinical studies to support the determination of substantial equivalence.
Conclusions:
Based on the information presented, the AIM Light Source and SafeLight Cable is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. The nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legal marketed predicate device, the PINPOINT System. There are no new issues of safety and/or effectiveness introduced by the AIM Light Source and SafeLight Cable for intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes using SPY AGENT™ GREEN the when used as instructed.