(21 days)
Not Found
No
The document describes a fluorescence imaging system that processes near-infrared and visible light images but does not mention the use of AI or ML for this processing or any other function.
No
The device is an illumination and imaging system used to visualize anatomical structures, blood flow, and tissue perfusion during surgery, not to directly treat a medical condition.
No.
The device is an imaging system designed to provide real-time endoscopic visible and near-infrared fluorescence imaging during surgery, aiding surgeons in visualizing vessels, blood flow, tissue perfusion, and bile ducts. It enables visual assessment during surgical procedures rather than diagnosing a condition or disease.
No
The device description explicitly lists multiple hardware components including a light source console, light cable, camera control unit, coupler, and laparoscope. While it includes image processing, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this system is used for real-time imaging within the body during surgery. It illuminates and captures fluorescence from an intravenously administered agent (ICG) within vessels and ducts.
- The device interacts directly with the patient's body. IVDs are typically used in a laboratory setting to analyze samples taken from a patient (like blood, urine, tissue). This system is used in vivo during a surgical procedure.
- The purpose is visualization and guidance during surgery. The intended use is to provide real-time imaging to assist surgeons in visualizing structures and blood flow during minimally invasive procedures. This is a surgical imaging tool, not a diagnostic test performed on a sample.
While the system uses an imaging agent (ICG) and processes images, its function is to provide visual information during a surgical procedure, not to diagnose a condition by analyzing a biological specimen.
N/A
Intended Use / Indications for Use
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use 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 standardof-care white light and, when indicated, intraoperative cholangiography. 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.
Product codes
OWN, FCS, FCW
Device Description
The Stryker AIM LED Light Source (L10 & L11) is part of the Stryker Infrared Fluorescence (IRF) Imaging System, which is an endoscopic illumination and imaging system for real-time high definition (HD) visible light and near-infrared fluorescence imaging of indocyanine green (ICG) during minimally invasive surgery.
The Stryker Infrared Fluorescence Imaging System consists of the following main components:
- . A light source console and a light cable for outputting light within a visible light spectrum as well as near-infrared light spectrum;
- . A camera control unit for processing near-infrared and visible light images, and a coupler that is attached to the laparoscope and camera head (cleared separately);
- A laparoscope for visible light and near-infrared light illumination and imaging ● (cleared separately)
- An imaging agent kit containing ICG ●
The Stryker AIM LED Light Source uses an illuminator with a laser light source to illuminate the area of surgery. The device is used in conjunction with ICG to achieve its intended use in fluorescence angiography. The ICG is administered intravenously prior to image obtainment. A laser light is illuminated to the site of the surgery using a laparoscope. Absorption of laser light causes excitation of the ICG in the vessels resulting in emission of infrared light at a different wavelength. The camera system captures the infrared emission, processes the image and displays it on a surgical monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic visible and near-infrared fluorescence imaging
Anatomical Site
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), ureter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons to perform minimally invasive surgery
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)
Bench testing was performed to demonstrate compatibility of the Stryker L10 and L11 LED Light Source with AIM with Stryker's SPY AGENT™ GREEN (Indocyanine green for Injection, USP). Results from the imaging studies demonstrated that there was no visible difference observed in fluorescence between Stryker's SPY AGENT™ GREEN and another commercially available ICG imaging agent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Stryker Agatha Szeliga Regulatory Affairs Manager 5900 Optical Court San Jose, California 95138
May 10, 2019
Re: K191046
Trade/Device Name: L10 LED Light Source with AIM, L11 LED Light Source with AIM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN, FCS, FCW Dated: April 19, 2019 Received: April 19, 2019
Dear Agatha Szeliga:
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
1
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.htm); 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 Stevenson, For Acting Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Stryker L10 and L11 LED Light Source with AIM (Advanced Imaging Modality)
Indications for Use (Describe)
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use 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 standardof-care white light and, when indicated, intraoperative cholangiography. 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and black. The word is centered and takes up most of the frame. The background is white.
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.
Submitter:
| Applicant | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|----------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Agatha Szeliga
Regulatory Affairs Manager
Tel: 604-422-7516
Fax: 604-232-9841
E-mail: agatha.szeliga@stryker.com |
| Date Prepared | April 19, 2019 |
Subject Device:
| Name of Device | Stryker L10 and L11 LED Light Source with AIM (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. §876.1500) | ||
| Regulatory Class | II | |
| Product Code | OWN1 | |
| FCS2 | ||
| FCW3 | ||
| 510(k) Review Panel | General & Plastic Surgery1 | |
| Gastroenterolgoy/ Urology2,3 |
1When used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging 2When used to trans-illuminate 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):
| Stryker AIM Light Source and SafeLight Cable | K173866 |
|---|---|
| L11 LED Light Source with AIM | K182160 |
Note: The predicate devices have not been subject to a design-related recall.
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Device Description:
The Stryker AIM LED Light Source (L10 & L11) is part of the Stryker Infrared Fluorescence (IRF) Imaging System, which is an endoscopic illumination and imaging system for real-time high definition (HD) visible light and near-infrared fluorescence imaging of indocyanine green (ICG) during minimally invasive surgery.
The Stryker Infrared Fluorescence Imaging System consists of the following main components:
- . A light source console and a light cable for outputting light within a visible light spectrum as well as near-infrared light spectrum;
- . A camera control unit for processing near-infrared and visible light images, and a coupler that is attached to the laparoscope and camera head (cleared separately);
- A laparoscope for visible light and near-infrared light illumination and imaging ● (cleared separately)
- An imaging agent kit containing ICG ●
The Stryker AIM LED Light Source uses an illuminator with a laser light source to illuminate the area of surgery. The device is used in conjunction with ICG to achieve its intended use in fluorescence angiography. The ICG is administered intravenously prior to image obtainment. A laser light is illuminated to the site of the surgery using a laparoscope. Absorption of laser light causes excitation of the ICG in the vessels resulting in emission of infrared light at a different wavelength. The camera system captures the infrared emission, processes the image and displays it on a surgical monitor.
Indications for Use:
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use 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.
The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
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| Feature | Subject Device | Predicate Device | Predicate Device |
|---|---|---|---|
| Stryker L10 and L11 LED | |||
| Light Source with AIM | Stryker AIM Light | ||
| Source and SafeLight | |||
| Cable | L11 LED Light Source | ||
| with Advanced | |||
| Imaging Modality | |||
| (AIM) | |||
| Manufacturer | Stryker Endoscopy | Same as subject device | Same as subject device |
| Submission | |||
| Reference | Current Submission | K173866 | K182160 |
| Intended Use | Endoscopic visible and near- | ||
| infrared imaging during | |||
| surgical procedures | Same as subject device | Same as subject device | |
| Indications | |||
| for Use | See NOTE 1 | See NOTE 2 | See NOTE 3 |
| Imaging | |||
| Modes | White Light | ||
| Near-infrared - Fluorescence | |||
| Near-infrared - | |||
| Transillumination | Same as subject device | Same as subject device | |
| Safety | |||
| Standards | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60825-1 | |||
| IEC 60601-2-18 | Same as subject device | Same as subject device | |
| Components | Light Source and SafeLight | ||
| Cable | Light Source and | ||
| SafeLight Cable | Light Source and | ||
| SafeLight Cable | |||
| SPY AGENT™ GREEN Kit | ICG Imaging Agent Kits | ICG Imaging Agent Kits | |
| Principle 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 | |
| Light Source/ | |||
| Laser | RGB LEDs | ||
| Infrared laser | Same as subject device | Same as subject device | |
| Single Use or | |||
| Reusable | Reusable | Same as subject device | Same as subject device |
| Contrast | |||
| Imaging | |||
| Agent | SPY AGENT™ GREEN | ||
| (Indocyanine green for | |||
| injection, USP) | Indocyanine green (ICG) | Indocyanine green | |
| (ICG) |
Comparison of Technological Characteristics with the Predicate Device:
NOTE 1: Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use 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
6
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.
NOTE 2: The Stryker® AIM Light Source and SafeLight Cable are indicated for use to provide realtime endoscopic visible and near-infrared fluorescence imaging. The Stryker® AIM Light Source and SafeLight Cable enable 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 and common hepatic duct), using near infrared imaging.
Fluorescence imaging of biliary ducts with the Stryker® AIM Light Source and SafeLight Cable are 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.
NOTE 3: 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 Safe Light 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 duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the L1 1 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.
Performance Testing:
The labeling modification proposed within this 510(k) submission for the Stryker L10 and L11 LED Light Source with AIM does not have an impact on the performance characteristics of the devices that were cleared in the previous submissions.
Bench testing was performed to demonstrate compatibility of the Stryker L10 and L11 LED Light Source with AIM with Stryker's SPY AGENT™ GREEN (Indocyanine green for Injection, USP). Results from the imaging studies demonstrated that there was no visible difference observed in fluorescence between Stryker's SPY AGENT™ GREEN and another commercially available ICG imaging agent.
Conclusions:
The information presented within this Special 510(k) premarket notification demonstrates that the Stryker L10 and L11 LED Light Source with AIM is substantially equivalent in design, intended use, principle of operation, technological characteristics and safety features to the predicate devices. There are no new issues of safety and/or effectiveness introduced as a result of the labeling modification proposing the use of the Stryker L10 and L11 Light Source with AIM in conjunction with SPY AGENT™ GREEN imaging agent. It has been demonstrated that the Stryker L10 and L11 LED Light Source with AIM is compatible for use in fluorescence angiography with Stryker's SPY AGENT™ GREEN imaging agent.