(88 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical performance targets for the device's diagnostic or imaging capabilities. Instead, it focuses on the device passing various design and safety standards. The "Performance - Animal" section states "Equivalent" to a legally marketed predicate device, which implies a comparative performance but doesn't quantify specific metrics.
| Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Electrical Safety | ANSI IEC 60601-1:2005 + A1:2012; | PASS |
| IEC 60601-2-18:2009 | PASS | |
| 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 |
| Software Validation & Verification | IEC 62304:2006 | PASS |
| Usability | IEC 62366-1:2015 | PASS |
| Performance - Bench | In accordance with device input specifications | PASS |
| Performance - Animal | Comparative testing to currently legally marketed device in accordance with 21CFR58 | PASS; Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "Performance - Animal" testing. However, it does not specify the sample size (i.e., the number of animals or cases) used for this test set.
- Data Provenance: The study mentioned is an animal study. The location or specific details of the study (e.g., country of origin, retrospective or prospective) are not provided, other than it being "in accordance with 21CFR58" (which refers to Good Laboratory Practice for nonclinical laboratory studies).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The type of animal study described generally wouldn't involve human expert readers in the same way a diagnostic imaging study would. The assessment of "equivalence" likely refers to objective measurements or observations in the animal model.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Since no information is given about human experts establishing ground truth or their interpretations, an adjudication method is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI Assistance
An MRMC comparative effectiveness study was not done. This document describes an imaging modality that assists surgeons with real-time visualization, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable in the context of the device described. The AIM Light Source and SafeLight Cable are imaging hardware designed to provide real-time visible and near-infrared fluorescence imaging to a human surgeon. It's not a standalone algorithm that provides an output without human interpretation. Its performance is about the quality of the image delivered for human assessment.
7. The Type of Ground Truth Used
For the "Performance - Animal" study, the ground truth would be established through direct observation and/or histological analysis in an animal model, validated against the known physiological processes of blood flow, tissue perfusion, biliary ducts, and lymphatic system activity when ICG is administered. The equivalence claim against a predicate device suggests that the ability to visualize these features was compared.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is an imaging hardware system, not a machine learning or AI algorithm that requires a separate training set. Its development would involve engineering and physical testing, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Neil R.P. Ogden, 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
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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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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 Endoscopy5900 Optical CourtSan Jose, CA 95138 |
|---|---|
| Contact Person: | April Malmborg, RACDirector, Regulatory AffairsPhone: (408) 754-2473Facsimile: (408) 754-2598Email: april.malmborg@stryker.com |
| Date Prepared: | August 22, 2019 |
Subject Device:
| Name of Device: | AIM Light Source and SafeLight™ Cable |
|---|---|
| Common orUsual Name | Light Source, Illuminator |
| ClassificationName: | 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: | OWN1FSC2FCW3 |
| 510(k) ReviewPanel: | General & Plastic Surgery1Gastroenterology/ 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.
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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 SafeLight Cable | PINPONT EndoscopicFluorescence ImagingSystem (primarypredicate) | AIM Light Source andSafe Light Cable(secondary predicate) | ||
| Manufacturer | Stryker | Novadaq TechnologiesULC (now a part ofStryker) | 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 SafeLight Cable | PINPONT EndoscopicFluorescence ImagingSystem (primarypredicate) | AIM Light Source andSafe Light Cable(secondary predicate) | ||
| Intended Use | Endoscopic white light andnear-infrared illumination andimaging during endoscopicprocedures. | 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 controlsRed/Green/Blue LEDs and anear-infrared laser diode whichare combined through dichroicmirrors and projected onto anoutput light collimator. A fiberoutput bundle can be insertedinto the light source to couplelight to the distal end and intoan endoscope. | Same as subject device. | Same as subject device. | |
| Components | Light Source and SafeLightCableCamera SystemLaparoscopesIRIS Ureteral KitImaging Agent | Video Processor/Illuminator (VPI)Light Guide CableCamera HeadLaparoscopesImaging Agent | Same as subject device | |
| Safety Standards | IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 60825-1 | Same as subject device | Same as subject device | |
| Light Source/ Laser | RGB LEDsInfrared Laser | Same as subject device | Same as subject device | |
| Infrared Wavelengths | 806nm (used for NIRfluorescence)830nm (used for NIRtransillumination) | 805nm (used for NIRfluorescence) | Same as subjectdevice | |
| L10ImagingModes | White Light | Manual | Same as subject device | Same as subject device |
| NIRFluorescence | ENV | ContrastOverlayColor SegmentedFluorescence | Same as subject device | |
| NIR Trans-illumination | IRIS | None | Same as subject device | |
| L11ImagingModes | White Light | ManualAutolight | Manual | Same as subject device |
| NIRFluorescence | ENVContrastOverlay | ContrastOverlayColor SegmentedFluorescence | Same as subject device | |
| Item | Subject Device | Predicate Devices | ||
| AIM Light Source and SafeLight Cable | PINPONT EndoscopicFluorescence ImagingSystem (primarypredicate) | AIM Light Source andSafe Light Cable(secondary predicate) | ||
| NIR Trans-illumination | IRIS | None | Same as subject device | |
| SafeLightCable | Single-Use/Reusable | Reusable | Same as subject device | Same as subject device |
Comparison of Technological Characteristics with the Predicate Device:
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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 60601-2-18:2009IEC 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:
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| 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 legallymarketed 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.
§ 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.