(89 days)
Not Found
No
The summary describes image processing and different imaging modalities but does not mention AI, ML, or related terms like deep learning or neural networks. The performance studies focus on standard imaging metrics and bench testing, not AI/ML model performance.
No
The device is a camera system and light source used for visualization during surgical procedures, aiding surgeons in their work, but it does not directly treat or prevent a disease or condition itself.
No
The device is described as a camera and light source system primarily used for visualization during surgical procedures, not for diagnosing conditions. Its purpose is to aid surgeons in performing minimally invasive surgery by providing real-time imaging of anatomical structures, blood flow, and tissue perfusion. While it assists in surgical assessment, it does not independently provide a diagnosis.
No
The device description explicitly mentions hardware components like a "4K Camera System," "LED Light Source," and "SafeLight Cable." While it includes image processing software, it is an integral 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The 1788 4K Camera System with Advanced Imaging Modality is an endoscopic imaging system used during surgical procedures to visualize internal structures within the body. It uses visible light, near-infrared illumination, transillumination, and cyan spectral imaging to aid surgeons in real-time.
- Intended Use: The intended use clearly describes its application in various surgical procedures for visualization within the patient's body. It does not involve testing samples taken from the body.
- Device Description: The description reinforces its function as an endoscopic imaging system for use during surgery.
While the device is used in conjunction with intravenously or interstitially administered agents (like SPY AGENT GREEN or pafolacianine) to enhance visualization, the device itself is not performing a diagnostic test on a biological sample. It is a tool for visualization during a medical procedure.
N/A
Intended Use / Indications for Use
The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.
A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repar, 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, 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.
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L12 LED Light Source with Advanced Imaging Modality 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.
Additionally, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with Advanced Imaging Modality and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The L12 LED Light Source with Advanced Imaging Modality 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, GWG, NWB, OWN, FCS, FCW
Device Description
Stryker's Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light, near-infrared illumination and transillumination, and cyan spectral imaging system. Near-infrared illumination is used for fluorescence imaging using SPY AGENT™ GREEN (indocyanine green for injection, USP) or CYTALUX™ (pafalocianine) injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. Cyan Spectral Imaging is intended as an alternative mode of visualization that uses narrow bands for illumination during endoscopic surgery to provide greater visualization of surface structures and fine capillary patterns of the mucosal membrane.
Mentions image processing
Digital
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic imaging (visible light, near-infrared fluorescence, near-infrared transillumination, cyan spectral imaging)
Anatomical Site
General laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery, plastic surgery, 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
Adults and pediatric patients.
Adults and pediatric patients aged one month and older (for visual assessment of vessels, blood flow and related tissue perfusion).
Adults and pediatric patients 12 to 17 years of age (for visualization of major extra-hepatic bile ducts).
Adults and pediatric patients > 6 years of age (for endonasal skull base surgery).
Intended User / Care Setting
General and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT/heurosurgeons and urologists. (Implied: hospital/surgical setting).
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 data was generated through bench testing and in accordance with recognized consensus standards.
Studies performed include:
- Electromagnetic Compatibility (IEC 60601-1-2:2014, IEC 60601-4-2:2016) - Passed
- Electrical Safety (ANSI AAMI ES 60601-1:2005 + A1:2012 + A2: 2021, IEC 60601-1-6:2010 + A1:2013 + A2:2020, IEC 60601-2-18:2009) - Passed
- Laser Safety (IEC 60825-1:2014, IEC 62471) and comparative testing to legally marketed predicate device - Passed
- Sterilization (ISO 17664-1:2021, ISO 17664-2:2021, ISO 14937:2009, AAMI TIR12:2020, AAMI TIR30:2011, AAMI ST58:2013/(R)2018) - Passed
- Software Verification and Validation (IEC 62304:2015) - Passed
- Usability (IEC 62366:2015 + A1:2020) - Passed
- Performance Testing - Bench: (in accordance with device input specifications, comparative testing to currently legally marketed predicate devices) including Spatial Uniformity, Minimum Detectable Fluorescence, Fluorescence Detection Depth, Clinically Meaningful Limits of Detection, Signal to Noise, Photobiological Safety (IEC 62417), Contrast - Passed
- Performance Testing (in accordance with user needs and intended uses) - 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.
K230605, K230754, K111425, K182606
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 logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right, the FDA logo is displayed in blue, with the acronym "FDA" stacked above the words "U.S. FOOD & DRUG ADMINISTRATION."
September 20, 2023
Stryker April Malmborg Senior Director, Regulatory Affairs 5900 Optical Court San Jose, California 95138
Re: K231854
Trade/Device Name: 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, GWG, NWB, OWN, FCS, FCW Dated: June 23, 2023 Received: June 23, 2023
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/cfpm/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/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 medical devices and radiation-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,
Tanisha L. Tanisha L. Hithe -S 2023.09.20 Hithe -S 09:19:05 -04'00'
Tanisha Hithe, MS, MHS Assistant 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
2
Indications for Use
510(k) Number (if known)
K231854
Device Name
1788 4K Camera System with Advanced Imaging Modality
Indications for Use (Describe)
The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.
A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repar, 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, 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 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT/heurosurgeons and urologists.
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.
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3
Indications for Use
510(k) Number (if known)
K231854
Device Name
L12 LED Light Source with Advanced Imaging Modality
Indications for Use (Describe)
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L12 LED Light Source with Advanced Imaging Modality 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.
Additionally, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with Advanced Imaging Modality and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The L12 LED Light Source with Advanced Imaging Modality is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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).
510(k) Number :
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | April Malmborg
Senior Director, Regulatory Affairs
Email: april.malmborg@stryker.com
Ph: (408) 754-2472 |
| Date Prepared: | June 23, 2023 |
Subject Device:
The subject device is the Advanced Imaging Modality (AIM) System and specifically the following system components:
| Name of Device: | 1788 4K Camera System with Advanced Imaging Modality |
|---|---|
| Common or Usual Name | 3-chip Video Camera |
| Classification Name: | Endoscope and Accessories (21 C.F.R. §876.1500) |
| Neurological Endoscope (21 C.F.R. §882.1480) | |
| Regulatory Class: | II |
| Product Code: | GCJ |
| GWG | |
| NWB | |
| 510(k) Review Panel: | General & Plastic Surgery |
| Neurology | |
| Gastroenterology/ Urology |
| Name of Device: | L12 LED Light Source with AIM |
|---|---|
| Common or Usual Name | Light Source, Illuminator |
| Classification Name: | Endoscope and Accessories (21 C.F.R. §876.1500) |
| Fiberoptic light ureteral catheter (21 C.F.R. §876.4020) | |
| Neurological Endoscope (21 C.F.R. §882.1480) | |
| Regulatory Class: | II |
| Product Code: | OWN |
| FCS | |
| FCW | |
| GWG | |
| NWB | |
| 510(k) Review Panel: | General & Plastic Surgery |
| Gastroenterology/ Urology | |
| Neurology |
5
Predicate Device(s):
| Advanced Imaging
Modality (AIM) System | 1788 4K Camera System
L12 LED Light Source | K230605 (primary)
K230754 (primary) |
|--------------------------------------------------------------------|-----------------------------------------------|----------------------------------------|
| Olympus VISERA ELITE Video System Center and
Xenon Light Source | | K111425 (secondary) |
| PINPOINT Endoscopic Fluorescence Imaging System | | K182606 (secondary) |
Device Description:
Stryker's Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light, near-infrared illumination and transillumination, and cyan spectral imaging system. Near-infrared illumination is used for fluorescence imaging using SPY AGENT™ GREEN (indocyanine green for injection, USP) or CYTALUX™ (pafalocianine) injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. Cyan Spectral Imaging is intended as an alternative mode of visualization that uses narrow bands for illumination during endoscopic surgery to provide greater visualization of surface structures and fine capillary patterns of the mucosal membrane.
Indications for Use:
1788 4K Camera System with Advanced Imaging Modality:
The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ sinuscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.
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 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT/neurosurgeons and urologists.
6
L12 LED Light Source with Advanced Imaging Modality:
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L12 LED Light Source with Advanced Imaging Modality 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.
Additionally, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with Advanced Imaging Modality and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The L12 LED Light Source with Advanced Imaging Modality is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
7
Comparison of Technological Characteristics with the Predicate Device:
| Item | Subject Device | Predicate Devices | |||
|---|---|---|---|---|---|
| Primary | Secondary | Secondary | |||
| Advanced Imaging | |||||
| Modality (AIM) System | Primary | ||||
| Advanced Imaging | |||||
| Modality (AIM) System | VISERA ELITE | PINPOINT System | |||
| Manufacturer | Stryker | Same as subject device | Olympus Medical | ||
| System | |||||
| Corporation | |||||
| K111425 | Same as subject | ||||
| device | |||||
| Submission Reference(s) | Current Submission | K230605; K230754 | K111425 | K182606 | |
| Intended Use | Endoscopic illumination | ||||
| and imaging during | |||||
| endoscopic procedures | Same as subject device | Same as subject | |||
| device | Same as subject | ||||
| device | |||||
| Indications for Use | NOTE 1 | Same as subject device | NOTE 2 | NOTE 3 | |
| System Components | Camera System (subject | ||||
| of submission) | |||||
| Light Source (subject of | |||||
| submission) and SafeLight | |||||
| Cable | |||||
| Endoscopes | |||||
| IRIS Ureteral Kit | |||||
| Imaging Agents | Same as subject device | Video Center | |||
| Xenon Light | |||||
| Source | |||||
| Videoscope | Video Processor/ | ||||
| Illuminator | |||||
| Camera Head | |||||
| Light Guide Cable | |||||
| Laparoscopes | |||||
| Imaging Agent | |||||
| Imaging Agents | SPY AGENT GREEN | ||||
| Pafolacianine | Same as subject device | Not applicable. | SPY AGENT | ||
| GREEN | |||||
| Principles of Operation | Via an endoscope, light is | ||||
| projected by a light source | |||||
| onto one or more image | |||||
| sensor(s) 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 | Same as subject | ||||
| device | |||||
| Safety Standards | IEC 60601-1 | ||||
| IEC 60601-2-18 | |||||
| IEC 60601-1-2 | |||||
| IEC 60601-4-2 | |||||
| IEC 60825-1 | |||||
| IEC 62471 | IEC 60601-1 | ||||
| IEC 60601-2-18 | |||||
| IEC 60601-1-2 | |||||
| IEC 60601-4-2 | |||||
| IEC 60825-1 | IEC 60601-1 | ||||
| IEC 60601-2-18 | |||||
| IEC 60601-2 | |||||
| IEC 62471 | IEC 60601-1 | ||||
| IEC 60601-2-18 | |||||
| IEC 60601-2 | |||||
| IEC 60825-1 | |||||
| Imaging | |||||
| Modes | White Light | White Light | Same as subject device | Same as subject | |
| device | Same as subject | ||||
| device | |||||
| NIR | |||||
| Fluorescence | ENV | ||||
| Contrast | |||||
| Overlay |
- without IRIS
- with IRIS
Color Segmented
Fluorescence - without IRIS
- with IRIS | ENV
Contrast
Overlay - without IRIS
- with IRIS | Not applicable. | Contrast
Overlay
Color Segmented
Fluorescence |
| | NIR Trans-
illumination | IRIS | Same as subject device. | Not applicable. | Not applicable. |
| | Cyan Spectral
Imaging
(CSI) | Cyan Spectral Imaging
(CSI) | Not Applicable. | Narrow Band
Imaging | Not applicable. |
| Camera
System | Image Sensor | CMOS image sensor | Same as subject device. | CCD image
sensor | Same as subject
device. |
| Item | | Subject Device | Predicate Devices | | |
| | | Advanced Imaging
Modality (AIM) System | Primary
Advanced Imaging
Modality (AIM) System | Secondary
VISERA ELITE | Secondary
PINPOINT System |
| | Image Processing/
Video Output | Digital | Same as subject device. | Same as subject device. | Same as subject device. |
| | Resolution | 4K (up to 3840 x 2160)
Up to 1920 x 1080 | Same as subject device. | Up to 1920 x 1080 | Up to 1920 x 1080 |
| | Frame Rate | 60 frames per second | Same as subject device. | Same as subject device. | Same as subject device. |
| Light
Source | Light Source/
Laser | RGB LEDs/
Infrared Laser | Same as subject device. | Xenon | Same as subject device. |
| | Excitation
Wavelength | 780 nm (used for NIR
fluorescence)
830 nm (used for NIR
transillumination) | Same as subject device. | Not applicable. | 806 nm (used for
NIR fluorescence) |
| | Laser Safety
Classification | Class 1M | Same as subject device. | Not applicable. | Class 3R |
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NOTE 1: The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectorny, 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, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectorny, 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 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT/neurosurgeons and urologists.
Upon intravenous administration of SPY AGENT™ GREEN (indocyanine green for injection, USP), the L12 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatic patients 12 to 17 years of age, using nearinfrared imaging. Fluorescence imaging of biliary ducts with the L12 Light Source with AIM 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. Additionally, the L12 Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediative patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using. Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source and SafeLight™ Cable is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The L12 Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
NOTE 2: The video system center has been designed to be used with Olympus cameras heads, endoscopes, light source and monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. The light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
NOTE 3: Upon intravenous administration of SPY AGENT™ GREEN, the PINPOINT Endoscopic Fluorescence Imaging System is used with SPY AGENT GREEN to perform intraoperative fluorescence anglography, 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 ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging of billary ducts with the
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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 bilization. Upon interstitial administration of SPY AGENT GREEN, the PINPOINT System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Performance Data:
| Test | Method | Result |
|---|---|---|
| Electromagnetic | ||
| Compatibility | In accordance with FDA-recognized voluntary consensus standard | |
| IEC 60601-1-2:2014 (19-8) | ||
| In accordance with FDA-recognized voluntary consensus standard | ||
| IEC 60601-4-2:2016 (19-19) | Pass | |
| Pass | ||
| Electrical Safety | In accordance with FDA-recognized voluntary consensus standard | |
| ANSI AAMI ES 60601-1:2005 + A1:2012 + A2: 2021 (19-46) | ||
| In accordance with FDA-recognized voluntary consensus standard | ||
| IEC 60601-1-6:2010 + A1:2013 + A2:2020 (5-132) | ||
| In accordance with FDA-recognized voluntary consensus standard | ||
| IEC 60601-2-18:2009 (9-114) | Pass | |
| Pass | ||
| Pass | ||
| Laser Safety | In accordance with FDA-recognized voluntary consensus standard | |
| IEC 60825-1:2014 (12-273) | ||
| In accordance with FDA-recognized voluntary consensus standard | ||
| IEC 62471 (12-249); and, | ||
| Comparative testing to legally marketed predicate device | Pass | |
| Pass | ||
| Sterilization | In accordance with FDA-recognized voluntary consensus standard | |
| ISO 17664-1:2021 (14-578) | ||
| In accordance with FDA-recognized voluntary consensus standard | ||
| ISO 17664-2:2021 (14-579) | ||
| In accordance with FDA-recognized voluntary consensus standard | ||
| ISO 14937:2009 (14-337) | ||
| In accordance with AAMI TIR12:2020 | ||
| In accordance with AAMI TIR30:2011 | ||
| In accordance with FDA-recognized voluntary consensus standard | ||
| AAMI ST58:2013/ (R)2018 (14-432) | Pass | |
| Pass | ||
| Pass | ||
| Pass | ||
| Pass | ||
| Pass | ||
| Software Verification | ||
| and Validation | In accordance with FDA-recognized voluntary consensus standard | |
| IEC 62304:2015 (13-79) | Pass | |
| Usability | In accordance with FDA-recognized voluntary consensus standard | |
| IEC 62366:2015 + A1:2020 (5-129) | Pass | |
| Performance Testing - | ||
| Bench | In accordance with device input specifications | |
| Comparative testing to currently legally marketed predicate devices: | ||
| Spatial Uniformity | ||
| Minimum Detectable Fluorescence | ||
| Fluorescence Detection Depth | ||
| Clinically Meaningful Limits of Detection | ||
| Signal to Noise | ||
| Photobiological Safety (IEC 62417) | ||
| Contrast | Pass | |
| Pass | ||
| Performance Testing | In accordance with user needs and intended uses | Pass |
NOTE: The Advanced Imaging Modality (AIM) System is not patient contacting; therefore, biocompatibility testing was not required to support the determination of substantial equivalence.
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NOTE: The Advanced Imaging Modality (AIM) System does not require clinical studies to support the determination of substantial equivalence.
Conclusions:
The Advanced Imaging Modality (AIM) System is the same or similar in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. In summary, the Advanced Imaging Modality (AIM) System is the same or similar with respect to safety and effectiveness to the legally marketed predicate devices.