(30 days)
No
The document describes image processing for display but does not mention AI, ML, or related terms, nor does it describe any features or performance metrics typically associated with AI/ML applications in medical imaging.
No
This device is an imaging system used during surgical procedures for visualization and does not provide a therapeutic effect.
Yes
The device is used for "visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts" and "fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes," which are diagnostic activities.
No
The device description explicitly lists multiple hardware components including a Camera System, Light Source and SafeLight Cable, Laparoscope, and IRIS Ureteral Kit. While it includes software for image processing, it is not solely software.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The described device is an endoscopic imaging system used during surgical procedures to visualize internal structures in real-time. It uses light (visible and near-infrared) and a camera to capture images directly from within the body.
- Lack of Specimen Analysis: The device does not analyze any biological specimens removed from the body. It is used for direct visualization of tissues and structures in situ.
- Intended Use: The intended use clearly describes its application in various surgical procedures for visualization and guidance, not for diagnostic testing of samples.
Therefore, the 1688 4K Camera System with Advance Imaging Modality and the L11 LED Light Source with Advanced Imaging Modality are surgical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
1688 4K Camera System with Advance Imaging Modality:
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality:
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 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 SafeLightTM Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, OWN, FCS, FCW
Device Description
The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using indocyanine green (ICG) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing near-infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible as well as near-infrared spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY AGENT™ GREEN (indocyanine green for injection, USP) used for fluorescence imaging.
The modified AIM System (subject device) and predicate device are the same, with the exception of the 1688 4K Pendulum Camera Head and the optional Defog feature. The 1688 4K Pendulum Camera Head was cleared under K200310 and works as intended with the L11 LED Light Source that was cleared under K182160, K191046 and K192292. The optional Defog feature reduces the likelihood of fogged images common to irrigated surgical procedures.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Real-time 4K visible white light and near-infrared light
Near-infrared - fluorescence
Near-infrared - transillumination
Anatomical Site
General laparoscopy, ear, sinus, various surgical sites for visualization including biliary ducts, lymphatic system, ureter.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
Minimally invasive and open surgical procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: Laser Output, System Temperature Verification, Image Quality Assessments - Results: Pass (demonstrates the optional Defog feature works as intended under clinically relevant ambient conditions)
Software Verification: IEC 62304:2015 - Results: Pass
NOTE: The AIM (Advanced Imaging Modality) System does not require clinical studies to support the determination of substantial equivalence.
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.
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker Divya Sekar Staff Regulatory Affairs Specialist 5900 Optical Ct. San Jose. California 95138
October 8, 2020
Re: K202592
Trade/Device Name: Advanced Imaging Modality System (1688 4K Camera System with Advanced Imaging Modality, L11 LED Light Source with Advanced Imaging Modality) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, OWN, FCS, FCW Dated: September 4, 2020 Received: September 8, 2020
Dear Divya Sekar:
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/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,
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) K202592
Device Name
Advanced Imaging Modality System (1688 4K Camera System with Advance Imaging Modality; L11 LED Light Source with Advanced Imaging Modality)
Indications for Use (Describe)
1688 4K Camera System with Advance Imaging Modality:
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality:
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 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 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)
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.
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4
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R Part 807.92
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Divya Sekar
Staff Regulatory Affairs Specialist
Phone: (669) 204-4851
Email: divya.sekar@stryker.com |
| Date Prepared: | September 8, 2020 |
Subject Device:
The subject device is the Advanced Imaging Modality System (1688 4K Camera System with Advance Imaging Modality; L11 LED Light Source with Advanced Imaging Modality), and specifically the following system components:
| Name of Device: | 1688 4K Camera System with Advance Imaging Modality |
|---|---|
| Common or Usual | |
| Name | 3-chip Video Camera |
| Classification Name: | Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500) |
| Regulatory Class: | II |
| Product Code: | GCJ |
| 510(k) Review Panel: | General & Plastic Surgery |
| Name of Device: | L11 LED Light Source with Advanced Imaging Modality |
|---|---|
| Common or Usual Name | Light Source, Illuminator |
| Classification Name: | Confocal Optical Imaging1 (21 C.F.R. §876.1500) |
| Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020) | |
| Light Source, Fiberoptic, Routine3 (21 C.F.R. §876.4020) | |
| Regulatory Class: | II |
| Product Code: | OWN1 |
| FCS2 | |
| FCW3 | |
| 510(k) Review Panel: | General & Plastic Surgery1 |
| Gastroenterology/ Urology2,3 |
1When used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging
2When used to transilluminate the ureter during open or laparoscopic surgical procedures
3When used to provide standard endoscopic visible light to support real-time endoscopic visible imaging.
5
Predicate Device(s):
| Primary
Predicate
Device | Advanced Imaging Modality System (1688 4K Camera
System with Advance Imaging Modality; L11 LED
Light Source with Advanced Imaging Modality) | K182160 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Reference
Predicate
Devices | 1688 4K Camera System with Advance Imaging
Modality | K200310 |
| | L11 LED Light Source with Advanced Imaging
Modality | K192292,
K191046 |
NOTE: The predicate devices have not been subject to a design-related recall.
Device Description:
The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using indocyanine green (ICG) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing near-infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible as well as near-infrared spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY AGENT™ GREEN (indocyanine green for injection, USP) used for fluorescence imaging.
The modified AIM System (subject device) and predicate device are the same, with the exception of the 1688 4K Pendulum Camera Head and the optional Defog feature. The 1688 4K Pendulum Camera Head was cleared under K200310 and works as intended with the L11 LED Light Source that was cleared under K182160, K191046 and K192292. The optional Defog feature reduces the likelihood of fogged images common to irrigated surgical procedures.
Indications for Use:
1688 4K Camera System with Advanced Imaging Modality:
The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ arthroscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion. Anterior cruciate ligament reconstruction. Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy. Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688
6
Video Camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality:
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.
NOTE: The 1688 4K Camera System with Advance Imaging Modality indications for use is identical to the predicate device cleared under K182160.
The L11 LED Light Source with Advanced Imaging Modality indications for use is similar to the predicate device cleared under K182160. The differences in the L11 LED Light Source with Advanced Imaging Modality indications for use were cleared under K191046 and K192292 (when used with 1688 4K Camera System cleared via K182160).
| Item | Subject Device
AIM (Advanced Imaging Modality) System | Predicate Device
AIM (Advanced Imaging Modality) System |
|----------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Manufacturer | Stryker | Same as subject device |
| Submission Reference | Current Submission | K182160 |
| Intended Use | Endoscopic visible and near-infrared light
illumination and imaging during surgical
endoscopic procedures | Same as subject device |
| Imaging Modes | White Light (Manual & Autolight1)
Near-infrared - fluorescence
Near-infrared - transillumination | White Light (Manual & Autolight)
Near-infrared - fluorescence
Near-infrared - transillumination |
Comparison of Technological Characteristics with the Predicate Device:
7
| Item | Subject Device
AIM (Advanced Imaging Modality) System | Predicate Device
AIM (Advanced Imaging Modality) System | |
|------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Safety Standards | IEC 60601-1
IEC 60601-2-18
IEC 60601-1-2
IEC 60825-1 | Same as subject device | |
| Camera
System | System Components | Camera Control Unit
Camera Head(s): Standard &
Integrated
Coupler | |
| | Camera Control Unit
Camera Head(s): Standard,
Integrated, and Pendulum2
Coupler | | |
| | Principles of Operation | Via an optical scope and coupler, light is
projected onto one or more complementary
metal oxide semiconductor image sensors
which acquire a continuous stream of image
data. The image data is processed to provide
a video stream that is then sent to a display
for viewing. | Same as subject device |
| | Image Sensor | CMOS image sensor | Same as subject device |
| | Image Processing/
Video Output | Digital | Same as subject device |
| | Resolution | 4K (up to 3840 x 2160) | Same as subject device |
| | Frame Rate | 60 frames per second | Same as subject device |
| Light
Source | Principles of Operation | An electronic driver controls Red/Green/Blue
LEDs & 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 |
| | Light Source/Laser | RGB LEDs
Infrared Laser | Same as subject device |
l The optional Defog feature is available in Autolight imaging mode for the subject device. It reduces the likelihood of fogged images common to irrigated surgical procedures.
2 The 1688 4K Pendulum Camera Head was cleared under K200310.
Performance Data:
The following performance data, including image quality assessments, were provided to demonstrate the optional Defog feature works as intended under clinically relevant ambient conditions (i.e. temperature and relative humidity) to support the substantial equivalence determination:
| Test | Method | Results |
|---|---|---|
| Performance Testing | Laser Output | |
| System Temperature Verification | ||
| Image Quality Assessments | Pass | |
| Software Verification | IEC 62304:2015 | Pass |
NOTE: The AIM (Advanced Imaging Modality) System does not require clinical studies to support the determination of substantial equivalence.
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Conclusions:
The comparison of the indications for use, technological characteristics and performance data demonstrates the subject device is substantially equivalent to the predicate device.