(317 days)
No
The summary describes standard endoscopic imaging technology with visible and near-infrared fluorescence capabilities. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image analysis, processing beyond basic display, or decision support. The description focuses on hardware components and the visualization of ICG fluorescence.
No.
Explanation: The device is an imaging system designed to aid surgeons in visualization during various surgical procedures, not to directly treat a medical condition.
No
The device is an endoscopic imaging system used to visualize internal structures during surgery. While it aids in surgical procedures by providing visualization, it does not diagnose medical conditions itself. It is a tool for surgeons to perform minimally invasive surgery and is indicated for "real time endoscopic visible and near-infrared fluorescence imaging" and visualization of "vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts".
No
The device description explicitly states that the system comprises a non-sterile camera control unit (CCU) console, camera head, and light engine source, which are hardware components.
Based on the provided information, the Arthrex SynergyID Endoscopic Imaging System is not an IVD (In Vitro Diagnostic) device.
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. This information is used for diagnosis, monitoring, or screening.
- Arthrex SynergyID Function: The Arthrex SynergyID Endoscopic Imaging System is an imaging system used during surgical procedures. It visualizes internal structures (vessels, bile ducts) in real-time using visible and near-infrared light, often in conjunction with a contrast agent (ICG) administered intravenously.
- No Specimen Analysis: The device does not analyze specimens taken from the body. It directly images structures within the body during surgery.
Therefore, the intended use and device description clearly indicate that this is a surgical imaging system, not a device for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Arthrex SynergyID Endoscopic Imaging System is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.
The Arthrex SynergyID Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization 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. Fluorescence imaging of biliary ducts with the Arthrex SynergyID Endoscopic Imaging 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 billary duct visualization.
Product codes
GCJ, IZI
Device Description
The Arthrex SynergyID Endoscopic Imaging System comprises a non-sterile camera control unit (CCU) console, camera head, and light engine source. The system integrates ultra-high-definition camera technology, LED lighting, and an image management system into a single console with a tablet interface in an identical manner as the Arthrex UHD4 System cleared under K153218.
The Arthrex SynergyID Endoscopic Imaging System camera control unit interacts with the near-infrared light source to be able to provide near-infrared (NIR) imaging to visualize the presence of Indocyanine Green (ICG).The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the external laser engine and the fluorescence response is then imaged with the camera, processed and displayed on an Arthrex UHD4 System monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic visible light, near-infrared fluorescence imaging
Anatomical Site
vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, and on the right is the FDA logo. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Arthrex Inc. Troy Brooks Principal Regulatory Affairs Specialist 1 Arthrex Way Naples, Florida 34108
July 22, 2021
Re: K202582
Trade/Device Name: Arthrex SynergyID Endoscopic Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, IZI Dated: June 17, 2021 Received: June 21, 2021
Dear Troy Brooks:
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 Aments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Neil R.P. Ogden 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
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Indications for Use
510(k) Number (if known) K202582
Device Name
Arthrex SynergyID Endoscopic Imaging System
Indications for Use (Describe)
The Arthrex SynergyID Endoscopic Imaging System is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.
The Arthrex SynergyID Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization 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. Fluorescence imaging of biliary ducts with the Arthrex SynergyID Endoscopic Imaging 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 billary duct visualization.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared | July 22, 2021 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Troy Brooks, RAC |
| Principal Regulatory Affairs Specialist | |
| 1-972-369-2712 | |
| Troy.Brooks@Arthrex.com | |
| Name of Device | Arthrex SynergyID Endoscopic Imaging System |
| Common Name | Endoscopic Video Camera System |
| Product Code | GCJ, IZI |
| Classification Name | 21 CFR 876.1500: Endoscope and accessories |
| 21 CFR 892.1600: Angiographic x-ray systems | |
| Regulatory Class | II |
| Predicate Device | K150956 – Pinpoint Endoscopic Fluorescence Imaging System (Primary Predicate) |
| K153218 – Arthrex UHD4 System | |
| Purpose of Submission | This 510(k) premarket notification is submitted to add near-infrared fluorescence |
| imaging, visualization of blood vessels, blood flow, related tissue perfusion and at | |
| least one major of the major extra hepatic bile duct indications for use. This 510(k) is | |
| also submitted to incorporate an external laser engine light source to provide the NIR | |
| excitation light for fluorescence visibility. | |
| Device Description | The Arthrex SynergyID Endoscopic Imaging System comprises a non-sterile camera |
| control unit (CCU) console, camera head, and light engine source. The system | |
| integrates ultra-high-definition camera technology, LED lighting, and an image | |
| management system into a single console with a tablet interface in an identical | |
| manner as the Arthrex UHD4 System cleared under K153218. |
The Arthrex SynergyID Endoscopic Imaging System camera control unit interacts with
the near-infrared light source to be able to provide near-infrared (NIR) imaging to
visualize the presence of Indocyanine Green (ICG).The ICG fluoresces when
illuminated through the laparoscope with NIR excitation light from the external laser
engine and the fluorescence response is then imaged with the camera, processed and
displayed on an Arthrex UHD4 System monitor. |
| Indications for Use | The Arthrex SynergyID Endoscopic Imaging System is intended to be used as an
endoscopic video camera in a variety of endoscopic surgical procedures, including but
not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical
procedures. The device is also intended to be used as an accessory for microscopic
surgery.
The Arthrex SynergyID Endoscopic Imaging System is indicated for use to provide real
time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous
administration and use of ICG consistent with its approved label, the system enables
surgeons to perform minimally invasive surgery using standard endoscope visible
light as well as visualization 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. Fluorescence imaging of biliary
ducts with the Arthrex SynergyID Endoscopic Imaging 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 biliary duct visualization. |
| Substantial
Equivalence Summary | The SynergyID System shares the same design features, materials, and intended use
as the predicate, The Arthrex Synergy UHD4 System, cleared under K153218.
Similarly, to the Arthrex Synergy UHD4, The SynergyID Endoscopic Imaging System
integrates ultra-high-definition camera technology, LED lighting, and an image
management system into a single console with a tablet interface. The SynergyID
Endoscopic imaging system also interacts with an optimized camera head,
endoscopes, and a flexible 0°- and 90°-degree light guide cable to support near-
infrared illumination and imagining. The SynergyID Endoscopic Imaging System-
camera control unit (CCU) interacts with the laser light source to provide near-
infrared (NIR) imaging. The principle of operation the SynergyID recognizes the near-
infrared illumination and imaging is equivalent to predicate, Pinpoint Fluorescence
Endoscopic System cleared under K150956. |
| | Accordingly, Arthrex believes that the Arthrex SynergyID Endoscopic Imaging System
is substantially equivalent to the original clearance Arthrex Synergy UHD4 cleared
under K153218 clearance and to the Pinpoint Endoscopic Fluorescence system
cleared under K150956. |
| Conclusion | The proposed Arthrex SynergyID Endoscopic Imaging System is substantially
equivalent to the predicate device in which the basic design feature, intended use,
principle of operation, major technical characteristics, product performance and
functionality are the same as the Arthrex UHD4 System cleared under K153218 and
the Pinpoint Endoscopic Fluorescence System cleared under K150956. |
| | The Arthrex SynergyID principle of operation for visualization under white visible
light, image management and accessory interaction remains identical as it was
originally cleared under K153218. The Arthrex SynergyID incorporates an external
engine light source which provides the NIR (near infrared) excitation light to cause
the fluorescence illumination. The principle of operation of this external light source
is identical to Pinpoint endoscopic fluorescence system video processor illuminator
(VIP) cleared under K150956. |
| | The differences between the proposed Arthrex SynergyID Endoscopic Imaging System
and the predicate devices listed above are primarily technological features that do
not affect the performance, principle of operation or impede the system from
executing its intended use. |
| | Based on the indications for use, technological characteristics, and the summary of
data submitted, Arthrex Inc. has determined that the proposed device is substantially
equivalent to the currently marketed predicate device. |
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