(71 days)
Not Found
No
The summary describes standard endoscopic imaging technology with visible and near-infrared light, image processing for display, and software validation. There is no mention of AI, ML, or any features indicative of learning or adaptive algorithms.
No
The device is described as an endoscopic video camera and imaging system used for diagnosis and surgical procedures, not for direct therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "visible light imaging in a variety of endoscopic diagnostic and surgical procedures." It also mentions "visualization of vessels, blood flow and related tissue perfusion" and "fluorescence imaging of biliary ducts," which are diagnostic activities.
No
The device description explicitly lists hardware components such as a camera control unit (CCU) console, camera heads, a laser light source, and laparoscopes. While it includes software, it is not solely software.
Based on the provided information, the Arthrex SynergyID Endoscopic Imaging System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for endoscopic imaging during surgical and diagnostic procedures. It visualizes anatomical structures in vivo (within the living body) using visible and near-infrared light.
- Device Description: The description details a system for capturing and displaying images from within the body. It involves a camera, light source, and image processing, all focused on visualizing internal anatomy.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens outside of the body, such as blood, tissue samples, or other bodily fluids. IVDs are specifically designed for testing these types of samples in a laboratory setting.
The device is an in vivo imaging system used during surgical and diagnostic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Arthrex SynergyID Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including but not limited to: orthopedic, spine, laparoscopic, urologic, sinuscopic, plastic surgical procedures within the thoracic cavity. 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 nearinfrared 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.
Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex SynergyID Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Product codes
GCJ, IZI
Device Description
The Arthrex Synergy® Endoscopic Imaging System includes a non-sterile camera control unit (CCU) console, camera heads, a laser light source, and laparoscopes. The system integrates ultra-high-definition camera technology, LED lighting, and an image management system into a single console with a tablet interface. The system provides real-time visible and near-infrared light illumination and imaging.
The Arthrex Synergy® Endoscopic Imaging System CCU interacts with the laser 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 a laparoscope with NIR excitation light from the laser light source and the fluorescence response is then imaged with the camera, processed and displayed on a monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Visible light imaging, 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), lymphatic system, including lymphatic vessels and lymph nodes.
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)
Performance Data:
Conformance to the following standards was demonstrated:
Biocompatibility:
ISO 10993-5:2009
ISO 10993-10:2010
Electrical Safety and EMC:
AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012
IEC 60601-1-2:2014
Software Validation and Verification Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. Activities included software validation/verification, regression testing, unit testing, code reviews and checks and integration testing.
Bench Testing:
Verification activities including engineering evaluation and functional analysis were conducted to demonstrate the accessory spine endoscopes are compatible with the Arthrex Synergy/D Endoscopic Imaging System. All verification activities conducted were successful and confirmed the accessory spine endoscopes are compatible with the Arthrex Synergy/D Endoscopic Imaging System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K202582, K182606, K201526, K201134
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.
0
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February 24, 2023
Arthex Inc. Troy Brooks Regulatory Affairs Team Lead 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K223759
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: February 16, 2023 Received: February 17, 2023
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 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,
Colin K. Chen -S
Colin Kejing Chen Acting 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) K223759
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 to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including but not limited to: orthopedic, spine, laparoscopic, urologic, sinuscopic, plastic surgical procedures within the thoracic cavity. 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 nearinfrared 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.
Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex SynergyID Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
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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3
| Date Prepared | January 27, 2023 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Troy Brooks, RAC |
| Regulatory Affairs Team Lead | |
| 1-239-643-5553 | |
| Troy.Brooks@Arthrex.com | |
| Name of Device | Arthrex Synergy® Endoscopic Imaging System |
| Common Name | Endoscopic Video Imaging 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 |
| Primary Predicate | |
| Device | K202582 - Arthrex Synergy® Endoscopic Imaging System, Arthrex Inc. |
| Additional Predicate | |
| Devices | K182606 - PINPOINT Endoscopic Fluorescence Imaging System, Novadaq Technologies |
| K201526 - TIPCAM1 Rubina Video Endoscope System, Karl Storz Endoscopy America | |
| K201134 - Arthrex NanoScope System, Arthrex Inc. | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| expanded indications for use for the existing Arthrex Synergy® Endoscopic Imaging | |
| System cleared under K202582. | |
| Device Description | The Arthrex Synergy® Endoscopic Imaging System includes a non-sterile camera |
| control unit (CCU) console, camera heads, a laser light source, and laparoscopes. | |
| The system integrates ultra-high-definition camera technology, LED lighting, and | |
| an image management system into a single console with a tablet interface. The | |
| system provides real-time visible and near-infrared light illumination and imaging. | |
| The Arthrex Synergy® Endoscopic Imaging System CCU interacts with the laser 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 a laparoscope | |
| with NIR excitation light from the laser light source and the fluorescence response is | |
| then imaged with the camera, processed and displayed on a monitor. | |
| Indications for Use | The Arthrex Synergy® Endoscopic Imaging System is intended to be used as an |
| endoscopic video camera to provide visible light imaging in a variety of endoscopic | |
| diagnostic and surgical procedures, including but not limited to: orthopedic, spine, | |
| laparoscopic, urologic, sinuscopic, plastic surgical procedures, and procedures within | |
| the thoracic cavity. The device is also intended to be used as an accessory for | |
| microscopic surgery. | |
| The Arthrex Synergy® 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 Synergy® 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. | |
| Upon interstitial administration and use of ICG consistent with its approved label, | |
| the Arthrex Synergy® Endoscopic Imaging System is used to perform intraoperative | |
| fluorescence imaging and visualization of the lymphatic system, including lymphatic | |
| vessels and lymph nodes. |
510(k) Summary
4
Technological Comparison
| | Arthrex
SynergyID
Endoscopic
Imaging System | Arthrex
SynergyID
Endoscopic
Imaging System | Novadaq
PINPOINT
Endoscopic
Fluorescence
Imaging System | Karl Storz
TIPCAM1 Rubina
Video Endoscope
System | Arthrex
NanoScope
System | Comparison |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Subject Device | | K182606
Additional
Predicate | K201526
Additional
Predicate | K201134
Additional
Predicate | |
| Classification | Class II | Class II | Class II | Class II | Class II | Equivalent |
| Product Code | GCJ, IZI | GCJ, IZI | GCJ, IZI | GCJ, FGB, HET | GCJ, HRX | Equivalent |
| 21 CFR | 876.1500
Endoscope and
Accessories | 876.1500
Endoscope and
Accessories | 876.1500
Endoscope and
Accessories | 876.1500
Endoscope and
Accessories | 876.1500
Endoscope and
Accessories | Equivalent |
| Combination
Product | No | No | No | No | No | Equivalent |
| Indications
For Use | The Arthrex
SynergyID
Endoscopic
Imaging System
is intended to
be used as an
endoscopic video
camera to
provide visual
imaging in a
variety of
endoscopic
diagnostic and
surgical
procedures,
including but
not limited to:
orthopedic,
spine,
laparoscopic,
urologic,
sinuscopic,
plastic surgical
procedures,
and procedures
within the
thoracic cavity.
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 | 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 | Upon
intravenous
administration
of TRADENAME
(ICG drug
product), the
PINPOINT
Endoscopic
Fluorescence
Imaging System
is used with
TRADENAME to
perform
intraoperative
fluorescence
angiography,
and it is also
indicated for use
in fluorescence
imaging of biliary
ducts, and when
indicated, during
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, | The TIPCAM1
Rubina Video
Endoscope
System is
intended to be
used together
with the camera
control unit
during diagnostic
and/or surgical
procedures
when endoscopic
video assistance
is required. For
use in all
endoscopy and
endoscopic
surgery within
the peritoneal
and thoracic
cavity, including
gynecological
and urological
anatomy. | The Arthrex
NanoScope
System is
intended to be
used as an
endoscopic video
camera in a
variety of
endoscopic
diagnostic and
surgical
procedures,
including but
not limited to:
orthopedic,
spine,
laparoscopic,
urologic,
sinuscopic, and
plastic surgical
procedures. The
device is also
intended to be
used as an
accessory for
microscopic
surgery. | The subject
device includes
the following
additional
indications
for use:
- fluorescence
imaging and
visualization
of the
lymphatic
system,
including
lymphatic
vessels and
lymph nodes - use as an
endoscopic
video camera
(i.e. visual
imaging) in
diagnostic
and surgical
procedures
for spine and
within the
thoracic cavity |
| | 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 Synergy®
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.
Upon interstitial
administration
and use of ICG
consistent with
its approved
label, the Arthrex
SynergyD
Endoscopic
Imaging System
is used to
perform
intraoperative
fluorescence
imaging and
visualization of
the lymphatic
system, including
lymphatic vessels
and lymph
nodes. | 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 Synergy®
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. | extra-hepatic
bile ducts (cystic
duct, common
bile duct or
common hepatic
duct), using
near-infrared
imaging.
Fluorescence
imaging of biliary
ducts with the
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 biliary duct
visualization.
Upon interstitial
administration
of TRADENAME
(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. | | | |
| System
Components | Camera Control
Unit
Light Source
Camera Heads
Scopes | Camera Control
Unit
Light Source
Camera Heads
Scopes | Video Processor
Illuminator (VPI)
Camera Head
Scopes | Camera Control
Unit
Camera/Scope
(integrated) | Console
Camera/Scope
(integrated) | Equivalent to
the primary
predicate
K202582.
Similar to
predicates
K182606
and K201526. |
| Imaging
Modes | White Light
NIR Fluorescence | White Light
NIR Fluorescence | White Light
NIR Fluorescence | White Light | White Light | Equivalent
per white light
indications and
NIR fluorescence
indications. |
| Safety
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-18
IEC 60825-1 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-18
IEC 60825-1 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-18
IEC 60825-1 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-18 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-18 | Equivalent |
| Light
Source | Integrated
(Visible)
External (NIR) | Integrated
(Visible)
External (NIR) | Integrated | Integrated | Integrated | Equivalent
to primary
predicate
K202582. |
| Image Sensor | CMOS | CMOS | CMOS | CMOS | CMOS | Equivalent |
| Image
Resolution | 3840 x 2160 | 3840 x 2160 | 1920 x 1080 | 3840 x 2160 | 400 x 400 | Equivalent to
predicates
K202582 and
K201526. |
| Frame
Rate | 60 FPS | 60 FPS | 60 FPS | 60 FPS | 30 FPS | Equivalent to
predicates
K202582,
K182606 and
K201526. |
| Fluorescence
Imaging
Excitation
Source | NIR laser | NIR laser | NIR laser | N/A | N/A | Equivalent |
| Excitation
Wavelength | 785nm | 785nm | 805nm | N/A | N/A | Equivalent
to primary
predicate
K202582.
Similar to
predicate
K182606. |
| Detection
Bandwidth | 810 to 940 nm | 810 to 940 nm | 825 to 850 nm | N/A | N/A | Equivalent
to primary
predicate
K202582.
Similar to
predicate
K182606.
See Note 1. |
| Excitation
Light Source
Intensity | 95 W/m² | 95 W/m² | Light source
is pulsed
(20 pulses/s,
2 mJ/pulse) | N/A | N/A | Equivalent
to primary |
| Maximum
Light
Intensity | 535 lumens | 535 lumens | Light source
is pulsed
(20 pulses/s,
2 mJ/pulse) | N/A | N/A | predicate
K202582.
Similar to
predicate
K182606. |
| Maximum
Output
Power | 1.37W | 1.37W | Light source is
pulsed
(20 pulses/s,
2 mJ/pulse) | N/A | N/A | See Note 2
and Note 3. |
| Depth of
Observation | 5 – 10mm | 5 – 10mm | Not available | N/A | N/A | Equivalent
to primary |
| Lateral
Resolution | 800 LLLP | 800 LLLP | Not available | N/A | N/A | predicate
K202582.
See Note 3. |
| Contrast
Agent | Indocyanine
Green (ICG) | Indocyanine
Green (ICG) | Indocyanine
Green (ICG) | N/A | N/A | Equivalent |
| NIR Scope
Viewing
Angle | 0°, 30°, 45° | 0°, 30°, 45° | 0°, 30°, 45° | N/A | N/A | Equivalent |
| NIR Scope
Diameter | 5.5mm, 10mm | 5.5mm, 10mm | 5.5mm, 10mm | N/A | N/A | Equivalent |
| NIR Scope
Length | 302 – 333mm | 302 – 333mm | 300 – 420mm | N/A | N/A | Equivalent
to primary
predicate
K202582.
Within range
of predicate
K182606. |
| NIR Scope
Field of View | 75° | 75° | 70° - 75° | N/A | N/A | Equivalent |
| (Visible)
Scope
Viewing
Angle | Endoscopes:
0°, 30°, 45°, 70° | Endoscopes:
0°, 30°, 45°, 70° | N/A | 0°, 30° | 0° | Endoscopes:
See Note 4.
Spine
Endoscopes:
See Note 5. |
| (Visible)
Scope
Diameter | Endoscopes:
1.9mm – 10mm
Spine
Endoscopes:
6.3mm - 10mm | Endoscopes:
1.9mm – 10mm | N/A | 10mm | 1.9mm | Endoscopes:
See Note 4.
Spine
Endoscopes:
See Note 5. |
| (Visible)
Scope Length | Endoscopes:
58mm – 459mm
Spine
Endoscopes:
130 - 181mm | Endoscopes:
58mm – 459mm | N/A | 317 - 320mm | 95mm | Endoscopes:
See Note 4.
Spine
Endoscopes:
See Note 5. |
| (Visible)
Scope Field
of View | Endoscopes:
75°– 105°
Spine
Endoscopes:
80° | Endoscopes:
75°– 105° | N/A | 82° | 120° | Endoscopes:
See Note 4.
Spine
Endoscopes:
See Note 5. |
5
6
7
Note 1: Detection Bandwidth for the subject device: NIR Sensor Spectral Response: 810mm - 940nm - 940nm. Because the subject device has wider detection bandwidth than the predicate K182606, this difference does not impact safety and effectiveness.
Note 2: The subject device has continuous wave laser whereas the predicate K182606 laser is pulsed. This difference does not impact safety and effectiveness as it is a system design only. Additionally, the existing Synergy® Endoscopic Imaging System (K202582) was deemed to be substantially equivalent to the PINPOINT Endoscopic Fluorescence Imaging System (K150956).
Note 3:
Subiect Device:
Excitation light source intensity: ~95W/m^2 at Light Guide Exit
Maximum light intensity: 535 lumens measured at Endoscope tip, 10mm 0 deg scope
Maximum output power: 1.37W
Dept of observation: 5-10mm
Lateral Resolution: NIR Resolution > 800 LPPH (Lines Per Picture Height) measured using an infrared resolution chart
Predicate K182606:
Dept of observation: Information is not available
Lateral Resolution: Information is not available
Note 4: These endoscopes are existing accessories to the Synergy" Endoscopic Imaging System (K202582). The FDA clearance applicable to these scopes is K941541 and K080560. Safety and effectiveness of the scopes for use in diagnostic and surgical procedures has been previously established as cleared by the FDA under K941541 and K080560.
Note 5: The spine endoscopes are accessories to the Synergy® Endoscopic Imaging System. The FDA clearance applicable to the spine endoscopes is K130778. Safety and effectiveness of the spine endoscopic procedures has been previously established as cleared by the FDA under K130778. As demonstrated within the submission, Arthrex has verified compatibility of the spine endoscopes with the Synergy10 Endoscopic Imaging System.
8
| Performance Data | Conformance to the following standards was demonstrated:
Biocompatibility:
ISO 10993-5:2009
ISO 10993-10:2010 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Electrical Safety and EMC:
AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012
IEC 60601-1-2:2014 |
| | Software Validation and Verification Testing:
Software verification and validation testing were conducted and documentation was
provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance
for the Content of Premarket Submissions for Software Contained in Medical
Devices." The software for this device was considered as a "moderate" level of
concern. Activities included software validation/verification, regression testing,
unit testing, code reviews and checks and integration testing. |
| | Bench Testing:
Verification activities including engineering evaluation and functional analysis were
conducted to demonstrate the accessory spine endoscopes are compatible with the
Arthrex Synergy/D Endoscopic Imaging System. All verification activities conducted
were successful and confirmed the accessory spine endoscopes are compatible with
the Arthrex Synergy/D Endoscopic Imaging System. |
| Conclusion | Based on the intended use, technological characteristics, and conducted performance
testing Arthrex has determined that the Synergy/D Endoscopic Imaging System is as
safe and as effective as the predicate devices. Any differences between the proposed
device and predicate devices are considered minor and do not raise different
questions concerning safety and effectiveness. |