(71 days)
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.
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.
The provided text is a 510(k) summary for the Arthrex SynergyID Endoscopic Imaging System. It outlines the device's indications for use, technological characteristics, and comparison to predicate devices, along with performance data related to standards conformance. However, it does not contain information about studies involving acceptance criteria based on metrics like Accuracy, Sensitivity, Specificity, AUC, or studies involving human readers or ground truth established by experts/pathology for the purpose of proving device performance relative to clinical metrics.
The "Performance Data" section primarily addresses conformance to safety and electrical standards, and software validation. It states that "functional analysis were conducted to demonstrate the accessory spine endoscopes are compatible with the Arthrex Synergy/D Endoscopic Imaging System." but does not provide an acceptance criterion or specific performance metrics from such a functional analysis beyond stating that all verification activities were successful.
Therefore, for this specific document, I cannot provide the detailed information requested in your prompt regarding:
- A table of acceptance criteria and reported device performance (in terms of clinical metrics).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance metrics.
- Type of ground truth used (beyond system compatibility/functional verification).
- Sample size for the training set.
- How the ground truth for the training set was established.
This document focuses on demonstrating substantial equivalence to predicate devices primarily through technological comparison and adherence to standards for safety and software, rather than reporting on clinical performance studies with specific statistical acceptance criteria for diagnostic accuracy or efficacy.
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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
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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
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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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| Date Prepared | January 27, 2023 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Troy Brooks, RACRegulatory Affairs Team Lead1-239-643-5553Troy.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 accessories21 CFR 892.1600: Angiographic x-ray systems |
| Regulatory Class | II |
| Primary PredicateDevice | K202582 - Arthrex Synergy® Endoscopic Imaging System, Arthrex Inc. |
| Additional PredicateDevices | K182606 - PINPOINT Endoscopic Fluorescence Imaging System, Novadaq TechnologiesK201526 - TIPCAM1 Rubina Video Endoscope System, Karl Storz Endoscopy AmericaK201134 - Arthrex NanoScope System, Arthrex Inc. |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance forexpanded indications for use for the existing Arthrex Synergy® Endoscopic ImagingSystem cleared under K202582. |
| Device Description | The Arthrex Synergy® Endoscopic Imaging System includes a non-sterile cameracontrol unit (CCU) console, camera heads, a laser light source, and laparoscopes.The system integrates ultra-high-definition camera technology, LED lighting, andan image management system into a single console with a tablet interface. Thesystem provides real-time visible and near-infrared light illumination and imaging. |
| The Arthrex Synergy® Endoscopic Imaging System CCU interacts with the laser lightsource to be able to provide near-infrared (NIR) imaging to visualize the presence ofIndocyanine Green (ICG). The ICG fluoresces when illuminated through a laparoscopewith NIR excitation light from the laser light source and the fluorescence response isthen 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 anendoscopic video camera to provide visible light imaging in a variety of endoscopicdiagnostic and surgical procedures, including but not limited to: orthopedic, spine,laparoscopic, urologic, sinuscopic, plastic surgical procedures, and procedures withinthe thoracic cavity. The device is also intended to be used as an accessory formicroscopic surgery. |
| The Arthrex Synergy® Endoscopic Imaging System is indicated for use to provide realtime endoscopic visible and near-infrared fluorescence imaging. Upon intravenousadministration and use of ICG consistent with its approved label, the system enablessurgeons to perform minimally invasive surgery using standard endoscope visiblelight as well as visualization of vessels, blood flow and related tissue perfusion, andat least one of the major extra-hepatic bile ducts (cystic duct, common bile duct orcommon hepatic duct), using near-infrared imaging. Fluorescence imaging of biliaryducts with the Arthrex Synergy® Endoscopic Imaging System is intended for use withstandard 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 intraoperativefluorescence imaging and visualization of the lymphatic system, including lymphaticvessels and lymph nodes. |
510(k) Summary
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Technological Comparison
| ArthrexSynergyIDEndoscopicImaging System | ArthrexSynergyIDEndoscopicImaging System | NovadaqPINPOINTEndoscopicFluorescenceImaging System | Karl StorzTIPCAM1 RubinaVideo EndoscopeSystem | ArthrexNanoScopeSystem | Comparison | |
|---|---|---|---|---|---|---|
| Device | Subject Device | K182606AdditionalPredicate | K201526AdditionalPredicate | K201134AdditionalPredicate | ||
| 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 | 876.1500Endoscope andAccessories | 876.1500Endoscope andAccessories | 876.1500Endoscope andAccessories | 876.1500Endoscope andAccessories | 876.1500Endoscope andAccessories | Equivalent |
| CombinationProduct | No | No | No | No | No | Equivalent |
| IndicationsFor Use | The ArthrexSynergyIDEndoscopicImaging Systemis intended tobe used as anendoscopic videocamera toprovide visualimaging in avariety ofendoscopicdiagnostic andsurgicalprocedures,including butnot limited to:orthopedic,spine,laparoscopic,urologic,sinuscopic,plastic surgicalprocedures,and procedureswithin thethoracic cavity.The device is alsointended to beused as anaccessory formicroscopicsurgery.The ArthrexSynergyIDEndoscopicImaging Systemis indicated foruse to providereal timeendoscopicvisible andnear-infraredfluorescenceimaging. Uponintravenousadministrationand use of ICGconsistent withits approved | The ArthrexSynergyIDEndoscopicImaging Systemis intended tobe used as anendoscopic videocamera in avariety ofendoscopicsurgicalprocedures,including butnot limited to:orthopedic,laparoscopic,urologic,sinuscopic, andplastic surgicalprocedures. Thedevice is alsointended to beused as anaccessory formicroscopicsurgery.The ArthrexSynergyIDEndoscopicImaging Systemis indicated foruse to providereal timeendoscopicvisible andnear-infraredfluorescenceimaging. Uponintravenousadministrationand use of ICGconsistent withits approvedlabel, the systemenables surgeonsto performminimallyinvasive surgeryusing standardendoscope | Uponintravenousadministrationof TRADENAME(ICG drugproduct), thePINPOINTEndoscopicFluorescenceImaging Systemis used withTRADENAME toperformintraoperativefluorescenceangiography,and it is alsoindicated for usein fluorescenceimaging of biliaryducts, and whenindicated, duringintraoperativecholangiography.The PINPOINTEndoscopicFluorescenceImaging Systemis indicated foruse to providereal timeendoscopicvisible and near-infraredfluorescenceimaging. ThePINPOINTSystem enablessurgeons toperformminimallyinvasive surgeryusing standardendoscopevisible light aswell as visualassessment ofvessels, bloodflow and relatedtissue perfusion, | The TIPCAM1Rubina VideoEndoscopeSystem isintended to beused togetherwith the cameracontrol unitduring diagnosticand/or surgicalprocedureswhen endoscopicvideo assistanceis required. Foruse in allendoscopy andendoscopicsurgery withinthe peritonealand thoraciccavity, includinggynecologicaland urologicalanatomy. | The ArthrexNanoScopeSystem isintended to beused as anendoscopic videocamera in avariety ofendoscopicdiagnostic andsurgicalprocedures,including butnot limited to:orthopedic,spine,laparoscopic,urologic,sinuscopic, andplastic surgicalprocedures. Thedevice is alsointended to beused as anaccessory formicroscopicsurgery. | The subjectdevice includesthe followingadditionalindicationsfor use:- fluorescenceimaging andvisualizationof thelymphaticsystem,includinglymphaticvessels andlymph nodes- use as anendoscopicvideo camera(i.e. visualimaging) indiagnosticand surgicalproceduresfor spine andwithin thethoracic cavity |
| to performminimallyinvasive surgeryusing standardendoscopevisible light aswell asvisualization ofvessels, bloodflow and relatedtissue perfusion,and at least oneof the majorextra-hepaticbile ducts (cysticduct, commonbile duct orcommon hepaticduct), usingnear-infraredimaging.Fluorescenceimaging of biliaryducts with theArthrex Synergy®EndoscopicImaging Systemis intended foruse withstandard of carewhite light, andwhen indicated,intraoperativecholangiography.The device is notintended forstandalone usefor biliary ductvisualization.Upon interstitialadministrationand use of ICGconsistent withits approvedlabel, the ArthrexSynergyDEndoscopicImaging Systemis used toperformintraoperativefluorescenceimaging andvisualization ofthe lymphaticsystem, includinglymphatic vesselsand lymphnodes. | visualization ofvessels, bloodflow and relatedtissue perfusion,and at least oneof the majorextra-hepaticbile ducts (cysticduct, commonbile duct orcommon hepaticduct), usingnear-infraredimaging.Fluorescenceimaging of biliaryducts with theArthrex Synergy®EndoscopicImaging Systemis intended foruse withstandard of carewhite light, andwhen indicated,intraoperativecholangiography.The device is notintended forstandalone usefor biliary ductvisualization. | extra-hepaticbile ducts (cysticduct, commonbile duct orcommon hepaticduct), usingnear-infraredimaging.Fluorescenceimaging of biliaryducts with thePINPOINTSystem isintended for usewith standard ofcare white light,and whenindicated,intraoperativecholangiography.The device is notintended forstandalone usefor biliary ductvisualization.Upon interstitialadministrationof TRADENAME(ICG drugproduct), thePINPOINTSystem is usedto performintraoperativefluorescenceimaging andvisualization ofthe lymphaticsystem, includinglymphatic vesselsand lymphnodes. | ||||
| SystemComponents | Camera ControlUnitLight SourceCamera HeadsScopes | Camera ControlUnitLight SourceCamera HeadsScopes | Video ProcessorIlluminator (VPI)Camera HeadScopes | Camera ControlUnitCamera/Scope(integrated) | ConsoleCamera/Scope(integrated) | Equivalent tothe primarypredicateK202582.Similar topredicatesK182606and K201526. |
| ImagingModes | White LightNIR Fluorescence | White LightNIR Fluorescence | White LightNIR Fluorescence | White Light | White Light | Equivalentper white lightindications andNIR fluorescenceindications. |
| SafetyStandards | IEC 60601-1IEC 60601-1-2IEC 60601-2-18IEC 60825-1 | IEC 60601-1IEC 60601-1-2IEC 60601-2-18IEC 60825-1 | IEC 60601-1IEC 60601-1-2IEC 60601-2-18IEC 60825-1 | IEC 60601-1IEC 60601-1-2IEC 60601-2-18 | IEC 60601-1IEC 60601-1-2IEC 60601-2-18 | Equivalent |
| LightSource | Integrated(Visible)External (NIR) | Integrated(Visible)External (NIR) | Integrated | Integrated | Integrated | Equivalentto primarypredicateK202582. |
| Image Sensor | CMOS | CMOS | CMOS | CMOS | CMOS | Equivalent |
| ImageResolution | 3840 x 2160 | 3840 x 2160 | 1920 x 1080 | 3840 x 2160 | 400 x 400 | Equivalent topredicatesK202582 andK201526. |
| FrameRate | 60 FPS | 60 FPS | 60 FPS | 60 FPS | 30 FPS | Equivalent topredicatesK202582,K182606 andK201526. |
| FluorescenceImagingExcitationSource | NIR laser | NIR laser | NIR laser | N/A | N/A | Equivalent |
| ExcitationWavelength | 785nm | 785nm | 805nm | N/A | N/A | Equivalentto primarypredicateK202582.Similar topredicateK182606. |
| DetectionBandwidth | 810 to 940 nm | 810 to 940 nm | 825 to 850 nm | N/A | N/A | Equivalentto primarypredicateK202582.Similar topredicateK182606.See Note 1. |
| ExcitationLight SourceIntensity | 95 W/m² | 95 W/m² | Light sourceis pulsed(20 pulses/s,2 mJ/pulse) | N/A | N/A | Equivalentto primary |
| MaximumLightIntensity | 535 lumens | 535 lumens | Light sourceis pulsed(20 pulses/s,2 mJ/pulse) | N/A | N/A | predicateK202582.Similar topredicateK182606. |
| MaximumOutputPower | 1.37W | 1.37W | Light source ispulsed(20 pulses/s,2 mJ/pulse) | N/A | N/A | See Note 2and Note 3. |
| Depth ofObservation | 5 – 10mm | 5 – 10mm | Not available | N/A | N/A | Equivalentto primary |
| LateralResolution | 800 LLLP | 800 LLLP | Not available | N/A | N/A | predicateK202582.See Note 3. |
| ContrastAgent | IndocyanineGreen (ICG) | IndocyanineGreen (ICG) | IndocyanineGreen (ICG) | N/A | N/A | Equivalent |
| NIR ScopeViewingAngle | 0°, 30°, 45° | 0°, 30°, 45° | 0°, 30°, 45° | N/A | N/A | Equivalent |
| NIR ScopeDiameter | 5.5mm, 10mm | 5.5mm, 10mm | 5.5mm, 10mm | N/A | N/A | Equivalent |
| NIR ScopeLength | 302 – 333mm | 302 – 333mm | 300 – 420mm | N/A | N/A | Equivalentto primarypredicateK202582.Within rangeof predicateK182606. |
| NIR ScopeField of View | 75° | 75° | 70° - 75° | N/A | N/A | Equivalent |
| (Visible)ScopeViewingAngle | Endoscopes:0°, 30°, 45°, 70° | Endoscopes:0°, 30°, 45°, 70° | N/A | 0°, 30° | 0° | Endoscopes:See Note 4.SpineEndoscopes:See Note 5. |
| (Visible)ScopeDiameter | Endoscopes:1.9mm – 10mmSpineEndoscopes:6.3mm - 10mm | Endoscopes:1.9mm – 10mm | N/A | 10mm | 1.9mm | Endoscopes:See Note 4.SpineEndoscopes:See Note 5. |
| (Visible)Scope Length | Endoscopes:58mm – 459mmSpineEndoscopes:130 - 181mm | Endoscopes:58mm – 459mm | N/A | 317 - 320mm | 95mm | Endoscopes:See Note 4.SpineEndoscopes:See Note 5. |
| (Visible)Scope Fieldof View | Endoscopes:75°– 105°SpineEndoscopes:80° | Endoscopes:75°– 105° | N/A | 82° | 120° | Endoscopes:See Note 4.SpineEndoscopes:See Note 5. |
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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.
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| Performance Data | Conformance to the following standards was demonstrated:Biocompatibility:ISO 10993-5:2009ISO 10993-10:2010 |
|---|---|
| Electrical Safety and EMC:AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012IEC 60601-1-2:2014 | |
| Software Validation and Verification Testing:Software verification and validation testing were conducted and documentation wasprovided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidancefor the Content of Premarket Submissions for Software Contained in MedicalDevices." The software for this device was considered as a "moderate" level ofconcern. 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 wereconducted to demonstrate the accessory spine endoscopes are compatible with theArthrex Synergy/D Endoscopic Imaging System. All verification activities conductedwere successful and confirmed the accessory spine endoscopes are compatible withthe Arthrex Synergy/D Endoscopic Imaging System. | |
| Conclusion | Based on the intended use, technological characteristics, and conducted performancetesting Arthrex has determined that the Synergy/D Endoscopic Imaging System is assafe and as effective as the predicate devices. Any differences between the proposeddevice and predicate devices are considered minor and do not raise differentquestions concerning safety and effectiveness. |
§ 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.