(87 days)
Upon intravenous administration of SPY AGENT™ GREEN (indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.
The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.
Upon interstitial administration of SPY AGENT™ GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The SPY-PHI System is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissuetransfer circulation for use in imaging during various surgical procedures.
The SPY-PHI System provides real-time, white-light and fluorescence imaging during surgical procedures. The system consists of a SPY-PHI imager/imaging head with an integrated light quide cable and a Video Processor/Illuminator (VPI).
Fluorescence imaging with the SPY-PHI System is achieved with the use of a fluorescence imaging agent, namely SPY AGENT™ GREEN (indocyanine green for injection, USP), which is supplied in single-use convenience kits for use in conjunction with the SPY-PHI System during surgical procedures.
During surgical procedures, SPY AGENT™ GREEN is administered to the patient. The SPY-PHI imaging head/imager provides illumination of the regions of a patient's body to be observed with near infrared (NIR) laser light to excite ICG fluorescence. Alternatively, the SPY-PHI imager provides white light illumination of the regions of a patient's body to be observed for color imaging.
The camera in the Imaging Head captures the fluorescent image under laser illumination or a color image under white light illumination. The VPI receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the SPY-PHI System are possible through switches at either the Imaging Head or the VPI. The SPY-PHI System is intended for use by trained healthcare professionals in the operating room.
This Traditional 510(k) premarket notification proposes a modification to the currently 510(k) cleared SPY-PHI System with the addition of a new software feature. The new software feature, referred to as the SPY-PHI Fluorescence Assessment Software, will offer real-time relative fluorescence quantification (i.e. relative fluorescence values) and visualization tools (i.e. color maps) on the SPY-PHI device. Addition of this new software feature has no impact on the current intended use of the SPY-PHI System. The SPY-PHI Fluorescence Assessment Software is a firmware module installed on the VPI component of the SPY-PHI System for use during open field surgery where fluorescence imaging is used.
The SPY-PHI Fluorescence Assessment Software enables quantification of fluorescence which may be used as an additional intraoperative tool to assist trained healthcare practitioners in the assessment of fluorescence response in tissue during various surgical procedures. The healthcare practitioner retains the ultimate responsibility for making the pertinent diagnosis based on their clinical judgment and standard practices.
The provided text describes performance testing for the SPY-PHI System with SPY-PHI Fluorescence Assessment Software, but it does not contain specific acceptance criteria, reported device performance metrics in a table, details of a study proving the device meets acceptance criteria, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC study information, standalone performance, or training set details.
Therefore, most of the requested information cannot be extracted from the given document.
Here's a summary of what is available regarding performance testing:
Description of Performance Testing:
The SPY-PHI System conducted performance testing through a design validation study for its new Fluorescence Assessment Software feature.
-
A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document states a design validation study was performed to assess suitability to meet user needs, but it does not detail specific acceptance criteria or quantitative performance results.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided in the document.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not provided in the document.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided in the document.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not provided in the document.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the software as an "additional intraoperative tool to assist trained healthcare practitioners," implying human-in-the-loop. It does not explicitly mention a standalone algorithm-only performance assessment.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided in the document. The study assessed "suitability of the design requirements... to meet user needs," which suggests a qualitative assessment of the software's functionality and utility rather than a direct comparison against a clinical ground truth.
-
The sample size for the training set: This information is not provided in the document.
-
How the ground truth for the training set was established: This information is not provided in the document.
The document primarily focuses on regulatory compliance and substantial equivalence to predicate devices, stating that the device was designed and developed in accordance with applicable requirements and standards, and that its safety and performance were verified through testing, including by accredited third-party laboratories. It also mentions software assessment for conformance with IEC 62304:2015.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Novadaq Technologies ULC (now a part of Stryker) Agatha Szeliga Regulatory Affairs Manager 8329 Eastlake Drive, Unit 101 Burnaby, British Columbia V5A 4W2 Canada
November 5, 2020
Re: K202244
Trade/Device Name: SPY-PHI System with SPY-PHI Fluorescence Assessment Software Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: IZI Dated: August 7, 2020 Received: August 10, 2020
Dear Agatha Szeliga:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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, Cancer Diagnosis & Treatment Team 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)
K202244
Device Name
SPY Portable Handheld Imaging (SPY-PHI) System with SPY-PHI Fluorescence Assessment Software
Indications for Use (Describe)
Upon intravenous administration of SPY AGENT™ GREEN (indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.
The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.
Upon interstitial administration of SPY AGENT™ GREEN, the SPY-PHI 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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Section 5 - 510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.
| Subject Device Trade Name: | SPY-PHI System with SPY-PHI Fluorescence AssessmentSoftware |
|---|---|
| Device Model Number: | HH9000 |
| Common Name: | Fluorescence Angiographic System |
| Regulation: | 21 CFR § 892.1600 |
| Classification Name: | Angiographic X-ray System |
| FDA 510(k) Review Panel: | General and Plastic Surgery |
| Product Code: | IZI |
| Classification: | Class II |
| Manufacturer: | Novadaq Technologies ULC. (now a part of Stryker)8329 Eastlake Drive, Unit 101Burnaby, British ColumbiaCanada, V5A 4W2 |
| Contact Name: | Agatha SzeligaRegulatory Affairs ManagerTel: 604-422-7516Fax: 604-232-9841 |
Date 510(k) Summary Prepared: August 5, 2020
Predicate Device(s) Information:
| Predicate Device Trade Name | SPY Portable HandheldImaging (SPY-PHI) System(primary predicate) | SPY Elite IntraoperativePerfusion Assessment System(secondary predicate tosupport technologicaldifferences/ software feature) |
|---|---|---|
| 510(k) Number | K200737 | K182907 |
| Submitter/510(k) Holder Name | Novadaq Technologies ULC.(now a part of Stryker) | Novadaq Technologies ULC.(now a part of Stryker) |
| Classification Name | Confocal Optical Imaging | Angiographic X-raySystem |
| Product Code and Regulation | OWN; 21 CFR § 876.1500 | IZI; 21 CFR § 892.1600 |
| Classification | Class II | Class II |
| Note: The predicate devices have not been subject to a design-related recall. |
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Device Description:
The SPY-PHI System is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissuetransfer circulation for use in imaging during various surgical procedures.
The SPY-PHI System provides real-time, white-light and fluorescence imaging during surgical procedures. The system consists of a SPY-PHI imager/imaging head with an integrated light quide cable and a Video Processor/Illuminator (VPI).
Fluorescence imaging with the SPY-PHI System is achieved with the use of a fluorescence imaging agent, namely SPY AGENT™ GREEN (indocyanine green for injection, USP), which is supplied in single-use convenience kits for use in conjunction with the SPY-PHI System during surgical procedures.
During surgical procedures, SPY AGENT™ GREEN is administered to the patient. The SPY-PHI imaging head/imager provides illumination of the regions of a patient's body to be observed with near infrared (NIR) laser light to excite ICG fluorescence. Alternatively, the SPY-PHI imager provides white light illumination of the regions of a patient's body to be observed for color imaging.
The camera in the Imaging Head captures the fluorescent image under laser illumination or a color image under white light illumination. The VPI receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the SPY-PHI System are possible through switches at either the Imaging Head or the VPI. The SPY-PHI System is intended for use by trained healthcare professionals in the operating room.
This Traditional 510(k) premarket notification proposes a modification to the currently 510(k) cleared SPY-PHI System with the addition of a new software feature. The new software feature, referred to as the SPY-PHI Fluorescence Assessment Software, will offer real-time relative fluorescence quantification (i.e. relative fluorescence values) and visualization tools (i.e. color maps) on the SPY-PHI device. Addition of this new software feature has no impact on the current intended use of the SPY-PHI System. The SPY-PHI Fluorescence Assessment Software is a firmware module installed on the VPI component of the SPY-PHI System for use during open field surgery where fluorescence imaging is used.
The SPY-PHI Fluorescence Assessment Software enables quantification of fluorescence which may be used as an additional intraoperative tool to assist trained healthcare practitioners in the assessment of fluorescence response in tissue during various surgical procedures. The healthcare practitioner retains the ultimate responsibility for making the pertinent diagnosis based on their clinical judgment and standard practices.
Indications for Use of the SPY-PHI System:
Upon intravenous administration of SPY AGENT™ GREEN (indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.
The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.
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Upon interstitial administration of SPY AGENT™ GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
| Comparison of Device Characteristics of the Subject Device and the Predicate Devices: | ||||
|---|---|---|---|---|
| SUBJECT DEVICE | PREDICATE DEVICE(primary predicate) | PREDICATE DEVICE(secondary predicate tosupport technologicaldifferences/ new softwarefeature) | ||
|---|---|---|---|---|
| Name | SPY Portable HandheldImaging (SPY-PHI) Systemwith SPY-PHIFluorescence AssessmentSoftware | SPY Portable HandheldImaging (SPY-PHI) System | SPY Elite IntraoperativePerfusion AssessmentSystem | |
| Company/ 510(k) Holder | Novadaq TechnologiesULC. (now a part ofStryker) | Novadaq TechnologiesULC. (now a part ofStryker) | Novadaq TechnologiesULC. (now a part ofStryker) | |
| Model | HH9000 | HH9000 | LC3000 | |
| 510(k) Reference | TBD (current submission) | K200737 | K182907 | |
| Product Code | IZI | OWN | IZI | |
| Regulation Number | 21 CFR 892.1600 | 21 CFR 876.1500 | 21 CFR 892.1600 | |
| Classification | Class II | Class II | Class II | |
| Combination Product | Yes | Yes | Yes | |
| Device ClassificationName | Angiographic X-ray System | Confocal Optical Imaging | Angiographic X-ray System | |
| Intended Use | Near infrared fluorescenceimaging for visualization ofblood flow and tissueperfusion before, during andafter surgical procedures,and intraoperativefluorescence imaging andvisualization of the lymphaticsystem, including lymphaticvessels and lymph nodes. | Near infrared fluorescenceimaging for visualization ofblood flow and tissueperfusion before, during andafter surgical procedures,and intraoperativefluorescence imaging andvisualization of the lymphaticsystem, including lymphaticvessels and lymph nodes. | Near infrared fluorescenceimaging for visualization ofblood flow and tissueperfusion before, duringand after surgicalprocedures. | |
| Indications for Use | Upon intravenousadministration of SPYAGENTTM GREEN(indocyanine green forinjection, USP) the SPY-PHISystem is used with SPYAGENTTM GREEN toperform intraoperativefluorescenceangiography. The SPY-PHI | Upon intravenousadministration of SPYAGENTTM GREEN(indocyanine green forinjection, USP) the SPY-PHISystem is used with SPYAGENTTM GREEN toperform intraoperativefluorescenceangiography. The SPY-PHI | Upon intravenousadministration of SPYAGENTTM GREEN(indocyanine green forinjection, USP) the SPYElite System is used withSPY AGENTTM GREEN toperform intraoperativefluorescenceangiography. The SPY | |
| SUBJECT DEVICE | PREDICATE DEVICE(primary predicate) | PREDICATE DEVICE(secondary predicate tosupport technologicaldifferences/ new softwarefeature) | ||
| Name | SPY Portable HandheldImaging (SPY-PHI) Systemwith SPY-PHIFluorescence AssessmentSoftware | SPY Portable HandheldImaging (SPY-PHI) System | SPY Elite IntraoperativePerfusion AssessmentSystem | |
| Company/ 510(k) Holder | Novadaq TechnologiesULC. (now a part ofStryker) | Novadaq TechnologiesULC. (now a part ofStryker) | Novadaq TechnologiesULC. (now a part ofStryker) | |
| System used is indicated foruse in adult and pediatricpatients one month of ageand older.The SPY-PHI System isindicated for fluorescenceimaging of blood flow andtissue perfusion before,during, and after: vascular,gastrointestinal, organtransplant, and plastic,micro- and reconstructivesurgical procedures.Upon interstitialadministration of SPYAGENT™ GREEN, theSPY-PHI System is used toperform intraoperativefluorescence imaging andvisualization of the lymphaticsystem, including lymphaticvessels and lymph nodes. | System is indicated for usein adult and pediatricpatients one month of ageand older.The SPY-PHI System isindicated for fluorescenceimaging of blood flow andtissue perfusion before,during, and after: vascular,gastrointestinal, organtransplant, and plastic,micro- and reconstructivesurgical procedures.Upon interstitialadministration of SPYAGENT™ GREEN, theSPY-PHI System is used toperform intraoperativefluorescence imaging andvisualization of the lymphaticsystem, including lymphaticvessels and lymph nodes. | Elite System used with SPYAGENT GREEN isindicated for use in adultand pediatric patients onemonth of age and older.The SPY Elite System isindicated for fluorescenceimaging of blood flow andtissue perfusion before,during, and after: vascular,gastrointestinal, organtransplant, and plastic,micro- and reconstructivesurgical procedures. | ||
| Patient Population | Adult patients and pediatricpatients (1 month of age andolder) | Adult patients and pediatricpatients (1 month of age andolder) | Adult patients and pediatricpatients (1 month of ageand older) | |
| Major DeviceComponents | VPI (VideoProcessor/Illuminator) withupgraded firmware for theSPY-PHI FluorescenceAssessment SoftwareSPY-PHI imager (withintegrated light guide cable) | VPI (Video Processor/Illuminator)SPY-PHI imager (withintegrated light guide cable) | Imaging console with adetector and signalprocessing software | |
| Operating Principle | Full color visible light andNIR fluorescence videoimaging. The imaging head | Full color visible light andNIR fluorescence videoimaging. The imaging head | NIR light from theillumination module in theimaging console is | |
| SUBJECT DEVICE | PREDICATE DEVICE(primary predicate) | PREDICATE DEVICE(secondary predicate tosupport technologicaldifferences/ new softwarefeature) | ||
| Name | SPY Portable HandheldImaging (SPY-PHI) Systemwith SPY-PHIFluorescence AssessmentSoftware | SPY Portable HandheldImaging (SPY-PHI) System | SPY Elite IntraoperativePerfusion AssessmentSystem | |
| Company/ 510(k) Holder | Novadaq TechnologiesULC. (now a part ofStryker) | Novadaq TechnologiesULC. (now a part ofStryker) | Novadaq TechnologiesULC. (now a part ofStryker) | |
| is positioned over the patientsuch that the NIR excitationlight is emitted andilluminates the area ofinterest. When the patient isinjected with ICG, the ICGbinds to the plasma in theblood and travels to the areaof interest through thebloodstream. The camera inthe Imaging Head capturesthe fluorescent image underlaser illumination or a colorimage under white lightillumination. The VPIreceives the video signalfrom the Imaging Head andprocesses and outputs thevideo image to a medicalgrade video monitor and/orvideo recorder. | is positioned over the patientsuch that the NIR excitationlight is emitted andilluminates the area ofinterest. When the patient isinjected with ICG, the ICGbinds to the plasma in theblood and travels to the areaof interest through thebloodstream. The camera inthe Imaging Head capturesthe fluorescent image underlaser illumination or a colorimage under white lightillumination. The VPIreceives the video signalfrom the Imaging Head andprocesses and outputs thevideo image to a medicalgrade video monitor and/orvideo recorder. | transmitted to the imaginghead via fiber-optic cable.The imaging head ispositioned over the patientsuch that the NIR excitationlight is emitted andilluminates the area ofinterest. When the patientis injected with ICG, theICG binds to the plasma inthe blood and travels to thearea of interest through thebloodstream. The NIRexcitation light emitted bythe SPY Elite imagingdevice causes the ICG tofluoresce. The fluorescenceimage signal is processedand simultaneouslyrecorded in computermemory and displayed onthe video monitors. | ||
| Safety Standards | IEC 60601-1IEC 60601-1-2IEC 60825-1 | IEC 60601-1IEC 60601-1-2IEC 60825-1 | IEC 60601-1IEC 60601-1-2IEC 60825-1 | |
| Environment of Use | Operating room | Operating room | Operating room | |
| Fluorescence excitationsource | NIR laser | NIR laser | NIR laser | |
| Imaging Modes | White Light SPY Overlay Color Segmented Fluorescence (CSF) Color map (raw color map and relative color map) | White Light SPY Overlay Color Segmented Fluorescence (CSF) | SPY Overlay Color Segmented Fluorescence (CSF) | |
| SUBJECT DEVICE | PREDICATE DEVICE(primary predicate) | PREDICATE DEVICE(secondary predicate tosupport technologicaldifferences/ new softwarefeature) | ||
| Name | SPY Portable HandheldImaging (SPY-PHI) Systemwith SPY-PHIFluorescence AssessmentSoftware | SPY Portable HandheldImaging (SPY-PHI) System | SPY Elite IntraoperativePerfusion AssessmentSystem | |
| Company/ 510(k) Holder | Novadaq TechnologiesULC. (now a part ofStryker) | Novadaq TechnologiesULC. (now a part ofStryker) | Novadaq TechnologiesULC. (now a part ofStryker) | |
| FluorescenceAssessmentFeatures &Tools | On-screentimer | On-screen timer (automatic) | Not available | On-screen timer (manual) |
| Signalstabilityindicator | Signal stability indicator(automatic) | Not available | Signal stability indicator(manual) | |
| Rawcolormap | Modified Jet Map as overlayon anatomical grayscaleimage | Not available | Jet Map | |
| Relativecolormap | Modified Jet Map as overlayon anatomical grayscaleimage | Not available | Not available | |
| Reference value | Available | Not available | Available | |
| Relativevalue | Available | Not available | Available | |
| Imaging Agent | SPY AGENT™ GREEN(indocyanine green forinjection, USP) | SPY AGENT™ GREEN(indocyanine green forinjection, USP) | SPY AGENT™ GREEN(indocyanine green forinjection, USP) |
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NOVADAQ Technologies ULC. (now a part of Stryker)
SECTION 5 - 510(k) Summary
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NOVADAQ Technologies ULC. (now a part of Stryker)
SECTION 5 - 510(k) Summary
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NOVADAQ Technologies ULC. (now a part of Stryker) SECTION 5 - 510(k) Summary
Performance Testing of the SPY-PHI System:
The SPY-PHI System was designed and developed in accordance with the applicable requirements and standards to establish performance and safety of the device's safety and performance were verified, including testing conducted by accredited third-party laboratories.
SPY-PHI was tested and determined to be in conformance with IEC 60601-1:2006 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2 (4th edition) and IEC 60825:2007 Safety of laser products -- Part 1: Equipment classification and requirements.
An assessment of the SPY-PHI System software was conducted to demonstrate conformance with the applicable requirements of IEC 62304:2015 Medical device software life-cycle processes. It has been demonstrated that all processes and activities necessary for the safe design and maintenance of SPY-PHI software are performed in accordance with the standard.
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A design validation study was performed to assess the suitability of the design requirements of the SPY-PHI Fluorescence Assessment Software as part of the SPY-PHI System to meet user needs. The results of the design validation study support the new fluorescence assessment software of the SPY-PHI System.
Conclusion & Summary of Substantial Equivalence:
Based on the information presented in this Traditional 510(k) premarket notification, and based on the fundamental scientific technological characteristics, principle of operation, intended use, environment of use, and indications for use, the SPY-PHI System with SPY-PHI Fluorescence Assessment Software has been demonstrated to be substantially equivalent to the predicate devices, the SPY-PHI System (FDA 510(k)-cleared in K200737) and the SPY Elite System (FDA 510(k)-cleared in K182907).
The SPY-PHI System with SPY-PHI Fluorescence Assessment Software intended for intraoperative fluorescence imaging for visualization of blood flow and tissue perfusion before, during and after various surgical procedures, does not raise any issues related to safety or effectiveness for this device when used as instructed.
§ 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.