(86 days)
No
The summary describes a fluorescence imaging system that captures and processes images for visual assessment. It mentions "processing" the video signal but does not include any terms or descriptions indicative of AI or ML algorithms being used for image analysis, interpretation, or decision support.
No.
The device is described as an "imaging system" used for visual assessment, not for direct treatment or therapy. It provides adjunctive information for evaluating tissue perfusion to aid surgical procedures, rather than performing a therapeutic function itself.
Yes
The device is used for the "visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion," which indicates it gathers information about a patient's physiological state to help assess a medical condition.
No
The device description explicitly lists hardware components: an Open Field Handheld Imaging Head, Light Guide, and Video Processor/Illuminator. It also describes the function of these hardware components in capturing and processing images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- Device Function: The SPY Phi Open Field Handheld Fluorescence Imaging System is an in vivo imaging system. It is used to visualize blood flow and tissue perfusion within the patient's body during surgical procedures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures" and "visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures." This is a direct observation of physiological processes within the living patient.
- Device Description: The description details how the system illuminates the patient's body and captures images of fluorescence from within the body after the injection of a contrast agent (ICG).
Therefore, the SPY Phi Open Field Handheld Fluorescence Imaging System is an in vivo imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SPY Phi Open Field Handheld Fluorescence Imaging System is an imaging system used in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
The SPY Phi Open Field Handheld Fluorescence Imaging System is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures.
Product codes
OWN
Device Description
The SPY PHI HH9000 is an imaging system used in capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissuetransfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and gastrointestinal surgeries.
The SPY PHI HH9000 consists of the following components: an Open Field Handheld Imaging Head (HH9030), Light Guide (PC9004), and the Video Processor/Illuminator (VPI) (PC9001).
Indocyanine green (ICG) is injected intravenously into the patient. The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared laser light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the regions of a patient's body to be observed for color imaging.
A CMOS 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 SPY PHI are possible through switches at either the Imaging Head or the VPI.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence Imaging, Near Infrared, White Light
Anatomical Site
Tissue and free flaps used in plastic, micro-, and reconstructive surgical procedures; vessels and related tissue during gastrointestinal surgical procedures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Performance Testing:
SPY PHI was designed and developed in accordance with applicable requirements and standards, and its performance and safety were verified by tests conducted by NOVADAQ and accredited third-party laboratories.
SPY PHI was tested and determined to be in conformance with IEC 60601-1:2006, IEC 60601-1-2 (30 edition), and IEC 60825:2007.
An assessment of the SPY PHI system software demonstrated conformance with IEC 62304:2006.
Animal Testing - Validation Data:
Animal studies, using a porcine model, were conducted to assess the suitability of the design requirements of SPY PHI to meet user needs and evaluated the in vivo fluorescence imaging capability of SPY PHI in the visualization of blood flow and tissue perfusion in reconstructive and gastrointestinal surgical procedures. The results of these studies support the proposed indications for use for the SPY PHI system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K133719, K132475, K063345, K100371
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 11, 2017
Novadaq Technologies Inc. Jen Pendlebury Director of Regulatory Affairs 8329 Eastlake Drive Unit 101 Burnaby, British Columbia V5A 4W2 CA
Re: K162885
Trade/Device Name: Spy Phi Open Field Handheld Fluorescence Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN Dated: October 14, 2016 Received: October 17, 2016
Dear Jen Pendlebury:
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
SPY Phi Open Field Handheld Fluorescence Imaging System
Indications for Use (Describe)
The SPY Phi Open Field Handheld Fluorescence Imaging System is an imaging system used in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
The SPY Phi Open Field Handheld Fluorescence Imaging System is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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.
| Trade Name: | SPY PHI Open Field Handheld Fluorescence Imaging System |
|---|---|
| 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: | OWN |
| Classification: | Class II |
| Manufacturer: | Novadaq Technologies Inc. |
| 8329 Eastlake Drive, Unit 101 | |
| Burnaby, British Columbia | |
| Canada, V5A 4W2 | |
| Contact Name: | Jen Pendlebury |
| Director of Regulatory Affairs | |
| Tel: (905) 629-3822 Ext. 205 | |
| Fax: (905) 247-0656 | |
| Date 510(k) Summary Prepared: | January 5, 2017 |
| Predicate Devices: | |
| Device Trade Name: | PDE-Neo |
| Submitter Name: | Hamamatsu Photonics, K.K. |
| Device Common Name: | Fluorescence Angiographic System |
| Product Code/Regulation: | IZI/ 21 CFR § 892.1600 |
| Classification: | Class II |
| Device Trade Name: | Fluobeam 800 Clinic® Imaging Device with Fluocase 800™ control |
| system | |
| Submitter Name: | Fluoptics |
| Device Common Name: | Fluorescence Imaging System |
| Product Code/Regulation: | OWN/21 CFR 876.1500 |
| Classification: | Class II |
SPY Imaging System (SP2000) – K063345; SPY Intra-operative Imaging Device Trade Name: System (SP2001) - K100371 Novadaq Technologies Inc. Submitter Name: Device Common Name: Fluorescence Angiographic System Product Code/Regulation: IZI/ 21 CFR § 892.1600 Classification: Class II
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Device Description:
The SPY PHI HH9000 is an imaging system used in capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissuetransfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and gastrointestinal surgeries.
The SPY PHI HH9000 consists of the following components: an Open Field Handheld Imaging Head (HH9030), Light Guide (PC9004), and the Video Processor/Illuminator (VPI) (PC9001).
Indocyanine green (ICG) is injected intravenously into the patient. The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared laser light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the regions of a patient's body to be observed for color imaging.
A CMOS 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 SPY PHI are possible through switches at either the Imaging Head or the VPI.
Indications for Use for the SPY PHI System:
"The SPY PHI Open Field Handheld Fluorescence Imaging system is an imaging system used in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures."
"The SPY PHI Open Field Handheld Fluorescence Imaging System is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures."
Summary of Technological Characteristics of the SPY PHI System and Predicate Devices:
SPY PHI and the predicate devices – PDE-Neo, Fluobeam 800 Clinic® Imaging Device with Fluocase 800™ control system, and the SPY Intra-operative Imaging System, have very similar technological characteristics. In addition, SPY PHI utilizes the following existing components of the PINPOINT Endoscopic Fluorescence Imaging System (FDA 510(k) cleared under K150956): the VPI (PC9001), including software and Light Guide Cable (PC9004).
SPY PHI and the predicate devices rely on near infrared fluorescence imaging for the visualization of blood flow and tissue perfusion during surgical procedures. Each of the devices contain a camera unit, a light source, and a video processor and controller, using ICG imaging agent to achieve fluorescence imaging. Upon injection of the imaging agent (ICG), absorption of laser light causes excitation of ICG which is followed by emission of near infrared fluorescence which is acquired by the camera unit as an image of the blood vessels and related tissue perfusion. The resulting images are displayed on a video monitor.
5
Performance Data:
Non-Clinical Performance Testing of the SPY PHI System
SPY PHI was designed and developed by Novadaq Technologies Inc. (NOVADAQ), in accordance with the applicable requirements and standards to establish performance and safety of the device's safety and performance were verified by tests conducted by NOVADAQ and 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 (30 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 62304:2006 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.
Animal Testing - Validation Data
Animal studies, using a porcine model, were conducted to assess the suitability of the design requirements of SPY PHI to meet user needs and evaluated the in vivo fluorescence imaging capability of SPY PHI in the visualization of blood flow and tissue perfusion in reconstructive and gastrointestinal surgical procedures. The results of these studies support the proposed indications for use for the SPY PHI system.
Conclusions & Summary of Substantial Equivalence
Based on the information submitted in this premarket notification, and based on the technological characteristics, principle of operation, intended use, environment of use, and indications for use, SPY PHI has been determined to be substantially equivalent to the predicate devices, the PDE-Neo (K133719), Fluobeam 800 Clinic® Imaging Device with Fluocase 800™ control system (K132475), and the SPY Intraoperative Imaging System (K063345 and K100371).
Any technological and design differences between SPY PHI and the predicate devices do not raise additional questions of safety or effectiveness.