(81 days)
Not Found
No
The document describes image processing but does not mention AI, ML, or related terms like deep learning or neural networks. The performance study focuses on the clinical efficacy of the imaging system and contrast agent, not on the performance of an AI/ML algorithm.
No
The device is used for imaging and visualization purposes, not for treating any condition. Its intended use is diagnostic, providing information for surgical procedures, and not therapeutic.
Yes
The device performs "fluorescence imaging of blood flow and tissue perfusion" and "fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes," which are diagnostic functions. The "Summary of Performance Studies" also discusses identifying lymph nodes, further indicating a diagnostic purpose.
No
The device description explicitly states that the SPY-PHI System consists of hardware components: the SPY Portable Handheld Imager/imaging head and the Video Processor/Illuminator. While it includes optional software, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the SPY-PHI System as being used with SPY AGENT GREEN (an injected contrast agent) to perform intraoperative fluorescence angiography and imaging of blood flow, tissue perfusion, and the lymphatic system within the patient's body. This is an in vivo application, meaning it's used on a living organism.
- Device Description: The device description confirms it's a real-time imaging system used during open-field surgical procedures to visualize structures in vivo using fluorescence from the injected agent.
- Lack of IVD Characteristics: An IVD is typically used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The SPY-PHI System does not perform this function.
The device is an in vivo imaging system used during surgical procedures.
N/A
Intended Use / Indications for Use
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the SPY-PH 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.
Upon intradermal administration of SPY AGENT GREEN, the SPY-PHI System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast cancer for which this procedure is a component of intraoperative management.
Product codes
IZI
Device Description
The SPY-PHI System is a real-time white-light and near-infrared illumination/ fluorescence imaging system used during open-field surgical procedures. Near-infrared illumination is used for fluorescence imaging using SPY AGENT® GREEN for the visual assessment of blood flow, tissue perfusion and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. It consists of the SPY Portable Handheld Imager/ imaging head with an integrated light guide and camera cable and the Video Processor/ Illuminator. Additionally, SPY-QP Fluorescence Assessment Software is provided as an optional upgrade to the SPY-PHI System that enables relative quantification of NIR fluorescence.
Mentions image processing
Digital Processing/ Video Output
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
White Light, Near-Infrared
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients one month of age and older.
Intended User / Care Setting
intraoperative
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 Testing:
- Electromagnetic Compatibility: In accordance with IEC 60601-1-2:2014, Medical electrical equipment, Part 1. General requirements for safety, 2. Collateral standard: Electromagnetic compatibility - Requirements and tests. Result: PASS.
- Electrical Safety: In accordance with IEC 60601-1:2005+A1:2012, Medical electrical equipment, Part 1. General requirements for safety and essential performance; & applicable national deviations; and IEC 60601-1-6:2020-07, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance. Result: PASS.
- Laser Safety: In accordance with IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements. Result: PASS.
- Usability: In accordance with IEC62366-1:2015, Medical devices -- Part 1: Application of usability engineering to medical devices. Result: PASS.
- Performance Testing - Bench: In accordance with design input specifications including optical imaging performance specifications. Result: PASS.
- Software: In accordance with IEC 62304:2006, Medical device software - Software life cycle processes. Result: PASS.
Performance Testing - Clinical:
The Novadaq Technologies ULC-sponsored FILM-B Clinical Study was performed under an IDE (G170109), in accordance with 21 CFR 812.
FILM-B was a single-arm, prospective. multi-center, open-label study in subjects with early stage breast cancers with clinically negative nodal status and who were scheduled for surgery that included clinically indicated sentinel lymph node biopsy with technetium 99m radioactive colloid (Tc99m). Subjects received Tc99m the day before or the day of surgery and SPY AGENT GREEN was injected into the identified breast of subjects at the beginning of the operative procedure. All subjects received the injection into a single breast. A total of 152 subjects were enrolled in the study. Lymphatic mapping was performed intraoperatively using the SPY-PHI System and a handheld gamma probe, or the surgeon's visual and palpation examination. The resected tissues were evaluated by histopathology to confirm presence of lymph nodes.
The FILM-B study design resulted in unbiased, quality, reliable and repeatable data for use in the evaluation of the effectiveness and safety of SPY AGENT GREEN and SPY-PHI in identifying lymph nodes during lymphatic mapping and sentinel lymph node biopsy in subjects with earlystage breast cancer. The FILM-B study met both the primary and secondary effectiveness endpoints.
The primary endpoint of the study was assessed by comparison of the proportion of lymph nodes identified by SPY AGENT GREEN and SPY-PHI with the proportion of LNs identified with Tc99m / gamma probe. Among the confirmed lymph nodes identified, 89% were identified using SPY AGENT GREEN and SPY-PHI, and 66% were identified using Tc99m /gamma probe, a difference of 23% [95% confidence interval 3.67% to 9.48%]; p
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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.
June 5, 2023
Novadaq Technologies ULC (a part of Stryker) Cara Cahill Manager, Regulatory Affairs 8329 Eastlake Drive, Unit 101 Burnaby, British Columbia V5A 4W2 Canada
Re: K230727
Trade/Device Name: SPY Portable Handheld Imaging (SPY-PHI) System Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: IZI Dated: March 15, 2023 Received: March 16, 2023
Dear Cara Cahill:
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
1
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 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 (OS) 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,
Jessica Carr -S
Jessica Carr, Ph.D. 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) K230727
Device Name
SPY Portable Handheld Imaging (SPY-PHI) System
Indications for Use (Describe)
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the SPY-PH 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.
Upon intradermal administration of SPY AGENT GREEN, the SPY-PHI System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast cancer for which this procedure is a component of intraoperative management.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is written in all lowercase letters.
510(k) Summary
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92(c)
Submitter:
| Applicant | Novadaq Technologies ULC (A Part of Stryker)
8329 Eastlake Drive, Unit 101
Burnaby, British Columbia V5A 4W2, Canada |
|----------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Cara Cahill
Manager, Regulatory Affairs
Phone: (408) 754-2473
Email: cara.cahill@stryker.com |
| Date Prepared | May 10, 2023 |
Subject Device:
| Name of Device | SPY Portable Handheld Imaging (SPY-PHI) System |
|---|---|
| Common or Usual Name | Fluorescence Angiographic System |
| Classification Name | Angiographic X-Ray System, 21 CFR 892.1600 |
| Regulatory Class | Class II |
| Product Code | IZI |
| 510(k) Review Panel: | Radiology |
Predicate Device:
| Predicate Devices | Manufacturer |
|---|---|
| SPY-PHI System with SPY-PHI Fluorescence Assessment | |
| Software (K202244)* | Novadaq Technologies ULC |
| (A Part of Stryker) | |
| SPY Portable Handheld Imaging (SPY-PHI) System | |
| (K200737) | Novadaq Technologies ULC |
| (A Part of Stryker) |
*primary predicate
Device Description:
The SPY-PHI System is a real-time white-light and near-infrared illumination/ fluorescence imaging system used during open-field surgical procedures. Near-infrared illumination is used for fluorescence imaging using SPY AGENT® GREEN for the visual assessment of blood flow, tissue perfusion and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. It consists of the SPY Portable Handheld Imager/ imaging head with an integrated light guide and camera cable and the Video Processor/ Illuminator. Additionally, SPY-QP Fluorescence Assessment Software is provided as an optional upgrade to the SPY-PHI System that enables relative quantification of NIR fluorescence.
4
Indications for Use:
| Item | Subject Device | Predicate Device | |
|---|---|---|---|
| SPY Portable Handheld Imaging (SPY-PHI) | |||
| System | SPY Portable Handheld Imaging | ||
| (SPY-PHI) System | |||
| Intended Use | Visible white light and near-infrared illumination | ||
| during open-field surgical procedures. | Same as subject device | ||
| Indications for Use | 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. | |||
| Upon intradermal administration of SPY AGENT | |||
| GREEN, the SPY-PHI System is indicated for | |||
| fluorescence imaging of lymph nodes and delineation | |||
| of lymphatic vessels during lymphatic mapping in | |||
| adults with breast cancer for which this procedure is a | |||
| component of intraoperative management. | 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. | |||
| Feature | Subject Device | Predicate Device | |
| Feature | SPY Portable Handheld Imaging (SPY-PHI) System | SPY Portable Handheld Imaging (SPY-PHI) System | |
| Manufacturer | Novadaq Technologies ULC. (a part of Stryker) | Same as subject device | |
| Submission Reference | Current Submission | K202244, K200737 | |
| Imaging System Type | Open-Field | Same as subject device | |
| Imaging Modes | White Light | ||
| Near-Infrared: |
- Overlay Mode1
- SPY Mode (Contrast) 1
- SPY Color Segmented Fluorescence (CSF) | Same as subject device | |
| Principles of Operation | Via Imager, light is transmitted through the Light Cable and projected to illuminate the surgical site/ area of interest. The light emitted and reflected from the surgical site/ area of interest (aside from NIR excitation light, which is blocked by an internal rejection filter) is acquired by the Imager, projected onto the image sensor and converted to a digital signal. The digital signal is transmitted via the Camera Cable to the VPI which receives the optical image information, processes the information, and outputs it to digital video. | Same as subject device | |
| System Components | SPY-PHI Imager
Video Processor/ Illuminator
SPY-QP Fluorescence Assessment Software | Same as subject device | |
| Safety Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60825-1 | Same as subject device | |
| Optical
Imaging
Specifications | Dynamic Range | The user shall be able to visualize SPY AGENT GREEN in physiology applications. The response on the system monitor to the minimum clinically relevant concentration of SPY AGENT GREEN shall be at least 6.9(ΔE), and the system response to the maximum clinically relevant concentration shall be at least twice that at low concentrations. | Same as subject device |
| | Localization | The user shall be able to visualize SPY AGENT GREEN in anatomy applications. The response on the system monitor shall be at least 10.35 (ΔΕ) under clinically relevant conditions. | Same as subject device |
| SPY-PHI Imager | Image Sensor: CMOS image sensor | Same as subject device | |
| Video Processor/ Illuminator | Light Source/ RGB LEDs | Same as subject device | |
| Feature | Subject Device | | Predicate Device |
| | SPY Portable Handheld Imaging (SPY- | | SPY Portable Handheld |
| | PHI) System | | Imaging (SPY-PHI) System |
| | Laser Safety | Class 3R | Same as subject device |
| | Class | | |
| | Wavelengths | White Light: | Same as subject device |
| | | 400 nm – 700 nm | |
| | | Near-infrared: 805 nm | |
| | Imaging | Digital | Same as subject device |
| | Processing/ | | |
| | Video Output | | |
| | Resolution | 1080p (1920x1080) | Same as subject device |
| | Frame Rate | 60 Hz | Same as subject device |
| Imaging Agent | | SPY AGENT GREEN (indocyanine green for | Same as subject device |
| | injection, USP) | | |
5
Comparison of Technological Characteristics with the Predicate Device:
6
1 SPY Mode (Contrast) and Overlay Mode are recommended for use in breast lymphatic mapping.
7
Performance Testing:
| Test | Method | Result |
|---|---|---|
| Electromagnetic | ||
| Compatibility | In accordance with IEC 60601-1-2:2014, Medical electrical | |
| equipment, Part 1. General requirements for safety, 2. Collateral | ||
| standard: Electromagnetic compatibility - Requirements and tests | PASS | |
| Electrical Safety | In accordance with: | |
| • IEC 60601-1:2005+A1:2012, Medical electrical equipment, Part 1. | ||
| General requirements for safety and essential performance; & | ||
| applicable national deviations | ||
| • IEC 60601-1-6:2020-07, Medical electrical equipment - Part 1-6: | ||
| General requirements for basic safety and essential performance | PASS | |
| Laser Safety | In accordance with IEC 60825-1:2014, Safety of laser products - Part | |
| 1: Equipment classification and requirements | PASS | |
| Usability | In accordance with IEC62366-1:2015, Medical devices -- Part 1: | |
| Application of usability engineering to medical devices | PASS | |
| Performance Testing - Bench | In accordance with design input specifications including optical | |
| imaging performance specifications | PASS | |
| Software | In accordance with IEC 62304:2006, Medical device software - | |
| Software life cycle processes | PASS |
Note: The device is not patient contacting. Therefore, biocompatibility does not apply.
Performance Testing - Clinical:
The Novadaq Technologies ULC-sponsored FILM-B Clinical Study was performed under an IDE (G170109), in accordance with 21 CFR 812.
FILM-B was a single-arm, prospective. multi-center, open-label study in subjects with early stage breast cancers with clinically negative nodal status and who were scheduled for surgery that included clinically indicated sentinel lymph node biopsy with technetium 99m radioactive colloid (Tc99m). Subjects received Tc99m the day before or the day of surgery and SPY AGENT GREEN was injected into the identified breast of subjects at the beginning of the operative procedure. All subjects received the injection into a single breast. A total of 152 subjects were enrolled in the study. Lymphatic mapping was performed intraoperatively using the SPY-PHI System and a handheld gamma probe, or the surgeon's visual and palpation examination. The resected tissues were evaluated by histopathology to confirm presence of lymph nodes.
The FILM-B study design resulted in unbiased, quality, reliable and repeatable data for use in the evaluation of the effectiveness and safety of SPY AGENT GREEN and SPY-PHI in identifying lymph nodes during lymphatic mapping and sentinel lymph node biopsy in subjects with earlystage breast cancer. The FILM-B study met both the primary and secondary effectiveness endpoints.
The primary endpoint of the study was assessed by comparison of the proportion of lymph nodes identified by SPY AGENT GREEN and SPY-PHI with the proportion of LNs identified with Tc99m / gamma probe. Among the confirmed lymph nodes identified, 89% were identified
8
using SPY AGENT GREEN and SPY-PHI, and 66% were identified using Tc99m /gamma probe, a difference of 23% [95% confidence interval 3.67% to 9.48%]; p