(81 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|---|
| Optical Imaging - 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. | PASS (Stated in "Performance Testing - Bench": "In accordance with design input specifications including optical imaging performance specifications") |
| Optical Imaging - 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. | PASS (Stated in "Performance Testing - Bench": "In accordance with design input specifications including optical imaging performance specifications") |
| Electromagnetic Compatibility (EMC) | In accordance with IEC 60601-1-2:2014, Medical electrical equipment... Electromagnetic compatibility - Requirements and tests. | PASS |
| Electrical Safety | In accordance with IEC 60601-1:2005+A1:2012 (Medical electrical equipment, Part 1) and IEC 60601-1-6:2020-07 (Medical electrical equipment - Part 1-6). | 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 IEC 62366-1:2015, Medical devices -- Part 1: Application of usability engineering to medical devices. | PASS |
| Software | In accordance with IEC 62304:2006, Medical device software - Software life cycle processes. | PASS |
| Clinical Effectiveness (Primary Endpoint) | SPY AGENT GREEN and SPY-PHI should demonstrate a statistically significant and greater proportion of lymph nodes identified compared to Tc99m / gamma probe. (Implicit: showing superiority or non-inferiority to a specified degree). | 89% of confirmed LNs identified by SPY AGENT GREEN and SPY-PHI vs. 66% identified by Tc99m / gamma probe, a difference of 23% [95% CI 3.67% to 9.48%]; p<0.0001. (Demonstrated superiority). |
| Clinical Effectiveness (Secondary Endpoint - Subject Detection Rate) | A high proportion of subjects should have at least one resected, confirmed lymph node detected by SPY AGENT GREEN and SPY-PHI or Tc99m / gamma probe. | Both methods combined identified at least 1 LN in 95% of subjects. |
| Clinical Effectiveness (Secondary Endpoint - Lymphatic Vessel Mapping) | SPY AGENT GREEN and SPY-PHI should effectively aid in the visualization of lymphatic vessels when identifying lymph nodes. | Lymphatic vessel mapping aided in the visualization of 99% of lymph nodes identified by SPY AGENT GREEN and SPY-PHI. Only 1% were identified without vessel visualization. |
| Clinical Safety | No serious adverse events associated with SPY AGENT GREEN, and no adverse device events or unexpected adverse device events associated with SPY-PHI. | No serious adverse events associated with SPY AGENT GREEN; no adverse device events or unexpected adverse device events associated with SPY-PHI. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 152 subjects enrolled in the FILM-B study.
- Data Provenance: The FILM-B study was a prospective and multi-center clinical study. The document does not explicitly state the country of origin, but it was conducted under an IDE (G170109) in accordance with 21 CFR 812, implying it was conducted under U.S. FDA regulations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text states that "The resected tissues were evaluated by histopathology to confirm presence of lymph nodes." It does not specify the number of histopathology experts or their qualifications. However, histopathology is a well-established method for confirming the presence of lymph nodes and is typically performed by trained pathologists.
4. Adjudication Method for the Test Set
The document does not explicitly mention an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth. It states that histopathology was used to confirm the presence of lymph nodes, which is a definitive diagnostic method. For the comparison of identification rates (SPY-PHI vs. Tc99m/gamma probe), the comparison involved the outcomes of two different intraoperative real-time methods against this histopathology-confirmed ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not explicitly done in the context of human readers improving with AI assistance.
- The study compared the device (SPY-PHI system used by surgeons intraoperatively) to another clinical method (Tc99m/gamma probe used by surgeons). It evaluates the device itself in a real-world surgical setting, not directly how human readers (like radiologists or pathologists) improve their diagnostic performance with AI assistance.
- The comparison focused on the utility of the SPY-PHI system with SPY AGENT GREEN for surgeons during lymphatic mapping for breast cancer, specifically in identifying lymph nodes and visualizing lymphatic vessels, compared to the traditional Tc99m/gamma probe.
- The "effect size" mentioned (a 23% difference in identified lymph nodes between SPY-PHI and Tc99m/gamma probe) refers to the comparative effectiveness of the device-dye system versus the traditional method, not an AI assistance effect on human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm only) performance study was not done in the context of this submission. The SPY-PHI System is described as a fluorescence imaging system used during open-field surgical procedures with intraoperative fluorescence angiography. The clinical study (FILM-B) evaluates its use by surgeons during procedures.
7. The Type of Ground Truth Used
The primary ground truth used for confirming the presence of lymph nodes was histopathology. This is considered a definitive diagnostic standard.
8. The Sample Size for the Training Set
The document does not mention a separate "training set" or its sample size. The clinical study (FILM-B) of 152 subjects appears to be the primary dataset for assessing the stated clinical effectiveness of the device. This device is an imaging system, not a machine learning algorithm that typically requires a large training set for development. The "Software" section mentions compliance with IEC 62304 standards, which applies to medical device software life cycle processes, but doesn't imply a machine learning development paradigm with distinct training/testing sets in the conventional AI sense.
9. How the Ground Truth for the Training Set Was Established
As no specific training set for a machine learning model is mentioned, the method for establishing its ground truth is not applicable or detailed in the provided text.
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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.
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
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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
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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) |
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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 101Burnaby, British Columbia V5A 4W2, Canada |
|---|---|
| Contact Person | Cara CahillManager, Regulatory AffairsPhone: (408) 754-2473Email: 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 AssessmentSoftware (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.
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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 illuminationduring open-field surgical procedures. | Same as subject device | |
| Indications for Use | Upon intravenous administration of SPY AGENTGREEN (indocyanine green for injection, USP), theSPY-PHI System is used with SPY AGENT GREENto perform intraoperative fluorescence angiography.The SPY-PHI System is indicated for use in adult andpediatric patients one month of age and older.The SPY-PHI System is indicated for fluorescenceimaging of blood flow and tissue perfusion before,during, and after: vascular, gastrointestinal, organtransplant, and plastic, micro- and reconstructivesurgical procedures.Upon interstitial administration of SPY AGENTGREEN, the SPY-PHI System is used to performintraoperative fluorescence imaging and visualizationof the lymphatic system, including lymphatic vesselsand lymph nodes.Upon intradermal administration of SPY AGENTGREEN, the SPY-PHI System is indicated forfluorescence imaging of lymph nodes and delineationof lymphatic vessels during lymphatic mapping inadults with breast cancer for which this procedure is acomponent of intraoperative management. | Upon intravenous administrationof SPY AGENT GREEN(indocyanine green for injection,USP) the SPY-PHI System is usedwith SPY AGENT GREEN toperform intraoperativefluorescence angiography. TheSPY-PHI System is indicated foruse in adult and pediatric patientsone month of age and older.The SPY-PHI System is indicatedfor fluorescence imaging of bloodflow and tissue perfusion before,during, and after: vascular,gastrointestinal, organ transplant,and plastic, micro- andreconstructive surgical procedures.Upon interstitial administration ofSPY AGENT GREEN, the SPY-PHI System is used to performintraoperative fluorescenceimaging and visualization of thelymphatic system, includinglymphatic vessels and lymphnodes. | |
| 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 LightNear-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 ImagerVideo Processor/ IlluminatorSPY-QP Fluorescence Assessment Software | Same as subject device | |
| Safety Standards | IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60825-1 | Same as subject device | |
| OpticalImagingSpecifications | 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) |
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Comparison of Technological Characteristics with the Predicate Device:
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1 SPY Mode (Contrast) and Overlay Mode are recommended for use in breast lymphatic mapping.
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Performance Testing:
| Test | Method | Result |
|---|---|---|
| ElectromagneticCompatibility | In accordance with IEC 60601-1-2:2014, Medical electricalequipment, Part 1. General requirements for safety, 2. Collateralstandard: 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 - Part1: 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 opticalimaging 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
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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<0.0001.
As a secondary endpoint, the number of subjects with at least one resected, confirmed lymph node detected by SPY AGENT GREEN and SPY-PHI or Tc99m / gamma probe was determined. Both methods identified at least 1 LN in 95% of subjects. Of these, 45% of subjects had lymph nodes detected with SPY AGENT GREEN and SPY-PHI only, 21% of patients had lymph nodes detected with Tc99m /gamma probe only and 11% of patients had lymph nodes detected with neither SPY AGENT GREEN and SPY-PHI or Tc99m gamma probe.
Another secondary endpoint evaluated the effectiveness of SPY AGENT GREEN and SPY-PHI as an intraoperative near-infrared fluorescence visualization tool for delineation and mapping of lymphatic vessels and the identification of lymph nodes. Lymphatic yessel mapping with SPY AGENT GREEN and SPY-PHI aided in the visualization of 99% of lymph nodes identified by SPY AGENT GREEN and SPY PHI. Only 1% of all lymph nodes identified by SPY AGENT GREEN and SPY-PHI were without the visualization of lymphatic vessels/ channels with SPY AGENT GREEN and SPY-PHI.
The safety of SPY AGENT GREEN and SPY-PHI was also evaluated. There were no serious adverse events associated with the use of SPY AGENT GREEN, or adverse device events or unexpected adverse device events associated with the use of SPY -PHI.
The results from the FILM-B study confirm that SPY AGENT GREEN and SPY-PHI is a clinically safe and effective too for the visualization of lymphatic vessels and identification of lymph nodes during lymphatic mapping for breast cancers.
Conclusions:
The SPY Portable Handheld Imaging (SPY-PHI) System is the same or similar in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. The clinical data from the FILM-B study demonstrate the performance of the SPY-PHI System when utilized with SPY AGENT GREEN for fluorescence imaging of lymph nodes and delineation of lymphatic vessels in the breast during lymphatic mapping. Risk management activities demonstrated that there are no new risks associated with the expanded indications for use. The combination of these data demonstrate the subject device is the same or similar, with respect to safety and effectiveness, to the legally marketed predicate device.
§ 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.