(57 days)
Not Found
No
The summary describes standard image signal processing for ultrasound and does not mention AI or ML.
No.
The device is used for qualitative and quantitative evaluation and imaging of vascular morphology, not for treating or providing therapy.
Yes
Explanation: The device is used for "qualitative evaluation of vascular morphology" and provides "an image of vessel lumen and wall structures." This involves obtaining and analyzing information about the body to aid in diagnosis.
No
The device description explicitly states that the system consists of hardware components including a cart mounted touchscreen PC Console, a patient interface module, and an optional Control Console, in addition to software.
Based on the provided information, the CORE M2 Vascular System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The CORE M2 Vascular System is an imaging system that directly examines the vascular morphology inside the patient's body using ultrasound. It does not analyze samples like blood, urine, or tissue.
- The intended use and device description clearly state it is used for imaging and evaluating vascular structures within the body. It is an adjunct to conventional angiographic procedures, which are also in-vivo procedures.
- The device description focuses on the imaging process using ultrasound and analyzing the received signals to produce images. This is characteristic of an in-vivo imaging system, not an in-vitro diagnostic test.
Therefore, the CORE M2 Vascular System falls under the category of an in-vivo imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The CORE M2 Vascular System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
Product codes (comma separated list FDA assigned to the subject device)
IYO, DSA
Device Description
The CORE M2 Vascular System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The system utilizes the acoustic impedance of vascular structures to provide cross sectional images from inside the vessel. The IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures to produce a 360° cross sectional image.
The CORE M2 Vascular System consists of a cart mounted touchscreen PC Console, a patient interface module (PIM) for connecting the IVUS Imaging Catheter to the PC Console, and an optional Control Console as an alternative to the touchscreen for control of the CORE M2 System.
Mentions image processing
The CORE M2 System has employed a new User Interface Design, and uses different hardware and software for image signal processing to produce the IVUS images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Pulsed Echo Imaging System
Anatomical Site
coronary arteries and vessels of the peripheral vasculature
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)
Design Verification
- Electrical safety and Electromagnetic Compatibility (EMC) testing were conducted on the CORE M2 system. The system complies with ANSI/AAMI ES60601-1:2005 + A2(R2012) + A1, IEC 60601-2-37:2007 standards for safety and IEC 60601-1-2:2014 standard for EMC.
- Environmental Testing was conducted to verify the CORE M2 system's performance under the environmental conditions as defined in the product specifications. The CORE M2 system was subjected to a range of humidity, temperature, and varying levels of shock and vibration. The results of this testing demonstrate the CORE M2 System remains functional under the required environmental conditions.
- Packaging testing was conducted on each of the CORE M2 System packages, consisting of the Panel PC, Panel PC Assembly, Cart, and Patient Interface Module per FDA recognized standards ASTM D4332-14 and ASTM D4169-16. The results of this testing demonstrate that the CORE M2 System packaging design is sufficient for transit conditions.
- Hardware Verification was performed on the CORE M2 System and each of its subassemblies to verify each meets its relevant product specifications. Testing was performed on the following:
- CORE M2 Panel PC
- Image Acquisition Printed Circuit Assembly
- Mobile Cart
- CORE M2 System, fully assembled
The results of this testing demonstrates the CORE M2 System and each of its subassemblies meet the defined product specifications.
Software Verification and Validation
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Unit, integration, and system level software testing was conducted on the CORE M2 v4.1 software, consisting of the application, firmware, and imaging library. The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator. The results of the software verification and validation demonstrate that the CORE M2 v4.1 software meets the defined software requirements.
Simulated Use / Usability Validation
Simulated Use/Usability Validation testing was conducted to ensure the CORE M2 System meets the user needs, satisfies the intended use, and demonstrates that users are able to use the device safely and effectively. The results of this validation demonstrate that the CORE M2 System meets the user needs.
Image Validation
An Image Validation was also conducted to confirm that the images acquired and displayed by the CORE M2 System are clinically acceptable for end users. The results of the image validation demonstrate that the CORE M2 system provides images which are clinically acceptable.
Summary
The results of the performance data for the CORE M2 System demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.
April 6, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Volcano Corporation Courtney Moore Regulatory Affairs Specialist 3721 Vallev Centre Dr Ste 500 San Diego, California 92130
Re: K170385
Trade/Device Name: Core® M2 Vascular System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, DSA Dated: March 10, 2017 Received: March 13, 2017
Dear Courtney Moore:
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
Mude Jellm
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170385
Device Name CORE® M2 Vascular System
Indications for Use (Describe)
The CORE M2 Vascular System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
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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3
510 (k) SUMMARY
| SPONSOR: | Volcano Corporation
3721 Valley Center Drive
San Diego, CA 92130 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Courtney Moore
Regulatory Affairs Specialist
Volcano Corporation
3721 Valley Center Drive
San Diego, CA 92130
Tel: (858) 764-1308
Fax: (858) 481-1027 |
| DATE PREPARED: | March 10, 2017 |
| DEVICE: | Volcano CORE® M2 Vascular System |
| TRADE NAME: | Volcano CORE® M2 Vascular System |
| COMMON NAME: | System, Imaging, Pulsed Echo, Ultrasonic |
| CLASSIFICATION: | 21 CFR Part 892.1560
IYO: Ultrasonic Pulsed Echo Imaging System
21 CFR Part 870.2900
DSA: Patient Transducer and Electrical Cable
Class II Device |
| PREDICATE DEVICE: | Volcano s5i/CORE and CORE Mobile Precision Guided
Therapy Systems (K153369) |
| DEVICE DESCRIPTION: | The CORE M2 Vascular System is used for the qualitative
and quantitative evaluation of vascular morphology in the
coronary arteries and vessels of the peripheral vasculature.
It is also indicated as an adjunct to conventional
angiographic procedures to provide an image of vessel
lumen and wall structures. The system utilizes the acoustic
impedance of vascular structures to provide cross sectional
images from inside the vessel. The IVUS catheter uses a
transducer near the distal tip to emit and receive high
frequency sound waves. The system is then able to analyze
the signal that is received by the transducer to differentiate
between vessel structures to produce a 360° cross sectional
image. |
4
The CORE M2 Vascular System consists of a cart mounted touchscreen PC Console, a patient interface module (PIM) for connecting the IVUS Imaging Catheter to the PC Console, and an optional Control Console as an alternative to the touchscreen for control of the CORE M2 System.
INDICATIONS FOR USE:
The CORE M2 Vascular System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
COMPARISON OF CHARACTERISTICS:
The CORE M2 System is a modification to the currently marketed CORE Mobile system. The CORE M2 system is designed to provide only IVUS imaging for the peripheral and coronary vasculature. The CORE M2 system interfaces with the same Digital IVUS Patient Interface Module and a subset of the Catheters that are used with the CORE Mobile System. The CORE M2 System is compatible with the following catheter models:
- Eagle Eye Platinum, Model 85900P ●
- . Eagle Eye Platinum Short Tip, Model 85900PST
- Visions PV .014P. Model 85910P .
- . Visions PV .035. Model 88901 and 81234
The CORE M2 System has employed a new User Interface Design, and uses different hardware and software for image signal processing to produce the IVUS images.
PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
Design Verification
- Electrical safety and Electromagnetic Compatibility ● (EMC) testing were conducted on the CORE M2 system. The system complies with ANSI/AAMI ES60601-1:2005 + A2(R2012) + A1, IEC 60601-2-37:2007 standards for safety and IEC 60601-1-2:2014 standard for EMC.
- Environmental Testing was conducted to verify the ● CORE M2 system's performance under the environmental conditions as defined in the product
5
specifications. The CORE M2 system was subjected to a range of humidity, temperature, and varying levels of shock and vibration. The results of this testing demonstrate the CORE M2 System remains functional under the required environmental conditions.
- Packaging testing was conducted on each of the . CORE M2 System packages, consisting of the Panel PC, Panel PC Assembly, Cart, and Patient Interface Module per FDA recognized standards ASTM D4332-14 and ASTM D4169-16. The results of this testing demonstrate that the CORE M2 System packaging design is sufficient for transit conditions.
- Hardware Verification was performed on the CORE ● M2 System and each of its subassemblies to verify each meets its relevant product specifications. Testing was performed on the following:
- o CORE M2 Panel PC
- Image Acquisition Printed Circuit Assembly o
- Mobile Cart o
o CORE M2 System, fully assembled The results of this testing demonstrates the CORE M2 System and each of its subassemblies meet the defined product specifications.
Software Verification and Validation
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Unit, integration, and system level software testing was conducted on the CORE M2 v4.1 software, consisting of the application, firmware, and imaging library. The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator. The results of the software verification and validation demonstrate that the CORE M2 v4.1 software meets the defined software requirements.
6
Simulated Use / Usability Validation
Simulated Use/Usability Validation testing was conducted to ensure the CORE M2 System meets the user needs, satisfies the intended use, and demonstrates that users are able to use the device safely and effectively. The results of this validation demonstrate that the CORE M2 System meets the user needs.
Image Validation
An Image Validation was also conducted to confirm that the images acquired and displayed by the CORE M2 System are clinically acceptable for end users. The results of the image validation demonstrate that the CORE M2 system provides images which are clinically acceptable.
Summary
The results of the performance data for the CORE M2 System demonstrate substantial equivalence to the predicate device.