(112 days)
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No
The document describes a software tool for offline calculation of iFR values from existing pressure recordings. There is no mention of AI, ML, or any learning algorithms. The process described is a deterministic calculation based on existing data.
No.
This device is an "offline analysis tool" that calculates iFR values from existing pressure recordings; it does not directly treat or diagnose a condition.
Yes
Explanation: The device is intended to "calculate iFR values" from pressure recordings, which are used to assess the "coronary and peripheral vasculature." Calculating and summarizing these values for a physician to interpret for diagnosis inherently makes it a diagnostic device. Its purpose is to provide information for the identification of a disease or condition.
Yes
The device is described as a "software tool" that performs offline analysis of existing pressure recordings. It does not include any hardware components and relies on data collected by other Volcano systems. The performance studies listed are software verification and validation.
Based on the provided information, the Volcano iFR® Harvest Modality is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Volcano iFR® Harvest Modality is a software tool that analyzes pressure recordings from within the body (coronary and peripheral vasculature). It does not analyze biological samples taken from the body.
- Intended Use: Its intended use is to calculate iFR values from pressure recordings, which is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, while it's a medical device used in a clinical setting, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Volcano iFR® Harvest Modality is an offline analysis tool of the currently marketed vasodilator-free pressurement module, iFR® Modality of the Volcano s5/s5i/CORE and CORE Mobile systems. It is intended to calculate iFR values from hyperemia-free FFR pressure recordings in a laptop or desktop setting only.
Product codes
IYO
Device Description
The Volcano Harvest iFR® Modality is a software tool designed to calculate offline iFR values from hyperemia-free FFR pressure recordings made using Volcano's s5 v3.2.x software. It takes an existing FFR case file, separates the baseline (iFR) and Pd/Pa (FFR under resting conditions) pressure runs, calculates the iFR values from the baseline runs, and prepares a report summarizing the values. Input case files are collected and archived on the s5 or s5i console from Volcano Corporation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance testing completed for a determination of substantial equivalence included the following:
- . Software Verification
- . Software Validation
The results of the performance data demonstrate equivalence to the predicate device.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design. The caduceus symbol is a common symbol for healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002
February 20, 2015
Volcano Corporation Neeta Sharma Director, Regulatory Affairs 3721 Valley Centre Drive, Suite 500 San Diego, CA 92130
Re: K143122 Trade/Device Name: Volcano Harvest iFR Modality Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO Dated: January 20, 2015 Received: January 22, 2015
Dear Ms. Sharma,
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
5l0(k) Number (if known) K143122
Page 1 of 1
Volcano Harvest iFR® Modality Device Name
Indications for Use
The Volcano iFR® Harvest Modality is an offline analysis tool of the currently marketed vasodilator-free pressurement module, iFR® Modality of the Volcano s5/s5i/CORE and CORE Mobile systems. It is intended to calculate iFR values from hyperemia-free FFR pressure recordings in a laptop or desktop setting only.
X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510 (k) SUMMARY
| SPONSOR: | Volcano Corporation
3721 Valley Center Drive
San Diego, CA 92130 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Neeta Sharma
Director, Regulatory Affairs
Volcano Corporation
3721 Valley Center Drive
San Diego, CA 92130
Tel: (858) 720-4187
Fax :( 858) 720-0335 |
| DATE PREPARED: | February 18, 2015 |
| DEVICE: | Volcano Harvest iFR® Modality |
| TRADE NAME: | Volcano Harvest iFR® Modality |
| COMMON NAME: | Ultrasonic Pulsed Echo Imaging System |
| CLASSIFICATION: | 21 CFR Part 892.1560
IYO: System, Imaging, Pulsed Echo, Ultrasonic
Class II Device |
| PREDICATE DEVICE: | Volcano iFR Modality (K133323) |
| DEVICE DESCRIPTION: | The Volcano Harvest iFR® Modality is a software tool
designed to calculate offline iFR values from hyperemia-
free FFR pressure recordings made using Volcano's s5
v3.2.x software. It takes an existing FFR case file, separates
the baseline (iFR) and Pd/Pa (FFR under resting
conditions) pressure runs, calculates the iFR values from
the baseline runs, and prepares a report summarizing the
values. Input case files are collected and archived on the s5
or s5i console from Volcano Corporation. |
| INTENDED USE: | The Volcano iFR® Harvest Modality is an offline analysis
tool of the currently marketed vasodilator-free pressure
measurement module, iFR® Modality of the Volcano
s5/s5i/CORE and CORE Mobile systems. It is intended to
calculate iFR values from hyperemia-free FFR pressure
recordings in a laptop or desktop setting only. |
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COMPARISON OF CHARACTERISTICS:
The Harvest iFR® Modality is an offline version of the iFR Modality with similar in intended use that both software are designed to measure blood pressure in the coronary and peripheral vasculature. Both softwares have identical technological features. The Harvest iFR® Modality software allows for an offline analysis of the pressure measurement readings to be done if desired by the physician in a laptop or desktop setting.
PERFORMANCE DATA:
Performance testing completed for a determination of substantial equivalence included the following:
- . Software Verification
- . Software Validation
The results of the performance data demonstrate equivalence to the predicate device.