(103 days)
Not Found
No
The summary describes a system for imaging and measuring physiological parameters (FFR) using optical and pressure sensing technology. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an imaging and diagnostic system used to provide information (images and FFR) to help physicians determine if therapeutic intervention is needed, but it does not perform any therapy itself.
Yes
The device is intended for "imaging of coronary arteries" and to "determine the physiological parameter, Fractional Flow Reserve (FFR)", which are diagnostic functions used to assess a patient's condition.
No
The device description explicitly lists hardware components like a cart-mounted computer, optical engine, Drive-motor and Optical Coupler (DOC), and USB receivers, indicating it is not solely software.
Based on the provided text, this device 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 C7 XR™ Imaging System with C7 Dragonfly™ Imaging Catheter is used for imaging coronary arteries directly within the body (in vivo). It also measures physiological parameters (pressure and FFR) directly within the body.
- No Sample Analysis: The device does not analyze samples taken from the patient. It interacts directly with the patient's anatomy.
Therefore, the device falls under the category of an in vivo diagnostic or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The C7 XR™ Imaging System with C7 Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The C7 XR™ Imaging System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
Product codes (comma separated list FDA assigned to the subject device)
NQQ, NOO
Device Description
The C7 XR™ Imaging System K093857 (C7 XR) and Dragonfly™ Imaging Catheter (Dragonfly Catheter or DF) provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real-time images. The C7 XR will include two USB receivers to accept radiofrequency signals from a distal intracoronary pressure transducer and a proximal aortic pressure transducer and display the acquired pressure waveforms and calculated Fractional Flow Reserve on the C7 XR system monitor.
The C7 with FFR system consists of the following components:
C7 XR Imaging System (K093857): A cart-mounted computer and optical engine control the device and function as user interface, display and data storage. It includes the Drive-motor and Optical Coupler (DOC). The DOC is an optical-electro-mechanical device that provides the optical interconnection between the C7 XR and Dragonfly Catheter, and controls the rotational and axial motion of the fiber-optic core within the catheter and will include two USB receivers to accept radiofrequency signals from the distal intracoronary pressure transducer and a proximal aortic pressure transducer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT) (utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue)
Anatomical Site
Coronary arteries, vessels 2.0 to 3.5 mm in diameter. Not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
Clinical performance evaluation (Usability Testing) indicates that the C7 XR™ Imaging System with FFR is substantially equivalent to the predicate devices C7 XR™ Imaging System (K093857) and RadiAnalyzer® Xpress (K092105).
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
K///201
AUG 1 0 2011
510(k) SUMMARY as required per 807.92(c)
LightLab Imaging, Inc. Submitter's Name and Address: One Technology Park Drive Westford, MA 01886
Name, Title, and Telephone Number of Contact:
Bryan Cowell, M.Sc., RAC Principal Regulatory Affairs Specialist Tel: (978) 399-1073 Fax: (978) 692-1409 bcowell@sjm.com
Date submission was prepared: April 28, 2011
Device Name:
C7 XRTM Imaging System with Fractional Flow Reserve (FFR) (ILUMIEN Guided Therapy System)
Common Name:
Imaging system
| Product Code: | NQQ |
|---|---|
| Class: | II |
| Classification Name and Rule: | Ultrasonic Pulsed Echo Imaging System |
Classification Panel:
21 CFR § 892.1560
Establishment Registration:
Establishment:
LightLab Imaging, Inc. One Technology Park Drive Westford, MA 01886
Registration Number: 3004672267
Owner/Operator:
LightLab Imaging, Inc. One Technology Park Drive Westford, MA 01886 Owner /Operator Number: 9101521
Legally Marketed Device Identification:
Optical Coherence Tomography Imaging System
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Proposed Device Description:
The C7 XR™ Imaging System K093857 (C7 XR) and Dragonfly™ Imaging Catheter (Dragonfly Catheter or DF) provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real-time images. The C7 XR will include two USB receivers to accept radiofrequency signals from a distal intracoronary pressure transducer and a proximal aortic pressure transducer and display the acquired pressure waveforms and calculated Fractional Flow Reserve on the C7 XR system monitor.
The C7 with FFR system consists of the following components:
C7 XR Imaging System (K093857): A cart-mounted computer and optical engine control the device and function as user interface, display and data storage. It includes the Drive-motor and Optical Coupler (DOC). The DOC is an optical-electro-mechanical device that provides the optical interconnection between the C7 XR and Dragonfly Catheter, and controls the rotational and axial motion of the fiber-optic core within the catheter and will include two USB receivers to accept radiofrequency signals from the distal intracoronary pressure transducer and a proximal aortic pressure transducer.
Proposed Intended Use:
C7 XR System (K093857) modification for Fractional Flow Reserve
The C7 XR™ Imaging System with C7 Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 DragonflyTM Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The C7 XR™ Imaging System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
Page 2 of 4
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2
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Predicate Devices:
- K093857 510(k) No .: . C7 XRTM Imaging System with C7 DragonflyTM Imaging Catheter Trade Name: SE Date: 04/30/2010 Manufacturer: LightLab Imaging, Inc.
- . 510(k) No .: K092105 Trade Name: RadiAnalyzer® Xpress SE Date: 10/09/2009 Manufacturer: Radi Medical Systems AB, Inc.
- 510(k) No.: K080813 . Trade Name: Pressure Wire® SE Date: 7/01/2008 Manufacturer: Radi Medical Systems AB, Inc.
Substantial Equivalence:
Assessment of non-clinical performance data for equivalence: The C7 XRTM Imaging System with FFR was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device(s).
Assessment of clinical performance data for equivalence:
Clinical performance evaluation (Usability Testing) indicates that the C7 XR™ Imaging System with FFR is substantially equivalent to the predicate devices C7 XR™ Imaging System (K093857) and RadiAnalyzer® Xpress (K092105):
Sterilization:
Not applicable. The C7 XR™ Imaging System with FFR is composed of the C7 XR System which is not supplied sterile. There are no modifications to the Dragonfly catheter in this submission.
Biocompatibility:
Not applicable. The C7 XR™ Imaging System with FFR does not directly contact the patient. If patient contact is made by C7 XR™ Imaging System with FFR it is transient and should be with intact unbroken skin. There are no modifications to the Dragonfly catheter in this submission.
Page 3 of 4
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3
Standards and Guidance Documentation for reference:
| Document
| Number/Standard | Description |
|---|---|
| ISO 13485 | Medical devices -- Quality management systems -- |
| Requirements for regulatory purposes | |
| ISO 14971 | Medical devices -- Application of risk management to medical |
| devices | |
| ISO 15223 | Medical devices -- Symbols to be used with medical device |
| labels, labeling and information to be supplied | |
| ISO 11607-1 | Packaging for terminally sterilized medical devices -- Part 1: |
| Requirements for materials, sterile barrier systems and | |
| packaging systems | |
| ISO 11607-2 | Packaging for terminally sterilized medical devices -- Part 2: |
| Validation requirements for forming, sealing and assembly | |
| processes | |
| ISO 10993 | Biological evaluation of medical devices |
| EN980 | Symbols for use in Labeling of Medical Devices |
| IEC 60601-1 | Medical electrical equipment - General requirements for basic |
| safety and essential performance | |
| IEC 60601-1-1 | Medical electrical equipment - Part 1-1: General requirements |
| for safety - Collateral standard: Safety requirements for medical | |
| electrical systems | |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements |
| for basic safety and essential performance - Collateral standard: | |
| Electromagnetic compatibility - Requirements and tests | |
| IEC 60825-1 | IEC 60825-1 - Part 1: Equipment classification, requirements |
| and user's guide | |
| IEC 62304 | Medical device software - Software lifecycle processes |
| EN 62366 | Medical devices. Application of usability engineering to |
| medical devices | |
| EN 60825-1 | Safety of laser products - Part 1: Equipment classification and |
| requirements | |
| 404P08 | Software Development Process |
| 405P02 | Software Validation Procedure |
| IEC 60601-1-4 | Medical electrical equipment - Part 1: General Requirements |
| for Safety - Collateral Standard: Programmable electrical | |
| medical systems | |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements |
| for basic safety and essential performance - Collateral standard: | |
| Usability |
Page 4 OF 4
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract emblem featuring three stylized horizontal lines that resemble an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
LightLab Imaging, Inc. c/o Mr. Bryan Cowell Principal Regulatory Affairs Specialist One Technology Park Drive Westford, MA 01886
AUG 1 0 2011
Re: K111201
Trade/Device Name: C7 XR Imaging System with Fractional Flow Reserve (FFR) Regulatory Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: II (two) Product Code: NOO Dated: July 13, 2011 Received: July 15, 2011
Dear Mr. Cowell:
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.
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
5
Page 2 - Mr. Bryan Cowell
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 device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): TBD
Device Name: C7 XRTM Imaging System with FFR (Fractional Flow Reserve)
Intended Use:
The C7 XR™ Imaging System with C7 Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The C7 XR™ Imaging System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
| Prescription Use
(Part 21 CFR 801 Subpart D) | ✓ | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K111201 |
|---|---|
| --------------- | --------- |
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