(93 days)
No
The summary describes a standard intravascular ultrasound (IVUS) catheter and imaging system, focusing on hardware components and basic image generation. There is no mention of AI, ML, or advanced image processing beyond real-time image generation from ultrasound echoes. The lack of information on training/test sets and performance metrics typically associated with AI/ML further supports this conclusion.
No
The device is used for imaging and evaluation of vascular morphology, not for treating a disease or condition.
Yes
The device is described as providing a "cross-sectional image" of blood vessels and generating "real-time images" of peripheral vessels, which is used for the "evaluation of vascular morphology," indicating its purpose is to aid in the diagnosis of conditions related to the structure of blood vessels.
No
The device description clearly details a physical catheter with a digital ultrasound transducer, connectors, and a hydrophilic coating, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Reconnaissance PV .018 Digital IVUS catheter is an intravascular imaging catheter. It uses ultrasound to create real-time images of the inside of blood vessels in the peripheral vasculature. It is used in vivo (within the living body) during a medical procedure.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly images the internal structures of blood vessels.
Therefore, the function and intended use of this device clearly fall outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Reconnaissance PV .018 Digital IVUS catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicted for use in cerebral vessels.
The Reconnaissance PV .018 Digital IVUS catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Product codes (comma separated list FDA assigned to the subject device)
OBJ, ITX
Device Description
The Reconnaissance PV .018 OTW IVUS Catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end and has a transducer that utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The Reconnaissance PV .018 Digital IVUS catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
The catheter has 150cm working length and a hydrophilic coating at the distal 40 cm to assist the clinician in advancing the catheter to the desired location. The minimum guide sheath is 5F (0.074") and the maximum guide wire Outer Diameter (OD) is 0.018" (0.46 mm).
At the proximal end, there is a PIM Connector and Y Connector (aka Y-Arm). The Y-Arm allows the catheter to incorporate the PIM Connector while still serving as an over-the-wire design. A Luer/hub fitting (aka the Y-Arm) is attached to the proximal end of the catheter via an integrated strain relief and provides a channel for the scanner lead wires, routed from the cylindrical ultrasound transducer array, to interface electrically with the patient interface module (PIM) connector. The Visions® PV 0.018 Catheter may only be used with Philips Imaging Systems, such as the CORE Series Precision Guided Therapy Systems such as the IntraSight System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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)
Not Found
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.
Visions PV .018 Digital IVUS Catheter (K150442), Visions EEP/EEP-ST/Visions PV .014P RX Digital IVUS Catheter (K143701)
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.
Visions PV .035 Digital IVUS Catheter (K153094)
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
May 22, 2020
Philips Image Guided Therapy Corporation Mary Stanners Regulatory Affairs Specialist 3721 Valley Centre Drive Ste 500 San Diego, California 92130
Re: K200410
Trade/Device Name: Reconnaissance PV .018 OTW Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: February 18, 2020 Received: February 19, 2020
Dear Mary Stanners:
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 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
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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 (QS) 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.
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular 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) K200410
Device Name
Reconnaissance PV .018 OTW Digital IVUS Catheter
Indications for Use (Describe)
The Reconnaissance PV .018 Digital IVUS catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicted for use in cerebral vessels.
The Reconnaissance PV .018 Digital IVUS catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the 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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510(k) SUMMARY
| SPONSOR: | Philips Image Guided Therapy Corporation
3721 Valley Centre Drive, Suite 500
San Diego, CA 92130 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Mary Stanners, RAC
Regulatory Affairs Specialist
Philips Image Guided Therapy Corporation
3721 Valley Centre Drive, Suite 500
San Diego, CA 92130
Tel: (858) 764-1296 |
| DATE PREPARED: | May 13, 2020 |
| DEVICE: | Intravascular Ultrasound Catheter |
| TRADE NAME: | Reconnaissance PV .018 OTW Digital IVUS Catheter |
| COMMON NAME: | Intravascular Ultrasound Catheter |
| CLASSIFICATION: | 21 CFR 870.1200
OBJ: Diagnostic Intravascular Catheter
21 CFR 892.1570
ITX: Diagnostic Ultrasound Transducer |
| PREDICATE DEVICES: | Visions PV .018 Digital IVUS Catheter (K150442)
Visions EEP/EEP-ST/Visions PV .014P RX Digital IVUS Catheter
(K143701) |
| REFERENCE DEVICE: | Visions PV .035 Digital IVUS Catheter (K153094) |
| DEVICE DESCRIPTION: | The Reconnaissance PV .018 OTW IVUS Catheter is an over-the-wire
intravascular imaging catheter with a digital ultrasound transducer
at the distal end and has a transducer that utilizes a 64-element
cylindrical array that radiates acoustic energy into the surrounding
tissue and detects the subsequent echoes. The information from the
echoes is used to generate real-time images of the peripheral
vessels. The Reconnaissance PV .018 Digital IVUS catheter is
designed for use as an adjunct to conventional angiographic
procedures to provide an image of the vessel lumen and wall
structures. |
| | The catheter has 150cm working length and a hydrophilic coating at
the distal 40 cm to assist the clinician in advancing the catheter to
the desired location. The minimum guide sheath is 5F (0.074") and
the maximum guide wire Outer Diameter (OD) is 0.018" (0.46 mm).
At the proximal end, there is a PIM Connector and Y Connector (aka
Y-Arm). The Y-Arm allows the catheter to incorporate the PIM
Connector while still serving as an over-the-wire design. A Luer/hub
fitting (aka the Y-Arm) is attached to the proximal end of the
catheter via an integrated strain relief and provides a channel for the
scanner lead wires, routed from the cylindrical ultrasound
transducer array, to interface electrically with the patient interface
module (PIM) connector. The Visions® PV 0.018 Catheter may only
be used with Philips Imaging Systems, such as the CORE Series
Precision Guided Therapy Systems such as the IntraSight System. |
| INDICATIONS FOR USE: | The Reconnaissance PV .018 Digital IVUS catheter is designed for use
in the evaluation of vascular morphology in blood vessels of the
peripheral vasculature by providing a cross-sectional image of such
vessels. This device is not currently indicted for use in cerebral
vessels.
The Reconnaissance PV .018 Digital IVUS catheter is designed for use
as an adjunct to conventional angiographic procedures to provide an
image of the vessel lumen and wall structures. |
| COMPARISON OF
CHARACTERISTICS | The Reconnaissance PV .018 OTW catheter is a modification to the
currently marketed PV .018 Digital IVUS Catheter cleared under
K150442 to an over the wire design. Philips has prior experience
with an over the wire digital IVUS catheter having obtained
clearance and marketed the PV .035 Digital IVUS catheter (K153094).
The subject device and predicates are all phased array catheters
using synthetic Aperture Intravascular technology. The subject and
predicates devices have the same principle of operation. The devices
incorporate an ultrasound transducer array located near the distal
tip of the catheter. The array radiates acoustic energy into the
surrounding tissue and detects the subsequent ultrasonic echoes.
The information from the echoes is transmitted to compatible
imaging systems and is used to generate real-time images of
peripheral vessel lumens and wall structures.
The subject device scanner and electrical components are the same
as those used in the predicate device Visions EEP/EEP-ST/Visions PV
.014P RX Digital IVUS Catheter (K143701).
There are differences in the catheter materials and coating of the
Reconnaissance catheter as compared to the predicates. The |
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| CONCLUSIONS | Based on the testing results, the Reconnaissance Digital IVUS
Catheter is substantially equivalent to the predicates. The data
support the performance and safety of the device.
Verification/validation demonstrate that the Reconnaissance
catheter will perform as intended in the defined conditions. |
| ------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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