Who is the manufacturer of Reconnaissance PV .018 OTW Digital IVUS Catheter?

Philips Image Guided Therapy Corporation filed the 510(k) submission for Reconnaissance PV .018 OTW Digital IVUS Catheter (K200410).

What is the FDA product code for Reconnaissance PV .018 OTW Digital IVUS Catheter?

OBJ. It is classified under 21 CFR 870.1200 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Reconnaissance PV .018 OTW Digital IVUS Catheter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Reconnaissance PV .018 OTW Digital IVUS Catheter?

Visions PV .018 Digital IVUS Catheter (K150442); Visions EEP/EEP-ST/Visions PV .014P RX Digital IVUS Catheter (K143701).

Who can help prepare an FDA 510(k) submission like Reconnaissance PV .018 OTW Digital IVUS Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Reconnaissance PV .018 OTW Digital IVUS Catheter

K200410 · Philips Image Guided Therapy Corporation · OBJ · May 22, 2020 · Cardiovascular

Device Facts

Record ID	K200410
Device Name	Reconnaissance PV .018 OTW Digital IVUS Catheter
Applicant	Philips Image Guided Therapy Corporation
Product Code	OBJ · Cardiovascular
Decision Date	May 22, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1200
Device Class	Class 2

Intended 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.

Device Story

Over-the-wire (OTW) intravascular ultrasound (IVUS) catheter; 64-element cylindrical transducer array at distal tip. Radiates acoustic energy into peripheral vessel tissue; detects echoes; transmits data to Philips imaging systems (e.g., CORE Series, IntraSight). Used in clinical settings by physicians as adjunct to angiography. Provides real-time cross-sectional images of vessel lumen and wall structures. Assists clinicians in vascular morphology evaluation; aids in procedural decision-making during peripheral interventions.

Clinical Evidence

Bench testing only. No clinical data presented. Verification and validation testing demonstrate the device performs as intended under defined conditions.

Technological Characteristics

64-element cylindrical ultrasound transducer array; 150cm working length; hydrophilic coating on distal 40cm. Compatible with 0.018" guidewires and 5F guide sheaths. Electrical interface via PIM connector. Phased array synthetic aperture technology. Standalone catheter for use with compatible Philips imaging systems.

Indications for Use

Indicated for evaluation of vascular morphology in peripheral vasculature via cross-sectional imaging. Adjunct to conventional angiography for imaging vessel lumen and wall structures. Contraindicated for use in cerebral vessels.

Regulatory Classification

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.

Predicate Devices

Visions PV .018 Digital IVUS Catheter (K150442)
Visions EEP/EEP-ST/Visions PV .014P RX Digital IVUS Catheter (K143701)

Reference Devices

Visions PV .035 Digital IVUS Catheter (K153094)

Related Devices

K153094 — Visions PV .035 Digital IVUS Catheter · Volcano Corporation · Dec 31, 2015
K253399 — Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter · Volcano Corporation (Dba Philips Image Guided Therapy Device · Oct 28, 2025
K143701 — EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM · Volcano Corporation · Aug 26, 2015
K181126 — Reprocessed Visions PV .035 Digital IVUS Catheter · Innovative Health, LLC · Jan 18, 2019
K150442 — Volcano Visions PV .018 Digital IVUS Catheter · Volcano Corporation · Sep 4, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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 | {4}------------------------------------------------ {5}------------------------------------------------ {6}------------------------------------------------ | 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. | |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|