(93 days)
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.
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.
I am sorry, but the provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets specific performance criteria. The text describes the product, its indications for use, and a comparison to predicate devices, but lacks the specific data points needed to answer your questions.
Here's what I can tell you based on the provided text, and what is missing:
Missing Information:
- Detailed Acceptance Criteria and Reported Device Performance Table: The document states "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." However, it does not provide a table outlining specific acceptance criteria (e.g., image resolution, penetration depth, signal-to-noise ratio) and the corresponding reported performance values for the Reconnaissance PV .018 OTW Digital IVUS Catheter.
- Sample Size for Test Set and Data Provenance: This information is not explicitly stated.
- Number of Experts and Qualifications for Ground Truth of Test Set: This information is not provided.
- Adjudication Method for Test Set: This information is not provided.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no mention of an MRMC study or any comparison of human reader performance with and without AI assistance.
- Standalone Performance Study: The document does not explicitly detail a standalone performance study of the algorithm without human-in-the-loop.
- Type of Ground Truth Used: The document mentions "testing results" and "verification/validation" but does not specify the type of ground truth used (e.g., another imaging modality, histological analysis, clinical outcomes).
- Sample Size for Training Set: This information is not provided.
- How Ground Truth for Training Set was Established: This information is not provided.
The document primarily focuses on the regulatory submission (510(k)) and establishing substantial equivalence to existing predicate devices based on design, indications for use, and principle of operation, rather than providing a detailed technical performance study in this summary. It mentions that "Verification/validation demonstrate that the Reconnaissance catheter will perform as intended," implying that studies were conducted, but the specifics are not included in this document.
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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 Corporation3721 Valley Centre Drive, Suite 500San Diego, CA 92130 |
|---|---|
| CONTACT/SUBMITTER: | Mary Stanners, RACRegulatory Affairs SpecialistPhilips Image Guided Therapy Corporation3721 Valley Centre Drive, Suite 500San Diego, CA 92130Tel: (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 870.1200OBJ: Diagnostic Intravascular Catheter21 CFR 892.1570ITX: 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-wireintravascular imaging catheter with a digital ultrasound transducerat the distal end and has a transducer that utilizes a 64-elementcylindrical array that radiates acoustic energy into the surroundingtissue and detects the subsequent echoes. The information from theechoes is used to generate real-time images of the peripheralvessels. The Reconnaissance PV .018 Digital IVUS catheter isdesigned for use as an adjunct to conventional angiographicprocedures to provide an image of the vessel lumen and wallstructures. |
| The catheter has 150cm working length and a hydrophilic coating atthe distal 40 cm to assist the clinician in advancing the catheter tothe desired location. The minimum guide sheath is 5F (0.074") andthe maximum guide wire Outer Diameter (OD) is 0.018" (0.46 mm).At the proximal end, there is a PIM Connector and Y Connector (akaY-Arm). The Y-Arm allows the catheter to incorporate the PIMConnector while still serving as an over-the-wire design. A Luer/hubfitting (aka the Y-Arm) is attached to the proximal end of thecatheter via an integrated strain relief and provides a channel for thescanner lead wires, routed from the cylindrical ultrasoundtransducer array, to interface electrically with the patient interfacemodule (PIM) connector. The Visions® PV 0.018 Catheter may onlybe used with Philips Imaging Systems, such as the CORE SeriesPrecision Guided Therapy Systems such as the IntraSight System. | |
| INDICATIONS FOR USE: | The Reconnaissance PV .018 Digital IVUS catheter is designed for usein the evaluation of vascular morphology in blood vessels of theperipheral vasculature by providing a cross-sectional image of suchvessels. This device is not currently indicted for use in cerebralvessels.The Reconnaissance PV .018 Digital IVUS catheter is designed for useas an adjunct to conventional angiographic procedures to provide animage of the vessel lumen and wall structures. |
| COMPARISON OFCHARACTERISTICS | The Reconnaissance PV .018 OTW catheter is a modification to thecurrently marketed PV .018 Digital IVUS Catheter cleared underK150442 to an over the wire design. Philips has prior experiencewith an over the wire digital IVUS catheter having obtainedclearance and marketed the PV .035 Digital IVUS catheter (K153094).The subject device and predicates are all phased array cathetersusing synthetic Aperture Intravascular technology. The subject andpredicates devices have the same principle of operation. The devicesincorporate an ultrasound transducer array located near the distaltip of the catheter. The array radiates acoustic energy into thesurrounding tissue and detects the subsequent ultrasonic echoes.The information from the echoes is transmitted to compatibleimaging systems and is used to generate real-time images ofperipheral vessel lumens and wall structures.The subject device scanner and electrical components are the sameas 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 theReconnaissance catheter as compared to the predicates. The |
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| CONCLUSIONS | Based on the testing results, the Reconnaissance Digital IVUSCatheter is substantially equivalent to the predicates. The datasupport the performance and safety of the device.Verification/validation demonstrate that the Reconnaissancecatheter will perform as intended in the defined conditions. |
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§ 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).