(27 days)
Not Found
No
The summary describes a guidewire with a sensor for measuring physiological parameters and transmitting the signal for analysis and display. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis and calculations mentioned are likely standard physiological calculations (e.g., FFR) based on the measured pressure and temperature, not AI/ML-driven analysis.
No
The device is described as a guidewire indicated to direct a catheter and to measure physiological parameters for diagnostic purposes, not for treating a condition.
Yes
The device is indicated to measure physiological parameters (blood pressure, blood temperature) in the heart and blood vessels, and the output is used for analysis, calculations, and display of these parameters, which is characteristic of a diagnostic device.
No
The device description explicitly states it is a guidewire with an integrated sensor element at the tip, which is a physical hardware component. It also mentions a torque device and connection cables/transmitters, further indicating it is not software-only.
Based on the provided information, the PressureWire™ X guidewire is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- PressureWire™ X Function: The PressureWire™ X guidewire is an invasive device that is introduced into the patient's blood vessels (in vivo) to directly measure physiological parameters like blood pressure and temperature. It does not analyze samples taken from the body.
The device is clearly described as being used within the patient's circulatory system to gather real-time physiological data. This is characteristic of an in vivo diagnostic or monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.
Product codes (comma separated list FDA assigned to the subject device)
DXO, DQX, DRG
Device Description
The PressureWire™ X guidewire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire™ X guidewire is available in two different lengths.
The guidewire is uniquely paired with a specific connection cable or with a specific transmitter. Both PressureWire™ X guidewire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system. The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the sensor is transmitted to associated equipment for analysis, calculations, and display of physiological parameters or indices based on pressure or temperature, e.g. Fractional Flow Reserve (FFR).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart and in the coronary and peripheral blood vessels
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)
Performance bench testing was completed as part of design verification to demonstrate safety and effectiveness, and that the subject device performed as intended. Tests were conducted to evaluate the following:
• Guidewire Tensile Strength
• Torque Strength
• Fatigue Resistance
• Fracture Resistance
• Signal Quality in Severe Bend
• Signal Quality during Pullback Procedure
Additionally, simulated-use testing was completed as part of design validation to demonstrate the subject device met user needs and the intended use. The following test was performed:
• Signal Drift
No new clinical testing was completed, nor relied upon, in support of this Special 510(k) submission.
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
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2018
St. Jude Medical (now part of Abbott Medical) Josh Johnson Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, Minnesota 55117
Re: K180558
Trade/Device Name: PressureWire™ X Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter tip pressure transducer Regulatory Class: Class II Product Code: DXO, DQX, DRG Dated: February 26, 2018 Received: March 1, 2018
Dear Josh Johnson:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Hillemann
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180558
Device Name PressureWire™ X
Indications for Use (Describe)
The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.
| 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
| 510(k) Number: | K180558 |
|---|---|
| Date Prepared: | March 27, 2018 |
| Submitter Name & | |
| Address: | St. Jude Medical |
| One St. Jude Medical Dr. | |
| St. Paul, MN 55117 | |
| Contact Person: | Josh Johnson |
| Regulatory Affairs Specialist | |
| Phone (651) 756-3767 | |
| Fax (651) 756-3301 | |
| josh.johnson@abbott.com | |
| Alternative Contact | |
| Person: | Marlene Peterson |
| Regulatory Affairs Manager | |
| Phone (651) 756-3268 | |
| Fax (651) 756-3301 | |
| marlene.peterson@abbott.com | |
| Proprietary Name: | PressureWire™ X |
| Common/Usual | |
| Name: | PressureWire |
| Product Classification | |
| Code: | Primary: DXO |
| Secondary: DQX & DRG | |
| Product Regulation | |
| Number and Name: | 870.2870, Catheter tip pressure transducer |
| 870.1330 – Wire, Guide, Catheter | |
| 870.2910 - Transmitters and Receivers, Physiological Signal, Radiofrequency | |
| Device Class: | II |
| Predicate Device: | PressureWire™ X (K161171 ) |
| Device Description: | The PressureWire™ X guidewire has an integrated sensor element at the tip to enable |
| measurements of physiological parameters. The wire is introduced into the patient's | |
| blood vessel. A torque device is used to steer the wire and sensor into the required | |
| position for pressure measurements according to standard clinical practice. | |
| PressureWire™ X guidewire is available in two different lengths. | |
| Intended Use: | The guidewire is uniquely paired with a specific connection cable or with a specific |
| transmitter. Both PressureWire™ X guidewire connection configurations connect to a | |
| diagnostic computer or a catheter laboratory hemodynamic recording system. | |
| The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for the | |
| purpose of directing the catheter through a vessel. The signal output from the sensor is | |
| transmitted to associated equipment for analysis, calculations, and display of | |
| physiological parameters or indices based on pressure or temperature, e.g. Fractional | |
| Flow Reserve (FFR). | |
| Indications for Use: | The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel |
| and to measure physiological parameters in the heart and in the coronary and peripheral | |
| blood vessels. Physiological parameters include blood pressure. The PressureWire™ X | |
| guidewire can also measure blood temperature. | |
| Comparison of | |
| Subject to Predicate | |
| Device: | A minor design modification was made to the pressure sensor jacket component of the |
| PressureWire™ X guidewire. Specifically, the sensor jacket design changed from a one- | |
| window to a three-window jacket design, and the window length was extended. The | |
| sensor jacket is located near the distal tip of the PressureWire™ X, and functions to | |
| protect the pressure sensor. The openings in the sensor jacket, or windows, function to | |
| allow fluid flow to the sensor. There were no other changes to the device or IFU. |
4
The intended use, indications for use, and technological characteristics of the PressureWire™ X device that is subject to this Special 510(K) submission are the same as the predicate, and are summarized in the following table:
| | PressureWire™ X
(Subject Device, K180558) | PressureWire™ X
(Predicate Device, K161171) | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary
Name: | PressureWire™ X | PressureWire™ X | |
| Common
Name: | PressureWire | PressureWire | |
| Product
Classific-
ation Code: | Primary: DXO
Secondary: DQX & DRG | Primary: DXO
Secondary: DQX & DRG | |
| Product
Regulation
Number &
Name: | Primary: 870.2870, Catheter tip
pressure transducer
Secondary: 870.1330, catheter
guide wire and 870.2910
radiofrequency physiological
signal transmitters and receivers | Primary: 870.2870, Catheter tip
pressure transducer
Secondary: 870.1330, catheter
guide wire and 870.2910
radiofrequency physiological
signal transmitters and receivers | |
| Device
Class: | II | II | |
| Device
Description: | The PressureWire™ X guidewire
has an integrated sensor element
at the tip to enable measurements
of physiological parameters. The
wire is introduced into the
patient's blood vessel. A torque
device is used to steer the wire
and sensor into the required
position for pressure
measurements according to
standard clinical practice.
PressureWire™ X guidewire is
available in two different lengths.
The guidewire is uniquely paired
with a specific connection cable
or with a specific transmitter.
Both PressureWire™ X
guidewire connection
configurations connect to a
diagnostic computer or a catheter
laboratory hemodynamic
recording system. | The PressureWire™ X guidewire
has an integrated sensor element
at the tip to enable measurements
of physiological parameters. The
wire is introduced into the
patient's blood vessel. A torque
device is used to steer the wire
and sensor into the required
position for pressure
measurements according to
standard clinical practice.
PressureWire™ X guidewire is
available in two different lengths.
The guidewire is uniquely paired
with a specific connection cable
or with a specific transmitter.
Both PressureWire™ X
guidewire connection
configurations connect to a
diagnostic computer or a catheter
laboratory hemodynamic
recording system. | |
| Intended
Use: | The PressureWire™ guidewire is
designed to fit inside a
percutaneous catheter for the
purpose of directing the catheter
through a vessel. The signal
output from the sensor is
transmitted to associated
equipment for analysis,
calculations, and display of | The PressureWire™ guidewire is
designed to fit inside a
percutaneous catheter for the
purpose of directing the catheter
through a vessel. The signal
output from the sensor is
transmitted to associated
equipment for analysis,
calculations, and display of | |
| | | temperature, e.g. Fractional Flow
Reserve (FFR). | temperature, e.g. Fractional Flow
Reserve (FFR). |
| | Indications
for Use: | The PressureWire™ X guidewire
is indicated to direct a catheter
through a blood vessel and to
measure physiological parameters
in the heart and in the coronary
and peripheral blood vessels.
Physiological parameters include
blood pressure. The
PressureWire™ X guidewire can | The PressureWire™ X guidewire
is indicated to direct a catheter
through a blood vessel and to
measure physiological
parameters in the heart and in the
coronary and peripheral blood
vessels. Physiological parameters
include blood pressure. The
PressureWire™ X guidewire can |
| | Contra-
indications: | also measure blood temperature.
This guidewire is contraindicated
for use in the cerebral
vasculature. | also measure blood temperature.
This guidewire is contraindicated
for use in the cerebral
vasculature. |
| | Technical
Specifi-
cations | Operating Pressure: -30 to +300
mmHg
Temp. Performance
Specification:
34 - 42°C
Radio Frequency Range:
2.4000 - 2.4835 GHz (ISM-band) | Operating Pressure: -30 to +300
mmHg
Temp. Performance
Specification:
34 - 42°C
Radio Frequency Range:
2.4000 - 2.4835 GHz (ISM-band) |
| Summary on Non-
Clinical Testing | Performance bench testing was completed as part of design verification to demonstrate
safety and effectiveness, and that the subject device performed as intended. Tests were
conducted to evaluate the following:
• Guidewire Tensile Strength
• Torque Strength
• Fatigue Resistance
• Fracture Resistance
• Signal Quality in Severe Bend
• Signal Quality during Pullback Procedure
Additionally, simulated-use testing was completed as part of design validation to
demonstrate the subject device met user needs and the intended use. The following test
was performed:
• Signal Drift | | |
| Summary of Clinical
Testing: | No new clinical testing was completed, nor relied upon, in support of this Special
510(k) submission. | | |
| Statement of
Equivalence: | The PressureWire™ X device described in this Special 510(k) submission is
substantially equivalent to the currently-marketed predicate device, K161171, based on
comparisons of the device classifications, technological characteristics, intended use,
and indications for use. The subject device met the pre-determined requirements, and
raised no new safety or effectiveness concerns. | | |
5