(262 days)
Not Found
No
The summary describes a guidewire with a sensor for physiological measurements and mentions standard clinical practice for positioning. There is no mention of AI, ML, image processing, or any data analysis beyond basic physiological parameter measurement. The performance studies focus on biocompatibility, sterilization, and mechanical properties, not algorithmic performance.
No.
The device is used to measure physiological parameters and guide a catheter, not to provide therapy.
Yes
The device is described as measuring physiological parameters in the heart and blood vessels, and it connects to a "diagnostic computer" or "catheter laboratory hemodynamic recording system," indicating its role in providing data for diagnosis.
No
The device description clearly details a physical guidewire with an integrated sensor, a torque device, and connection cables/transmitters, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels." This describes a device used within the body to perform measurements in vivo.
- Device Description: The description details a guidewire with an integrated sensor that is introduced into the patient's blood vessel. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside the body. IVDs are specifically designed for testing these types of samples in vitro.
Therefore, the PressureWire is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
PressureWire™ 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.
Product codes
DXO, DQX, DRG
Device Description
The PressureWire 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 is available in two different lengths.
The guidewire is uniquely paired with a specific connection cable for PressureWire Certus or with a specific transmitter for PressureWire Aeris (subject device). Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The 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
The PressureWire has been tested and is in compliance with ISO 10993-1:2009 with C1:2010), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO TS 11135-2:2008, Sterilization of health care products -Ethylene Oxide - Part 2 Guidance on the application of ISO 11135-1, USP 33-NF 28 General chapter Particulate matter in injections, and USP 36 Containers - Plastics.
In addition to the Biocompatibility, Sterilization and Particulate testing performed design verification and validation was performed on the PressureWire in compliance with internal design control procedures which included bench testing. This bench testing included physical, mechanical and coating integrity testing for fractures, friction force, and wire diameter and straightness.
The results of this testing concludes the PressureWire is determined to be safe and effective and is substantially equivalent to the predicate device PressureWire Certus and PressureWire Aeris.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
St Jude Medical Systems AB Mr. Jeffrey Roberts Principal Regulatory Affairs Specialist Palmbladsgatan 10, Box 6350 SE-751 35 Uppsala, Sweden
Re: K140466
Trade/Device Name: PressureWire Certus and Aeris Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO, DQX, DRG Dated: September 25, 2014 Received: September 29, 2014
Dear Mr. Roberts:
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 (reporting of medical
1
Page 2 - Mr. Jeffrey Roberts
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 contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K140466
Device Name PressureWire
Indications for Use (Describe)
PressureWire™ 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.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY 510(K) NUMBER: K140466
for the St. Jude Medical Systems AB PressureWire™ (per 21CFR 807.92)
1. SUBMITTER/510(K) HOLDER
St. Jude Medical Systems AB Palmbladsgatan 10, Box 6350 SE-751 35 Uppsala, Sweden
Contact Person: Jeffrey Roberts 978-577-3451 Telephone:
Date Prepared: 11/5/14
2. DEVICE NAME
| Proprietary Name: | PressureWire™ |
|---|---|
| Common/Usual Name: | PressureWire™ Guidewire |
| Classification Name: | Transducer, Pressure, Catheter Tip (870.2870) |
| Wire, Guide, Catheter (870.1330) | |
| Transmitters and Receivers, physiological signal, | |
| radiofrequency (870.2910) |
3. PREDICATE DEVICE
PressureWire™ Certus™ and PressureWire™ Aeris™, cleared September 5, 2013 under K131452.
4. DEVICE DESCRIPTION
The PressureWire 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 is available in two different lengths.
The guidewire is uniquely paired with a specific connection cable for PressureWire Certus or with a specific transmitter for PressureWire Aeris (subject device). Both PressureWire
4
connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.
5. INTENDED USE
PressureWire™ 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.
6. PREDICATE DEVICE COMPARISON
PressureWire was cleared by FDA under 510(k) K131452 on September 5, 2013. The subject device is substantially equivalent to the predicate device in terms of intended use, indication for use, operational characteristics, and fundamental design and technology characteristics.
The subject device, PressureWire™ (models Certus™ and Aeris™), has been modified with regards to the hydrophobic PTFE coating on the proximal part of the guidewire.
7. TESTING SUMMARY
The PressureWire has been tested and is in compliance with ISO 10993-1:2009 with C1:2010), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO TS 11135-2:2008, Sterilization of health care products -Ethylene Oxide - Part 2 Guidance on the application of ISO 11135-1, USP 33-NF 28 General chapter Particulate matter in injections, and USP 36 Containers - Plastics.
In addition to the Biocompatibility, Sterilization and Particulate testing performed design verification and validation was performed on the PressureWire in compliance with internal design control procedures which included bench testing. This bench testing included physical, mechanical and coating integrity testing for fractures, friction force, and wire diameter and straightness.
The results of this testing concludes the PressureWire is determined to be safe and effective and is substantially equivalent to the predicate device PressureWire Certus and PressureWire Aeris.
8. SUBSTANTIAL EQUIVALENCE
The fundamental scientific technology for the subject device is the same as for predicate device regarding signal transfer, mechanical properties and intended use. Pressure Wire is substantially equivalent to the predicated device in intended use, indication for use, fundamental design and technology, and operating principles, Both devices connect to a diagnostic computer or a catheter laboratory hemodynamic recording system to enable
5
measurements of physiological parameters with a minor design change incorporated into the Pressure Wire guidewire from the predicate device:
- Modification of the hydrophobic PTFE coating on the proximal part of the guidewire.
The subject device, PressureWire™ (models Certus™ and Aeris™), meets the design inputs and raises no new safety or efficacy concerns. PressureWire™ is determined to be substantially equivalent to the presently marketed predicate device, K131452.
8. CONCLUSION
The results of these activities demonstrate that the PressureWire is as safe, as effective, and performs as well as or better than the predicate device.