(262 days)
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.
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.
This FDA 510(k) summary for the PressureWire device (K140466) describes a modification to an already cleared device, not a new initial clearance study with acceptance criteria for clinical performance. Therefore, many of the requested categories related to clinical study design and performance metrics will not be fully addressed in this document.
The primary purpose of this 510(k) is to demonstrate substantial equivalence to a predicate device (PressureWire Certus and Aeris, K131452) after a minor design change. The "acceptance criteria" here are focused on demonstrating that the modified device maintains the safety and efficacy of the predicate, and performs comparably, rather than meeting specific performance thresholds against a clinical ground truth.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a 510(k) for a modification, the "acceptance criteria" largely revolve around demonstrating that the modified device (PressureWire with new coating) performs equivalently or better than the predicate device in non-clinical tests. Clinical performance metrics like sensitivity, specificity, or reader improvement are not evaluated in this type of submission for this device.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2009 | "The PressureWire has been tested and is in compliance with ISO 10993-1:2009 with C1:2010), Biological evaluation of medical devices..." |
| Sterilization | Compliance with ISO TS 11135-2:2008 | "...ISO TS 11135-2:2008, Sterilization of health care products -Ethylene Oxide - Part 2 Guidance on the application of ISO 11135-1..." |
| Particulate Matter | Compliance with USP 33-NF 28 <788> and USP 36 <661> | "...USP 33-NF 28 General chapter <788> Particulate matter in injections, and USP 36 <661> Containers - Plastics." |
| Physical/Mechanical | Integrity for fractures, friction force, wire diameter & straightness (comparable to predicate) | "bench testing included physical, mechanical and coating integrity testing for fractures, friction force, and wire diameter and straightness." Results conclude it is "safe and effective and is substantially equivalent to the predicate device." |
| Coating Integrity | Maintained or improved after modification | "coating integrity testing." Results conclude it is "safe and effective and is substantially equivalent to the predicate device." |
Note: The document explicitly states: "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." This overall "acceptance" is based on the comprehensive testing summarized above.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of human clinical data. The "test set" here refers to physical samples of the modified guidewire for bench testing. The document does not specify the number of individual guidewires tested for each category (e.g., how many wires were tested for friction, how many for fractures).
- Data Provenance: The testing was "performed design verification and validation ... in compliance with internal design control procedures which included bench testing." This implies internal testing by the manufacturer (St. Jude Medical Systems AB, Sweden). The data is retrospective in the sense that it's generated after the design modification but for internal verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For this type of device modification and 510(k) submission, there isn't a "ground truth" established by external experts in the same way one would for a diagnostic AI device requiring expert interpretation. The "ground truth" for the non-clinical tests is based on established engineering standards (ISO, USP) and the performance characteristics of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. There's no human interpretation or subjective assessment of the test results that would require adjudication. Bench testing results are typically objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and would measure the impact of an AI algorithm on reader performance. The PressureWire is a medical instrument for direct physiological measurement, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not directly applicable. The PressureWire is the standalone device; it's a sensor-equipped guidewire that measures physiological parameters. There isn't a separate "algorithm" in the sense of an AI model that could be evaluated standalone from the physical device. The device's performance is determined by its physical and electrical characteristics.
7. The Type of Ground Truth Used
For the non-clinical testing performed:
- Engineering Standards: Compliance with ISO 10993-1, ISO TS 11135-2, USP 33-NF 28 <788>, and USP 36 <661>.
- Predicate Device Performance: The underlying "ground truth" for the modification's impact is that the modified device's performance should be equivalent to or better than the original predicate device (K131452) across relevant physical and functional parameters, as established during the predicate's original clearance.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
{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
{2}------------------------------------------------
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)
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: 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 <788> Particulate matter in injections, and USP 36 <661> 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.
§ 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).