(102 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 vessel.
PressureWire® is a .014" guidewire with an integrated pressure and temperature sensor. together with a detachable cable or transmitter/receiver for connection to a diagnostic computer or a cathlab hemodynamic recording system.
The provided 510(k) summary for the PressureWire® Aeris and PressureWire® Receiver describes its technical characteristics and claims substantial equivalence to predicate devices. However, the document does not describe the acceptance criteria and a study proving the device meets those criteria, as typically understood for sophisticated diagnostic or AI-powered devices.
Instead, this submission focuses on functional/safety testing to demonstrate that the new device (which incorporates wireless technology) is as safe and performs as well as previous wired versions. It does not present a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy or effect size.
Here's an analysis based on the information provided, highlighting the absence of what was requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states "satisfies safety and performance requirements of the device specifications." This implies internal specifications, but the specific, measurable criteria are not disclosed. | "Electrical safety, EMC, radio, sterilization and performance testing indicate that PressureWire® satisfies safety and performance requirements of the device specifications and do not raise additional safety issues." |
Explanation: The 510(k) summary does not define explicit, quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for a particular diagnostic task). The "performance testing" mentioned is likely related to the device's functional integrity as a pressure guidewire, rather than its diagnostic efficacy in a clinical setting against a gold standard. The primary focus of this 510(k) is the change from a wired to a wireless signal transfer mechanism.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable. The document does not describe a clinical performance study involving a test set of patient data.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No, this device is a medical instrument (pressure guidewire) for measuring physiological parameters, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. The device itself is the "standalone" instrument. It measures physiological parameters for clinicians to interpret. There is no "algorithm only" performance to evaluate in the context of interpretation, as this is not an AI-driven image analysis or diagnostic software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not explicitly stated or applicable as no clinical performance study against a diagnostic ground truth is described. The "performance requirements" would likely be engineering specifications for pressure and temperature measurement accuracy and reliability, validated against calibrated standards or in-vitro models rather than clinical ground truth for diagnostic interpretation.
8. The sample size for the training set
- Sample size for training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable.
Summary of Device and 510(k) Filing:
The K080813 submission for the PressureWire® Aeris focuses on the technical modifications of an existing device (PressureWire®) by introducing a wireless signal transfer mechanism. The key argument for substantial equivalence is that the new wireless version performs its intended function (directing a catheter and measuring physiological parameters) and meets safety standards just like its predicate wired versions. The 510(k) summary explicitly states: "The guidewire part of subject device is identical to the predicate device (K062769)." The "Functional/Safety Testing" mentioned refers to electrical, EMC, radio, sterilization, and general performance testing to ensure the new wireless components do not introduce new safety concerns or functional degradation compared to the wired predicate. This is a common approach for 510(k) submissions where the changes are primarily technological rather than a new diagnostic claim or a new type of device.
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JUL - 1 2008
510(k) Summary 5.
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements in the Safe Medical Device Act 1990 and 21 CFR §807.92
| Submitted by: | Radi Medical Systems ABPalmbladsgatan 10SE-754 50 Uppsala, SwedenPhone:(+46) 18161000 |
|---|---|
| Contact Person: | Björn Palmgren |
| Date Prepared: | June 10, 2008 |
| Proprietary Name: | Pressure Wire® |
| Common Name: | Pressure Guidewire |
| Classification Name: | Transducer, Pressure, Catheter Tip (870.2870)Wire, Guide, catheter (870.1330)Transmitters and receivers, physiological signal, radiofrequency(870.2910)Diagnostic intravascular catheter. (870.1200) |
| Predicate Devices: | PressureWire® (K062769)PressureWire® System (K972793)Wireless Physiologic Monitoring System (K053016)Mikro-Tip Catheter Pressure Transducer (K883651) |
Description of the Device:
PressureWire® is a .014" guidewire with an integrated pressure and temperature sensor. together with a detachable cable or transmitter/receiver for connection to a diagnostic computer or a cathlab hemodynamic recording system.
Intended Use of the Device:
PressureWire® is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the senor is used for calculation and presentation of any physiological parameters, functions or indices based on temperature or pressure, e.g. Fractional Flow Reserve (FFR). The indication has been modified to address that the device is not only suitable for usage within peripheral and coronary vessels but also for intracardiac measurements within the actual heart.
Indication for Use of the Device:
Pressure Wire® 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 vessel.
Technical Characteristics:
The guidewire part of subject device is identical to the predicate device (K062769).
The new version PressureWire® Aeris, transfer the signal using frequency hoping in the 2.4 GHz frequency radio band, instead of cable. The output from the PressureWire Receiver is compliant with the ANSI/AAMI BP22 standard.
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Functional/Safety Testing:
Electrical safety, EMC, radio, sterilization and performance testing indicate that PressureWire® satisfies safety and performance requirements of the device specifications and do not raise additional safety issues.
Conclusion:
On the basis of the testing conducted, it may be concluded that PressureWire® satisfies specified safety and performance requirements. PressureWire® is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 2008
Radi Medical Systems AB c/o Mr. Björn Palmgren Regulatory Affairs Officer Palmbladsgatan 10 SE-75450 Uppsala SWEDEN
Re: K080813
Trade Name: PressureWire® Aeris and PressureWire® Receiver Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO and DQX Dated: June 9, 2008 Received: June 11, 2008
Dear Mr. Palmgren:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Mr. Björn Palmgren
or any Fedcral 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Ashley B. Bran
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:
Device Name:
PressureWire®
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 vessel.
Prescription Use______________________________________________________________________________________________________________________________________________________________ X (Per 21 CFR 801.Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Devices
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§ 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).