(80 days)
Not Found
No
The summary describes a guidewire with integrated sensors for measuring physiological parameters, with no mention of AI or ML capabilities.
No
The device is indicated to direct a catheter and measure physiological parameters, not to treat a condition.
Yes
The device description explicitly states it has a "detachable cable for connection to a diagnostic computer," and its intended use includes measuring "physiological parameters," both strong indicators of a diagnostic function.
No
The device description explicitly states it is a ".014" guidewire with an integrated pressure and temperature sensor, together with a detachable cable," indicating it is a hardware device with integrated sensors and a cable, not solely software.
Based on the provided information, the PressureWire® is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The PressureWire® is used within the body (in the coronary and peripheral blood vessels) to measure physiological parameters directly.
- The intended use describes directing a catheter and measuring physiological parameters in vivo. This is a direct measurement within the patient, not an analysis of a sample taken from the patient.
- The device description confirms it's a guidewire with sensors for pressure and temperature. These are measurements taken directly from the blood vessel.
Therefore, the PressureWire® is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PressureWire® has the same intended use as the submitter's predicate device. Pressure Wire® 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 pressure or temperature, e.g. Fractional Flow Reserve (FFR).
PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.
Product codes
DXO, DQX
Device Description
Pressure Wire® is a .014" guidewire with an integrated pressure and temperature sensor, together with a detachable cable for connection to a diagnostic computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Biocompatibility and performance testing indicate that PressureWire® satisfies safety and performance requirements of the device specifications and do not raise additional safety issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PressureWire® Sensor, K031662, Safe-Cross Deflecting Catheter, K040481
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
K062769
510(k) Summary
| Submitter: | Radi Medical Systems AB
Palmbladsgatan 10
SE-754 50 Uppsala, Sweden
Phone:(+46) 18161000 | DEC - 4 2006 |
|----------------------|---------------------------------------------------------------------------------------------------|--------------|
| Contact: | Mats Granlund | |
| Date Prepared: | September 13, 2006 | |
| Proprietary Name: | PressureWire® | |
| Common Name: | Pressure Guidewire | |
| Classification Name: | Catheter Tip Pressure Transducer (21 CFR 870.2870)
Product Code DXO | |
| Predicate Devices: | PressureWire® Sensor, K031662
Safe-Cross Deflecting Catheter, K040481 | |
Device Description
Pressure Wire® is a .014" guidewire with an integrated pressure and temperature sensor, together with a detachable cable for connection to a diagnostic computer.
Intended Use of the Device:
PressureWire® has the same intended use as the submitter's predicate device. Pressure Wire® 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 pressure or temperature, e.g. Fractional Flow Reserve (FFR).
Technological Characteristics:
PressureWire® is similar in basic material, design, construction and mechanical performance to the predicate device. The main modification is that the distal part has been coated with a hydrophilic coating.
Performance Data
Biocompatibility 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 device.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 2006
Radi Medical Systems c/o Mats Granlund Director, Quality & Regulatory Affairs Palmbladsgatan 10 Uppsala, Sweden SE-754 50
Re: K062769 Trade/Device Name: PressureWire® Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter tip pressure transduccr Regulatory Class: II Product Code: DXO, DQX Dated: October 25, 2006 Received: October 26, 2006
Dear Mr. Granlund:
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 net 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.
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Page 2 - Mr. Mats Granlund
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); 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdri/industry/support/index.html.
Sincerely yours,
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): K062769
Device Name:
Pressure Wire®
Indications for Use:
PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision of Cardiovascular Devices
510(k) Number K062769
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