(29 days)
Not Found
No
The summary describes a pressure wire for physiological measurements and mentions modifications to the transmitter, but there is no mention of AI, ML, or related concepts.
No
The device is indicated for directing a catheter and measuring physiological parameters, which are diagnostic functions, not therapeutic ones.
Yes
The device is indicated to "measure physiological parameters in the heart and in the coronary and peripheral blood vessels" and connects to a "diagnostic computer or a catheter laboratory hemodynamic recording system," indicating its role in diagnosis.
No
The device description explicitly states that the device is a "PressureWire" with an "integrated sensor element at the tip" and a "transmitter." These are hardware components, not solely software.
Based on the provided information, the PressureWire™ is not an In Vitro Diagnostic (IVD).
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 patient's 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 confirms its use within the living organism.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, including blood, tissue, and urine, taken from the human body to provide information for diagnosis, monitoring, or screening. The PressureWire™ does not operate on specimens taken from the body; it operates directly within the body.
Therefore, the PressureWire™ is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 vessels.
Product codes (comma separated list FDA assigned to the subject device)
DRG, DQX, DXO
Device Description
The subject device, PressureWire™ Aeris™, is a new version of the predicate device (K131452), with the same name. 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 ( not subject device for this submission) 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
heart, 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)
A summary of PressureWire™ Design Control Activities with regards to risk analysis and verification and validation activities is provided in this 510k submission. The modifications applies to the transmitter part of the PressureWire™ Aeris™ and do not change the operational principle. The successful completion of verification activities demonstrates that PressureWire™ meets the required product specifications. Based on passing verification criteria for mechanical and signal testing, PressureWire™ performs substantially equivalent to predicate devices.
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
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
T. JUDE MEDICA
Jude Medical Systems AB +46 (0)18 161000 Fax +46 (0)18 161099
. 2 0 2013
Corporate ID no: 556335-9446
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements in 21 CFR $807.92
| Submitted by: | St. Jude Medical Systems AB
Palmbladsgatan 10, Box 6350
SE-751 35 Uppsala, Sweden
Phone:+46 18 161000
Fax: +46 18 161099 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ellinor Nami |
| Date Prepared: | November 15, 2013 |
| Proprietary Name: | PressureWire™ |
| Common Name: | PressureWire™ Guidewire |
| Classification Name: | Transducer, Pressure, Catheter Tip (870.2870)
Wire, Guide, Catheter (870.1330)
Transmitters and Receivers, physiological signal,
radiofrequency (870.2910) |
| Predicate Device: | (K131452) PressureWire™ Aeris™ cleared September 5,
2013
PressureWire™ Aeris™ and PressureWire™ Receiver™,
K080813, cleared July 1, 2008. |
Device Description:
The subject device, PressureWire™ Aeris™, is a new version of the predicate device (K131452), with the same name. 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 ( not subject device for this submission) 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.
Indication 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.
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 indication for use, operational
1
Image /page/1/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of black squares on the left, with the words "ST. JUDE MEDICAL" in a serif font to the right. Below the company name, in smaller letters, is the phrase "MORE CONTROL LESS RISK".
St. Jude Medical Systems AB almbladsgatan 10 x 6350, SE-751 35 Uppsala Tel +46 (0)18 161000 Fax +46 (0)18 161099
Corporate ID no: 556335-9446
characteristics, and fundamental design and technology characteristics. Below list identifies the changes to the subject device.
- Change to PressureWire Aeris Transmitter Hardware -
- Change to PressureWire Aeris Transmitter Software *
- -Change to PressureWire Aeris Transmitter Enclosure
- Change to PressureWire Aeris packaging ..
- Change to PressureWire Aeris IFU .
- Change to the sterilization cycle .
Testing summary:
A summary of PressureWire™ Design Control Activities with regards to risk analysis and verification and validation activities is provided in this 510k submission. The modifications applies to the transmitter part of the PressureWire™ Aeris™ and do not change the operational principle. The successful completion of verification activities demonstrates that PressureWire™ meets the required product specifications. Based on passing verification criteria for mechanical and signal testing, PressureWire™ performs substantially equivalent to predicate devices.
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 measurements of physiological parameters with minor changes incorporated into the Pressure Wire from the predicate device including:
- Change to PressureWire Aeris Transmitter Hardware -
- -Change to PressureWire Aeris Transmitter Software
- Change to PressureWire Aeris Transmitter Enclosure .
- Change to PressureWire Aeris packaging -
- Change to PressureWire Aeris IFU -
- Change to the sterilization cycle -
The subject device, PressureWire™ 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.
Conclusion:
Based on the similarities in indication for use, design features and functional features, the modified PressureWire™ Aeris™ is substantially equivalent to the currently marketed predicate device PressureWire™ Aeris™, K131452.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center . WO66-G609 Silver Spring, MD 20993-0002
Image /page/2/Picture/3 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that represents human services.
December 20, 2013
St. Jude Medical Systems Ab Erdulfo De Peralta 4 Robbins Rd. Westford, MA 01886 US
Re: K133587
Trade/Device Name: PressureWire Aeris Agile Tip; PressureWire Aeris Agile Tip 300 Regulation Number: 21 CFR 870.1330 Regulation Name: Pressure Wire Guide Wire Regulatory Class: Class II Product Code: DRG, DQX, DXO Dated: November 18, 2013 Received: November 21, 2013
Dear Erdulfo De Peralta:
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 (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.
3
Page 2 - Erdulfo De Peralta
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance 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. 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.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k)
Number
| (if known) | K133587 |
|---|---|
| Device Name | PressureWire |
| Indications | |
| for Use | 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 vessels. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801. 109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------------------------------- | --- | ---- | ---------------------- |
Digitally signed by
Owen P. Faris -S
Date: 2013.12.20
16:22:48 -05'00'