(114 days)
PressureWire Net is intended to condition physiological signals from measuring devices (PressureWire and an external pressure transducer), transmit and receive via radiofrequency, and reconditions the signals to its original format so that those can be displayed on and/or recorded in a receiving device (RadiAnalyzer Xpress or other Monitor systems). The physiological signals can also be distributed via cable.
Indication for Use:
PressureWire Net is indicated to condition a physiological signal from the cardiovascular system, transmit and receive via radiofrequency, and recondition the signal to its original format so that it can be displayed. The physiological signal can also be distributed via cable.
PressureWire Net is a radiofrequency physiological signal transmitter and receiver that is used for conditioning a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a host system.
PressureWire Net receives signals from the manufacturer's PressureWire and from a standard external pressure transducer, and then transmits those signals to a host system for further calculation and presentation. The subject device expands the contact range to also include a standard USB connector.
The provided text is a 510(k) summary for the PressureWire Net device. The information details the device's intended use, substantial equivalence to predicate devices, and regulatory compliance. However, it does not include specific details about acceptance criteria, a study proving the device meets those criteria, or any of the detailed performance metrics, sample sizes, or ground truth establishment methods typically found in clinical validation studies.
This document focuses on establishing substantial equivalence based on non-clinical performance data (adherence to standards and internal design procedures) and a literature review/product performance of predicate devices. There is no mention of a standalone algorithm study, MRMC study, or any specific study designed to measure the device's diagnostic performance against defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated from the document:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided in the document. The substantial equivalence is based on the device being "as safe and effective for its intended use as the predicate device(s)" based on its design and adherence to standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set or clinical performance data from a specific study is described. The assessment is based on non-clinical data and a literature review of predicate device performance.
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)
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
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
No. An MRMC comparative effectiveness study was not done or described. This device is not an AI-assisted diagnostic tool; it is a physiological signal transmitter and receiver.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was described. This device is hardware that transmits physiological signals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth for a clinical study is mentioned. The device's safety and effectiveness are supported by its design adherence to standards and the performance of predicate devices.
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning device, there is no mention of a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning device, there is no training set mentioned.
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OCT 2 1 2011
510(k) SUMMARY as required per 807.92(c)
Submitter:
Name, Title, and Telephone Number of Contact:
| Mats Granlund, Ph.D.Director Quality & Regulatory AffairsSt. Jude Medical Systems ABUppsala, SwedenPhone: (+46) 0 18 161000FAX: (+46) 0 18 161099email: | |
|---|---|
| Date of Submission: | August 3, 2011 |
| Product Code: | DRG |
| Classification Name: | Radio Frequency Physiological Signal Transmitter and Receiver |
| Class: | II |
| Establishment Registration: 8030904 |
Legally Marketed Device Identification: PressureWire Net
Proposed Device Description:
PressureWire Net is a radiofrequency physiological signal transmitter and receiver that is used for conditioning a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a host system.
PressureWire Net receives signals from the manufacturer's PressureWire and from a standard external pressure transducer, and then transmits those signals to a host system for further calculation and presentation. The subject device expands the contact range to also include a standard USB connector.
Proposed Intended Use:
PressureWire Net is intended to condition physiological signals from measuring devices (PressureWire and an external pressure transducer), transmit and receive via radiofrequency, and
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reconditions the signals to its original format so that those can be displayed on and/or recorded in reconditions the signals to its original format 30 that these satems). The physiological signals can also be distributed via cable.
Indication for Use:
Indication for USE:
PressureWire Net is indicated to condition a physiological signal from the cardiovascular system, Pressurewite Net is indicated to condition a proving career.
transmit and receive via radiofrequency, and recondition the signal to its original format so that it ti allsint and receive via radion ical also be distributed via cable.
Predicate Devices:
- K092105 510(k): t Trade Name: RadiAnalyzer Xpress 01/19/2005 SE Date: Manufacturer: Radi Medical Systems AB, Inc.
- K080813 510(k) : . Trade Name: PressureWire 7/01/2008 SE Date: Manufacturer: Radi Medical Systems AB, Inc.
Substantial Equivalence:
Assessment of non clinical performance data for equivalence:
Assessment of non onlines tested in accordance with applicable standards and internal design The Fressure who recedures and was determined to be as safe and effective for its intended use as the predicate device(s).
Assessment of clinical performance data for equivalence:
Assoconient or virined evaluation based on literature review and product performance of the Onlined porcernited on the predicate device indicates that the PressureWire Net is substantially equivalent to the predicate devices.
Sterilization:
Not Applicable. The system is not supplied sterile.
Biocompatibility:
Not Applicable. The device does not directly contact the user or patient.
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K111854 pg 3 of 3
Standards and Guidance Documents for Reference:
| Standards No | Standards Organization | Standard Title | Version |
|---|---|---|---|
| 60601-1 | IEC | Medical Electrical equipment - Part 1: General requirements for safety and essential performance | 2005-12 |
| 60601-1-2 | IEC | Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance –Collateral standard: Electromagnetic compatibility – Requirements and Tests | 2007-03 |
| 60601-1-4 | IEC | Medical electrical equipment – Part 1-4: General requirements for safety – Collateral Standard: Programmable electrical medical systems | 2000-04 |
| 60601-2-34 | IEC | Medical electrical equipment – Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment | 2000-10 |
| C22.2 No.601.1-M90 | CAN/CSA | Medical Electrical Equipment - Part 1: General Requirements for Safety |
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird symbol, with three curved lines representing the wings and a wavy line representing the body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 21 2011
St. Jude Medical Systems AB c/o Mr. Mats Granlund Palmbladsgatan 10 Uppsala Sweden SE-751 35
Re: K111854
Trade/Device Name: PressureWire Net (AO USB Receiver, WI-Box, WI-Box PSU kit, WI-Box Xpress cable, PW USB Receiver) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: August 3, 2011 Received: August 8, 2011
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 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 contractly and warranties. We remind you, however, that device labeling must be truthful and not micheading.
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 devire (1 n. 1) found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FTDA 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); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersQffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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,
Bram / Zuckerman, M.D. Directør Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) K111854
Number (if known)
Device Name PressureWire Net
PressureWire Net is intended to condition physiological signals from measuring Intended Use devices (PressureWire and an external pressure transducer), transmit and receive via radiofrequency, and reconditions the signals to its original format so that those can be displayed on and/or recorded in a receiving device (RadiAnalyzer Xpress or other Monitor systems). The physiological signals can also be distributed via cable.
Indication for Use:
PressureWire Net is indicated to condition a physiological signal from the cardiovascular system, transmit and receive via radiofrequency, and recondition the signal to its original format so that it can be displayed. The physiological signal can also be distributed via cable.
Prescription Use
AND/OR
Over - The- Counter Use_
(Part 21 CFR 801 Subpart D)
(Part 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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K111854 |
§ 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).