(65 days)
The Wireless Physiologic Monitoring System is indicated for use on patients requiring pressure monitoring. The Wireless Physiologic Monitoring System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.
The Edwards Lifesciences' Wireless Physiologic Monitoring System replaces the existing cabling between disposable blood pressure transducers and bedside monitors in hospital settings. The wireless link allows the system to support all transducer performance requirements and specifications currently supported with a direct cable connection. Existing system cabling connectors are retained in the event that all available channels are filled, or in the unlikely event that issues are found in particular situations that preclude the use of the wireless connection. The Wireless Physiologic Monitoring System utilizes two types of wireless technology to provide a convenient solution for replacing cabling between the disposable pressure transducer and the patient monitor. Radio Frequency Identification (RFID) is utilized as a convenient method to initially setup the system, and the Wireless Medical Telemetry Service band (WMTS) is used for the continuous transmission of data from the transducers to the monitor during normal operation.
The provided text does not contain detailed information about specific acceptance criteria, a study that proves the device meets those criteria, or the methodology typically associated with such studies (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies for AI devices).
The document is a 510(k) summary for the Edwards Lifesciences' Wireless Physiologic Monitoring System. It states that the device has undergone functional and safety testing and has been shown to be "substantially equivalent" to predicate devices. This type of regulatory submission focuses on demonstrating equivalency rather than proving performance against specific acceptance criteria in the way a clinical trial for a novel device or an AI-powered diagnostic might.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
Missing. The document generally states that "The wireless link allows the system to support all transducer performance requirements and specifications currently supported with a direct cable connection." However, it does not provide a table detailing those performance requirements or specific numerical results from testing. It refers to "Functional/Safety Testing" but gives no specifics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. The document does not mention any specific test set sample sizes or data provenance for performance evaluation.
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)
Missing. This type of information is not relevant or reported for this device, which performs wireless transmission of physiological data rather than a diagnostic interpretation requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing. Not applicable given the nature of the device and information provided.
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
Missing. This is an AI-specific study type, and this device is a wireless physiological monitoring system, not an AI diagnostic tool. Therefore, an MRMC study is not relevant and not reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing. This is typically discussed in the context of AI algorithms. The device performs data transmission, and its "standalone performance" would relate to its ability to accurately transmit data, which is vaguely referred to as supporting "all transducer performance requirements." No specific standalone performance study details are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Missing. The concept of "ground truth" as typically defined for diagnostic or AI devices is not applicable to this wireless data transmission system. Its performance evaluation would likely involve comparing wirelessly transmitted data to directly cabled data, with the direct cable connection serving as a de-facto "truth" for accurate signal transmission. However, no specifics are given.
8. The sample size for the training set
Missing. As this is not an AI/machine learning device, there's no concept of a "training set."
9. How the ground truth for the training set was established
Missing. Not applicable.
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K05-30/6
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DEC 3 0 2005
510(k) Summary
5
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614-5686 |
|---|---|
| Contact Person: | Diane PetersonProject Manager, Regulatory Affairs |
| Date Prepared: | October 24, 2005 |
| Trade name: | Wireless Physiologic Monitoring System |
| ClassificationName: | Transducer, Pressure, Catheter tip(21 CFR 870.2870) Transmitters and receivers, physiologicalsignal, radiofrequency (21 CFR 870.2910) |
| Predicate Devices: | Phoenix Disposable Pressure Transducer#73-600 SurgiChip Tag Surgical Marker M3290A IntelliVue Information CenterSoftware Rel. F.0 and M4840A TelemetrySystem II with M4841A TelePac+ MPT 24 and VitalView 24 |
| DeviceDescription: | The Edwards Lifesciences' Wireless PhysiologicMonitoring System replaces the existing cablingbetween disposable blood pressure transducers andbedside monitors in hospital settings. The wirelesslink allows the system to support all transducerperformance requirements and specificationscurrently supported with a direct cable connection.Existing system cabling connectors are retained inthe event that all available channels are filled, or inthe unlikely event that issues are found in particularsituations that preclude the use of the wirelessconnection.The Wireless Physiologic Monitoring System utilizestwo types of wireless technology to provide a |
October 24, 2005 510(k) Notification for the Wireless Physiologic Monitoring System Page 11
convenient solution for replacing cabling between the
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Edwards
disposable pressure transducer and the patient monitor. Radio Frequency Identification (RFID) is utilized as a convenient method to initially setup the system, and the Wireless Medical Telemetry Service band (WMTS) is used for the continuous transmission of data from the transducers to the monitor during normal operation. The Wireless Physiologic Monitoring System is Intended Use: indicated for use on patients requiring pressure monitoring. The Wireless Physiologic Monitoring System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers. The Wireless Physiologic Monitoring System has Comparative been demonstrated to be as safe and effective as Analysis: the predicate devices for its intended use. The Wireless Physiologic Monitoring System has Functional/Safety successfully undergone functional testing as well as Testing: electrical safety testing. This product has been
The Wireless Physiologic Monitoring System is Conclusion: substantially equivalent to the predicate devices.
shown to be equivalent to the predicate devices.
October 24, 2005 510(k) Notification for the Wireless Physiologic Monitoring System Page 12
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2005
Edwards Lifesciences LLC c/o Ms. Diane Peterson Project Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614
Re: K053016
Trade Name: Wireless Physiologic Monitoring System Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II (two) Product Code: DXO Dated: October 24, 2005 Received: October 26, 2005
Dear Ms. Peterson:
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.
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Page 2 - Ms. Diane Peterson
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blumminion 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 Statement 4
510(k) Number (if known):
Device Name: Wireless Physiologic Monitoring System
Indications for Use:
The Wireless Physiologic Monitoring System is indicated for use on patients requiring pressure monitoring. The Wireless Physiologic Monitoring System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.
Prescription Use X________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use __ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bihmmuma
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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).