(65 days)
73-600
Not Found
No
The description focuses on wireless transmission technology (RFID and WMTS) for replacing cables and mentions functional and electrical safety testing, not AI/ML algorithms. There are no mentions of AI, DNN, or ML in the provided text.
No
The device is described as a "Wireless Physiologic Monitoring System" that transmits pressure information from disposable pressure transducers to remote patient monitors, replacing existing cabling. Its stated purpose is monitoring and transmission, not active therapy or treatment.
No
The device is described as a replacement for existing cabling between pressure transducers and bedside monitors, facilitating the wireless transmission of pressure information. It is not reported to interpret data or provide diagnostic insights.
No
The device description explicitly states it utilizes two types of wireless technology (RFID and WMTS) and replaces existing cabling, indicating it includes hardware components for wireless transmission and reception.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pressure monitoring" on patients and the "wireless transmission of pressure information." This involves monitoring physiological parameters directly from the patient, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device replaces cabling between pressure transducers and monitors. Pressure transducers are used to measure physical pressure within the body (e.g., blood pressure). This is a direct physiological measurement, not an in vitro test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Wireless Physiologic Monitoring System is a device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DXO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The Wireless Physiologic Monitoring System has successfully undergone functional testing as well as electrical safety testing.
Key Metrics
Not Found
Predicate Device(s)
Phoenix Disposable Pressure Transducer #73-600, SurgiChip Tag Surgical Marker M3290A, IntelliVue Information Center Software Rel. F.0, M4840A Telemetry System II with M4841A TelePac+ MPT 24 and VitalView 24
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
K05-30/6
Image /page/0/Picture/1 description: The image shows the word "Edwards" in a serif font. Above the word is a graphic that appears to be a stylized letter "E" or a design element. The graphic is composed of a grid-like pattern in the background, with the letter or design element in white, creating a contrast.
DEC 3 0 2005
510(k) Summary
5
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614-5686 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Diane Peterson
Project Manager, Regulatory Affairs |
| Date Prepared: | October 24, 2005 |
| Trade name: | Wireless Physiologic Monitoring System |
| Classification
Name: | Transducer, Pressure, Catheter tip
(21 CFR 870.2870) Transmitters and receivers, physiological
signal, radiofrequency (21 CFR 870.2910) |
| Predicate Devices: | Phoenix Disposable Pressure Transducer
#73-600 SurgiChip Tag Surgical Marker M3290A IntelliVue Information Center
Software Rel. F.0 and M4840A Telemetry
System II with M4841A TelePac+ MPT 24 and VitalView 24 |
| Device
Description: | 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 |
October 24, 2005 510(k) Notification for the Wireless Physiologic Monitoring System Page 11
convenient solution for replacing cabling between the
1
Image /page/1/Picture/0 description: The image shows a close-up of what appears to be a letter 'E' or a similar symbol, possibly part of a logo or design. The letter is white and stands out against a background of varying shades of gray and black, creating a textured or pixelated effect. The background includes grid-like patterns and circular shapes, adding to the abstract nature of the image. The overall composition suggests a stylized or artistic representation rather than a straightforward depiction of the letter.
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
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of government.
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.
3
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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