(142 days)
Not Found
No
The summary describes a standard pressure monitoring kit and transducer with no mention of AI or ML capabilities, data processing, or performance metrics typically associated with AI/ML devices.
No.
The device is used for monitoring pressure (intravascular, intracranial, or intrauterine), which is a diagnostic function rather than a therapeutic one. It provides data for clinicians but does not directly treat or alleviate a medical condition.
Yes
The device monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure, which are physiological parameters used to diagnose a patient's condition.
No
The device description explicitly details hardware components such as a sterile, single-use kit, disposable sterile cables, and a disposable pressure transducer with a pressure sensor. It does not describe a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside the body.
- Device Function: The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is used for in vivo (within the living body) pressure monitoring. It directly measures pressure within blood vessels, the skull, or the uterus.
- Intended Use: The intended use clearly states monitoring intravascular, intracranial, or intrauterine pressure, which are all internal body locations.
- Device Description: The description details a transducer that interfaces with a patient monitor to display pressure data, consistent with direct physiological monitoring.
Therefore, this device falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DXO
Device Description
The Edwards Lifesciences Pressure Monitoring kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data.
The TruWave disposable pressure transducer has a straight, flow through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravascular, intracranial, or intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and other appropriate clinical environments.
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)
The subject device is identical to the predicate devices in terms of intended use/ indications for use, and technology. The proposed change to the device is a material change to a component of an existing legally marketed device. Testing was conducted to ensure that the change in material did not alter the performance of the TruWave disposable pressure transducer.
The TruWave disposable pressure transducer kits successfully passed biocompatibility and functional testing.
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
§ 870.2870 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
May 1, 2019
Edwards Lifeciences, LLC Ye Seul Kim Senior Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K183413
Trade/Device Name: TruWave Disposable Pressure Transducer Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO Dated: March 29, 2019 Received: April 1, 2019
Dear Ye Seul Kim:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Matthew Hillebrenner Director (Acting) DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183413
Device Name
TruWave Disposable Pressure Transducer
Indications for Use (Describe)
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
SECTION 5 – 510(k) SUMMARY
| 510(k) Submitter | Edwards Lifesciences, LLC | |
|---|---|---|
| Contact Person | Primary Contact | Secondary Contact |
| Ye Seul Kim | ||
| Senior Specialist, Regulatory Affairs | ||
| Edwards Lifesciences | ||
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| Tel: (949) 250 - 2445 | ||
| Fax: (949) 809 - 5425 | ||
| Email: yeseul_kim@edwards.com | Renate MacLaren | |
| Senior Manager, Regulatory Affairs | ||
| Edwards Lifesciences | ||
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| Tel: (949) 250 - 5783 | ||
| Fax: (949) 809 – 2941 | ||
| Email: renate_maclaren@edwards.com | ||
| Date Prepared | December 7, 2018 | |
| Trade Name | TruWave™ | |
| Common Name | Disposable Pressure Transducer | |
| Classification | ||
| Name | Transducer, pressure, catheter tip (21 CFR 870.2870) | |
| Regulation | ||
| Class/Product | ||
| Code | Class II | |
| DXO | ||
| Primary | ||
| Predicate Device | K171996, TruWave Disposable Pressure Transducer (cleared 10/23/2017) | |
| Secondary | ||
| Predicate Device | K142749, TruWave Disposable Pressure Transducer (cleared 01/18/2015) | |
| Device | ||
| Description | The Edwards Lifesciences Pressure Monitoring kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data. |
The TruWave disposable pressure transducer has a straight, flow through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device. | |
| Indications for
Use/Intended Use | The Pressure Monitoring kit with TruWave disposable pressure transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring. | |
| Comparative
Analysis | The subject device is identical to the predicate devices in terms of intended use/ indications for use, and technology. The proposed change to the device is a material change to a component of an existing legally | |
| | marketed device. Testing was conducted to ensure that the change in
material did not alter the performance of the TruWave disposable
pressure transducer. | |
| | The subject TruWave disposable pressure transducer has been shown
to be substantially equivalent to the predicate devices for its intended
use in hospitals and other appropriate clinical environments. | |
| Functional/
Safety Testing | The TruWave disposable pressure transducer kits successfully passed
biocompatibility and functional testing. | |
| Conclusion | The subject TruWave disposable pressure transducer kits are
substantially equivalent to the predicate TruWave disposable pressure
transducer kits (K171996 and K142749). | |
4