(112 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 training/test sets.
No
The device monitors pressure but does not provide therapy or treatment.
Yes
Explanation: The device monitors intravascular, intracranial, or intrauterine pressure, which are diagnostic indicators of a patient's condition.
No
The device description explicitly states it is a "sterile, single-use kit" that includes a "disposable sterile cable" and a "TruWave Disposable Pressure Transducer," indicating it is a hardware device with physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer directly monitors pressure within the body (intravascular, intracranial, intrauterine). It is a device that interacts with the patient's internal environment, not with specimens taken from the patient.
Therefore, based on the intended use and device description, this device falls under the category of a non-IVD medical device used for physiological monitoring.
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
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 TruWave disposable pressure transducer kits successfully passed biocompatibility, functional testing, electrical performance and safety testing, and usability testing. The products also passed all biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
October 23, 2017
Edwards Lifesciences, LLC Renate MacLaren Senior Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K171996
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: September 21, 2017 Received: September 22, 2017
Dear Renate Maclaren:
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. Iisting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 Industry and Consumer Education (DICE) 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.
Sincerely,
M.A. Wilhelm
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Section 5 – 510(k) Summary
K171996
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 2015691 |
| Contact Person: | Renate A. MacLaren, Ph.D.
Senior Manager, Regulatory Affairs
Edwards Lifesciences
One Edwards Way
Irvine, CA 92614
Tel: (949) 250 - 5783
Fax: (949) 809 – 2941 |
| Date: | June 30, 2017 |
| Trade Name: | TruWave™ Disposable Pressure Transducer |
| Common Name: | Disposable Pressure Transducer |
| Classification Name: | Transducer, pressure, catheter tip
21 CFR 870.2870 |
| Product Code: | DXO, Class II |
| Primary Predicate
Device: | K141495, Pressure Monitoring Kit with TruWave Disposable
Pressure Transducers (cleared 09/03/2014) |
| 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. |
| Comparison to
Predicate Device: | The subject device of this Traditional 510(k) is identical to its
predicate device in terms of intended use/ indications for use, and
technology. The proposed changes to the device include a change
of sterilization method (100% Ethylene Oxide to E-beam radiation),
change in the PVC plasticizer from DEHP to the following non-
phthalate plasticizers: Tris-(2-Ethylhexyl) Trimellitate (TOTM) for
the drip chamber housing in the IV sets and Cyclohexane-1, 2-
dicarboxylic acid diisononyl ester (DINCH®) for tubing. Update to
product labeling to reflect changes in sterilization method (from EO
to E-beam radiation) and removal of phthalate symbol on all levels
of packaging. Clarifying the design verification (electrical) test
results in the Instructions for Use 'Performance Specifications'
section to comply with AAMI/ ANSI BP22: 1994/(R) 2016. Testing
was conducted to ensure that the change in sterilization method
and change in materials did not alter the performance of the
TruWave DPT kits. The TruWave disposable pressure transducer
kits have been shown to be substantially equivalent to the predicate
device for its intended use in hospitals and other appropriate clinical
environments. |
| Functional/Safety
Testing: | The TruWave disposable pressure transducer kits successfully
passed biocompatibility, functional testing, electrical performance
and safety testing, and usability testing. The products also passed
all biocompatibility testing. |
| Conclusion: | The subject TruWave Disposable Pressure Transducer kits are
substantially equivalent to the predicate TruWave Disposable
Pressure Transducer Kits (K141495 and K142749) |
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