(116 days)
Not Found
No
The summary describes a pressure monitoring kit and transducer with no mention of AI or ML capabilities. The performance studies focus on comparing the device to a predicate and evaluating its physical performance characteristics.
No.
The device is a pressure monitoring kit designed to display pressure data, not to treat or alleviate a medical condition.
Yes
The device is described as monitoring "intravascular blood pressure, intracranial pressure, and intrauterine pressure," which are physiological parameters used to assess a patient's condition for diagnosis and treatment.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring pressure within the body (intravascular, intracranial, or intrauterine). This involves direct interaction with the patient's internal environment.
- Device Description: The device is a pressure monitoring kit with a transducer that measures pressure directly from fluid within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro). IVDs are designed to analyze samples like blood, urine, tissue, etc., in a laboratory setting or at the point of care, but not by directly measuring parameters within the living patient.
Therefore, this device falls under the category of a medical device used for physiological monitoring, 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
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, intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/hospital
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)
Performance testing was conducted to compare the proposed device to the predicate device. The results of the performance testing indicate that the scientific technology and materials of the proposed device is unchanged from the legally marketed device (predicate). The TruWave disposable pressure transducer has successfully passed functional- performance post MRI exposure, the testing included pressure accuracy (nonlinearity and hysteresis).
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, one behind the other, representing people. The faces are simple and abstract, with flowing lines suggesting hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 16, 2015
Edwards Lifesciences, LLC. Mr. Andrew S. Mazurkiewicz, Jr., MBA/MKT Senior Associate, Regulatory Affairs Critical Care One Edwards Way, CA 92614
Re: K142749
Trade/Device Names: TruWave™ Disposable Pressure Transducers Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II (two) Product Code: DXO Dated: December 2, 2014 Received: December 4, 2014
Dear Mr. Mazurkiewicz:
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 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
1
Page 2 - Mr. Andrew S. Mazurkiewicz, Jr.
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/CentersOffices/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION 4 - INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K142749
Device Name: TruWave™ Disposable Pressure Transducer
Indications For Use:
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
Prescription Use _ X__
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
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K142749
SECTION 5 – 510(k) SUMMARY
| TruWave™ Disposable Pressure Transducer 510(k) | |
|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLC |
| Contact Person | Andrew S. Mazurkiewicz, Jr., |
| MBA/MKT Edwards Lifesciences | |
| One Edwards Way | |
| Irvine, CA 92614 | |
| Tel: (949) 250-5167 | |
| Date Prepared | September 23, 2014 |
| Trade Name | TruWave™ |
| Common Name | Disposable Pressure Transducer |
| Classification | |
| Name | Transducer, pressure, catheter tip |
| Regulation | |
| Class/Product | |
| Code | 21 CFR 870.2870 |
| Class II | |
| DXO | |
| Predicate Device(s) | K141495 - TruWave Disposable Pressure Transducer (Cleared |
| 9/3/2014) | |
| 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. | |
| Device | |
| Characteristics | Single Use Sterile (EtO) |
| Prevalent Patient Contact Materials: Polycarbonate, PVC, Soda-Lime | |
| Glass | |
| Environment of | |
| Use | Healthcare facility/hospital |
| Materials of Use | Polycarbonate, PVC, Soda-Lime Glass |
| Consensus standards: ISO 10993-4:2002, ISO 10993-5:2009, ISO | |
| 10993-10:2010, ISO 10993-11:2006 | |
| Key Performance | |
| Specifications | Integral flush device: 3 mL/hr or 30 mL/hr |
| Operating Pressure Range: -50 to + 300 mmHg | |
| Nonlinearity and Hysteresis: ±1.5% of reading or ± 1 mmHg, whichever | |
| is greater | |
| 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 | Performance testing was conducted to compare the proposed device to |
| the predicate device. The results of the performance testing indicate that | |
| the scientific technology and materials of the proposed device is | |
| unchanged from the legally marketed device (predicate). | |
| The proposed change to the TruWave disposable pressure transducer | |
| has been shown to be safe, effective, and substantially equivalent to the | |
| predicate device (TruWave disposable pressure transducer) for its | |
| intended use in hospitals and other appropriate clinical environments. | |
| Functional/ Safety | |
| Testing | The TruWave disposable pressure transducer has successfully passed |
| functional- performance post MRI exposure, the testing included | |
| pressure accuracy (nonlinearity and hysteresis). | |
| Conclusion | The TruWave disposable pressure transducers has been shown to be |
| safe, effective, and substantially equivalent to the predicate device | |
| (TruWave disposable pressure transducer) for its intended use in | |
| hospitals and other appropriate clinical environments. |
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