(116 days)
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
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.
The provided document describes a 510(k) premarket notification for the TruWave™ Disposable Pressure Transducer. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of regulatory submission focuses on comparing a new device to an existing one, rather than proving novel efficacy or conducting extensive clinical trials as would be required for a PMA.
Therefore, the information available pertains to the device's performance against a predicate and functional/safety testing, rather than a clinical study establishing diagnostic accuracy or effectiveness in a "predictive" sense, as would be typical for AI/ML devices. Many of the requested fields (such as multi-reader multi-case studies, expert adjudication for ground truth, or effect size of AI assistance) are not applicable to this type of device and submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Key Performance Specifications) | Reported Device Performance |
|---|---|
| Integral flush device flow rate | 3 mL/hr or 30 mL/hr (depending on the variant) |
| Operating Pressure Range | -50 to +300 mmHg |
| Nonlinearity and Hysteresis | ±1.5% of reading or ± 1 mmHg, whichever is greater |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of clinical data for diagnostic accuracy. The testing performed was primarily performance testing to compare the device to a predicate. The document states:
- "Performance testing was conducted to compare the proposed device to the predicate device."
- "The TruWave disposable pressure transducer has successfully passed functional- performance post MRI exposure, the testing included pressure accuracy (nonlinearity and hysteresis)."
The details of the sample size (e.g., number of units tested, number of measurements) for these performance tests are not provided. Similarly, the "data provenance" in terms of subject demographics or clinical setting is not applicable as it's not a clinical study involving human patients to establish diagnostic performance. The tests are likely bench or laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. As this is not a diagnostic AI/ML device, there is no "ground truth" established by experts in the context of interpreting medical images or clinical data. The performance criteria (e.g., pressure accuracy) are determined by quantitative laboratory measurements against set standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. There is no "adjudication method" described, as there are no expert interpretations or clinical diagnoses being made that would require adjudication.
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
No. This is not an AI-assisted device for human interpretation, therefore an MRMC study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a hardware device (a disposable pressure transducer) and does not involve AI algorithms operating in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for evaluating the performance of this device is based on technical specifications and established measurement standards, rather than clinical outcomes or expert consensus on a diagnosis. For example, pressure accuracy (nonlinearity and hysteresis) would be measured against a highly accurate reference pressure measurement system.
8. The sample size for the training set
Not Applicable. This is a hardware medical device; it does not involve machine learning or a "training set" in the computational sense.
9. How the ground truth for the training set was established
Not Applicable. There is no training set for this device.
{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)
{3}------------------------------------------------
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 LifesciencesOne Edwards WayIrvine, CA 92614Tel: (949) 250-5167 |
| Date Prepared | September 23, 2014 |
| Trade Name | TruWave™ |
| Common Name | Disposable Pressure Transducer |
| ClassificationName | Transducer, pressure, catheter tip |
| RegulationClass/ProductCode | 21 CFR 870.2870Class IIDXO |
| Predicate Device(s) | K141495 - TruWave Disposable Pressure Transducer (Cleared9/3/2014) |
| Device Description | The Edwards Lifesciences Pressure Monitoring Kit with TruWavedisposable pressure transducer is a sterile, single-use kit thatmonitors intravascular blood pressure, intracranial pressure, andintrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with anEdwards Lifesciences cable that is specifically wired for the patientmonitor used to display the pressure data.The TruWave Disposable Pressure Transducer has a straight, flow-through design, where the fluid is passed across the pressuresensor. The DPT is available either with or without an integral flush |
| device. | |
| DeviceCharacteristics | Single Use Sterile (EtO)Prevalent Patient Contact Materials: Polycarbonate, PVC, Soda-LimeGlass |
| Environment ofUse | Healthcare facility/hospital |
| Materials of Use | Polycarbonate, PVC, Soda-Lime GlassConsensus standards: ISO 10993-4:2002, ISO 10993-5:2009, ISO10993-10:2010, ISO 10993-11:2006 |
| Key PerformanceSpecifications | Integral flush device: 3 mL/hr or 30 mL/hrOperating Pressure Range: -50 to + 300 mmHgNonlinearity and Hysteresis: ±1.5% of reading or ± 1 mmHg, whicheveris greater |
| Indications forUse/Intended Use | The Pressure Monitoring Kit with TruWave Disposable PressureTransducer is for use on patients requiring intravascular, intracranial, orintrauterine pressure monitoring. |
| ComparativeAnalysis | Performance testing was conducted to compare the proposed device tothe predicate device. The results of the performance testing indicate thatthe scientific technology and materials of the proposed device isunchanged from the legally marketed device (predicate).The proposed change to the TruWave disposable pressure transducerhas been shown to be safe, effective, and substantially equivalent to thepredicate device (TruWave disposable pressure transducer) for itsintended use in hospitals and other appropriate clinical environments. |
| Functional/ SafetyTesting | The TruWave disposable pressure transducer has successfully passedfunctional- performance post MRI exposure, the testing includedpressure accuracy (nonlinearity and hysteresis). |
| Conclusion | The TruWave disposable pressure transducers has been shown to besafe, effective, and substantially equivalent to the predicate device(TruWave disposable pressure transducer) for its intended use inhospitals and other appropriate clinical environments. |
{4}------------------------------------------------
§ 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).