(150 days)
Not Found
No
The device description and performance studies focus on the physical components, electrical safety, and basic performance metrics of a pressure transducer, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is used for monitoring blood pressure, not for providing therapy or treatment.
Yes
The device is used for "monitoring intravascular, intracranial, or intrauterine pressures," which involves measuring physiological parameters to assess a patient's condition, classifying it as a diagnostic function.
No
The device description clearly details a physical, sterile, single-use pressure transducer with a silicon chip, electrodes, fluid path, stopcock, flush device, and cables. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor intravascular, intracranial, or intrauterine pressure. This involves measuring physical parameters within the body, not analyzing samples taken from the body (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description details a pressure transducer that interacts directly with the patient's internal environment to measure pressure. It doesn't describe components for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample collection, or analysis of biological specimens, which are hallmarks of IVD devices.
Therefore, the TruWave Disposable Pressure Transducer is 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 (comma separated list FDA assigned to the subject device)
DXO
Device Description
The TruWave Disposable Pressure Transducer is a sterile, single-use device that is used to monitor intravascular, intracranial, and intrauterine pressures. The pressure transducer has a straight, flow-through design across the pressure sensor, and is available with or without the integral flush device. The pressure sensor is a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A transparent fluid path with an integral stopcock at one end and an integral flush device (either 3mL or 30mL) at the other end encloses the sensor. The enclosure of the TruWave Disposable Pressure Transducer has a pathway for air to enter the housing and acts as a vent. A disposable cable (available in 10-inch/25 cm and 48-inch/120 cm lengths) attached to the pressure transducer housing interfaces with an Edwards Lifesciences reusable cable that is specifically wired for the monitor being used. The TruWave Disposable Pressure Transducer can be mounted on the patient's arm using an arm strap or it may be mounted on an IV pole in a holder.
The TruWave Disposable Pressure Transducer may be a component in various pressure monitoring kits or systems.
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
hospital setting or other appropriate clinical environment.
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)
Biocompatibility testing was performed in accordance with ISO 10993-1: 2018 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and FDA guidance document, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”, issued on September 4, 2020.
Electromagnetic compatibility (EMC) and Electromagnetic Immunity (EMI) testing were conducted and comply with the IEC 60601-1, IEC 60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC.
Electrical safety testing (including defibrillator challenge, dielectric strength, liquid ingress, and leakage current) was performed in accordance with ANSI/AAMI BP22:1994/(R)2016 and IEC 60601-2-34: 2011
Testing (including accuracy, excitation/signal impedance, light sensitivity, symmetry, and overpressure) was conducted per ANSI/AAMI BP22:1994/(R)2016 and IEC 60601-2-34: 2011.
Magnetic resonance safety testing was performed based on ASTM F2503- 20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
Mechanical testing was performed in accordance with ANSI/AAMI BP22:1994/(R) 2016 and Edwards' design requirements.
The usability/human factors of the TruWave Disposable Pressure Transducer were evaluated by healthcare provider users.
All device acceptance criteria were met. Results of non-clinical testing show that the subject device TruWave Disposable Pressure Transducer meets its intended use and demonstrate that the device is as safe, as effective, and performs as well as the predicate device. The differences between the subject device and predicate device do not raise new issues of safety and/or effectiveness. Therefore, the subject device TruWave Disposable Pressure Transducer is substantially equivalent to the predicate device TruWave Disposable Pressure Transducer (K183413).
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 22, 2022
Edwards Lifesciences LLC Carmen Chen Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K222216
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: November 22, 2022 Received: November 22, 2022
Dear Carmen Chen:
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.
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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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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SECTION 5. 510(K) SUMMARY
| 510(k) Submitter | Edwards Lifesciences, LLC
One Edwards Way
Irvine, CA, USA 92614 | | |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Primary Contact
Carmen G Chen
Manager, Regulatory Affairs
Edwards Lifesciences
One Edwards Way
Irvine, CA 92614
Telephone: (949) 250 - 5469
Fax: (949) 809 - 2954
Email:
Carmen.Chen@edwards.com | Secondary Contact
Karen O'Leary
Sr. Director, Regulatory Affairs
Edwards Lifesciences
One Edwards Way
Irvine, CA 92614
Telephone: (949) 610-9179
Fax: (949) 809 - 2954
Email:
Karen.OLeary@edwards.com | |
| | Date Prepared | December 21, 2022 | |
| Trade Name | TruWave™ | | |
| Common Name | Disposable Pressure Transducer | | |
| Regulation
Number/
Regulation
Name | 21 CFR 870.2870 / Transducer, Pressure, Catheter Tip | | |
| Product Code | DXO | | |
| Regulation Class | Class II | | |
| Predicate Device | K183413- TruWave Disposable Pressure Transducer (cleared 01 May 2019) | | |
| Device
Description | The TruWave Disposable Pressure Transducer is a sterile, single-use
device that is used to monitor intravascular, intracranial, and intrauterine
pressures. The pressure transducer has a straight, flow-through design
across the pressure sensor, and is available with or without the integral
flush device. The pressure sensor is a pressure sensitive silicon chip with
two electrodes for excitation voltage and two electrodes for signal output.
A transparent fluid path with an integral stopcock at one end and an
integral flush device (either 3mL or 30mL) at the other end encloses the
sensor. The enclosure of the TruWave Disposable Pressure Transducer has
a pathway for air to enter the housing and acts as a vent. A disposable
cable (available in 10-inch/25 cm and 48-inch/120 cm lengths) attached to
the pressure transducer housing interfaces with an Edwards Lifesciences
reusable cable that is specifically wired for the monitor being used. The
TruWave Disposable Pressure Transducer can be mounted on the patient's | | |
| | arm using an arm strap or it may be mounted on an IV pole in a holder. | | |
| | The TruWave Disposable Pressure Transducer may be a component in various pressure monitoring kits or systems. | | |
| 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 TruWave Disposable Pressure Transducer device of this
Traditional 510(k) is identical to the predicate device cleared in K183413
in terms of indications for use/intended use except for the proposed design,
material, and labeling changes to the device. See table below. Differences
in technological characteristics do not raise any new concerns of safety and
effectiveness. Verification and validation testing for the subject device
demonstrate safety and effectiveness. The TruWave Disposable Pressure
Transducer has shown to be substantially equivalent to the predicate device
for its intended use in a hospital setting or other appropriate clinical
environment. | | |
| Device Testing | Biocompatibility testing was performed in accordance with ISO 10993-1:
2018 – Biological evaluation of medical devices – Part 1: Evaluation and
testing within a risk management process, and FDA guidance document,
Use of International Standard ISO 10993-1, “Biological evaluation of
medical devices – Part 1: Evaluation and testing within a risk management
process”, issued on September 4, 2020. | | |
| | Electromagnetic compatibility (EMC) and Electromagnetic Immunity
(EMI) testing were conducted and comply with the IEC 60601-1, IEC
60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC. | | |
| | Electrical safety testing (including defibrillator challenge, dielectric
strength, liquid ingress, and leakage current) was performed in accordance
with ANSI/AAMI BP22:1994/(R)2016 and IEC 60601-2-34: 2011 | | |
| | Testing (including accuracy, excitation/signal impedance, light sensitivity,
symmetry, and overpressure) was conducted per ANSI/AAMI
BP22:1994/(R)2016 and IEC 60601-2-34: 2011. | | |
| | Magnetic resonance safety testing was performed based on ASTM F2503-
20 Standard Practice for Marking Medical Devices and Other Items for
Safety in the Magnetic Resonance Environment. | | |
| | Mechanical testing was performed in accordance with ANSI/AAMI
BP22:1994/(R) 2016 and Edwards' design requirements. | | |
| | The usability/human factors of the TruWave Disposable Pressure
Transducer were evaluated by healthcare provider users. | | |
| | All device acceptance criteria were met. Results of non-clinical testing | | |
| Conclusion | show that the subject device TruWave Disposable Pressure Transducer | | |
| | meets its intended use and demonstrate that the device is as safe, as | | |
| | effective, and performs as well as the predicate device. The differences | | |
| | between the subject device and predicate device do not raise new issues of | | |
| | safety and/or effectiveness. Therefore, the subject device TruWave | | |
| | Disposable Pressure Transducer is substantially equivalent to the predicate | | |
| | device TruWave Disposable Pressure Transducer (K183413). | | |
| Function/Parameter | Subject Device
(K222216) | Predicate Device
(K183413) | Comparison |
| Device Name | TruWave™ Disposable
Pressure Transducer | TruWave™ Disposable
Pressure Transducer | Same |
| 510(k) Number | K222216 | K183413
(cleared on 01 April 2019) | Not Applicable |
| Manufacturer | Edwards Lifesciences, LLC | Edwards Lifesciences, LLC | Same |
| Device Classification | Class II | Class II | Same |
| Regulation Number | 21 CFR §870.2870- Catheter
tip pressure transducer | 21 CFR §870.2870- Catheter
tip pressure transducer | Same |
| Product Code | DXO | DXO | Same |
| Intended Use | The Pressure Monitoring Kit
with TruWave DPT is used
on patients requiring
intravascular, intracranial, or
intrauterine pressure
monitoring. | The Pressure Monitoring Kit
with TruWave DPT is used
on patients requiring
intravascular, intracranial, or
intrauterine pressure
monitoring. | Same |
| Indications for Use | The Pressure Monitoring Kit
with TruWave DPT is for
use on patients requiring
intravascular, intracranial, or
intrauterine pressure
monitoring. | The Pressure Monitoring Kit
with TruWave DPT is for
use on patients requiring
intravascular, intracranial, or
intrauterine pressure
monitoring. | Same |
| Operating Principle | The TruWave DPT sensor
consists of a silicon chip
which when fluid flows
through the fluid path allows
a piezo-electric diaphragm of
the chip to be deflected,
which changes resistance of
the circuit, which
correspondingly causes a
change in voltage. This
voltage change is transmitted
through the cable to a patient
monitor. | The TruWave DPT sensor
consists of a silicon chip
which when fluid flows
through the fluid path allows
a piezo-electric diaphragm of
the chip to be deflected,
which changes resistance of
the circuit, which
correspondingly causes a
change in voltage. This
voltage change is transmitted
through the cable to a patient
monitor. | Same |
| Design | Straight, flow-through design
across the pressure sensor
Housing with curved side
grips and arm mount strap
slots | Straight, flow-through design
across the pressure sensor
Housing with straight side
grips and arm mount strap
slots | Same
Different because the subject
device has curved side grips.
No new issues of safety and
effectiveness. |
| | No test port | Has test port | Different because the subject
device does not contain a test
port.
No new issues of safety and
effectiveness. |
| Function/Parameter | Subject Device
(K222216) | Predicate Device
(K183413) | Comparison |
| | Has small profile analog pressure sensor with 4 contact pads | Has large profile analog pressure sensor with 5 contact pads | Different because the subject device contains a new, smaller analog pressure sensor. The following tests were conducted:
• Biocompatibility
• EMC/EMI and Electrical Safety and Performance
• MR Safety
• Mechanical
No new issues of safety and effectiveness. |
| | Integrated flush device;
Molded-in fluid channel as the restrictor to regulate flow | Integrated flush device;
Bonded-in PVC capillary tubing component as the restrictor to regulate flow | Different because the subject device does not contain a PVC capillary tubing (i.e., flow restrictor) component. The following tests were conducted:
• Biocompatibility
• Mechanical
No new issues of safety and effectiveness. |
| | Integrated stopcock;
3-way stopcock body molded into flowpath and stopcock handle mechanically assembled | Integrated stopcock;
3-way stopcock bonded onto housing using UV cure adhesive | Different. The following tests were conducted:
• Biocompatibility
• Mechanical
No new issues of safety and effectiveness. |
| | Flush pull-tab is angled at 45° from the Housing | Flush pull-tab is angled at 90° from the Housing | Different because the flush pull-tab (i.e., Snap-tab) of the subject device is angled at 45° instead of 90° from the Housing. The following tests were conducted:
• Biocompatibility
• Mechanical
• Design Validation
No new issues of safety and effectiveness. |
| Function/Parameter | Subject Device
(K222216) | Predicate Device
(K183413) | Comparison |
| | Disposable cable is 10 inches
in length and has four copper
wires | Disposable cable is 12 inches
in length and has five copper
wires | Different because the
disposable cable of the
subject device is shorter, has
one less conductive wire, and
has a smaller cross-section
than the predicate device.
The following tests were
conducted:
• EMC/EMI and
Electrical Safety
and Performance
• MR Safety
• Mechanical
No new issues of safety and
effectiveness. |
| Materials | Sensor Gel:
Silicone
Sensor Gel Cup:
Polybutylene terephthalate
(PBT) | Sensor Gel:
Silicone
Sensor Gel Cup:
Polycarbonate | Same |
| | | | Different. The following
tests were conducted:
• Biocompatibility
• EMC/EMI and
Electrical Safety
and Performance
• Mechanical
No new issues of safety and
effectiveness. |
| | Resistors:
Laser-trimmed integrated
circuit | Resistors:
Laser-trimmed screened
ероху | Different. The following
tests were conducted:
• EMC/EMI and
Electrical Safety
and Performance
• MR Safety
No new issues of safety and
effectiveness. |
| | Spring terminals:
Beryllium copper | Pads and metallization:
Palladium silver | Different. The following
tests were conducted:
• EMC/EMI and
Electrical Safety
and Performance
• MR Safety
• Mechanical
No new issues of safety and
effectiveness. |
| | Sensor Seal:
Silicone gasket | Sensor Seal:
Ultraviolet cure (acrylic)
adhesive | Different. The following
tests were conducted:
• Biocompatibility
• EMC/EMI and
Electrical Safety
and Performance
• Mechanical
No new issues of safety and
effectiveness. |
| Function/Parameter | Subject Device
(K222216) | Predicate Device
(K183413) | Comparison |
| | Flush pull-tab:
Silicone | Flush pull-tab:
Silicone | Different; slight changes in
chemical composition. The
following tests were
conducted:
• Biocompatibility
• Mechanical
No new issues of safety and
effectiveness. |
| | Stopcock body:
Polycarbonate | Stopcock body:
Polycarbonate | Same |
| | Housing:
Polycarbonate | Housing:
Polycarbonate | Same |
| | Disposable cable jacket:
PVC with plasticizer | Disposable cable jacket:
PVC with plasticizer | Different. The following test
was conducted:
• Mechanical
No new issues of safety and
effectiveness. |
| | Molded-in Fluid Channel
Restrictor:
Polycarbonate | Capillary Tubing Restrictor:
PVC with DINCH plasticizer | Different; eliminating PVC
and integrating the flow
restrictor into the flowpath.
The following tests were
conducted:
• Biocompatibility
• Mechanical
No new issues of safety and
effectiveness. |
| Accessories | Pressure Tubing | Pressure Tubing | Same |
| | Stopcocks | Stopcocks | Same |
| | Flush device
(3mL/hr or 30 mL/hr) | Flush device
(3mL/hr or 30 mL/hr) | Same |
| | IV Set | IV Set | Same |
| | VAMP (Venous Arterial
Blood Management
Protection System) | VAMP (Venous Arterial
Blood Management
Protection System) | Same |
| | Disposable holder/TruClip
holder | Disposable holder/TruClip
holder | Same |
| | IV Pole Clamp, IV Pole
Mount Plate | IV Pole Clamp, IV Pole
Mount Plate | Same |
| | Arm Mount Plate/Strap | Arm Mount Plate/Strap | Same |
| | Compatible monitor cable | Compatible monitor cable | Same |
| Sterilization | 100% Ethylene Oxide
E-beam radiation | 100% Ethylene Oxide
E-beam radiation | Same |
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