(169 days)
No
The document describes an "algorithm" for measuring and assessing pressure signals, but there is no mention of AI, ML, deep learning, neural networks, or any related terms. The validation process involves comparing the algorithm's output to annotations by human experts, which is a common method for validating traditional algorithms as well.
No.
The device provides additional quantitative information for reference only, and explicitly states that no therapeutic decisions should be made based solely on its parameters.
Yes
Explanation: The device measures pulmonary artery occlusion pressure and assesses the quality of the measurement, providing quantitative information about a patient's physiological condition. This information is used by clinicians for reference to understand the patient's state, which is a diagnostic function.
No
The device is described as an "algorithm" that is intended to be used "with a Swan-Ganz pulmonary artery catheter connected to a pressure cable and pressure transducer." While the algorithm itself is software, its function is entirely dependent on and integrated with specific hardware components (catheter, cable, transducer) to acquire the necessary data (pressure waveforms). The 510(k) summary describes the device in the context of this hardware setup, indicating it is not a standalone software-only device.
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.
- Device Function: The Smart Wedge algorithm analyzes pressure waveforms obtained from a Swan-Ganz catheter inserted into the pulmonary artery. This is a direct measurement of physiological pressure within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use describes measuring and assessing pulmonary artery occlusion pressure and its quality. This is a hemodynamic measurement, not a diagnostic test performed on a biological sample.
Therefore, the Smart Wedge algorithm 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
When used in combination with a Swan-Ganz catheter connected to a pressure transducer, the Edwards Lifesciences Smart Wedge algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressurement. The Smart Wedge algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge algorithm parameters.
Product codes
DOK
Device Description
The Smart Wedge algorithm is designed to provide the value at end-expiration of the pulmonary artery occlusion pressure (PAOP) signal, also called pulmonary wedge pressure, pulmonary capillary wedge pressure (PCWP), or pulmonary artery wedge pressure (PAWP), and to assess the quality of the pulmonary artery occlusion pressure measurement. The Smart Wedge algorithm is intended to be used with a Swan-Ganz pulmonary artery catheter connected to a pressure cable and pressure transducer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary Artery
Indicated Patient Age Range
over 18 years of age
Intended User / Care Setting
The Smart Wedge algorithm is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting.
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
Software verification and validation testing used waveforms retrospectively collected from ICU and OR patients. The basis for determination of substantial equivalence included retrospective clinical validation testing for PAOP identification and PAOP measurement. The references (i.e., consensus) were independent annotations by three experienced health care providers (HCPs).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification:
The verification of the Smart Wedge algorithm was performed using waveforms retrospectively collected from ICU and OR patients. The basis for determination of substantial equivalence included retrospective clinical validation testing as shown in Table 1 for PAOP identification and Table 2 for PAOP measurement, with the references (i.e., consensus) being independent annotations by three experienced health care providers (HCPs). Results for the Smart Wedge algorithm met or exceeded predicate device performance.
Table 1: Performance Results of PAOP Identification
225 PAP waveforms from 129 patients. Reference value obtained via Mode of three HCP annotations.
Sensitivity: 100% [100,100]
Specificity: 96% [92, 100]
PPV: 95% [89, 99]
NPV: 100% [100, 100]
Table 2: Performance Results of PAOP Measurements
110 PAOP measurements from 59 Patients. Reference value obtained via Average PAOP measurement of three HCPs.
MAE: 1.1 mmHg [0.8, 1.5]
Bias: 0.4 mmHg [0.1, 0.7]
Std: 1.7 mmHg [1.4, 2.0]
Correlation r: 0.98
Clinical Performance:
No clinical trial was performed in support of the subject 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
PAOP Identification:
Sensitivity: 100%
Specificity: 96%
PPV: 95%
NPV: 100%
PAOP Measurement:
Mean Absolute Error (MAE): 1.1 mmHg
Bias: 0.4 mmHg
Standard Deviation (Std): 1.7 mmHg
Correlation (r): 0.98
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
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August 18, 2023
Edwards Lifesciences, LLC Jennifer Wilbur Director, Regulatory Affairs Program Management 1 Edwards Way Irvine. California 92614
Re: K230579
Trade/Device Name: Smart Wedge algorithm Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: July 14, 2023 Received: July 14, 2023
Dear Jennifer Wilbur:
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
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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230579
Device Name Smart Wedge algorithm
Indications for Use (Describe)
When used in combination with a Swan-Ganz catheter connected to a pressure transducer, the Edwards Lifesciences Smart Wedge algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressurement. The Smart Wedge algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge algorithm parameters.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| I. Submitter | ||
|---|---|---|
| Sponsor | Edwards Lifesciences, LLC | |
| One Edwards Way | ||
| Irvine, CA, USA 92614 | ||
| Establishment Registration | ||
| Number | 2015691 | |
| Contact Person | Primary Contact | Secondary Contact |
| Jennifer Wilbur | ||
| Director, Regulatory Affairs | ||
| Program Management | ||
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| Telephone: (949) 756-4436 | ||
| Email: | ||
| jennifer_wilbur@edwards.com | Karen Clement | |
| Sr. Director, Regulatory Affairs | ||
| Edwards Lifesciences | ||
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| Telephone: (949) 250-4746 | ||
| Email: | ||
| Karen Clement@edwards.com | ||
| Date Prepared | July 14, 2023 | |
| II. Device Information | ||
| Trade Name | Smart Wedge algorithm | |
| Common Name | Pulmonary Artery Occlusion Pressure (PAOP) | |
| Regulation Number/ | ||
| Regulation Name | 21 CFR 870.1425 / | |
| Computer, Diagnostic, Programmable | ||
| Product Code | DQK | |
| Regulation Class | Class II | |
| III. Predicate Device | ||
| Predicate Device | The GE CARESCAPE B650 Patient Monitor (K213181, cleared April | |
| 13, 2022) manufactured by GE Healthcare Finland Oy, and its | ||
| pulmonary artery occlusion pressure measurement are being utilized | ||
| for substantial equivalence as a predicate to the Smart Wedge | ||
| algorithm in terms of similar technology (principles of operation, | ||
| functionality and performance) and same/similar indications/intended | ||
| use. | ||
| IV. Device Description | ||
| Device Description | The Smart Wedge algorithm is designed to provide the value at end- | |
| expiration of the pulmonary artery occlusion pressure (PAOP) signal, | ||
| also called pulmonary wedge pressure, pulmonary capillary wedge | ||
| pressure (PCWP), or pulmonary artery wedge pressure (PAWP), and | ||
| to assess the quality of the pulmonary artery occlusion pressure | ||
| measurement. |
The Smart Wedge algorithm is intended to be used with a Swan-Ganz
pulmonary artery catheter connected to a pressure cable and pressure
transducer. | |
| V. Indications for Use and Intended Use | | |
| Indications for Use | When used in combination with a Swan-Ganz catheter connected to a
pressure cable and pressure transducer, the Edwards Lifesciences
Smart Wedge algorithm measures and provides pulmonary artery
occlusion pressure and assesses the quality of the pulmonary artery
occlusion pressure measurement. The Smart Wedge algorithm is
indicated for use in critical care patients over 18 years of age receiving
advanced hemodynamic monitoring. The Smart Wedge algorithm is
considered to be additional quantitative information regarding the
patient's physiological condition for reference only and no therapeutic
decisions should be made based solely on the Smart Wedge algorithm
parameters. | |
| Intended Use | The Smart Wedge algorithm is intended to be used by qualified
personnel or trained clinicians in a critical care environment in a
hospital setting. The Smart Wedge algorithm is intended to measure
and provide accurate pulmonary artery occlusion pressure and to
assess the quality of the pulmonary artery occlusion pressure
measurement. | |
| VI. Comparison of Technological Characteristics with Predicate Device | | |
| Comparison to Predicate
Device | The subject device and predicate devices are based on the following
same technological elements:
Hemodynamic Parameters & Technological Characteristics:
The subject device and predicate device (GE CARESCAPE
B650 Patient Monitor, K213181, cleared April 13, 2022) both
measure and provide pulmonary artery pressure, have software
and provide flag/message outputs.
The subject device and predicate device (GE CARESCAPE
B650 Patient Monitor, K213181, cleared April 13, 2022) both
measure and provide pulmonary artery occlusion pressure. | |
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Accessories/Components:
- . The subject device and predicate device (GE CARESCAPE B650 Patient Monitor, K213181, cleared April 13, 2022) both obtain a pressure waveform measurement from a commercially available pulmonary artery catheter connected to a pressure cable and pressure transducer to obtain a pulmonary artery pressure waveform measurement.
Intended Use/Indications for Use:
- · The subject device and predicate device (GE CARESCAPE B650 Patient Monitor, K213181, cleared April 13, 2022) both have similar intended use/indications for use.
- o The subject device has the same indications/intended purpose as the predicate with respect to its use by trained clinicians in a healthcare environment and with respect to the hemodynamic monitoring of invasive pressure in adult patients.
The following technological differences exist between the subject and predicate device:
Algorithm Modifications:
- The subject Smart Wedge algorithm provides the following ● functional and safety enhancements over the predicate (GE CARESCAPE B650 Patient Monitor, K213181, cleared April 13. 2022):
-
PAOP Measurement: The subject Smart Wedge algorithm will not only display a PAOP measurement like the predicate device, but it will also display PAOP within mean absolute error Overall Conclusion:
The subject Smart Wedge algorithm successfully passed all functional
and performance testing, including software verification and
validation and bench studies. Completion of all performance
verification and validation activities demonstrated that the subject
device meets its predetermined design and performance specifications.
Verification activities performed confirmed that the differences in the
features and design did not adversely affect the safety and
effectiveness of the subject device. The testing performed
demonstrates that the subject Smart Wedge algorithm is substantially
equivalent to its legally marketed predicate. |
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