(144 days)
The ClearSight™ finger cuff is indicated for patients over 18 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with the EV1000 Clinical Platform NI.
The ClearSight™ finger cuff noninvasively measures blood pressure and associated hemodynamic parameters when used with a compatible Edwards' hemodynamic monitor.
The ClearSight™ system consists of a Pump-Unit, a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (EVHRS or also referred to as HRS), the ClearSight™ finger cuff, and a compatible Edwards monitor.
The ClearSight system is currently compatible and cleared for use with the monitor of the EV1000 Clinical Platform NI (EV1000NI). The purpose of this 510(k) submission is to obtain clearance for enhancements of the ClearSight™ finger cuff as well as updated indications for use to allow for flexibility of the ClearSight finger cuff to be used with a compatible Edwards' hemodynamic monitoring system.
The provided document describes the clearance of the ClearSight™ finger cuff (K190130) by the FDA. The device is a non-invasive blood pressure measurement system.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, it indicates that the device's performance was evaluated based on the ISO 81060-2 standard, which defines clinical validation requirements for non-invasive sphygmomanometers. This standard typically specifies accuracy requirements in terms of mean difference and standard deviation between the device's measurements and a reference standard (e.g., intra-arterial blood pressure).
The document states: "The ClearSight™ finger cuff have successfully passed all testing." This implies that the device met the performance requirements outlined in ISO 81060-2, but the specific numerical performance metrics (e.g., mean difference, standard deviation) are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "clinical validation study" was conducted in accordance with ISO 81060-2. However, it does not specify the sample size used for this study. It also does not provide information on the data provenance (e.g., country of origin of the data, retrospective or prospective nature of the study).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Given that the clinical validation was for a blood pressure measurement device according to ISO 81060-2, the "ground truth" would typically be established by a reference standard. For blood pressure measurements, this is commonly invasive intra-arterial blood pressure. The standard also requires specific procedures for simultaneous measurements.
The document does not mention the involvement of experts in establishing the "ground truth" in the way it would apply to imaging or diagnostic algorithms requiring expert interpretation. Instead, the ground truth for blood pressure measurement is typically objective physiological data obtained through a recognized reference method.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
For blood pressure measurement accuracy, the concept of "adjudication" (as found in diagnostic studies with observer variability) is generally not directly applicable. The comparison is typically between the device's automated measurements and the objective reference standard. Any discrepancies are analyzed statistically, not through an adjudication process between human readers.
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 MRMC comparative effectiveness study was done, and this type of study is not relevant for this device. The ClearSight™ finger cuff is a non-invasive blood pressure measurement system, not an AI-powered diagnostic tool that assists human readers in interpreting images or complex data. Therefore, the concept of human reader improvement with or without AI assistance does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is inherently a standalone measurement device. It directly measures blood pressure and associated hemodynamic parameters. Its performance, as validated by the clinical study, is the "algorithm only" performance (though it's a hardware device with embedded algorithms). The indications state it is "used with the EV1000 Clinical Platform NI," implying it's part of a system, but its primary function is direct measurement, not an assistive role to a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As indicated under point 3, the ground truth for the clinical validation of a non-invasive blood pressure monitor according to ISO 81060-2 is almost certainly invasive intra-arterial blood pressure measurements, considered the gold standard for continuous blood pressure monitoring.
8. The sample size for the training set
The document does not mention a training set. For a traditional medical device like a blood pressure cuff, there isn't a "training set" in the same sense as for machine learning algorithms. The device is designed, calibrated, and then validated.
9. How the ground truth for the training set was established
As there is no mention of a training set in the context of machine learning, this question is not applicable to the information provided about the ClearSight™ finger cuff. The device's underlying principles are based on physiological measurement techniques, not on learning from a labeled dataset.
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Edwards Lifesciences, LLC Christine Chun Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
June 21, 2019
Re: K190130
Trade/Device Name: ClearSight"10 finger cuff Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: May 17, 2019 Received: May 20, 2019
Dear Christine Chun:
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 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
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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 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 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) K190130
Device Name ClearSight™ finger cuff
Indications for Use (Describe)
The ClearSight™ finger cuff is indicated for patients over 18 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with the EV1000 Clinical Platform NI.
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
| ClearSight™ finger cuff | |
|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLC |
| Contact Person | Christine J. ChunManager, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Tel: (949) 250 – 2500Fax: (949) 809 – 7303 |
| Date Prepared | January 21, 2019 |
| Trade Name | ClearSight™ finger cuff |
| Common Name | System, measurement, blood-pressure, non-invasive |
| ClassificationName | Non-Invasive Blood Pressure Measurement(21 CFR 870.1130) |
| Regulation Class /Product Code | Class IIDXN |
| Primary PredicateDevice | K160552 – ClearSight finger cuff included in the EV1000Clinical Platform™ NI and the ClearSight™ Finger Cuff orClearSight™ System (cleared June 1, 2016). |
| SecondaryPredicate (forBiocompatibilityonly) | K140312 – ClearSight finger cuff included in the EV1000Clinical Platform™ NI and the ClearSight™ Finger Cuff orClearSight™ System (cleared June 1, 2016). |
| Device Description | The ClearSight™ finger cuff noninvasively measures bloodpressure and associated hemodynamic parameters when used witha compatible Edwards' hemodynamic monitor.The ClearSight™ system consists of a Pump-Unit, a PressureController (PC2) that is worn on the wrist, a Heart ReferenceSensor (EVHRS or also referred to as HRS), the ClearSight™finger cuff, and a compatible Edwards monitor.The ClearSight system is currently compatible and cleared for usewith the monitor of the EV1000 Clinical Platform NI(EV1000NI). The purpose of this 510(k) submission is to obtainclearance for enhancements of the ClearSight™ finger cuff aswell as updated indications for use to allow for flexibility of theClearSight finger cuff to be used with a compatible Edwards'hemodynamic monitoring system. |
| IndicationsforUse/Intended Use | The ClearSight™ finger cuff is indicated for patients over 18years of age to noninvasively measure blood pressure andassociated hemodynamic parameters when used with the EV1000Clinical Platform NI. |
| ComparativeAnalysis | The subject ClearSight™ finger cuff, a component to theClearSight™ system cleared under K160552 on June 01, 2016 hasbeen enhanced by incorporating an alignment tab, self-coilingfeature, sizing window and reusable tape closure mechanism toimprove application consistency. The indications have beenupdated to allow flexibility for use with a compatible Edwards'hemodynamic monitor. |
| Functional/ SafetyTesting | The subject ClearSight™ finger cuff is identical to the predicatedevice in terms of intended use and technology. To ensure that theenhancements do not raise any new concerns of safety andeffectiveness, and are substantially equivalent to the predicatedevice, biocompatibility, clinical validation study, human factorsengineering and packaging testing were conducted in accordanceto ISO 10993-10, ISO 81060-2, ASTM D4169 and ANSI/AAMIHE75, respectively. Furthermore, functional testing wasconducted to show performance is not affected.The ClearSight™ finger cuff have successfully passed all testing. |
| Conclusion | The subject ClearSight™ finger cuff is substantially equivalent tothe predicate device for their intended use in hospitals and otherappropriate clinical environments. |
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§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).