(144 days)
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No
The document describes a non-invasive blood pressure monitoring system and its components, with no mention of AI or ML technologies in the device description, intended use, or performance studies.
No
The device measures blood pressure and associated hemodynamic parameters; it does not treat or alleviate a medical condition.
Yes
The device is indicated to "noninvasively measure blood pressure and associated hemodynamic parameters," which are measurements used to diagnose a patient's health status.
No
The device description explicitly lists multiple hardware components: Pump-Unit, Pressure Controller (PC2), Heart Reference Sensor (EVHRS), and the ClearSight™ finger cuff itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "noninvasively measure blood pressure and associated hemodynamic parameters". This involves measuring physiological parameters directly from the patient's body.
- Device Description: The description details a system that interacts with the patient's finger to obtain measurements. It does not mention analyzing samples of human origin (like blood, urine, tissue, etc.) in vitro (outside the body).
- Lack of IVD Indicators: There are no mentions of analyzing samples, reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures physiological parameters in vivo (within the living body).
N/A
Intended Use / Indications for Use
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.
Product codes
DXN
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
over 18 years of age
Intended User / Care Setting
hospitals and other appropriate clinical environments.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device testing included biocompatibility, clinical validation study, human factors engineering, and packaging testing in accordance to ISO 10993-10, ISO 81060-2, ASTM D4169 and ANSI/AAMI HE75, respectively. Furthermore, functional testing was conducted to show performance is not affected.
The ClearSight™ finger cuff have successfully passed all testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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. Chun |
| Manager, Regulatory Affairs | |
| Edwards Lifesciences | |
| One Edwards Way | |
| Irvine, CA 92614 | |
| Tel: (949) 250 – 2500 | |
| Fax: (949) 809 – 7303 | |
| Date Prepared | January 21, 2019 |
| Trade Name | ClearSight™ finger cuff |
| Common Name | System, measurement, blood-pressure, non-invasive |
| Classification | |
| Name | Non-Invasive Blood Pressure Measurement |
| (21 CFR 870.1130) | |
| Regulation Class / | |
| Product Code | Class II |
| DXN | |
| Primary Predicate | |
| Device | K160552 – ClearSight finger cuff included in the EV1000 |
| Clinical Platform™ NI and the ClearSight™ Finger Cuff or | |
| ClearSight™ System (cleared June 1, 2016). | |
| Secondary | |
| Predicate (for | |
| Biocompatibility | |
| only) | K140312 – ClearSight finger cuff included in the EV1000 |
| Clinical Platform™ NI and the ClearSight™ Finger Cuff or | |
| ClearSight™ System (cleared June 1, 2016). | |
| Device Description | 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. | |
| Indications | |
| for | |
| Use/Intended Use | 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. | |
| Comparative | |
| Analysis | The subject ClearSight™ finger cuff, a component to the |
| ClearSight™ system cleared under K160552 on June 01, 2016 has | |
| been enhanced by incorporating an alignment tab, self-coiling | |
| feature, sizing window and reusable tape closure mechanism to | |
| improve application consistency. The indications have been | |
| updated to allow flexibility for use with a compatible Edwards' | |
| hemodynamic monitor. | |
| Functional/ Safety | |
| Testing | The subject ClearSight™ finger cuff is identical to the predicate |
| device in terms of intended use and technology. To ensure that the | |
| enhancements do not raise any new concerns of safety and | |
| effectiveness, and are substantially equivalent to the predicate | |
| device, biocompatibility, clinical validation study, human factors | |
| engineering and packaging testing were conducted in accordance | |
| to ISO 10993-10, ISO 81060-2, ASTM D4169 and ANSI/AAMI | |
| HE75, respectively. Furthermore, functional testing was | |
| conducted to show performance is not affected. | |
| The ClearSight™ finger cuff have successfully passed all testing. | |
| Conclusion | The subject ClearSight™ finger cuff is substantially equivalent to |
| the predicate device for their intended use in hospitals and other | |
| appropriate clinical environments. |
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