(204 days)
The Acumen™ IQ finger cuff is indicated for patients over 18 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with the HemoSphere advanced monitoring platform.
The Acumen IQ finger cuff is intended to noninvasively measure blood pressure and use the information to derive hemodynamic parameters when connected to an Edwards' HemoSphere Advanced Monitoring platform.
The provided text describes a 510(k) premarket notification for the Acumen IQ finger cuff, which is a modified version of a previously cleared device (K190130). The modification involves expanding the finger circumference size range and removing a finger sizing aid. The submission states that the device is identical to the predicate device in terms of design, intended use, and technology.
The document mentions that usability testing was conducted in accordance with ANSI/AAMI HE75 and that clinical performance testing was completed to ensure the finger cuffs perform as intended, and that the Acumen IQ finger cuff has successfully passed all testing. However, the actual acceptance criteria and device performance results from these studies are not explicitly provided in the given text. The text only broadly states that the device "successfully passed all testing."
Without the specific details of the clinical performance testing, a comprehensive table of acceptance criteria and reported device performance cannot be generated. Similarly, concrete information regarding sample sizes, data provenance, ground truth establishment, MRMC studies, or standalone performance is not available in the provided document.
Therefore,Based on the provided text, a complete answer to your request is not possible. The document states that clinical performance testing was completed and successfully passed, but it does not provide the specific acceptance criteria or the numerical results of this performance testing.
Here's a breakdown of what can be inferred and what is missing:
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Table of Acceptance Criteria and the Reported Device Performance: This information is not provided in the document. The text only states that "clinical performance testing was completed to ensure the finger cuffs perform as intended" and that the device "has successfully passed all testing." No specific criteria (e.g., accuracy, precision) or numerical performance values are given.
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Sample size used for the test set and the data provenance: This information is not provided in the document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document.
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Adjudication method for the test set: This information is not provided in the document.
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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: This information is not provided in the document. The device is a "noninvasive blood pressure measurement system," not an AI diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is a measurement device. Its "performance" would inherently be standalone in its measurement capability once the cuff is applied. However, specific methodology (e.g., comparison to invasive measurements) and results are not provided.
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The type of ground truth used: Given that the device non-invasively measures blood pressure, the ground truth for clinical performance testing would typically be established using a reference method for blood pressure measurement, such as invasive arterial line measurements or a highly accurate non-invasive oscillometric device that meets specific standards (e.g., ISO or BHS protocols). However, this is not explicitly stated in the document.
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The sample size for the training set: This information is not provided in the document. (Note: For a device like a blood pressure monitor, there might not be a "training set" in the same sense as an AI algorithm that learns from data. It's more about calibration and validation against ground truth.)
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How the ground truth for the training set was established: This information is not provided in the document.
In summary, the provided FDA clearance letter and 510(k) summary confirm that usability and clinical performance testing were conducted and passed, but they do not detail the specific acceptance criteria, performance results, or methodologies of those studies.
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October 24, 2023
Edwards Lifesciences, LLC Anna Hwang; Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K230919
Trade/Device Name: Acumen IQ finger cuff Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 31, 2023 Received: April 3, 2023
Dear Anna Hwang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
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 Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K230919
Device Name Acumen IQ finger cuff
Indications for Use (Describe)
The Acumen™ IQ finger cuff is indicated for patients over 18 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with the HemoSphere advanced monitoring platform.
| 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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| Acumen IQ™ finger cuff 510(k) Summary | |
|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLCOne Edwards WayIrvine, CA, USA 92614 |
| Contact Person | Primary Contact |
| Anna HwangManager, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Tel: (949) 250-0902Fax: (949) 809-7303Email:Anna_Hwang@edwards.com | |
| Secondary Contact | |
| Karen O'LearySr. Director, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Telephone: (949) 610-9179Fax: (949) 809 - 2954Email:Karen_OLeary@edwards.com | |
| Date Prepared | March 31, 2023 |
| Trade Name | Acumen IQ finger cuff |
| Common Name | System, measurement, blood-pressure, non-invasive |
| RegulationNumber /Regulation Name | 21 CFR 870.1130 / Non-Invasive Blood Pressure Measurement |
| Product Code | DXN |
| Regulation Class | Class II |
| Predicate Device | K190130 - Acumen IQ finger cuff (cleared June 21, 2019) |
| Device Description | The Acumen IQ finger cuff is intended to noninvasively measureblood pressure and use the information to derive hemodynamicparameters when connected to an Edwards' HemoSphere AdvancedMonitoring platform. |
| Indications forUse | The Acumen IQ finger cuff is indicated for patients over 18 years ofage to noninvasively measure blood pressure and associatedhemodynamic parameters when used with the HemoSphere AdvancedMonitoring Platform. |
| Intended Use | The intended purpose is to noninvasively measure blood pressure anduse the information to derive hemodynamic parameters whenconnected to the HemoSphere Advanced Monitoring Platform. |
| Comparison toPredicate Device | The subject Acumen IQ finger cuff is being modified to expand thefinger circumference size range from 51 - 60 mm to 43 - 71 mm aswell as removal of the finger sizing aid from the packaging. There are |
| Acumen IQTM finger cuff 510(k) Summary | |
| no changes to the physical design of the finger cuff, its components,dimensional features, or materials of construct. | |
| Device Testing | The subject Acumen IQ finger cuff is identical to the predicate devicein terms of design, intended use and technology. To ensure that thesize range extension and removal of the sizing aid do not raise any newconcerns of safety and effectiveness and are substantially equivalentto the predicate device, usability testing was conducted in accordancewith ANSI/AAMI HE75. Furthermore, clinical performance testingwas completed to ensure the finger cuffs perform as intended.The Acumen IQ finger cuff has successfully passed all testing. |
| Conclusion | The subject Acumen IQ finger cuff is substantially equivalent to thepredicate device. |
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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).