(204 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on noninvasive measurement and derivation of parameters without indicating algorithmic learning.
No.
The device is used for non-invasively measuring blood pressure and hemodynamic parameters, which are diagnostic/monitoring functions, not therapeutic.
Yes
The device is indicated to "noninvasively measure blood pressure and associated hemodynamic parameters," which are measurements used for diagnosis or monitoring.
No
The device description explicitly states "The Acumen IQ finger cuff is intended to noninvasively measure blood pressure... when connected to an Edwards' HemoSphere Advanced Monitoring platform." This indicates a physical finger cuff component is part of the device, making it a hardware device with potential software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is used to "noninvasively measure blood pressure and associated hemodynamic parameters." This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of biological material outside the body.
- Device Description: The description reinforces this by stating it "noninvasively measure blood pressure and use the information to derive hemodynamic parameters." Again, this is a direct measurement from the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances within those samples
- Providing information about a disease state, condition, or physiological state based on sample analysis.
Therefore, the Acumen™ IQ finger cuff is a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger
Indicated Patient Age Range
over 18 years of age
Intended User / Care Setting
Not Found
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)
Device Testing: The subject Acumen IQ finger cuff is identical to the predicate device in terms of design, intended use and technology. To ensure that the size range extension and removal of the sizing aid do not raise any new concerns of safety and effectiveness and are substantially equivalent to the predicate device, usability testing was conducted in accordance with ANSI/AAMI HE75. Furthermore, clinical performance testing was completed to ensure the finger cuffs perform as intended. The Acumen IQ finger cuff has successfully passed all testing.
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
§ 870.1130 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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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3
| Acumen IQ™ finger cuff 510(k) Summary | |
|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLC |
| One Edwards Way | |
| Irvine, CA, USA 92614 | |
| Contact Person | Primary Contact |
| Anna Hwang | |
| Manager, Regulatory Affairs | |
| Edwards Lifesciences | |
| One Edwards Way | |
| Irvine, CA 92614 | |
| Tel: (949) 250-0902 | |
| Fax: (949) 809-7303 | |
| Email: | |
| Anna_Hwang@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 | March 31, 2023 |
| Trade Name | Acumen IQ finger cuff |
| Common Name | System, measurement, blood-pressure, non-invasive |
| Regulation | |
| Number / | |
| 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 measure |
| blood pressure and use the information to derive hemodynamic | |
| parameters when connected to an Edwards' HemoSphere Advanced | |
| Monitoring platform. | |
| Indications for | |
| Use | 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. | |
| Intended Use | The intended purpose is to noninvasively measure blood pressure and |
| use the information to derive hemodynamic parameters when | |
| connected to the HemoSphere Advanced Monitoring Platform. | |
| Comparison to | |
| Predicate Device | The subject Acumen IQ finger cuff is being modified to expand the |
| finger circumference size range from 51 - 60 mm to 43 - 71 mm as | |
| well 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 device |
| in terms of design, intended use and technology. To ensure that the | |
| size range extension and removal of the sizing aid do not raise any new | |
| concerns of safety and effectiveness and are substantially equivalent | |
| to the predicate device, usability testing was conducted in accordance | |
| with ANSI/AAMI HE75. Furthermore, clinical performance testing | |
| was 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 the |
| predicate device. |
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