(181 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the measurement method as based on established physiological principles (PWTT, PWV, NIRS) rather than AI/ML algorithms.
No.
The device is strictly a diagnostic tool for measuring blood pressure and pulse rate, not for treatment.
Yes
The device is described as measuring blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosis. While it doesn't provide a diagnosis itself, the measurements it provides are critical inputs for medical diagnosis.
No
The device description explicitly states it is a "small, lightweight, handheld device" that uses "dual Piezo Sensors and radial artery parameters from Near InfraRed Spectroscopy (NIRS) Optic sensor" to measure blood pressure. This indicates the device includes hardware components for data acquisition, making it a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The definition of an IVD involves testing samples like blood, urine, or tissue outside the body to obtain information about a person's health.
- This device measures blood pressure and pulse rate directly from the patient's wrist. It uses sensors (Piezo and NIRS) to take measurements in vivo (within the living body), not by analyzing a specimen taken from the body.
The device is a non-invasive blood pressure monitor, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patients of ages 20 -70 with wrist circumference from 13.5 cm to 21.5 cm and BMI
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION" in blue.
February 5, 2025
Accurate Meditech Inc. % Douglas Herrington Consultant Herrington Consulting LLC No 64, Haijing 3rd St. Sanzhi District New Taipei City, 252002 Taiwan
Re: K242352
Trade/Device Name: Accurate Mini Non-invasive blood pressure monitor (AMB-001) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 1, 2024 Received: August 8, 2024
Dear Douglas Herrington:
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.
1
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).
Your device is also subject to, among other requirements, the Quality System (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/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,
Aneesh S. Deoras -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
3
Indications for Use
Submission Number (if known)
Device Name
Accurate Mini Non-invasive blood pressure monitor (AMB-001)
Indications for Use (Describe)
The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patients of ages 20 -70 with wrist circumference from 13.5 cm to 21.5 cm and BMI Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR Part 807.92
Submitter
Accurate Meditech Inc. 8F .- 10, No. 12, Ln. 609, Sec. 5, Chongxin Rd., Sanchong Dist., New Taipei City 241406, Taiwan
Phone: +886 2 2999 1596 Fax: +886 2 2999 1196 Contact Person: Kuan-Jen, Wang
Date Prepared: 2024/5/23
Subject Device Information
| Trade/Device Name | Accurate Mini Non-invasive blood pressure monitor (AMB-001) |
|---|---|
| Model | AMB-001 |
| Common Name | Non-invasive blood pressure monitor |
| Regulatory | Class II |
| Classification | 870.1130 Noninvasive blood pressure measurement system |
| Submission type | Traditional 510(k) |
| Product Code | DXN |
Predicate Device Information
| Predicate Device | Sponsor: Accurate Meditech Inc. |
|---|---|
| Device: Accurate 24 BPM | |
| 510(K) Number: K222658 |
Device Description:
Accurate Mini Non-Invasive blood pressure monitor device is a small, lightweight, handheld device intended to measure and display blood pressure trending (Systolic and Diastolic) and spotcheck of pulse rate. Measurement is performed on the wrist at the radial artery. This blood pressure monitor uses the pulse wave transit time with the hemodynamic method to measure the systolic and diastolic blood pressure and pulse rate. This device serves to measure the systolic and diastolic blood pressure and pulse rate of adults in a non-invasive manner.
5
Indications for Use:
| The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patients (age 20-70) population with wrist circumference ranging from 13.5 cm to 21.5 cm and BMImmHg ) | $\leq$ 6.95/6.95 | 2.33 | 2.16 |
|---|---|---|---|
| Results | pass | pass |
The Mean Absolute Percentage Error (MAPE) calculated that there is a 1.164% difference between Accurate Mini BPM and the reference device, which is less than 5% and meets the accuracy of the specification.
| Characteristic | Actual subjects | |
|---|---|---|
| Subject, n | 40 | |
| Overall results for all study subjects | ||
| Achieved | ||
| Pass Requirements | Pulse Rate | |
| MAPE |