(292 days)
Not Found
No
The summary describes a device that uses established physiological measurement techniques (PWTT, PWV, NIRS) and does not mention any AI or ML components in its operation or data processing. The performance studies focus on standard clinical validation against a predicate device and relevant standards, without mentioning AI/ML-specific evaluation metrics or methodologies.
No.
The device is described as a monitor intended for measuring blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. It provides information about a patient's physiological state but does not directly treat or alleviate a medical condition.
Yes
The device is intended for measuring blood pressure and pulse rate, which are physiological parameters. While it measures these parameters, the "Intended Use / Indications for Use" section states its purpose as "spot-checking of adult patients" and to "obtain results" for these measurements. It measures and displays a "blood pressure trending" indication, but does not provide analysis or interpretation of these measurements to establish a diagnosis, or to guide treatment decisions. Therefore, it is a monitoring device rather than a diagnostic one.
No
The device description explicitly states it is a "small, lightweight, handheld device" that uses "dual Piezo Sensors and radial artery parameters from NIRS Optic sensors" to measure blood pressure. This indicates the presence of physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device measures blood pressure and pulse rate directly from the patient's wrist using non-invasive methods (Pulse Wave Transit Time, Piezo Sensors, NIRS Optic sensors). It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for measuring blood pressure and pulse rate in adult patients, not for analyzing biological samples.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
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 patient (age 20-70) population with wrist circumference ranging 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).
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August 7, 2023
Accurate Meditech Inc. % Douglas Herrington Official Correspondent Herrington Consulting LLC No 64, Haijing 3rd St Sanzhi District New Taipei City, 252 Taiwan
Re: K222658
Trade/Device Name: Accurate 24 Non-invasive blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN
Dear Douglas Herrington:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 21, 2023. Specifically, FDA is updating this SE Letter to correct the official contact name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Stephen Browning OHT2: Office of Cardiovascular Devices, 240-402-5241, Stephen.Browning@fda.hhs.gov.
Sincerely,
Stephen C. Browning -S
Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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June 21, 2023
Accurate Meditech Inc. Wang Kuan-Jen General Manager 8F-10, No. 12, Lane 609, Sec. 5, Chongxin Rd., Sanchong Dist., New Taipei City, 241406 Taiwan
Re: K222658
Trade/Device Name: Accurate 24 Non-invasive blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 15, 2023 Received: May 15, 2023
Dear Wang Kuan-Jen:
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/ofdocs/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.
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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 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 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.
Robert T. Kazmierski -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
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Indications for Use
510(k) Number (if known) K222658
Device Name
Accurate 24 Non-invasive blood pressure monitor
Indications for Use (Describe)
The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patient (age 20-70) population with wrist circumference ranging from 13.5 cm to 21.5 cm and BMI ☐ Prescription Use (Part 21 CFR 801 Subpart D) | ☒ Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. 510(k) Summary
This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR Part 807.92
5.1 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: 2023/6/17
5.2 Subject Device Information
| Trade/Device Name | Accurate 24 Non-invasive blood pressure monitor |
|---|---|
| Model | Accurate 24 BPM |
| 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 |
5.3 Predicate Device Information
| Predicate Device | Sponsor: Biobeat Technologies Ltd |
|---|---|
| Device: BB-613 WP | |
| 510(K) Number: K190792 |
5.4 Device Description:
Accurate 24 Non-Invasive blood pressure monitor device is a small, lightweight, handheld device intended to measure and display blood pressure trending (Systolic and Diastolic) and spot-check of pulse rate. Measurement is performed on the wrist of 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.
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5.5 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 BMI