(267 days)
The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications for ambulatory blood pressure monitoring.
Ambulatory Blood Pressure Monitor
This FDA 510(k) clearance letter for the Meditech ABPM-06 (BP6) does not provide the detailed information required to fill out the table regarding acceptance criteria and study results. This document is a clearance letter, which confirms that the device has been found substantially equivalent to a predicate device, but it does not typically contain the raw study data or a detailed breakdown of the performance validation study.
The letter only states:
- Device Name: Meditech ABPM-06 (BP6)
- Intended Use: "automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications for ambulatory blood pressure monitoring."
- Regulation Name: Noninvasive Blood Pressure Measurement System
- Regulatory Class: Class II
- Product Code: DXN
To answer your request, one would typically need access to the full 510(k) submission, which would include the performance study reports.
However, based on the information provided and general knowledge of blood pressure device validation, I can make some inferences about typical acceptance criteria for non-invasive blood pressure monitors, but these are not explicitly stated in the provided document.
Here is what would typically be expected, but not found in the provided text:
Inferred Acceptance Criteria and Reported Device Performance (Typical for BP Monitors)
| Acceptance Criteria (Inferred/Typical) | Reported Device Performance (Not found in document) |
|---|---|
| Accuracy (Mean Difference to Reference Standard) | This information is not provided in the FDA clearance letter. A typical standard like ISO 81060-2 requires a mean difference (device vs. reference) of ≤ ±5 mmHg for both systolic and diastolic, with a standard deviation of ≤ 8 mmHg. |
| Accuracy (Standard Deviation of Differences) | This information is not provided in the FDA clearance letter. A typical standard like ISO 81060-2 requires a standard deviation of differences (device vs. reference) of ≤ 8 mmHg for both systolic and diastolic. |
| Bias (e.g., AAMI/ISO Standard requirements for absolute differences within certain ranges) | This information is not provided in the FDA clearance letter. For example, AAMI/ISO standards often require that specific percentages of differences fall within certain mmHg ranges (e.g., 60% within ±5 mmHg, 85% within ±10 mmHg, 95% within ±15 mmHg). |
| Clinical Performance (e.g., successful measurements, cuff fit, patient comfort in ambulatory setting) | This information is not provided in the FDA clearance letter. The intended use mentions "ambulatory circumstances," implying that the device was likely tested for usability and performance in a real-world, mobile setting. However, specific metrics are not given. |
| Safety (e.g., absence of adverse events, pneumatic system pressure limits) | This information is not provided in the FDA clearance letter, beyond the general statement of clearance. Safety testing is inherent in device approval, but specific criteria and results are not detailed here. |
| Technical Performance (e.g., battery life, data storage, communication with software) | This information is not provided in the FDA clearance letter. While implied by "preprogrammed by the adjoining software," specific performance metrics are absent. |
| Software Validation (e.g., correct data acquisition, storage, and transfer consistent clinical decision support, user interface functionality) | This information is not provided in the FDA clearance letter. As the device uses "adjoining software," software validation would have been a part of the submission, but its specific acceptance criteria and results are not detailed here. The letter only broadly mentions "preprogrammed by the adjoining software." |
Based on the provided document, the following details are not available:
- Sample size used for the test set and the data provenance: Not mentioned. Such studies typically involve a clinical trial with a specified number of subjects (e.g., 85 subjects as per ISO 81060-2).
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned. For blood pressure monitors, ground truth is typically established by trained human observers using a mercury or auscultatory sphygmomanometer according to standardized protocols.
- Adjudication method for the test set: Not mentioned. The ground truth for BP devices is usually a consensus or average of multiple simultaneous auscultatory measurements by trained observers.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable to a standalone blood pressure monitor (it's not an AI-assisted diagnostic imaging device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone measurement device. Its performance is evaluated against an independent reference standard, typically human auscultation.
- The type of ground truth used: Not explicitly stated, but for blood pressure monitors, it's typically auscultatory measurement by trained observers or a validated reference device.
- The sample size for the training set: Not applicable as this is a non-AI hardware device that uses an "oscillometric method." There isn't a "training set" in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA clearance letter is a regulatory document confirming substantial equivalence and does not contain the detailed technical and clinical study results that would provide answers to most of your specific questions. That information would be found in the original 510(k) submission.
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February 10, 2021
Meditech Ltd. % Ray Kelly Consultant Arazy Group Consultants Inc. 3422 Leonardo Lane New Smyrna Beach, Florida 32168
Re: K201332
Trade/Device Name: Meditech ABPM-06 (BP6) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 23, 2020 Received: January 12, 2021
Dear Ray Kelly:
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
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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 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,
LT 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) K201332
Device Name
Meditech ABPM-06 (BP6)
Indications for Use (Describe)
The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications for ambulatory blood pressure monitoring.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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).