(273 days)
The ADFLOW Personal Health Center (PHC) is indicated for and consists of
-
- A Blood Pressure Monitor (BPM) that is used for the measurement of blood pressure and heart rate by members of the general public. The device does not perform any diagnoses; it only provides blood pressure and heart rate data to the users, who are advised to consult a physician.
-
- a Body Composition Monitor (BCM) that is used as a body fat analyzer that estimates the percent body fat (%BF), percent lean body mass (%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis).
The PHC is intended for healthy subjects between 8 and 92 years.
The ADFLOW Personal Health Center (PHC) consists of a Blood Pressure Monitor (BPM) and a Body Composition Monitor (BCM). The BPM measures blood pressure and heart rate. The BCM estimates percent body fat, percent lean body mass, and percent total body water using bioelectrical impedance analysis (BIA).
This document is a 510(k) clearance letter from the FDA for the ADFLOW Personal Health Center. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a product's technical documentation or clinical study results.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It briefly mentions the "Indications for Use" for the Blood Pressure Monitor (BPM) and Body Composition Monitor (BCM) components, but does not provide any specific acceptance criteria or study data demonstrating the device meets those criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not available.
- If a standalone performance study was done: Not available.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
This document serves as an FDA clearance letter, not a detailed technical or clinical study summary. To obtain the information you're looking for, you would typically need to consult a different type of document, such as the 510(k) submission summary, a clinical study report, or the device's technical specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center ~ WO66-G609 Silver Spring, MD 20993-0002
April 15, 2013
Adflow Health Network Inc. c/o Mr. Glen Feye (Accurate Consultants Inc.) 3232 Ibis Street San Diego, CA 92103
Re: K122076
Trade Name: ADFLOW Personal Health Center Regulation Number: 21 CFR 878.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN, MNW Dated: March 21, 2013 Received: March 29, 2013
Dear Mr. Feye:
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. 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 mav publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Glen Feye
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Owen P. Faris -S
2013.04.15
'15:53:15 -04'00'
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 5
INDICATIONS FOR USE
510(k) Number (if known): K122076
ADFLOW Personal Health Center- Model v2.0 Device Name:
Indications for Use:
The ADFLOW Personal Health Center (PHC) is indicated for and consists of
-
- A Blood Pressure Monitor (BPM) that is used for the measurement of blood pressure and heart rate by members of the general public. The device does not perform any diagnoses; it only provides blood pressure and heart rate data to the users, who are advised to consult a physician.
-
- a Body Composition Monitor (BCM) that is used as a body fat analyzer that estimates the percent body fat (%BF), percent lean body mass (%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis).
The PHC is intended for healthy subjects between 8 and 92 years.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2013.04.15 15:49:48
-04'00'
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).