(94 days)
The AVITA BPM1x Series device automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the wrist. The device is intended to be used by adults with a wrist circumference ranging from 125 mm to 210 mm (approx. 4.9 ~ 8.3 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.
AViTA BPM1x series Wrist Type Blood Pressure Monitor
The provided text is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain the detailed information required to answer your questions about acceptance criteria, study design, ground truth establishment, or performance metrics.
Specifically, the document:
- Declares the device substantially equivalent to a predicate device. This means the new device performs similarly to an existing, legally marketed device.
- Lists the indications for use (wrist blood pressure monitor for adults, 125-210 mm wrist circumference, home use, detects irregular heartbeats).
- Outlines regulatory requirements for the manufacturer (registration, labeling, MDR, GMP, etc.).
- Identifies the product code and regulatory class.
It does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or expert qualifications.
- Information on ground truth methods, training/test set sizes, or how ground truth was established for these sets.
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
To answer your questions, one would need access to the actual 510(k) submission, which would include the performance study reports and data. The provided letter is the FDA's decision based on that submission, not the submission itself.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
DEC 1 6 2010
AVITA Corporation c/o Ms. Jennifer Reich Harvest Consulting Corporation 2904 N. Boldt Drive Flagstaff, AZ 86001
Re: K102624
Trade/Device Name: AViTA BPM1x Series Wrist Type Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 07, 2010 Received: December 13, 2010
Dear Ms. Reich:
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.
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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Page 2 - A V iTA Corporation c/o Ms. Jennifer Reich
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/ReportalProblem/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,
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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Indications for Use
510(k) Number (if known): K102624
Device Name: AViTA BPM1x series Wrist Type Blood Pressure Monitor AViTA Corporation
Indications for Use:
The AVITA BPM1x Series device automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the wrist. The device is intended to be used by adults with a wrist circumference ranging from 125 mm to 210 mm (approx. 4.9 ~ 8.3 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V (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)
W. Wood
diovascular Devices
510(k) Number 102624
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).