(112 days)
The AViTA BPM6x Series Arm Type Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 229 mm -330 mm (approx.: 9 ~ 13 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 BPM6x Series Arm Type Blood Pressure Monitor
The provided text is a 510(k) summary from the FDA for the AViTA BPM6x Series Arm Type Blood Pressure Monitor. It outlines the device's indications for use and states that it has been found substantially equivalent to legally marketed predicate devices. However, it does not contain the detailed acceptance criteria and study information requested.
The document is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This sort of data is typically found in a clinical study report, which is not included.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. This type of study is more common for diagnostic imaging devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This is also more relevant for AI-driven diagnostic devices.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned. This would be relevant for machine learning-based algorithms, which is not explicitly stated to be part of this blood pressure monitor.
- How the ground truth for the training set was established: Not mentioned.
What the document does indicate about the device:
- Device Name: AViTA BPM6x Series Arm Type Blood Pressure Monitor
- Intended Use: Measures systolic and diastolic blood pressure and pulse rate of an adult individual using a non-invasive oscillometric technique with an inflatable arm cuff.
- Cuff Circumference: Limited to 229 mm - 330 mm (approx. 9-13 inches).
- Intended Environment: Home use.
- Additional Feature: Detects irregular heartbeats during measurement and displays a symbol along with readings.
- Regulatory Classification: Class II (two) medical device.
- Product Code: DXN (Noninvasive blood pressure measurement system).
- Approval Type: 510(k) premarket notification (meaning it was found substantially equivalent to a predicate device).
To obtain the detailed acceptance criteria and study data, one would typically need access to the full 510(k) submission, which includes test reports and clinical data. This public summary only confirms the FDA's decision based on that submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Avita (Wujiang) Co., LTD c/o: Ms. Jennifer Reich Harvest Consulting Corp. (USA) 2904 N. Boldt Drive Flagstaff, AZ 86001
JAN 1 8 2012
Re: K112825
Trade Name: Avita arm type blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II (two) Product Code: DXN (Noninvasive blood pressure measurement system). Dated: 12/15/2011 Received: 12/16/2011
Dear Mrs. Reich:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarell by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and ment date of the Medical Device Amendments, or to conninered proc to May 20, 1978) the excordance with the provisions of the Federal Food, Drug, devices that have been roomsting approval of a premarket approval application (PMA). and Cosmetion recry rece) market the device, subject to the general controls provisions of the Act. The T ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and devices, good manufacturing praction, as thing
adulteration. Please note: CDRH does not evaluate information related to contract liability adultcraiton. Treasonote: ODFET assess as 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 If your device is classified (300 a0010) inse the major regulations affecting your device can be may be subject to additional controliations, 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 - 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 or any I 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 CI ic Fat 607), abouting (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 11 70 a dos://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 I ou may other 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.
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Sincerely yours,
Bram D. Zuckerman, M.D.
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
Device Name: AViTA BPM6x Series Arm Type Blood Pressure Monitor AViTA Corporation
Indications for Use:
The AViTA BPM6x Series Arm Type Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 229 mm -330 mm (approx.: 9 ~ 13 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
V 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)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K112825 |
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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).