(112 days)
Not Found
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The "Not Found" entries for AI/ML mentions, training/test sets, and performance metrics further support this conclusion.
No
The device is a blood pressure monitor intended for measurement and detection, not for treating a disease or condition.
Yes
Explanation: The device measures systolic and diastolic blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status. It also detects irregular heartbeats, providing information that can be used for diagnostic purposes.
No
The device description explicitly states it is an "Arm Type Blood Pressure Monitor" and uses an "inflatable cuff wrapped around the upper arm," indicating it is a hardware device with a physical component for measurement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AViTA BPM6x Series Arm Type Blood Pressure Monitor measures blood pressure and pulse rate using a non-invasive oscillometric technique on the upper arm. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for measuring blood pressure and pulse rate on an adult individual by wrapping a cuff around the upper arm.
Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
DXN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult
Intended User / Care Setting
home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.
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.
1
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.
-6-
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
2
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 |
Page 1 of 1