(127 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and Bluetooth data transfer, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is intended for measurement and monitoring of blood pressure and pulse rate, not for providing therapy or treatment.
Yes
Explanation: The device measures blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status, making it a diagnostic device.
No
The device description explicitly mentions hardware components like an inflated cuff, electrical air pump, mechanical valve, and LCD for displaying results. While it has Bluetooth connectivity for data transfer, it is fundamentally a hardware device with integrated software.
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 Bluetooth Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the upper arm and using the oscillometric method. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
Therefore, the device falls under the category of a non-invasive medical device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is arm type Blood Pressure Monitor that applies oscillometric method to measure human Systolic, Diastolic blood pressure and heart rate The measurement results are displayed on the LCD and transmitted to Bluetooth enabled devices, such as a PC , a PDA or a printer.
The devise is designed for adult.
The AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. At the end of each measurement, the results will be displayed on LCD. AViTA BPM656ZB through its Bluetooth wireless communication port can also transfer the measurement results to other electronic devices, such as a PC , a PDA or a printer.
The device is indicated for adult in home use. The arm circumference range shall be between 9 inches (23 cm) to 17 inches (43 cm). The end users should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DRG
Device Description
The AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB} is designed to measure the systolic and diastolic blood pressure, and pulse rate (heart of an individual).
The device uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff. The measurement results are displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point.
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)
Bench testing was conducted and demonstrated that any differences in technological characteristics compared to the predicate device do not raise new questions of safety or effectiveness. The device conforms to applicable standards including EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements.
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.
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
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
1. Submitter's Name: AViTA Corporation
| Address: | 9F, No. 78, SEC. 1, Kwang-Fu Rd., San-Chung, Taipei
County., Taiwan, 241 | |
|----------|-----------------------------------------------------------------------------|-------------|
| Phone: | +886-2-8512-1568 | DEC 07 2007 |
| Fax: | +886-2-8512-1347 | |
| Contact: | Mr. Casper Chen / Vice President of R&D | |
2. Device Name :
| Trade Name: | AVITA Bluetooth Blood Pressure Monitor , | |
|---|---|---|
| Model no.: BPM656ZB | ||
| Common Name: | Non-Invasive Blood Pressure Monitor | |
| Classification name | System , Measurement , Blood-Pressure , Non-Invasive |
- The AVITA Bluetooth Blood Pressure Monitor (Model 3. DEVICE CLASS no.: BPM656ZB) has been classified as Regulatory Class: II Panel: 74 Product Code: DXN Regulation Number: 2ICFR 870.1130
- The predicate device is the A&D Medical UA-767PBT Digital 4. Predicate Device: Blood Pressure Monitor(K040371) marketed by A & D ENGINEERING, INC ..
- The device is arm type Blood Pressure Monitor that applies 5. Intended Use: oscillometric method to measure human Systolic, Diastolic blood pressure and heart rate The measurement results are displayed on the LCD and transmitted to Bluetooth enabled devices, such as a PC , a PDA or a printer.
The devise is designed for adult.
1
6. Device Description: The AViTA Bluetooth Blood Pressure Monitor (Model
no.: BPM656ZB} is designed to measure the systolic and diastolic blood pressure, and pulse rate (heart of an individual).
The device uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff. The measurement results are displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point.
-
- Performance In terms of operating specification, Safety & EMC Summary: requirements, the device conforms to applicable standards included EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements.
8. Conclusions:
The_AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) has the same intended use and similar technological characteristics as the A&D Medical UA-767PBT Digital Blood Pressure Monitor(K040371) marketed by A & D ENGINEERING, INC.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, The AVITA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) is substantially equivalent to the predicate devices.
2
Public Health Service
Image /page/2/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name encircling an emblem. The emblem is a stylized representation of a human figure, with three lines forming the head, torso, and legs, suggesting movement or progress.
DEC 0 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AViTA Corporation c/o Ms. Jennifer Reich 2904 Boldt Drive Flagstaff, AZ 86001
Re: K072137
Trade/Device Name: AViTA Bluetooth Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN, DRG Dated: November 6, 2007 Received: November 8, 2007
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 such 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.
3
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B.Zimmerman Jr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ___K072137
Device Name: AViTA Bluetooth Blood Pressure Monitor , Model no .: BPM656ZB AVITA Corporation
Indications For Use:
The AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. At the end of each measurement, the results will be displayed on LCD. AViTA BPM656ZB through its Bluetooth wireless communication port can also transfer the measurement results to other electronic devices, such as a PC , a PDA or a printer.
The device is indicated for adult in home use. The arm circumference range shall be between 9 inches (23 cm) to 17 inches (43 cm). The end users should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation.
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)
Bllumema
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number
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