(121 days)
Not Found
No
The summary describes a standard blood pressure monitor using an inflating cuff and LCD display, with no mention of AI, ML, or related concepts.
No.
The device is intended for measurement and monitoring, not for treating a disease or condition.
No
Explanation: The device measures blood pressure and pulse rate, which are physiological parameters, not conditions or diseases. While these measurements can be used by a healthcare professional as part of a diagnostic process, the device itself is described as a "Blood Pressure Meter" and its primary function is measurement, not diagnosis. It provides data, not a diagnosis of a condition.
No
The device description explicitly states it uses an "inflating cuff which is wrapped around the wrist" and has an "LCD panel," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a noninvasive blood pressure monitor that measures physiological parameters directly from the body (blood pressure and pulse rate) using a cuff. It does not analyze any biological specimens.
The description clearly indicates it's a device for measuring vital signs directly from the patient, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
AVITA BPM1 Series Wrist Type Blood Pressure Meter is intended to measure the systolic and diastolic blood pressure, and pulse rate(heart rate) by using an inflating cuff which is wrapped around the wrist. The Device is indicated for use by people over 15 years old in home use.
The device is noninvasive and provide systolic, diastolic blood pressure and pulse rate(heart rate) measurements by using an inflating cuff which is wrapped around the wrist. All values can be read out in one LCD panel. The device is indicated for use by people over 15 years old in home use.
Product codes
DXN
Device Description
AVITA BPM1 Series Wrist Type Blood Pressure Meter is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
over 15 years old
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
A comparison study with device that use auscultatory method was performed to validate the performance of the AVITA BPM1 Series Wrist Type Blood Pressure Meter. The comparison study demonstrated that the clinical repeatability of AVITA BPM1 Series Wrist Type Blood Pressure Meter is statistically and clinically acceptable.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 23 2003
(030230
1 of 2
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
...
| 1.0 | Submitter's Name: | AVITA Corp |
|---|---|---|
| Address: | 9F, No. 78, Sec. 1, Kwang-Fu Rd., San-Chung, Taipei County, | |
| Taiwan, R.O.C. | ||
| Phone: | 001-886-2-85121568 | |
| Fax: | 001-886-2-85121347 | |
| Contact: | Mr. Geo Lin, General Manager | |
| 2.0 | Device Name: | AVITA BPM1Series (Wrist Type) Blood Pressure Meter (or Monitor) |
| Model No.: BPM1XY | ||
| ► The first Character (blank, 0-9 or A-Z )is for the minor | ||
| change revision of device (The Minor change meaning | ||
| device change that do not affect the conformity test result of | ||
| EMC & Safety, ie. IEC 60601-1 and IEC 60601-1-2 ) | ||
| ► The second Character (blank, 0-9 or A-Z ) is for the color of | ||
| the housing | ||
| (for example Wellex Blood Pressure Monitor # BPM101, is for | ||
| the first revision of device design and the present version of color & | ||
| artwork) | ||
| 3.0 | Classification: | Class II |
| 4.0 | Predicate Device: | AVITA BPM1 Series Wrist Type Blood Pressure Monitor has |
| similar general design with HL-168D Wrist Blood Pressure | ||
| Monitor(K012310) marketed by Health & Life Co., Ltd.. | ||
| 5.0 | Device Description: | AVITA BPM1 Series Wrist Type Blood Pressure Meter is |
| designed to measure the systolic and diastolic blood pressure, and | ||
| pulse rate(heart of an individual). | ||
| 6.0 | Intended Use: | AVITA BPM1 Series Wrist Type Blood Pressure Meter is |
| intended to measure the systolic and diastolic blood pressure, and | ||
| pulse rate(heart rate) by using an inflating cuff which is wrapped | ||
| around the wrist. The Device is indicated for use by people over 15 | ||
| years old in home use. |
1
7.0 Performance Summary:
In terms of operating specification, Safety & EMC 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. A comparison study with device that use auscultatory method was performed to validate the performance of the AVITA BPM1 Series Wrist Type Blood Pressure Meter. The comparison study demonstrated that the clinical repeatability of AVITA BPM1 Series Wrist Type Blood Pressure Meter is statistically and clinically acceptable.
8. Conclusions:
The AVITA BPM1 Series Wrist Type Blood Pressure Meter have the same intended use and similar technological characteristics as HL-168D Wrist Blood Pressure Monitor(K012310) marketed by Health & Life Co., Ltd.. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the AVITA BPM1 Series Wrist Type Blood Pressure Meter is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, with a bird-like wing extending from the head of the first profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2003
AViTA Corporation c/o Ms. Jennifer Reich 3892 South America West Trail Flaggstaff. AZ 86001
Re: K030230
Trade Name: AViTA BPM 1 Series (Wrist type) Blood Pressure Meter (or Monitor) Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive blood measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: April 7, 2003 Received: April 18, 2003
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.
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
3
Page 2 - Ms. Jennifer Reich
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 (OS) 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _________________________________________________________________________________________________________________________________________________________________________
510 (k) NUMBER (IF KNOWN): K032230
AVITA BPM1 Series Wrist Type Blood Pressure Meter DEVICE NAME: AVITA Corp.
INDICATIONS FOR USE:
The device is noninvasive and provide systolic, diastolic blood pressure and pulse rate(heart rate) measurements by using an inflating cuff which is wrapped around the wrist. All values can be read out in one LCD panel. The device is indicated for use by people over 15 years old in home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| Over-The-Counter | |
| (Optional Format) | X |
| 510(k) Number | K030230 |