(168 days)
Not Found
No
The summary describes a standard blood pressure monitor using a cuff and LCD display, with no mention of AI or ML terms or functionalities.
No.
The device is for measuring blood pressure and pulse rate, which are diagnostic measurements for monitoring health conditions, not for treating a disease or condition.
Yes
The device is described as a "Blood Pressure Meter (or Monitor)" that measures "systolic and diastolic blood pressure, and pulse rate," which are diagnostic measurements used to assess a patient's health.
No
The device description explicitly states it uses a cuff wrapped around the arm and has an LCD panel, indicating it is a hardware device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The description clearly states the device is noninvasive and measures blood pressure and pulse rate by using a cuff wrapped around the arm. This is a measurement taken on the body, not from a specimen taken from the body.
Therefore, based on the provided information, the AVITA BPM6 series Blood Pressure Meter is a non-invasive medical device used for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
AVITA BPM6 series Blood Pressure Meter is intended to measure human begins Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD DISPLAY. Measurement position is on adult arm only.
The device is noninvasive and provides systolic, diastolic blood pressure and pulse rate measurements by using an cuff which is wrapped around the arm. All values can be read out in one LCD panel. Measurement is for adult only.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
AVITA BPM6 series Blood Pressure Meter(or Monitor) 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
Arm
Indicated Patient Age Range
Adult only
Intended User / Care Setting
Not Found
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)
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 BPM6 series Blood Pressure Meter. The comparison study demonstrated that the clinical repeatability of AVITA BPM6 series Blood Pressure Meter is statistically and clinically acceptable.
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
APR - 9 2004
510(K) SUMMARY
K033397 p112-
This summary of 510(k) safety and effectiveness information is being submitted in accordance in 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 BPM6 series Blood Pressure Meter(or Monitor) |
| Model No.: | BPM6XY (X= 0 or 1 , Y=1,2 or 3) | |
| The first Character (X= 0 or 1 ) represents for type of case housing. | ||
| The second Character (Y=1,2 or 3 ) represents for type of product specification. | ||
| 3.0 | Classification: | Class II |
| 4.0 | Predicate Device: | AVITA BPM6 series Blood Pressure Meter(or Monitor) has similar general design with OMRON HEM-757 Blood Pressure |
| Monitor(K001670) marketed by Omron Healthcare, Inc.. | ||
| 5.0 | Device Description: | AVITA BPM6 series Blood Pressure Meter(or Monitor) is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual). |
| 6.0 | Intended Use: | AVITA BPM6 series Blood Pressure Meter is intended to measure human begins Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD DISPLAY. Measurement position is on adult arm only. |
| 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 BPM6 series Blood Pressure Meter. The comparison study demonstrated that the clinical repeatability of AVITA BPM6 series Blood Pressure Meter is statistically and clinically acceptable. |
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1
Conclusions: 8.
o. "Conclusione:
The AVITA BPM6 series Blood Pressure Meter have the same intended use and similar mle AVTA Blance 21000 Bress 21000
technological characteristics as OMRON HEM-757 Blood Pressure Monitor(K001670) technological characteristions as Chitter Contained in this submission and mailkeled by Official realthours, mon more connological characteristics do
clinical testing supplied demonstrate that any differences in the same of the st cifical testing supplied demonstrate that any and the AVITA BPM6 series Blood not raiso and not is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like strokes.
Public Health Service
APR - 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AVITA Corporation c/o Ms. Jennifer Reich Harvest Consulting Corp. 3892 South America West Trail Flagstaff, AZ 86001
Re: K033397
Trade Name: AViTA BPM6 Series Blood Pressure Meter (Monitor) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Received: March 02, 2004
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
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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 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 Office of Compliance at (301) 594-4648. 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,
Dana R. Lo Jones
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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Page 4 - Ms. Jennifer Reich
Indications for Use
510(k) Number: K033397
Device Name: Avita BPM6 Series Blood Pressure Meter (or Monitor)
Indications For Use:
The device is noninvasive and provides systolic, diastolic blood pressure and pulse rate measurements by using an cuff which is wrapped around the arm. All values can be read out in one LCD panel. Measurement is for adult only.
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)
Duna R. Lochner
(Division 3) - Jil) Division of Cardiovascular Devices
510(k) Number_K033399