(80 days)
Not Found
No
The description details standard oscillometric blood pressure measurement techniques and electronic signal analysis, without mentioning any AI or ML algorithms. The performance studies focus on standard device testing and compliance with existing standards, not on the validation of AI/ML performance.
No.
The device is intended to measure blood pressure and pulse rate, which is a diagnostic function, not a therapeutic intervention.
Yes
The device measures properties related to a person's health (blood pressure and pulse rate) which can be used to monitor or indicate a medical condition.
No
The device description explicitly mentions an "inflatable cuff" and an "electronic semiconductor pressure sensor," indicating hardware components are integral to its function. The performance studies also include hardware-specific tests like "Reliability Test Drop Testing" and "EMC Test."
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 Microlife Wrist Watch Blood Pressure Monitor measures blood pressure and pulse rate by using a non-invasive technique involving a cuff wrapped around the wrist. This is a direct measurement of physiological parameters from the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate of an adult individual. This aligns with a general medical device for monitoring vital signs, not an IVD for analyzing biological samples.
- Device Description: The description details the non-invasive method of measurement using a cuff and electronic sensors, further confirming it's not an IVD.
Therefore, the Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 is a non-invasive medical device for monitoring blood pressure and pulse rate, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
Product codes
DXN
Device Description
The Microlife Wrist Watch Blood Pressure Monitor BP3AX1 is designed to The Microllie Whist Waten Blood i Toobal of an individual by wing a nonmeasure the Systoms, diactorio and parolf wrapped around wrist. Our method to Invasive technique with an inhatable stimilar to the auscultatory method but deline systellic and diastollo proboution is comment than stethoscope and uses an electronic semioondable proceed in proceed in cuff pressure to mercury manometer. The sonoor convention to define the systolic, diastolic and electrical signals, by analyzing those argulars.
calculating pulse rate is a well known technique in the market and is the so called "oscillometric method".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
adult individual
Intended User / Care Setting
Over-The Counter 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)
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Microlife l esting information demonstrating school, and the intended environment Automatic Blood Fressure Monitor, Model Bridge, Model in accordance with the FDA
of use is supported by testing that was conducted in accordance with the FDA of use is supported by tooting the were for Premarket Notification November 1993 Drait Treviewer Guidanos for and Environmental Performance Requirements.
The following testing was conducted:
- General Functions Test a.
- Reliability Test Operation Conditions b.
- Reliability Test Drop Testing ்.
- Reliability Test Storage ರ.
- Reliability Test Vibrating Testing e.
- EMC Test بت
- IEC 60601-1 Safety Test ದ.
None of the testing demonstrated any design characteristics that violated the None of the testing demonistratou any courgh ulted in any safety hazards. It was requirements of the Renovife Automatic Blood Pressure Monitor, Model our conclusion that the mievant requirements of the aforementioned tests.
Discussion of Clinical Tests Performed: 8.
ANSI/AAMI SP10-1992 "National Standard for Electronic or Automated ANOI/VAMI OF 10 1652 * 16 1652 * 15ting was performed. All relevant sections were Sphyghlomanometers tooling was ponomical relevant requirements of this standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K# 021305
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
113
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in This summary of Jio(K) Salety and Shoulds.
accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K04000 2
Submitter's Identification: 1.
Microlife Intellectual Property GmbH, Switzerland Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland
Date Summary Prepared: December 30, 2003
Contact: Mr. Gerhard Frick
Name of the Device: 2.
Microlife Blood Pressure Monitor Model BP3AX1
Predicate Device Information: 3.
The Microlife Wrist Watch Automatic Blood Pressure Monitor, Models BP3AX1 is The Microllie Wrist Waternatio Blood Pressure Monitor, Monitor, Model BP-3BU1-5, K# 021305.
Device Description: বা
The Microlife Wrist Watch Blood Pressure Monitor BP3AX1 is designed to The Microllie Whist Waten Blood i Toobal of an individual by wing a nonmeasure the Systoms, diactorio and parolf wrapped around wrist. Our method to Invasive technique with an inhatable stimilar to the auscultatory method but deline systellic and diastollo proboution is comment than stethoscope and uses an electronic semioondable proceed in proceed in cuff pressure to mercury manometer. The sonoor convention to define the systolic, diastolic and electrical signals, by analyzing those argulars.
calculating pulse rate is a well known technique in the market and is the so called "oscillometric method".
1
Intended Use: 5.
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 is a device The Microllie While While William and diastolic blood pressure and pulse rate of an intelluou to modours the a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
Comparison to Predicate Devices: 6.
All devices use the well known oscillometric method within the software algorithm All develop as a no diastolic blood pressure and pulse rate. A wrist to determine the cystem and artically; deflate rate is controlled by one linear inniatuolo oun 10 innition pressures are transferred via tubing to a sensor in all valve and the donation procession uses semiconductor pressure sensor instead afma. Dut our revir me sensor on the predicate device to translate the pressure or capacitive proceere signals that can be interpreted by an integrating circuit. vance to oloothour determined each unit operates the linear valve to release the pressure to zero.
Unlike the predicate device, our new model BP3AX1 uses a piezo-resitive Onlike the products consolternation of cuff pressure. The basic theory of the sensor is stated below:
The diffusion-type semiconductor pressure sensor has four pressure senitive rho diffact type ossistors which are formed on the diaphragm surface of silicon of in substrate by a conventional diffusion process of IC production technique.
The piezo resistors change those resistivity by applied stress called as piezo r no prozo rother oven the diaphragm is formed by the applied pressure.
The resistivity change of the four resisters which consist of the wheatstone brige r no rooletinty onany on need and bridge output voltage by a externally supplied driving current or voltage.
V oc P
Where V is the sensor output voltage P is the applied pressure
In addition in our pressure monitor, we have deleted the printer function.
2
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Microlife l esting information demonstrating school, and the intended environment Automatic Blood Fressure Monitor, Model Bridge, Model in accordance with the FDA
of use is supported by testing that was conducted in accordance with the FDA of use is supported by tooting the were for Premarket Notification November 1993 Drait Treviewer Guidanos for and Environmental Performance Requirements.
The following testing was conducted:
- General Functions Test a.
- Reliability Test Operation Conditions b.
- Reliability Test Drop Testing ்.
- Reliability Test Storage ರ.
- Reliability Test Vibrating Testing e.
- EMC Test بت
- IEC 60601-1 Safety Test ದ.
None of the testing demonstrated any design characteristics that violated the None of the testing demonistratou any courgh ulted in any safety hazards. It was requirements of the Renovife Automatic Blood Pressure Monitor, Model our conclusion that the mievant requirements of the aforementioned tests.
Discussion of Clinical Tests Performed: 8.
ANSI/AAMI SP10-1992 "National Standard for Electronic or Automated ANOI/VAMI OF 10 1652 * 16 1652 * 15ting was performed. All relevant sections were Sphyghlomanometers tooling was ponomical relevant requirements of this standard.
Conclusions: 9.
We have demonstrated that the Microlife Automatic Blood Pressure Monitor, We have domonistrative as the and effective as the predicate, the Microlife Automatic Blood Pressure Monitor, Model BP-3BU1-5 based on electrical, Automatic Blood Frossars well as the FDA as well as the FDA DCRND nechanioal and Driver Guidance for Premarket Notification November 1950 Drat: "Ronows Standard, SP10-1992 testing results.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with three stylized human profiles incorporated into its body. The eagle is facing right, and the profiles are stacked vertically.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2004
Microlife Intellectual Property GmbH c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K040002
Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 30, 2003 Received: January 2, 2004
Dear Ms. Goldstein-Falk:
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
4
Page 2 -- Ms. Susan D. Goldstein-Falk
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) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. lochner
Image /page/4/Picture/5 description: The image shows a simple, hand-drawn symbol. It appears to be a stylized representation of a knot or a loop, with lines intersecting and curving to form a closed shape. The drawing is somewhat rough, suggesting it was created quickly or informally.
() Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exhibit B
Page __ 1 __ of __ 1 __ 1 __
510(k) Number (if known): __ k 04000 2
Microlife Wrist Watch Blood Pressure Monitor, Model Device Name: BP3AX1
Indications For Use:
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use _X (21 CFT 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Kirchner
J-vision Sign-Off) ് നടിന്ന് വ്യൂസ് വിശ്വാസ Devices
510(k) Number_k 040002