(55 days)
K# 013485, K#012472
Not Found
No
The description focuses on the oscillometric method and irregular heartbeat detection, which are standard signal processing techniques, not AI/ML. There is no mention of AI, ML, or related concepts like training/test sets.
No
The device is intended to measure blood pressure and pulse rate, and detect irregular heartbeat; it does not provide therapy or treatment.
Yes
Explanation: The device measures blood pressure and pulse rate, and detects irregular heartbeats, which are physiological parameters used to assess a health condition or identify a disease.
No
The device description explicitly mentions an inflatable cuff, a pressure sensor, and the oscillometric method, all of which are hardware components used for measurement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for measuring blood pressure and pulse rate using a non-invasive technique on the upper arm. This is a physiological measurement taken directly from the body, not a test performed on a sample of biological material (like blood, urine, or tissue) outside of the body.
- Device Description: The description reinforces the non-invasive nature of the measurement using an inflatable cuff and an electronic pressure sensor. It describes the "oscillometric method," which is a common technique for non-invasive blood pressure measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on materials taken from the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This blood pressure monitor does not fit that description.
N/A
Intended Use / Indications for Use
The Microlife Upper Arm Blood Pressure Monitor, Model BP 3BT0-AP, 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 upper arm.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-AP is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
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 individual
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)
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Microlife Automatic Blood Pressure Monitor, Model BP3BT0-AP in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.
The following testing was conducted:
- General Functions Test a.
- Reliability Test Operation Conditions b.
- Reliability Test Drop Testing C.
- Reliability Test Storage d.
- Reliability Test Vibrating Testing e.
- (. EMC Test
- IEC 60601-1 Safety Test ப்.
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Microlife Automatic Blood Pressure Monitor, Model BP-3BT0-AP tested met all relevant requirements of the aforementioned tests.
Discussion of Clinical Tests Performed:
Since the blood pressure measuring algorithm in this device is exactly the same as in the predicate device, BP3BT0-1, no clinical validation for blood pressure measurement is required. Instead, we conducted a simulator comparison study for the function of irreqular heartbeat detection.
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.
K# 013485, K#012472
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
EXHIBIT # 1
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K0414) /
1. Submitter's Identification:
Microlife Intellectual Property GmbH, Switzerland Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland
Date Summary Prepared: May 26, 2004
Contact: Mr. Gerhard Frick
2. Name of the Device:
Microlife Blood Pressure Monitor, Model BP3BT0-AP
3. Predicate Device Information:
The Microlife Upper Arm Automatic Blood Pressure Monitor. Model BP-3BTO-AP is substantially equivalent to the Microlife Automatic Blood Pressure Monitor. Model BP-3BT0-1, K# 013485, and, the A&D Medical Lifesource Blood Pressure Monitor, Model UA-787V, K#012472.
4. Device Description:
The Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-AP is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
1
റ Intended Use:
The Microlife Upper Arm Blood Pressure Monitor, Model BP-3BT0-AP, 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 upper arm.
The device detects the appearance of irregular heartbeat during measurement, and cives a warning signal with the reading once the irregular heartbeat is detected.
6. Comparison to Predicate Devices:
Both the subject device and Microlife predicate use the well known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. Both devices use a similar capacitance-type pressure sensor to translate the pressure variations to electrical signals that can be interpreted by an integrating circuit. For both devices, the software is capable of a split slope resolution to improve accuracy over the entire range. The subject device differs from the Microlife predicate in the irregular heartbeat detection function.
Both the subject device and the A&D Medical Lifesource predicate have the same indications for use. Both devices include an irregular heartbeat detection function. Both the subject device and the A&D Medical Lifesource predicate use the well known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Microlife Automatic Blood Pressure Monitor, Model BP3BT0-AP in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.
The following testing was conducted:
- General Functions Test a.
2
KO-1411 p. 313
- Reliability Test Operation Conditions b.
- Reliability Test Drop Testing C.
- Reliability Test Storage d.
- Reliability Test Vibrating Testing e.
- (. EMC Test
- IEC 60601-1 Safety Test ப்.
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Microlife Automatic Blood Pressure Monitor, Model BP-3BT0-AP tested met all relevant requirements of the aforementioned tests.
8. Discussion of Clinical Tests Performed:
Since the blood pressure measuring algorithm in this device is exactly the same as in the predicate device, BP3BT0-1, no clinical validation for blood pressure measurement is required. Instead, we conducted a simulator comparison study for the function of irreqular heartbeat detection.
9. Conclusions:
We have demonstrated that the Microlife Automatic Blood Pressure Monitor, Model BP3BT0-AP, is as safe and effective as the predicate, the Microlife Automatic Blood Pressure Monitor, Model BP-3BT0-1, and, the A&D Medical Lifesource, based on electrical, mechanical and environmental testing results as well as the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", and, the ANSI/AAMI Voluntary Standard, SP10-1992 testing results.
3
Image /page/3/Picture/1 description: The image is a seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 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: K041411
Trade Name: Microlife Upper Arm Blood Pressure Monitor, Model BP-3BT0-AP Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 26, 2004 Received: May 27, 2004
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becare ined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surve in the encrea, 1976, the enactment date of the Medical Device Amendments, or to econimer of Price Corner of Hassified in accordance with the provisions of the Federal Food, Drug, de noos mat have occh revat do not require approval of a premarket approval application (PMA). and Oosmeter Fee (110) and 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.
4
Page 2 - Ms. Susan D. Goldstein-Falk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Icase oc advised that I Dr Fristiantes syour device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must of any I cach statutes and regulations and limited to: registration and listing (21 Comply with an the 11ct 311 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by tions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control problem marketing your device as described in your Section 510(k) I mis letter will and w you'll begin finding of substantial equivalence of your device to a legally prematicated predicated with 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 if you desire specific arroliance at (301) 594-4648. Also, please note the regulation entitled, Connact the Orized of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your rossumer 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,
Neil R. Ogden
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
510(k) Number (if known): K041411
Device Name: Microlife Upper Arm Blood Pressure Monitor, Model BP-3BT0-AP
Indications For Use:
The Microlife Upper Arm Blood Pressure Monitor, Model BP 3BT0-AP, 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 upper arm.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
| Prescription Use
(Per 21 CFR 801 Subpart D) | OR | Over-The Counter Use X
(21 CFT 807 Subpart C) |
| ------------------------------------------------ | ---- | -------------------------------------------------- |
|---|
(Division Sign-Off)
Division of Cardiovascular Devices
| 310(k) Number | K041411 |
|---|---|
| --------------- | --------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)