(319 days)
Not Found
No
The description details a standard pressure-based blood pressure measurement method and mentions software for calculation, but there is no indication of AI/ML algorithms being used for analysis or interpretation. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is intended for measuring blood pressure and pulse rate, which is a diagnostic function, not a therapeutic intervention.
Yes
Explanation: The device is intended for measuring adult blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status. While it doesn't diagnose a specific disease, the measurement of these parameters contributes to the diagnostic process by providing essential data points for evaluating patient conditions.
No
The device description explicitly mentions hardware components like a blood pressure cuff, air pump, pressure sensor, and CPU, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "measuring adult blood pressure and pulse rate." This is a physiological measurement taken directly from the body, not a test performed on a sample (like blood, urine, or tissue) outside of the body.
- Device Description: The description details a pressure-based method using a cuff and sensor to measure pressure changes in the arteries. This is a physical measurement, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Detecting or measuring substances within those samples (analytes)
- Providing information for the diagnosis, monitoring, or treatment of diseases based on sample analysis.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
It is intended for measuring adult blood pressure and pulse rate over-the-counter.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.
The arm automatic blood pressure monitor BF1112, BF1112, BF1113 and BF1115 have the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult
Intended User / Care Setting
Home
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)
Laboratory testing was conducted to validate and verify that Arm automatic blood pressure monitor met all requirements of related international standards, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of the bellow consensus standards.
Clinical study has been evaluated according to ANSI/AAMI SP10.
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
K130325 DEC 2 4 2013
510(k) Summary
1. Applicant
| Applicant Name: | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
|---|---|
| Address: | 2/F West, M-7 Sinosteel Building, Maqueling Estate, |
| Hi-Tech Industrial Park, Nanshan District, | |
| Shenzhen 518057. China |
Contact person:
| Name: | Xie Qiongyu |
|---|---|
| Phone numbers: | 86-0755-26710795 |
| Fax numbers: | 86-0755-26012025 |
| E-mail: | xieqy@bpump.com.cn |
| Date Prepared: | 2013-1-30 |
2. Device information
- . Trade name: Arm automatic blood pressure monitor
- Model No .: BF1110, BF1112, BF1113 and BF1115
- . Regulation Description: Noninvasive blood pressure measurement system.
- Regulation Number: 21 CFR 870.1130
- � Product Code: DXN
- . Class: II
- . Review Panel: Cardiovascular
- Indications for Use: It is intended for measuring adult blood pressure and pulse rate � over-the-counter.
3. Predicate Devices
- . Noninvasive blood pressure measurement system
- . K-number: K121932
- � Product Code: DXN
- Intended User � Over the counter
- � Patient Population This device is intended for use on adults
- Indications for Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
- Manufactured by: e Omron Healthcare, Inc.
Page 1 of 3
1
4. Description of the device
Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.
The arm automatic blood pressure monitor BF1112, BF1112, BF1113 and BF1115 have the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.
5. Testing data and Clinical study
Laboratory testing was conducted to validate and verify that Arm automatic blood pressure monitor met all requirements of related international standards, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of the bellow consensus standards.
Clinical study has been evaluated according to ANSI/AAMI SP10.
| Applied Standard: |
|---|
| Electrical Safety and performance requirements: |
| IEC 60601-1 |
| AAMI performance standard ANSI/AAMI SP10 |
| Home-used medical equipment requirements and Environmental test: |
| IEC 60601-1-11 |
| Electromagnetic Compatibility Requirements: |
| EN 60601-1-2 |
| Biocompatibility Evaluation for NIBP Cuff |
| ISO 10993-1, ISO 10993-5, ISO 10993-10 |
| Clinical Evaluation: |
| ANSI/AAMI SP10 |
6. Comparison to Predicate Devices
| Items | Arm automatic blood pressure monitor | Noninvasive blood pressure
measurement system |
|----------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Manufacture | SHENZHEN PUMP MEDICAL: SYSTEM CO.,
LTD. | Omron Healthcare, Inc. |
| Model
Specific
ation | BF1110 & BF1112 | HEM-7200-Z (BP742) |
| | BF1113 & BF1115 | |
| Intended use | It is intended for measuring adult blood pressure
and pulse rate. | The device is a digital monitor
intended for use in measuring
blood pressure and pulse rate
in adult patient population. |
2
| | | | The device detects the
appearance of irregular
heartbeats during
measurement and gives a
warning signal with readings. |
|-----------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Patient
population | Adult | Adult | |
| Environment
of use | Home | Home | |
| Measuring
Principle | Oscillometric Method | Oscillometric Method | |
| Measuremen
t Range | Pressure: 0mmHg280mmHg37.3kPa)
(0kPa
Pulse Rate: 40bpm ~ 180bpm | Pressure: 0mmHg299mmHg240 V) | 4 AAA Alkaline battery or
Pulse Rate: 40bpm ~
180bpm | |
| Accuracy | Pressure:±3mmHg (±0.4kPa)
Pulse Rate: ±5% | | Pressure: ±3mmHg (±0.4kPa)
or 2% of reading
Pulse Rate:
±5% |
| Display | TN-LCD Digital
Display | BF1113: VA-LCD Digital
Display
BF1115:TN-LCD
Digital
Display | LCD |
| Memory | 90 sets memory of
measurement values | 50 sets of measurement
values (blood pressure
and pulse rate) for each
user (Memory1 and
Memory 2) | 30 sets of measurement
values (blood pressure and
pulse rate) for each user (A
and B) |
| Power
Source | 4 AA Alkaline
battery or AC Adaptor
(AC 100
AC Adaptor (AC 100~
240 V ) | 4 AA batteries or AC Adaptor
(AC 100240 V) |+40°C;
| Operating
Environment | Temperature: +5°C
Humidity: ≤93%RH | | Temperature: +10°C~+40°C:
Humidity: 30 to 85%RH |
| Storage and
Transport
Environment | Temperature: -25°C~+70°C;
Humidity: 10%95% | | Temperature: -25°C+60°C:
Humidity: 10%~95% |
| Weight | 294g
(Without batteries) | 270g
(Without batteries) | 340g (Not Including batteries) |
| Size | 140mm×110mm×70mm | | 141mm×123mm×85mm |
The subject device is Substantially Equivalent (SE) to the predicate device which is US legally market device.
7. Conclusion
As stated above, the Arm automatic blood pressure monitors (Models: BF1110, BF1112, BF1113 and BF1115) are safe and effective, and comply with the appropriate medical device standards. And they are substantially equivalent to the earlier identified predicate devices.
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 24, 2013
Shenzhen Pumo Medical System Co., Ltd. c/o Ms. Ivy Chen, Shenzhen Huatongwei International Inspection Co., Ltd. Keji Nan No. 12 Road, Hi-tech Park Shenzhen. Guangdong CHINA 518057
Re: K130325
Trade/Device Names: Arm Automatic Blood Pressure Monitor, with models BF1110, BF1112, BF1113 and BF1115 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 3, 2013 Received: December 12, 2013
Dear Ms. Chen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Ivy Chen
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _K130325
Device Name: Arm automatic blood pressure monitor
Indications for Use:
It is intended for measuring adult blood pressure and pulse rate.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODIE)
Date:
2013.12.24
09:39:44 -05'00'
Page 1 of 1