(206 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor with a microprocessor and basic functions like memory and irregular heartbeat detection. There is no mention of AI, ML, or related concepts.
No
The device is a diagnostic tool designed to measure blood pressure and pulse rate, not to treat a condition. While it detects irregular heartbeats, this is a monitoring function, not a therapeutic intervention.
Yes
Explanation: The device measures blood pressure and pulse rate, and also detects and warns of irregular heartbeats, which are indicators of potential medical conditions, thus serving a diagnostic function.
No
The device description explicitly lists hardware components such as a microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD, and Bluetooth.
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 Belter Blood pressure meter measures blood pressure and pulse rate directly from the patient's arm using a cuff and the oscillometric technique. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) of an adult person. This is a direct measurement on the body, not an analysis of a sample.
Therefore, the Belter Blood pressure meter falls under the category of a non-invasive medical device for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Belter Blood pressure meter is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Belter Blood pressure meter can automatically complete the inflation,deflation and measurement .which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference ranging from 22 cm to 36cm by the oscillometric technique. User can select the blood pressure unit mmHg or KPa.
The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve and LCD. The subject device is powered by four AA alkaline batteries.
The device has a memory function that automatically stores up to 60 sets of the latest measurements. It can also display the latest measurement result.
The subject device embeds a Bluetooth that allows it to transport the measurement data to nearby receiving end.
The device also detects the appearance of irregular heartbeats during measurement. and gives a warning signal with readings.
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
Intended User / Care Setting
medical facilities or at 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)
The following practices were followed and monitored for development of the Belter Blood pressure meter:
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for . Safety, 1988+A1:1991+A2:1995
- . IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests. 2007
- ANSI/AAMISP10 Manual, electronic, or automated sphygmomanometers, . 2002/A1:2003
- Medical electrical equipment --Part 1-11: . IEC60601-1-11 General requirements for basic safety and essential performance -Collateral Standard : Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment,2010
- . ISO 10993-1, Biological evaluation of medical devices-Part 1: Evaluation and testing, 2009
- . ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
- . ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010
- . EN1060-1:A1:1995+A2:2009 Non-invasive sphygmomanometers -Part 1: General requirements,2010
- . EN1060-3 ,Non-invasive sphygmomanometers -Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems,2005
- . EN1060-4 Non-invasive sphygmomanometers - Part 4:Test procedures to determine the overall system accuracy of automated Non-invasive sphygmomanometers,2004
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
Image /page/0/Picture/0 description: The image shows the word "OBELTER" in a bold, sans-serif font. The letters are black and have a slightly distressed or textured appearance, as if they were printed on a rough surface. The letters are arranged horizontally, with each letter clearly legible despite the textured effect.
510(K) Summary
JUL 2 5 2014 K134029
Date: December 12, 2013
Section 5
Submitter Information
Name: Shenzhen Belter Health Measurement and Analysis Technology Co.,ltd Address: 702,704, block C ,Tsinghua Unis science park,No.13 Langshan Rd,Hi-Tech Industrial park(north),Nanshan District,518057 shenzhen,People's Republic of China Tel: 0755-61869839 Fax: 0755-61869122 Contact person: pang ming E-mail: pangm@ebelter.com
Name of device
Trade name: Belter Blood pressure meter ,Model: ePA-46B Common name: Belter Blood pressure meter Classification name: System, Measurement, Blood Pressure, Noninvasive Production regulation: 21CFR 870.1130 Product code: DXN
Predicate Device
HEM-7200-Z (BP742)( Omron Healthcare Inc.,DXN,K121932)
Description
The Belter Blood pressure meter can automatically complete the inflation,deflation and measurement .which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference ranging from 22 cm to 36cm by the oscillometric technique. User can select the blood pressure unit mmHg or KPa.
The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve and LCD. The subject device is powered by four AA alkaline batteries.
The device has a memory function that automatically stores up to 60 sets of the latest measurements. It can also display the latest measurement result.
The subject device embeds a Bluetooth that allows it to transport the measurement data to nearby receiving end.
The device also detects the appearance of irregular heartbeats during measurement. and gives a warning signal with readings.
1
Intended use
Belter Blood pressure meter is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Substantially Equivalent
The Belter Blood pressure meter (ePA-46B) has the similar essential performance and the same Operation Principle as the predicated devices.
| Belter | Omron | ||
|---|---|---|---|
| Compared | ePA-46B | HEM-7200-Z (BP742) | |
| (K121932) | |||
| item | |||
| Indications | |||
| for Use | Belter Blood pressure | ||
| meter is intended to | |||
| measure the systolic and | |||
| diastolic blood pressure as | |||
| well as the pulse rate of | |||
| adult person. It can be | |||
| used at medical facilities or | |||
| at home. | |||
| The device detects the | |||
| appearance of irregular | |||
| heartbeats during | |||
| measurement and gives a | |||
| warning signal with | |||
| readings. | 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. | Similar | ||
| Intended | |||
| patient | Adult | Adult | Same |
| Environmen | |||
| t of use | medical facilities or home | Home | Similar |
| Operation | |||
| Principle | Oscillometric | Oscillometric | Same |
| Measureme | |||
| nt Range | Pressure: 0-280mmHg | ||
| Pulse Rate: 40-200 bpm | Pressure: 0-299mmHg | ||
| Pulse Rate: 40 -180bpm | Similar | ||
| Accuracy | Pressure : ±3mmHg | ||
| (±0.4kPa) | |||
| Pulse Rate: ±5% | Pressure: ±3mmHg | ||
| (±0.4kPa) or 2% | |||
| of reading | |||
| Pulse Rate: ±5% | Similar | ||
| Display | |||
| screen | LCD | LCD | Same |
| Scale | |||
| Selection | mmHg/Pka | mmHg/Pka | Same |
| Cuff | 22-36 cm | 22-46cm | Similar |
| Memory | 60sets | 30sets | Similar |
| Power | |||
| supply | 4 AA batteries | 4 AA batteries or AC | |
| Adaptor (AC 100-240 V) | Similar | ||
| Operating | |||
| Environmen | |||
| t | Temperature : +10°C ~ | ||
| +40°C ; Humidity : 30 ~ | |||
| 85%RH | Temperature : +10°C ~ | ||
| +40°C; Humidity : 30 to | |||
| 85%RH | Similar | ||
| Storage | |||
| Environmen | |||
| t | Temperature : -20 °C ~ | ||
| +50°C; | |||
| Humidity: 20%~95% | Temperature : -25 °C ~ | ||
| +60°C; | |||
| Humidity: 10%~95% | Similar | ||
| Weight | 196g | 340g(Not Including | |
| batteries) | Similar | ||
| Size | 74mm×152mm×33mm | 141mm×123mm×85mm | Similar |
| Conformanc | |||
| e standard | IEC 60601-1, IEC | ||
| 60601-1-2, ANSI/AAMI | |||
| SP10, ISO 10993-5,-10 | IEC 60601-1, IEC | ||
| 60601-1-2, ANSI/AAMI | |||
| SP10, ISO 10993-5,-10 | Same |
Table 1
2
Image /page/2/Picture/0 description: The image shows the word "BELTER" with a symbol that looks like a lowercase "e" in front of it. The text is in a bold, sans-serif font and appears to be slightly distressed or textured. The color of the text is black, and the background is white.
Performance Data
The following practices were followed and monitored for development of the Belter Blood pressure meter:
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for . Safety, 1988+A1:1991+A2:1995
- . IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests. 2007
- ANSI/AAMISP10 Manual, electronic, or automated sphygmomanometers, . 2002/A1:2003
- Medical electrical equipment --Part 1-11: . IEC60601-1-11 General requirements for basic safety and essential performance -Collateral Standard : Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment,2010
- . ISO 10993-1, Biological evaluation of medical devices-Part 1: Evaluation and testing, 2009
- . ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
- . ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010
- . EN1060-1:A1:1995+A2:2009 Non-invasive sphygmomanometers -Part 1: General requirements,2010
- . EN1060-3 ,Non-invasive sphygmomanometers -Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems,2005
- . EN1060-4 Non-invasive sphygmomanometers - Part 4:Test procedures to determine the overall system accuracy of automated Non-invasive
3
Image /page/3/Picture/0 description: The image shows the word "BELTER" with a circled "c" copyright symbol in front of it. The text is in a bold, sans-serif font and appears to be slightly distressed or weathered. The letters are all capitalized and evenly spaced. The overall impression is that of a logo or brand name.
sphygmomanometers,2004
Conclusion
The Belter Blood pressure meter (ePA-46B) is substantially equivalent to the predicate devices.
.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing the bird's wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
July 25, 2014
ShenZhen Belter Health Measurement and Analysis Technology Co., Ltd Mr. Pang Ming, RA Manager 702,704, block C, Tsinghua Unis Science Park, No. 13 Langshan Rd, Hi-tech industrial park (north), Nanshan District, Shenzhen, Guangdong 518057 People's Republic of China
Re: K134029
Trade/Device Names: Belter Blood Pressure Meter, Model ePA-46B Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: June 17, 2014 Received: June 20, 2014
Dear Mr. Pang:
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.
5
Page 2 - Mr. Pang Ming
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 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/CDRH/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/Resourcesfor You/Industry/default.htm.
Image /page/5/Picture/5 description: The image shows a signature block. The text "Sincerely yours," is at the top of the image. Below that is a signature that appears to say "KOLA". The text "Ken Skodacek for" is at the bottom of the image.
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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Section 4 Indications for Use
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Belter Blood pressure meter
Model: ePA-46B
Indications for Use
Belter Blood pressure meter is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Sub part D)
Over-The-Counter Use __ X _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Bram Zuckerman