(111 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor with Bluetooth transmission, and there is no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is a digital monitor for measuring blood pressure and pulse rate, which are diagnostic/monitoring functions, not therapeutic.
No
The device is a digital monitor for measuring blood pressure and pulse rate, providing a warning signal for irregular heartbeats. While it identifies a potential irregularity, it does not provide a definitive diagnosis of a medical condition. A diagnostic device would typically offer information about the presence, nature, or extent of a disease or condition requiring further medical evaluation or intervention.
No
The device description explicitly lists hardware components such as shell, button, display screen, air tube, cuff, battery, air pump, and mechanical valve, 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 device measures blood pressure and pulse rate. These are physiological measurements taken directly from the patient's body, not tests performed on samples of biological material (like blood, urine, or tissue) outside of the body.
- Device Description: The description details a physical device that interacts with the patient's arm via a cuff and measures pressure changes. This is consistent with a non-invasive physiological monitoring device.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples, or any other typical characteristics of an in vitro diagnostic device.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes
DXN
Device Description
The 2006-2B, 2006, 2006, 2005 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic blood pressures and heart beats are transmitted via air pressure in the inflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by air pump. The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement. The measurement results including diastolic, systolic pressures and heart pulse rate are displayed on the LCD. The proposed device equipped with Bluetooth transmission function, which enable user to transmit the measurement results from the device to a mobile phone through Bluetooth. Users can manage the measurement results by the mobile application.
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 patient population
Intended User / Care Setting
Home / 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)
Clinical Testing: Clinical accuracy and repeatability testing was conducted according to ISO 81060-2 Non-Invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type. The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards. 86 subjects were included. The result was Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 21, 2020
Bioland Technology Ltd. Yiging Feng, R.A No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen, Guangdong 518116 China
Re: K201467
Trade/Device Name: Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 18, 2020 Received: August 25, 2020
Dear Yiqing Feng:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201467
Device Name
Blood Pressure Monitor, 2005, 2006, 2006-2, 2006-2B
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
A. Applicant
Name: Bioland Technology Ltd. Adress: No. A6B7 (Block G) Shangrong Industrial.Zone, No.5 Baolong Road, Baolong Community Longgang District, 518116 Shenzhen, Guangdong PEOPLE'S REPUBLIC OF CHINA Tel: +86 755 3690 0999 Fax: +86 755 3329 6299 Contact person: Yiqing Feng E-mail: regulator-a@bioland.com.cn
B. Subject device
Trade name: Blood Pressure Monitor Model: 2005, 2006, 2006-2, 2006-2B Classification name: System, Measurement, Blood-Pressure, Non-Invasive Regulation Medical Specialty: Cardiovascular Product Code: DXN Regulation number: 830.1130 Device class: Class 2 Code of Federal Regulations: 21CFR 870.1130
C. Predicate Device
Device name: HEM-9210T K number: K163235 Manufacturer: Omron Healthcare, Inc.
D. Indication 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.
E. Device Description
The 2006-2B, 2006, 2006, 2005 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic blood pressures and heart beats are transmitted via air pressure in the inflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by air pump. The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement. The measurement results including diastolic, systolic pressures and heart pulse rate are displayed on the LCD. The proposed device equipped with Bluetooth transmission function, which enable user to transmit the measurement results from the device to a mobile phone through Bluetooth. Users can manage the measurement results by the mobile application.
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| Device | Subject Device | Predicate Device | Remarks |
|---|---|---|---|
| Manufacturer | Bioland Technology Ltd | Omron Healthcare, Inc | N/A |
| Model | 2005, 2006, 2006-2, 2006-2B | HEM-9210T | N/A |
| Classification | II | II | Same |
| Product code | DXN | DXN | Same |
| Classification | System, Measurement, | System, Measurement, Blood-Pressure, | |
| name | Blood-Pressure, Non-Invasive | Non-Invasive | Same |
| Regulation No. | 870.1130 | 870.1130 | Same |
| 510(K) number | N/A | K163235 | N/A |
| Intended 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. | 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. | Same | ||
| Environmental | |||
| of use | Home | Home | Same |
| Patient | |||
| Population | Adult | Adult | Same |
| Measurement | |||
| method | Cuff oscillometric method | Cuff oscillometric method | Same |
| Measurement | Pressure: 0 to 300 mmHg | Pressure: 0 to 299 mmHg | Similar |
| range | Pulse Rate: 40 to 195 beats/min | Pulse Rate: 40 to 180 beats/min | Similar |
| Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | Same |
| Measuring | |||
| accuracy | Pressure: Within ±3mmHg | ||
| Pulse Rate: Within ±5% | Pressure: Within ±3mmHg or 2% of | ||
| reading | |||
| Pulse Rate: Within ±5% of reading | Similar | ||
| Cuff | 22-32cm | 22-42cm | similar |
| Inflation method | Automatic by electric pump | Automatic by electric pump | Same |
| Deflation | |||
| method | Automatic pressure release valve | Automatic pressure release valve | Same |
| Display | LCD digital display | LCD digital display | Same |
| Power Source | 4*AA batteries | 4*AA batteries or AC adapter | Similar |
| Display | LCD Display | LCD Display | Same |
| Operating | |||
| Environment | |||
| Condition | 15~40°C, RH≤85% (non-condense) | 10 °C~40 °C, 15 to 90% RH | Similar |
| Storage | |||
| Environment | -20~55°C, RH≤93% (non-condense) | -20~60°C, 10 to 95% RH | Similar |
| Device | Subject Device | Predicate Device | Remarks |
| Condition | |||
| Dimension | |||
| mm(LDH) | 1309553 (2005) | Different | |
| 14010960 (2006) | 10714179 | Note 1 | |
| 1579664(2006-2&2006-2B) | |||
| Weight | Approx.313g (2005) | ||
| Approx.350g (2006) | |||
| Approx.495g (2006-2) | Approx. 290g (10oz) | ||
| (Not including battery) | Different | ||
| Note 1 | |||
| Approx.496g (2006-2B) | |||
| (Including battery) | |||
| Irregular Heart | |||
| beat Feature | Yes | Yes | Same |
| Bluetooth | Yes (only 2006-2B applied) | Yes | Similar |
| Low battery | |||
| indication | Yes | Yes | Same |
| Patient contact | |||
| materials | Surface contact | Surface contact | |
| Skin | Skin | Same | |
| Limited duration of use |