(119 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement technology and does not mention AI or ML.
No
The device is described as a digital monitor for measuring blood pressure and pulse rate. While it provides readings that can be used for health monitoring, it does not exert a therapeutic effect on the body; it only provides diagnostic information.
Yes.
The device measures blood pressure and pulse rate, and detects irregular heartbeats, which are physiological parameters used to assess and monitor health conditions.
No
The device description explicitly lists hardware components such as "shell, button, display screen, air tube, cuff and battery," indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients. 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 the body.
- Device Description: The description details a physical device that interacts with the patient's arm to take measurements. It uses air pressure and an oscillometric method, which are standard techniques for non-invasive blood pressure monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This blood pressure monitor does not fit that definition.
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 2008, A221-2 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic, diastolic 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.
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 patient population.
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)
Clinical accuracy and repeatability testing based on ISO 81060-2:2018. 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. Verdict: 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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
January 26, 2021
Bioland Technology Ltd. Yiging Feng. RA No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen, Guangdong 518116 China
Re: K202934
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: December 24, 2020 Received: December 28, 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,
for 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) K202934
Device Name
Blood Pressure Monitor, 2008, A221-2
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 heatbeats 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, 518116Shenzhen, Guangdong PEOPLE'S REPUBLIC OF CHINA Tel: +86 755 3690 0999 Fax: +86755 3329 6299 Contact person: Yiging Feng E-mail: regulator-a@bioland.com.cn
B. Subject device
Trade name: Blood Pressure Monitor Model: 2008, A221-2 Classification name: System, Measurement, Blood-Pressure, Non-Invasive Regulation Medical Specialty: Cardiovascular Product Code: DXN Regulation number: 830.1130 Device class: Class II Code of Federal Regulations: 21CFR 870.1130
C. Predicate Device
Device name: Blood Pressure Monitor K number: K201467 Manufacturer: Bioland Technology Ltd.
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 2008, A221-2 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic, diastolic 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.
F. Substantial Equivalence table
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| Device | Subject Device | Predicate Device | Remarks |
|---|---|---|---|
| Manufacturer | Bioland Technology Ltd | Bioland Technology Ltd | N/A |
| Model | 2008, A221-2 | 2005 | N/A |
| Classification | II | II | Same |
| Product code | DXN | DXN | Same |
| Classification | System, Measurement, | System, Measurement, | Same |
| name | Blood-Pressure, Non-Invasive | Blood-Pressure, Non-Invasive | Same |
| Regulation No. | 870.1130 | 870.1130 | Same |
| 510(K) number | N/A | K201467 | 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 | |||
| Site | Upper arm | Upper arm | Same |
| Measurement | |||
| method | Oscillometric method | Oscillometric method | Same |
| Measurement | |||
| range | Pressure: 0 to 300 mmHg | ||
| Pulse Rate: 40 to 195 beats/min | Pressure: 0 to 300 mmHg | ||
| Pulse Rate: 40 to 195 beats/min | Same | ||
| Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | Same |
| Measuring | |||
| accuracy | Pressure: Within $ ± $ 3mmHg | ||
| Pulse Rate: Within $ ± $ 5% | Pressure: Within $ ± $ 3mmHg | ||
| Pulse Rate: Within $ ± $ 5% | Same | ||
| Cuff | 22-32cm | 22-32cm | Same |
| Inflation method | Automatic by electric pump | Automatic by electric pump | Same |
| Deflation | |||
| method | Automatic pressure release valve | Automatic pressure release valve | Same |
| Power Source | 4*AA batteries | 4*AA batteries | Same |
| Display | LCD Display | LCD Display | Same |
| Operating | |||
| Environment | |||
| Condition | 5~40°C (41°F ~104°F), 15%~85% RH | ||
| (non-condense) | 15°C~40°C(59°F ~104°F), RH≤85% | ||
| (non-condense) | Similar | ||
| Storage | |||
| Environment | |||
| Condition | -20 | ||
| (non-condense) | -20 | ||
| (non-condense) | Same | ||
| Device | Subject Device | Predicate Device | Remarks |
| Memory | 2*50 sets (2008) | ||
| 50 sets (A221-2) | 128 sets | Different | |
| Note 1 | |||
| Auto power off time | Within 3min | Within 3min | Same |
| Weight | Approx 208g (Not including battery) | Approx. 313g ( Including battery) | Different |
| Note 2 | |||
| Dimension | |||
| (LDH) | 135mm100mm53mm | 130mm95mm53mm | Different |
| Note 3 | |||
| Irregular Heart beat Feature | Yes | Yes | Same |
| Low battery indication | Yes | Yes | Same |
| Classify blood pressure level bar | Yes | No | Different |
| Note 4 | |||
| Patient contact materials | Surface contact Skin | ||
| Limited duration of use |