(265 days)
Not Found
No
The summary describes a standard digital blood pressure monitor and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device measures blood pressure and pulse rate for diagnostic reference, but it does not treat or alleviate a medical condition.
Yes
The 'Intended Use' section states that "the physician reference the result to diagnose," indicating its role in providing information for diagnostic purposes.
No
The device description explicitly states it contains a "main body" and "power wire," indicating physical hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: This device is a blood pressure monitor. It measures blood pressure and pulse rate directly from the patient's body using a cuff on the upper arm. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate for physician reference in diagnosis. While the results are used for diagnosis, the measurement itself is not an in vitro test.
Therefore, based on the provided information, this device clearly falls outside the definition of an In Vitro Diagnostic. It is a medical device used for physiological measurement.
N/A
Intended Use / Indications for Use
This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose. Environments of use: Hospital and other medical establishment. Patient population: Adult (exclude pregnant women ).
Product codes
DXN
Device Description
Clinical Automatic blood pressure monitor have two models that are DBP-01HP and DBP-01P,The Clinical Automatic blood pressure monitor is used to measure the blood pressure of adult in hospital or other medical establishment. It's contain of main body , power wire.it can show the time and measure result, print the measure result .There is a difference between DBP-01HP with DBP -01P. DBP-01HP show the measure result and time by the LCD screen,DBP-01P show the measure result and time by the LED screen.
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 (exclude pregnant women)
Intended User / Care Setting
Hospital and other medical establishment
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 Investigation: ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.
Sample Size: 85 subjects from the general population (mean age, 69.9 years; 43 men).
Key results: The mean device-observer difference was 1.32±3.18 mmHg for SBP and 0.78±3.15 mmHg for DBP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5±8 mmHg). Criterion 2 was satisfied with the SDs of the 85 participants being well below the maximum values required by the protocol (6.80 and 6.89 mmHg for SBP and DBP pressure, respectively).
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
March 26, 2024
Shenzhen Hingmed Medical Instrument Co., Ltd. Huang Yongban, RA Manager 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District Shenzhen. GuangDong 518102 China
Re: K231984
Trade/Device Name: Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 20, 2024 Received: February 20, 2024
Dear Huang Yongban:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about mediation-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,
Stephen C. Browning -S
LCDR 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) K231984
Device Name
Clinical Automatic Blood Pressure Monitor (DBP-01P, DBP-01HP)
Indications for Use (Describe)
This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose.
Environments of use: Hospital and other medical establishment.
Patient population: Adult (exclude pregnant women ).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Shenzhen Hingmed Medical Instrument Co., Ltd Establishment Registration Number: Applying Address: 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District, Shenzhen,,GuangDong , People's Republic of China Tel: +86-0755-232069446 Contact Person (including title): Yongban Huang (Manger Representative) E-mail: hyb@hingmed.com
2. Subject Device Information
Type of 510(k): Traditional
Common Name:Noninvasive blood pressure measurement system
Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Trade Name: Clinical Automatic Blood Pressure Monitor
Model Name: DBP-01P,DBP-01HP
Review Panel: Cardiovascular
Product Code: DXN
Regulation Number: 21 CFR 870.1130
Regulatory Class: Class II
3. Predicate Device Information
| Sponsor | A&D Company, Ltd |
|---|---|
| Device Name | UA-1200BLE Ultraconnect Digital Blood Pressure |
| Model or type Name | UA-1200BLE |
| 510(k) Number | K163683 |
| Product code | DXN |
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| Regulation Number | 21 CFR 870.1130 |
|---|---|
| Regulation class | Class II |
4. Indications for Use
This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose. Environments of use: Hospital and other medical establishment Patient population: Adult (exclude pregnant women )
Device Description 5.
Clinical Automatic blood pressure monitor have two models that are DBP-01HP and DBP-01P,The Clinical Automatic blood pressure monitor is used to measure the blood pressure of adult in hospital or other medical establishment. It's contain of main body , power wire.it can show the time and measure result, print the measure result .There is a difference between DBP-01HP with DBP -01P. DBP-01HP show the measure result and time by the LCD screen,DBP-01P show the measure result and time by the LED screen. Photos of DBP-01HP &DBP-01P:
Image /page/5/Picture/6 description: The image shows two different models of the Hingmed blood pressure monitor. The left image shows the DBP-01HP model, which has a screen and buttons on the base. The right image shows the DBP-01P model, which has a smaller screen and fewer buttons. The screen on the DBP-01P model shows a blood pressure reading of 125/84 mmHg and a pulse of 75 bpm.
6. Substantial Equivalence table
| Device | Subject Device | Predicate Device | Remarks |
|---|---|---|---|
| Manufacture | Shenzhen Hingmed Medical | ||
| Instrument Co., Ltd | A&D Company, Ltd | NA | |
| Model | DBP-01P,DBP-01HP | UA-1200BLE | NA |
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| classification | II | II | Same |
|---|---|---|---|
| Product code | DXN | DXN | Same |
| Regulation No. | 870.1130 | 870.1130 | Same |
| 510(K) number | N/A | K163683 | NA |
| Intended use/ Indicate for use | This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose | Measure blood pressure (systolic and diastolic) and pulse rate | Same |
| Environmental of use | Hospital and other medical establishment | Home or clinical use | Difference |
| Patient population | Adult (exclude pregnant women ) | Adult | Same |
| Measurement site | Upper Arm | Upper Arm | Same |
| Measurement method | Oscillometric method | Oscillometric method | Same |
| Measurement range | Pressure:0 to 289 | ||
| Pulse rate:40 to 200bpm | Pressure:0 to 299mmHg | ||
| Pulse rate:40 to 180beats per minute | similar | ||
| Measuring accuracy | Pressure:within $\pm$ 3mmHg | ||
| Pulse Rate: whichever is grater( $\pm$ 3bpm or $\pm$ 3%) | Pressure:within $\pm$ 3mmHg | ||
| Pulse Rate: $\pm$ 5% | similar | ||
| Cuff | 17-42cm | 22-42cm | similar |
| Inflation | Automatic internal pump | Automatic internal pump | Same |
| Deflation | Automatic rapid deflation | Solenoid valve for rapid exhaust | Same |
| Power source | mains | 3.7V Li-ion batteries or AC adaptor as an option | Difference |
| Protection against electrical shock | Class I, Type B | Class I, Type B | same |
| Display | LCD display or LED display | OLED Display | Difference |
| Operation Environment condition | 5°C-40°C; RH: 10%-95%; non-condensing,atmospheric pressure(70KPa-106Kpa) | 50°F (10°C) to 104°F (40°C) | |
| 15%RH to 85%RH | Difference | ||
| Storage Environment Condition | -20°C-55°C, RH≤90% (non-condensing) 70KPa-106Kpa | -4°F (-20°C) to 140°F (60°C) | |
| 10%RH to 95%RH | Difference | ||
| Memory | NA | Last 60 measurements | Difference |
| user | |||
| Weight | About 6Kg | 205g without batteries | Difference |
| Dimension(LDH) | About W:310×L:478×H:300mm | 40(W)x126(H)x26(D) mm | Difference |
| Patient | |||
| contact | |||
| materials | Surface contact Skin | ||
| Limited duration of use |