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

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.

AI/ML Overview

This document is a 510(k) premarket notification for a Class II medical device, the "Clinical Automatic Blood Pressure Monitor (DBP-01P, DBP-01HP)," manufactured by Shenzhen Hingmed Medical Instrument Co., Ltd. The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (UA-1200BLE Ultraconnect Digital Blood Pressure) to secure FDA clearance.

The information provided does not include detailed acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device, as the filing is for a traditional, non-AI medical device (a blood pressure monitor). Therefore, I will extract the closest equivalent information related to performance testing and "acceptance criteria" for this type of device, which is primarily based on established international standards for non-invasive sphygmomanometers.

Here's an interpretation of the request in the context of the provided document:

1. A table of acceptance criteria and the reported device performance

The relevant "acceptance criteria" for a blood pressure monitor are its accuracy specifications, as defined by international standards.

Acceptance Criteria (from ISO 81060-2:2018)	Reported Device Performance (DBP-01P)	Metric
Criterion 1: Mean device-observer difference ≤ ±5 mmHg with SD ≤ 8 mmHg	1.32 mmHg (for SBP), 0.78 mmHg (for DBP)	Mean Device-Observer Difference
Criterion 1: Standard Deviation (SD) of device-observer difference ≤ 8 mmHg	3.18 mmHg (for SBP), 3.15 mmHg (for DBP)	SD of Device-Observer Difference
Criterion 2: SD of the 85 participants being below the maximum values required by the protocol	6.80 mmHg (for SBP), 6.89 mmHg (for DBP)	SD Across Participants
Manufacturer's Stated Performance (General)	Pressure: Within ± 3 mmHg	Measurement Accuracy (Pressure)
Manufacturer's Stated Performance (General)	Pulse Rate: Whichever is greater (± 3 bpm or ± 3%)	Measurement Accuracy (Pulse Rate)

Note: The document references ISO 81060-2:2018, which has two main criteria for accuracy. Criterion 1 (Mean and SD of device-observer difference) and Criterion 2 (SD of the differences for all subjects). The reported performance satisfies both.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: 85 subjects.
Data Provenance: The document states the study was a "clinical investigation" and does not specify a country of origin for the patients, but given the manufacturer's location (Shenzhen, China), it can be inferred the study likely took place in China. It was a prospective study conducted for the purpose of validating the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For a blood pressure monitor, the "ground truth" is typically established by trained observers (human auscultatory method) using a reference sphygmomanometer. The document does not specify the exact number, training, or qualifications of the observers, but adherence to ISO 81060-2 standards implies that qualified personnel performed these measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not explicitly describe an adjudication method for the "test set" in the sense of expert consensus for classification. For blood pressure validation, the comparison is typically between the automated device readings and simultaneous auscultatory measurements by human observers. Discrepancies are handled according to the specific methodology described in ISO 81060-2, which involves multiple readings and specific statistical analysis, rather than an "adjudication" in the AI sense.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC study was not done.
AI Assistance: This device is a traditional blood pressure monitor and does not incorporate AI. Therefore, there is no AI assistance to measure improvement in human readers. The clinical validation method directly assesses the device's accuracy against a known standard, not against human performance or human-AI collaboration.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense, the primary clinical validation described is a "standalone" performance assessment of the device's measurement accuracy. The device's measurement (algorithm's output) is compared directly to the gold standard (human auscultatory readings). The human "in the loop" here is the observer performing the reference measurement, not interacting with AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was simultaneous auscultatory measurements performed by trained human observers using a reference sphygmomanometer, in accordance with the ISO 81060-2 standard. This is considered the expert-derived reference standard for non-invasive blood pressure.

8. The sample size for the training set

This document describes the validation of a traditional medical device (blood pressure monitor), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design is based on established oscillometric principles, not on learned data.

9. How the ground truth for the training set was established

As there is no "training set" for an AI/ML algorithm, this question is not applicable to the submitted device.

Summary

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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.

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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.

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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.

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 MedicalInstrument 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 289Pulse rate:40 to 200bpm	Pressure:0 to 299mmHgPulse rate:40 to 180beats per minute	similar
Measuring accuracy	Pressure:within $\pm$ 3mmHgPulse Rate: whichever is grater( $\pm$ 3bpm or $\pm$ 3%)	Pressure:within $\pm$ 3mmHgPulse 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
Patientcontactmaterials	Surface contact SkinLimited duration of use<24 hours	Surface contact SkinLimited duration of use<24 hours	Same
BloodPressureReadingClassificationCriteria	WHO ClassificationCriteria	USA JNC VII	Difference

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5. non-clinical Test Summary

Clinical Automatic blood pressure monitor has been evaluated the safety and performance by lab bench testing,as following:

Electrical safety test according to IEC 60601-1 and IEC 80601-2-30 standards Electromagnetic compatibility test according to IEC 60601-1-2 standard Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards

6.Brief discussions of clinical tests

ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type;

In this clinical investigation, The DBP-01P was tested in 85 subjects from the general population (mean age, 69.9 years; 43 men) using a wide-range cuff for arm circumferences from 17 to 42 cm. 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).

Also, 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). The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2

7.Comparison to predicate device and conclusion

The technological characteristics, features, - specifications, materials, mode of and intended use of clinical automatic blood pressure monitor is operation. substantially equivalent to the predicate devices quoted above.

between the subject device and predicate devices do not rise The differences new issues of safety or effectiveness.

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8.Conclusion

Non-clinical performance was conducted on the subject device and all tests met specified criteria. Based on the information provided in this submission, the Clinical Automatic blood pressure monitor is substantially equivalent to the predicate device, UA-1200BLE UltraConnect Digital Blood Pressure.

Regulation Number and Section

§ 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).