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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the blood pressure monitor, organized according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is gauged against established international standards. The most relevant standard for clinical accuracy is ISO 81060-2:2018.

Acceptance Criteria (from ISO 81060-2:2018)	Reported Device Performance (from Clinical Testing)
Clinical accuracy and repeatability requirements as per 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. (Verdict: Pass)
Pressure Measurement Accuracy: Within ± 3mmHg	Within ± 3mmHg (Also listed in "Substantial Equivalence table")
Pulse Rate Measurement Accuracy: Within ± 5%	Within ± 5% (Also listed in "Substantial Equivalence table")

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 86 subjects.
Data Provenance: The clinical data for the subject device (2008, A221-2) came from a clinical report of its predicate device (model: 2005, K number: K201467). The document does not specify the country of origin of this clinical data, nor does it explicitly state if the study was retrospective or prospective. However, given that it's a clinical validation study for a medical device according to a standard, it is highly probable that it was a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for the clinical study. ISO 81060-2:2018, the referenced standard for clinical accuracy, typically outlines requirements for independent observers and reference measurement methods, often involving trained clinicians using auscultation for comparison.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the clinical study. Clinical validation studies for blood pressure monitors following ISO 81060-2 typically involve multiple observers taking reference measurements (e.g., auscultation) to compare against the automated device, and often mechanisms for resolving discrepancies. However, specific details are not provided here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. This type of study is more common for imaging diagnostics where multiple human readers interpret cases. The clinical study performed here focuses on the accuracy and repeatability of the device itself against established reference methods per ISO 81060-2.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The clinical accuracy and repeatability testing, based on ISO 81060-2, assesses the device's performance directly in measuring blood pressure and pulse rate without human-in-the-loop assistance for the measurement process itself. The document states "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." This refers to the device operating autonomously to take measurements.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy study would have been established by a reference method as stipulated by ISO 81060-2. This typically involves simultaneous auscultatory measurements performed by trained observers (often two) using a mercury sphygmomanometer or another validated reference device, compared against the readings from the automated blood pressure monitor.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This type of information is usually relevant for AI/ML-based devices. For a non-invasive blood pressure monitor, the "algorithm" refers to the signal processing and oscillometric method used to derive blood pressure values, which is based on established physiological principles and engineering, rather than a trainable machine learning model in the conventional sense that would require a distinct training set. The device's "algorithm" (the software algorithm for measurement) is stated to be the same as the predicate, suggesting it's a fixed algorithm, not one that undergoes iterative training.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.

Summary

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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

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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)
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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

E. Device Description

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 intendedfor use in measuring blood pressureand pulse rate in adult patientpopulation. The device detects theappearance of irregular heartbeatsduring measurement and gives awarning signal with readings.	The device is a digital monitor intendedfor use in measuring blood pressure andpulse rate in adult patient population.The device detects the appearance ofirregular heartbeats during measurementand gives a warning signal with readings.	Same
Environmentalof use	Home	Home	Same
PatientPopulation	Adult	Adult	Same
MeasurementSite	Upper arm	Upper arm	Same
Measurementmethod	Oscillometric method	Oscillometric method	Same
Measurementrange	Pressure: 0 to 300 mmHgPulse Rate: 40 to 195 beats/min	Pressure: 0 to 300 mmHgPulse Rate: 40 to 195 beats/min	Same
Pressure sensor	Semiconductor pressure sensor	Semiconductor pressure sensor	Same
Measuringaccuracy	Pressure: Within $ ± $ 3mmHgPulse Rate: Within $ ± $ 5%	Pressure: Within $ ± $ 3mmHgPulse Rate: Within $ ± $ 5%	Same
Cuff	22-32cm	22-32cm	Same
Inflation method	Automatic by electric pump	Automatic by electric pump	Same
Deflationmethod	Automatic pressure release valve	Automatic pressure release valve	Same
Power Source	4*AA batteries	4*AA batteries	Same
Display	LCD Display	LCD Display	Same
OperatingEnvironmentCondition	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
StorageEnvironmentCondition	-20~~55°C(-4°F~~131°F), RH≤93%(non-condense)	-20~~55°C(-4°F~~131°F), RH≤93%(non-condense)	Same
Device	Subject Device	Predicate Device	Remarks
Memory	2*50 sets (2008)50 sets (A221-2)	128 sets	DifferentNote 1
Auto power off time	Within 3min	Within 3min	Same
Weight	Approx 208g (Not including battery)	Approx. 313g ( Including battery)	DifferentNote 2
Dimension(LDH)	135mm100mm53mm	130mm95mm53mm	DifferentNote 3
Irregular Heart beat Feature	Yes	Yes	Same
Low battery indication	Yes	Yes	Same
Classify blood pressure level bar	Yes	No	DifferentNote 4
Patient contact materials	Surface contact SkinLimited duration of use<24 hours	Surface contact SkinLimited duration of use<24 hours	Same
EMC	IEC 60601-1-2:2014	IEC 60601-1-2:2014	Same
Electrical Safety	IEC 60601-1:2005/A1:2012	IEC 60601-1:2005/A1:2012	Same
Performance	IEC 80601-2-30	IEC 80601-2-30	Same
Biocompatibility	ISO 10993-5: 2009ISO 10993-10: 2010	ISO 10993-5: 2009ISO 10993-10: 2010	Same
Clinical	ISO 81060-2	ISO 81060-2	Same

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Note 1: The memory size of subject device and predicate device are different. But the difference is very slight, it will not affect the main function and the intended use of the subject device. At the same time memory size of subject device is clearly indicated in user manual and gift-box. Therefore, the difference will not result in safety and effectiveness issue of the subject device.

Note 2 and Note 3: The weight and dimension between the subject device and predicate device is a little different, but the difference will not affect the main function and the intended use of the subject device, furthermore the weight and dimension is indicated in the user manual and gift-box. Thus, the difference will not result in safety and effectiveness issue of the subject device.

Note 4: The subject device has the "Classify blood pressure level bar" function and the predicate device is not. The "Classify blood pressure level bar" function will not affect the main function and the intended use of the subject device, meanwhile the "Classify blood pressure level bar" function of subject device is clearly indicated in user manual. So the difference will not result in safety and

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effectiveness issue of the subject device.

G. Predicate Device Comparison

The subject device and the predicate device have the same intended use, same measuring range, measuring accuracy and the other similar technical parameters, they both use cuff oscillometric method to detect blood pressure and pulse rate. Thus, the subject device is substantially equivalent to the predicate device.

Testing name	Referenced standard	Summary result	Verdict
Electric safetytesting	IEC 60601-1: 2005/A1;:2012 Medicalelectrical equipment Part 1: Generalrequirements for basic safety and essentialperformanceFDA Recognition number: 19-4	The subject complies with theapplicable requirements setforth in the referenced electricsafety standard.	Pass
EMC testing	IEC 60601-1-2:2014Medical electricalequipment - Part 1-2: General requirements forbasic safety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements and testsFDA Recognition number: 19-8	The subject complies with theapplicable requirements setforth in the referenced EMC	Pass
Electric safety formedical deviceused in the homehealthcareenvironment	IEC 60601-1-11:2015Medical electricalequipment - General requirements for basicsafety and essential performance - Part 1-11:Collateral Standard: Requirements for medicalelectrical equipment and medical electricalsystems used in the home healthcareenvironment.FDA Recognition number: 19-14	The subject complies with theapplicable requirements setforth in the referenced IEC60601-1-11:2015	Pass
Performancetesting	IEC 80601-2-30:2018 Medical electricalequipment-Part 2-30: Particular requirementsfor the basic safety and essential performanceof automated non-invasivesphygmomanometersFDA Recognition number: 3-123	The subject complies with theapplicable requirements setforth in the referencedperformance standard.	Pass
Biocompatibilitytesting	ISO 10993-1:2018Biological evaluation ofmedical devices -- Part 1: Evaluation andtesting within a risk management process	The subject complies with theapplicable requirements setforth in the referenced	Pass
Testing name	Referenced standard	Summary result	Verdict
	FDA Recognition number: 2-258	biological evaluation standard.
	ISO 10993-5:2009Biological evaluation of
	medical devices -- Part 5: Tests for In Vitrocytotoxicity
	FDA Recognition number: 2-245
	ISO 10993-10:2010Biological evaluation of
	medical devices -- Part 10: Tests for irritationand delayed-type hypersensitivity
	FDA Recognition number: 2-174

H. Non-clinical test

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I. Clinical Testing

Due to the subject device and predicate device (K number: K201467) having the same software algorithm, key components and cuff, the clinical report of blood pressure monitor (model: 2005,K number: K201467) can be applied to the traditional 510(k) as the clinical report of the subject device. Thus, the clinical data of the subject device came from the predicate device, and the clinical test information of the predicate device is as follows:

Name of clinicaltesting	Referenced standard	Summary of testing	Patient population(number ofsubjects)	Verdict
Clinical accuracyand repeatabilitytesting	ISO 81060-2:2018Non-Invasivesphygmomanometers –Part 2: Clinical validationof automatedmeasurement type.FDA Recognition number:3-160	The methods andcriteria of clinicalaccuracy andrepeatability testing hadbeen clinically assessedto meet therequirements of clinicalaccuracy per thereferenced standards.	86 subjects	Pass

J. 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 subject device, 2008, A221-2 blood pressure monitor is substantially equivalent to the predicate device, Blood Pressure Monitor 2005.

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).