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 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.

AI/ML Overview

The provided 510(k) summary describes the acceptance criteria and the study that proves the Bioland Technology Ltd. Blood Pressure Monitor (models 2005, 2006, 2006-2, 2006-2B) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The core clinical performance acceptance criteria for the Blood Pressure Monitor are derived from the ISO 81060-2 standard ("Non-Invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type"). While 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," it doesn't explicitly list the numerical acceptance criteria from ISO 81060-2 within the summary. However, based on common interpretations of ISO 81060-2 for blood pressure monitors, the key performance metrics involve accuracy and standard deviation for both systolic and diastolic blood pressure.

A general understanding of typical ISO 81060-2 requirements suggests the following for blood pressure:

Mean difference: within ±5 mmHg
Standard deviation: ≤ 8 mmHg

The document only states "The subject device complies with the applicable requirements set forth in the referenced performance standard" for performance and clinical testing, implying these ISO-defined criteria were met. For pulse rate, the non-clinical comparison table mentions "Pulse Rate: Within ±5%," which is a direct performance claim.

Criterion Type	Acceptance Criteria (typically from ISO 81060-2 and product specification)	Reported Device Performance (Summary statement)
Blood Pressure	Clinical Accuracy (ISO 81060-2): - Mean difference: ≤ ±5 mmHg - Standard deviation: ≤ 8 mmHg	Assessed to meet the requirements of clinical accuracy per the referenced standards (ISO 81060-2). Explicit numerical values for mean difference and standard deviation are not provided in this summary, but compliance with the standard implies these criteria were met.
Pulse Rate Accuracy	Within ±5% (as per non-clinical comparison table)	"Pulse Rate: Within ±5%" (This is listed under "Measuring accuracy" in the non-clinical comparison table, implying both predicate and subject meet this. The clinical study also assesses repeatability.) The clinical study summary 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," which would include pulse rate.
Repeatability	(Criteria defined by ISO 81060-2 for repeatability)	Clinical accuracy and repeatability testing assessed to meet the requirements of clinical accuracy per the referenced standards.

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

Sample Size: 86 subjects.
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Clinical studies for device approval are almost universally prospective, but this is not explicitly confirmed here. The manufacturer is based in China.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth. Clinical validation of automated sphygmomanometers per ISO 81060-2 typically involves simultaneous auscultatory measurements by trained observers (at least two) as the reference method. However, this detail is missing from the summary.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method. For ISO 81060-2, it would typically involve comparing measurements from two (or more) trained observers to ensure high inter-observer agreement, or using standardized automated devices as a reference.

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

This section is not applicable to this device. This is a standalone diagnostic device for blood pressure measurement, not an AI-powered image analysis or diagnostic aid requiring human reader comparison.

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

Yes, a standalone study was done. The clinical testing described as "Clinical accuracy and repeatability testing" against the ISO 81060-2 standard is a standalone assessment of the device's algorithmic performance. The device provides automatic measurements without requiring human interpretation of raw data.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for blood pressure measurement in ISO 81060-2 studies is typically established by simultaneous measurements using a reference method, usually auscultatory measurements performed by trained human observers using a mercury or an appropriate non-invasive sphygmomanometer. The document states it meets ISO 81060-2, implying this method was used, but does not explicitly detail it.

8. The Sample Size for the Training Set

The document does not provide any information about a training set. This device is likely based on established oscillometric principles and does not typically involve machine learning requiring large training datasets in the same way an AI diagnostic algorithm would. The "clinical testing" described here is for validation, not training.

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

As no training set is mentioned or directly implied for this type of device, this information is not applicable.

Summary

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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

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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,

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)

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

E. Device Description

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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 monitorintended for use in measuring bloodpressure and pulse rate in adultpatient population. The device detectsthe appearance 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
Measurementmethod	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
Measuringaccuracy	Pressure: Within ±3mmHgPulse Rate: Within ±5%	Pressure: Within ±3mmHg or 2% ofreadingPulse Rate: Within ±5% of reading	Similar
Cuff	22-32cm	22-42cm	similar
Inflation method	Automatic by electric pump	Automatic by electric pump	Same
Deflationmethod	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
OperatingEnvironmentCondition	15~40°C, RH≤85% (non-condense)	10 °C~40 °C, 15 to 90% RH	Similar
StorageEnvironment	-20~55°C, RH≤93% (non-condense)	-20~60°C, 10 to 95% RH	Similar
Device	Subject Device	Predicate Device	Remarks
Condition
Dimensionmm(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)	DifferentNote 1
	Approx.496g (2006-2B)
	(Including battery)
Irregular Heartbeat Feature	Yes	Yes	Same
Bluetooth	Yes (only 2006-2B applied)	Yes	Similar
Low batteryindication	Yes	Yes	Same
Patient contactmaterials	Surface contact	Surface contact
	Skin	Skin	Same
	Limited duration of use<24 hours	Limited duration of use<24 hours
Biocompatibility	ISO 10993-5: 2009	ISO 10993-5: 2009	Same
	ISO 10993-10: 2010	ISO 10993-10: 2010	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
Clinical	ISO 81060-2	ISO 81060-2	Same

F. Substantial Equivalence table

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Note 1: Although the appearance and weight of subject device and predicate device exits the difference, the difference is not a factor in function of the device; therefore, the difference of the appearance and weight has no influence on safety and effectiveness of product.

G. Predicate Device Comparison

The subject device and the predicate device have the same intended use and the similar technical parameters, they both use cuff oscillometric method to detect human body blood pressure and pulse rate. They have similar measuring range and measuring accuracy, only the appearance size and weight are different. Thus, the subject device is substantially equivalent to the predicate devices.

H. Non-clinical test

Testing name	Referenced standard	Summary result	Verdict
Electric safety	IEC 60601-1: 2005/A1: 2012 Medical electrical	The subject complies with the	Pass
testing	equipment Part 1: General requirements forbasic safety and essential performanceFDA Recognition number: 19-4	applicable requirements setforth in the referenced electricsafety standard.
EMC testing	IEC 60601-1-2:2014 Medical 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 60601-1-11:2015 Medical 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.	The subject complies with theapplicable requirements setforth in the referenced IEC60601-1-11:2015	Pass
Performancetesting	IEC 80601-2-30: 2018 Medical electricalequipment -- Part 2-56: Particularrequirements for basic safety and essentialperformance of automated non-invasivesphygmomanometers standards forperformance effectiveness.FDA Recognition number: 3-123	The subject complies with theapplicable requirements setforth in the referencedperformance standard.	Pass
Biocompatibilitytesting	ISO 10993-1:2018 Biological evaluation ofmedical devices -- Part 1: Evaluation andtesting within a risk management processFDA Recognition number: 2-258ISO 10993-5: 2009 Biological evaluation ofmedical devices -- Part 5: Tests for In VitrocytotoxicityFDA Recognition number: 2-245ISO 10993-10: 2010 Biological evaluation ofmedical devices -- Part 10: Tests for irritationand delayed-type hypersensitivityFDA Recognition number: 2-174	The subject complies with theapplicable requirements setforth in the referencedbiological evaluation standard.	Pass
QoS testing	47 CFR PART 15 Subpart C, Radio frequencydevices subpart C - Intentional radiators	The subject complies with theapplicable requirements setforth in the referenced	Pass
		standard.

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I. Clinical Testing

Name ofclinicaltesting	Referenced standard	Summary of testing	Patient population(number of subjects)	Verdict
Clinicalaccuracy andrepeatabilitytesting	ISO 81060-2 Non-Invasivesphygmomanometers – Part2: Clinical validation ofautomated measurementtype.FDA Recognition number:3-160	The methods and criteriaof clinical accuracy andrepeatability testing hadbeen clinically assessedto meet the requirementsof clinical accuracy perthe referenced standards.	86 subjects	Pass

J. Conclusion

Non-clinical performance and clinical tests were conducted on the subject device and all tests met specified criteria. Base on the information provided in this submission the subject device, 2005, 2006, 2006-2 and 2006-2B blood pressure monitor are substantially equivalent to the predicate device, Noninvasive Blood Pressure Measurement System, HEM-9210T.

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).