Bokang Digital Blood Pressure Monitor, Model BK6001, Model BK6002 and Model BK6023 are non-invasive blood pressure (NIBP) monitors which use a standard oscillometric measurement method and intend for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate by using an inflating cuff which is wrapped around the upper arm or wrist. The device is indicated for use in adults only.

Device Description

Non-invasive blood pressure (NIBP) monitors which use a standard oscillometric measurement method and intend for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate for adults only.

Model BK6001 is a semi-auto digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated by a manual air pump.

Model BK6002 is an automatic digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated automatically by an electrical air pump.

Model BK6023 is a wrist automatic digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the wrists. The cuff is inflated automatically by a electrical air pump.

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 rapidly and automatically released by a electric valve at a constant rate after the measurement. The measurement results including diastolic, systolic pressure and heart pulse rate are displayed on the LCD. Besides the real-time display, the blood pressure and pulse values are also averaged, stored, and recalled from the last data.

AI/ML Overview

The provided 510(k) summary for the Bokang Digital Blood Pressure Monitors (Models BK6001, BK6002, BK6023) indicates that the devices were tested to meet the requirements of the ANSI/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure Monitor Guidance."

Here's an attempt to break down the information, acknowledging that specific numerical acceptance criteria and a detailed study report are not explicitly provided in the given text. The document states that clinical studies were performed and "evaluated clinical bias, clinical uncertainty and clinical repeatability per the Bokang Clinical Test Protocol outline and meet the requirement of AAMI SP10." However, the exact performance values like accuracy (mean difference and standard deviation) or sensitivity/specificity are not presented.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Based on AAMI SP10):
While not explicitly stated in the document with specific numerical thresholds, the AAMI SP10 standard for non-invasive sphygmomanometers typically requires:

Mean Difference (Bias): For systolic and diastolic blood pressure, the mean difference between the device and a reference standard (e.g., auscultation by trained observers) should be within ±5 mmHg.
Standard Deviation (Precision): For systolic and diastolic blood pressure, the standard deviation of the differences should be no greater than 8 mmHg.

Reported Device Performance:
The document states that the devices "meet the requirement of AAMI SP10" and that "clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability." However, the actual numerical values for bias, standard deviation, clinical uncertainty, or repeatability are not provided in this summary. Therefore, a table with specific performance numbers cannot be created from the given text.

Performance Metric	Acceptance Criteria (Typically AAMI SP10)	Reported Device Performance (from document)
Systolic BP
Mean Difference	≤ ±5 mmHg	"meets the requirement of AAMI SP10" (No specific numerical bias reported)
Standard Deviation	≤ 8 mmHg	"meets the requirement of AAMI SP10" (No specific numerical SD reported)
Diastolic BP
Mean Difference	≤ ±5 mmHg	"meets the requirement of AAMI SP10" (No specific numerical bias reported)
Standard Deviation	≤ 8 mmHg	"meets the requirement of AAMI SP10" (No specific numerical SD reported)
Pulse Rate	Typically ≤ ±5% or similar	Not specified beyond general statement of meeting AAMI SP10

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

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: "Controlled human clinical studies were conducted." The country of origin for the studies is not explicitly stated, but the company is located in Wenzhou, China, suggesting the studies were likely conducted there. The studies were prospective as they are described as "controlled human clinical studies."

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

The document implies that the ground truth for blood pressure measurements in clinical studies would have been established by trained medical professionals (e.g., physicians or nurses) using a reference standard (such as auscultation). However, the number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not mentioned in the provided 510(k) summary.

4. Adjudication Method for the Test Set

The specific adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth in the clinical studies is not described in the provided text.

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

No, an MRMC comparative effectiveness study was not done as described for typical AI device evaluations. This document describes a traditional medical device (blood pressure monitor) validation, not an AI system. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Yes, a standalone performance assessment was effectively done. The Bokang Digital Blood Pressure Monitors are standalone devices designed to automatically measure and display blood pressure and pulse rate. The clinical studies evaluated the device's performance without human intervention in the measurement process itself (beyond applying the cuff and initiating the measurement), comparing its output to a reference standard. The results of these tests, by demonstrating compliance with AAMI SP10, reflect the standalone performance of the algorithm.

7. The Type of Ground Truth Used

The ground truth used for validating blood pressure monitors in clinical studies compliant with AAMI SP10 is typically reference blood pressure measurements obtained through auscultation (e.g., by a trained observer using a stethoscope and sphygmomanometer), often with multiple readings and potentially averaged. This is a form of expert standard or clinical gold standard rather than pathology or outcome data.

8. The Sample Size for the Training Set

This device is a traditional non-invasive blood pressure monitor, not an AI/machine learning algorithm that requires a "training set." Therefore, the concept of a separate training set is not applicable to this device. The development and calibration would typically involve engineering tests and internal validation, but not a "training set" in the context of machine learning.

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

As mentioned above, the concept of a "training set" and associated ground truth establishment is not applicable to this traditional medical device.

Summary

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Image /page/0/Picture/2 description: The image shows a logo with the text "CBOKANG" in a bold, stylized font. The letters are large and prominent, with a unique design that makes them stand out. Below the main text, there is a smaller line of text that appears to be part of the logo, possibly indicating a company name or slogan. The overall design is clean and professional, suggesting a brand identity.

温州市博康仪表有限公司

ROKANG INSTRUMENTS CO.,LTD

510(K) Summary

Johnny Cao and Jack Cheng Contact Hangzhou Gainder Enterprises Administration Consulting Co., Ltd Room 1623,Block B, No.83 north Qiutao Road, Hangzhou,310016 P.R.China Tel: +86-571-86984378 Fax: +86-571-89265351

Xiang Youwang Submitter Wenzhou Bokang Instruments Co.,Ltd Haining road, Haibin Longwan, Wenzhou, Zhejiang 325024 P.R.China Tel:+86-577-86876969 Fax:+86-577-86880123

Bokang Digital Blood Pressure Monitor, Model BK6001, Model Proprietary Name BK6002 and Model BK6023

Noninvasive blood pressure measurement system. Common Name Noninvasive blood pressure measurement system. Classification Name

Cardiovascular Panel

Classification

classification name	21 CFRsection	Product code	Class
Noninvasive bloodpressuremeasurementsystem.	870.1130	DXN	II

Predicate Device

A & D LifeSource UA-704 Digital Blood Pressure Monitor (K032499) Bioland Blood Pressure Monitor Model 2001, 2003, 3000 (K083681)

Description and Indication for Use

Description and Hidreanon 10. Son-invasive blood pressure (NIBP) monitors which use a standard oscillometric measurement method and intend for noninvasive wither ass a buildira over in the blood pressure and determination of pulse rate for adults only.

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Image /page/1/Picture/0 description: The image shows a logo with the text "BBOKANG" in a stylized font. Below the logo, there is some smaller text that is difficult to read. To the right of the logo, there is Chinese text followed by the English translation "BOKANG INSTRUMENTS CO., LTD.". The logo and text appear to be for a company or organization.

Model BK6001 is a semi-auto digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated by a manual air pump.

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Performance

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Bokang Digital Blood Pressure Monitors have been tested to meet the requirement of ANSI/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure Monitor Guidance"

Substantial Equivalency

After analyzing both bench and clinical testing data, it is the conclusion of Bokang Digital Blood Pressure Monitor. Model BK6001, Model BK6002 and Model BK6023 are substantial equivalent to the predicate device, A & D LifeSource UA-704 Digital Blood Pressure Monitor (K032499) and Bioland Blood Pressure Monitor Model 2001, 2003, 3000 (K083681).

Discussion of Clinical Tests Performed:

Controlled human clinical studies were conducted using the Bokang Digital Blood Pressure Monitor, Model BK6001, Model BK6002 and Model BK6023. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Bokang Clinical Test Protocol outline and meet the requirement of AAMI SP10.

Conclusions:

Bokang Digital Blood Pressure Monitor, Model BK6001, Model BK6002 and Model BK6023 have the same intended use and similar technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, Bokang Digital Blood Pressure Monitors are substantially equivalent to the predicate devices

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services USA. The seal features the department's logo, which is a stylized eagle with three stripes representing the department's mission of providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the seal.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 2 1 2012

Wenzhou Bokang Instruments Co., Ltd. c/o Mr. Xiang Youwang President Haining Road Haibin Longwan Zone Wenzhou, Zhejiang 325024 P.R. China

Re:

K11141

Trade/Device Names:

Bokang Semi-auto Digital Blood Pressure Monitor, Model BK6001 Bokang Automatic Digital Blood Pressure Monitor, Model BK6002 Bokang Wrist Digital Blood Pressure Monitor, Model BK6023

Regulatory Number: 21 CFR 870.1130

Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated

Received: February 8, 2012

Dear Mr. Xiang:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and

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Page 2 - Mr. Xiang Youwang

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limpited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use Form

Page 1 of 1

KI11141 510(k) Number (if known): _

Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/ OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number	K111141

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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).