Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2004, Model 2005, model 3000, Model 3001 and Model 3002, are Sphygmomanometer with Electronic Manometer ntended to be used for the indirect (non-invasive) measurement of diastohc, systolic blood pressure and pulse rate for adults only.

Device Description

Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2005, model 3000, Model 3001 and Model 3002, are Sphygmomanometers with Electronic Manometer intended to be used for the indirect (non-mvasive) measurement of diastohe, systolic blood pressure and pulse rate for adults only.

Bioland Blood Pressure Montor Model 2001 and Model 2004 respectively use an inflation cuff wrapped around the upper arm The cuff is inflated by a manual air pump

Bloland Blood Pressure Monitor Model 2003 and Model 2005 respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated by an electrical air pump

Bioland Blood Pressure Montor Model 3000, Model 3002, respectively uses inflation cuffs wrapped around the wrists. The cuff is inflated automatically by an electrical arr pump

The systolic, diastolic blood pressures and heart beats are transmitted via air pressure in the mflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by arr 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 results including dastolic. systolic pressures and heart pulse rate are displayed on the LCD

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the Bioland Blood Pressure Monitor models:

Acceptance Criteria and Device Performance for Bioland Blood Pressure Monitors

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Bioland Blood Pressure Monitors are primarily based on the ANSI/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure (NIBP) Monitor Guidance". The clinical performance is evaluated against the accuracy of a mercury-type sphygmomanometer.

Acceptance Criteria (from ANSI/AAMI SP-10 & Clinical Study)	Reported Device Performance (Models 2001, 2003, 2004, 2005, 3000, 3001, 3002)
ANSI/AAMI SP-10 Standard Conformance:	Conformed for all applicable sections:
- General requirements	Conformed
- Device labeling	Conformed
- Outer container	Conformed
- Information manual	Conformed
- Component replacement	Conformed
- Power system labeling	Conformed
- Labeling for battery-powered devices	Conformed
- Storage conditions	Conformed
- Operating conditions	Conformed
- Vibration and shock	Conformed
- Voltage range	Conformed
- Life	Conformed
- Maximum cuff pressure	Conformed
- Cuff deflation	Conformed
- Electrical safety	Conformed (also complies with EN 60601-1 1990 and EN 60601-1-2/2001)
- Conductive components	Conformed
- Pressure indicator accuracy	Conformed
- Overall system efficacy (referenced to Auscultatory method)	Conformed
- Intra-arterial method as reference	Not applicable
- Battery-powered devices	Conformed
- Requirements for devices with manual inflation systems	Conformed (for Model 2001/2004)
Clinical Accuracy (compared to mercury sphygmomanometer):	Reported Performance:
- Within +/- 3 mmHg	Model 2001/2003: 89.7% (78/87) Model 2004/2005: 90.8% (79/87) Model 3000/3001/3002: 90.8% (79/87)
- Within +/- 5 mmHg	Model 2001/2003: 96.6% (84/87) Model 2004/2005: 96.6% (84/87) Model 3000/3001/3002: 94.3% (82/87)
- Within +/- 8 mmHg	Model 2001/2003: 100% (87/87) Model 2004/2005: 100% (87/87) Model 3000/3001/3002: 100% (87/87)

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

Sample Size: The clinical test involved 87 patients for each group of models (Model 2001/2003, Model 2004/2005, Model 3000/3001/3002). It is not explicitly stated if these are unique patients across all model groups or if the same 87 patients were tested with different models. Assuming 87 unique patients for each grouped model as presented.
Data Provenance: The study was conducted in Feng Gang Overseas Chinese Hospital. The type of study (retrospective or prospective) is not explicitly stated, but clinical tests are typically prospective. The country of origin is implicitly China, given the hospital's name and location.

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

The ground truth was established by "normal mercury-type sphygmomanometers." This implies that the measurements were taken by healthcare professionals trained in using these devices. The document does not specify the number of experts, their qualifications (e.g., specific medical titles, years of experience), or if multiple experts were involved in taking reference measurements for the same patient.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1, or none) for establishing ground truth measurements from the mercury sphygmomanometers. It simply refers to "comparing to normal mercury-type sphygmomanometers," which suggests that the direct readings from these reference devices were used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the device's measurements against a reference standard (mercury sphygmomanometer), not against human readers' performance with and without AI assistance. This device is a standalone measurement system, not an AI-assisted diagnostic tool for human interpretation.

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

Yes, a standalone performance study was done. The Bioland Blood Pressure Monitors are automatic devices that measure blood pressure using an oscillometric method. The clinical tests evaluate the accuracy of these devices' measurements (algorithm only) compared to the ground truth established by mercury sphygmomanometers, without human intervention in operating the device or interpreting its output.

7. The Type of Ground Truth Used

The ground truth used was "normal mercury-type sphygmomanometers." This is an accepted and common reference standard for non-invasive blood pressure measurement devices.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. This is a medical device clearance, and the focus is on the validation/test set performance against established clinical and engineering standards. For such devices, manufacturers typically use proprietary algorithms developed with internal data, and the submission primarily demonstrates performance on a separate, independent test set.

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

Since information about a specific training set is not provided, the method for establishing its ground truth is also not detailed in this summary.

Summary

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K083681

510 (K) Summary

JAN 1 6 2009

Submitter:

David Lee Bioland Technology Ltd Block C, G/F Ming Court, 19 - 23 Ming Yuen Western St., North Point Hong Kong

Tel: +852 2503 0868 Fax +852 2503 0898 Email. Info@bioland com hk

· DA CDRH DMC

DEC 1 2 2008

Received

Manufacturer: Bioland Technology Ltd Block C, G/F Ming Court, 19-23 Ming Yuen Western St , North Point Hong Kong

Tel + 852 2503 0868 Fax + 852 2503 0898 Email info@bioland.com hk

Device Name:

Proprietary Name Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2004, Model 2005, model 3000, Model 3001 and Model 3002 Common/Usual Namer Non-invasive Blood Pressure Measurement System Device Name Non-invasive Blood-pressure Measurement System Product Code DXN Classification Class П

Predicate Device:

A & D LifeSource UA-704 Digital Blood Pressure Monitor (K032499), A & D LifeSource UB-328 Digital Blood Pressure Monitor (K040229) A & D Medical UA-767BT Dıgıtal Blood Pressure Monıtor (K040371)

201 -

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Product Code DXN Manufacturer: A & D Engineering, Inc. Establishment Number· 2082313 Owner/Operator Number: 8031633

Description and Intended Use:

Technological Characteristics:

Bioland Blood Pressure Montor Model 2001 and Model 2004 respectively use an inflation cuff wrapped around the upper arm The cuff is inflated by a manual air pump

Bloland Blood Pressure Monitor Model 2003 and Model 2005 respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated by an electrical air pump

Bioland Blood Pressure Montor Model 3000, Model 3002, respectively uses inflation cuffs wrapped around the wrists. The cuff is inflated automatically by an electrical arr pump

Device Tests

Bioland Blood Pressure Montor Model 2001, Model 2004, Model 2005, MODEL 3000, Model 3001 and Model3002 meet ANSI/AAMI SP-10 standard and FDA gurdance "Non-myasive Blood Pressure (NIBP) Monitor Guidance" Please refer to the table below for the list of AAMI SP-10 tests Broland Blood Pressure Monitor Model 2003, Model 2004, Model 2005, Model 3000, Model 3001 and Model 3002 are clinically tested The applicant devices use the identical software codes and pressure detection related hardware as the predicate device to determine systolic, and pulse rate Bioland Blood Pressure Montor Model 2001, Model 2003, Model 2005, Model 3000, Model 3000, Model 3001 and Model 3002 comply with the standard EN 60601-1 1990. and EN 60601-1-2/2001. see Attachment 4. Electrical Safety Test Report and Attachment 5 & 6, EMC Test Report

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SP10 Standard test result

SP-10	Title	Model	Model	Model
Section #		2001/2004	2003/2005	3000/3001/3002
		Test Results & Comments
4.1 1	General	Conformed	Conformed	Conformed
1 1.2.1	Device labeling	Conformed	Conformed	Conformed
4 1 2.2	Outer container	Conformed	Conformed	Conformed
4.1 3	Information manual	Conformed	Conformed	Conformed
4.1 4 1	Componentreplacement	Conformed	Conformed	Conformed
4 1 4.2	Power system labeling	Conformed	Conformed	Conformed
4 1.4.3	Labeling forbattery-powereddevices	Conformed	Conformed	Conformed
4.2 1	Storage conditions	Conformed	Conformed	Conformed
4 2 2	Operating conditions	Conformed	Conformed	Conformed
4 2 3	Vibration and shock	Conformed	Conformed	Conformed
4.2 4 1	Voltage range	Conformed	Conformed	Conformed
4 2 4 2	Life	Conformed	Conformed	Conformed
4.3 1 1	Maximum cuffpressure	Conformed	Conformed	Conformed
4312	Cuff deflation	Conformed	Conformed	Conformed
4 3 2	Electrical safety	Conformed	Conformed	Conformed
4 3 3	Conductivecomponents	Conformed	Conformed	Conformed
4 4 1	Pressure indicatoraccuracy	Conformed	Conformed	Conformed
4 4 2	Overall systemefficacy	Conformed	Conformed	Conformed
4 4 2.1	Auscultatory methodas the referencestandard	Conformed	Conformed	Conformed
4 4 2 2	Intra-arterial methodas the referencestandard	Not applicable	Not applicable	Not applicable
4.4.3	Battery-powered devices	Conformed	Conformed	Conformed
4 5	Requirements for devices with manualConform-ed inflation systems	Conformed	Conformed	Conformed

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Chnical tests on blood pressure on patients using Bioland Blood Pressure Monitor Model 2003, Model 2004, Model 2005, Model 3000, Model 3002 comparing to normal mercury-type sphygmomanometers were conducted in Feng Gang Overseas Chinese Hospital. The differences of measuring results between the electric Blood Pressure Montor and normal mercury sphygmomanometers are briefly listed in the following table:

Item/Diff	Within+/-3mmHg	Within+/-5mmHg	Within+/-8mmHg
Model 2001/2003	78/87(89.7%)	84/87(96.6%)	87/87(100%)
Model 2004/2005	79/87(90.8%)	84/87(96.6%)	87/87(100%)
Model 3000/3001/3002	79/87(90.8%)	82/87(94.3%)	87/87(100%)

The accuracy of test result found acceptable

There was no any injury occurred during clinical test

Substantıal Equivalency

All tests, including standards conformance and clinical, show the subject Devices Bioland Blood Pressure Montor Model 2001, Model 2003, Model 2004, Model 3000, Model 3001 and Model 3002 are substantial equivalent to the predicate devices

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Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2009

Bioland Technology Ltd c/o Mr Morten Simon Christensen Underwriters Laboratories, Inc 455 E Trimble Road San Jose, California 95131-1230

Re K083681

Trade/Device Name Blood Pressure Monitors Model 2001, Model 2003, Model 2004, Model 2005, Model 3000, Model 3001 and Model 3002 Regulation Number 21 CFR 870 1130 Regulation Name Non-Invasive Blood Pressure Measurement System Regulatory Class Class II Product Codes DXN Dated January 5, 2008 Received January 12, 2008

Dear Mr Christensen

2011 12:00 11 11 11 11 11 11 11 11 11 11 12 12 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 1

1. 1. 1. 1. 11

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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulterat1on

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

Franchise in the first

Chilian The Real Program Comment of Comments of Comments

100 300 11 11 11 11 11 11 2 11 2 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11

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Page 2 -Mr Morton Simon Christensen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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), 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 This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Brometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Drysson of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html

Antilian Sala add

The state the state the state the state of the states of the states of the states of the states of the states of the states of the states of the states of the state of the st

Sincerely yours.

Bram D Zuckerman, M D Director Dıvısıon of Cardıovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2004, Device Name Model 2005, model 3000, Model 3001 and Model 3002

Indications for Use

· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

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

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

Bearing, 2018-11-0

18.11.2

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) 1/16/09

Division of Cardiovascular Devices

510(k) Number K083681

Page 1 of 1

A Broom To Park I

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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).