(35 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor and does not mention any AI or ML components or capabilities. The performance studies compare the device to traditional mercury sphygmomanometers, not to AI/ML-based systems.
No
The device is described as a blood pressure monitor intended for measurement, not for treatment.
Yes
This device is a blood pressure monitor intended for indirect (non-invasive) measurement of diastolic, systolic blood pressure, and pulse rate, which are used to diagnose and monitor cardiovascular conditions.
No
The device description explicitly details hardware components such as inflation cuffs, manual and electrical air pumps, transducers, mechanical valves, and an LCD display, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Bioland Blood Pressure Monitor measures blood pressure and pulse rate indirectly and non-invasively by using a cuff and an electronic manometer. It does not analyze any biological specimens from the body.
- Intended Use: The intended use clearly states "indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate". This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the Bioland Blood Pressure Monitor falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2004, Model 2005, model 3000, Model 3001 and Model 3002, are Sphygmomanometer with Electronic Manometer intended to be used for the indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate for adults only.
Product codes (comma separated list FDA assigned to the subject device)
DXN
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm, wrists
Indicated Patient Age Range
Adults only
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical tests on blood pressure on patients (sample size not specified, but results are out of 87 measurements) using Bioland Blood Pressure Monitor Model 2003, Model 2004, Model 2005, Model 3000, Model 3002 were conducted in Feng Gang Overseas Chinese Hospital, comparing to normal mercury-type sphygmomanometers. Annotation protocol not specified.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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". All listed sections of the SP-10 standard were conformed to.
Clinical Tests:
Clinical 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.
Key results (Differences of measuring results between the electric Blood Pressure Montor and normal mercury sphygmomanometers out of 87 measurements):
- Model 2001/2003: 78 within +/-3mmHg (89.7%), 84 within +/-5mmHg (96.6%), 87 within +/-8mmHg (100%)
- Model 2004/2005: 79 within +/-3mmHg (90.8%), 84 within +/-5mmHg (96.6%), 87 within +/-8mmHg (100%)
- Model 3000/3001/3002: 79 within +/-3mmHg (90.8%), 82 within +/-5mmHg (94.3%), 87 within +/-8mmHg (100%)
The accuracy of test result found acceptable. There was no any injury occurred during clinical test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Model 2001/2003: Within+/-3mmHg (89.7%), Within+/-5mmHg (96.6%), Within+/-8mmHg (100%)
Model 2004/2005: Within+/-3mmHg (90.8%), Within+/-5mmHg (96.6%), Within+/-8mmHg (100%)
Model 3000/3001/3002: Within+/-3mmHg (90.8%), Within+/-5mmHg (94.3%), Within+/-8mmHg (100%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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)
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Product Code DXN Manufacturer: A & D Engineering, Inc. Establishment Number· 2082313 Owner/Operator Number: 8031633
Description and Intended Use:
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.
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
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
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
2
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 | Component | |||
| replacement | Conformed | Conformed | Conformed | |
| 4 1 4.2 | Power system labeling | Conformed | Conformed | Conformed |
| 4 1.4.3 | Labeling for | |||
| battery-powered | ||||
| devices | 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 cuff | |||
| pressure | Conformed | Conformed | Conformed | |
| 4312 | Cuff deflation | Conformed | Conformed | Conformed |
| 4 3 2 | Electrical safety | Conformed | Conformed | Conformed |
| 4 3 3 | Conductive | |||
| components | Conformed | Conformed | Conformed | |
| 4 4 1 | Pressure indicator | |||
| accuracy | Conformed | Conformed | Conformed | |
| 4 4 2 | Overall system | |||
| efficacy | Conformed | Conformed | Conformed | |
| 4 4 2.1 | Auscultatory method | |||
| as the reference | ||||
| standard | Conformed | Conformed | Conformed | |
| 4 4 2 2 | Intra-arterial method | |||
| as the reference | ||||
| standard | Not applicable | Not applicable | Not applicable | |
| 4.4.3 | Battery-powered devices | Conformed | Conformed | Conformed |
| 4 5 | Requirements for devices with manual | |||
| Conform-ed inflation systems | Conformed | Conformed | Conformed |
3
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
4
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
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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
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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
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
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
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
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A Broom To Park I
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