BIOLAND BLOOD PRESSURE MONITOR
Device Facts
| Record ID | K083681 |
|---|---|
| Device Name | BIOLAND BLOOD PRESSURE MONITOR |
| Applicant | Bioland Technology, Ltd. |
| Product Code | DXN · Cardiovascular |
| Decision Date | Jan 16, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence, 3rd-Party Reviewed |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K083681 · Jan 16, 2009 | BIOLAND BLOOD PRESSURE MONITOR | Bioland Technology, Ltd. | Clinical patient data from Feng Gang Overseas Chinese Hospital | Clinical testing was performed on patients to compare the accuracy of the Bioland Blood Pressure Monitors against standard mercury-type sphygmomanometers in a hospital setting. | Clinical accuracy; Hospital-based testing; Blood pressure monitoring |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Comparative clinical evaluation | Patients; Sample Size: 87; Number of Sites: 1 | Mercury-type sphygmomanometers | Difference in systolic/diastolic blood pressure measurements (mmHg) |
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.
Device Story
Non-invasive blood pressure monitors (sphygmomanometers) for adult use; models include upper-arm (cuff-based) and wrist-based variants. Input: air pressure signals from inflated cuff. Operation: oscillometric method; manual or electrical air pump inflation; preset mechanical valve controls deflation. Output: systolic/diastolic blood pressure and pulse rate displayed on LCD. Used in home or clinical settings by patients or clinicians. Device determines blood pressure via pressure transducer and software-based analysis of pressure oscillations. Benefits: provides convenient, non-invasive monitoring of cardiovascular parameters.
Clinical Evidence
Clinical testing conducted at Feng Gang Overseas Chinese Hospital comparing subject devices to mercury-type sphygmomanometers. Sample size: 87 patients. Primary endpoints: accuracy of systolic/diastolic measurements. Results: 90.8%-96.6% of measurements within +/- 5mmHg, 100% within +/- 8mmHg. No injuries reported.
Technological Characteristics
Oscillometric measurement principle using pressure transducers. Models feature either manual or electrical air pump inflation. Components include inflation cuffs (upper arm or wrist) and LCD display. Complies with ANSI/AAMI SP-10, EN 60601-1, and EN 60601-1-2 standards. Software uses identical algorithms and pressure detection hardware as predicate devices.
Indications for Use
Indicated for non-invasive measurement of diastolic, systolic blood pressure and pulse rate in adult patients.
Regulatory Classification
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.
Predicate Devices
- 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 Digital Blood Pressure Monitor (K040371)
Submission Summary (Full Text)
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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)
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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
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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 | Component<br>replacement | Conformed | Conformed | Conformed |
| 4 1 4.2 | Power system labeling | Conformed | Conformed | Conformed |
| 4 1.4.3 | Labeling for<br>battery-powered<br>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<br>pressure | Conformed | Conformed | Conformed |
| 4312 | Cuff deflation | Conformed | Conformed | Conformed |
| 4 3 2 | Electrical safety | Conformed | Conformed | Conformed |
| 4 3 3 | Conductive<br>components | Conformed | Conformed | Conformed |
| 4 4 1 | Pressure indicator<br>accuracy | Conformed | Conformed | Conformed |
| 4 4 2 | Overall system<br>efficacy | Conformed | Conformed | Conformed |
| 4 4 2.1 | Auscultatory method<br>as the reference<br>standard | Conformed | Conformed | Conformed |
| 4 4 2 2 | Intra-arterial method<br>as the reference<br>standard | Not applicable | Not applicable | Not applicable |
| 4.4.3 | Battery-powered devices | Conformed | Conformed | Conformed |
| 4 5 | Requirements for devices with manual<br>Conform-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
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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
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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
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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
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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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