(149 days)
Not Found
No
The summary describes a standard patient monitor with basic physiological parameter monitoring and alarming capabilities. There is no mention of AI, ML, or any advanced data processing that would suggest the use of such technologies.
No
The device is a patient monitor that diagnoses and monitors multiple physiological parameters and displays them. It does not provide any treatment or therapeutic intervention.
No
The device monitors physiological parameters, but its intended use statement explicitly says it is "intended for use by trained healthcare personnel to diagnose and monitor multiple physiological parameters," not to diagnose disease itself. The monitoring of parameters is part of diagnosis, but the device itself does not make the diagnosis.
No
The device description explicitly mentions hardware components such as an LCD screen, a built-in thermal printer, and a lithium-ion battery, indicating it is a physical medical device with integrated software, 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 diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device function: The description clearly states that the device monitors physiological parameters of human patients. This means it is directly monitoring the patient's vital signs in vivo (within the living body).
- Parameters monitored: The parameters listed (ECG, SpO2, NIBP, temperature, respiration) are all measured directly from the patient's body, not from a sample taken from the body.
Therefore, the Bionet BM3Plus Patient Monitor is a patient monitor, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The patient monitor is intended for use by trained healthcare personnel to diagnose and monitor multiple physiological parameters of human patients. It can be used on patients from adults to neonates. The device is designed as a bedside and portable monitor that can operate in all professional medical facilities.
Physiological data include but are not restricted to: electrocardiogram, pulse oximetry, pulse rate, noninvasive blood pressure, temperature, and respiration. The data output is displayed on an LCD screen and/or through a built-in printer as numerical data or in waveform. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits.
The patient monitor is not intended for use as an apnea monitor. The patient monitor is not intended for use during MRI or CT scans.
Product codes
MWI
Device Description
Bionet BM3Plus Patient Monitor ("BM3Plus" or the "subject device") is a multifunctional device that monitors vital signs of human patients from neonates to adults. Parameters monitored by BM3Plus include electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, noninvasive blood pressure (NIBP), temperature, and respiration. Data output is displayed in numeric and/or wave form(s) on a 7-inch color LCD screen. Selected parameters and waves can also be shown in print via a built-in 58 mm thermal printer. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits.
BM3Plus is compact and can be used in either stationary mode or on the move in all professional medical facilities. Its energy source can come from AC input or lithium-ion battery. BM3Plus' LAN connection capability enables the device to be built into a monitoring system, so that one person can monitor several patients at a time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
from neonates to adults
Intended User / Care Setting
trained healthcare personnel, bedside and portable monitor that can operate in all professional medical facilities.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical test is not applicable to BM3Plus.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY (21 C.F.R. 807.92)
1. Submitter Identification:
LEE & XIAO 2600 Mission Street, Suite 100 San Marino, CA 91108 Telephone: (626) 799-0998
DEC 1 1 2008
(082008 0/3
Contact Person: Yingchao Xiao, Esq.
Date: November 28, 2008
2. Device Name:
Trade Name: Bionet BM3Plus Patient Monitor Common Name: Multifunctional patient monitor Classification Name: Monitor, Physiological, Patient
3. Predicate Device:
Goldway UT4000F Patient Monitor (K021154)
4. Device Description:
Bionet BM3Plus Patient Monitor ("BM3Plus" or the "subject device") is a multifunctional device that monitors vital signs of human patients from neonates to adults. Parameters monitored by BM3Plus include electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, noninvasive blood pressure (NIBP), temperature, and respiration. Data output is displayed in numeric and/or wave form(s) on a 7-inch color LCD screen. Selected parameters and waves can also be shown in print via a built-in 58 mm thermal printer. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits.
BM3Plus is compact and can be used in either stationary mode or on the move in all professional medical facilities. Its energy source can come from AC input or lithium-ion battery. BM3Plus' LAN connection capability enables the device to be built into a monitoring system, so that one person can monitor several patients at a time.
5. Statement of Intended Use:
1
The patient monitor is intended for use by trained healthcare personnel to diagnose and monitor multiple physiological parameters of human patients. It can be used on patients from adults to neonates. The device is designed as a bedside and portable monitor that can operate in all professional medical facilities.
Physiological data include but are not restricted to: electrocardiogram, pulse oximetry, pulse rate, noninvasive blood pressure, temperature, and respiration. The data output is displayed on an LCD screen and/or through a built-in printer as numerical data or in waveform. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits.
The patient monitor is not intended for use as an apnea monitor. The patient monitor is not intended for use during MRI or CT scans.
6. Comparison with Predicate Device:
Both BM3Plus and UT4000F are designed to monitor basic physiological parameters of human patients from neonates to adults. The predicate and the subject devices both monitor ECG, SpO2, pulse rate, NIBP, temperature, and respiration. The predicate device can also monitor, as optional functions, invasive blood pressure and carbon dioxide, which are absent on the subject device.
In addition, the subject and the predicate devices use similar technologies and have little difference in terms of their functional specifications, conformation to consensus standards, energy use, biocompatibility, mechanics, or environment for use. Where differences do exist between the subject device and the predicate devices, those adaptations comply with relevant recognized consensus standards and do not affect the safety or effectiveness of BM3Plus. The differences include, but not limited to, BM3Plus', LAN output, Li-ion battery use, and compact design. These adaptations enhance the performances of the subject device yet do not interfere with its safety or effectiveness.
7. Testing:
BM3Plus meets the following recognized consensus standards:
- IEC 60601-1 (1988-12) + A1(1993) + A2(1995) l
- IEC 60601-1-2 (2001) 트
- IEC 60601-1-4 (1999-10) 트
- IEC 60601-2-27 (1994-04) ■
- IEC 60601-2-30 (1999-12), EN 60601-2-30(2000) ■
- IEC 60601-2-49 (2001-07), EN60601-2-49(2001) 트
- EN 12470-4 (2001) 트
- EN 865 (1997) I
- EN 1060-1(1995-12), EN 1060-3 (1997-9) I
2
- ISO 14971-1 (1998-10) .
Clinical test is not applicable to BM3Plus.
8. Conclusion:
BM3Plus and UT4000F have the same intended use and have no major technological difference. In addition, where BM3Plus differs from UT4000F, the technological anterested the safety or effectiveness of BM3Plus. Therefore, according to the principles FDA 510(k) notification, the subject device is substantially equivalent to the predicate device.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming three curved lines. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2008
Bionet Co., Ltd. c/o Lee & Xiao Mr. Yingchao Xiao 2600 Mission St., Suite 100 San Marino, California 91108
Re: K082008
Trade/Device Name: Bionet BM3Plus Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI Dated: November 5, 2008 Received: November 10, 2008
Dear Mr. Xiao:
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 adulteration.
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. 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
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Page 2 - Mr. Yingchao Xiao
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 (OS) 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 Biometrics' (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 Division 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.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
(v.2)
510(k) Number (if known): _ K 08 2008
Device Name: Bionet BM3Plus Patient Monitor
Indications for Use:
The patient monitor is intended for use by trained healthcare personnel to diagnose and monitor multiple physiological parameters of human patients. It can be used on patients from adults to neonates. The device is designed as a bedside and portable monitor that can operate in all professional medical facilities.
Physiological data include but are not restricted to: electrocardiogram, pulse oximetry, pulse rate, noninvasive blood pressure, temperature, and respiration. The data output is displayed on an LCD screen and/or through a built-in printer as numerical data or in waveform. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits.
The patient monitor is not intended for use as an apnea monitor. The patient monitor is not intended for use during MRI or CT scans.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
e of Device Evaluation (ODE) Concurrence of CD
Fred/S/2/14 B Zuckerman
(Division Sign Off)
(Division Sign-Off) /
Division of Cardiovascular Devices
510(k) Number K082008