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.

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.

AI/ML Overview

This document describes the Bionet BM3Plus Patient Monitor, but it explicitly states that "Clinical test is not applicable to BM3Plus."

Therefore, a study demonstrating the device meets specific acceptance criteria based on clinical performance data is not provided in this submission. The submission focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized consensus standards and a comparison of technical specifications.

Here's an analysis based on the provided text, primarily addressing why many of the requested points cannot be answered:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document lists several IEC and EN standards (e.g., IEC 60601-1, IEC 60601-1-2, EN 865, EN 1060-1, etc.) that the BM3Plus meets. These standards themselves contain detailed performance and safety requirements, which serve as the acceptance criteria for the device's design, electrical safety, electromagnetic compatibility, and specific parameter monitoring capabilities (e.g., ECG, NIBP, SpO2).
Reported Device Performance: The document states that the BM3Plus "meets" these standards. However, it does not provide a table of specific numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity) for each monitored parameter (ECG, SpO2, NIBP, temperature, respiration) and how they measure up against a set of clinical acceptance criteria derived from a performance study. The statement "Clinical test is not applicable to BM3Plus" means such a table based on clinical data is not included.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. Since no clinical performance study was conducted or presented, there is no test set, sample size, or data provenance from a clinical perspective. The "testing" referred to in the document pertains to adherence to recognized consensus standards, which typically involves bench testing, electrical safety testing, and EMC testing, not clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. As no clinical performance study was conducted, there was no ground truth established by experts for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. No clinical test set means no adjudication method was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable / Not provided. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

Not applicable / Not provided. The BM3Plus is a patient monitoring device, not a standalone algorithm. Its performance is inherent in its hardware, firmware, and sensor technology, and its "standalone" performance is measured against the technical specifications within the consensus standards it claims to meet.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not provided for clinical performance. For the non-clinical testing against consensus standards, the "ground truth" would be the reference measurements and specifications defined within those standards and performed by calibrated testing equipment, not clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable / Not provided. Since this is not an AI/machine learning device requiring a training set, this question is not relevant.

9. How the ground truth for the training set was established

Not applicable / Not provided. As there is no training set mentioned, this question is not relevant.

In summary of what is provided:

The submission for the Bionet BM3Plus Patient Monitor establishes its safety and effectiveness through substantial equivalence to an existing predicate device (Goldway UT4000F Patient Monitor, K021154) and by demonstrating compliance with a list of recognized consensus standards (IEC, EN, ISO). The document explicitly states that "Clinical test is not applicable to BM3Plus," meaning that the acceptance criteria are primarily met through engineering design verification and validation against these standards, rather than through a clinical performance study with human subjects or patient data.

Summary

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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:

5. Statement of Intended Use:

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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

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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.

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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

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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 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

Regulation Number and Section

§ 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).