The VS-800 Vital Signs Monitor is used to monitor physiological parameters, including Sp02, PR and NIBP on adults, pediatric and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

The device is not intended for transport or home use.

Device Description

The VS-800 Vital Signs Monitor is battery or line-powered monitor used on human patient. The Vital Signs Monitor acquires the physiological signals non-invasive blood pressure (NIBP) and pulse oxygen saturation of the blood (SpO2). These physiological signals are converted into digital data and processed. The VS-800 Vital Signs Monitor examines the data for alarm conditions and presents them on the front panel. The Vital Signs Monitor also provides user with the convenient operating control and human-machine interface (HMI),

The optional built-in recorder provides hard copies of all digital data and waveforms as well as Tabular and Graphic Trend Information, and storage the previous monitoring data information when power off accidentally.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing substantial equivalence to a predicate device and adherence to various safety and performance standards rather than reporting specific quantitative performance metrics against pre-defined acceptance criteria.

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Overall Safety and Efficacy	Be as safe, as effective, and perform as well as or better than the legally marketed predicate device (PM-8000 Patient Monitor K#043348).	Demonstrated through laboratory testing, hazard analysis, and compliance with numerous industry and safety standards to be substantially equivalent and perform at least as well as the predicate device.
SpO2 Accuracy	Similar to predicate device (PM-8000), comply with relevant ANSI/AAMI, IEC, EN, and ISO standards (e.g., EN865). Specific numerical criteria not provided.	"Parameters' specification of the VS-800 Vital Signs Monitor, including SpO2... is similar to the predicate PM-8000 Patient Monitor." Compliance with EN865 is stated.
Pulse Rate (PR) Accuracy	Similar to predicate device (PM-8000), comply with relevant ANSI/AAMI, IEC, EN, and ISO standards. Specific numerical criteria not provided.	"Parameters' specification of the VS-800 Vital Signs Monitor, including... PR... is similar to the predicate PM-8000 Patient Monitor."
Non-Invasive Blood Pressure (NIBP) Accuracy	Similar to predicate device (PM-8000), comply with relevant ANSI/AAMI, IEC, EN, and ISO standards, specifically ANSI/AAMI Standards SP10. Specific numerical criteria not provided.	"Parameters' specification of the VS-800 Vital Signs Monitor, including... NIBP... is similar to the predicate PM-8000 Patient Monitor." Testing conducted according to ANSI/AAMI Standards SP10.
Electrical Safety	Meet requirements of IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4. Prevent excessive electrical leakage current.	Testing performed by third-party agencies to ensure compliance with applicable industry and safety standards, including IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4.
Software Functionality & Data Accuracy (Misdiagnosis Prevention)	Software design and signal processing should not lead to inaccurate diagnostic data.	Hazard analysis of the system and its software was performed, and testing was conducted to validate the systems overall operation to address the risk of misdiagnosis due to inadequate design.
Alarm Functionality	Adequate design for audible and visual indicators to prevent inadequate response to the patient's condition.	Hazard analysis addressed the risk of inadequate design of the system's ability to alert users.
Environmental Performance	Meet all environmental testing identified in FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document.	Laboratory testing was conducted to validate and verify that the VS-800 Vital Signs Monitor met all design specifications, including environmental testing.
Risk Management	Comply with ISO 14971. Address risks like electrical shock and misdiagnosis.	Testing assured compliance with ISO14971. Hazard analysis performed for electrical shock and misdiagnosis.

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

Test Set Sample Size: Not specified. The document mentions "laboratory testing" and "third-party agencies" for safety testing, but the number of patients or samples used for these tests is not provided.
Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing described is "laboratory testing" and appears to be internal validation and verification, potentially involving some human subjects for performance against standards like SP10, but details are lacking. The country of origin for the testing itself is not explicitly stated, but the submitter is from Shenzhen, P. R. China.

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

Not applicable/Not specified. The document describes engineering and standards compliance testing, not a clinical study where expert ground truth would typically be established for diagnostic accuracy. The testing for NIBP (ANSI/AAMI SP10) would involve comparison against a reference method, but this is a technical standard, not a subjective expert assessment. The "misdiagnosis" risk area implies the accuracy of "diagnostic data" is critical, but how its ground truth was established for testing purposes is not detailed beyond "inadequate design of the signal processing and measurement circuitry or program can lead generation of inaccurate diagnostic data."

4. Adjudication Method for the Test Set:

Not applicable/Not specified. As mentioned above, the testing described is not a clinical study involving subjective interpretation from experts requiring adjudication.

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

No. An MRMC study was not performed. This device is a vital signs monitor, not an image interpretation or diagnostic aid that would typically involve multiple human readers. The study focuses on the device's technical performance and safety.

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

Yes, implicitly. The entire testing described ("Laboratory testing," "hazard analysis," "system validation," "safety testing by third party agencies," testing "according to the requirements outlined in the ANSI/AAMI Standards SP10") focuses on the performance of the device itself (the "algorithm only" in the context of a simple monitor) rather than its impact on human reader performance. The device provides "digital data" and "processed" signals, implying standalone functionality.

7. The Type of Ground Truth Used:

Reference Standards/Predicate Device Comparison:
- For NIBP, the ground truth is established by the requirements and reference measurements outlined in ANSI/AAMI Standards SP10.
- For SpO2 and PR, the implied ground truth is the performance "similar to the predicate PM-8000 Patient Monitor" and compliance with EN865 and other general standards.
- For safety, the ground truth is defined by IEC 60601-1 series, ISO 14971, and other applicable safety standards.

8. The Sample Size for the Training Set:

Not applicable/Not specified. This device is a vital signs monitor, not a machine learning or AI-driven diagnostic system that typically involves a distinct "training set" in the modern sense. Its development would involve traditional embedded systems engineering and calibration, not machine learning model training.

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

Not applicable. As a traditional vital signs monitor, there isn't a "training set" in the context of supervised learning. The device's internal algorithms and calibrations would be developed based on engineering principles, physiological models, and empirical testing against reference instruments and standards.

Summary

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510(K) SUMMARY Exhibit #1

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K060281

Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: +86 755 2658 2888 Fax: +86 755 2658 2680

Contact Person: ●

Li Dongling
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: ●

Jan. 16, 2005

Name of the device:

Trade/Proprietary Name: VS-800 Vital Signs Monitor
Common Name: Vital Signs Monitor .
Classification

21 CFR 870.2300 Cardiac monitor (including cardiotachometer and rate alarm)	Class
21 CFR 870.1130 Non-Invasive blood pressure measurement System	Class
21 CFR 870.2700 Oximeter, Pulse	Class
21 CFR 870.2710 Ear Oximeter, Pulse	Class

Legally Marketed Predicate Device:

K043348 PM-8000 Patient Monitor (by Mindray Co., Ltd.)

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Description:

Statement of intended Use:

This device is used to monitor physiologic parameters, including SpO2, PR and NIBP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

This device is not intended for transport or home use.

Comparison of Technological Characteristics:

The VS-800 Vital Signs Monitor is substantially equivalent to systems currently marketed predicate devices. The design, components, storage technology and energy source of the VS-800 Vital Signs Monitor are similar to the predicate device named PM-8000 Patient Monitor (K#043348). Both VS-800 Vital Signs Monitor and PM-8000 Patient Monitor provide a means for interfacing with a patient, collecting parameter specific physiological data, and processing the data for alarm generation and display of numeric values and waveforms on a bedside or central monitoring system. The monitoring parameters of the PM-8000 Patient Monitor cover those of the VS-800 Vital Signs Monitor. And the parameters' specification of the VS-800 Vital Signs Monitor, including SpO2, PR and NIBP, is similar to the predicate PM-8000 Patient Monitor,

The notable difference between the technical specifications of the VS-800 Vital Signs Monitor and PM-8000 Patient Monitor is shown as following:

While the monitoring parameters of the PM-8000 Patient Monitor cover those of the VS-800 Vital Signs Monitor, but the parameters' specification of the VS-800 Vital Signs Monitor, including SpO2, PR and NIBP, is similar to the predicate PM-8000 Patient Monitor, and all these parameters of the pending device and the predicate device comply with some

. . . . . . . . . . . . . . . . . . . . . . .

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ANSI/AAMI standards, IEC standards, EN standards and ISO standards.

These technological differences do not affect the safety or efficacy of the device. Any safety issues that may be raised by a software controlled medical device are the same issues already addressed by the predicate device and are addressed in the systems hazard analysis and in the system validation.

Testing:

Laboratory testing was conducted to validate and verify that the VS-800 Vital Signs Monitor met all design specifications and was substantially equivalent to the predicate devices. This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall operation. Some safety testing has been performed by third party agencies to ensure the device complies with applicable industry and safety standards. The VS-800 Vital Signs Monitor has also been tested to assure compliance with the requirements of various published standards, including EN865. IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, IEC60601-2-30, and ISO14971.

Testing of the non-invasive blood pressure portion of the system was conducted according to the requirements outlined in the ANSI/AAMI Standards SP10 "Electronic automated sphygmomanometers."

Although the device is neither life supporting nor life sustaining, diagnostic information derived from the use of the device and alarms generated by the device may be critical to the proper management of the patient. So, the areas of risk for this device are the same as other devices in this class, and the following:

Electrical shock
chassis Excessive electrical leakage current can disturb the normal electrophysiology of the heart.
Misdiagnosis
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Inadequate design of the signal processing and measurement circuitry or program can lead generation of inaccurate diagnostic data.. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.
- --Inadequate design of the device's software, used to make various measurements, can lead to generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.
- Inadequate design of the systems ability to alert the users through audible and ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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visual indicators, can lead to user mistrust and/or inadequate response to the patient's condition. If an inadequate response to the patient's condition should occur the patient may unnecessarily be placed at risk.

Conclusion:

The conclusions drawn from clinical and laboratory testing of the VS-800 Vital Signs Monitor demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the PM-8000 Patient Monitor numbered K#043348(by Mindray Co., Ltd).

and the comments of

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2006

Shenzhen Mindray Bio-Medical Electronics Co. Ltd. c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K060281

Trade Name: VS-800 Vital Signs Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: June 16, 2006 Received: June 19, 2006

Dear Ms. Goldstein-Falk:

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.

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Page 2 - Ms. Susan D. Goldstein-Falk

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 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 I ogally 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 Office of Compliance at (240) 276-0120. Also, please note the regulation enjitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Bhemnia for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Heath

Enclosure

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Page

510(k) Number (if known):

Device Name: VS-800 Vital Signs Monitor

Indications For Use:

The device is not intended for transport or home use.

Prescription Use × (Per 21 CFR 801 Subpart D)

Over-The Counter Use OR (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Bairamova
Division Sign Off

(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.