This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, end-tidal CO2 concentration, respiration rate, body temperature, and so on, it allows comprehensive analysis of patient's physiological conditions.

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

Device Description

UP-7000 Patient Monitor is a modular designed patient monitor. It monitors the patient's Electrocardiograph (ECG), respiratory rate (RR) and bo dy temperature (TEMP) by measuring physical parameters with variety modules. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic, diastolic and mean) by the oscillating method. It can detect the blood oxygen saturation (SpO₂) and pulse rate (PR) non-invasively by the photoelectric method. Finally, it can extend CO2 monitor which measures the End-tidal Carbon dioxide, Inspired CO2 and Respiratory Rate. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. After CPU analyzing and calculating, the parameters are displayed on the screen in a graphical representation and it can record and/or print if necessary. The alarm activates if the monitored parameters go over the specified limits, alerting the medical professional.

AI/ML Overview

Acceptance Criteria and Device Performance for Patient Monitor, Model UP-7000

This submission for the Patient Monitor, Model UP-7000, primarily focuses on demonstrating substantial equivalence to predicate devices through adherence to recognized performance and safety standards. The provided documentation does not detail specific, quantitative acceptance criteria for device performance parameters like accuracy, sensitivity, or specificity, nor does it present detailed study results proving a device meets such criteria to the level often seen for diagnostic AI/ML devices. Instead, the submission relies on compliance with established international and medical device standards.

1. Table of Acceptance Criteria and Reported Device Performance

Function/Parameter	Acceptance Criteria (Standard Compliant)	Reported Device Performance
General Safety and Performance	Compliance with general requirements for safety and essential performance of medical electrical equipment. (e.g., IEC 60601-1: 1990+A1+A2+A13, IEC 60601-1-2: 2007 (EMC), IEC 60601-1-4: 2000 (programmable medical electrical systems), IEC 60601-1-6:2006 (usability), IEC 60601-1-8: 2006 (alarms))	"Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1. Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." The device is concluded to be "safe and effective and substantially equivalent to predicate devices." This implies that the device successfully passed all tests stipulated by these general safety and performance standards.
ECG/Heart Rate	Compliance with particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment. (e.g., IEC 60601-2-27 :2005)	"Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." This confirms compliance with IEC 60601-2-27. Specific performance metrics (e.g., heart rate accuracy range, artifact rejection) are not enumerated in this summary.
SpO2 (Functional Oxygen Saturation)	Compliance with particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. (e.g., ISO 9919: 2005)	"Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." This confirms compliance with ISO 9919. Specific performance metrics (e.g., SpO2 accuracy, perfusion index range) are not enumerated.
NIBP (Non-invasive Blood Pressure)	Implied compliance with relevant standards for non-invasive blood pressure measurement. (Not explicitly listed in relation to a specific NIBP standard, but "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device.")	"Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." NIBP is measured by the oscillating method. Specific performance metrics (e.g., accuracy against a reference method) are not enumerated.
CO2 (End-tidal CO2 concentration, Respiration Rate)	Compliance with particular requirements for the basic safety and essential performance of respiratory gas monitors. (e.g., ISO 21647: 2004(E))	"Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." This confirms compliance with ISO 21647. Specific performance metrics (e.g., EtCO2 accuracy, respiration rate accuracy) are not enumerated.
Biological Evaluation (Biocompatibility)	Compliance with biological evaluation of medical devices standards. (e.g., ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010)	The device was tested for biocompatibility according to ISO 10993 series, with all test results reported as satisfactory. This means it passed tests for evaluation and testing, in vitro cytotoxicity, and irritation and delayed-type hypersensitivity.

2. Sample Size for Test Set and Data Provenance

The provided 510(k) summary does not specify the sample size used for any performance testing or the provenance of any data (e.g., country of origin, retrospective or prospective). The submission largely relies on the declaration of compliance with recognized performance and safety standards, rather than presenting a detailed clinical study with a specific test set.

3. Number of Experts and Their Qualifications for Ground Truth

The provided document does not mention the use of experts to establish ground truth for a test set. This type of submission, pertaining to a patient monitor (a hardware device measuring physiological parameters), typically relies on established calibration standards and validated reference measurement systems for performance testing, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method

Given the nature of the device and the absence of expert involvement in establishing ground truth, there is no mention of an adjudication method in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done as described in the provided summary. This type of study would be relevant for devices that assist human readers in making diagnostic interpretations, which is not the primary function of this patient monitor.

6. Standalone (Algorithm Only) Performance Study

The device itself is a standalone patient monitor that directly measures physiological parameters. Therefore, the "standalone performance" is essentially the device's ability to accurately measure these parameters. The submission indicates that "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." This implies that the device's performance was evaluated independently against these standards. However, no specific detailed results of such a standalone study (e.g., accuracy metrics for each parameter) are provided in the summary.

7. Type of Ground Truth Used

The ground truth used for testing this patient monitor would generally be based on:

Reference standard measurements: Comparison against highly accurate and calibrated reference devices or methods for each physiological parameter (e.g., a calibrated ECG simulator for ECG and heart rate testing, a reference oximeter for SpO2, a known pressure source for NIBP, calibrated gas mixtures for CO2).
Biocompatibility testing: Laboratory assays for cytotoxicity, irritation, and hypersensitivity.
Electrical and mechanical safety testing: Verification against defined thresholds and criteria in the relevant IEC standards.

The summary states that "Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device." These standards implicitly define the required ground truth and evaluation methods.

8. Sample Size for the Training Set

This device is a hardware patient monitor that measures physiological parameters, not an AI/ML device that requires a "training set" in the conventional sense of machine learning. Therefore, the concept of a "training set" as it applies to AI/ML is not relevant to this submission and no sample size for training is provided.

9. How Ground Truth for the Training Set Was Established

As explained above, this device does not typically utilize a "training set" in the context of AI/ML. The "ground truth" for its development and validation would have been established through engineering design, component validation, and testing against physical standards and known physiological inputs, in accordance with the cited international electrical and medical device standards.

Summary

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510(k) Summary

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

Date: November 13, 2012

OCT 0 1 2013

Company and Correspondent making the submission:

Name - Shenzhen Creative Industry Co., Ltd.

Address - 2/F, Block 3, Nanyou Tian'an Industry Town, Hi-Tech Industrial

Park(north), Shenzhen City, Guangdong Province

Telephone - +86-755-26434955

Fax - +86-755-26435433

Contact - Ms. Wang Jia

Email - charliemack@irc-us.com

2. Device :

Trade/proprietary name: Patient Monitor, UP-7000

Common Name : Patient Monitor

Classification Name :

Function	Product Code
ECG/RESP(including theHeart Rate)	MWI
SPO2 (functionaloxygensaturation)	DQA
NIBP (Non-invasive bloodpressure)	DXN
CO2 (end-tidalCO2concentration)(including theRespiration Rateby the thoraximpedancemethod (used withECG lead)	CCK

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3. Predicate Devices :

ﺗﺮ

Description	Predicate Device #1	Predicate Device #2
Name and model	Vital Signs Monitor, PC-900A	PM-9000 Express PortablePatient Monitor
Manufacturer	Shenzhen Creative Industry Co., LTD.	Shenzhen Mindray Bio-medicalElectronics Co., LTD.
510(K) Number	K093016	K053234

4. Classifications Names & Citations :

Function	Product Code	Citations
ECG/RESP(including theHeart Rate)	MWI	21CFR870.2300
SPO2 (functionaloxygensaturation)	DQA	21CFR870.2300
NIBP (Non-invasive bloodpressure)	DXN	21CFR870.2300
CO2 (end-tidalCO2concentration)(including theRespiration Rateby the thoraximpedancemethod (used withECG lead)	CCK	21CFR868.1400

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5. Description :

ﺗﺮ

5.1 General

5.2 Features

This monitoring system may be used to monitor up to 10 of a patient's physical parameters: End-tidal Carbon Dioxide (EtCO2), Inspired Carbon Dioxide (InsCO2), ECG, heart rate, non-invasive blood pressure (NIBP), Respiratory Rate (RR), body temperature (TEMP), Pulse Oxygen Saturation (SpO₂), Pulse Rate and Perfusion Index (PI).

. It can measure SpO2, Pulse Rate, and Perfusion Index; the plethysmogram can be displayed on LCD.
It can measure End-tidal CO2 (EtCO2), Inspired CO2 and Respiration Rate. . The CO2 waveform can be displayed on LCD.
It can measure ECG, heart rate and Respiration Rate (RR). which enables . simultaneous monitoring of several ECG waveforms and display on LCD.
It can measure non-invasive blood pressure (NIBP) and body temperature . (TEMP); the measure value can be displayed on LCD.
Real-time monitoring of battery capacity, when the battery power is . insufficient, low battery voltage alarm indication will display on LCD screen.
The customer could use either mainstream or sidestream for the same . monitor.

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Long-distance alarm function. o
Network function makes it to upload the stored data to a central station. .
Two operating modes: normal monitoring and power saving mode. .
Flexible menu setup and audible/visual alarm function. o
It is battery powered and can also be powered by AC mains power supply. .
Built-in printer is optional. .

Indication for use :

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

1. Comparison with predicate device :
  The design of the Shenzhen Creative Industry Co., Ltd. UP-7000 monitor is very similar to the predicates and testing to the following standards: IEC 60601-1: 1990+A1+A2+A13 Medical devices Part1: General requirements for safety and Amendment 1, Amendment 2 and Amendment 13; IEC 60601-1-2: 2007 Medical electrical equipment-part 1-2; IEC 60601-1-4: 2000 Medical devices part 1-4; IEC 60601-1-6:2006 Medical electrical equipment-Part 1-6; IEC 60601-1-8: 2006 General requirements for basic safety and essential performance; IEC 60601-2-27 :2005 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment; IEC 60601-2-49: 2001 Medical Electrical Equipment Part 2-49; ISO 7000 Graphical symbols for use on equipment-Registered symbols; ISO 21647: 2004(E) Medical electrical equipment-Particular requirements for the basic safety and essential performance of respiratory gas monitors; ISO 9919: 2005 Medical electrical equipment - Particular requirements for the basic safety and essential

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K123711 pg 5 of 5

performance of pulse oximeter equipment for medical use SpO2; ISO 15223: 2000 Medical devices-Symbols to be used with medical device labels, labeling and information to be supplied; ISO/IEC GUIDE 37-1995 Instructions for use of products of consumer interest; ISO 10993-1:2009Biological evaluation of medical devices--Part 1: Evaluation and testing; ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5 Tests for In Vitro Cytotoxicity; ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10:Tests for Irritation and Delayed-Type Hypersensitivity; IEC 60068-2-6 Mechanical Vibration - Sine; IEC 60068-2-64: Mechanical Vibration - Random demonstrates that the Shenzhen Creative Industry Co., Ltd, Patient Monitor, model UP-7000 is substantially equivalent to the predicates, the Shenzhen Creative Vital Signs Monitor PC-900 and the Shenzhen Mindray PC-9000 Express.

Safety and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1. Testing to specific ISO standards was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.

9. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Shenzhen Creative Industry Co., Ltd. concludes that the Patient Monitor, Model UP-7000 is safe and effective and substantially equivalent to predicate devices as described herein.

END,

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like shapes extending upwards and to the right. Below the bird is a wavy line, possibly representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 1, 2013

Shenzhen Creative Industry Co., Ltd c/o Mr. Charles Mack Principal Engineer 12226 Washington Lane Parker, AZ 85344

Re: K123711

Trade/Device Name: Patient Monitor/Model UP-7000 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI, DQA, DXN, CCK Dated: September 16, 2013 Received: September 20, 2013

Dear Mr. Mack:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Charles Mack

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Owen-DEaris-S

for 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

510(k) Number (if known):

Device Name: Patient Monitor, Model UP-7000

Indications for Use:

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR -

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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).