Who is the manufacturer of All-in-One Health Monitor, PC-303?

Shenzhen Creative Industry Co., Ltd. filed the 510(k) submission for All-in-One Health Monitor, PC-303 (K170047).

What is the FDA product code for All-in-One Health Monitor, PC-303?

MWI. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for All-in-One Health Monitor, PC-303?

510(k) clearance (submission type: Traditional).

What are the predicate devices for All-in-One Health Monitor, PC-303?

UP-7000 Patient Monitor (K123711).

Who can help prepare an FDA 510(k) submission like All-in-One Health Monitor, PC-303?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

All-in-One Health Monitor, PC-303

K170047 · Shenzhen Creative Industry Co., Ltd. · MWI · Sep 9, 2017 · Cardiovascular

Device Facts

Record ID	K170047
Device Name	All-in-One Health Monitor, PC-303
Applicant	Shenzhen Creative Industry Co., Ltd.
Product Code	MWI · Cardiovascular
Decision Date	Sep 9, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Pediatric

Intended Use

The All-in-One Health Monitor PC-303 is a device designed for spot-checking measuring of the patient's physiological parameters, such as Non-Invasive Blood Pressure (NIBP), Oxygen saturation (SpO2), Pulse Rate (PR) and Body Temperature (TEMP): Additionally, the device is available to communicate with the compatible Blood Glucose Monitoring System and ECG monitor to make the measurement. This device is applicable for Adult and Pediatic (age>3 years old) use in clinical institutions and has no conditions or factors of contraindication.

Device Story

Mobile modular patient monitor; measures SpO2/PR via photoelectric sensors, NIBP via oscillometric method, and body temperature via infrared probe. Optional external connectivity via USB to compatible blood glucose meters and ECG monitors. Used in clinical institutions by healthcare providers. Device receives digital signals from internal modules and external linked devices; processes data for display on 4.3" segmented LCD and storage of up to 999 records. Provides real-time parameter monitoring; assists clinicians in spot-checking patient vitals; aids in clinical decision-making through immediate physiological data acquisition.

Clinical Evidence

Bench testing only. Performance testing validated device operation within specified parameters, including wireless/USB data transfer and compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-30, and ISO 80601-2-61. Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed no cytotoxicity, irritation, or sensitization. NIBP accuracy verified against standard mean deviation requirements.

Technological Characteristics

Modular patient monitor; 4.3" segmented LCD; powered by AC or 3.7VDC rechargeable lithium battery. Sensing: photoelectric (SpO2), oscillometric (NIBP), infrared (TEMP). Connectivity: USB interface for external glucose/ECG modules. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 80601-2-61 (SpO2), IEC 60601-2-30 (NIBP), ISO 10993 (biocompatibility).

Indications for Use

Indicated for spot-checking physiological parameters (NIBP, SpO2, PR, TEMP) in adult and pediatric patients (age ≥3 years) in clinical institutions. Optional connectivity for blood glucose and ECG monitoring.

Regulatory Classification

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.

Predicate Devices

UP-7000 Patient Monitor (K123711)

Reference Devices

Creative SpO2 sensor (K063641)
Valeo VT-601E IR Ear thermometer (K111463)
G-777G BLOOD GLUCOSE MONITORING SYSTEM (K113077)
PC-80 Easy ECG Monitor (K073152)

Related Devices

K051375 — VITAL SIGNS MONITOR · Mediana Co., Ltd. · Jul 28, 2005
K014255 — DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 · Ge Medical Systems Information Technologies · Jul 2, 2002
K192092 — Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 · Seca GmbH & Co. KG · Jan 23, 2020
K022193 — DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N · Ge Medical Systems Information Technologies · Aug 1, 2002
K131818 — VITAL SIGNS MONITOR · Edan Instruments, Inc. · Aug 30, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 9, 2017 Shenzhen Creative Industry Co., Ltd. % Mr. Charles Mack Principal Engineer IRC, LLC 7808 Rush Creek Drive Pasco. Washington 99301 Re: K170047 Trade/Device Name: All-in-One Health Monitor, PC-303 Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (Without Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MWI, DQA, DXN, FLL, NBW, DSH Dated: July 22, 2017 Received: August 1, 2017 Dear Mr. Charles 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, M.A. Wilhelm for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170047 Device Name All-in-One Health Monitor, PC-303 #### Indications for Use (Describe) The All-in-One Health Monitor PC-303 is a device designed for spot-checking measuring of the patient's physiological parameters, such as Non-Invasive Blood Pressure (NIBP), Oxygen saturation (SpO2), Pulse Rate (PR) and Body Temperature (TEMP): Additionally, the device is available to communicate with the compatible Blood Glucose Monitoring System and ECG monitor to make the measurement. This device is applicable for Adult and Pediatic (age>3 years old) use in clinical institutions and has no conditions or factors of contraindication. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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: April14, 2017 #### 1. Company and Correspondent making the submission: Name - Shenzhen Creative Industry Co., Ltd. Address - 2/F, Block 3, Nanyou Tian'an Industry Town Shenzhen, China 518054 Tel: +86-755-26431671 Fax: +86-755-26435433 Contact - Mrs. Jia Wang General Manager US Agent and Correspondent Mr. Charles Mack PRINCIPAL ENGINEER IRC USA 7808 Rush Creek Drive, Pasco, Wa. 99301 USA Tel: 931-6254938 Email: charliemack@irc-us.com #### 2. Device : | Trade/proprietary name: | All-in-One Health Monitor, PC-303 | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Patient Monitor | | Classification Name: | Monitor, Physiological, Patient (without arrhythmia detection or alarms) | | Classification ProCode: | MWI | | Device Class: | II | | Regulation Number: | 870.2300 | | Other ProCodes: | DQA, Oximeter DXN, System Mearurement, Blood Pressure, non-invasive FLL, Thermometer, electronic, clinical NBW, System, test, blood glucose OTC DSH, Recorder, magnetic tape for ECG | {4}------------------------------------------------ ### 3. Predicate Devices : | Manufacturer | PredicateDevice | 510(k) Number | SubmittedDevice | |----------------------------------------------|----------------------------|------------------|--------------------------------------| | Shenzhen Creative Industry Co., Ltd | UP-7000 Patient Monitor | K123711 | All-in-One Health Monitor, PC-303 | ### 4. Classifications Names & Citations : Primary: MWI, monitor,physiological,patient(without arrhythmia detection or alarms) Secondary: DQA, SpO2 Pulse Rate; DXN, NIBP; FLL, Temperature; NBW, Blood Glucose; DSH, ECG #### 5. Device Description: #### Device Description: The All-in-One Health Monitor, PC-303 is mobile modular designed patient monitor. It monitors the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic, diastolic and mean) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. Additionally, the device is also capable to link and communicate with the compatible Blood Glucose Meter and ECG monitor to make the measurement. This device system measure the patient's physical parameters with variety modules. It takes digital signals from NIBP, SpO2, Temperature module through COM ports, and receives ECG data, blood glucose data from compatible legally marketed ECG Monitor or BLOOD GLUCOSE MONITORING Device. The software to process the data, then display parameters on the screen and storage some useful information. This device is applicable for use in clinical institutions and has no conditions or factors of contraindication. #### Device Features: This monitoring system may be used to monitor up to 10 of a patient's physical parameters such as Pulse Oxygen Saturation (SpO2), Pulse Rate; Non-invasive blood pressure (NIBP); Body temperature (TEMP); ECG, heart rate and BLOOD GLUCOSE: - Large numeric display, segmented LCD panel, real-time clock display. Blood pressure measurements can be activated or canceled by one shortcut button. - Oximetry technique displays SpO2 & pulse rate measurements by smart sensors. {5}------------------------------------------------ - Smart infrared temperature probe presents measurements of body temperature. - o Blood pressure, oxygen saturation, pulse rate and temperature can be measured simultaneously. - Blood Glucose meter option can be connected to the device. - The Easy ECG Monitor option can be connected to the device. - Data storage with recall, up to 999 groups of records can be stored and recognized by patient ID. - . Power management with power saving mode, auto power off and low battery indicator: | | Function | Product Code | Module 510K Status | |--------------------------------------|--------------------|-----------------|-----------------------------------------------------| | Built-in Function: | | | | | Built-in | SpO2 Pulse Rate | DQA | Creative SpO2 sensor only (K063641) | | Built-in | NIBP | DXN | Creative B01-WK126 NIBP Module | | Built-in | TEMP | FLL | Valeo VT-601E IR Ear thermometer (K111463) | | External Linked Function (Optional): | | | | | External Linked Function | Blood Glucose | NBW | G-777G BLOOD GLUCOSE MONITORING SYSTEM (K113077) | | External Linked Function | ECG | DSH | PC-80 Easy ECG Monitor (K073152) | Below is a brief tabular display of the monitor functions and operations. ### 6. Indication for use: The All-in-One Health Monitor, PC-303 is a device designed for spot-checking measuring of the patient's physiological parameters, such as Non-Invasive Blood Pressure (NIBP), Oxygen saturation (SpO2), Pulse Rate (PR) and Body Temperature (TEMP); Additionally, the device is available to communicate with the compatible Blood Glucose Monitoring System and ECG monitor to make the measurement. This device is applicable for Adult and Pediatric (age≥3 years old) use in clinical institutions and has no conditions or factors of contraindication. ### 7. Comparison with predicate device: Shenzhen Creative Industry Co., Ltd. believes that the All-in-One Health Monitor, PC-303 is substantially equivalent to the (K123711) Patient Monitor (Shenzhen Creative Industry Co., Ltd.). {6}------------------------------------------------ | Table of Comparison to Predicate Device | | | |---------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General Specifications Characteristics | | | | Name and model | Subject Device All-in-One Health Monitor, PC-303 | Predicate Device UP-7000 Patient Monitor | | 510K Applicant | Shenzhen Creative Industry Co., LTD. | Shenzhen Creative Industry Co., LTD. | | 510(K) Number | N/A | K123711 | | Physical dimension(mm) /weight(kg) | 165(L) X 96(W) X 68(H)/ 0.44kg | 300 (L) x150 (W) x290 (H)/ 5.2kg | | Display | 4.3" Segment LCD | 12.1" Color TFT | | Type, Degree of protection against electric shock | Class II with internal electric power supply. SpO2/NIBP/TEMP: Type BF applied part. | Class I with internal electric power supply. Where the integrity of the external protective earth(ground) in the installation or its conductors is in doubt, the equipment shall be operated from its internal electric power supply(batteries) CO2: BF (defibrillation proof) SpO2/NIBP /TEMP/ECG/RESP: CF (defibrillation proof) | | Power supply | Battery or AC | Battery or AC | | Power requirement | (100-240) VAC, 50/60Hz, 15VA; Rechargeable lithium battery, 3.7VDC | (100-240) VAC 50/60Hz 100VA; Rechargeable sealed lead-acid battery, 12V 2.3AH | | Battery charging indicator | Available | Available | | Low battery indicator | Available | Available | | Battery charge time, typ. | Maximum 8 hours for charging | Maximum 13-15 hours for charging | | Flammable anesthetics | N/A | N/A | | Operating condition | Temperature: 5°C ~ 40°C Humidity: 30% ~ 80%, noncondensing Atmospheric pressure: 70.0kPa~106.0kPa | Temperature: 5°C ~ 40°C Humidity: 30% ~ 80%, noncondensing Atmospheric pressure: 70.0kPa~106.0kPa | | Storage condition | Temperature: -20°C~60°C Humidity: 10%~95%, noncondensing Atmosphere: 53kPa~106kPa | Temperature: -20°C~60°C Humidity: 10%~95%, noncondensing Atmosphere: 53kPa~106kPa | | EMC | The equipment meets the requirements of IEC 60601-1-2 | The equipment meets the requirements of IEC 60601-1-2 | | Optional printer | N/A | Available | | Characteristics | Subject Device | Predicate Device | | Name and model | All-in-One Health Monitor, PC-303 | UP-7000 Patient Monitor | | Manufacturer | Shenzhen Creative Industry Co., LTD. | Shenzhen Creative Industry Co., Ltd. | | 510(K) Number: | N/A | K123711 | | SpO2 module | Identical | Creative SpO2 module with the same principle as PC- 60(K063641) Creative SpO2 sensor only | | Patient type | Identical | Adult, pediatric patients | | SpO2 measurement accuracy | Adult and Pediatric: $\pm$ 3% (during 70%-100%) Undefined (during 0-70%) | Adult and Pediatric: $\pm$ 3% (during 70%-100%) Undefined (during 0-70%) | | Alarm range (%) | No Alarm | High Limit: 1%-100% Lower Limit. 0%-99% | | Pulse rate measurement range | 30 bpm-240 bpm | 30 bpm-240 bpm | | Pulse rate accuracy | $\pm$ 2bpm or $\pm$ 2% (whichever is greater) | $\pm$ 2bpm or $\pm$ 2% (whichever is greater) | | Alarm range-Pulse rate (bpm) | No Alarm | High Limit: 1bpm-300bpm Lower Limit. 0bpm-299bpm | {7}------------------------------------------------ # Build-in Function: #### SpO₂ / Pulse Rate #### NIBP | Characteristics | Subject Device | Predicate Device | |-------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------| | Name and model | All-in-One Health Monitor, PC-303 | UP-7000 Patient Monitor | | Manufacturer | Shenzhen Creative Industry Co., LTD. | Shenzhen Creative Industry Co., Ltd. | | 510(K) Number: | N/A | K123711 | | NIBP module | Creative B01-WK126 NIBP Module | SunTech Advantage 2.0 NIBP Module | | Method | Oscillometric method | Oscillometric method | | Patient type | Adult and Pediatric patients | Adult and Pediatric patients | | Unit of measure | mmHg & kPa | mmHg & kPa | | Pressure measurement range - Systolic | 60 mmHg - 255mmHg | Adult: 40 mmHg - 260mmHg Pediatric: 40 mmHg - 160mmHg | | Pressure measurement range - Diastolic | 30 mmHg - 195mmHg | Adult: 20 mmHg - 200mmHg Pediatric: 20 mmHg - 120mmHg | | BP accuracy | Mean deviation values: ±5 mmHg; | Mean deviation values: ±5 mmHg; | | | Standard deviation <= 8 mmHg. | Standard deviation <= 8 mmHg. | | Cuff pressure range | 0 to 300mmHg | 0 to 300mmHg | | Over pressure protector | Cuff pressure exceeds 300mmHg (Adult & Pediatric modes) at any time. | Internal operating software ensures that: -- | | | | Maximum cuff inflation time is limited to 75 Seconds | {8}------------------------------------------------ | | | | | Duration of blood pressure reading is limited to • 130 seconds (Adult mode), 90 seconds (Pediatric mode) Additional redundant safety circuitry oversees normal operation and will override to abort a reading if: • Cuff pressure exceeds 300 mmHg (Adult & Pediatric modes) at any time. • The cuff has been inflated for 180 seconds (Adult & Pediatric modes). | | |----------------|-----------|----------------|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Alarm setup | Systolic | High Limit | No Alarm | Adult: 31 mmHg -280 mmHg Pediatric: 30 mmHg -200 mmHg | | | | | Lower Limit | No Alarm | Adult: 29 mmHg -279 mmHg Pediatric: 29 mmHg -199 mmHg | | | | Diastolic | High Limit | No Alarm | Adult: 11 mmHg -232 mmHg Pediatric: 11 mmHg -150 mmHg | | | | | Lower Limit | No Alarm | Adult: 10 mmHg -231 mmHg Pediatric: 10 mmHg -149 mmHg | | | Alarm method | | | No Alarm | Sound light alarm and record the alarm status for review | | {9}------------------------------------------------ #### TEMP | Characteristics | Subject Device | Predicate Device | |-----------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | Name and model | All-in-One Health Monitor, PC-303 | UP-7000 Patient Monitor | | Manufacturer | Shenzhen Creative Industry Co., Ltd. | Shenzhen Creative Industry Co., Ltd. | | 510(K) Number: | N/A | K123711 | | TEMP Module | Valeo VT-601E IR Ear thermometer cleared under K111463 | TEMP module cleared under K982140 | | Fundamental scientific technology | Infrared technology | Thermo-resistor type | | Patient type | Adult, Pediatric | Adult, Pediatric | | Unit of measure | °C or °F | °C or °F | | Measurement site | Ear | Body surface | | Temperature measurement range | 32.0°C to 43.0°C (90°F to 109.5°F) | 32.0°C to 43.9°C (90°F to 109.9°F) | | Temperature measurement accuracy | ±0.2°C (36.0°C to 39.0°C), ±0.3°C (the rest); ±0.4°F (96.8°F to 102.2°F), ±0.5°F (the rest) | ±0.1°C (35.0°C to 39.0°C) ±0.2°F (95.0°F to 102.2°F) | {10}------------------------------------------------ External Linked Functions (Optional): The subject device is also capable to link and communicate with the legally marketed compatible Blood Glucose Meter and EGG monitor to take measurements. Blood Glucose (K113077) | Name and model: | G-777G BLOOD GLUCOSE MONITORING SYSTEM | | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Manufacturer | BIOLAND TECHNOLOGY LTD. | | | 510(K) Number: | K113077 | | | Physical dimension/ weight | 81(L) X 62(W) X 19(H)/ 60g | | | Test sites: | Fingertip, forearm | | | Power requirement | CR2032 3V lithium coin battery x1 | | | Patient type | Adult, pediatric patients | | | Glucose Operating Range | (1.1-33.3) mmol/L or (20-600) mg/dL | | | Glucose Sample Types | Whole Blood | | | Glucose Sample volume | 0.7µl | | | Glucose Hematocrit Compensation | N/A | | | Glucose Assay Time | <10s | | | Calibration | N/A | | | Data Upload | USB | | | Compatible Test Strips | N/A | | | Operating condition | Temperature: 10℃ - 40℃ Humidity: 20%-80%RH | | | Connection Method with the subject device | Connection Method: Using the optional link cable for the Blood Glucose Meter, connect the Blood Glucose Meter to the connector on the right side of the All-in-One Health Monitor marked "GLU" ("if"). When the device shows ', this indicates that the blood glucose meter is linked successfully. 5- Principle: The PC-303 All-in-One Health Monitor receives data from Blood Glucose Meter via the USB data interfaces for data communication, and the PC-303 looks over measurement result stored in Glucose Meter in real time. | | | | | | {11}------------------------------------------------ ECG (K073152) | Name and model: | PC-80 Easy ECG Monitor | |------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Shenzhen Creative Industry Co., Ltd. | | 510(K) Number: | K073152 | | Physical dimension/ weight | 115(L) X 58(W) X 18(H)/100g | | Type, Degree of protection against electric shock | Internal power source, Type B | | Power requirement | Two 1.5Vdc Alkaline battery (AAA) | | Patient type | Adult, pediatric patients | | Number of electrodes employed | 3 embedded metal electrodes or using 3 adhesive ECG electrodes by connection to the lead wire | | Heart rate measuring range | 30bpm-240bpm | | Resolution | 1bpm | | Heart rate measuring precision | ±2bpm or ±2%, whichever is greater | | Sweep speed | 20mm/s±10% | | Signal bandwidth | 0.5Hz-40Hz | | Internal noise level | ≤30uVp-p | | CMRR | ≥60dB | | Display sensitivity | 4.8mm/mV±10% | | Operating condition | Temperature: 5°C-40°C Humidity: ≤80%, noncondensing Atmospheric pressure: 86.0kPa-106.0kPa | | Storage condition | Temperature: -20°C-55°C Humidity: ≤95%, noncondensing Atmosphere: 50kPa-106kPa | | EMC | The equipment meets the requirements of IEC 60601-1-2 | | Connection method with the subject device | Connection Method: 1. Connect the ECG accessory to the connector on the upper side of device marked "ECG". 2. Choose one of the methods to take the ECG measurement. 3. When the ECG accessory is connected to All-in-One Health Monitor successfully, press the "Start" button on the ECG accessory to activate the ECG measurement. 4. When "ECG" appears on the display screen of the All-in-One Health Monitor, it means the ECG accessory has begun to take the ECG measurement. 5. 30 Seconds later, the result will display on the screen of the terminal device, and the measurement will terminate. Principle: The PC-303 All-in-One Health Monitor receives data from Easy ECG Monitor via the USB data interfaces for data communication, and the PC-303 looks over measurement result stored in Easy ECG Monitor in real time. | {12}------------------------------------------------ # 8. Safety and Performance Data: | Serial Number/Version | Standard and Description | Scope | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | IEC 60601-1: 1990+A1+A2+A13 | Medical devices Part1: General requirements for safety and Amendment 1, Amendment 2 and Amendment 13 | General requirements: Electrical Safety | | IEC 60601-1-2: 2007 | Medical electrical equipment- part 1-2: General requirements for basic safety and essential performance – Collateral standards: Electromagnetic compatibility –Requirements and tests | General requirements: EMC | | IEC 60601-2-30: 2000 | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers | General requirements: Software | | IEC80601-2- 30_NIBP | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers | General requirements: Usability | | ISO80601-2- 61_SpO2 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | General requirements: Alarm system | | IEC/TR60878: 2003 | Graphical symbols for electrical equipment in medical practice | General requirements: Graphical symbols | | ISO 10993-1:2009 | Biological evaluation of medical devices--Part 1: Evaluation and testing | Biological evaluation | | ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5 Tests for In Vitro Cytotoxicity. | General requirements: Biological Estimation | | ISO 10993- 10:2010 | Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Delayed-Type Hypersensitivity | General requirements: Biological Estimation | | ISO 13485: 2003 | Medical devices-Quality management systems- Requirements for regulatory purposes | Quality system | All of the test results noted in the table above were satisfactory. {13}------------------------------------------------ | Serial Number | Standard and Description | Scope | |--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | ECG K073152 | | | | IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | General requirements: Electrical Safety | | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | General requirements: EMC | | AAMI EC 38 | Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems | Basic safety and essential performance of ambulatory electrocardiographic (ECG) systems | | Temp-K111463 | | | | ASTM E1965:1998(2009) | Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature | General Thermometer Performance | | IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | General requirements: Electrical Safety | | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | General requirements: EMC | {14}------------------------------------------------ | Serial Number | Standard and Description | Scope | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | SPO2 K063641 | | | | IEC60601-1:1988 A1:1991,+ A2:1995 | General requirements for Safety and Essential Performance | General requirements: Electrical Safety | | IEC 60601-1-4 | Medical Devices Part 1-4: General Requirements for Safety - Programmable Medical Electrical Equipment | General requirements Software | | IEC 60601-1- 1:2000 | Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems | General requirements: Electrical Safety | | IEC60601-1- 2:2007 | Medical Electrical Equipment-Part 1-2:General Requirements for Safety - 2.Collateral Standard-Electromagnetic compatibility - Requirements and tests | General requirements: EMC | {15}------------------------------------------------ | Serial Number | Standard and Description | Scope | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | IEC 61010-1: 2010 | General requirements for Safety and Essential Performance | General requirements: Electrical Safety | | IEC 61010-2-101 | Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment | IVD General Safety Requirements | | IEC 61326-1: 2012 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements | General requirements: EMC | | IEC 61326-2-6 | Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment | General requirements: EMC | | ISO 15197 | In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus | IVD Glucose performance and Safety | | CLSI GP42-A6: 2008 | Procedures and devices for the collection of diagnostic capillary blood specimens | General technique for capillary blood specimens | | IEEE ISO 11073- 10417 | Health informatics -- Personal health device communication Part 10417: Device Specialization -- Glucose Meter | Communication between personal telehealth glucose meter devices and compute engines | | ISO 10993-1: 2009 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process | Biological Evaluation | {16}------------------------------------------------ ### 9. Testing Summary: IEC 60601-1: 1990+A1+A2+A13: Testing was performed to validate the safety of this medica…