(247 days)
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.
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.
The provided document describes the All-in-One Health Monitor, PC-303, and its substantial equivalence to a predicate device (UP-7000 Patient Monitor, K123711). The acceptance criteria are primarily based on meeting relevant international standards for medical electrical equipment and specific performance characteristics in comparison to the predicate device.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are not explicitly stated as distinct numerical targets in a single table within the document but are inferred from the comparison with the predicate device and the adherence to recognized international standards. The "reported device performance" is the claim of compliance with these standards and the equivalent performance to the predicate.
| Parameter/Characteristic | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (PC-303) |
|---|---|---|
| General | ||
| Safety | Compliance with IEC 60601-1 | "All the requirements of IEC 60601-1 were evaluated in this test report" (with specific exclusions) |
| EMC | Compliance with IEC 60601-1-2 | "Testing was performed to ascertain Electromagnetic Compatibility to other electrical devices... Emissions tests... Immunity tests... Harmonics current... Voltage fluctuation" - all passed. |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 | "Test article Contact Lens Case extract did not show potential toxicity to L-929 cells." "Test article extracts showed no significant evidence of causing ocular irritation." "Test article extract showed no significant evidence of causing skin sensitization." |
| Performance | Equivalent to predicate device | "Each function operated within the design parameters, within the performance criteria established by the pertinent IEC standards." "established the equivalency to the predicate device." |
| SpO2 Measurement | ||
| Patient Type | Adult and Pediatric | Adult and Pediatric patients |
| Measurement Accuracy | $\pm$3% (70%-100%), Undefined (0-70%) | $\pm$3% (during 70%-100%), Undefined (during 0-70%) |
| Pulse Rate 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) |
| Alarms | Functional alarms (Predicate has High/Low Limit) | No Alarm (for SpO2 and Pulse Rate) |
| NIBP Measurement | ||
| Method | Oscillometric method | Oscillometric method |
| Patient Type | Adult and Pediatric Patients | Adult and Pediatric patients |
| Mean Deviation | $\pm$5 mmHg | $\pm$5 mmHg |
| Standard Deviation | $\le$8 mmHg | $\le$8 mmHg |
| Cuff Pressure Range | 0 to 300mmHg | 0 to 300mmHg |
| Over Pressure Protection | Internal operating software with limits, circuitry | Cuff pressure exceeds 300mmHg (Adult & Pediatric modes) at any time. (Similar to predicate's circuitry) |
| Alarms | Functional alarms (Predicate has High/Low Limit) | No Alarm (for NIBP Systolic/Diastolic) |
| Temperature Measurement | ||
| Patient Type | Adult, Pediatric | Adult, Pediatric |
| Unit of Measure | °C or °F | °C or °F |
| Measurement Site | Ear (for PC-303) | Ear |
| Measurement Range | 32.0°C to 43.0°C (90°F to 109.5°F) | 32.0°C to 43.0°C (90°F to 109.5°F) |
| Measurement Accuracy | $\pm$0.2°C (36.0-39.0°C), $\pm$0.3°C (rest) | $\pm$0.2°C (36.0°C to 39.0°C), $\pm$0.3°C (the rest); $\pm$0.4°F (96.8°F to 102.2°F), $\pm$0.5°F (the rest) |
| Blood Glucose (External Linked) | ||
| Integration | Communication with compatible system | "receives data from Blood Glucose Meter via the USB data interfaces for data communication" |
| Performance | As per G-777G BLOOD GLUCOSE MONITORING SYSTEM (K113077) | The linked device is a legally marketed system (K113077) |
| ECG (External Linked) | ||
| Integration | Communication with compatible system | "receives data from Easy ECG Monitor via the USB data interfaces for data communication" |
| Performance | As per PC-80 Easy ECG Monitor (K073152) | The linked device is a legally marketed system (K073152) |
2. Sample size used for the test set and the data provenance
The document states that "Clinical testing was performed for the NIBP functions and are submitted as part of this submission." However, it does not specify the sample size used for this clinical testing or the data provenance (e.g., country of origin, retrospective/prospective).
For biocompatibility testing, the "In Vitro Cytotoxicity Test" used L929 mouse fibroblast cells, and the "Tests for irritation and skin sensitization" used guinea pigs. These are standard biological test methods, not human clinical sample sizes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for any of the performance or clinical studies.
4. Adjudication method for the test set
The document does not describe any adjudication method used for the test set.
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
This device is a patient monitor with built-in and external measurement capabilities for physiological parameters (SpO2, NIBP, TEMP, Blood Glucose, ECG). It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance would not be applicable and was not reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a medical instrument that provides physiological measurements. Its performance is inherent in its measurement capabilities and adherence to performance standards. The "standalone" performance is essentially its ability to accurately measure the parameters as specified, which is verified through testing against standards and comparison to a predicate device. The document mentions "Performance testing was performed to ensure that all of the device operated within specified parameters independently and with all other functions of the device operating." This indicates standalone performance testing of its direct measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the measurements would typically be established by highly accurate reference instruments or established clinical methods, as dictated by the specific IEC/ISO/ASTM standards (e.g., for NIBP, a reference sphygmomanometer; for SpO2, a co-oximeter with induced hypoxia studies; for temperature, a reference thermometer). The document implies adherence to these standards for validation rather than explicitly stating ground truth derivation methods for each measurement. For NIBP, the reference to "clinical testing" would imply comparison to a clinically accepted gold standard.
8. The sample size for the training set
This device is a physiological monitor, not an AI/machine learning device that typically requires a "training set" in the context of algorithm development. Therefore, the concept of a training set sample size does not apply here.
9. How the ground truth for the training set was established
As the device does not employ a machine learning algorithm requiring a "training set," this question is not applicable.
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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
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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)
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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: 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 arrhythmiadetection or alarms) |
| Classification ProCode: | MWI |
| Device Class: | II |
| Regulation Number: | 870.2300 |
| Other ProCodes: | DQA, OximeterDXN, System Mearurement, Blood Pressure, non-invasiveFLL, Thermometer, electronic, clinicalNBW, System, test, blood glucose OTCDSH, Recorder, magnetic tape for ECG |
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3. Predicate Devices :
| Manufacturer | PredicateDevice | 510(k)Number | SubmittedDevice |
|---|---|---|---|
| ShenzhenCreativeIndustry Co.,Ltd | UP-7000 PatientMonitor | K123711 | All-in-One HealthMonitor, 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.
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- 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 | ProductCode | Module 510K Status | |
|---|---|---|---|
| Built-in Function: | |||
| Built-in | SpO2Pulse 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 | BloodGlucose | 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.).
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| Table of Comparison to Predicate Device | ||
|---|---|---|
| General SpecificationsCharacteristics | ||
| Name and model | Subject DeviceAll-in-One Health Monitor, PC-303 | Predicate DeviceUP-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 ofprotection againstelectric 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 protectiveearth(ground) in the installation or its conductors is indoubt, the equipment shall be operated from its internalelectric 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 chargingindicator | 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°CHumidity: 30% ~ 80%, noncondensingAtmospheric pressure: 70.0kPa~106.0kPa | Temperature: 5°C ~ 40°CHumidity: 30% ~ 80%, noncondensingAtmospheric pressure: 70.0kPa~106.0kPa |
| Storage condition | Temperature: -20°C~60°CHumidity: 10% | Temperature: -20°C~60°CHumidity: 10% |
| 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 measurementaccuracy | 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 measurementrange | 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-300bpmLower Limit. 0bpm-299bpm |
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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 measurementrange - Systolic | 60 mmHg - 255mmHg | Adult: 40 mmHg - 260mmHgPediatric: 40 mmHg - 160mmHg |
| Pressure measurementrange - Diastolic | 30 mmHg - 195mmHg | Adult: 20 mmHg - 200mmHgPediatric: 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 & Pediatricmodes) at any time. | Internal operating software ensures that: -- |
| Maximum cuff inflation time is limited to 75Seconds |
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| Duration of blood pressure reading is limited to• 130 seconds (Adult mode), 90 seconds (Pediatricmode)Additional redundant safety circuitry oversees normaloperation 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). | |||||
|---|---|---|---|---|---|
| Alarmsetup | Systolic | HighLimit | No Alarm | Adult: 31 mmHg -280 mmHgPediatric: 30 mmHg -200 mmHg | |
| LowerLimit | No Alarm | Adult: 29 mmHg -279 mmHgPediatric: 29 mmHg -199 mmHg | |||
| Diastolic | HighLimit | No Alarm | Adult: 11 mmHg -232 mmHgPediatric: 11 mmHg -150 mmHg | ||
| LowerLimit | No Alarm | Adult: 10 mmHg -231 mmHgPediatric: 10 mmHg -149 mmHg | |||
| Alarm method | No Alarm | Sound light alarm and record the alarm status for review |
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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) |
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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 subjectdevice | Connection Method:Using the optional link cable for the Blood Glucose Meter, connect the Blood Glucose Meter to theconnector 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 datainterfaces for data communication, and the PC-303 looks over measurement result stored in GlucoseMeter in real time. | |
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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 againstelectric 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°CHumidity: ≤80%, noncondensingAtmospheric pressure: 86.0kPa-106.0kPa |
| Storage condition | Temperature: -20°C-55°CHumidity: ≤95%, noncondensingAtmosphere: 50kPa-106kPa |
| EMC | The equipment meets the requirements of IEC 60601-1-2 |
| Connection method with the subjectdevice | 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 ECGaccessory 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 willterminate.Principle: The PC-303 All-in-One Health Monitor receives data from Easy ECG Monitor via the USB datainterfaces for data communication, and the PC-303 looks over measurement result stored in Easy ECGMonitor in real time. |
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8. Safety and Performance Data:
| SerialNumber/Version | Standard and Description | Scope |
|---|---|---|
| IEC 60601-1:1990+A1+A2+A13 | Medical devices Part1: General requirements for safetyand Amendment 1, Amendment 2 and Amendment 13 | Generalrequirements:Electrical Safety |
| IEC 60601-1-2:2007 | Medical electrical equipment-part 1-2: General requirements for basic safety andessential performance – Collateral standards:Electromagnetic compatibility –Requirements and tests | Generalrequirements:EMC |
| IEC 60601-2-30:2000 | Medical electrical equipment - Part 2-30: Particularrequirements for the basic safety and essentialperformance of automated non-invasivesphygmomanometers | Generalrequirements:Software |
| IEC80601-2-30_NIBP | Medical electrical equipment - Part 2-30: Particularrequirements for the basic safety and essentialperformance of automated non-invasivesphygmomanometers | Generalrequirements:Usability |
| ISO80601-2-61_SpO2 | Medical electrical equipment - Part 2-61: Particularrequirements for basic safety and essentialperformance of pulse oximeter equipment | Generalrequirements:Alarm system |
| IEC/TR60878:2003 | Graphical symbols for electrical equipment in medicalpractice | Generalrequirements:Graphical symbols |
| ISO 10993-1:2009 | Biological evaluation of medical devices--Part 1:Evaluation and testing | Biologicalevaluation |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5 Testsfor In Vitro Cytotoxicity. | Generalrequirements:BiologicalEstimation |
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices – Part 10:Tests for Irritation and Delayed-Type Hypersensitivity | Generalrequirements:BiologicalEstimation |
| 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.
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| 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 | ||
| ASTME1965:1998(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 |
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| Serial Number | Standard and Description | Scope |
|---|---|---|
| SPO2 K063641 | ||
| IEC60601-1:1988A1:1991,+A2:1995 | General requirements for Safety and Essential Performance | Generalrequirements:Electrical Safety |
| IEC 60601-1-4 | Medical Devices Part 1-4: General Requirements for Safety -Programmable Medical Electrical Equipment | GeneralrequirementsSoftware |
| IEC 60601-1-1:2000 | Medical electrical equipment -- Part 1-1: General requirements forsafety - Collateral standard: Safety requirements for medical electricalsystems | Generalrequirements:Electrical Safety |
| IEC60601-1-2:2007 | Medical Electrical Equipment-Part 1-2:General Requirements for Safety- 2.Collateral Standard-Electromagnetic compatibility - Requirementsand tests | Generalrequirements:EMC |
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| Serial Number | Standard and Description | Scope |
|---|---|---|
| IEC 61010-1: 2010 | General requirements for Safety and Essential Performance | Generalrequirements:Electrical Safety |
| IEC 61010-2-101 | Safety Requirements for Electrical Equipment for Measurement, Controland Laboratory Use - Part 2-101: Particular Requirements for In VitroDiagnostic (IVD) Medical Equipment | IVD General SafetyRequirements |
| IEC 61326-1:2012 | Electrical equipment for measurement, control and laboratory use - EMCrequirements - Part 1: General requirements | Generalrequirements:EMC |
| IEC 61326-2-6 | Electrical equipment for measurement, control and laboratory use. EMCrequirements. Particular requirements. In vitro diagnostic (IVD) medicalequipment | Generalrequirements:EMC |
| ISO 15197 | In vitro diagnostic test systems -- Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus | IVD Glucoseperformance andSafety |
| CLSI GP42-A6:2008 | Procedures and devices for the collection of diagnostic capillary bloodspecimens | General techniquefor capillary bloodspecimens |
| IEEE ISO 11073-10417 | Health informatics -- Personal health device communication Part 10417:Device Specialization -- Glucose Meter | Communicationbetween personaltelehealth glucosemeter devices andcompute engines |
| ISO 10993-1:2009 | Biological evaluation of medical devices -- Part 1: Evaluation and testingwithin a risk management process | BiologicalEvaluation |
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9. Testing Summary:
IEC 60601-1: 1990+A1+A2+A13: Testing was performed to validate the safety of this medical device. All the requirements of IEC 60601-1 were evaluated in this test report except the following clauses: 1) 12.2 & 15.1 Usability according to IEC/EN 60601-1-6 is not evaluated in this report. 2) 10.4 Lasers and light emitting diodes (LDEs) according to IEC/EN 60825-1 is not evaluated in this report. 3) 11.7 Biocompatibility of ME
EQUIPMENT and ME SYSTEMS according to ISO 10993 is not evaluated in this report. 4) 17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS according to IEC 60601-1-2 is not evaluated in this report.
IEC 60601-1-2: 2007: Testing was performed to ascertain Electromagnetic Compatibility to other electrical devices. The testing performed was as follows:
Emissions tests: According to IEC 60601-1-2: 2014, ISO 80601-2-61:2011 Clause 202, ISO 80601-2-56:2009 Clause 202, IEC 80601-2-30: 2009+A1:2013 Clause 202, searching for the highest disturbance.
lmmunity tests: According to IEC 60601-1-2: 2014. ISO 80601-2-61:2011 Clause 202, ISO 80601-2-56:2009 Clause 202, IEC 80601-2-30: 2009+A1:2013 Clause 202, searching for the highest disturbance.
Harmonics current: According to IEC 61000-3-2, searching for the highest disturbance.
Voltage fluctuation: According to IEC 61000-3-3, searching for the highest disturbance.
IEC 60601-2-30: 2000: Testing was performed to determine the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment. The equipment may be attended or unattended. The object of the testing was to establish particular adherence to requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment, with special attention being paid to the avoidance of hazards due to the inflation process. The PC-303 passed the safety requirements of this standard.
ISO80601-2-61 SpO2: The testing in performed to this standard was to establish particular basic safety and essential performance requirements for pulse oximeter equipment and its accessories. The PC-303 passed the safety requirements of this standard.
ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. The purpose of the test is to assess the potential cytotoxicity of test article Contact Lens Case in the In Vitro Cytotoxicity Test using L929 mouse fibroblast cells (From ATCC), which was sensitive to extractable cytotoxic articles. Under the conditions of this study, the test articles Contact Lens Case extract did not show potential toxicity to L-929 cells with polar and non-polar extracts.
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ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The test was designed to evaluate the potential of a test article extract to cause ocular irritation. According to what observed, the response of ocular on testing side does not exceed that on the control side. Thus, it is identified as grade 0. All animals were not found abnormal clinical symptoms. except ocular reactions. All animals were normal weight change. Under the conditions of this study, the test article extracts showed no significant evidence of causing ocular irritation.
ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The purpose of this test is to evaluate the potential of a test article extract to cause skin sensitization in the quinea pig. All animals were not found abnormal clinical symptoms except skin reactions. All animals were normal weight change. The positive rate of all test group animals was 0%. The positive rate of all negative control animals was 0%. Under the conditions of this study, the test article extract showed no significant evidence of causing skin sensitization in the guinea pig.
Performance Testing: Performance testing was performed to ensure that all of the device operated within specified parameters independently and with all other funcitons of the device operating. The testing also included wireless testing and the transfer of data via a USB. Each function operated within the design parameters, within the performance criteria established by the pertinent IEC standards. This established the equivalency to the predicate device.
10. Clinical:
Clinical testing was performed for the NIBP functions and are submitted as part of this submission.
The design of the submitted device specifications is substantially the same as the predicate, but adds a cleared NIBP module, made by SunTech.
All the labeling and characteristics of the submitted All-in-One Health Monitor, PC-303 are the same as the predicate device and most typical Patient Monitors currently on the market. The submitted device and predicate both are used for measuring patient SpO2, Pulse Rate, NIBP, TEMP and the optional linked functions of Blood Glucose and ECG.
11. 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 All-in-One Health Monitor, PC-303 is substantially equivalent to predicate devices as described herein.
END
§ 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).