(247 days)
No
The summary describes a standard multi-parameter patient monitor that collects and displays physiological data. There is no mention of AI, ML, or any advanced data processing beyond basic signal processing and display.
No
The device is described as a health monitor for spot-checking physiological parameters and does not mention any therapeutic function or intervention.
No
The device is described as an "All-in-One Health Monitor" for "spot-checking measuring of the patient's physiological parameters" and "monitors" various parameters. This language suggests a role in patient monitoring and measurement, not direct diagnosis. While it collects data that might be used for diagnostic purposes by a clinician, the device itself is not presented as making a diagnosis.
No
The device description explicitly mentions hardware components like modules for NIBP, SpO2, and Temperature, and the ability to link with external hardware like Blood Glucose Meters and ECG monitors. It processes digital signals from these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The All-in-One Health Monitor PC-303 measures physiological parameters directly from the patient's body (NIBP, SpO2, PR, TEMP). While it can communicate with a Blood Glucose Monitoring System, the blood glucose measurement itself is performed by a separate, compatible device (which is an IVD). The PC-303 is receiving and displaying data from that IVD, but it is not performing the in vitro test itself.
- Lack of Sample Analysis: The device description focuses on non-invasive measurements and receiving data from other devices. There is no mention of analyzing biological samples.
Therefore, the PC-303 is a patient monitor that collects and displays physiological data, and can integrate data from other devices, but it does not perform in vitro diagnostic tests.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, DXN, FLL, NBW, DSH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear (for temperature)
Fingertip, forearm (for blood glucose)
Indicated Patient Age Range
Adult and Pediatric (age≥3 years old)
Intended User / Care Setting
Clinical institutions
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and Performance Data:
IEC 60601-1: 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: usability, lasers and light emitting diodes (LDEs), biocompatibility of ME EQUIPMENT and ME SYSTEMS, electromagnetic compatibility.
IEC 60601-1-2: 2007: Testing was performed to ascertain Electromagnetic Compatibility to other electrical devices. Emissions tests, Immunity tests, Harmonics current, and Voltage fluctuation were performed according to relevant IEC standards.
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 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 test showed no potential toxicity to L-929 cells with polar and non-polar extracts.
ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The test for ocular irritation showed no significant evidence of causing ocular irritation. The test for skin sensitization 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 functions 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.
Clinical testing was performed for the NIBP functions and are submitted as part of this submission.
Key Results: All test results noted were satisfactory. The PC-303 passed the safety requirements of the tested standards. The performance testing demonstrated that each function operated within the design parameters and established equivalency to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 measurement accuracy: $\pm$ 3% (during 70%-100%), Undefined (during 0-70%)
Pulse rate accuracy: $\pm$ 2bpm or $\pm$ 2% (whichever is greater)
BP accuracy: Mean deviation values: $\pm$ 5 mmHg; Standard deviation
§ 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).
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
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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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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.).
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| 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 |