Patient Monitor
Device Facts
| Record ID | K192343 |
|---|---|
| Device Name | Patient Monitor |
| Applicant | Shenzhen Creative Industry Co., Ltd. |
| Product Code | DQA · Cardiovascular |
| Decision Date | Dec 31, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate(HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions. This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.
Device Story
Patient monitor (models K10, K12, K15) tracks vital signs including ECG, heart rate, NIBP, SpO2, respiration rate, body temperature, and EtCO2. Device inputs include physiological signals via ECG leads, SpO2 sensors, NIBP cuffs, temperature probes, and CO2 modules (mainstream/sidestream). System processes signals to display real-time waveforms and numerical parameters on an integrated TFT LCD. Operated by qualified professionals in hospitals/clinics; provides audible/visual alarms for out-of-range parameters. Battery or AC-powered; optional printer available. Output assists clinicians in assessing patient physiological status and making timely clinical decisions. Benefits include continuous, comprehensive monitoring of critical patient parameters.
Clinical Evidence
Clinical validation performed for NIBP module per ISO 81060-2:2013. Other parameters supported by bench testing and compliance with recognized standards including IEC 60601-1, IEC 60601-2-49, ISO 80601-2-61 (SpO2), ISO 80601-2-55 (CO2), IEC 60601-2-27 (ECG), and ISO 80601-2-56 (TEMP). Biocompatibility testing conducted per ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Multi-parameter monitor with TFT LCD (10.4", 12.1", or 15"). Powered by AC (100-240V) or internal 11.1V Li-ion battery. Sensing: ECG (CF-type, defibrillation-proof), SpO2 (CF-type), NIBP (oscillometric), RESP (thoracic impedance), TEMP (thermo-resistor), CO2 (infrared absorption). Connectivity: optional printer. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-49, ISO 80601-2-61, ISO 80601-2-55, IEC 60601-2-27, IEC 80601-2-30, ISO 81060-2, ISO 80601-2-56.
Indications for Use
Indicated for monitoring vital physiological signs (ECG, HR, NIBP, SpO2, RESP, TEMP, EtCO2) in adult and pediatric patients, excluding neonates. Intended for use in hospitals and clinical institutions by qualified professionals.
Regulatory Classification
Identification
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
Predicate Devices
- UP-7000 Patient Monitor (K123711)
Reference Devices
- PC-60 (K063641)
- Respironics LoFlo EtCO2 Module (K053174)
- CAPNOSTAT 5 EtCO2 Module (K042601)
- ECG Cable (K082959)
- Clinical electronic Thermometers (K982140)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 31, 2019
Shenzhen Creative Industry Co., Ltd. % Charlie Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K192343
Trade/Device Name: Patient Monitor, Models K10, K12 and K15 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DQA, CCK, FLL, MWI Dated: November 17, 2019 Received: November 26, 2019
Dear Charlie 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Stephen Browning Acting Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K192343
Device Name Patient Monitor, Models K10, K12, K15
#### Indications for Use (Describe)
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate(HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.
Type of Use (Select one or both, as applicable)
| <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-.052z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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K192343
Image /page/3/Picture/1 description: The image shows the logo for Creative Medical. The logo consists of a blue square made up of four smaller squares, each containing a hand with three fingers. To the right of the square is the text "CREATIVE MEDICAL" in blue, with "CREATIVE" on top and "MEDICAL" on the bottom.
# Shenzhen Creative Industry Co., Ltd.
510(k) Summary (21 CFR §807.92)
# Submitter Information:
| Submitter Name: | Shenzhen Creative Industry Co., Ltd. |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park,<br>Songbai Road, Xili Street, Nanshan District, Shenzhen,<br>PR China 518110 |
| Telephone: | +86-755-26433325 |
| Fax: | +86-755-26435433 |
| Contact Person: | Ms. Jia Wang<br>General Manager |
| Email: | charliemack@irc-us.com |
Date of Preparation: December 26, 2019
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# Subject Devices :
Trade/proprietary name: Patient Monitor, Models K10, K12, K15 Common Name: Patient Monitor
Classification
| Function | Product<br>Code | CFR | Panel |
|----------|-----------------|----------|------------------|
| SpO2 | DQA | 870.2700 | Anesthesiology |
| CO2 | CCK | 868.1400 | Anesthesiology |
| ECG/RESP | MWI | 870.2300 | Cardiovascular |
| NIBP | DXN | 870.1130 | Cardiovascular |
| TEMP | FLL | 880.2910 | General Hospital |
# Predicate Devices :
Trade Name: UP-7000 Patient Monitor
510(k) Reference: K123711
Common Name: Patient Monitor
## Regulation Number:
| Function | Product Code | CFR | Panel |
|----------|--------------|----------|------------------|
| SpO2 | DQA | 870.2700 | Anesthesiology |
| CO2 | CCK | 868.1400 | Anesthesiology |
| ECG/RESP | MWI | 870.2300 | Cardiovascular |
| NIBP | DXN | 870.1130 | Cardiovascular |
| TEMP | FLL | 880.2910 | General Hospital |
Regulatory Class: Class II
Manufacturer:
Shenzhen Creative Industry Co., LTD.
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## Purpose of Submission
This is a new traditional 510(K) submission of Patient Monitor, Models K10, K12, K15.
## Device Description
#### Overview
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, pulse rate (PR), noninvasive blood pressure (NIBP), functional oxygen saturation (SpOz), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.
There are three versions of the K serial Patient Monitor, K10, K12 and K15. The primary difference is physical dimension and display TFT size; all other specifications remain unchanged. All versions have the same indications for use.
## Features
This monitoring system may be used to monitor a patient's physical parameters as followed: End-tidal Carbon Dioxide (EtCO2), Forced inspiratory carbon dioxide (FiCO2), ECG, heart rate, non-invasive blood pressure (NIBP), Respiratory Rate(RR), body temperature(TEMP), Pulse Oxygen Saturation (SpOz) and Pulse Rate(PR).
- . It can measure SpO2, Pulse Rate, and Perfusion Index displays on the LCD.
- It can measure End-tidal CO2 (EtCO2), FiCO2, and Respiration Rate. The CO2 . waveform displays on the LCD.
- . lt can measure ECG, heart rate, and Respiration Rate(RR). Which enables simultaneous monitoring of several ECG waveforms and display on the LCD.
- It can measure non-invasive blood pressure(NIBP) and body . temperature(TEMP); the measured value can be displayed on LCD.
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- . Real-time monitoring of battery capacity, when the battery power is insufficient, low battery voltage alarm indication displays on the LCD screen.
- The customer could use either mainstream or sidestream for the same monitor.
- Two operating modes: normal monitoring and power-saving mode.
- Flexible menu setup and audible/visual alarm function.
- . It is battery powered and can also be powered by an AC mains power supply.
- . The built-in printer is optional.
#### Indication for use
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult, pediatric (but not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, Heart rate (HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.
#### Comparison with the predicate device:
Shenzhen Creative Industry Co., Ltd. believes that the Shenzhen Creative Industry Co., Ltd. Patient Monitor, Models K10, K12, K15 is substantially equivalent to the Shenzhen Creative Industry UP-7000 Patient Monitor (K123711). General Specifications (physical/electrical and operational properties) Remark: For the subject K serial Patient Monitor, there are three variations K10, K12, K15; The primary is physical dimension and display TFT size, all other specification remain unchanged. They have the same indications for use. The minor differences in the technological characteristics do not raise issues of safety and effectiveness. The subject device is identical to the predicate device. Please refer to the following pages for specific difference details.
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K192343
# Comparison to Predicate Devices
| | Characteristics | Submitted Device | Predicate Device | Difference Discussion |
|------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Physical dimension(mm)<br>/weight(kg) | K10: 295mm(L)x178mm(D)<br>x334mm(H)/4.5kg<br>K12: 313mm(L)x178mm(D)<br>x334mm(H)/5.2kg<br>K15: 357mm(L)x178mm(D)<br>x334mm(H)/5.7kg | 300 (L) x150 (D) x290 (H)/ 5.2kg | The physical dimension difference does not<br>raise any new questions of safety and<br>effectiveness. |
| | Display | K15: 26.4cm(15") TFT<br>K12: 30.7cm(12.1") TFT<br>K10: 26.4cm(10.4") TFT | 12.1" Color TFT | The display dimension difference does not<br>raise any new questions of safety and<br>effectiveness. |
| | Type, Degree of<br>protection against electric<br>shock | Class I with internal electric power supply.<br>Where the integrity of the external<br>protective earth(ground) in the installation<br>or its conductors is in doubt, the<br>equipment shall be operated from its<br>internal electric power supply(batteries)<br>CO2: BF(defibrillation proof)<br>ECG/RESP/TEMP/SPO2<br>/NIBP:CF(defibrillation proof) | Class I with internal electric power supply.<br>Where the integrity of the external<br>protective earth (ground) in the installation<br>or its conductors is in doubt, the equipment<br>shall be operated from its internal electric<br>power supply(batteries)<br>CO2: BF(defibrillation proof)<br>ECG/RESP/TEMP/SPO2<br>/NIBP:CF(defibrillation proof) | Identical |
| | Power supply | Battery or AC | Battery or AC | Identical |
| | AC Power Supply | 100~240V 50/60Hz 65VA | 100~240V 50/60Hz 100VA | The subject devices are powered by an<br>external adapter and lithium battery which<br>full match the design requirement and<br>complying the applicable standards,<br>including IEC60601-1, IEC60601-1-2, and<br>IEC62133 |
| | Internal power source | Rechargeable Sealed Li-ion battery 11.1V<br>4.4AH | Rechargeable sealed lead-acid battery,<br>12V 2.3AH | The subject devices are powered by an<br>external adapter and lithium battery which<br>full match the design requirement and<br>complying the applicable standards,<br>including IEC60601-1, IEC60601-1-2, and<br>IEC62133 |
| Characteristics | Submitted Device | Predicate Device | Difference Discussion | |
| Battery charging indicator | Yes | Yes | Identical | |
| Low battery indicator | Yes | Yes | Identical | |
| Battery charge time, typical | Maximum 13~15 hours for charging | Maximum 13~15 hours for charging | Identical | |
| Flammable anesthetics | N/A | N/A | Identical | |
| Operating condition | Temperature: 5C–40C:<br>Humidity: 30%—80%,non-condensing<br>Atmospheric pressure: 70kPa–106.0kPa | Temperature: 5C–40C;<br>Humidity: 30%—80%,non-condensing<br>Atmospheric pressure: 70kPa–106.0kPa | Identical | |
| Storage condition | Temperature: -20C–60C:<br>Humidity: 10%—95%,non-condensing<br>atmosphere: 53kPa–106kPa | Temperature: -20C–60C;<br>Humidity: 10%—95%,noncondensing<br>atmosphere: 53kPa–106kPa | Identical | |
| EMC | The equipment meets the requirements of<br>IEC 60601-1-2:2014 | The equipment meets the requirements of<br>IEC 60601-1-2:2007 | Identical | |
| Power-on self-test | Yes | Yes | Identical | |
| Optional printer | Yes | Yes | Identical | |
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2. SPO₂- Same as in Predicate Device
| | Characteristics | Submitted Device | Predicate Device | Difference Discussion |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------|
| | Name and model | Patient Monitor, Models K10, K12, K15 | UP-7000 Patient Monitor | N/A |
| | Manufacturer | Shenzhen Creative Industry Co., Ltd. | Shenzhen Creative Industry Co., Ltd. | N/A |
| | 510(K) Number: | N/A | K123711 | N/A |
| | SPO2 module | Creative SPO2 module KM-SPO-03(AFE) with the same principle as UP-7000(K123711)Creative SPO2 sensor only | Creative SPO2 module KM-SPO-03(AFE) with the same principle as PC-60(K063641)Creative SPO2 sensor only | No change |
| | Patient type | Adult, pediatric (but not neonatal) patients | Adult, pediatric patients | No change |
| | SPO2 display range | 0%~100% | 0%~100% | No change |
| | SPO2 measurement accuracy | Adult and Pediatric (but not neonatal): ±3% (during 70%~100%) Undefined (during 0~70%) | Adult and Pediatric: ±3% (during 70%~100%) Undefined (during 0~70%) | No change |
| | Alarm range (%) | High Limit: 1%~100% Lower Limit. 0%~99% | High Limit: 1%~100% Lower Limit. 0%~99% | No change |
| | Pulse rate measurement range | 30 bpm~240 bpm | 30 bpm~240 bpm | No change |
| | Pulse rate accuracy | ±2bpm or ±2% (whichever is greater) | ±2bpm or ±2% (whichever is greater) | No change |
| | Alarm range-Pulse rate (bpm) | High Limit: 1bpm~300bpm Lower Limit. Obpm~299bpm | High Limit: 1bpm~300bpm Lower Limit. Obpm~299bpm | No change |
| Characteristics | Submitted Device | Predicate Device | Difference Discussion | |
| Name and model | Patient Monitor, Models K10, K12, K15 | UP-7000 Patient Monitor | N/A | |
| Manufacturer | Shenzhen Creative Industry Co., Ltd. | Shenzhen Creative Industry Co., Ltd. | N/A | |
| 510(K) Number: | N/A | K123711 | N/A | |
| CO2 module | Respironics LoFloTM EtCO2 (Side-<br>stream) Module(K053174) and<br>CAPNOSTAT 5 EtCO2 (Main-stream)<br>Module(K042601) | Respironics LoFIoTM EtCO2 (Side-stream)<br>Module(K053174) and CAPNOSTAT 5<br>EtCO2 (Main-stream) Module(K042601) | No change | |
| CO2 measurement method | Infrared absorption method | Infrared absorption method | No change | |
| CO2 measure mode | Sidestream or Mainstream | Sidestream or Mainstream | No change | |
| Measuring parameters | EtCO2, FiCO2 and Respiration Rate | EtCO2, FiCO2 and Respiration Rate | No change | |
| CO2 Response Time | Sidestream: <3seconds (includes<br>transport time and rise time).<br>Mainstream: < 60ms (rise time) | Sidestream: <3seconds (includes transport<br>time and rise time).<br>Mainstream: < 60ms (rise time) | No change | |
| Units | mmHg, kPa or Vol% | mmHg, kPa or Vol% | No change | |
| CO2 measure range | EtCO2: 0~150mmHg<br>FiCO2: 3~50mmHg | EtCO2: 0~150mmHg<br>FiCO2: 3~50mmHg | No change | |
| CO2 Resolution | 0.1mmHg (0~69mmHg)<br>0.25mmHg (70~150mmHg) | 0.1mmHg (0~69mmHg)<br>0.25mmHg (70~150mmHg) | No change | |
| CO2 Accuracy | 0~40 mmHg $\pm$ 2mmHg<br>41~70 mmHg $\pm$ 5% of reading<br>71~100 mmHg $\pm$ 8% of reading<br>101~150mmHg $\pm$ 10% of reading | 0~40 mmHg $\pm$ 2mmHg<br>41~70 mmHg $\pm$ 5% of reading<br>71~100 mmHg $\pm$ 8% of reading<br>101~150mmHg $\pm$ 10% of reading | No change | |
| Respiration Rate measure<br>range | 2~150rpm (Sidestream) or 0~150rpm<br>(Mainstream) | 2~150rpm (Sidestream) or 0~150rpm<br>(Mainstream) | No change | |
| Respiration Rate resolution | 1 rpm | 1rpm | No change | |
| Respiration Rate accuracy | $\pm$ 2rpm | ±2rpm | No change | |
| Flow Rate | 50ml/min ±10 ml/min (Sidestream) | 50ml/min ±10 ml/min (Sidestream) | No change | |
| No Breath Alarm Delay | 10~60s | 10~60s | No change | |
| Alarm adjustment range of<br>EtCO2 | High Limit: 1mmHg~160mmHg<br>Lower Limit. 0mmHg~159mmHg | High Limit: 1mmHg~160mmHg<br>Lower Limit. 0mmHg~159mmHg | No change | |
| Alarm adjustment range of<br>RR | High Limit: 1bpm~150bpm<br>Lower Limit. Obpm~149bpm | High Limit: 1bpm~150bpm<br>Lower Limit. Obpm~149bpm | No change | |
| Characteristics | Submitted Device | Predicate Device | Difference Discussion | |
| Name and model | Patient Monitor, Models K10, K12, K15 | UP-7000 Patient Monitor | N/A | |
| Manufacturer | Shenzhen Creative Industry Co., Ltd. | Shenzhen Creative Industry Co., Ltd. | N/A | |
| 510(K) Number: | N/A | K123711 | N/A | |
| ECG Module | Creative ECG/RESP module;<br>ECG Cable cleared under K082959 of<br>UNIMED MEDICAL SUPPLIES INC. | Creative ECG/RESP module;<br>ECG Cable cleared under K082959 of<br>UNIMED MEDICAL SUPPLIES INC. | No change | |
| Lead | AHA, EURO | AHA, EURO | No change | |
| Lead option | Yes | Yes | No change | |
| Gain | 2.5mm/mV(x0.25) 5mm/mV(x0.5),<br>10mm/mV(x1), 20mm/mV(x2) ,40<br>mm/mV(x4)and AUTO | 2.5mm/mV(x0.25) 5mm/mV(x0.5),<br>10mm/mV(x1), 20mm/mV(x2) ,40<br>mm/mV(x4)and AUTO | No change | |
| Sweep speed | 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s | 12.5mm/s, 25mm/s, 50mm/s | Similar | |
| Range of heart rate<br>monitoring | 15 bpm ~ 350 bpm | 15 bpm ~ 350 bpm | No change | |
| Resolution | 1bpm | 1bpm | No change | |
| Precision | ±1% or ± 2 bpm, whichever is greater. | ±1% or ± 2 bpm, whichever is greater. | No change | |
| Alarm setting | Adult high Limit: (1~350) bpm<br>Adult low Limit: (0~349) bpm<br>Pediatric (but not neonatal) high<br>Limit: (1~350) bpm Pediatric (but<br>not neonatal) low Limit: (0~349)<br>bpm | Adult high Limit: (1~350) bpm<br>Adult low Limit: (0~349) bpm<br>Pediatric high Limit: (1~350) bpm<br>Pediatric low Limit: (0~349) bpm | No change | |
| Input resistance | 2: 10MO(differential) | 2: 5MO(single ended) | Similar | |
| CMRR | Diagnostic mode: 2: 90dB<br>Monitor mode: 2: 105dB<br>Operation mode: 2: 105dB | Diagnostic mode: 2: 90dB<br>Monitor mode: 2: 105dB<br>Operation mode: 2: 105dB | No change | |
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3. CO2 - Same as in Predicate Device
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#### 4. ECG – Same as in Predicate Device
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| Characteristics | Submitted Device | Predicate Device | Difference Discussion |
|--------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anti-polarized voltage | +/-300mV | +/-300mV | No change |
| ECG mode | Monitoring, Diagnostic, Operation | Monitoring, Diagnostic | Added one "Operation" mode,<br>and the difference does not<br>raise any new questions of<br>safety and effectiveness and<br>still complies with the IEC<br>60601-2-27 requirement<br>same as Predicate device. |
| Frequency characteristic | Monitoring mode: 0.67Hz-40 Hz<br>Diagnostic mode: 0.05 Hz-75 Hz<br>Operation mode:1Hz-20Hz | Monitoring mode: 0.5 Hz-40 Hz<br>Diagnostic mode: 0.05 Hz-75 Hz | A little difference in frequency<br>characteristic but it does not<br>raise any new questions of<br>safety and effectiveness and<br>still complies with the IEC<br>60601-2-27 requirement<br>same as Predicate device. |
| Safeguard | CF | CF | No change |
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5.RESP – Same as in Predicate Device
| Characteristics | Submitted Device | Predicate Device | Difference Discussion |
|-------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------|
| Name and model | Patient Monitor, Models K10, K12, K15 | UP-7000 Patient Monitor | N/A |
| Manufacturer | Shenzhen Creative Industry Co., Ltd. | Shenzhen Creative Industry Co., Ltd. | N/A |
| 510(K) Number: | N/A | K123711 | N/A |
| RESP Module | Creative ECG/RESP module;<br>ECG Cable cleared under K082959 of<br>UNIMED MEDICAL SUPPLIES INC. | Creative ECG/RESP module;<br>ECG Cable cleared under K082959 of<br>UNIMED MEDICAL SUPPLIES INC. | No change |
| Lead | Optional: lead I and lead II; default lead II | Optional: lead I and lead II; default lead II | No change |
| Measurement technique | Thoracic impedance | Thoracic impedance | No change |
| Sweep speed | 6.25mm/s,12.5mm/s, | 6.25mm/s,12.5mm/s, | No change |
| Respiration excitation<br>Waveform | <300uA, sinusoid, 75kHz (±10%) | <300uA, sinusoid, 75kHz (±10%) | No change |
| Respiration impedance test<br>Range | 0.3 to 3 O | 0.3 to 3 O | No change |
| Baseline impedance range | 200 to 2500O(using an ECG cable with<br>1kO resistance) | 200 to 2500O(using an ECG cable with 1kO<br>resistance) | No change |
| Differential input<br>impedance | >2.5 MO | >2.5 MO | No change |
| Linear Signal Range | 3O p-p minimum | 3O p-p minimum | No change |
| Bandwidth | 0.2 to 2Hz(-3 dB) | 0.2 to 2Hz(-3 dB) | No change |
| RESP rate measuring<br>range | 0rpm~120rpm | 0rpm~120rpm | No change |
| RESP rate accuracy | ±2% or ±2 rpm, whichever is greater | ±2% or ±2 rpm, whichever is greater | No change |
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# 6. NIBP – New NIBP Module
| Characteristics | Subject Device | Predicate Device | Difference Discussion |
|-------------------------------------------|-------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name and model | Patient Monitor, Models K10, K12, K15 | UP-7000 Patient Monitor | N/A |
| Manufacturer | Shenzhen Creative Industry Co., Ltd. | Shenzhen Creative Industry Co., Ltd. | N/A |
| 510(K) Number: | N/A | K123711 | N/A |
| NIBP module | KM-NIBP-12V02/SMD | SunTech Advantage 2.0 NIBP Module | The new NIBP module used in<br>subject devices complies with the<br>same IEC80601-2-30 standards<br>and design requirement as<br>Predicate device. |
| Method | Oscillometric method | Oscillometric method | Identical |
| Patient type | Adult and Pediatric (not neonatal): patients | pediatric and adult patients | Identical |
| Unit of measure | mmHg & kPa | mmHg & kPa | Identical |
| Pressure measurement | Adult: 40 ~ | Adult: 40 ~ 260mmHg | The new NIBP module used in |
| range - Systolic | pediatric (not neonatal):: 40 ~<br>200mmHg | pediatric: 40 ~ 160mmHg | subject devices has little difference<br>in measurement range, but still<br>complying with the same<br>IEC80601-2-30 standards and<br>design requirement as Predicate<br>device. |
| Pressure measurement<br>range - Diastolic | Adult: 10 ~ 210mmHg<br>pediatric (not neonatal):: 10 ~<br>150mmHg | Adult: 20 ~ 200mmHg<br>pediatric: 20 ~ 120mmHg | The new NIBP module used in<br>subject devices has little difference<br>in measurement range, but still<br>complying with the same<br>IEC80601-2-30 standards and<br>design requirement as Predicate<br>device. |
{15}------------------------------------------------
| | Characteristics | Subject Device | Predicate Device | Difference Discussion |
|----|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Pressure measurement<br>range-Mean pressure | Adult: 20 ~ 230<br>mmHg<br>pediatric (not neonatal):: 20 ~ 165mmHg | Adult: 26 ~ 220mmHg<br>pediatric: 26 ~ 133mmHg | The new NIBP module used in subject<br>devices has little difference in<br>measurement range, but still complying<br>with the same IEC80601-2-30 standards<br>and design requirement as Predicate<br>device. |
| 53 | BP accuracy | Max. mean deviation values: $\pm$ 5 mmHg;<br>Max. standard deviation: 8 mmHg. | mean deviation values: $\pm$ 5 mmHg;<br>Standard deviation: <= 8 mmHg. | Identical |
| | Standard compliance | IEC/ISO 80601-2-30:2009+A1:2013<br>ANSI/AAMI/ISO 81060-2:2009 | Meets ANSI/AAMI SP10:2002,<br>EN1060-4:2004 | The new NIBP module complies with the<br>new FDA recognized standards. |
| | Cuff pressure range | 0 to 300mmHg | 0 to 300mmHg | Identical |
| | Overpressure protector | Internal operating software ensures that:-<br>Maximum cuff inflation time is limited<br>to 50 seconds (Adult mode), 35<br>seconds (Pediatric (not neonatal):mode) Duration of blood pressure reading is<br>limited to 120 seconds (Adult mode), 90<br>seconds (Pediatric (not neonatal): mode) Additional redundant safety circuitry<br>oversees the normal operation and<br>overrides to abort a reading if: cuff<br>pressure exceeds 300mmHg (Adult<br>mode) or 240mmHg (Pediatric (not<br>neonatal):mode) at any time. The cuff<br>has been inflated for 180 seconds<br>(Adult & Pediatric (notneonatal):modes) | Internal operating software ensures that:--<br>Maximum cuff inflation time is<br>limited to 75 seconds Duration of blood pressure reading<br>is limited to 130 seconds (Adult<br>mode), 90 seconds (Pediatric<br>mode) Additional redundant safety circuitry<br>oversees the normal operation and<br>overrides to abort a reading if:<br>Cuff pressure exceeds 300mmHg<br>(Adult & Pediatric modes)at any<br>time. The cuff h…
