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 Description

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.

AI/ML Overview

This document, a 510(k) summary for the Shenzhen Creative Industry Co., Ltd. Patient Monitor, Models K10, K12, and K15, primarily focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Creative Industry UP-7000 Patient Monitor, K123711) rather than detailing the specific acceptance criteria and study proving performance for a novel AI/software device.

Therefore, much of the requested information regarding AI device performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training) is not applicable or present in this document. This document describes a traditional medical device (patient monitor) and its components, and the "study" referred to is non-clinical and clinical testing to ensure compliance with relevant performance standards for vital sign monitoring.

However, I can extract the information that is applicable based on the provided text, particularly focusing on the performance criteria for the integrated vital sign modules.

Here's an analysis based on the provided text:

Device: Patient Monitor, Models K10, K12, K15

Indications for Use: Monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients, including ECG, heart rate (HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), and end-tidal CO2 concentration (EtCO2). Applicable for use in hospitals and clinical institutions, operation by qualified professionals only.

Study Type: This is a 510(k) submission seeking substantial equivalence to a predicate device. The "studies" involve non-clinical (safety and performance) and clinical (NIBP validation) testing against recognized standards rather than a comparative effectiveness study of a novel AI algorithm's diagnostic performance.

1. Table of acceptance criteria and the reported device performance:

The document lists performance specifications for each physiological parameter module, often directly comparing them to the predicate device. The acceptance criteria are implicitly that the devices meet or are substantially equivalent to the established performance requirements of the predicate device and relevant industry standards.

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)	Difference Discussion (Relevance)
SpO2 Accuracy	Adult & Pediatric: ±3% (70%-100%), Undefined (0-70%)	Adult & Pediatric: ±3% (70%-100%), Undefined (0-70%)	No change.
Pulse Rate Accuracy (SpO2)	±2 bpm or ±2% (whichever is greater)	±2 bpm or ±2% (whichever is greater)	No change.
CO2 Accuracy (0-40 mmHg)	±2 mmHg	±2 mmHg	No change.
CO2 Accuracy (41-70 mmHg)	±5% of reading	±5% of reading	No change.
CO2 Accuracy (71-100 mmHg)	±8% of reading	±8% of reading	No change.
CO2 Accuracy (101-150 mmHg)	±10% of reading	±10% of reading	No change.
Respiration Rate Accuracy (CO2)	±2 rpm	±2 rpm	No change.
Heart Rate Precision (ECG)	±1% or ±2 bpm, whichever is greater	±1% or ±2 bpm, whichever is greater	No change.
RESP Rate Accuracy	±2% or ±2 rpm, whichever is greater	±2% or ±2 rpm, whichever is greater	No change.
NIBP BP Accuracy (Mean Deviation)	±5 mmHg	Max. mean deviation values: ±5 mmHg	Identical.
NIBP BP Accuracy (Standard Deviation)	<= 8 mmHg	Max. standard deviation: 8 mmHg	Identical.
Temperature Measurement Accuracy	±0.1C (35.0C-39.0C); ±0.2C (rest)	±0.2C (25.0C-45.0C); ±0.4C (rest)	Difference noted, but stated to "not raise any new questions of safety and effectiveness and still complies with the ISO80601-2-56 requirement."
NIBP Overpressure Protector (Adult Cuff Pressure)	Cuff pressure exceeds 300mmHg	Cuff pressure exceeds 300mmHg	Identical.
NIBP Overpressure Protector (Pediatric Cuff Pressure)	Cuff pressure exceeds 300mmHg	Cuff pressure exceeds 240mmHg	Subject device is more stringent (lower max pressure).

Note: The document explicitly states for the NIBP and TEMP modules that "The new [module] used in subject devices complies with the same ISO [standard] and design requirement as Predicate device." This implies the acceptance criterion for these components is compliance with the cited ISO standards (e.g., ISO 80601-2-30 for NIBP, ISO 80601-2-56 for TEMP).

2. Sample size used for the test set and the data provenance:

Test Set Sample Size:
- For NIBP (Non-invasive sphygmomanometers) clinical validation (ISO 81060-2), this standard typically requires a minimum of 85 subjects (adults and children combined) for a full validation. While the exact number isn't stated in the provided text, the reference to this specific standard implies adherence to its sample size requirements.
- For other parameters (SpO2, CO2, ECG, RESP, TEMP), the "performance data" section refers to IEC/ISO standards (e.g., 60601-2-49, 80601-2-61, 80601-2-55, 60601-2-27, 80601-2-56). These standards define particular requirements for the performance of the devices and often involve bench testing, simulations, or phantom studies rather than large-scale human clinical trial "test sets" in the AI sense.
Data Provenance: Not specified in the provided text (e.g., country of origin). The testing is referred to as "Non-Clinical Study" and "Clinical Study" without detail on whether retrospective or prospective data was used, except for the NIBP clinical validation which would be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable in the AI/Software Sense: This document describes a traditional patient monitor. The "ground truth" for a patient monitor's vital sign measurements is established against recognized reference measurement methods or calibrated instruments (e.g., a known SpO2 reading from a CO-oximeter, a calibrated pressure sensor for NIBP, or a physiological simulator for ECG).
For NIBP (ISO 81060-2): This standard for clinical validation of automated sphygmomanometers typically requires measurements to be taken by trained observers (not necessarily "experts" in the diagnostic sense, but highly skilled in manual auscultatory measurements) and compared against a reference standard. The number of observers is also specified in the standard (e.g., at least 3 observers taking sequential measurements). Their "qualification" would be their training and demonstrated proficiency in the reference method.

4. Adjudication method for the test set:

Not Applicable in the AI/Software Sense: There is no "adjudication" of expert interpretations as seen in AI studies, as the device measures physiological parameters directly.
For NIBP (ISO 81060-2): The standard defines specific statistical methods for comparing the device's measurements to the reference measurements, often involving Bland-Altman analysis and calculating mean difference and standard deviation. There's no "adjudication" in the sense of resolving conflicting human interpretations; rather, it's a statistical comparison to a pre-defined reference.

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:

Not Applicable: This device is a patient monitor, not an AI diagnostic imaging tool or a system that assists human "readers" with interpretation. Therefore, no MRMC study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable in the AI/Software Sense: The described device functions as a standalone vital sign monitor. Its "performance" is inherently "algorithm only" in that its internal processing generates the vital sign values. However, this is not an "AI algorithm" in the context of complex pattern recognition or decision support. The performance is assessed by comparing its output against reference standards, which is a form of standalone evaluation for a monitor.

7. The type of ground truth used:

The ground truth for the performance evaluations of this patient monitor would be derived from:

Reference Measurements/Calibrated Standards:
- Physiological Simulators: For ECG, RESP, and potentially SpO2 and NIBP, to generate known, controlled physiological signals.
- Calibrated Instruments: For SpO2 (e.g., CO-oximeter), CO2 (calibrated gas mixtures), NIBP (auscultatory measurements by trained observers or calibrated pressure transducers), and Temperature (calibrated thermometers).
- In-vitro/Bench Testing: As implied by adherence to IEC/ISO performance standards, which often dictate specific test setups and reference instruments.
Clinical Data (for NIBP): As per ISO 81060-2, the ground truth for NIBP accuracy relies on trained human observers taking simultaneous or sequential auscultatory blood pressure measurements (the "reference method").

8. The sample size for the training set:

Not Applicable: This device is a traditional patient monitor, not an AI/machine learning device that requires a "training set" in the context of deep learning models. Its algorithms are based on established physiological signal processing principles.

9. How the ground truth for the training set was established:

Not Applicable: As stated above, there is no "training set" for this type of device. The ground truth for its performance verification (as opposed to AI training) is established using validated, calibrated reference standards and methods as described in point 7.

Summary

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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 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)

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

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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,Songbai Road, Xili Street, Nanshan District, Shenzhen,PR China 518110
Telephone:	+86-755-26433325
Fax:	+86-755-26435433
Contact Person:	Ms. Jia WangGeneral 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	ProductCode	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 instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

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)/weight(kg)	K10: 295mm(L)x178mm(D)x334mm(H)/4.5kgK12: 313mm(L)x178mm(D)x334mm(H)/5.2kgK15: 357mm(L)x178mm(D)x334mm(H)/5.7kg	300 (L) x150 (D) x290 (H)/ 5.2kg	The physical dimension difference does notraise any new questions of safety andeffectiveness.
	Display	K15: 26.4cm(15") TFTK12: 30.7cm(12.1") TFTK10: 26.4cm(10.4") TFT	12.1" Color TFT	The display dimension difference does notraise any new questions of safety andeffectiveness.
	Type, Degree ofprotection against electricshock	Class I with internal electric power supply.Where the integrity of the externalprotective earth(ground) in the installationor its conductors is in doubt, theequipment shall be operated from itsinternal electric power supply(batteries)CO2: BF(defibrillation proof)ECG/RESP/TEMP/SPO2/NIBP:CF(defibrillation proof)	Class I with internal electric power supply.Where the integrity of the externalprotective earth (ground) in the installationor its conductors is in doubt, the equipmentshall be operated from its internal electricpower supply(batteries)CO2: BF(defibrillation proof)ECG/RESP/TEMP/SPO2/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 anexternal adapter and lithium battery whichfull match the design requirement andcomplying the applicable standards,including IEC60601-1, IEC60601-1-2, andIEC62133
	Internal power source	Rechargeable Sealed Li-ion battery 11.1V4.4AH	Rechargeable sealed lead-acid battery,12V 2.3AH	The subject devices are powered by anexternal adapter and lithium battery whichfull match the design requirement andcomplying the applicable standards,including IEC60601-1, IEC60601-1-2, andIEC62133
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:Humidity: 30%—80%,non-condensingAtmospheric pressure: 70kPa–106.0kPa	Temperature: 5C–40C;Humidity: 30%—80%,non-condensingAtmospheric pressure: 70kPa–106.0kPa	Identical
Storage condition	Temperature: -20C–60C:Humidity: 10%—95%,non-condensingatmosphere: 53kPa–106kPa	Temperature: -20C–60C;Humidity: 10%—95%,noncondensingatmosphere: 53kPa–106kPa	Identical
EMC	The equipment meets the requirements ofIEC 60601-1-2:2014	The equipment meets the requirements ofIEC 60601-1-2:2007	Identical
Power-on self-test	Yes	Yes	Identical
Optional printer	Yes	Yes	Identical

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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-stream) Module(K053174) andCAPNOSTAT 5 EtCO2 (Main-stream)Module(K042601)	Respironics LoFIoTM EtCO2 (Side-stream)Module(K053174) and CAPNOSTAT 5EtCO2 (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 (includestransport time and rise time).Mainstream: < 60ms (rise time)	Sidestream: <3seconds (includes transporttime and rise time).Mainstream: < 60ms (rise time)	No change
Units	mmHg, kPa or Vol%	mmHg, kPa or Vol%	No change
CO2 measure range	EtCO2: 0~~150mmHgFiCO2: 3~~50mmHg	EtCO2: 0~~150mmHgFiCO2: 3~~50mmHg	No change
CO2 Resolution	0.1mmHg (0~~69mmHg)0.25mmHg (70~~150mmHg)	0.1mmHg (0~~69mmHg)0.25mmHg (70~~150mmHg)	No change
CO2 Accuracy	0~~40 mmHg $\pm$ 2mmHg41~~70 mmHg $\pm$ 5% of reading71~~100 mmHg $\pm$ 8% of reading101~~150mmHg $\pm$ 10% of reading	0~~40 mmHg $\pm$ 2mmHg41~~70 mmHg $\pm$ 5% of reading71~~100 mmHg $\pm$ 8% of reading101~~150mmHg $\pm$ 10% of reading	No change
Respiration Rate measurerange	2~~150rpm (Sidestream) or 0~~150rpm(Mainstream)	2~~150rpm (Sidestream) or 0~~150rpm(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 ofEtCO2	High Limit: 1mmHg~~160mmHgLower Limit. 0mmHg~~159mmHg	High Limit: 1mmHg~~160mmHgLower Limit. 0mmHg~~159mmHg	No change
Alarm adjustment range ofRR	High Limit: 1bpm~~150bpmLower Limit. Obpm~~149bpm	High Limit: 1bpm~~150bpmLower 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;ECG Cable cleared under K082959 ofUNIMED MEDICAL SUPPLIES INC.	Creative ECG/RESP module;ECG Cable cleared under K082959 ofUNIMED 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),10mm/mV(x1), 20mm/mV(x2) ,40mm/mV(x4)and AUTO	2.5mm/mV(x0.25) 5mm/mV(x0.5),10mm/mV(x1), 20mm/mV(x2) ,40mm/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 ratemonitoring	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) bpmAdult low Limit: (0~~349) bpmPediatric (but not neonatal) highLimit: (1~~350) bpm Pediatric (butnot neonatal) low Limit: (0~~349)bpm	Adult high Limit: (1~~350) bpmAdult low Limit: (0~~349) bpmPediatric high Limit: (1~~350) bpmPediatric low Limit: (0~~349) bpm	No change
Input resistance	2: 10MO(differential)	2: 5MO(single ended)	Similar
CMRR	Diagnostic mode: 2: 90dBMonitor mode: 2: 105dBOperation mode: 2: 105dB	Diagnostic mode: 2: 90dBMonitor mode: 2: 105dBOperation mode: 2: 105dB	No change

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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,and the difference does notraise any new questions ofsafety and effectiveness andstill complies with the IEC60601-2-27 requirementsame as Predicate device.
Frequency characteristic	Monitoring mode: 0.67Hz-40 HzDiagnostic mode: 0.05 Hz-75 HzOperation mode:1Hz-20Hz	Monitoring mode: 0.5 Hz-40 HzDiagnostic mode: 0.05 Hz-75 Hz	A little difference in frequencycharacteristic but it does notraise any new questions ofsafety and effectiveness andstill complies with the IEC60601-2-27 requirementsame 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;ECG Cable cleared under K082959 ofUNIMED MEDICAL SUPPLIES INC.	Creative ECG/RESP module;ECG Cable cleared under K082959 ofUNIMED 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 excitationWaveform	<300uA, sinusoid, 75kHz (±10%)	<300uA, sinusoid, 75kHz (±10%)	No change
Respiration impedance testRange	0.3 to 3 O	0.3 to 3 O	No change
Baseline impedance range	200 to 2500O(using an ECG cable with1kO resistance)	200 to 2500O(using an ECG cable with 1kOresistance)	No change
Differential inputimpedance	>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 measuringrange	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 insubject devices complies with thesame IEC80601-2-30 standardsand design requirement asPredicate 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 ~200mmHg	pediatric: 40 ~ 160mmHg	subject devices has little differencein measurement range, but stillcomplying with the sameIEC80601-2-30 standards anddesign requirement as Predicatedevice.
Pressure measurementrange - Diastolic	Adult: 10 ~ 210mmHgpediatric (not neonatal):: 10 ~150mmHg	Adult: 20 ~ 200mmHgpediatric: 20 ~ 120mmHg	The new NIBP module used insubject devices has little differencein measurement range, but stillcomplying with the sameIEC80601-2-30 standards anddesign requirement as Predicatedevice.

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	Characteristics	Subject Device	Predicate Device	Difference Discussion
	Pressure measurementrange-Mean pressure	Adult: 20 ~ 230mmHgpediatric (not neonatal):: 20 ~ 165mmHg	Adult: 26 ~ 220mmHgpediatric: 26 ~ 133mmHg	The new NIBP module used in subjectdevices has little difference inmeasurement range, but still complyingwith the same IEC80601-2-30 standardsand design requirement as Predicatedevice.
53	BP accuracy	Max. mean deviation values: $\pm$ 5 mmHg;Max. standard deviation: 8 mmHg.	mean deviation values: $\pm$ 5 mmHg;Standard deviation: <= 8 mmHg.	Identical
	Standard compliance	IEC/ISO 80601-2-30:2009+A1:2013ANSI/AAMI/ISO 81060-2:2009	Meets ANSI/AAMI SP10:2002,EN1060-4:2004	The new NIBP module complies with thenew FDA recognized standards.
	Cuff pressure range	0 to 300mmHg	0 to 300mmHg	Identical
	Overpressure protector	Internal operating software ensures that:-Maximum cuff inflation time is limitedto 50 seconds (Adult mode), 35seconds (Pediatric (not neonatal):mode) Duration of blood pressure reading islimited to 120 seconds (Adult mode), 90seconds (Pediatric (not neonatal): mode) Additional redundant safety circuitryoversees the normal operation andoverrides to abort a reading if: cuffpressure exceeds 300mmHg (Adultmode) or 240mmHg (Pediatric (notneonatal):mode) at any time. The cuffhas been inflated for 180 seconds(Adult & Pediatric (notneonatal):modes)	Internal operating software ensures that:--Maximum cuff inflation time islimited to 75 seconds Duration of blood pressure readingis limited to 130 seconds (Adultmode), 90 seconds (Pediatricmode) Additional redundant safety circuitryoversees the normal operation andoverrides to abort a reading if:Cuff pressure exceeds 300mmHg(Adult & Pediatric modes)at anytime. The cuff has been inflated for 180seconds (Adult & Pediatricmodes).	The Maximum cuff inflation time (Adultmode) of the subject device is shorterthan the Predicate device. The bloodpressure reading time (adult mode) isshorter than the Predicate device.The difference does not raise any newquestions of safety and effectiveness.

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Characteristics			Subject Device	Predicate Device	DifferenceDiscussion
Alarmsetup	Systolic	HighLimit	Adult: 30~~280 mmHgPediatric (not neonatal): 30~~200 mmHg	Adult: 31~~280 mmHgPediatric: 30~~200 mmHg	Similar
		LowerLimit	Adult: 29~~279 mmHgPediatric (not neonatal):: 29~~199 mmHg	Adult: 29~~279 mmHgPediatric: 29~~199 mmHg	Identical
	Diastolic	HighLimit	Adult : 11~~232 mmHgPediatric (not neonatal):: 11~~150 mmHg	Adult : 11~~232 mmHgPediatric: 11~~150 mmHg	Identical
		LowerLimit	Adult : 10~~231 mmHgPediatric (not neonatal):: 10~~149 mmHg	Adult : 10~~231 mmHgPediatric: 10~~149 mmHg	Identical
Alarm method			Sound light alarm, and record the alarmstatus for review	Sound light alarm, and record the alarmstatus for review	Identical

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7. TEMP – New TEMP 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
TEMP Module	KRK-TEMP PCBA 601S-E3	Clinical electronic Thermometers (K982140)	The new TEMP module used in subjectdevices complies with the sameISO80601-2-56 standards and designrequirement as Predicate device.
Measurement means	Thermo-resistor type	Thermo-resistor type	Identical
Patient type	Adult, Pediatric (not neonatal):	Adult, Pediatric	Identical
Unit of measure	C or F	C or F	Identical
Measurement site	Body surface	Body surface	Identical
Temperature measurementrange	21.0C to 50.0C (69.8F to 122F)	32.0C to 43.9C (90F to 109.9F)	The difference in measurement rangedoes not raise any new questions ofsafety and effectiveness and stillcomplies with the ISO80601-2-56requirement same as Predicate device.
Temperature measurementaccuracy	±0.2C(25.0C to 45.0C)±0.4C for the rest of the range	±0.1C(35.0C to 39.0C)±0.2F(95.0F to 102.2F)±0.2C the rest	The difference in measurementaccuracy does not raise any newquestions of safety and effectivenessand still complies with the ISO80601-2-56 requirement same as Predicatedevice.

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Safety and Performance Data :

To establish substantial equivalence to the identified predicate devices, tests were completed as defined below to the subject devices, Patient Monitor, Models K10, K12. K15. The results of the testing demonstrate that the devices comply with the applicable standards requirements, and the devices are substantially equivalent to the predicate devices.

Non-Clinical Study:

Safety and EMC

IEC 60601-1: 2005+A1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2014 Medical devices part 1-2: General requirements for basic safety and essential performance - Collateral standards: electromagnetic compatibility - Test and requirements

Performance Data:

IEC 60601-2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment (2011)
-ISO 80601-2-61 Second Edition 2017-12, medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment. (Anesthesiology)
-ISO 80601-2-55 First edition 2011-12-15 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
IEC 60601-2-27 Medical Electrical Equipment Part 2-27: Particular Requirements -For The Basic Safety And Essential Performance Of Electrocardiographic Monitoring Equipment [Including Corrigendum 1 (2012)]
ANSI AAMI EC53:2013 ECG trunk cables and patient lead wires -
-IEC 80601-2-30 Edition 1.1 2013-07 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
-ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
-ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
-IEC 60601-1-8 Edition 2.1 2012-11 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

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Biocompatibility

ISO 10993-5: 2009 Biological evaluation of medical devices Part 5 Tests for In -Vitro Cytotoxicity
ISO10993-10: 2010 Biological evaluation of medical Devices Part 10: Tests for -Irritation and Delayed-Type Hypersensitivity
-The subject device is classified as a surface device and contact (hand, chest) for a limited duration.

Clinical Study:

ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers Part -2: Clinical validation of automated measurement type

Conclusion:

The differences between subject devices and predicate device do not raise issues of safety and effectiveness based on the indication for use, technological characteristics, and performance testing. The subject device complies with the same applicable standards as the predicate device.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, the subject device, Patient Monitor, K10, K12, K15 is safe and effective and substantially equivalent to predicate devices as described herein

END

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).