The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.

The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.

Device Description

PC-900A vital signs monitor is a small Multi-parameter Patient Monitor, which can monitor the vital physiological parameters: Carbon Dioxide (CO2), Pulse Oxygen Saturation (SpO2), respiration and pulse rate. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. The specific sensors have been previously cleared by the FDA 510(k) process. (For specifics, please refer to the Description Section). After CPU analyzing and calculating, the parameters can display on the screen in a graphical way, record and/or print if necessary. The alarm will work if the parameters over the limits to take medical practitioner's attention.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Vital Signs Monitor, Model PC-900A:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria for a new clinical trial. However, it does list performance specifications and accuracy claims for the device. These can be interpreted as the functional acceptance criteria the manufacturer aims for, by comparing them to predicate devices.

Parameter	Acceptance Criteria (Implied by equivalence and typical performance claims)	Reported Device Performance (PC-900A)
SpO₂ Measurement Range	Similar to predicate devices (e.g., 1%-100%)	70%~99%
SpO₂ Accuracy	Similar to predicate devices (e.g., Adult/Pediatric: ±2% (70-100%), Neonate: ±3% (70-100%))	Adult and Pediatric: $\pm$ 3% (during 70%~~99%)Undefined (during 0~~70%)
SpO₂ Alarms	High and lower alarms, adjustable limits	High and lower alarms. The limits are adjustable.
Pulse Rate Display Range	Similar to predicate devices (e.g., 20 bpm ~ 250 bpm)	30 bpm~240 bpm
Pulse Rate Accuracy	Similar to predicate devices (e.g., ±3 bpm)	$\pm$ 2bpm or $\pm$ 2% (whichever is greater)
Pulse Rate Alarms	High and lower alarms, adjustable limits	High and lower alarms. The limits are adjustable.
CO₂ Module	Use of previously cleared modules (e.g., Respironics LoFlo™ EtCO2, CAPNOSTAT 5 EtCO2)	Respironics LoFlo™ EtCO2 (Side-stream) Module(K053174) and CAPNOSTAT 5 EtCO2 (Main-stream) Module(K042601)
CO₂ Measurement Method	Infrared absorption method	Infrared absorption method
CO₂ Measure Mode	Sidestream or Mainstream	Sidestream or Mainstream
CO₂ Response Time	Sidestream: <3s (includes transport and rise); Mainstream: <60ms (rise time)	Sidestream: <3seconds (includes transport time and rise time).Mainstream: <60ms (rise time)
CO₂ Accuracy (EtCO₂: 0-150mmHg)	0-40 mmHg ±2mmHg, 41-70 mmHg ±5% of reading, 71-100 mmHg ±8% of reading, 101-150mmHg ±10% of reading (for Respironics LoFlo/CAPNOSTAT)	0~~40 mmHg ±2mmHg41~~70 mmHg ±5% of reading71~~100 mmHg ±8% of reading101~~150mmHg±10% of reading
CO₂ Accuracy (EtCO₂: 0-99mmHg)	0-38 mmHg: ± 2 mmHg; 39-99 mmHg: ± (5% of reading + 0.08% for every 1 mmHg above 38 mmHg) (Oridion Capnostream) OR 0-40mmHg ±2mmHg; 41-76mmHg ±8% of reading; 77-99mmHg ±10% of reading (Edan M3B)	0~~38 mmHg: ± 2 mmHg; 39~~99 mmHg: ± (5% of reading + 0.08% for every 1 mmHg above 38 mmHg) (from Oridion column)0~~40mmHg ±2mmHg; 41~~76mmHg ±8% of reading; 77~99mmHg±10% of reading (from Edan column)
Respiration Rate Measure Range	2-150 rpm or 0-150 rpm	2~~150rpm (Sidestream) or 0~~150rpm (Mainstream)
Respiration Rate Accuracy	Similar to predicate (e.g., 0-70 rpm: ±1 rpm; 71-120 rpm: ±2 rpm; 121-150 rpm: ±3 rpm for Capnostream)	±2rpm (General Statement)0~~70 rpm: ±1 rpm; 71~~120 rpm: ±2 rpm; 121~150 rpm: ±3 rpm (Detailed breakdown, presumably for the CO2 module)
Flow Rate (Sidestream)	50ml/min ±10 ml/min	50ml/min ±10 ml/min (Sidestream)50 (42.5≤flow≤65) ml/min, flow measured by volume (From predicate description, likely applicable to the module)
Suffocation Alarm Delay	10~60s	10~60s
Alarms of EtCO₂, RR	High and lower alarms, adjustable limits	High and lower alarms. The limits are adjustable.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not provide details on the sample size for a "test set" or data provenance (e.g., country of origin, retrospective/prospective clinical data).

The document states: "The PC 900A has undergone Third Party safety testing in accordance with IEC standards and completed performance testing in accordance with IEC standards." This typically refers to bench testing and electrical safety, not clinical performance studies with a specific test set of patients whose data is then explicitly analyzed for the stated performance metrics. The performance metrics are likely derived from the specifications of the integrated modules (e.g., SpO2 module, CO2 module) and validated through benchtop testing or limited in-vivo testing to meet the module's specified accuracy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. As the submission focuses on substantial equivalence based on technical specifications and predicate device comparison, a formal process of establishing ground truth by a panel of clinical experts for a dedicated test set is not described. The accuracy claims for SpO2 and CO2 modules are derived from their own clearances and internal validation data, which typically involve comparisons to reference methods rather than expert consensus on subjective data.

4. Adjudication Method for the Test Set

This information is not provided. Given the lack of a detailed clinical test set and expert review, an adjudication method would not be applicable in the context described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this 510(k) summary. This type of study is more common for diagnostic imaging AI systems where human interpretation is a key component. The Vital Signs Monitor is a device that provides numerical physiological parameters, not an interpretation of complex data by a human reader.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance data presented are standalone performance specifications of the device and its integrated modules. For example, the SpO2 accuracy and CO2 accuracy are direct measurements of the device's ability to provide accurate physiological readings, independent of a human operator's interpretation, other than their ability to correctly apply the sensors. No "algorithm only" study is explicitly mentioned as a separate entity, but the performance claims are inherently about the device's measurement capabilities.

7. The Type of Ground Truth Used

For the SpO2 and CO2 accuracy claims, the ground truth would typically be established by a reference method (e.g., co-oximetry for SpO2, calibrated gas analyzers for CO2) during controlled laboratory or clinical studies for the respective sensors/modules. The 510(k) refers to the use of "Creative SpO2 module with the same principle as PC-60(K063641) Creative SpO2 sensor only" and "Respironics LoFlo™ EtCO2 (Side-stream) Module(K053174) and CAPNOSTAT 5 EtCO2 (Main-stream) Module(K042601)." The accuracy statements for these components are derived from their own prior regulatory clearances and the studies that supported them, which would have used appropriate gold standard reference methods. The document itself does not detail these ground truth methodologies for this specific submission, but rather references the cleared modules.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Vital Signs Monitor is a hardware device integrating sensors and processing units, not an AI software system that undergoes "training" in the machine learning sense. The underlying algorithms for parameter measurements (like SpO2 and CO2) are based on established physiological principles and signal processing, not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable due to the nature of the device (hardware monitor, not a machine learning model).

Summary

{0}------------------------------------------------

MAR 3 0 2010

Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and letters. The sequence appears to be K093016. The numbers and letters are written in a dark ink, and the background is white. The handwriting is somewhat stylized, with some characters slightly distorted.

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.

ﮧ

Date: September 6, 2009

Company and Correspondent making the submission:

Name - Shenzhen Creative Industry Co., Ltd.

Address - 2/F, Block 3, Nanyou Tian'an Industry Town,

Nanshan District, Shenzhen City

Shenzhen, GD P. R. China

Telephone - +86 755 2643 3514

Fax - +86-755-2643 5433

Contact - Wang Jia

Email – jia-wang@163.com

2. Device :

Trade/proprietary name: Vital Signs Monitor, Model PC-900A

: Oximeter Common Name

400 analyzer, gas, carbon-dioxide, gaseous-p

Classification Name : 21CFR870.2700, Oximeter, DQA

21CFR868.1400, 400 analyzer, gas, carbon-dioxide,

gaseous-p, CCK

Predicate Devices:

Predicate Model	Manufacturer	K Number	Submitted Device
Capnostream 20	OridionCapnography,Incorporated	K060065	Vital Signs Monitor, ModelPC-900A
Vital SignsMonitor (ModelM3B)	EdanInstruments,Incorporated	K083821	Vital Signs Monitor, ModelPC-900A

{1}------------------------------------------------

Classifications Names & Citations : 21CFR 870.2700, DQA 21CFR868.1400, CCK
Description :

4.1 General

1. Indication for use :
  The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.

The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.

1. Comparison with predicate device: Please see next page for the comparison table.

{2}------------------------------------------------

Element ofComparison	Subject Device	Claimed SE Device 1	Claimed SE Device 2
Company	Shenzhen Creative Industry Co.,Ltd.	Oridion Medical 1987 Ltd.	Edan Instruments, Inc.
FDA510(K)Number	N/A	K060065	K083821
Device Name	Vital Signs Monitor	Portable BedsideCapnograph/Pulse OximeterCapnostream™ 20	Vital Signs Monitor
Model Number	PC-900A		M3B
Power Supply	Battery or AC	Battery or AC	Battery or AC
Internal PowerSupply	rechargeable sealed lead-acidbattery, 12V 2.3AH	rechargeable Lithium-Ion battery,14.8V 4.4AH	rechargeable Lithium-Ion battery,14.8V 4.4AH
AC Power Supply	100~250V 50/60Hz 90VA	100~240V 50/60Hz 90VA	100~240V 50/60Hz 45VA
The type ofprotection againstelectric shock	Class I and internally powered perIEC 60601-1.	Class I and internally powered perIEC 60601-1.	Class I and internally powered perIEC 60601-1.
The degree ofprotection againstelectric shock	Type BF	Type BF	Type BF

Comparison with legally marketed predicate device

33 of 738

{3}------------------------------------------------

Display	Dimensions(mm)	Intended patient population	Intended Use
LED and LCD display	$360(L) \times 320(D) \times 410(H)$	Adult, pediatric patients	The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is use for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO₂ and respiration rate.The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.
TFT Display	$220 (L) x192 (D) x167 (H)$	Adult, pediatric and neonate patients	The Capnostream2 0 is intended for CO2 and SPO2 indications. The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.
LCD display	$173.5(L) x 189(D) x 241(H)$	Adult, pediatric and neonate patients	The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and C02.The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal usage in a hospital environment and intra-hospital moves.The Vital Signs Monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

34 of 738

{4}------------------------------------------------

Nurse call function		Yes	Yes	Yes	CO₂ module	CO₂ measurement method	CO₂ measure mode
SpO₂					Respironics LoFlo™ EtCO2 (Side-stream) Module(K053174) andCAPNOSTAT 5 EtCO2 (Main-stream) Module(K042601)	Infrared absorption method	Sidestream or Mainstream
SpO₂ module	Creative SpO₂ module with thesame principle as PC-60(K063641)Creative SpO₂ sensor only		Masimo SET pulse oximetry andMasimo SpO₂ Sensors	Nellcor Nell-1 OXI-Max SpO₂module and Nellcor sensor	Microstream EtCO2 Module	Microstream® non-dispersive infrared (NDIR) spectroscopy	Sidestream
SpO₂ measurerange	70%~99%		1%~100%	1%~100%	Respironics LoFlo™ EtCO2 (Side-stream) Module and RepironicsCAPNOSTAT 5 EtCO2 (Main-stream) Module	Infrared absorption method	Sidestream or Mainstream
Accuracy of SpO₂	Adult and Pediatric:$\pm$ 3% (during 70%~~99%)Undefined (during 0~~70%)		Adult and Pediatric:$\pm$ 2% (during 70%~100%)Neonate:$\pm$ 3% (during 70%~~100%)Undefined (during 0~~70%)	Adult and Pediatric:$\pm$ 2% (during 70%-100%)Neonate:$\pm$ 3% (during 70%-100%)Undefined (during 0~70%)	Measuring parameters	CO₂ Response Time	Units
Alarm of SpO₂	High and lower alarms.The limits are adjustable.		High and lower alarms.The limits are adjustable.	The limit is adjustable.	EtCO₂, InsCO₂ and Respiration Rate	Sidestream: <3seconds (includes transport time and rise time).Mainstream: <60ms (rise time)	mmHg, kPa or Vol%
Pulse rate displayrange	30 bpm~240 bpm		25 bpm ~240 bpm	20bpm~250bpm	EtCO2, FICO2 and Respiration Rate	2.95 s (typical)	mmHg, kPa or Vol%
Accuracy of pulserate	$\pm$ 2bpm or $\pm$ 2% (whichever isgreater)		$\pm$ 3 bpm	$\pm$ 3bpm	EtCO₂, InsCO₂ and Respiration Rate	<3seconds (includes transport time and rise time)	mm Hg, kPa or %
Alarm of pulserate	High and lower alarms.The limits are adjustable.		High and lower alarms.The limits are adjustable.	The limit is adjustable.	CO₂ measure range	CO2 Accuracy	Respiration Rate
CO₂					EtCO₂: 0~~150mmHgInsCO₂: 3~~50mmHg	0~~40 mmHg ±2mmHg41~~70 mmHg ±5% of reading71~~100 mmHg ±8% of reading101~~150mmHg±10% of reading	2~150rpm (Sidestream) or
CO₂, EtCO₂, FICO₂ Range: 0~99 mmHg	0~~38 mmHg: ± 2 mmHg39~~99 mmHg: ± (5% of reading + 0.08% for every 1 mmHg above 38 mmHg)	0~150 rpm
EtCO₂: 0~~99mmHgInsCO₂: 0~~99mmHg	0~~40mmHg ±2mmHg41~~76mmHg ±8% of reading77~99mmHg±10% of reading	0~150bpm

35 of 738

85
of
734

{5}------------------------------------------------

36 of 738

61738

{6}------------------------------------------------

measure range
0~150rpm (Mainstream)	0~70 rpm: ±1 rpm
Respiration Rate accuracy	±2rpm	71~120 rpm: ±2 rpm	±2rpm
		121~150 rpm: ±3 rpm
Flow Rate	50ml/min ±10 ml/min (Sidestream)	50 (42.5≤flow≤65) ml/min, flowmeasured by volume	50ml/min ±10 ml/min(Sidestream)
Suffocation Alarm Delay	10~60s	10~60s	10~40s
Alarm of EtCO₂	High and lower alarms.The limits are adjustable.	High and lower alarms.The limits are adjustable.	The limit is adjustable.
Alarm of RR	High and lower alarms.The limits are adjustable.	High and lower alarms.The limits are adjustable.	The limit is adjustable.

. .

37 of 738

the country of the county of the county of

سر

{7}------------------------------------------------

7. Safety and Performance Data :

Please refer to the Declaration of Conformity for the comprehensive list of testing performed on the PC 900A Vital Signs Monitor. The PC 900A has undergone Third Party safety testing in accordance with IEC standards and completed performance testing in accordance with IEC standards. In that this device has software of Moderate concern; the appropriate level of Software evaluation was performed.

8. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Shenzhen Creative Industry Co., Ltd. concludes that Vital Signs Monitor, Model PC-900A, is safe and effective and substantially equivalent to predicate devices as described herein.

1. Shenzhen Creative Industry Co., Ltd. will update and include in a summary any other information deemed seasonably necessary by the FDA.
  END

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Creative Industry Company, Limited C/O Mr. Charlie Mack Principal Engineer International Regulatory Consultants, LLC 77325 Joyce Way Echo, Oregon 97826

MAR 3 0 2010

Re: K093016

Trade/Device Name: Vital Signs Monitor, Model PC-900A Regulation Number: 21CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, CCK Dated: March 18, 2010 Received: March 24, 2010

Dear Mr. 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.

{9}------------------------------------------------

Page 2- Mr. Mack

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

hr for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{10}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Vital Signs Monitor, Model PC-900A

Indications for Use:

The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital J environment. It is intended to be used only under regular supervision of clinical personnel.

Prescription Use _ AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schutten

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

Page 1 of

4093016 510(k) Number:

30 of 738

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).