VITAL SIGNS MONITOR

K093016 · Shenzhen Creative Industry Co., Ltd. · DQA · Mar 30, 2010 · Cardiovascular

Device Facts

• Record ID: K093016
• Device Name: VITAL SIGNS MONITOR
• Applicant: Shenzhen Creative Industry Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Vital Signs Monitor (PC-900A) performs non-invasive continuous monitoring of SpO2, pulse rate, CO2, and respiration rate. Device utilizes external sensors to collect physiological signals; internal circuitry amplifies and processes these signals. CPU performs calculations; results displayed on integrated LED/LCD screen. Device features adjustable alarms for physiological parameters exceeding set limits. Intended for use in hospital settings by clinical personnel. Provides real-time monitoring to assist in patient assessment and clinical decision-making.

Clinical Evidence

Bench testing only. Device underwent safety and performance testing in accordance with IEC standards. No clinical data provided.

Technological Characteristics

Multi-parameter monitor; battery (sealed lead-acid) or AC powered. Class I, Type BF protection. LED/LCD display. Dimensions: 360x320x410mm. SpO2 and CO2 monitoring via external sensors. Software of moderate concern. Connectivity: standalone.

Indications for Use

Indicated for non-invasive continuous monitoring of SpO2, pulse rate, CO2, and respiration rate in adult and pediatric patients in hospital environments under clinical supervision.

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

• Capnostream 20 (K060065)
• Vital Signs Monitor (Model M3B) (K083821)

Reference Devices

• PC-60 (K063641)
• Respironics LoFlo EtCO2 Module (K053174)
• CAPNOSTAT 5 EtCO2 Module (K042601)

Submission Summary (Full Text)

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MAR 3 0 2010

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### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

ﮧ

Date: September 6, 2009

1. 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 - [phone]

Fax - [phone]

Contact - Wang Jia

Email – [e-mail]

## 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 | Oridion<br>Capnography,<br>Incorporated | K060065 | Vital Signs Monitor, Model<br>PC-900A |
| Vital Signs<br>Monitor (Model<br>M3B) | Edan<br>Instruments,<br>Incorporated | K083821 | Vital Signs Monitor, Model<br>PC-900A |

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

4. Description :

4.1 General

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.

- 5. 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.

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

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| Element of<br>Comparison | Subject Device | Claimed SE Device 1 | Claimed SE Device 2 |
|-------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------|
| Company | Shenzhen Creative Industry Co.,<br>Ltd. | Oridion Medical 1987 Ltd. | Edan Instruments, Inc. |
| FDA510(K)<br>Number | N/A | K060065 | K083821 |
| Device Name | Vital Signs Monitor | Portable Bedside<br>Capnograph/Pulse Oximeter<br>Capnostream™ 20 | Vital Signs Monitor |
| Model Number | PC-900A | | M3B |
| Power Supply | Battery or AC | Battery or AC | Battery or AC |
| Internal Power<br>Supply | rechargeable sealed lead-acid<br>battery, 12V 2.3AH | rechargeable Lithium-Ion battery,<br>14.8V 4.4AH | rechargeable Lithium-Ion battery,<br>14.8V 4.4AH |
| AC Power Supply | 100~250V 50/60Hz 90VA | 100~240V 50/60Hz 90VA | 100~240V 50/60Hz 45VA |
| The type of<br>protection against<br>electric shock | Class I and internally powered per<br>IEC 60601-1. | Class I and internally powered per<br>IEC 60601-1. | Class I and internally powered per<br>IEC 60601-1. |
| The degree of<br>protection against<br>electric shock | Type BF | Type BF | Type BF |

Comparison with legally marketed predicate device

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| 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.<br>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.<br>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.<br>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. |

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| Nurse call function | | Yes | Yes | Yes | CO₂ module | CO₂ measurement method | CO₂ measure mode |
|-------------------------------------|------------------------------------------------------------------------------------------------|-----------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------|
| SpO₂ | | | | | Respironics LoFlo™ EtCO2 (Side-stream) Module(K053174) and<br>CAPNOSTAT 5 EtCO2 (Main-stream) Module(K042601) | Infrared absorption method | Sidestream or Mainstream |
| SpO₂ module | Creative SpO₂ module with the<br>same principle as PC-60(K063641)<br>Creative SpO₂ sensor only | | Masimo SET pulse oximetry and<br>Masimo SpO₂ Sensors | Nellcor Nell-1 OXI-Max SpO₂<br>module and Nellcor sensor | Microstream EtCO2 Module | Microstream® non-dispersive infrared (NDIR) spectroscopy | Sidestream |
| SpO₂ measure<br>range | 70%~99% | | 1%~100% | 1%~100% | Respironics LoFlo™ EtCO2 (Side-stream) Module and Repironics<br>CAPNOSTAT 5 EtCO2 (Main-stream) Module | Infrared absorption method | Sidestream or Mainstream |
| Accuracy of SpO₂ | Adult and Pediatric:<br>$\pm$ 3% (during 70%~99%)<br>Undefined (during 0~70%) | | Adult and Pediatric:<br>$\pm$ 2% (during 70%~100%)<br>Neonate:<br>$\pm$ 3% (during 70%~100%)<br>Undefined (during 0~70%) | Adult and Pediatric:<br>$\pm$ 2% (during 70%-100%)<br>Neonate:<br>$\pm$ 3% (during 70%-100%)<br>Undefined (during 0~70%) | Measuring parameters | CO₂ Response Time | Units |
| Alarm of SpO₂ | High and lower alarms.<br>The limits are adjustable. | | High and lower alarms.<br>The limits are adjustable. | The limit is adjustable. | EtCO₂, InsCO₂ and Respiration Rate | Sidestream: <3seconds (includes transport time and rise time).<br>Mainstream: <60ms (rise time) | mmHg, kPa or Vol% |
| Pulse rate display<br>range | 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 pulse<br>rate | $\pm$ 2bpm or $\pm$ 2% (whichever is<br>greater) | | $\pm$ 3 bpm | $\pm$ 3bpm | EtCO₂, InsCO₂ and Respiration Rate | <3seconds (includes transport time and rise time) | mm Hg, kPa or % |
| Alarm of pulse<br>rate | High and lower alarms.<br>The limits are adjustable. | | High and lower alarms.<br>The limits are adjustable. | The limit is adjustable. | CO₂ measure range | CO2 Accuracy | Respiration Rate |
| CO₂ | | | | | EtCO₂: 0~150mmHg<br>InsCO₂: 3~50mmHg | 0~40 mmHg ±2mmHg<br>41~70 mmHg ±5% of reading<br>71~100 mmHg ±8% of reading<br>101~150mmHg±10% of reading | 2~150rpm (Sidestream) or |
| CO₂, EtCO₂, FICO₂ Range: 0~99 mmHg | 0~38 mmHg: ± 2 mmHg<br>39~99 mmHg: ± (5% of reading + 0.08% for every 1 mmHg above 38 mmHg) | 0~150 rpm | | | | | |
| EtCO₂: 0~99mmHg<br>InsCO₂: 0~99mmHg | 0~40mmHg ±2mmHg<br>41~76mmHg ±8% of reading<br>77~99mmHg±10% of reading | 0~150bpm | | | | | |

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| 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, flow<br>measured by volume | 50ml/min ±10 ml/min<br>(Sidestream) |
| Suffocation Alarm Delay | 10~60s | 10~60s | 10~40s |
| Alarm of EtCO₂ | High and lower alarms.<br>The limits are adjustable. | High and lower alarms.<br>The limits are adjustable. | The limit is adjustable. |
| Alarm of RR | High and lower alarms.<br>The limits are adjustable. | High and lower alarms.<br>The limits are adjustable. | The limit is adjustable. |

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## 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.

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

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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.

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#### 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known):

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

Indications 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 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:

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