PC-60NW FINGERTIP OXIMETER

K120502 · Shenzhen Creative Industry Co., Ltd. · DQA · Dec 7, 2012 · Cardiovascular

Device Facts

• Record ID: K120502
• Device Name: PC-60NW FINGERTIP OXIMETER
• Applicant: Shenzhen Creative Industry Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 7, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The PC-60NW Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries. This device is applicable for spot-checking of SpO2 and pulse rate in home and clinic for adult and pediatric patients. This device is recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.

Device Story

Fingertip pulse oximeter; measures SpO2 and pulse rate via finger-mounted sensor; displays data on OLED color dot matrix screen including plethysmogram, bar graph, and perfusion index. Used in home or clinic settings by patients or clinicians for spot-checking. Features automatic start-up upon finger insertion; includes wireless module for data transmission to computer. Provides real-time physiological monitoring to assist in identifying hypoxemia; aids clinical decision-making by offering non-invasive, convenient alternative to blood gas analysis.

Clinical Evidence

Bench testing only. Device validated against system V&V plan, including electrical safety (IEC 60601-1-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-1), and pulse oximeter performance standards (ISO 9919:2005, ISO 80610-2-61). No clinical trial data presented.

Technological Characteristics

OLED color dot matrix display; wireless communication module; powered by 2 AAA batteries. Biocompatible materials per ISO 10993-1. Standards: IEC 60601-1-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 9919:2005 and ISO 80610-2-61 (SpO2 performance).

Indications for Use

Indicated for spot-checking pulse rate and functional oxygen saturation (SpO2) in adult and pediatric patients with finger thickness 1.0-2.2 cm. Recommended for use on index finger in home or clinical settings.

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

• Shenzhen Creative Industry Co., Ltd, PC-60 Fingertip Oximeter (K063641)

Submission Summary (Full Text)

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KI2OSO2

# 510(k) Summary

# DEC 0 7 2012

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

# Date: October 15, 2012

# 1. Company:

Name - Shenzhen Creative Industry Co., Ltd. Address Addr. 2/F, Block 3, Nanyou Tian'an Industry Town, Shenzhen, GD 518054, P.R. China Telephone - [phone] Fax - [phone] Contact - Mrs. Wang Jia Email [e-mail]

## Correspondent:

Name- IRC Address- 77325 Joyce Way, Echo, Oregon 97826 Telephone- 931-625-4938 Fax- 541-376-5063 Contact- Charlie Mack Email- [e-mail]

# 2. Device :

| Trade/proprietary name | PC-60NW Fingertip Oximeter |
|------------------------|----------------------------|
| Common Name | Oximeter |
| Classification Name | Oximeter |

3. Predicate Devices :

Shenzhen Creative Industry Co., Ltd, PC-60 Fingertip Oximeter K063641

This submission is an Abbreviated 510(k) submission, based upon standards and the predicate is simply the original basis of the submitted device.

4. Classifications Names & Citations :

21CFR 870.2700 Oximeter, DQA, Class2

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Description :

General

The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, and the so-called O2 concentration in the blood. It is an important bio-parameter for the respiration. Many of the respiration disease will cause hypoxemia, even damage the patient's life. As a result, monitoring the SpO2 is indispensable in the clinical rescuing. The traditional monitoring method is to take the patient's blood sample and analyze the sample by the blood gas analyzer, measure out the O2 pressure and calculate the SpO2 finally. Traditionally SpO2 measure is based on the clinical help of sapling human blood, and getting O2 pressure by hemo-air analysis using hemo-air analyzer, then calculate the SpOz. This method is inconvenient and discontinuous. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Fingertip Oximeter. The device can measure the body pulse simultaneously.

The PC-60NW Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries, it is small in size, convenient to use, and easy to carry. This device is applicable for spot-checking of SpO2 and pulse rate in home and clinic. The index finger is the recommended site. It is intended for spotchecking adult and pediatric patients on fingers between 1.0 -2.2 . cm thick.

This oximeter has the function of wireless data transmission. The user can effectively transmit the data to computer through the wireless communication module.

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### 5. Indication for use :

The PC-60NW Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's fing er, and indicating the pulse intensity by a bar-graph display.

This device is powered by 2 AAA batteries. This device is applicable for spot-checking of SpO2 and pulse rate in home and clinic for adult and pediatric patients. This device is recommended for use o n the index finger, for patients with fingers of 1.0 - 2.2 cm thick.

### 6. Comparison with predicate device :

Shenzhen Creative Industry Co., Ltd, PC-60 Fingertip Oximeter K063641

This submission is an Abbreviated 510(k) submission, based upon standards and the predicate is simply the original basis of the submitted device.

7. Safety and Performance Data :

# Summary of Performance Testing

The Model PC-60 Fingertip Oximeter substantially has been tested in accordance with the system V & V plan and summary included with the submission using production equivalent units prior to release to market. A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of design control procedure. Shenzhen Creative Industry, LTD quality system confirms to 21 CFR820, ISO 9001, ISO13485 and CMDCAS ISO 13485. Testing performed to Electrical Safety IEC 60601-1-1:1988, EMC Requirements IEC 60601-1-2, Biocompatibility IEC 10993-1, SPO2 Basic Safety and performance ISO 9919:2005, Basic Electrical safety and performance for Pulse Oximeters, ISO 80610-2-61 and pertinent FDA quidance documents, complied with the specific requirements for safety and performance.

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- 8. Differences between Predicate and Submitted PC60-NW:
The only difference between the submitted device and the predicate is in the display. The predicate uses a seven segment LCD to display the SPO2 and Pulse rate. Also the predicate displays the pulse amplitude with a 16 segment bar graph. The submitted device uses an OLED color dot matrix to display SPO2, Pulse Rate/perfusion index and plethysmogram and bar graph. The submitted device has two new features of automatic start-up two seconds after the finger is inserted and the new device has wireless PC connection capabilities.

#### 9. Conclusions:

The performance data cited in the non- clinical testing performed is sufficient to demonstrate substantial equivalence to 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 Shenzhen Creative Industry Co., Ltd. concludes that the PC-60NW Fingertip Oximeter is safe and effective and complies with the acceptance criteria in the SP02 standards and FDA guidance documents as described herein.

END

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Image /page/4/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Shenzhen Creative Industry Company, Limited C/O IRC Mr. Charles Mack Principal Engineer 77325 Joyce Way ECHO, OR 97826

#### Re: K120502

Trade/Device Name: PC-60NW Fingertip Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: November 28, 2012 Received: December 04, 2012

## 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.

DEC 0 7 2012

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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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

**Kwame** O. Ulmer

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

Enclosure

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#### Indications for Use

# Indications for Use

510(k) Number (if known): K / 20562

Device Name: PC-60NW Fingertip Oximeter

Indications For Use:

- The PC-60NW Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display.
This device is powered by 2 AAA batteries. This device is applicable for spotchecking of SpO2 and pulse rate in home and clinic for adult and pediatric patients. This device is recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.

AND/OR Prescription Use _ (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) raval Roaphs

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lester W. Schultheis Jr 2012.12.07 11:31:42 -05'00'

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

K120502 510(k) Number;

15

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