OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316

K100815 · Oxypulse · DQA · Jun 16, 2010 · Cardiovascular

Device Facts

• Record ID: K100815
• Device Name: OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316
• Applicant: Oxypulse
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The OxiBlue Fingertip Puls) Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arterial overan saturation (SpO2) and pulse rate of patients in home care. It is intended for adu't and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiBlue can transmit in the either a USB cable or wireless Bluetooth technology. The OxiPro Fingertip Pulse Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arter. V oxygen saturation (SpO2) and pulse rate of patients in home care. It is intended for adu' and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiPro can transmit Pro vio : USB cable, and does not include Bluetooth technology.

Device Story

Fingertip pulse oximeters measure SpO2 and pulse rate via optical sensors; intended for home use by adult and pediatric patients. OxiBlue model supports data transmission via USB or Bluetooth; OxiPro model supports USB only. Devices provide continuous or spot-check monitoring; output displayed for user review. Data transmission facilitates remote monitoring or record keeping. Benefits include non-invasive, convenient tracking of oxygen saturation and heart rate outside clinical settings.

Technological Characteristics

Fingertip pulse oximeter; optical sensing technology; battery-powered; dimensions accommodate finger thickness 0.8-2.5 cm; connectivity via USB or Bluetooth (OxiBlue) and USB (OxiPro).

Indications for Use

Indicated for continuous or spot-check measurement of functional arterial oxygen saturation (SpO2) and pulse rate in adult and pediatric patients with finger thickness 0.3-1.0 inch (0.8-2.5 cm) in home care 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.

Submission Summary (Full Text)

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

Oxypulse C/O Mr. James A. Dunning President Qualpro Consulting, LLC One Macdonal Center, 1 North Macdonald Suite # 8 Mesa, Arizona 85201

JUN 1 62010

Re: K100815

Trade/Device Name: OxiBlue Fingertip Pulse Oximeter and OxiPro Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 18, 2010 Received: March 23, 2010

Dear Mr. Dunning:

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 fabeling 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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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 (QS) 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,

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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## Indication for use

510(k) Number (if Imown in K100815

Device Name: OxiBlue Fingertip Pulse Oximeter and OxiPro Fingertip Pulse Oximeter

Indications for Use:

The OxiBlue Fingertip Puls) Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arterial overan saturation (SpO2) and pulse rate of patients in home care. It is intended for adu't and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiBlue can transmit in the either a USB cable or wireless Bluetooth technology.

The OxiPro Fingertip Pulse Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arter. V oxygen saturation (SpO2) and pulse rate of patients in home care. It is intended for adu' and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiPro can transmit Pro vio : USB cable, and does not include Bluetooth technology.

Prescription Use × (Part 21 CFR 801 Subpar: D)

AND/OR

Over-The-Cou8nter Use ‫( (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE I THO'N THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

C . . currence of CDRH, Office of Device Evaluation (ODE)

L. Schult

Division Sign-Off) iivision of Anesthesiology, General Hospital fection Control, Dental Devices

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10(k) Number: KC 100815

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