PULSE OXIMETER MODEL P10

K100225 · Mediana Co., Ltd. · DQA · Feb 9, 2011 · Cardiovascular

Device Facts

• Record ID: K100225
• Device Name: PULSE OXIMETER MODEL P10
• Applicant: Mediana Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The P10 pulse oximeter is intended to be used to monitor functional arterial oxygen saturation (SpO2) and pulse rate in all areas of a hospital, hospital, hospital-type facilities, intra-hospital transport and home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist. Note: The continuous monitoring and Spot check mode are user-selectable. The mode of operation is the continuous monitoring except when the Spot Check Mode (03) is enabled.

Device Story

P10 Pulse Oximeter; lightweight, compact (58x105x21mm, 90g) handheld device; powered by 3 AAA alkaline batteries. Inputs: non-invasive optical signals via reusable SpO2 sensors (YM-1, YM-2, YM-5) processed by MD1 module. Outputs: SpO2 and pulse rate displayed on LCD. Used in hospitals, transport, and home settings by clinicians or trained technicians. Operation modes: continuous monitoring or spot check. Device provides real-time physiological data to assist clinicians in assessing patient oxygenation status; aids in clinical decision-making regarding respiratory support or patient monitoring.

Clinical Evidence

Clinical hypoxia testing conducted on 10 healthy adult volunteers (diverse demographics). Accuracy of P10 pulse oximeter validated against SaO2 obtained via co-oximetry reference method on radial arterial blood samples. No adverse events or complications reported. Data supports accuracy claims across the specified saturation range. Bench testing included biocompatibility (ISO 10993), electrical safety (ISO 60601-1), EMC (ISO 60601-1-2), and SpO2 performance (ISO 9919).

Technological Characteristics

Handheld pulse oximeter; dimensions 58x105x21mm; weight 90g; power source 3 AAA alkaline batteries. Uses MD1 SpO2 module and reusable YM-1/YM-2/YM-5 sensors. Measures functional arterial oxygen saturation via non-invasive optical sensing. Conforms to ISO 10993 (biocompatibility), ISO 60601-1 (electrical safety), ISO 60601-1-2 (EMC), and ISO 9919 (SpO2).

Indications for Use

Indicated for monitoring functional arterial oxygen saturation (SpO2) and pulse rate in adult, pediatric, and neonate patients in hospital, intra-hospital transport, and home environments. Intended for use by trained technicians, doctors, nurses, or medical specialists.

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

• Nellcor Puritan Bennett Handheld Pulse Oximeter, Model NPB-40 (K963707)
• Mediaid inc. Pulse Oximeter, Model 3X Series (K071610)
• Masimo Corp. Masimo SET Pulse Oximeter, Model RAD-5 (K033296)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

#### Submitter

Mediana Co.,Ltd. Wonju Medical Industry Park, 1650-1 Donghwa-ri, Munmak-eup, Wonju-si, Gangwon-do. Korea Tel) [phone] Fax) [phone] Company Contact: Amy.M.H Kim, Manager of Requlatory Affairs Rang.S.S Kim, Specialist of Requlatory Affairs Date Summary Prepared: July 20th, 2010

## Device Name

Trade Name: Common Name: Classification Name: Classification: Product code:

P10, Pulse Oximeter Pulse Oximeter Non-invasive pulse oximetry, SpO2 (21CFR870.2700) Class II DQA

## Predicate Devices (Legally Marketed Devices)

The predicate devices for Pulse oximeter, P10 is:

- Nellcor Puritan Bennett (division of Tyco Healthcare Inc.) Handheld Pulse Oximeter, Model NPB-40 cleared by FDA through 510(k) No. K963707, and
- Mediaid inc. Pulse Oximeter, Model 3X Series cleared by FDA through 510(k) No. K071610, and
- . Masimo Corp. Masimo SET Pulse Oximeter, Model RAD-5 cleared by FDA through 510(k) No. K033296.

## Device Description

The P10 Pulse Oximter is to monitor non-invasive functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate for adult, pediatric and neonate patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.

The Mediana P10 Pulse Oximeter is a lightweight and compact device (58×105×21mm and 90g) powered by 3 Alkaline AAA batteries. The monitor provides patient data and monitoring status on LCD displays. MD1 module is used for SpO2 module, and YM-1 reusable sensor is used for SpO2 sensor.

## Intended Use

The P10 pulse oximeter is intended to be used to monitor functional arterial oxygen saturation (SpO2) and pulse rate in all areas of a hospital-type facilities, intra-hospital transport and home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist.

- Note: The continuous monitoring and Spot check mode are user-selectable. The mode of operation is the continuous monitoring except when the Spot Check Mode (03) is enabled.

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#### Summary of Technical Characteristics of the Device Compared to the Predicate Devices (Legally Marketed Devices)

The Mediana pulse oximeter, Model P10 is substantially equivalent to the Mediaid inc., Model 3X series, Masimo, Model RAD-5, and Nellcor Puritan Bennett (division of Tyco Healthcare Inc.), Model NPB-40.

- · The Pulse Oximetry (SpOz) specifications and performance are equivalent to the Mediaid inc., model 3X Series and Masimo Corp., model RAD-5. The P10 pulse oximeter uses the SpO2 module (MD1) and the SpO2 sensor (YM-1, YM-2 and YM-5). The SpO2 module (MD1) has the clinical validation report. A copy of the clinical report mentioned is in Section 17-O at the end of the 510(K) submission files. The operation principle of Mediana Model P10 is same as those of the Mediaid inc., model 3X series, the Masimo, model RAD-5 and Nellcor Puritan Bennett, model NPB-40. (The units measure functional saturation ~ oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen.)
- · The Pulse rate (PR) specifications and performance derived from Non-Invasive Pulse Oximetry (SpQz) are equivalent to the Mediaid inc., model 3X Series and Masimo Corp., model RAD-5.

#### Summary of Performance Testing in order to demonstrate substantial equivalence

The Mediana pulse oximeter, Model P10 substantially have been tested in accordance with the system V & V plan and summary (#MDR-YW090626-01) included with the submission using production equivalent units prior to release to market.

Biocompatibility(ISO 10993), electrical safety(ISO 60601-1), EMC(ISO 60601-1-2) and SpOz (ISO 9919) testing were also performed to demonstrate conformance with established industry standards. These standards are applicable for predicate devices in common.

A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of Mediana design control procedure. Mediana's quality system confirms to 21CFR820, ISO 9001, ISO13485 and CMDCAS ISO 13485 certified by DNV (Det Norske Veritas) and OMI (Quality Measuring Instrument).

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## Clinical Tests Submitted

Clinical hypoxia testing was performed under an institutionally approved protocol with subject informed consent. Clinical testing was performed with human adult volunteers to validate the accuracy of P10 pulse oximeter with accessory sensors versus arterial oxygen saturation(SaO2) as obtained by co-oximetry reference method on radial arterial blood samples. No adverse events or complications were noted during the study.

| Subject # | Age | Race | Sex | Physical Condition |
|-----------|-----|------------------|-----|--------------------|
| 1 | 27 | White | M | 6'0", 225lb |
| 2 | 21 | White | M | 6'0", 180lb |
| 3 | 26 | White | M | 5'11", 205lb |
| 4 | 21 | Hispanic | F | 4'11", 105lb |
| 5 | 29 | White | F | 5'6", 148lb |
| 6 | 20 | White | F | 5'4", 140lb |
| 7 | 28 | African American | M | 6'0", 190lb |
| 8 | 23 | White | M | 5'7", 150lb |
| 9 | 34 | Hispanic | F | 5'1", 113lb |
| 10 | 30 | Hispanic | M | 5'7", 175lb |

The list of human adult volunteers is shown below.

Sample(SpOz) and reference(SaOz) values were evaluated for ARMs accuracy in accordance with recognized methods. Data obtained from the clinical tests support device accuracy claims for the specified saturation range.

As described above, testing above demonstrates that the P10 pulse oximeter monitor with accessory sensors are equivalent to predicate sensors as substantiated by laboratory and clinical testing.

Device safety is supported by use of biocompatible patient contact materials and compliance testing to recognized standards.

#### Conclusions

As stated above, the Mediana pulse oximeter, Model P10 is safe and effective and complies with the appropriate medical device standards and is substantially equivalent to the earlier identified predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – W()66-G609 Silver Spring, MI) 20993-0002

Mediana Company, Limited C/O Mr. Charlie Mack International Regulatory Consultants 77325 Joyce Way Echo, Oregon 97826

FEB - 9 2011

Re: K100225 Trade/Device Name: P10, Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Pulse Oximeter Regulatory Class: II Product Code: DQA Dated: February 3, 2011 Received: February 7, 2011

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 Devices marke 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 provisions 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 misoranding 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 Rederal Register

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Page 2- Mr. Mack

Enclosure

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 Fequirement 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) (2) CFR 803); good manufacturing practice requirements as set forther the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (21 CFR Pari 200
the Act) 21 CER 1000 1050 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/About/DA/CentersQffices/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 premaince. Also
(21CFR Part 807 97) For questions of 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

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 Assis
http://www.fil 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

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## INDICATIONS FOR USE

#### Applicant:

Mediana Co.,Ltd. Dongwha Medical Instrument Complex, 1650-1 Donghwa-ri, Munmak-eup, Wonju-si, Gangwon-do, Korea Telephone: [phone] Fax: [phone]

510(k) Number: J

Device Name: P10, Pulse Oximeter

#### Indications for Use:

The P10 pulse oximeter is intended to be used to monitor functional arterial oxygen saturation (SpO2) and pulse rate in all areas of a hospital, hospital, hospital-type facilities, intra-hospital transport and home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist.

Note: The continuous monitoring and Spot check mode are user-selectable. The mode of operation is the continuous monitoring except when the Spot Check Mode (03) is enabled.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use O OR Over-The-Counter_ (Per 21CFR801.109)

L. Schulten

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