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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Mediana P10 Pulse Oximeter, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting explicit numerical acceptance criteria for a new device. However, the core performance metric for a pulse oximeter is its accuracy in measuring functional arterial oxygen saturation (SpO2). The clinical testing was conducted to support the device's accuracy claims.

Acceptance Criteria Category	Specific Criteria (Inferred from Predicate Equivalence & Clinical Study)	Reported Device Performance
SpO2 Accuracy	Equivalent to predicate devices (Mediaid 3X Series, Masimo RAD-5)	Data obtained from clinical tests support device accuracy claims for the specified saturation range. (Specific numerical accuracy, e.g., ±2%, is not detailed in the provided summary, but implied by equivalence to predicates and "ARMs accuracy in accordance with recognized methods").
Pulse Rate Accuracy	Equivalent to predicate devices (Mediaid 3X Series, Masimo RAD-5)	Performance derived from Non-Invasive Pulse Oximetry (SpO2) are equivalent to predicate devices.
Biocompatibility	Conformance to ISO 10993	Testing performed to demonstrate conformance.
Electrical Safety	Conformance to ISO 60601-1	Testing performed to demonstrate conformance.
EMC (Electromagnetic Compatibility)	Conformance to ISO 60601-1-2	Testing performed to demonstrate conformance.
Pulse Oximetry Standards	Conformance to ISO 9919	Testing performed to demonstrate conformance.

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

Sample Size for Test Set: 10 human adult volunteers.
Data Provenance: Clinical hypoxia testing was performed in the context of an institutionally approved protocol, indicating a prospective study. The subjects were described as a mix of White, Hispanic, and African American individuals. The location of the study is not explicitly stated, but Mediana Co.,Ltd. is based in Korea and the 510(k) submission was processed in the US, suggesting the study could have been conducted in either region or internationally.

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

The ground truth for arterial oxygen saturation (SaO2) was established by a co-oximetry reference method on radial arterial blood samples. This method itself (co-oximetry) is the gold standard for measuring SaO2. While not explicitly stated as "experts," the performance of this co-oximetry method and the collection of arterial blood samples would necessitate highly skilled medical professionals (e.g., physicians, nurses, lab technicians) with expertise in arterial blood sampling and operating co-oximeters. The number of such professionals involved is not specified.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement using a co-oximetry reference method, not by expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the standalone accuracy of the pulse oximeter against a reference standard, not on how human readers' performance would improve with AI assistance. Pulse oximeters are typically standalone measurement devices.

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

Yes, a standalone performance study was done. The clinical hypoxia testing evaluated the accuracy of the P10 pulse oximeter against the co-oximetry reference method. This assesses the device's inherent measurement capabilities.

7. The Type of Ground Truth Used

The ground truth used was outcomes data / reference standard measurement in the form of arterial oxygen saturation (SaO2) obtained by the co-oximetry reference method from radial arterial blood samples. This is considered a highly accurate and direct measure for assessing pulse oximeter performance.

8. The Sample Size for the Training Set

The provided 510(k) summary does not explicitly mention a "training set" or "training data" in the context of a machine learning or AI algorithm. Pulse oximeters operate on well-established physiological principles and signal processing, rather than requiring extensive machine learning training sets in the same way an AI diagnostic imaging device would. The "clinical validation report" for the SpO2 module (MD1) mentioned in section 17-O might contain more details about any internal data used for calibration or algorithm refinement, but it's not detailed in this summary.

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

As no specific "training set" is mentioned in the context of machine learning, this question is not directly applicable. If the device uses algorithms that were developed using internal data, the ground truth for that development would typically be established through similar methods (e.g., comparison to co-oximetry) during the R&D phase of the SpO2 module.

Summary

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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) +82-33-742-5400 Fax) +82-33-742-5483 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

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.

End of Section -

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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 (800) 638-2041 or (301) 796-7100 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: (82) 70 7092 9965 Fax: (82) 2 542 7447

510(k) Number: J

Device Name: P10, Pulse Oximeter

Indications for Use:

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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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).