(379 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on standard pulse oximetry technology and validation methods.
No.
A therapeutic device is used to treat or cure a condition, whereas this device is described as a pulse oximeter intended for monitoring arterial oxygen saturation and pulse rate. The text explicitly states its purpose is "to monitor functional arterial oxygen saturation (SpO2) and pulse rate".
No
A pulse oximeter monitors physiological parameters (oxygen saturation and pulse rate) but does not provide a medical diagnosis itself.
No
The device description explicitly states it is a lightweight and compact device with physical dimensions and weight, powered by batteries, and includes an LCD display, an SpO2 module (MD1), and a reusable SpO2 sensor (YM-1). These are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body.
- Device Function: The P10 pulse oximeter is described as a device that monitors functional arterial oxygen saturation (SpO2) and pulse rate non-invasively. This means it measures these parameters by placing a sensor on the patient's body (likely a finger or toe), without taking any samples from the body.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device directly measures physiological parameters from the patient.
Therefore, based on the provided information, the P10 pulse oximeter is a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonate patients
Intended User / Care Setting
medically trained personnel, physician or licensed health care professional, technician, doctor, nurse or medical specialist / general hospital and alternate care facilities, hospital-type facilities, intra-hospital transport and home environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Sample Size: 10 human adult volunteers
Data Source: Clinical hypoxia testing
Annotation Protocol: Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical hypoxia testing to validate accuracy against co-oximetry reference method. Testing in accordance with the system V & V plan. Biocompatibility (ISO 10993), electrical safety (ISO 60601-1), EMC (ISO 60601-1-2) and SpOz (ISO 9919) testing.
Sample Size: 10 human adult volunteers for clinical testing.
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results: Data obtained from the clinical tests support device accuracy claims for the specified saturation range. 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). 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
- 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
4
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:
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.
(Please do not write below this line – continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use O OR Over-The-Counter_ (Per 21CFR801.109)
L. Schulten
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