(145 days)
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No
The description details a standard pulse oximetry technology based on light absorption and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device measures arterial oxygen saturation and pulse rate but does not directly treat or prevent medical conditions. It provides diagnostic information but is not therapeutic itself.
Yes
The device measures arterial oxygen saturation and pulse rate to provide information about the patient's physiological state, which can be used to inform a diagnosis or monitor a medical condition. The "Indications for Use" section mentions "basic patient sleep screening", which implies a diagnostic application.
No
The device description explicitly details the use of hardware components (red and infra red light, photodiode) to obtain measurements, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
- Device Description: The Mediaid Pulse Oximeter Model 34 is described as a non-invasive device that measures arterial oxygen saturation and pulse rate by directing light through a pulsating vascular bed. This measurement is taken on the body, not from a sample taken from the body.
Therefore, because the device operates non-invasively and does not analyze samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Mediaid pulse oximeter model 34 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in hospitals, physician's offices, emergency medical facilities, or at home. The model 34 can store data in memory for later review and documentation and also features a sleep mode for Basic overnight screening.
Non-invasive measurement of arterial oxygen saturation and pulse rate in hospitals, physician's office, emergency medical facilities, or at home. The model 34 can store data in memory for later review and documentation and also features a sleep mode for basic patient sleep screening.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Mediaid Pulse Oximeter Model 34 is designed to measure the percentage of functional oxygenated hemoglobin to total hemoglobin.
Noninvasive arterial oxygen saturation measurement is obtained by directing red and infra red light through a pulsating vascular bed. The pulsating arterioles in the path of the light beam cause a change in the amount of light detected by a photodiode. The pulse oximeter determines the oxygen saturation of arterial blood by measuring the ratio of transmitted red to infrared light within the pulse waveform. The non-pulsatile signal is removed electronically for the purpose of calculation. Therefore, skin, bone, and other non-pulsating substances do not interfere with the measurement of arterial oxygen saturation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, physician's offices, emergency medical facilities, or at home.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Performance testing was conducted during clinical hypoxia studies conducted in an independent research lab. Mediaid Pulse Oximeter Model 34 were compared to arterial blood samples analyzed on a laboratory cooximeter and found to be equivalent to predicate device accuracy claims. Bench testing was performed to verify pulse rate accuracy. Biocompatibility, electrical safety, and EMC testing were also performed to demonstrate conformance with established industry standards.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted during clinical hypoxia studies conducted in an independent research lab. Mediaid Pulse Oximeter Model 34 were compared to arterial blood samples analyzed on a laboratory cooximeter and found to be equivalent to predicate device accuracy claims. Bench testing was performed to verify pulse rate accuracy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the word "MEDIAID" in bold, black letters. The word is centered within a white oval shape. A black border surrounds the oval, creating a contrasting outline.
5172 24-01-2023 14:54:54 5172 24-01-2023 14:54:54
8.714.367.2848 • 8.714.367.2852 • WWW.MEDIAING.COM
Section 5 - 510(k) Summary of Safety and Effectiveness
Submitter Information: Mediaid, Inc. 17517 Fabrica Way #H Cerritos, CA 90703 Registration # 2087439
Contact: Jayesh Patel, CEO Telephone: 714-367-2848 Fax: 714-367-2852
NOV - 5 2007
Date Prepared: May 2nd 2007
Product Name & Classification:
Mediaid Model# M30 and M34 Common Name: Pulse Oximeter Regulation: 870.2700 Product Code: DQA Class: II
Predicate Device:
Mediaid (formally Palco Labs) Pulse Oximeter Model 34 is substantially equivalent to Mediaid / Palco Pulse Oximeter Model 305 marketed under K943842 and Nonin Model 2500 marketed under K050056. Comparative matrices between the proposed devices and other devices are provided. Please refer to section 12.
Model 34 is identical to other marketed devices, with the exception that the power source battery is Li-ion and USB port is added to the existing topography of Mediaid/Palco Pulse Oximeters.
Description:
The Mediaid Pulse Oximeter Model 34 is designed to measure the percentage of functional oxygenated hemoglobin to total hemoglobin.
Noninvasive arterial oxygen saturation measurement is obtained by directing red and infra red light through a pulsating vascular bed. The pulsating arterioles in the path of the light beam cause a change in the amount of light detected by a photodiode. The pulse oximeter determines the oxygen saturation of arterial blood by measuring the ratio of transmitted red to infrared light within the pulse waveform. The non-pulsatile signal is removed electronically for the purpose of calculation. Therefore, skin, bone, and other non-pulsating substances do not interfere with the measurement of arterial oxygen saturation.
MEDIAID PALCO PULSE OXIMETERS
1
Image /page/1/Picture/0 description: The image shows the word "MEDIAID" in bold, black letters. The word is centered within a white oval shape. The oval is surrounded by a black border.
714.357.2846 | 714.367.2852 | WWW.MEDIAINC.COM
Product images are included. Please refer to section 11.
Intended Use:
Mediaid pulse oximeter model 34 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in hospitals, physician's offices, emergency medical facilities, or at home. The model 34 can store data in memory for later review and documentation and also features a sleep mode for Basic overnight screening.
Comparison to Predicate Device:
Mediaid SpO2 Sensors use the same theory and principle of operation as the predicate device. Design characteristics are equivalent in terms of safety and effectiveness, as demonstrated by product testing and accuracy claims.
Performance Data & Conclusions:
Performance testing was conducted during clinical hypoxia studies conducted in an independent research lab. Mediaid Pulse Oximeter Model 34 were compared to arterial blood samples analyzed on a laboratory cooximeter and found to be equivalent to predicate device accuracy claims. Bench testing was performed to verify pulse rate accuracy.
Biocompatibility, electrical safety, and EMC testing were also performed to demonstrate conformance with established industry standards.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2007
Mr. Jayesh Patel Chief Executive Officer Mediaid. Incorporated 17517 Fabrica Way, Suite H Cerritos, California 90703
Rc: K071610
Trade/Device Name: Mediaid Pulse Oximeter M30 and M34 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 22, 2007 Received: October 24, 2007
Dear Mr. Patel:
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.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Patel
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nil RP Oglan
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K071610
Device Name: Mediaid Pulse Oximeter M30 and M34
Indications for Use: Non-invasive measurement of arterial oxygen saturation and pulse rate in hospitals, physician's office, emergency medical facilities, or at home. The model 34 can store data in memory for later review and documentation and also features a sleep mode for basic patient sleep screening.
Prescription Use __ XX_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miri Shlyf
The