(145 days)
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.
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.
The provided text describes a 510(k) summary for the Mediaid Pulse Oximeter Models M30 and M34. However, it does not contain specific acceptance criteria or detailed results of a study that directly compare the device's performance against predefined criteria in a quantifiable table format.
The document generally states that "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." It also notes "Bench testing was performed to verify pulse rate accuracy."
Given the limitations of the provided text, I will construct a response based on the information available and indicate where specific details are missing.
Acceptance Criteria and Device Performance for Mediaid Pulse Oximeter Models M30 and M34
The provided 510(k) summary indicates that the Mediaid Pulse Oximeter Models M30 and M34 underwent performance testing to establish substantial equivalence to predicate devices. While specific numerical acceptance criteria and a detailed table of results are not included in the provided text, the summary states that the device was found to be "equivalent to predicate device accuracy claims" based on clinical hypoxia studies and bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance | Comments from Document |
|---|---|---|---|
| SpO2 Accuracy | (Implied: Equivalent to predicate device accuracy claims) | Found to be equivalent to predicate device accuracy claims | Based on clinical hypoxia studies comparing device readings to arterial blood samples analyzed on a laboratory cooximeter. |
| Pulse Rate Accuracy | (Implied: Acceptable accuracy) | Accuracy verified through bench testing. | Specific numerical accuracy not provided. |
| Biocompatibility | (Implied: Conformance with established industry standards) | Conformance demonstrated. | |
| Electrical Safety | (Implied: Conformance with established industry standards) | Conformance demonstrated. | |
| EMC Testing | (Implied: Conformance with established industry standards) | Conformance demonstrated. |
Missing Information: The document does not explicitly state the numerical acceptance criteria for SpO2 accuracy (e.g., RMS difference within a certain percentage) or pulse rate accuracy. It relies on the assertion of equivalence to predicate device claims.
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated for either the clinical hypoxia study or the bench testing. The document refers to "clinical hypoxia studies" without specifying the number of subjects or data points.
- Data Provenance:
- Clinical Hypoxia Studies: Conducted in an "independent research lab." The country of origin of the data is not specified.
- Study Type: These appear to be prospective studies, as they involved testing the device against arterial blood samples.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. For the SpO2 accuracy, the ground truth was established by "arterial blood samples analyzed on a laboratory cooximeter." While the cooximeter itself is an objective measurement tool, the expertise of the individuals operating and interpreting the cooximeter data is not mentioned.
4. Adjudication Method
This information is not applicable/not provided for the types of tests described. The primary ground truth for SpO2 was objective (laboratory cooximeter readings from arterial blood samples).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done according to this document. The testing focused on the standalone performance and accuracy of the device against objective measurements, rather than evaluating the improvement of human readers with AI assistance. Pulse oximeters typically provide direct measurements and are not systems designed for human interpretation of complex images or signals requiring subjective reader analysis and subsequent adjudication.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone study was done. The clinical hypoxia studies and bench testing directly assessed the performance of the Mediaid Pulse Oximeter Model 34 itself, independent of human interpretation or intervention beyond standard device operation. The device's SpO2 readings were compared to the "ground truth" established by the laboratory cooximeter, representing its standalone accuracy.
7. Type of Ground Truth Used
- For SpO2 Accuracy: The ground truth used was objective laboratory measurements from arterial blood samples analyzed on a laboratory cooximeter (gold standard for arterial oxygen saturation measurement).
- For Pulse Rate Accuracy: The ground truth method is not explicitly detailed beyond "bench testing," but it would typically involve comparison to a known, accurately generated pulse signal.
8. Sample Size for the Training Set
- This information is not applicable and not provided for this device. Pulse oximeters are typically developed using established physiological principles and calibration, not through machine learning models that require training sets with ground truth labels.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable and not provided for this device, as it does not rely on a training set in the context of machine learning.
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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
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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.
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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.
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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
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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
§ 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).