(283 days)
Mediaid's compatible sensors are indicated as accessories to pulse oximeters used on Pulse Oximeters manufactured by Nonin Inc for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in infant, pediatric, and adult patients.
Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 connector.
The Mediaid SpO2 Sensors are intended for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The device's performance was evaluated through clinical hypoxia studies and bench testing.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Equivalent to predicate device accuracy claims | Found to be equivalent to predicate device accuracy claims |
| Pulse Rate Accuracy | Demonstrated through bench testing | Bench testing was performed to verify pulse rate accuracy |
| Biocompatibility | Conformance with established industry standards | Performed to demonstrate conformance with established industry standards |
| Electrical Safety | Conformance with established industry standards | Performed to demonstrate conformance with established industry standards |
| EMC Testing | Conformance with established industry standards | Performed to demonstrate conformance with established industry standards |
Note: The document states "equivalent to predicate device accuracy claims" for SpO2 accuracy, but it does not explicitly state numerical acceptance criteria for SpO2 or pulse rate. It implies that the predicate device's accuracy claims serve as the benchmark.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "clinical hypoxia studies" without providing the number of subjects.
- Data Provenance: Clinical hypoxia studies were conducted in an "independent research lab." The country of origin is not specified, but the submission is to the US FDA. The studies appear to be prospective, as they are described as "conducted" for the purpose of the device's evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated. The ground truth for SpO2 measurements was established using "arterial blood samples analyzed on a laboratory co-oximeter." The expertise of those analyzing the co-oximeter results is not detailed.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for SpO2 was derived from objective measurements (laboratory co-oximetry of arterial blood samples), not from expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The evaluation focuses on the device's performance against a reference standard (co-oximetry) and predicate device equivalence, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done for the SpO2 sensor. The "clinical hypoxia studies" evaluated the Mediaid SpO2 sensors against arterial blood samples analyzed on a laboratory co-oximeter, demonstrating the algorithm's (sensor's) ability to measure SpO2 directly. Bench testing was also performed solely on the device to verify pulse rate accuracy.
7. Type of Ground Truth Used
- SpO2: Objective measurement from "arterial blood samples analyzed on a laboratory co-oximeter."
- Pulse Rate: Not explicitly stated, but likely derived from a validated reference method during bench testing.
8. Sample Size for the Training Set
Not applicable. The document describes a medical device (SpO2 sensor) rather than an AI-powered diagnostic algorithm that typically requires a distinct training set. The device's operation is based on established electro-optical principles, not on machine learning requiring a training phase with labeled data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no specific training set for an AI/ML algorithm described.
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APA 12 2027
P 714.367.2848 • F 714.367.2852 • WWW.MEDIAIDINC.COM
061896
Section 5 - 510(k) Summary of Safety and Effectiveness
DB-9 style connector, with an adapter cable for Datex-compatible models.
Description:
Intended Use:
Mediaid SpO2 Sensors are indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
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 SpO2 sensors were compared to arterial blood samples analyzed on a laboratory co-oximeter 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 was also performed to demonstrate conformance with established industry standards.
Submitter Information:
Mediaid, Inc. 17517 Fabrica Way #H Cerritos, CA 90703 Registration # 2087439
Contact:
Mahesh Patel, CFO Telephone: 714-367-2848 Fax: 714-367-2852
Date Prepared: June 28, 2006
Product Name & Classification: Mediaid Model# CTS050-2101N AND CTS060-2101N
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7 14.367.2848 . F 71.4.367.2852 . WWW.MEDIAIDINC.COM
Common Name: SpO2 Sensor (accessory to pulse oximeter) Regulation: 21 CFR 870.2700 Product Code: DQA Class: II
Predicate Device:
Mediaid (formerly Palco) currently markets its own pulse oximetry system under K994372 and K911191. Mediaid wishes to extend its product line to include its own brand of pulse oximeter sensors that are compatibile with Nonin pulse oximeters. Nonin pulse oximeter sensors are marketed under K001930 and K002690.
Description:
Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 connector.
Intended Use:
Mediaid SpO2 sensors are intended for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
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 and was shown to validate performance claims and accuracy. Bench testing was performed to verify pulse rate accuracy.
Biocompatibility, electrical safety, and EMC testing was also performed to demonstrate conformance with established industry standards.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2007
Mr. Mahesh Patel Mediaid, Incorporated 17517 Fabrica Way, Suite H Cerritos, California 90703
Re: K061896
Trade/Device Name: Mediaid Pulse Oximeter Sensors, Models CST050-2101N and CST060-2101N
Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 30, 2007 Received: April 2, 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 either 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 (OS) 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 proceed 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suttie Y. Nolan Omd
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
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Mediaid Pulse Oximeter Sensors
Indications for Use: -
Mediaid's compatible sensors are indicated as accessories to pulse oximeters used on Pulse Oximeters manufactured by Nonin Inc for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in infant, pediatric, and adult patients.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
cheuto
nal Hospal,
on Control Devices
k) Number: K061896
2k)
§ 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).