MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N

K061896 · Mediaid, Inc. · DQA · Apr 12, 2007 · Cardiovascular

Device Facts

• Record ID: K061896
• Device Name: MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N
• Applicant: Mediaid, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Mediaid SpO2 Sensors are indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

Device Story

Mediaid SpO2 sensors are electro-optical accessories for pulse oximeters; used for continuous, non-invasive monitoring of arterial oxygen saturation and pulse rate. Device utilizes two LEDs (light sources) and one photodiode (detector) to measure light absorption of functional arterial hemoglobin; no skin penetration, electrical contact, or heat transfer occurs. Sensors are housed in adhesive film, rigid spring-loaded clips, or foam/Velcro wraps; connect to oximeters via DB-9 connector. Operated by clinicians in clinical settings; output displayed on compatible Nonin pulse oximeter. Provides real-time physiological data to assist healthcare providers in patient assessment and monitoring.

Clinical Evidence

Clinical hypoxia studies conducted in an independent research lab compared Mediaid SpO2 sensors to arterial blood samples analyzed on a laboratory co-oximeter. Results demonstrated equivalence to predicate device accuracy claims. Bench testing verified pulse rate accuracy. Biocompatibility, electrical safety, and EMC testing performed per industry standards.

Technological Characteristics

Electro-optical sensor; two LEDs and one photodiode. Form factors: adhesive film, rigid spring-loaded clip, or foam/Velcro wrap. Connectivity: DB-9 connector for Nonin pulse oximeters. Non-invasive, no heat transfer. Biocompatibility, electrical safety, and EMC testing performed.

Indications for Use

Indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in infant, pediatric, and adult patients using Nonin pulse oximeters.

Regulatory Classification

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.

Predicate Devices

• Mediaid (formerly Palco) pulse oximetry system (K994372)
• Mediaid (formerly Palco) pulse oximetry system (K911191)
• Nonin pulse oximeter sensors (K001930)
• Nonin pulse oximeter sensors (K002690)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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 [phone]. 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 [phone] or [phone] 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)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

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