MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS

K041964 · Mediaid, Inc. · DQA · Sep 14, 2004 · Cardiovascular

Device Facts

• Record ID: K041964
• Device Name: MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS
• Applicant: Mediaid, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

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; they function without skin penetration, electrical contact, or heat transfer. The sensor utilizes two LEDs as light sources and one photodiode as a detector to measure light absorption of functional arterial hemoglobin. The sensor is housed in adhesive film, rigid spring-loaded clips, or foam/Velcro wraps and connects to pulse oximeters via a DB-9 connector (with adapter cables for specific models). Used in clinical settings, the device provides continuous data to the host oximeter, which processes the signal to display oxygen saturation and pulse rate. This information assists clinicians in patient monitoring and clinical decision-making regarding respiratory status.

Clinical Evidence

Clinical evidence includes hypoxia studies conducted in an independent research laboratory. The sensors were compared against arterial blood gas analysis to validate accuracy for oxygen saturation and pulse rate monitoring. Additional bench testing confirmed biocompatibility, electrical safety, and electromagnetic compatibility (EMC) per industry standards.

Technological Characteristics

Electro-optical sensor; two LEDs and one photodiode; DB-9 connector; adhesive, clip, or wrap form factors. Non-invasive, no electrical contact or heat transfer. Compatible with Nellcor, BCI, and Datex pulse oximeters.

Indications for Use

Indicated for continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in patients requiring such monitoring.

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)
• Nellcor pulse oximeter sensors (K863784)
• BCI pulse oximeter sensors (K030930)
• Datex pulse oximeter sensors (K962156)
• Datex pulse oximeter sensors (K983684)
• Datex pulse oximeter sensors (K991823)

Submission Summary (Full Text)

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K041964

Appendix C Page 1 of 1

SEP 1 4 2004

#### 510(k) Summary

#### Submitter Information:

Mediaid, Inc. 4025 Spencer St., Suite 103 Torrance, CA 90503

#### Contact:

Mahesh Patel, COO Telephone: [phone] Fax: [phone]

Date Prepared: July 15, 2004

#### Product Name:

Common Name: SpO2 Sensor (accessory to pulse oximeter)

#### 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 Nellcor, BCI, and Datex pulse oximeters. Nellcor, BCI, and Datex pulse oximeter sensors are marketed under K863784, K030930, K962156, and K983684, K991823, and K991823.

#### 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 style connector, with an adapter cable for Datex-compatible models.

#### Intended Use:

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

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### Comparison to Predicate Device:

Mediaid SpO2 Sensors use the same theory and principle of operation as the predicate Mevice. Design characteristics are equivalent in terms of safety and effectiveness, as demonstrated by product testing and accuracy claims.

## Performance Data & Conclusions:

2 or s which was conducted during clinical hypoxia studies conducted in an independent research lab. Mediaid SpO2 sensors were compared to arterial blood mucpendent research fab. Theatars Specieseter and found to be equivalent to predicate Samples analyzed on a facorater J ou vi formed 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2004

Mediaid, Incorporated C/O Ms. Krista Oakes Principal Amica Solutions 2300 McDermott Road # 200-207 Plano, Texas 75025

Re: K041964

Trade/Device Name: Mediaid SpO2 Sensor Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 10, 2004 Received: September 10, 2004

Dear Ms. Oakes:

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 - Ms. Oakes

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled on that your device complies with other requirements mean that FDA has made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally receital statutes and regaratests, including, but not limited to: registration You must comply with an the Act 3 roquite.com/s/21/centers/2017); good manufacturing practice and if the (21 CFR Part 607), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (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) I his letter will anow you to begin mailoring your device of your device to a premarket nothleation. The I Dr mining or sassification 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), If you desire specific advice for your do roo su caracter also, please note the regulation please contact the Online of Comphanes an (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sman Manatactacions , 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clive

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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Appendix B Page 1 of 1

# Statement of Indications For Use

K641964 510(k) # Device Name: Mediaid SpO2 Sensor

Indications for Use:

The Mediaid SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _X

or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Auu Sulion

(Division Sign-Off) (Division Sign-Ont
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K041484