FLEXI-STAT SP02 EAR SENSOR

K042675 · Elekon Industries U.S.A., Inc. · DPZ · Dec 6, 2004 · Cardiovascular

Device Facts

• Record ID: K042675
• Device Name: FLEXI-STAT SP02 EAR SENSOR
• Applicant: Elekon Industries U.S.A., Inc.
• Product Code: DPZ · Cardiovascular
• Decision Date: Dec 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2710
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Flexi-Stat SpO2 Ear Sensor is an electro-optical sensor for pulse oximetry; functions without skin penetration, electrical contact, or heat transfer. Device clips to patient ear; contains two LEDs (light sources) and one photodiode (light detector). Sensor connects to pulse oximeter via DB-9 cable. Measures light absorption of functional arterial hemoglobin to determine oxygen saturation and pulse rate. Used in clinical settings; operated by healthcare professionals. Output displayed on connected oximeter; assists clinicians in monitoring patient oxygenation status; enables timely clinical intervention for hypoxemia.

Clinical Evidence

Clinical hypoxia studies conducted in an independent research lab compared the device to arterial blood samples analyzed on a laboratory co-oximeter. Results demonstrated equivalence to predicate device accuracy claims. Pulse rate accuracy was validated via bench testing using a pulse rate simulator. Biocompatibility, electrical safety, and EMC testing performed per industry standards.

Technological Characteristics

Electro-optical sensor; two LEDs and one photodiode; ear clip housing; DB-9 connector. Non-invasive; no skin penetration or heat transfer. Complies with biocompatibility, electrical safety, and EMC standards.

Indications for Use

Indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 kg.

Regulatory Classification

Identification

An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

Predicate Devices

• Nellcor Dura-Y ear sensor (K944760)

Submission Summary (Full Text)

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DEC - 6 2004

Appendix C Page 1 of 2

K042675

# 510(k) Summary

### Submitter Information:

Elekon Industries, USA, Inc. 3848 Del Amo Blvd. Torrance CA 90503 USA

#### Contact:

Tom Dietiker, President Tel: [phone] Fax:[phone]

### Date Prepared:

September 13, 2004

## Product Name:

Common Name: SpO2 Ear Sensor (accessory to pulse oximeter - ear oximeter) Trade Name(s): Flexi-Stat SpO2 Ear Sensor

## Predicate Device:

Elekon Flexi-Stat™ ear sensor is substantially equivalent to the Nellcor Dura-Y ear sensor marketed under K944760.

#### Description:

The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions 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 a durable ear clip housing. The sensor cable is terminated in a DB-9 style connector.

#### Intended Use:

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

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#### Comparison to Predicate Device:

The Flexi-Stat SpO2 Ear Sensor uses 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. The Flexi-Stat was compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims.

Pulse rate accuracy was validated using bench testing with a pulse rate simulator.

Biocompatibility, electrical safety, and EMC testing was also performed to demonstrate conformance with established industry standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2004

Elekon Industries U.S.A., Incorporated C/O Ms. Krista Oakes Principal Amica Solutions 2300 McDermott Road, #200-207 Plano, Texas 75025

Re: K042675

Trade/Device Name: Flexi-Stat SpO2 Ear Sensor Regulation Number: 21 CFR 870.2710 Regulation Name: Ear Oximeter Regulatory Class: II Product Code: DPZ Dated: September 14, 2004 Received: October 4, 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 vour 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 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/dsma/dsmamain.html

Sincerely vours.

Susan Rumme
Chiu-Lin, Ph.D.

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) # (if known):

Device Name: Flexi-Stat SpO2 Ear Sensor

Indications for Use:

Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 kg

Prescription Use __ x (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)

Aun Syleon

(Division Sig Division of Anesthesiology, General Hospital, Infection Control. Denta

510(k) Number: K042615