FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS

K041522 · Elekon Industries U.S.A., Inc. · DQA · Sep 14, 2004 · Cardiovascular

Device Facts

• Record ID: K041522
• Device Name: FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
• Applicant: Elekon Industries U.S.A., Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• 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 Sensor is an electro-optical accessory for pulse oximeters; functions without skin penetration, electrical contact, or heat transfer. Device utilizes two light-emitting diodes (LEDs) as light sources and one photodiode as a detector to measure light absorption of functional arterial hemoglobin. Components are housed in adhesive film; cable terminates in a DB-9 connector with adapter options for compatibility. Used in clinical settings to provide real-time oxygen saturation and pulse rate data to a host oximeter. Healthcare providers use output to monitor patient status and inform clinical decisions regarding oxygenation. Benefits include non-invasive, continuous monitoring of patient vital signs.

Clinical Evidence

Clinical hypoxia studies were conducted comparing the Flexi-Stat SpO2 Sensor to arterial blood samples analyzed on a laboratory co-oximeter. Results demonstrated that the device is equivalent to predicate device accuracy claims. Biocompatibility, electrical safety, and EMC testing were performed to demonstrate conformance with established industry standards.

Technological Characteristics

Electro-optical sensor; two LEDs and one photodiode; adhesive film housing; DB-9 connector with adapter cables. Non-invasive, no electrical contact or heat transfer. Conforms to biocompatibility, electrical safety, and EMC industry standards.

Indications for Use

Indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing ≥ 30 kg.

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

• Nellcor (K86378)
• BCI (K991823)
• Datex (K962156)
• Datex (K983684)
• Envitec (K992215)

Submission Summary (Full Text)

{0}------------------------------------------------

K041522

INDUSTRIES USA, INC.

SEP 1 4 2004

3848 Del Amo Blvd., Suite #304 Torrance, CA 90503 Tel: [phone] Fax: [phone] Internet: www.elekon.com

## 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:

June 4, 2004

#### Product Name:

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

#### Predicate Device:

Elekon Flexi-Stat™ sensors are substantially equivalent to Nellcor, BCI, and Datex pulse oximeter sensors marketed under 510(k) # K86378, K991823, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 510(k) # K992215.

#### 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 adhesive film. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datexcompatible models.

Appendix C Page 1 of 2

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for ELEKON INDUSTRIES USA, INC. The logo consists of a square with rounded corners on the left, inside of which is a stylized letter E. To the right of the square is the word "ELEKON" in bold, followed by "INDUSTRIES USA, INC." in a smaller font.

Appendix C Page 2 of 2

3882 Del Amo Blvd., Suite #601 Torrance, CA 90503 Tel: [phone] Fax: [phone] Internet: www.elekon.com

### Intended Use:

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

## Comparison to Predicate Device:

The Flexi-Stat SpO2 Sensor uses the same theory and principle of operation as the The I foxt But Sportsenaracteristics 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 i crorinance rosting was conderlexi-Stat was compared to arterial blood samples malyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims.

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

{2}------------------------------------------------

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 image of an eagle with its wings spread.

SEP 1 4 2004

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elekon Industries, USA, Incorporated C/O Ms. Krista Oakes Principal Amica Solutions, Incorporated 2300 McDermott Road, Suite 200-207 Plano, Texas 75025

Re: K041522

Trade/Device Name: Flexi-Stat SpO2 Sensor Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 7, 2004 Received: September 10, 2004

Dear Ms. Oakes:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in Includio for use sutted in the encosement date of the enactment date of the Medical Device interstate collinered proct to ria, 20, 1770, act reclassified in accordance with the provisions of Amendinents, of to devrees that have of the end the require approval of a premarket the rederal Pood, Drug, and Commay, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the fist ation, 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 If your device is classified (See above) for a controls. Existing major regulations affecting (PMA), it may of subject to Sach adate f Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Ms. Oakes

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DTC issuaires on that your device complies with other requirements Incall that I DA has made a astes and regulations administered by other Federal agencies. of the Act of ally I edelar statutes and reguirements, including, but not limited to: registration 1 ou must comply with and the research (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), lasting (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality of 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) This letter will anow Jour Jour Sinding of substantial equivalence of your device to a premarket notification. - The rice 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), If you desire specific at not 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 may obtain other general and Consumer Assistance at its toll-free Dribber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

{4}------------------------------------------------

Appendix B Page 1 of 1

# Statement of Indications For Use

K041522 510(k) # Device Name: Flexi-Stat SpO2 Sensor

Indications for Use:

Indications for Ose. The Flexi-Stal SpO2 Sensor is marethed 1000itoring in patients weighing ≥ 30 kg.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-the-Counter Use __

Aun Sullivan

(Division Sign-Off) (Division Sign-QII)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Anesthosion
Infection Control, Dental Device

510(k) Number: