DISPOSABLE NON-ADHESIVE SPO2 SENSORS

K042705 · Elekon Industries U.S.A., Inc. · DQA · Dec 29, 2004 · Cardiovascular

Device Facts

• Record ID: K042705
• Device Name: DISPOSABLE NON-ADHESIVE SPO2 SENSORS
• Applicant: Elekon Industries U.S.A., Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 29, 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 sensor for pulse oximetry; functions without skin penetration, electrical contact, or heat transfer. Device utilizes two LEDs and one photodiode housed in adhesive film to measure light absorption of functional arterial hemoglobin. Connects to pulse oximeter via DB-9 connector or adapter cable. Used in clinical settings for continuous monitoring of oxygen saturation and pulse rate. Output is processed by the host oximeter to provide real-time physiological data, enabling clinicians to assess patient oxygenation status and make timely clinical decisions. Benefits include non-invasive, continuous monitoring across adult, pediatric, and neonatal populations.

Clinical Evidence

Clinical hypoxia studies conducted in an independent research lab. Subject device compared to arterial blood samples analyzed on a laboratory co-oximeter. Results demonstrated accuracy equivalent to predicate device claims.

Technological Characteristics

Electro-optical sensor; two LEDs and one photodiode; adhesive film housing; DB-9 connector; compatible with pulse oximeters. Non-invasive, no electrical contact or heat transfer.

Indications for Use

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

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

• Flexi-Stat SpO2 Sensors (K041522)

Submission Summary (Full Text)

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DEC 2 9 2004

K042705

Appendix C Page 1 of 2

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

#### Predicate Device:

The proposed devices are identical to the devices cleared under K041522, with the exception of added pediatric claims and a change to the wrap material from nonadhesive to adhesive.

#### 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.

#### 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 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.

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

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2004

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

Re: K042705

Trade/Device Name: Flexi-Stat SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: November 29, 2004 Received: December 6, 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 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 (QS) 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.

Cluts

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 Sensor

Indications for Use:

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

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)

Oive

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental I 510(k) Number