FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

K041644 · Elekon Industries U.S.A., Inc. · DQA · Jul 29, 2004 · Cardiovascular

Device Facts

• Record ID: K041644
• Device Name: FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)
• Applicant: Elekon Industries U.S.A., Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 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 accessory for pulse oximeters; functions without skin penetration, electrical contact, or heat transfer. Device utilizes two LEDs as light sources and one photodiode as a light detector to measure light absorption of functional arterial hemoglobin. Housed in a foam and Velcro wrap; connects to oximeter via DB-9 cable (with adapter for Datex models). Used in clinical settings for continuous monitoring of oxygen saturation and pulse rate. Healthcare providers use the oximeter output to assess patient oxygenation status and guide clinical interventions. Benefits include non-invasive, real-time physiological monitoring.

Clinical Evidence

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

Technological Characteristics

Electro-optical sensor; foam and Velcro wrap housing; two LEDs and one photodiode; DB-9 connector with adapter cable. Non-invasive, no electrical contact or heat transfer. Tested for biocompatibility, electrical safety, and EMC per industry standards.

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

• Nellcor pulse oximeter sensors (K86378)
• BCI pulse oximeter sensors (K030930)
• Datex pulse oximeter sensors (K962156)
• Datex pulse oximeter sensors (K983684)
• Envitec after-market sensors (K992215)

Submission Summary (Full Text)

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Appendix C Page 1 of 2

# Koyl 644

JUL 2 9 2004

# 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 11, 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, K030930, 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 a foam and Velcro wrap. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.

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#### 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 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

Image /page/2/Picture/1 description: The image shows the logo of the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The bird is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

JUL 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041644

Trade/Device Name: Flexi-Stat SpO2 Sensor Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 11, 2004 Received: June 17, 2004

Dear Ms. Oakes:

We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the referenced doove and have to the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, of to arrivand Cosmetic Act (Act) that do not require approval of a premarket the Federal 2 000, Drag) . You may, therefore, market the device, subject to the general approvin application (she 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 (1 mr), it ney of 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 I Teast be advisod that 1 Dr. o termination that your device complies with other requirements modifine in 1 DT may made statutes and regulations administered by other Federal agencies. or the Act of any I each and the Act's requirements, including, but not limited to: registration r od inting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF read 007), mailing systems (QS) regulation (21 CFR Part 820); and if requirements as bet form mode of 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) Fins feter will and in your began 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), n you acontact 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 yours,

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): K041644

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)

Ques Sfr

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