The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing ≥ 30 kg.

Device 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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Elekon Flexi-Stat SpO2 Sensor based on the provided 510(k) submission:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Clinically equivalent to predicate devices (Nellcor, BCI, Datex, Envitec sensors) in terms of safety and effectiveness.	"Performance testing was conducted during clinical hypoxia studies conducted in an independent laboratory. In these studies, accuracy of 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	Conformed to established industry standards.
Electrical Safety	Conformed to established industry standards.
EMC Testing	Conformed to established industry standards.

Note: The document does not provide specific numerical targets for SpO2 accuracy (e.g., standard deviation or root mean square error) within a defined range. Instead, it refers to equivalence to predicate device accuracy claims.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "clinical hypoxia studies" without specifying the number of subjects or data points.
- Data Provenance: The studies were conducted in an "independent laboratory." The country of origin is not specified but given the submitter is "Elekon Industries, USA, Inc." it's likely they were conducted in the USA or a region with comparable regulatory standards. The study appears to be prospective, involving induced hypoxia, rather than retrospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified for SpO2 accuracy. The ground truth for SpO2 accuracy was established by "arterial blood samples analyzed on a laboratory co-oximeter." There is no mention of experts interpreting these co-oximeter results; rather, the co-oximeter itself provides the objective measurement.
Adjudication method for the test set:
- Not applicable. The ground truth was based on objective laboratory measurements (co-oximetry) of arterial blood samples, not subjective assessments requiring expert adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an SpO2 sensor, which provides a direct physiological measurement, not an AI-assisted diagnostic tool that requires human interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is a standalone device in the sense that its performance, as an accessory to a pulse oximeter, is evaluated based on its direct measurements compared to a gold standard (co-oximetry), without requiring a human-in-the-loop to interpret its output for the accuracy study. The sensor outputs a numerical SpO2 value.
The type of ground truth used:
- Objective measurement (Laboratory Co-Oximetry): Arterial blood samples were analyzed on a laboratory co-oximeter to provide the gold standard for arterial oxygen saturation.
The sample size for the training set:
- Not applicable. As a medical device (sensor) that measures a physiological parameter, there is no "training set" in the machine learning sense for the core SpO2 measurement algorithm itself, which is based on established electro-optical principles. The performance testing focuses on validation.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of this device's SpO2 measurement function.

Summary

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

K041522

INDUSTRIES USA, INC.

SEP 1 4 2004

3848 Del Amo Blvd., Suite #304 Torrance, CA 90503 Tel: 310-370-8022 Fax: 310-370-8079 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: 310-370-8022 Fax:310-861-5619

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:

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: 310-370-8022 Fax: 310-370-8079 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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

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:

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).