(99 days)
No
The description focuses on the electro-optical nature of the sensor and its function based on light absorption, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is described as a sensor for monitoring oxygen saturation and pulse rate, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate a medical condition.
Yes
The device is indicated for "continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring," which are diagnostic measurements of a patient's health status.
No
The device description explicitly states it is an electro-optical sensor with physical components (LEDs, photodiode, cable, connector) housed in adhesive film, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Flexi-Stat SpO2 Sensor is a non-invasive device that measures oxygen saturation and pulse rate directly from the patient's body using optical means. It does not analyze samples taken from the body.
The description clearly states it functions "without skin penetration, electrical contact, or heat transfer" and is "connected between the patient and the oximeter." This is characteristic of a non-invasive physiological monitoring device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing ≥ 30 kg.
Product codes (comma separated list FDA assigned to the subject device)
DQA
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 Datex-compatible models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients weighing ≥ 30 kg.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K86378, K991823, K962156, K983684
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
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: 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
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: