(68 days)
Not Found
No
The description focuses on the electro-optical sensor technology and standard performance testing, with no mention of AI or ML.
No.
The description indicates the device is for "monitoring" rather than treating a condition.
Yes
The device monitors continuous, non-invasive functional arterial oxygen saturation and pulse rate, which are used to assess a patient's physiological state and potential problems, thereby aiding in diagnosis.
No
The device description explicitly states it is an "electro-optical sensor" with physical components like LEDs, a photodiode, and an ear clip housing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Function: The Flexi-Stat(tm) SpO2 Sensor is a non-invasive device that measures oxygen saturation and pulse rate directly from the patient's ear using optical means. It does not analyze samples taken from the body.
The device is a medical device used for patient monitoring, but it falls outside the scope of in vitro diagnostics.
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.
Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 kg
Product codes
DPZ
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 a durable ear clip housing. The sensor cable is terminated in a DB-9 style connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
patients weighing >10 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 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.
Pulse rate accuracy was validated using bench testing with a pulse rate simulator.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2710 Ear oximeter.
(a)
Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.(b)
Classification. Class II (performance standards).
0
DEC - 6 2004
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: 310-370-8022 Fax:310-861-5619
Date Prepared:
September 13, 2004
Product Name:
Common Name: SpO2 Ear Sensor (accessory to pulse oximeter - ear oximeter) Trade Name(s): Flexi-Stat SpO2 Ear Sensor
Predicate Device:
Elekon Flexi-Stat™ ear sensor is substantially equivalent to the Nellcor Dura-Y ear sensor marketed under K944760.
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 durable ear clip housing. The sensor cable is terminated in a DB-9 style connector.
Intended Use:
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
1
Comparison to Predicate Device:
The Flexi-Stat SpO2 Ear 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.
Pulse rate accuracy was validated using bench testing with a pulse rate simulator.
Biocompatibility, electrical safety, and EMC testing was also performed to demonstrate conformance with established industry standards.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 2004
Elekon Industries U.S.A., Incorporated C/O Ms. Krista Oakes Principal Amica Solutions 2300 McDermott Road, #200-207 Plano, Texas 75025
Re: K042675
Trade/Device Name: Flexi-Stat SpO2 Ear Sensor Regulation Number: 21 CFR 870.2710 Regulation Name: Ear Oximeter Regulatory Class: II Product Code: DPZ Dated: September 14, 2004 Received: October 4, 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 vour 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.
3
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 (OS) 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Rumme
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
Indications for Use
510(k) # (if known):
Device Name: Flexi-Stat SpO2 Ear Sensor
Indications for Use:
Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 kg
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)
Aun Syleon
(Division Sig Division of Anesthesiology, General Hospital, Infection Control. Denta
510(k) Number: K042615