(85 days)
No
The device description focuses on electro-optical principles and hardware components. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is indicated for monitoring and measurement, specifically "non-invasive functional arterial oxygen saturation and pulse rate monitoring," which are diagnostic or monitoring functions, not therapeutic interventions.
Yes
The device is indicated for monitoring arterial oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly details hardware components (electro-optical sensor, LEDs, photodiode, silicone casing, cable, connector) which are integral to its function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. The core function of an IVD is to examine biological specimens like blood, urine, tissue, etc., outside of the living organism to provide information about a person's health.
- This device is a sensor that measures physiological parameters on the body. The Flexi-Site SpO2 Ear Sensor is placed on the patient's ear and uses light to measure oxygen saturation and pulse rate in vivo (within the living body). It does not analyze a sample taken from the patient.
The description clearly states it's a "non-invasive functional arterial oxygen saturation and pulse rate monitoring" device that functions "without skin penetration." This aligns with the definition of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Flexi-Site SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
The Flexi-Site SpO2 Ear Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing > 30 kg.
Product codes
73 DPZ
Device Description
The Flexi-Site 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 silicone casing. The sensor cable is terminated in a Hypertronics 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 > 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 independent research lab. The Flexi-Site was compared to arterial blood samples analyzed on a laboratory co-oximeter. Accuracy (Ams) for the Flexi-Site was 3.84% across the range of 70%-100% SaO2
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (Ams) for the Flexi-Site was 3.84% across the range of 70%-100% SaO2
Predicate Device(s)
Reference Device(s)
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
OCT 1 7 2001
Appendix C
Page 1 of 2
510(k) Summary
Submitter Information:
Epic Medical Equipment Services, Inc. 1800 E. 10th Street, Suite 300 Plano, TX 75074
Contact:
Krista Oakes Vice President, Regulatory Affairs and Quality Assurance Telephone: (972) 801-9854 Fax: (972) 801-9859
Date Prepared:
September 12, 2001
Product Name:
Common Name: SpO2 Ear Sensor (accessory to ear oximeter) Trade Name(s): Flexi-Site SpO2 Ear Sensor
Predicate Device:
This product is substantially equivalent to the original Flexi-Site sensor, marketed under K964055, the Flexi-Site ear sensor marketed under K010718, and the Ohmeda 6051-0000-115 sensor marketed under K850494. Accuracy is equivalent to the Nellcor Dura-Y ear sensor, marketed under K944760.
Description:
The Flexi-Site 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 silicone casing. The sensor cable is terminated in a Hypertronics style connector.
Intended Use:
The Flexi-Site SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
1
Comparison to Predicate Device:
The Flexi-Site SpO2 Sensor uses the same theory and principle of operation as the predicate device. The design is equivalent to the original Flexi-Site, with the addition of a filter and an ear clip accessory to facilitate use on the ear.
Performance Data & Conclusions:
Performance testing was conducted during clinical hypoxia studies conducted in an independent research lab. The Flexi-Site was compared to arterial blood samples analyzed on a laboratory co-oximeter. Accuracy (Ams) for the Flexi-Site was 3.84% across the range of 70%-100% SaO2
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2001
Ms. Krista Oakes Epic Medical Equipment Services 1800 10th Street Suite 300 Plano, TX 75074
Re: K012333
Flexi-Site SpO2 Ear Sensor Regulation Number: 870.2710 Regulation Name: Impedance Plethysmograph Regulatory Class: III (three) Product Code: 73 DPZ Dated: September 13, 2001 Received: September 17, 2001
Dear Mr. 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.
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
3
Page 2 - Ms. Krista Oakes
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix B Page 1 of 1
Statement of Indications For Use
510(k) # KOIZ333 Device Name: Flexi-Site SpO2 Ear Sensor
Indications for Use:
The Flexi-Site SpO2 Ear Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing > 30 kg.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Division of Cardiovascular & Respiratory Devices
510(k) Number R012333