(88 days)
No
The device description focuses on the optical and electrical components of a standard pulse oximetry sensor and does not mention any AI or ML processing of the data. The performance studies described are standard accuracy tests for pulse oximetry.
No.
The device is for monitoring purposes, specifically continuous non-invasive functional arterial oxygen saturation and pulse rate monitoring, not for treating any condition.
No
This device is a sensor used for continuous monitoring of arterial oxygen saturation and pulse rate. While it provides physiological data, its intended use is for monitoring, not for diagnosing a specific disease or condition. Diagnostic devices are typically used to identify the presence or absence of a disease or condition.
No
The device description explicitly details hardware components including a reusable clip-on finger sensor with optical components (LEDs and a photodiode), a hard plastic case, and cables with connectors. It is an electrooptical sensor, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The device described is a sensor that measures oxygen saturation and pulse rate non-invasively by being placed on the patient's finger. It uses optical means to analyze light absorption within the body.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the body. It directly interacts with the patient's body to gather data.
Therefore, based on the provided information, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
"Reusable sensor for continuous non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. with the Datex Satlite and AS/3 monitors."
Product codes
DQA
Device Description
The Epic Medical Equipment Services. Inc. E403-09 SpO2Finger Sensor is a reusable clip-on finger sensor with the optical components, protected in a hard plastic case. It functions without skin penetration, electrical contact, or heat transfer. This electrooptical sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The E403-09 Finger 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 E403-09 is three feet in length and is terminated in a DB9 style connector as is the predicate sensor. The E403-09 is used with E710-09 10 foot cable which both extends the length of the E403-09 as well as adapts the DB9 connector to a Nicolay style connector which connects to the oximeter.
The E412-09 is equivalent to the E403-09 (3 foot) plus E710-09 (10 foot). The E412-09 is 12 feet long and terminates with a Nicolay style connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
patients weighing more than 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)
Controlled hypoxia studies were conducted in which device data was compared to blood samples analyzed on a multiwavelength hemoximeter. These tests were conducted to establish the accuracy of the E403-09.
The testing carried out for the E403-09 indicates that it meets its design and performance requirements. Clinical validation studies demonstrates the successful use of the sensor and its ability to provide accurate information.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Epic Series E100 SpO2 Finger Sensor (K970098), Satlite Plus Pulse Oximeter (K905140)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Epic Medical Equipment Services
Page
940082
510(k) Summary of Safety and Effectiveness Information 10.0
| Date:
Establishment: | 7 January, 1999
Epic Medical Equipment Services
1800 10th Street Suite 300
Plano, TX 75074 |
|-------------------------|-----------------------------------------------------------------------------------------------------|
| Official Correspondent: | Jeffrey Secunda
VP R&D
972-801-9854
972-801-9859 (fax) |
| Model Number /Name: | E403-09 SpO2 Finger Sensor |
| Classification Name: | Oximeter - 74 DQA (CV)
21 CFR 820.2700 (Class II) |
| Predicate Devices: | Epic Series E100 SpO2 Finger Sensor (K970098)
Satlite Plus Pulse Oximeter (K905140) |
Description of the Device:
The Epic Medical Equipment Services. Inc. E403-09 SpO2Finger Sensor is a reusable clip-on finger sensor with the optical components, protected in a hard plastic case. It functions without skin penetration, electrical contact, or heat transfer. This electrooptical sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The E403-09 Finger 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 E403-09 is three feet in length and is terminated in a DB9 style connector as is the predicate sensor. The E403-09 is used with E710-09 10 foot cable which both extends the length of the E403-09 as well as adapts the DB9 connector to a Nicolay style connector which connects to the oximeter.
The E412-09 is equivalent to the E403-09 (3 foot) plus E710-09 (10 foot). The E412-09 is 12 feet long and terminates with a Nicolay style connector.
Statement of the Intended Use:
"Reusable sensor for continuous non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. with the Datex Satlite and AS/3 monitors."
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510(k) Summary of Safety and Effectiveness Information - continued 10.0
Technological Characteristics Summary:
The E403-09 utilizes a red and infrared LED of the same or tighter specifications as the predicate device. The designated oximeter energizers the LED's which transmit light through a pulsatile arterial bed. The photodiode is of comparable design as the predicate device. The photodiode senses the signal strength of the two LED's which vary with the amount of energy transmitted through the tissue. The oximeter receives the signal from the photodiode and calculates a value for functional oxygen saturation (SpO2).
Discussion of Non-Clinical Tests:
Testing has been carried out to ensure that the proposed devices meets the requirements of the following standards: Mechanical, electrical, thermal, and environmental conditions: EN 60601-1 Electromagnetic compatibility: EN 60601-1-2 Biocompatibility: ISO 10993-1 (EN 30993-1). The device also meets relevant performance and safety requirements from the standard for Pulse Oximeters, EN 865 (ASTM F1415-92).
Discussion of Clinical Tests:
Controlled hypoxia studies were conducted in which device data was compared to blood samples analyzed on a multiwavelength hemoximeter. These tests were conducted to establish the accuracy of the E403-09.
Conclusions Demonstrating Safety Effectiveness and Performance:
The testing carried out for the E403-09 indicates that it meets its design and performance requirements. Clinical validation studies demonstrates the successful use of the sensor and its ability to provide accurate information.
Signed:
Sa
Date: 1/7/99
Jeffrey'S Epic Medical Equipment Services
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 19 1999
Mr. Jeffrey Secunda Vice President R & D Epic Medical Equipment Services 1800 10th Street, Suite 300 Plano, TX 75074
Re: K990082 E403-09 SpO2 Finger Sensor Requlatory Class: II (two) Product Code: DQA Dated: January 7, 1999 Received: January 11, 1999
Dear Mr. Secunda:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Edward F. Waddell
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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, ² Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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11.0 Intended Use
Statement of the Indicated Use:
"Reusable sensor for continuous non-invasive functional arterial oxygen saturation and - reasure benever in for patients weighing more than 30 kg. with the Datex Satlite and AS/3 monitors."
Atl. A. Giall.
(Division Sign-Off) Division of Cardiovascular, Re and Neurological Devices 510(k) Number