Product and the company
I am introducing a new device and I will be discussing it here. The name of the device will be Oxytissue Sensor and the company which will manufacture this device is Medic Well Corp. After an in-depth analysis of many options, I have chosen this company to manufacture the device because it has the capacity and it will prove to be cost efficient as well. The device will be attached to any body part specifically where the blood flow is properly detectable. The device will be attached to the body with help of a body sticker and it is attached on one side of the device. The device will be powered by a mini cell. The top side of the device will have a display screen that will show the reading of the blood flow. The product will be the first of its kind because some of the variations are already available in the market. Many of these devices are wearable on the wrists and some of them can be worn on arms as well. Oxytissue will be unique and better than any other product of similar category.
Description of Product
The main feature of Oxytissue Sensor is that it will be a wireless device and can be attached to any body part of people that belong to any age group. However, this device will be preferable for the elder people as well as the disabled. The device will be able to detect and display the glucose level, hemoglobin level, blood pressure, body temperature and various other readings and can be checked with the push of a button. The device is safe and effective to use and is substantially equivalent to any legally marketed device and is not subject to pre-market approval under 21 CFR §807.92(a)(3).
Oxytissue Sensor will be connectable to laptops as well as smartphones and the data can be traced by anyone using the mobile application specifically designed for this device. The mobile application will be available on iOS and android and the date will be available online 24/7. Another very useful feature of this device is that no blood sample will be to display the information. The technology used in this device to collect date from the blood is infrared rays and all the essentials of the blood will be automatically measured. A detailed report can also be accessed through the mobile application for further assessments and analysis from the medical experts. The device intended to be used in the following manner,
- The device is used by attaching it to any body part using the sticker.
- The body parts that are ideal are where the blood flow is easily detectable.
- The device will be able to detect and display the glucose level, hemoglobin level, blood pressure as well as body temperature.
- The device will be able to collect data from the body using infrared rays.
- The result will also be available on smartphones and laptops via specially designed software for each platform.
Predicate Device Comparison Table
In this table, Oxytissue Sensor is compared with Omron Project Zero Wrist Blood Pressure Monitor, which focusing on the fact that it has substantial equivalence (SE) with Omron Project Zero which is a legally marketed device.
Areas of Comparison Omron Project Zero Oxytissue Sensor
Intended Use only measure the blood pressure blood pressure, glucose level and hemoglobin level
Target Population anyone can use anyone can use
Where it can be used wearable on the wrist only can stick on any body part
Human Factors none none
Performance long lasting battery timing long lasting battery timing
Materials high quality materials high quality materials
Other Device Compatibility can be used with iOS and Android can be used with iOS, Android and Windows
Electrical Safety safe to charge, directly and indirectly safe to charge directly or indirectly
Water resistivity no water resistivity water resistant
Design wearable on the wrist attachable to any body part
Sterility N/A N/A
Thermal Safety can be used in 10ºC to 50ºC can be used in 5ºC to 50ºC
Biocompatibility Biocompatible Biocompatible
CFR Regulation and product code for Oxytissue Sensor
Title 21, Parts 862-892 of the CFR regulation that addresses the issues regarding the devices and FDA has classified over 1700 distinctive types of devices. The FDA 510(k) Product Code for Oxytissue sensor will be K146381.
Three Questions for FDA
- I plan to conduct the following biocompatibility test for Oxytissue, the tests are as follows,
Do you agree?
- I plan to test the device with a group of people in order to assess the safety and usability of the device. Is my projected approach for assessing human elements such as ease-to-use and control, effective alarm triggering, and safe device connections adequate for the purpose of the usage of Oxytissue Sensor?
- Is the ‘low-level concern’ adequate level of concern for Oxytissue Sensor’s mobile and Windows application?