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Pre-Submission a future 510(k)


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,

  1. The device is used by attaching it to any body part using the sticker.
  2. The body parts that are ideal are where the blood flow is easily detectable.
  3. The device will be able to detect and display the glucose level, hemoglobin level, blood pressure as well as body temperature.
  4. The device will be able to collect data from the body using infrared rays.
  5. 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

Image result for medical sensor wearable devices

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

  1. I plan to conduct the following biocompatibility test for Oxytissue, the tests are as follows,
  2. Sensitization
  3. Cytotoxicity

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?

Source: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf

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