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Medical Device Databases

Classification

Definition: Any product intended for diagnosis or for use in the care, treatment or prevention of disease that is not a drug.

Basics: 510(k) is substantial equivalence

PMAA is pre market approval application is a new device which equivilant to other devices.

IDE: the exemption made for clinical trials which are required for some devices

Class 1

Non Life Sustaining

Premarket notification or 510(k), registration, device listing, GMP, and proper records still required

EX. tongue depressors, stethescope

Class 2

Not Life sustaining but needs to meet accuracy and reproducibility levels

510(k), registration, device listing, GMP, and proper records required

Exempt from proving safety and efficacy

Some rare class 3 devices may fall back into this class

Class 3

Life sustaining or supporting

Always require PMAA

Failure mode, animal tests, toxicology studies, clinical trials

IDE - Clinical Studies

IRB approval by each institution

Classification Analysis

Glucometers are probably a class 2 device. We can use devices such as glucometers and auto-analysers as our predicate devices. I will determine later what level of equivalence we'll need. Also the estimated time for a 510(k) is 1-2 years. 510(k) is clearing a product not approving one.

Registration

Everybody from manufacturer, preparations, propagation, compounding, or processing must register

Not raw materials, licensed practitioners, manufacturers solely for teaching and research

Updated Yearly

Registration Analysis

Registration shows an exception for manufacturers who make just to teach or research. This may be a good way to make some revenue while further designing and going through regulation

510(k)

Substantially Equivalent if :

  • Same intended use
  • Same Tech Characteristics
  • different tech characteristics but does not raise any questions of safety and efficacy

Look at Image 510eq.PNG

Types of 510(k)

  • Identical Device
  • One or more predicate devices
  • Samples of labeling & brief statement of equivalence required ( Differences chart recommended)
  • Equivalent but not Identical
  • Sufficient evidence showing why differing tech does not effect safety and efficacy
  • no clinical data required
  • Complex Devices or Major tech differences
  • Needs to demonstrate that new features or new uses do not diminish the safety and effectiveness
  • No new significant risks posed
  • Will always require submission of data
  • Software Product
  • Is reviewed. the depth of review is determined by the level of concern by the FDA

Types of 510(k) Analysis

I really don't know at this point what type of 510(k) is necessary. Research needs to be done to find similar devices. Meeting with the FDA is the common thing to do to see what you will need to provide to put your product to market. Also we need to know that our software will be reviewed, and that means any app that we make. A 510(k) will be between 50-100 pages long.

510(k) Format

  • Submitters Name, Address, telephone #, contact person, and date of submission
  • Name of Device
  • Identification of predicate devices
  • Description of the device, how it works, scientific concepts which form the basis, significant physical and performance characteristics
  • Intended use of the device, descriptions of the disease associated, description of population to which device is intended. If indication are different than predicates a summary of why the differences are not critical to use of the device and why they do not affect safety and effectiveness when used as labeled.
  • Compare tech to predicate

If Equivalence is based on performance data then additionally:

  • Brief discussion of non clinical tests
  • Brief Discussion of clinical tests where applicable
  • conclusion drawn from tests from a safety and effectiveness perspective

FDA Checklist for Submission attached as Checklist1 & Checklist2

Special 510(k)

For manufacturer amending their own product

Cannot affect the intended use

cannot alter the fundamental science of tech

Abbreviated 510(k)

Special guidance documents, controls, or recognized standards exist.

Abbreviated 510k analysis

We need to figure out if we can take advantage of this.

Analysis Summary

Our device is a class 2 device. We need to look up prior devices.

We should look to other methods and exemptions to provide revenue before and build credibility before trying FDA. We should use an 510(k) consulting service $5500 to do a classification and regulatory analysis. Like 30k to compile, deal with FDA & submit.

[1] King, Paul H., and Richard C. Fries. "Chapter 16." Design of Biomedical Devices and Systems. New York: Marcel Dekker, 2003. N. pag. Print.