[ RadSafe ] What is the meaning of 510(k) Thermography screening for breast cancer in Canada

Wed Nov 28 11:09:43 CST 2012

Dear Dr Ken Marshall,

Thank you very much for the clarification. You may recall that I approached the list members seeking information on 510(k) process as the Mumbai Municipal Corporation was planning to buy a few No Touch Breast Scan units for breast cancer screening. I got the impression that the buyers were not aware of their limitations. These units secured US FDA clearance under 510 (k)  process. I wrote about the developments as a rapid response in the British Medical Journal on Nov 20 and  also published an article in a popular news paper on Nov 22. I have marked copies to all in my last message on the topic.. 

I am very pleased to see that CBC News Canada has come out with a news item on the unbridled use of thermography for breast cancer screening in Canada on November 27. This can be accessed at:

http://www.cbc.ca/news/health/story/2012/11/26/nl-thermography-clinics-canada-1127.html?autoplay=true

With best regards
Parthasarathy

________________________________
 From: Kenneth Marshall <kenneth.marshall at carestream.com>
To: The International Radiation Protection (Health Physics) Mailing List <radsafe at health.phys.iit.edu> 
Sent: Monday, 26 November 2012, 17:10
Subject: Re: [ RadSafe ] What is the meaning of 510(k) approval process of USFDA?

A 510K is an FDA application form process for devices which are "similar" 
to devices that have already been approved by the US FDA. 

Its actually a bit more comprehensive than merely an application form as 
often much supporting data will need to be provided.  That is why your 
device has merit and is justifiably useful to the medical arts. 

Mammography is a very, very cautiously approached modality by the FDA, 
often requiring much attention to detail, and you will probably need to 
offer much in the way of supporting documentation demonstrating the 
quality is acceptable to the US FDA standards and quality control 
requirements. 

Ken Marshall, RRPT
Carestream Health 
Radiation & Laser Safety Officer
Phone 585-627-8523

From:   <edmond0033 at comcast.net>
To:     "parthasarathy k s" <ksparth at yahoo.co.uk>, "The International 
Radiation Protection \(Health Physics\) MailingList" 
<radsafe at health.phys.iit.edu>
Date:   11/19/2012 07:28 PM
Subject:        Re: [ RadSafe ] What is the meaning of 510(k) approval 
process of      USFDA?
Sent by:        radsafe-bounces at health.phys.iit.edu

I will get back to you tomorrow on what a 510(k) means.

Ed Baratta

edmond0033 at comcast.net

-----Original Message----- 
From: parthasarathy k s
Sent: Friday, November 16, 2012 1:12 AM
To: The International Radiation Protection( Health Physics) Mailing List
Subject: [ RadSafe ] What is the meaning of 510(k) approval process of 
USFDA?

Friends,

I need some guidance.

(1) What is meant by 510 (k) approval of US FDA for medical devices.

(2) What are the limitations

There was at least one instance in which a medical device called No Touch 
Breast Scan (NTBS) is marketed in to India and advertised with subtle 
statements that it has some advantages over mammography in diagnosing 
breast 
cancer among young women. The statements highlight the "deficiencies" of 
mammography difficulties in diagnosis of breast cancer in hard breasts, 
ionizing radiation, use of compression devices etc

I request  the list members conversant with the US FDA market approval 
process describe the process; I get the impression that the company is 
claiming too much once the device got 510(k) approval after a long 
"fight".

Any critique on NTBA which is based on thermography is welcome.

Regards
Paarthasarathy
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