John just completed the successful submission of a 510(k) for three epidural needles. The submission cleared the US FDA in October 2007. The submission included a multi-page FMECA and FDA MAUDE review and analysis, as well as the standard comparison matrix w/ the predicate device, in order to substantiate the SE claim. These are standard activities that are performed for the client with these type of submisions.

DEVELOP HEADER BAG SEAL TESTER, TEST AND CONTROL CHART

John recently completed a project to develop / fabricate a low cost, NIST-traceable calibrateable pull tester to perform real time seal strength tests on pouch seals. The project also included SOPs on the test and three different X-bar and R control charts, including the establishment of the control chart limits (average, and 1-, 2-, and 3-sigma limits), and a training component.


IVT SEMINAR CONSULTANT

John was selected to assist in the development and selection of topics for the Institute of Validation Technology's Process Validation 3 day symposium being held in San Diego CA in December.

See IVT Process Validation brochure.


AWARD NOMINATION

John E. Lincoln, principal, has been selected as one of the top three authors of articles of 2005, and nominated for the "Article of the Year Award". This award is given annually to the article selected by the author's peers, that was published in the "Journal of GXP Compliance", and the Institute of Validation Technology. The nominated article is "Risk Management Fundamentals: Documenting Medical Device Risk Analysis Based on the ISO 14971 Model", and Case Study, 20 pp., April 2005 issue.



NEW 510(K) APPROACH (Ref: IVT Article by J. E. Lincoln)

We recently completed a 510(k)for a discography syringe. This was a totally new medical device. However, we were able to show substantial equivalence to existing discography kits, which used standard, general purpose syringes in them. Since this new product had a pressure read-out display and utilized software, we also demonstrated that safety and efficacy were similar to control syringes used in cardiology.

Risk analysis was accomplished by:

1) FMECA, as discussed in ISO 14971; and

2) A detailed analysis of the FDA's MAUDE / MDR / Safety Alert databases. (See 'Risk Management' below.)

Results of both were included in the 510(k) submission. As a result, we could prove safety without the need for clinicals.

The 510(k) was found to be substantially equivalent by the Agency.


RISK MANAGEMENT

The new concern of medical device companies is Risk Management, required by the FDA, and using the ISO 14971:2001 standard. ISO (and the FDA) require the following, physically contained in or referenced as to location, in a product's Risk Management File.

The Risk Management (RM) File must address a product RM Plan, and the RM Process:

1) risk analysis;

2) risk evaluation;

3) risk control; and

4) post-production information.

This is usually accomplished by:

o Product descriptive and use data;

o Hazard List, per ISO 14971, and addressing those elements that apply; and also drawing upon other sources including MAUDE (with sources referenced in the File);

o A FMEA or FMECA (Failure Mode, Effects, [and Criticality] Analysis);

o A FTA (Fault Tree Analysis);

o A HAZOP (Hazard and Operability Study -- process analysis; if applicable);

o An analysis of any unremediated risks (in the ALARP);

o A final conclusion as to the safety of the device.

John E. Lincoln, principal consultant, J. E. Lincoln and Associates