CBER 510(k) Challenges and Strategies Susan Finneran Director of Clinical and Regulatory Affairs

CBER 510(k) Challenges and Strategies

Susan Finneran

Director of Clinical and Regulatory Affairs

Copyright © 2009 Haemonetics Corp.2

Background on Haemonetics

NYSE traded company2,070 employees world wideBased in Braintree, MA. Hospital and blood collection customers in more than 80

countries

Vision: To be the Global Leader in Blood Management

Solutions


BloodCollection

Processing& Testing

Inventory &Distribution

Hospital BBInventory

Transfusion Preparation

Recruitment& Interview Point of Care

Pre Intra Post

HospitalBlood Center

Blood Use Optimization

Reports

Dashboards

Business DesignInSight™ Model

Dashboards

Automation Nation™

Business SolutionsLean & Six Sigma

Blood Collections Optimization

Consulting Services Blood Use OptimizationConsulting Services

Donor Recruitment

Programs

Cymbal®

PCS2

MCS+

TEG® cardioPAT®

OrthoPAT®

Cell Saver®

Information Management

Devices

Services

We have a growing portfolio of customer solutions

ACP®215

3


Haemonetics Devices

Automated Apheresis Devices Equipment, imbedded software and disposable sets Submitted to CBER 510(k) with clinical studies Recently down classified (Class II)

Autotransfusion Devices Equipment, imbedded software and disposable sets Submitted to CDRH Class II Laboratory Studies


Types of 510ks submitted to CBER

Traditional – 90%

Special -10%

STED- none

Abbreviated- none

Third Party- not eligible for CBER devices


Premarket Notification Devices that are submitted to CBER (Hematology Division)

Automated Apheresis (Blood Collection) Systems Disposables used in blood collection Laboratory Equipment Blood Establishment Computer software

CDRH- 3700 510(k)s / year

CBER- 100 510(k)s / year


What else does CBER Review?

BLA- Biologic License Applications

Blood Centers submit for a license to manufacture blood products

NDA’s- New Drug Applications

Anticoagulant and Blood Nutrient solutions

510(k)s- Premarket Notifications

Blood collection devices

IDEs/INDs- Investigational Device Exemptions/ Investigation New Drug

Devices and solutions

PMAs – Premarket approval

Not yet


Substantially Equivalent???

“That’s a CDRH term… that doesn’t apply to CBER devices”


Substantially Equivalent is part of the equation..

But more importantly… must meet Blood quality standards

Hemolysis at the end of storageResidual White blood cell content Red cell recovery after filtrationTotal hemoglobin in the blood productplatelet count


Blood Quality standards can be found in…

Guidance documents Memo’s to blood establishmentsPrior 510ksTranscripts from public meetings

BUT not in the Code of Federal Regulations??


Scenario #1 Plasma- Secret criteria

Automated device already cleared to collect plasma labeled as FFP (frozen within 6 hours)

Very limited criteria published for plasmaClinical trial designed to qualify FFP and plasma frozen

within 24 hoursFDA has a host of parameters which now must be testedCommunication with competitors reveals everyone has a

slightly different list


#2 In vivo recovery: Higher is better

IDE submitted for a trial to qualify an apheresis device for collection of two units of red cells.

Acceptance criteria includes in vivo recovery criteria which has been applied in submissions for 10+ years.

Upon submitting 510(k) FDA informs us there is not more stringent criteria.

…public session one slide contained a reference to more stringent criteria

Communication with competitors reveals everyone has a slightly different criteria.


#3 Tell me what you got and them we’ll tell you the criteria

Public meeting a new criteria is revealed for plateletsPre-meeting with FDA is held concerning acceptance

criteria for a clinical studyStatistical boundaries were not definedFDA asked us to provide analysis with various confidence

levels, 90%, 95% and 99%FDA determines criteria based on our analysis


Effective Strategies

Type C: pre- 510(k) meeting to discuss strategyCollaboration with competitors- let’s get in a room and

hash this out.Offer to develop guidance documents through a working

groupDevelop relationships with FDA to get a heads up about

what initiatives are in process IDE submissionRequest for meta-analysis of data for products marketedFight fire with fire: Statistician as a resource


What can we learn from CBER

Substantial equivalence is an antiquated termA new model will be developed to ensure safety and

effectiveness for non-PMA devicesPerformance standards will be developedFDA may want to raise the bar… but this must be based

on reality In God we trust all… all others bring data Access to a Statistician is critical FDA does not have enough resources.. get involved and help

to develop standards.

Thanks for your attention

Questions??

Comments???

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CBER 510(k) Challenges and Strategies Susan Finneran Director of Clinical and Regulatory Affairs