Rac Exam : 510K

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21 CFR 807 (e)

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510 K of Medical Device Amendments 1976 to FD&C Act
Preamendment devices prior to 28 May 1976 are grandfathered

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510 K Class I and II Requirements

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Market introduction
Marketed but first time by manufacturer
Marketed but requires change or modification affecting S&E
Has a new intended use

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Substantial Equivalence (SE) Requirements

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Same tech char as predicate or
Differ tech char but raise no new or differ question for S&E
Same intended use

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Exemptions from Premarket Notification 21 CFR 862 - 892

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All Class I devices, except Restriced
Some Class II
Custom devices
Distributors of 510K cleared devices

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510 K Content

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Labeling (desc.specs, use, direct)
SE info
Modification data or intended use
510 K summary

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SMDA Provisions to 510K

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Manufacturer must receive written SE order before commercial distribution
510K summary or statement
Summaries or statements made public 30 days after SE notice

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510k Review

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CDRH responsibility
90 days statutory requirement
Request for addit. info put submission on hold for 30; if no response the 510k is withdrawn. 90 day clock starts again after response.

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510K Types

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Traditional : standard filing
Special : device modification doesnt affect intended use or tech
Abbrev. : Conformance w/ recognized standard to reduce data

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Basis of Abbrev 510k Submission

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Guidance document already exists
A special control has been established
There is a Declaration of Conformity to a recognized standard.

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Special Controls

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controls that provide assurance for Class II devices for S&E
types: surveillance, performance, registries, guidelines

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Recognized Standards

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More than 800 Standards
must include Dec. of Conformity

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Special 510K Modifications

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Types of Mods resulting from design control process:
Energy type
environmental specs
performance specs
dimensional specs
software/firmware
sterilization
packaging

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Content of 510 described in 21 CFR 807.87 includes...

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Name
Class
Reg #
Indications for Use Statement
510K summary
Proposed Labeling
Substantial Equivalence
Performance Data
Truthful Statement

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Class I Device Types

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toothbrushes, O2 masks, irrigating syringes (half devices are Class I)

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Class II Device Types

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Ultrasound Systems, Holter Cardiac Monitors, Pregnancy Test Kits, Central Line Catheters (3200 device cleared every year)

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Analyte Specific Reagents

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a. "antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens." (864.4020a)
b. Class I, Class II (blood banking; CMV reagents) Class III (fatal diseases, TB/ blood donor screening, Hep) 864.4020b Subject to General Controls, cGMP, QSR,
c. Label Class I - "ASR Analytical and Perf Char are not established. Class II/III - "ASR.... Except as a component of approved/cleared test - 809.10(e)1

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Medical Device Definition

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an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is
a. USP or NF
b. diagnosis of disease or in the cure, mitigation, treatment, or prevention of disease, in man or other animals
c. affect structur or function w/o being metabolized or chemical action

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General Purpose Reagents

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a. Classified as chem reagent not labeled or diagnostic specific (21 CFR 864.4010(a))
b. Class I; exempt from 510k limited to 864.9
c. Label "For lab Use" (809.10d)
d. Types: HCL, test tubes, pipettes, general staining

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Research Use Only (RUO) - Pre-commercial

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a. "lab phase of dev and not an effective IVD" 809.10c2i
b. Label "For Research Only, not for diagnostic procedures"
c. reagents, system, instruments assessed for potential use or for basic research

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Investigational Use Only (IUO) - Precommercial

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a. "product testing compared to prior products" 809.10(c)2ii
b. used in clinical invest. or research for S&E 812.3(h)
c. Label " IUO. Perf char of this product have not been established."

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Existing IVD classified in

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21 CFR 862 Clin Chem & Tox Devices
21 CFR 864 Hematology and Pathology Devices
21 CFR 866 Immuno and Microbio Devices

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Class I IVD Types

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Class I - clinical tests for urine, pH and Osmolality; IHC reagents/kits; serological reagent for immuno and micro
"Reserved Devices" - class I IVD's with 510k
General Controls - Reg, Listing, cGMP/QSR, labeling (801 and 809)

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Class II IVD Types

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clin test for newborn screening for metabolic disorders, hema test for sickle cell, micro for pathogens
Special Controls - perf stand, labeling and postmarket surveillance

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Class III IVD Types

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screening for various cancers or blood supply for infectious agents
PMA - General and Specific Controls, cGMP & clin evidence (sensitivity and specificity) of SE in the intended use

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IVD Definition

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"reagents, instruments, systems intended for use in diagnosis of disease, in order to cure, mitigate, treat or prevent disease or its sequalae." 21 CFR 809.3 or FD&C 201 (h) or PHSA 351
Defining char. is specimen is taken from human body.