Guidance for Cardiovascular Intravascular Filter 510(k) Submissions - Guidance for Industry and FDA Staff | Guideline Explorer

Description

This document supersedes document Guidance for the Submission of 510(k) Premarket Notifications for Cardiovascular Intravascular Filters, February 11, 1997.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3

Surgical Gowns

Subject of the premarket notification guidance; Subject of the 510(k) review requirements; Device requiring barrier features and specifications in critical areas; Medical device subject to 510(k) submission

Surgical Drapes

Subject of the premarket notification guidance; Subject of the 510(k) review requirements; Device requiring sterility assurance level of 10-6; Medical device subject to 510(k) submission

Medical Device Kit

A package consisting of at least one medical device and additional components like drugs or biologics

Stakeholders

2

applicant

entity submitting marketing applications

Manufacturer

Entity responsible for submitting NDINs

Regulatory Context

Regulatory Activities

1

510(k)

Premarket notification submission type

Document Types

4

Cover Letter

Required component of the QMS information in a submission

510(k) summary

Includes all classification product codes considered relevant

Labels and Labeling

Required information for the device submission

Summary of Safety and Effectiveness

document for Thoratec HeartMate II

Attributes

3

Sterility Assurance Level

Quality parameter that must remain unchanged for the policy

Intended use

Significant changes to intended use are likely remanufacturing.; The purpose for which the device is used, which must not change.

Sterility Assurance Level 10-6

Required for surgical drapes and gowns used in surgical procedures

Technical Details

Substances

4

Ethylene Oxide

sterilization facilities that use a gas called ethylene oxide (EtO) to sterilize medical devices; Common method of terminal sterilization of medical devices; sterilization facility change involving EtO; Sterilant used in the manufacturing process

EtO

Ethylene oxide residues information required

Ethylene Chlorohydrin

Residue to be measured following EtO sterilization; state the level of residue in parts per million

Ethylene Glycol

Contaminant (EG) that causes fatal poisonings.; High-risk drug component contaminant associated with fatalities.; testing of drug components for contamination

Testing Methods

2

Air Permeability

ASTM D737-75 testing method

Biocompatibility Testing

information that relates to the overall safety and effectiveness

Processes

2

Sterility Information

Required information regarding the sterile state of the device

Sterilization

Required for contaminated equipment and media before disposal

Clinical Concepts

1

Infections

serious adverse events resulting from BCC contamination; potential for serious adverse events including life-threatening infections

Identified Hazards

Hazards

2

Microorganisms

Pathogens that can grow in poorly maintained seams or organic material.

Body fluids

protect from the transfer of body fluids

Standards & References

External Standards

10

NFPA 702

Flammability testing standard

AAMI

Association for the Advancement of Medical Instrumentation

ASTM ES-21-1992

Standard Test Method for Resistance of Protective Clothing Materials to Synthetic Blood; Barrier performance test standard

ASTM ES-22-1992

Test Method for Resistance of Protective Clothing Materials to Penetration by Bloodborne Pathogens; Barrier performance test standard

AATCC Test Method 127-1989

Water Resistance: Hydrostatic Pressure

NFPA Standards

Standards for the Use of Inhalation Anesthetics

AATCC Test Method 61-1989

Colorfastness to Laundering, Home and Commercial: Accelerated

ASTM D1424

Elemendorf Tear test; Strength testing standard

ASTM D1682

Grab Tensile/Elongation test; Strength testing standard

AAMI Radiation Standard

Standard method for validating sterilization cycles

Specifications

2

Intended Use

validate computer software used as part of production or the quality system for its intended use

Sterility Assurance Level

Sterility Assurance Level (SAL) stated

Related CFR Sections (4)

21CFR862.9§ 862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the casRead full regulation →
21CFR878.4040§ 878.4040 Surgical apparel.
(a) Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgicalRead full regulation →
21CFR878.4370§ 878.4370 Surgical drape and drape accessories.
(a) Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector thaRead full regulation →
21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Adulterated under section 501(f)(1)(B)

1

Misbranded under section 502(o)

1

Failure to establish and maintain procedures to control the design

1

Failure to validate a process

1

Failure to establish and maintain procedures for corrective and preventive actions

1

Misbranding under Section 502(c) for Failure to Have Compliant Labeling

1

Misbranding under Section 502(t)(2) for Failure to Submit Required Information to GUDID

Guidance for Cardiovascular Intravascular Filter 510(k) Submissions - Guidance for Industry and FDA Staff