Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities | Guideline Explorer

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

5

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

Kits

Premarket notification requirements for device kits

Sterilizers

Intended for Use in Health Care Facilities; Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities; Labeling for a sterilizer indicates the types of medical devices compatible with the process.

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

Infection Control Devices

Branch responsible for the guidance

Stakeholders

4

510(k) applicants

Entities submitting data to FDA for device clearance

Sponsor

Entity responsible for submitting applications under section 524B

Manufacturer

Entity responsible for submitting NDINs

Applicant

Entity submitting development data and knowledge; Entity performing the work process for change

Regulatory Context

Regulatory Activities

1

510(k)

Premarket notification submission type

Document Types

4

Summary of Safety and Effectiveness

document for Thoratec HeartMate II

510(k) summary

Includes all classification product codes considered relevant

Cover Letter

Required component of the QMS information in a submission

Labels and Labeling

Required information for the device submission

Attributes

4

Sterility Assurance Level

Quality parameter that must remain unchanged for the policy

Material Composition

Feature for comparison between new device and predicate

Intended Use

Evidence of a new intended use based on communications

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 residues

Ethylene oxide levels remaining after sterilization

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

Processes

3

Sterility Information

Required information regarding the sterile state of the device

Sterilization method

Method used to achieve sterility 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

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

Specifications for the device

Required technical details in the device description section

Tensile Strength

physical characteristic measured before and after aging

Related CFR Sections (5)

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 →
21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

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

1

Failure to adequately establish and maintain procedures for implementing CAPA

1

Misbranded under section 502(f)(1)

1

Unapproved Device Violations

1

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

1

Recent Cases

Related Warning Letters (4)

Related MFDS Guidelines

Korean regulatory guidelines covering similar topics