The Basics

December 1, 2000

Class II 510(K) Medical Device

Class II 510(K) Medical Device

By Becki Harter

Sterilizing instruments. With all of the implications involved with this procedure, itis easy to understand how the trays, cassettes, and containers used to sterilize them mayslip under the cracks. These sterilization trays, cassettes and containers, referred to asClass II medical devices, play an important role in maintaining the sterility ofinstruments used in the healthcare facility. For example, if an instrument has beensterilized in a tray that is not safe for sterilization, is the instrument sterile? Inaddition, there are now a large variety of Class II devices available for use, how arehealthcare facilities to know which are safe, sterilizable, and proven effective? Thereare ways to ensure the correct answer to these questions. The Food and Drug Administration(FDA) has established regulatory requirements, 510(K), to provide the medical practicumwith the "reasonable assurance of safety and effectiveness" of Class II devices.

The Basics

These are examples of Class II instrument sterilization trays and containers.

According to the Medical Device Packaging Handbook, a medical device is definedas "an instrument, apparatus, implement, machine, contrivance, implant, in vitroreagent, other similar or related article including any component, part or accessory whichdoes not achieve any of its principle intended purposes through chemical action within oron the body of Man or animal..." Further, if the device is intended for human use,and is marketed in the US, it must be classified as either a Class I, Class II, or ClassIII medical device. The classification of the device is dependent upon its specific useand will determine what controls and/or regulations are in place regarding its use.

 

Class I Medical Devices :
General Controls

  • Truthful labeling.

  • Establishment of registration.

  • Product listing.

  • Premarket notification.

  • Record keeping requirements.

  • Adherence to Good Manufacturing Practices.

Class II Medical Devices:
Special Controls

  • Performance standards.

  • Specific instrument requirements in which general controls would not assure safety and effectiveness.

Class III Medical Devices:
Premarket Approval

  • Requires data before it is introduced into interstate commerce.

Class II Medical Devices:
Sterilization Trays, Cassettes, and Containers

Class II medical devices, such as sterilization trays, cassettes and containers, require a510(k) premarket notification. The Federal register, dated October 21, 1980, under CFR880.6850 states

  • Sec. 880.6850 Sterilization Wrap

  • Identification. A Sterilization wrap (pack, sterilization wrapper, bag, or accessories) is a device intended to be used to enclose another medical device (instrument/implant) that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed medical device (instrument/implant) until used.

  • Classification. Class II (performance Standards).

What is 510(k)?

510(k), premarket notification, is an amendment made to the Food and Drug and CosmeticAct in May of 1976. It was developed to regulate, control and provide reasonable assuranceof the safety and effectiveness of medical devices. The Act was expanded in 1990 by theSafe Medical Devices Act to clarify and regulate medical devices. Submission requirementsare dependent upon the class of the medical device. Class II 510(k) submissionrequirements include:

  • Submitter's name, address, telephone number, contact person and date submitted.

  • Name of the device, including the trade/propriety names, the common or usual name and the classification name if known.

  • Identification of the device to which the device is substantially equivalent (SE-that the device is similar to).

  • A description of the device that includes: how the device is used; the basis of the device; the performance characteristics of the device such as design, materials and physical properties; statement of intended use; and a statement of how the device compares to other devices that are already marketed with similar use.

Resources

This information is not confidential. Manufacturers and distributors of Class II 510(k)medical devices are aware that they are required to provide this information. However, toassist in the disbursement of information, the FDA has established the Division of SmallManufacturers Assistance (DSMA) to aid healthcare workers and facilities in acquiring theneeded information. If it is discovered that a sterilization tray, cassette or containerdoes not have Class II 510(k) certification it must be reported immediately to theInfection Control/Risk Management Departments as a potential risk to patient safety.

  • There are instances when a manufacturer or distributor will say that they do not need a certification. These include:

  • The 510(k) includes the instrument, implant, and the sterilization tray (extremely rare), and would be listed separately.

  • The manufacturer and/or distributor may simply not be aware of the new mandate. In this case refer them to the DSMA.

  • The manufacturer and/or distributor may have a different intended use for the tray. For example, they may declare that the device is for storage, not sterilization. When notified of a different intended use, the company must either properly inform the healthcare provider of the intended use or they must immediately report and change status of the medical device.

Start Asking Questions

As healthcare providers, we must be aware of regulations and technicalities when itcomes to patient safety. We are advocates for our patients and we must take an active rolein regulating the well-being of those we serve. If an instrument has been sterilized in atray that is not sterile, we must be aware of the implications. That, in a nutshell, isthe importance of Class II 510(K) certification. Below is a list of questions thathealthcare providers should be aware of and know regarding their medical devices:

  • What the intended use (e.g., sterilization or storage)?

  • What are the cleaning, disinfecting, and/or sterilizing recommendations for the device--including the recommended sterilization method (i.e., steam, ETO, plasma, or paracetic acid)?

  • What testing data is available to determine the devices sterility capability?

  • What performance problems and/or /weaknesses (e.g., latches, lids, wetness retention, and extended drying times) would affect sterilization?

Becki Harter is a Certified Surgical Technologist with 15 years of experience. Sheis also a medical consultant for national sterilization tray/cassette/container companies.