Class II 510(K) Medical Device
By Becki Harter
Sterilizing instruments. With all of the implications involved with this procedure, it is easy to understand how the trays, cassettes, and containers used to sterilize them may slip under the cracks. These sterilization trays, cassettes and containers, referred to as Class II medical devices, play an important role in maintaining the sterility of instruments used in the healthcare facility. For example, if an instrument has been sterilized in a tray that is not safe for sterilization, is the instrument sterile? In addition, there are now a large variety of Class II devices available for use, how are healthcare facilities to know which are safe, sterilizable, and proven effective? There are 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 practicum with the "reasonable assurance of safety and effectiveness" of Class II devices.
According to the Medical Device Packaging Handbook, a medical device is defined as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, other similar or related article including any component, part or accessory which does not achieve any of its principle intended purposes through chemical action within or on 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 Class III medical device. The classification of the device is dependent upon its specific use and will determine what controls and/or regulations are in place regarding its use.
Class I Medical Devices :
- Truthful labeling.
- Establishment of registration.
- Product listing.
- Premarket notification.
- Record keeping requirements.
- Adherence to Good Manufacturing Practices.
Class II Medical Devices:
- Performance standards.
- Specific instrument requirements in which general controls would not assure safety and effectiveness.
Class III Medical Devices:
- 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 a 510(k) premarket notification. The Federal register, dated October 21, 1980, under CFR 880.6850 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)?
This is a Class I Mayo Stand Tray
510(k), premarket notification, is an amendment made to the Food and Drug and Cosmetic Act in May of 1976. It was developed to regulate, control and provide reasonable assurance of the safety and effectiveness of medical devices. The Act was expanded in 1990 by the Safe Medical Devices Act to clarify and regulate medical devices. Submission requirements are dependent upon the class of the medical device. Class II 510(k) submission requirements 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.
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, to assist in the disbursement of information, the FDA has established the Division of Small Manufacturers Assistance (DSMA) to aid healthcare workers and facilities in acquiring the needed information. If it is discovered that a sterilization tray, cassette or container does not have Class II 510(k) certification it must be reported immediately to the Infection 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 it comes to patient safety. We are advocates for our patients and we must take an active role in regulating the well-being of those we serve. If an instrument has been sterilized in a tray that is not sterile, we must be aware of the implications. That, in a nutshell, is the importance of Class II 510(K) certification. Below is a list of questions that healthcare 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. She is also a medical consultant for national sterilization tray/cassette/container companies.