Guidance for Industry and FDA Staff: Spinal Systems 510(k)s

Guidance for Industry and FDA Staff: Spinal Systems 510(k)s

Status of Guidance:
Final

Name of Organization:
U.S. Food and Drug Administration
Center for Devices and Radiological Health

Date of Guidance:
September 2000

Target Audience:
Makers of spinal devices and reviewers at the U.S. Food and Drug Administration (FDA).

Laws and Regulations Referenced:
21 CFR 50: Describes how human subjects are to be protected in clinical trials
21 CFR 56: Describes the role of institutional review boards
21 CFR 801: Describes the labeling requirements for medical devices
21 CFR 801.109: Defines the term “prescription device”
21 CFR 807.87: Outlines the requirements of a Premarket Notification
21 CFR 812: Outlines the requirements of an Investigational Device Exemption
21 CFR 888.3050: Classifies spinal interlaminal fixation orthoses as Class II medical devices under the FDA’s classification system
21 CFR 888.3060: Classifies spinal intervertebral body fixation orthoses as Class II medical devices under the FDA’s classification system
21 CFR 888.3070: Classifies pedicle screw spinal systems as either Class II or Class III medical devices under the FDA’s classification system, depending on nature of clinical use
63 FR 40025: Reclassifies certain pedicle screw spinal systems as Class II medical devices under the FDA’s classification system

Definitions:
510(k) submission: The application under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, which provides a streamlined way to request FDA approval for a device that is substantially similar to another device the FDA has already approved.

Spinal system: A complete spinal implant including all parts (Source: Preparation and Review of Investigational Device Exemption Applications for Total Artificial Discs)

Component: An individual part of a spinal system (Source: Preparation and Review of Investigational Device Exemption Applications for Total Artificial Discs)

Background:
The FDA issued this guidance to help the makers of spinal devices create complete 510(k) applications that include the information the FDA needs to decide whether to approve the devices.

Summary:
A device maker may submit a 510(k) application to request FDA approval of a spinal device. The device may be (1) new but similar to one the FDA has already approved, (2) an approved device that has been modified with new parts, or (3) an approved device that is intended to treat a condition that wasn’t listed in the original approval. This guidance applies to spinal systems that are made of metal plates and rods, and various types of screws that are inserted into the pedicle bones of the spine (pedicle screw systems). The guidance does not apply to systems that use screws inserted into the facet bones (facet screw systems).

The guidance provides simple tables showing various types of spinal systems, the conditions they are used to treat, and their classification under the FDA’s risk category system. It recommends that device makers state at the beginning of their 510(k) application where their device falls on these tables. It also recommends including a table listing all components of the device and the details of each component (size, material, where it attaches to the spine, etc.)

An important part of any 510(k) application is the description of conditions the product is intended to treat. This guidance recommends that applicants include detailed descriptions and avoid general terms like “instability.” The guidance provides examples of how these statements should be worded.

In order to show how a device performs when the spine is in motion, the FDA recommends the device maker conduct mechanical testing and submit the results with the 510(k) application. The guidance provides tables showing which types of testing are recommended for the various types of spinal systems. The two main types of mechanical testing are static testing, in which the device must be able to withstand certain weights, and fatigue testing, in which the device must continue to perform well after many repetitions of certain motions. The guidance gives detailed recommendations on how many samples should be used and how the tests should be designed. It also outlines a recommended structure for the test report.

The guidance further recommends wear testing be conducted on any device that may shed particles of material into the body. It recommends animal studies for new uses and new materials, or following unfavorable mechanical testing results.

While all drugs must be tested in humans before gaining FDA approval, most medical devices can avoid this type of costly testing. If the device maker can show that their new product is similar to an existing, approved product, clinical testing is usually not required. Moreover, a traditional 510(k) application may not even be necessary if the device is a minor modification of an already approved product. In such cases, the device maker may submit a Special 510(k), which is simpler to produce.

In addition to the testing results and detailed device description, the 510(k) application should also include the proposed package labeling and the full package insert for FDA review. The guidance specifically recommends certain warning labels for devices that are surgically challenging to implant, or in cases where the approved uses are very specific and using the implant otherwise would pose serious risk. Finally, the application should also include a manual that provides instructions to the spinal surgeon on how to implant the device, and how to remove it if necessary.

Rationale:
Many different types of spinal systems exist to treat a wide variety of conditions. The FDA needs different testing results and information depending on the design and intended use of the spinal system. This guidance helps clarify what information the device maker should submit based on the type of product they wish to market.

Resulting Recommendations:

· A spinal system may be approved under a 510(k) application without human testing if it is similar to a system that was already approved.

· The 510(k) application should explain whether the device is new, a modification of an existing device, or an existing device proposed to treat a new condition.

· The type of device should be defined according to the condition it is intended to treat.

· The list of conditions the device is intended to treat should be specific (eg, spinal stenosis) and should avoid vague terms (eg, instability).

· The 510(k) application should include a table listing all components of the spinal system.

· Mechanical testing (both static and fatigue) should be performed depending on the device type, and according to the recommendations outlined in the guidance.

· Wear testing should be conducted in any spinal system that may shed particles of material into the body.

· Animal studies should be conducted if the device is being used to treat new conditions, if it is a substantially new design, if it consists of a new material, or if results of mechanical testing are unfavorable.

· Animal studies should include a control group of animals for comparison.

· All mechanical testing should replicate a “worst case scenario,” ie, the situation in which the device is most likely to fail.

· Package labels, package inserts, and surgical manuals should be included in the 510(k) application.

Impact:
This guidance clarifies what type of testing and information should be included in a 510(k) application depending on the type of spinal device being submitted. It helps device makers submit a complete application to the FDA, which in turn should allow more efficient review and a quicker decision, potentially bringing the latest advances in spinal device technology to patients without delay.