In 2007, the ARANZ Medical Silhouette system gained US Food and Drug Administration (FDA) approval as a Class I Medical Device (510k number K070426). Silhouette was the first device of its type to be put through a full 510(k) pre-market notification process. The pre-market notification process is a detailed FDA process of scientific and regulatory review to evaluate the safety and effectiveness of medical devices. Essentially, an approval is a license granted to the applicant to market their particular medical device in the US.
The FDA has now exempted almost all Class I medical devices from the 510k pre-market notification requirement, which means that other similar devices in the market will not need to go through the rigorous assessments that Silhouette went through before they can be marketed in the US. Silhouette has become the gold standard in wound care to which others compare themselves. In fact, other new market entrants have cited Silhouette as a Predicate Device in their applications for pre-market approvals, significantly reducing the burden of proof they need to provide about their devices before they can market in the US.
What was involved in the pre-market notification process for Silhouette?
ARANZ Medical undertook a detailed 300-page application for the Silhouette 510(k) pre-market notification that included information such as:
- the applicant and manufacturer
- proof of compliance with standards and regulations
- device identification and classification
- system diagram
- mechanical drawings and dimensions
- laser information and classification
- validation of measurement accuracy
- labelling information
- substantial equivalence comparison of predicate devices
- statement of intended use
- software functionality and validation
- hazard analysis
Read more about the FDA Premarket Notification 510(k) process.
What is a Class I Medical Device and what FDA standards do Class I medical devices need to meet now?
The FDA has established classifications for around 1,700 different generic types of devices and grouped them into 16 medical specialties. Each type of device is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls.
The FDA has exempted most Class I devices from the premarket notification [510(k)] requirements. However, these devices are not exempt from other general controls, such as all medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA. Read more about the FDA exemptions and Good Manufacturing Practice requirements.
What other standards and regulations does Silhouette comply with?
Silhouette has ISO 13485 Medical Devices certification, which is the International standard that outlines the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This certification requires an annual surveillance audit and recertification every three years, by an independent certification body.
These audits also include EC certification based on Directive 93/42/EEC as a Class I medical device with measuring function. This certification allows Silhouette to display a CE mark. The CE mark on a product is a manufacturer’s declaration that a product complies with the essential requirements of the relevant European Product Directives. The CE mark on a medical device indicates that a certification body has audited the manufacturer and authorized the use of the CE mark.
Silhouette also has these regulatory approvals: Health Canada – Therapeutic Products Directorate, TGA Approval (AUS), and WAND Registration (NZ).
Silhouette has already been used in around 100 clinical studies globally in all phases of research, from pre-clinical to post-marketing, to support study endpoints including data submitted for successful FDA Approvals. Read More.
Maree Roan, Quality and Regulatory Manager, ARANZ Medical
Doc Number: 2016-00673