(63 days)
The Straumann Extraoral implant is an endosseous implant intended for placement in the skull, mainly in the mastoid process, periorbital, and perinasal regions. Its purpose is to provide rigid retention for maxillofacial epitheses such as eye, ear and nose epitheses.
The Extraoral implant is a solid, threaded, self-tapping implant made from titanium, Grade 4. It is available in insertion lengths ranging from 2.5 mm to 5.0 mm. It has the same rough surface as the as cleared Straumann endosseous dental implants in contact with bone for osseointegration and a smooth machined surface to allow for the attachment of epithelial tissue.
This K990408 document is a 510(k) summary for a medical device (Straumann Extraoral Implant), and as such, it does not contain a study or data to prove that the device meets acceptance criteria. The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove performance against specific acceptance criteria through a new study.
Therefore, the requested information elements related to a study (acceptance criteria table, sample sizes, expert details, adjudication, MRMC study, standalone performance, ground truth types, training set size and ground truth establishment) cannot be extracted from this document because such a study is not presented.
The document focuses on:
- Description of the Device: A solid, threaded, self-tapping implant made from titanium, Grade 4, available in various lengths. It has a rough surface for bone contact and a smooth surface for epithelial tissue attachment.
- Intended Use: Endosseous implant for placement in the skull (mastoid, periorbital, perinasal regions) for rigid retention of maxillofacial epitheses (eye, ear, nose).
- Basis for Substantial Equivalence: Claims equivalence to several predicate devices (Nobel Biocare Craniofacial Implant, Leibinger Bone Anchored Craniofacial Implant, ITI SLA Dental Implant, Bud Craniofacial Implant) based on intended use, material, and design.
The FDA's letter (APR 16 1999) confirms that they reviewed the 510(k) notification and determined the device to be substantially equivalent to previously marketed devices. This regulatory pathway does not typically require the submission of new clinical or performance study data as would be found in a Premarket Approval (PMA) application or a clinical trial for a novel device.
§ 878.3800 External aesthetic restoration prosthesis.
(a)
Identification. An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.