(99 days)
The ONE UP disposable keratome head is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.
The ONE UP disposable keratome head and suction ring are identical in design, concept and principle to the predicate PLANCON microlamellar keratome single piece head K 970 377, the only difference being that the keratome head, the ring and the handle are made of high density plastic material. The stainless steel blade and the plastic blade holder are similar to the blade and blade holder of the above predicate. The keratome head has dovetails guides which engage in the dovetails of the suction ring. The blade oscillates by means of the same turbine of the predicate device referred above. The power unit is similar in characteristics, principles and functions to the power units of legally marketed keratomes. The ONE UP disposable keratome head comes preassembled and presterilized in a copolyester sealed tray, sealed with TYVEK ® peel off cover. The sterilisation is performed under validated gamma radiation cycle with sterility assurance level of 10 ° and dosimetric release. The plastic materials used for patient contact portion of device have been tested according to classification of USP and the grades used passes classes I through VI, and are deemed to be biocompatible.
The provided document focuses on the substantial equivalence of the MORIA ONE UP disposable keratome head to predicate devices and does NOT contain information about acceptance criteria, device performance, specific studies, sample sizes, ground truth establishment, or expert involvement as requested.
The submission is a 510(k) premarket notification, which primarily aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This process typically relies on comparing design, materials, and intended use, rather than extensive new clinical trials or performance studies with specific acceptance criteria as might be seen for novel devices or PMA submissions.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document states: "The ONE UP disposable keratome head performs equivalently to the predicate devices for creating circular lamellar resection of a predetermined diameter and thickness, and do not raise new issues of safety and effectiveness." (Section 7. Discussion of tests and results). This statement is the core of their "proof" of meeting safety and effectiveness, based on substantial equivalence to existing devices.
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.