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Zirconia Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Zirconia Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Zirconia Guided Surgery Kit Cases requre the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterlization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Dynamic Air Removal (pre-vacuum) – Exposure at 132°C for 4 minutes, 20-minute dry time. Gravity displacement – Exposure at 132°C for 15 minute dry time. Ziroonia Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The Zirconia Guided Surgery Kit Case and the associated instruments is 342.2 g. The weight of the empty Kit is 236.8 grams. Zirconia Guided Surgery Kit Case are recommended not to be stacked during sterilization.

Nuvo CF Guided Surgery Kit Cases are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Nuvo CF Guided Surgery Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo CF Guided Surgery Kit Cases require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles: Fractionated vacuum): exposure at 132°C for 4 minutes, drying for 20 minutes. Gravity displacement: exposure at 132°C for 15 minutes, drying for 30 minutes. Nuvo CF Guided Surgery Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Nuvo CF Guided Surgery Kit Cases and the associated instruments is approximately 693 g. The weight of the empty case is 487 grams. Nuvo CF Guided Surgery Kit Cases are not recommended to be stacked during sterilization.

The Zirconia and Nuvo CF Guided Surgery Kit Cases subject to this submission are reusable rigid containers, composed by a case bottom, a removable inner tray and a lid, which are made of autoclavable polymer. They are indicated to hold various dental instruments (not subject of this submission) in order to organize, sterilize and protect them. Sterilization via moist heat (steam) is performed by the healthcare provider.

This document is a 510(k) Summary for the Zirconia and Nuvo CF Guided Surgery Kit Cases. It describes the non-clinical performance data used to evaluate the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Southern Implants Instrument Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA Cleared sterilizer for one of the following cycles:

• · Pre-vacuum Steam At 132ºC for 4 minutes with a 20 minutes dry time.
• · Pre-vacuum Steam At 135°C for 3 minutes with a 20 minutes dry time.

The trays are not intended for sterilization of non-porous loads.

The trays are recommended not to be stacked during sterilization.

The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams).

Southern Implants (Pty.) Ltd. does not make any lumen claims for the Southern Implants Instrument Trays.

The device 'instrument trays' is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior Components during sterilization. Each tray consists of three components: a base tray, a lid and an internal individualized insert tray. All three the components are perforated for steam sterilization. The internal insert tray and base has the ability to hold individualized pieces and accessories which include dental tools, drills and ratchets /wrenches.

The lid, base and insert are made of Radel R-5000. This material is a polymer resin.

The instruments to be sterilized in the proposed tray are all non-porous devices and include dental surgical drills and tools.

The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared sterilization wrap mush be used for sterilization purposes to maintain the sterility of the contents

The provided text describes the acceptance criteria and the results of a study for the "Southern Implants Instrument Trays" device.

Here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

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Indications for Use for Drill Stop Pre-Mounted Kit and Drill Stop Kit: Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Instrument Kits are intended to allow sterilization of the enclosed medical devices. Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The Kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat using one of the following cycles: Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minute dry time Gravity displacement -Exposure at 132 °C for 15 minutes, 30-minute dry time. Instrument Kits are intended for sterilization of nonporous loads. The combined weight of the Kit and the associated instruments is 194.90 grams. The weight of the 189.12 grams. Instrument Kits are recommended not to be stacked during sterilization.

The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in polymer. The design of the subject devices include grommets manufactured from polyphenylsulfone that retain the instruments within the tray. The subject device kit cases are provided nonsterile to the end-user.

The provided text describes the acceptance criteria and the study conducted for the NUVO Implant System - NUVO Instrument Kit Cases, a device intended for sterilizing other medical devices.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

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