(107 days)
Helix NGM Compact Surgical Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures.
Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument 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 (pre-vacuum)- Exposure at 132 °C for 4 minutes, 20-minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Surgical Kit Case and the associated instruments is 268.0 g. The weight of the empty Kit Case is 208.15 grams. Neodent Instrument Kit Cases should not 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 autoclavable polymer. The design of the subject devices include grommets manufactured from medical grade silicone that retain the instruments within the tray. They also presents markings that guide instrument use during procedures. The subject device kit cases are provided nonsterile to the end-user.
The provided document is a 510(k) Premarket Notification for a medical device (Neodent Implant System - Helix NGM Compact Surgical Kit Cases). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through a clinical study with primary and secondary endpoints often seen in drug trials or some Class III device PMAs.
Therefore, the "acceptance criteria" here refer to the performance standards the device must meet to demonstrate substantial equivalence to its predicate for its stated indications for use, primarily regarding sterilization and reusability. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted.
Here's the breakdown based on your request, using the information available in the provided FDA document:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Custom | Manual cleaning validation (Test Soil: Blood Soil (BLSO) Cleaning Method: Manual Residuals Tested: Hemoglobin and Protein) | Visual Inspection: No Visible Soil | |
| Hemoglobin Test: |
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).