(106 days)
Indications for Use for Neodent Complement Kit Cases:
Neodent Instrument 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 using one of the following cycles:
Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-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 Complement Case and the associated instruments is 75,7 g. The weight of the empty Kit Case is 53.62 grams.
Neodent Instrument Kit Cases should not be stacked during sterilization.
Indications for Use for Nuvo Complement Kit Cases:
Nuvo™ Instrument 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. Nuvo™ Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Nuvo™ 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 using one of the following cycles:
Dynamic Air Removal (pre-vacuum)- Exposure at 132 ℃ for 4 minutes, 30-minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Nuvo™ Instrument Kit Cases are intended for sterilization of non-porous loads. The combined weight of the Complement Case and the associated instruments is 75.7 g. The weight of the empty Kit Case is 52.72 grams.
Nuvo™ Instrument Kit Cases should not be stacked during sterilization.
The subject devices Complement Kit Cases consist of a storage case for Neodent and Nuvo instruments set. They are made of autoclavable polymer, the case has silicone holders to store and hold each instrument securely during sanitization and surgical procedures. The case can be equipped according to the procedure.
The provided text is a 510(k) summary for a medical device (Complement Kit Cases), focusing on the device's substantial equivalence to a predicate device. It details non-clinical performance data.
Here's the information extracted and organized according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Results |
|---|---|---|---|
| Custom (Manual cleaning validation_ Test Soil: Blood Soil (BLSO) Cleaning Method: Manual_ Residuals Tested: Hemoglobin and Protein) | Manual cleaning validation | 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).