STERISAFE HP TABLE-TOP STEAM STERILIZER

• K Number: K140736
• Device Name: STERISAFE HP TABLE-TOP STEAM STERILIZER
• Manufacturer: MILTON E PEDRAZZI D.D.S., INC.
• Date Cleared: 2015-01-20 ( 302 days)
• Product Code: FLE
• Regulation Number: 880.6880
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The SteriSafe HP Table-Top Steam Sterilizer is designed to sterilize and flush dental handpieces in a clinical setting. It uses saturated steam at high pressure to effectively kill microorganisms. The unit is intended to sterilize and flush moisture stable handpieces must be suitable for steam sterilization up to 135°C (275°F). The sterilization cycle is as follows:

| CYCLE | TEMPERATURE | STERILIZATION TIME
TURNAROUND TIME | LOAD | INTENDED USE |
|-----------|-----------------------------------------------------------|---------------------------------------|---------------------------------|----------------------------------------|
| Unwrapped | Sterilization
Temperature 132°C | 10 minutes / 23 minutes | Maximum Load
is 3 Handpieces | Sterilize & Flush
Dental Handpieces |
| | Sterilization
Temperature Control
132°C =0° to +3°C | | Maximum Load
Weight is 150z | |

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter for a steam sterilizer, not an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, and ground truth for an AI/ML device.

The document discusses the substantial equivalence of the SteriSafe HP Table-Top Steam Sterilizer to predicate devices. The "acceptance criteria" in this context would typically refer to the device meeting performance standards for sterilization, such as temperature, pressure, and sterilization time, as outlined in the "Indications for Use" section. However, this is for a physical sterilizer, not an AI/ML algorithm.

Therefore, I cannot extract the following information from the provided text:

• Table of acceptance criteria and reported device performance (for an AI/ML device): The document provides operational parameters for the sterilizer (temperature, time, load) but not performance metrics related to AI/ML.
• Sample size used for the test set and data provenance: Not applicable to a physical sterilizer.
• Number of experts used to establish the ground truth and qualifications: Not applicable to a physical sterilizer.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The text focuses on the regulatory approval process for a conventional medical device (a steam sterilizer) based on substantial equivalence, not on the validation of an AI/ML algorithm.

Regulation Number and Section

§ 880.6880 Steam sterilizer.

(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).