STERIS TEN SIXTEEN STEAM STERILIZER

• K Number: K982332
• Device Name: STERIS TEN SIXTEEN STEAM STERILIZER
• Manufacturer: STERIS Corporation
• Date Cleared: 1999-01-20 ( 202 days)
• Product Code: FLE , OCT
• Regulation Number: 880.6880
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The STERIS Ten Sixteen is a tabletop steam sterilizer designed to sterilize heat and moisture- stabile materials used in hospital, dental or veterinary environments. The STERIS Ten Sixteen Tabletop Steam Sterilizer is available in a 10" x 16" inch chamber configuration.

The STERIS Ten Sixteen Tabletop Steam Sterilizer is equipped with the following factoryprogrammed set sterilization cycles and cycle values:

| CYCLES | RECOMMENDED LOAD | STERILIZE
TEMP. | STERILIZE
TIME | DRY TIME |
|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------------|---------------------------|
| UNWRAPPED | Unwrapped Instrument tray with
a single instrument (No lumens
and no dental handpieces). | 270°F (132°C) | 3 minutes | 0 minute |
| WRAPPED | Wrapped instrument pack: one
pack, maximum weight 1300 g
(2.87 lbs). Paper-peel Pouches:
maximum 5 pouches, one
instrument per pack, total
maximum weight 500 g (1.1 lb).
(No lumens and no dental
handpieces). | 270°F (132°C) | 10 minutes | 45 minutes |
| LIQUID | Vented Borosilicate glass
containers (500ml or smaller). | 250°F (121°C) | 40 minutes | 10 minutes
(Cool Time) |
| PACKED | Fabric pack(s): maximum weight
1050 g (2.32 lbs). | 250°F (121°C) | 30 minutes | 30 minutes |

Device Description

The STERIS Ten Sixteen Steam Sterilizer is a Class II medical device as defined by 21 CFR §880.6880. The Ten Sixteen is a tabletop steam sterilizer designed to sterilize heat and moisture-stabile materials used in hospital, dental or veterinary environments. The STERIS Ten Sixteen Tabletop Steam Sterilizer is available in a 10" x 16" inch chamber configuration.

AI/ML Overview

The STERIS Ten Sixteen Steam Sterilizer operates with several factory-programmed cycles, each with specific acceptance criteria related to sterilization temperature, time, and dry time. The device's performance is demonstrated through studies showing the complete kill of biological indicators.

1. Table of Acceptance Criteria and Reported Device Performance:

Cycles	Recommended Load	Sterilize Temp. (Acceptance Criteria)	Sterilize Time (Acceptance Criteria)	Dry Time (Acceptance Criteria)	Reported Device Performance
UNWRAPPED	Unwrapped Instrument tray with a single instrument (No lumens and no dental handpieces).	270°F (132°C)	3 minutes	0 minute	Meets Criteria: "complete kill of biological indicators and documenting an appropriate safety factor or sterility assurance level of less than 10-6"
WRAPPED	Wrapped instrument pack; Paper-peel Pouches. (No lumens and no dental handpieces).	270°F (132°C)	10 minutes	45 minutes	Meets Criteria: "complete kill of biological indicators and documenting an appropriate safety factor or sterility assurance level of less than 10-6"
LIQUID	Vented borosilicate glass containers (500ml or smaller).	250°F (121°C)	40 minutes	10 minutes (Cool Time)	Meets Criteria: "complete kill of biological indicators and documenting an appropriate safety factor or sterility assurance level of less than 10-6"
PACKED	Fabric packs.	250°F (121°C)	30 minutes	30 minutes	Meets Criteria: "complete kill of biological indicators and documenting an appropriate safety factor or sterility assurance level of less than 10-6"

Study Proving Device Meets Acceptance Criteria:

The efficacy of the STERIS Ten Sixteen Steam Sterilizer is demonstrated through a rigorous qualification and validation process that utilizes Bacillus stearothermophilus spores as the Most Resistant Organism (MRO) to steam. This organism is used to ensure a worst-case test of the sterilizer's efficacy across all forms of microbial and viral contamination.

The core of the study's findings is "showing complete kill of biological indicators and documenting an appropriate safety factor or sterility assurance level of less than 10^-6" (probability of less than one chance out of one million of a non-sterile indicator).

Additional Information Not Available in the Provided Text:

2. Sample size used for the test set and the data provenance: The document does not specify the exact sample size for the test set (number of biological indicators or test runs). It broadly states that "qualification studies were in compliance with the Association for the Advancement of Medical Instrumentation (AAMI) standard for biological indicators (AAMI-ST19)." The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from studies conducted by STERIS during product development and validation for the US market. The studies are prospective in nature, as they are part of the initial development and qualification of the device before market release.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. The ground truth (sterilization efficacy) is established by the scientific principle of killing Bacillus stearothermophilus spores and achieving a specific sterility assurance level, rather than expert consensus on individual results.

4. Adjudication method for the test set: Not applicable in the context of biological indicator testing. The outcome (kill or no-kill of biological indicators) is a direct, objective measurement.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable. The device is a steam sterilizer, not an AI-powered diagnostic tool requiring human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable to a steam sterilizer. The device functions standalone in achieving sterilization, with human interaction primarily for loading, cycle selection, and monitoring, not for interpreting results in a way that an algorithm would.

7. The type of ground truth used: The ground truth is objective biological efficacy – the complete kill of Bacillus stearothermophilus spores within biological indicators, demonstrating a Sterility Assurance Level (SAL) of less than 10^-6. This is a scientific and microbiological ground truth, not pathology slides or outcomes data.

8. The sample size for the training set: The document does not provide a specific sample size for a "training set" in the context of sterilizer validation. Instead, it refers to "development, qualification and validation" studies, which imply repeated testing to establish the parameters and efficacy of the cycles.

9. How the ground truth for the training set was established: The ground truth for establishing the sterilization cycles (analogous to a "training set" for physical parameters) was established by using B. stearothermophilus spores as the MRO under worst-case loading conditions. The process involves systematically testing different temperature and time combinations until "complete kill of biological indicators" and the required SAL (

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).