STERILEMAX

K953938 · Barnstead/Thermolyne Corp. · FLE · Jan 30, 1997 · General Hospital

Device Facts

• Record ID: K953938
• Device Name: STERILEMAX
• Applicant: Barnstead/Thermolyne Corp.
• Product Code: FLE · General Hospital
• Decision Date: Jan 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The "Sterilemax" provides sterilization of standard loads of medical and dental instruments, as do the predicate units.

Device Story

Tabletop steam sterilizer; utilizes water reservoir, heat source, and sealed chamber to sterilize instruments. Operates via four standard cycles (wrapped/unwrapped instruments, packs, dental handpieces) and one non-clinical liquid cycle. Microprocessor-controlled; user interacts via 80-character alpha-numeric display providing cycle status, instructions, and fault messages. Safety features include door interlocks and over-temperature controls. Used in clinical/dental settings by healthcare staff to ensure instrument sterility; output is sterilized medical/dental equipment.

Clinical Evidence

Bench testing only. Validation performed using half-cycle analysis and total kill endpoint for all four standard cycles and the dental handpiece cycle. Results confirmed all recommended loads were rendered sterile on half-cycles.

Technological Characteristics

Chamber: stainless steel; Door: cast aluminum; Gasket: silicone. Conforms to ASME code for pressure vessels. Safety standards: UL/CUL3101-1, IEC 1010-1-92. Microprocessor-controlled cycles. 80-character alpha-numeric display. Dimensions: 12" diameter x 18" deep.

Indications for Use

Indicated for sterilization of standard medical and dental instrument loads. Not for use with liquids in clinical applications.

Regulatory Classification

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.

Predicate Devices

• Tuttenauer American Gold (K833837)
• MDT S-8 (K910777)

Submission Summary (Full Text)

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JAN 29 1997
K953938

# 510(k) Safety and Effectiveness Summary

## Manufacturer:
Barnstead/Thermolyne Corporation
2555 Kerper Boulevard
Dubuque, Iowa 52001
Phone [phone] Fax [phone]

## Contact Name:
Craig Case, Product Manager

## Date Prepared:
January 17, 1997

## Common Name:
Autoclave, table top steam Sterilizer

## Trade Name:
"Sterilemax"

## Classification Name:
Steam Sterilizer (per 21 CFR 880.6880)
(size category less than two cubic feet)

## Substantial Equivalence:
The B/T (Barnstead/Thermolyne) "Sterilemax" is claimed to be substantially equivalent in safety and effectiveness to the following two steam sterilizers currently approved and legally marketed; the Tuttenauer American Gold - 510(k) No. K833837 and the MDT S-8 - 510(k) No. K910777.

## General Description:
The B/T "Sterilemax" is a table top steam sterilizer. As in the case of the predicate units, the Sterilemax has a water reservoir, a heat source and a sealed chamber.

The unit is designed with four standard cycles and one optional cycle. The standard cycles are: wrapped instruments (10 min at 135 C.), unwrapped instruments (3 min at 135 C), packs (30 minutes at 121 C.), the optional cycle for dental handpieces (10 min at 132 C.) and liquids for non-clinical applications (15 min at 121 C.).

## Design and Materials:
The chamber is constructed of stainless steel with a cast aluminum door and a silicone sealing gasket. The pressure chamber and components are designed, tested and stamped for conformance to ASME code.

A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the process per the programmed parameters. The software has been validated and documented under the requirements outlined in the "Reviewer Guide for Computer Controlled Medical Devices."

## Intended Use:
The "Sterilemax" provides sterilization of standard loads of

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medical and dental instruments, as do the predicate units.

## Technology Considerations:

The unit has an 80 character alpha-numeric display. This display provides program and process information to the user, as well as fault condition messages. The display also provides the user with instructions regarding device operation.

The unit meets the requirements of UL/CUL3101-1, IEC 1010-1-92 safety standards. The unit is designed with additional user safety features such as, door interlocks and over temperature controls.

The chamber is 12" diameter by 18" deep. This chamber is somewhat larger than the predicate units. The general construction and operation is similar to the claimed predicate units.

## Safety and Effectiveness:

Evaluations have been completed to validate the safety and effectiveness of the unit. The plan for this testing was derived from AAMI and accepted industry standards. Validation testing was performed using the half cycle analysis and total kill endpoint for each of the four standard cycles and the optional cycle for dental handpieces. The unit rendered all recommended loads sterile on half cycles.

The liquid cycle is not recommended for clinical applications.

## Conclusion:

It is the conclusion of Barnstead/Thermolyne that the Sterilemax is substantially equivalent to the predicate devices; the Tuttenauer American Gold - 510(k) No. K833837 and the MDT S-8 - 510(k) No. K910777. Based on the test data submitted the Sterilemax provides effective sterilization of recommended loads with recommended cycles.