ACCESS (POWERCLAVE)

K954736 · Mdt Biologic Co. · FLE · Aug 15, 1996 · General Hospital

Device Facts

• Record ID: K954736
• Device Name: ACCESS (POWERCLAVE)
• Applicant: Mdt Biologic Co.
• Product Code: FLE · General Hospital
• Decision Date: Aug 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

Access (Powerclave) Steam Sterilizer Controls are to be used with "Castle" brand sterilizers manufactured by MDT Biologic Company for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, and liquids.

Device Story

Microprocessor-based control system for hospital steam sterilizers; upgrade to existing control systems. Inputs: operator commands via interactive graphic touch screen. Outputs: automated control of sterilization cycles. Used in industrial, laboratory, and healthcare settings; operated by facility staff. Device manages sterilization parameters for wrapped/unwrapped instruments and liquids. Chamber vessel and piping remain unchanged from existing sterilizer hardware. Benefits: modern interface and updated microprocessor control for sterilization process management.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Microprocessor-based control system; interactive graphic touch screen interface. Designed to ANSI/AAMI ST-8-1994, UL-544, CSA C22.2, IEC 601.1. Pressure vessels constructed to ASME Section VIII.

Indications for Use

Indicated for use in industrial, laboratory, and health care facilities to control steam sterilizers for the sterilization of wrapped and unwrapped surgical instruments and liquids.

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

• Castle Microcomputer Control (K820783)

Submission Summary (Full Text)

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K954736

This summary is for the:

| Trade name | MDT Biologic Company ACCESS (Powerclave) |
| --- | --- |
| Common name | sterilizer controls |
| Classification name | steam sterilizer (per 21 CFR 880.6880) |

ref. 21 CFR 807.92(a)(2)

We believe this product to be substantially equivalent to Castle Microcomputer Control K820783.

ref. 21 CFR 807.92(a)(3)

The MDT Biologic Company Access (Powerclave) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, Access (Powerclave) Steam Sterilizer Controls are to be used with "Castle" brand sterilizers manufactured by MDT Biologic Company for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, and liquids.

The difference between predicate sterilizer controls and the Access controls is that the Access controls are provided with more modern microprocessor/software, and interactive graphic touch screen operator interface. The chamber vessel and piping remain unchanged.

ref. 21 CFR 807.92 (a)(4), (5) & (6)

The ANSI/AAMI ST-8 - 1994 American National Standard for Hospital Steam Sterilizers was used to establish the minimum construction and performance requirements for this product.

This product has also been designed to meet the requirements of UL-544, CSA C22.2, and IEC 601.1 safety standards for medical devices. The vessels are designed and constructed to Section VIII of the ASME pressure vessel code and each vessel is so certified.

We believe the product to conform to the above requirements.

No clinical testing is required for this submittal

ref. 21 CFR 807.92(b)(1), (2) & (3)

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