BELIMED STEAM STERILIZER, MODEL TOP 5000

K021223 · Sauter AG · FLE · Jun 26, 2002 · General Hospital

Device Facts

• Record ID: K021223
• Device Name: BELIMED STEAM STERILIZER, MODEL TOP 5000
• Applicant: Sauter AG
• Product Code: FLE · General Hospital
• Decision Date: Jun 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Belimed Steam Sterilizer TOP 5000 is intended for the terminal sterilization of heat and moisturestable materials in healthcare facilities.

Device Story

Steam sterilizer for healthcare facilities; processes heat/moisture-stable materials including instrument trays, fabric packs, and liquids. Microprocessor-controlled cycles (Prevac, Liquid, Express, Flash) manage temperature, exposure time, and drying. Operator selects cycle based on load type; device monitors parameters; aborts cycle and alerts user upon malfunction. Ensures sterility assurance level (SAL) of at least 10^-6. Benefits include reduced risk of cross-contamination via validated sterilization of surgical instruments and medical devices.

Clinical Evidence

Bench testing only. Validation performed per AAMI/ANSI-ST8 (1994). Studies confirmed SAL of at least 10^-6 for all cycles (Prevac, Flash, Liquid) via biological indicators and time-at-temperature measurements. Moisture retention and water loss metrics met specifications. Bowie-Dick test confirmed air removal efficacy.

Technological Characteristics

Steam sterilization; microprocessor-controlled. Materials: Unfired pressure vessels per ASME Section VIII, Div 1. Safety standards: UL 3101-1, CSA C22.2 No. 1010-1 (IEC1010-1). Configurations: Single/double door, floor flush designs. Sterilization cycles: Prevac, Liquid, Express, Flash. Connectivity: Not specified.

Indications for Use

Indicated for sterilization of non-porous and porous heat and moisture-stable materials in healthcare facilities. Includes instrument trays, fabric packs, and liquid loads.

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

• Amsco Century Medium Steam Sterilizer (K0110865)
• Amsco Steam Sterilizer (K964332)

Submission Summary (Full Text)

{0}------------------------------------------------

K021223

# JUN 2 6 2002

# 510(k) SUMMARY

# Submitter Information.

Hans Stadler SAUTER AG Head of product development Zelgstrasse 8 CH-8583 Sulgen/ Switzerland [phone] Date Summary Prepared: July 9, 2001

## Introduction

The Belimed Steam Sterilizer TOP 5000 is a Class II medical device as defined by 21 CFR §880.6880. The Belimed Steam Sterilizer TOP 5000 is substantially equivalent to the predicate devices, the Amsco Century Medium Steam Sterilizer, K0110865 and Amsco Steam Sterilizer K964332.

The Belimed Steam Sterilizer TOP 5000 is intended for the terminal sterilization of heat and moisturestable materials in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1)

| CYCLES | STERILIZE<br>TEMP | STERILIZE<br>TIME | DRY TIME | RECOMMENDED LOAD |
|---------------------------|-------------------|-------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------|
| PREVAC<br>270° F (132°C) | 270° F<br>(132°C) | 4 minutes | 20 minutes | Double-wrapped Instrument Trays, max.<br>weight of 17 lbs (7.7 kg) each. Fabric packs.<br>Refer to Table 2 for recommended quantities. |
| PREVAC<br>270° F (132°C) | 270° F<br>(132°C) | 4 minutes | 5 minutes | Fabric Packs.<br>Refer to Table 2 for recommended quantities. |
| LIQUID<br>250° F (121°C) | 250° F<br>(121°C) | 45 minutes | - | Refer to Table 3 for Guidelines |
| EXPRESS<br>270° F (132°C) | 270° F<br>(132°C) | 4 minutes | 3 minutes | Single Wrapped Instrument Tray with non<br>porous single instrument |
| FLASH<br>270° F (132°C) | 270° F<br>(132°C) | 3 minutes | 1 minute | Unwrapped Instrument Tray with a single<br>Instrument |
| FLASH<br>270° F (132°C) | 270° F<br>(132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray with non porous<br>multiple instruments (max. weight of 17 lbs) |

Table 1: Factory programmed sterilization cycles

{1}------------------------------------------------

| Table 2 : Recommended Loads | | | |
|-------------------------------------|------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Sterilizer Chamber Size | (mm) Wrapped Instrument<br>Trays 20"x10"<br>max. 17lb each | Fabric Packs<br>11"x11"x9"<br>max. 6.6lb each | Fabric Packs<br>23"x11"x11"<br>max. 17lb each |
| 26"x 42.5"x 41" (660 x 1080 x 1040) | 9 | 18 | 9 |
| 26"x 42.5"x 55" (660 x 1080 x 1400) | 12 | 30 | 12 |
| 26"x 42.5"x 67" (660 x 1080 x 1700) | 15 | 36 | 15 |
| 26"x 42.5"x 79" (660 x 1080 x 2000) | 18 | 42 | 18 |
| 26"x 48.5"x 43" (660 x 1230 x 1100) | 9 | 18 | 9 |
| 26"x 48.5"x 55" (660 x 1230 x 1400) | 12 | 30 | 12 |
| 26"x 48.5"x 67" (660 x 1230 x 1700) | 15 | 36 | 15 |
| 26"x 48.5"x 79" (660 x 1230 x 2000) | 18 | 42 | 18 |

The following table (Table 2) is SAUTER's recommended loads by sterilizer chamber size:

The following table (Table 3) is SAUTER AG's Guidelines for liquid cycle processing: Table 3: Guidelines for liquid 250°F cycle processing

| Sterilizer Chamber Size | (mm) | Volume of Liquid in One Container | Number of containers |
|-------------------------------------|------|-----------------------------------|----------------------|
| 26"x 42.5"x 41" (660 x 1080 x 1040) | | 1000 ml | 126 |
| 26"x 42.5"x 55" (660 x 1080 x 1400) | | 1000 ml | 168 |
| 26"x 42.5"x 67" (660 x 1080 x 1700) | | 1000 ml | 210 |
| 26"x 42.5"x 79" (660 x 1080 x 2000) | | 1000 ml | 252 |
| 26"x 48.5"x 43" (660 x 1230 x 1100) | | 1000 ml | 126 |
| 26"x 48.5"x 55" (660 x 1230 x 1400) | | 1000 ml | 168 |
| 26"x 48.5"x 67" (660 x 1230 x 1700) | | 1000 ml | 210 |
| 26"x 48.5"x 79" (660 x 1230 x 2000) | | 1000 ml | 252 |

### Effectiveness

Efficacy of sterilizer function and exposure time recommendations ate ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10° reduction. SAUTER AG validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, the Belimed Steam Sterilizer TOP 5000 will be validated to meet the requirements of AAMI/ANSI-ST8, Third Edition, January 1994.

{2}------------------------------------------------

The results of the Belimed Sterilizer TOP 5000 verification studies demonstrate that the sterilizer performs as intended and are summarized as follows:

- All PREVAC cycles verified using the fabric test pack, as described in Section 5.5.1 AAMI/ANSI-. ST8 were qualified according to section 5.5.1 AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10* through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1/2 cycle, a moisture retention of less than 3% increase in presterilization test pack weight, and exhibited no wet spots.
- All PREVAC cycles verified using full load instruments trays were qualified according to section . 5.5.3 of AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1½ cycle, a moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper.
- All FLASH cycles verified using the unwrapped instrument tray were qualified according to section t 7.7.3 AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10° through achievement of a time-at-temperature sufficient to produce an FO of at least 12 by 1/2 cycle and exhibited no wet spots.
- All LIQUID cycles verified using three 1'000 ml flasks, as described in section 5.5.2.1 of . AAMI/ANSI-ST8, were qualified according to section 5.5.2 of AAMI/ANSI-ST8. These cycles demonstrated a sterility assurance level of at least 10th through achievement of a time-attemperature sufficient to produce an FO of at least 12 by ½ cycle, a water loss not exceeding 50 ml, and automatic sealing of the flask closure. A temperature of 121°C was achieved and maintained in the center of the liquid for at least 12 minutes.
- The BD cycle was verified using the Bowie-Dick Test Pack were qualified according to section 5.6 . of AAMI/ANSI-ST8, and demonstrated a uniform color change throughout the test sheet.
- . The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Pre-market Submissions for Software Contained in Medical Devices (5/29/98)".

### Safety

SAUTER AG sterilizers including the Belimed Steam Sterilizer TOP 5000 have been designed. constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Belimed Steam Sterilizer TOP 5000 will comply with the following requirements:

- ينهنجي جي Underwriter Laboratory (UL) Code 3101-1
- 2. Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 (IEC1010-1)

{3}------------------------------------------------

- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired 3. pressure vessels
### Hazards-Failure of Performances

Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another who was not otherwise infected prior to the incident.

To avoid failure, the user must ensure the materials, instruments and devices to be sterilized are thoroughly cleaned, that the manufacturer's instructions for use are followed., that the cycle to be used for each type of sterilizer load has been validated, that the sterilizer has been maintained in accordance with the sterilizer's manufacturer's maintenance schedule and is operating properly, and that each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.

Today, there are many steam sterilizers in daily use in hospitals throughout the United States. The incident of sterilizer malfunction or sterilization process failure is relatively rare considering the wide spread use of steam sterilizers. Further, there are no known reports in the literature of patient infection that have resulted from steam sterilizer failure. The technology designed in Belimed Steam Sterilizer TOP 5000 provides microprocessor controller safequards that aborts the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.

#### User information

SAUTER AG provides information to the user that is intended to insure safe and effective use of steam sterilization in its detailed Operator's Manual and other labeling. SAUTER AG also recommends the use and periodic review of the AAMI steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in health care facilities.

{4}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three parallel, curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Sauter AG C/O Mr. Mark Job Responsible Third Party Official TUV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K021223

Trade/Device Name: Belimed Steam Sterilizer, Model Top 5000 Regulation Number: 880.6880 Regulation Name: Stream Sterilizer Regulatory Class: II Product Code: FLE Dated: May 10, 2002 Received: June 12, 2002

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Mr. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Tin othy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

{6}------------------------------------------------

# INDICATIONS FOR USE STATEMENT DEVICE NAME: BELIMED STEAM STERILIZER TOP 5000

## INDICATIONS FOR USE:

The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1)

| CYCLES | STERILIZE TEMP | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD |
|---------------------------|-------------------|----------------|------------|----------------------------------------------------------------------------------------------------------------------------------------|
| PREVAC<br>270° F (132°C) | 270° F<br>(132°C) | 4 minutes | 20 minutes | Double-wrapped Instrument Trays, max.<br>weight of 17 lbs (7.7 kg) each. Fabric packs.<br>Refer to Table 2 for recommended quantities. |
| PREVAC<br>270° F (132°C) | 270° F<br>(132°C) | 4 minutes | 5 minutes | Fabric Packs. |
| LIQUID<br>250° F (121°C) | 250° F<br>(121°C) | 45 minutes | 0 minute | Refer to Table 3 for Guidelines |
| EXPRESS<br>270° F (132°C) | 270° F<br>(132°C) | 4 minutes | 3 minutes | Single Wrapped Instrument Tray with non porous single instrument |
| FLASH<br>270° F (132°C) | 270° F<br>(132°C) | 3 minutes | 1 minute | Unwrapped Instrument Tray with a single Instrument |
| FLASH<br>270° F (132°C) | 270° F<br>(132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray with non porous multiple instruments (max. weight of 17 lbs) |

Table 1: Factory programmed Sterilization Cycles

{7}------------------------------------------------

| Table 2: Recommended Loads | | | |
|-------------------------------------|-------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Sterilizer Chamber Size<br>(mm) | Wrapped Instrument<br>Trays 20"x10"<br>max. 17lb each | Fabric Packs<br>11"x11"x9"<br>max. 6.6lb each | Fabric Packs<br>23"x11"x11"<br>max. 17lb each |
| 26"x 42.5"x 41" (660 x 1080 x 1040) | 9 | 18 | 9 |
| 26"x 42.5"x 55" (660 x 1080 x 1400) | 12 | 30 | 12 |
| 26"x 42.5"x 67" (660 x 1080 x 1700) | 15 | 36 | 15 |
| 26"x 42.5"x 79" (660 x 1080 x 2000) | 18 | 42 | 18 |
| 26"x 48.5"x 43" (660 x 1230 x 1100) | 9 | 18 | 9 |
| 26"x 48.5"x 55" (660 x 1230 x 1400) | 12 | 30 | 12 |
| 26"x 48.5"x 67" (660 x 1230 x 1700) | 15 | 36 | 15 |
| 26"x 48.5"x 79" (660 x 1230 x 2000) | 18 | 42 | 18 |

· The following table (Table 2) is SAUTER's recommended loads by sterilizer size:

The following table (Table 3) is SAUTER AG's Guidelines for liquid cycle processing:

| Sterilizer Chamber Size | (mm) | Volume of Liquid in One<br>Container | Number of containers |
|-------------------------------------|------|--------------------------------------|----------------------|
| 26"x 42.5"x 41" (660 x 1080 x 1040) | | 1000 ml | 126 |
| 26"x 42.5"x 55" (660 x 1080 x 1400) | | 1000 ml | 168 |
| 26"x 42.5"x 67" (660 x 1080 x 1700) | | 1000 ml | 210 |
| 26"x 42.5"x 79" (660 x 1080 x 2000) | | 1000 ml | 252 |
| 26"x 48.5"x 43" (660 x 1230 x 1100) | | 1000 ml | 126 |
| 26"x 48.5"x 55" (660 x 1230 x 1400) | | 1000 ml | 168 |
| 26"x 48.5"x 67" (660 x 1230 x 1700) | | 1000 ml | 210 |
| 26"x 48.5"x 79" (660 x 1230 x 2000) | | 1000 ml | 252 |

Table 3: Guidelines for liquid cycle processing

{8}------------------------------------------------

The Belimed Steam Sterilizer TOP 5000 is offered in the following medium-size configurations:

26″x 42.5″x 41″ (660 mm x 1080 mm x 1040 mm) 26″x 42.5″x 41″ (660 mm x 1080 mm x 1040 mm) 26"x 42.5″x 55″ (660 mm x 1080 mm x 1400mm) 26"x 42.5"x 55" (660 mm x 1080 mm x 1400mm) 26"x 42.5"x 67" (660 mm x 1080 mm x 1700mm) 26"x 42.5"x 67" (660 mm x 1080 mm x 1700mm) 26"x 42.5"x 79″ (660 mm x 1080 mm x 2000mm) 26"x 42.5″x 79″ (660 mm x 1080 mm x 2000mm) 26"x 48.5"x 43" (660 mm x 1230 mm x 1100mm) 26″x 48.5″x 43″ (660 mm x 1230 mm x 1100mm) 26″x 48.5″x 55″ (660 mm x 1230 mm x 1400mm) 26"x 48.5″x 55″ (660 mm x 1230 mm x 1400mm) 26"x 48.5"x 67″ (660 mm x 1230 mm x 1700mm) 26"x 48.5"x 67″ (660 mm x 1230 mm x 1700mm) 26″x 48.5″x 79″ (660 mm x 1230 mm x 2000mm) 26″x 48.5″x 79″ (660 mm x 1230 mm x 2000mm)

Single Door, Prevacuum Double Door, Prevacuum Single Door, Prevacuum Double Door. Prevacuum Single Door, Prevacuum Double Door, Prevacuum Single Door, Prevacuum Double Door, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum Single Door, Floor Flush Design, Prevacuum Double Door, Floor Flush Design, Prevacuum

(Division Sign-Off)
Division of D

on Control eral Hospital Device

**510(k) Number** K02122