BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8

K033538 · Sauter AG · FLE · Feb 2, 2004 · General Hospital

Device Facts

• Record ID: K033538
• Device Name: BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8
• Applicant: Sauter AG
• Product Code: FLE · General Hospital
• Decision Date: Feb 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6880
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Belimed Steam Sterilizer TOP 5000, series 4-8, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 Series 4 - 8 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).

Device Story

Steam sterilizer for healthcare facilities; processes non-porous and porous heat/moisture-stable materials (textiles, glassware, instruments). Uses factory-programmed cycles (Prevac, Liquid, Express, Flash) to achieve sterility assurance level (SAL) of at least 10^-6. Features motorized vertical door for compact design; vacuum pump; microprocessor controller. Operator selects cycle; device monitors conditions; aborts cycle and provides alerts if parameters fail. Benefits patient by reducing risk of cross-contamination via effective sterilization of medical devices.

Clinical Evidence

Bench testing only. Validation performed per AAMI/ANSI ST-8:2001 and ANSI/AAMI ST37:1996. Cycles verified using biological indicators, fabric test packs, and instrument trays. Results confirmed SAL of at least 10^-6, F0 values >= 12, and moisture retention within limits. Bowie-Dick test confirmed uniform steam penetration.

Technological Characteristics

Steam sterilizer; microprocessor-controlled; motorized vertical door. Materials: ASME Section VIII, Division 1 pressure vessel. Standards: AAMI/ANSI ST-8:2001, EN285:1996, UL 61010A-1/2-041, CSA C22.2 No. 1010-1. Connectivity: Standalone. Sterilization: Steam.

Indications for Use

Indicated for sterilization of non-porous and porous heat and moisture-stable materials in healthcare facilities, including textiles, glassware, and wrapped or unwrapped instrument trays.

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

• Belimed Steam Sterilizer TOP 5000 Series 9 - 18

Submission Summary (Full Text)

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#### K03 3538 21 1.2 510(k) Summary

| Date: | Nov., 30°.2003 | FEB - 2 2003 |
|-----------------------------|-----------------------------------------------------------------------|--------------|
| Submitter's Name / Address: | Sauter AG<br>Zelgstrasse 8<br>CH- 8583 Sulgen / Switzerland | |
| Contact Person: | Hans Stadler, Head of Product Development,<br>Email: [e-mail] | |
| Trade Name: | Belimed Steam Sterilizer TOP 5000<br>Series 4 - 8 | |
| Classification: | Steam Sterilizer - Class II, as listed per 21C.F.R. 880.6880 | |
| Predicate Device: | Belimed Steam Sterilizer TOP 5000<br>Series 9 - 18 | |

#### DEVICE DESCRIPTION:

The Belimed Steam Sterilizer TOP 5000 Series 4 – 8 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer TOP 5000 Series 9 - 18.

The smaller Chamber size incorporates additional flexibility, in comparison to Series 9 -- 18, and allows to operate the sterilizer in an economical way.

Motorized vertical door movement leads to an optimal compact design, and allows the operation of the sterilizer, where space is limited.

## COMPARISON TO THE PREDICATE DEVICE:

The Belimed Steam Sterilizer TOP 5000 Series 4 -- 8, is very similar to the predicate device. Modifications made from the predicate device include:

- ಾ Smaller chamber size
- t : Vacuum-pump according to smaller chamber size
- Vertical door movement ନ୍ତ
- Software updates t

## INDICATIONS FOR USE:

The Belimed Steam Sterilizer TOP 5000 Series 4 -- 8 is designed for Sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 Series 4 -- 8 is equipped with the following factoryprogrammed Sterilization cycles and cycle values, which are identical with Series 9 - 18 (Table 1).

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| CYCLES | STERILIZE TEMP | STERILIZE TIME(min) | DRY TIME (min) | RECOMMENDED LOAD |
|--------------------------|-------------------|---------------------|----------------|----------------------------------------------------------------------------------------------------------------------------------------|
| PREVAC<br>270° F (132°C) | 270° F<br>(132°C) | 4 | 20 | 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 | 5 | Fabric Packs. |
| LIQUID<br>250°F (121°C) | 250° F<br>(121°C) | 45 | 0 | Liquids not intended for direct patient<br>contact!<br>Refer to Table 3 for Guidelines |
| EXPRESS<br>270°F (132°C) | 270° F<br>(132°C) | 4 | 3 | Single Wrapped Instrument Tray with non<br>porous single instrument |
| FLASH<br>270° F (132°C) | 270° F<br>(132°C) | 3 | 1 | Unwrapped Instrument Tray with a single<br>Instrument |
| FLASH 270° F<br>(132°C) | 270° F<br>(132°C) | 10 | 1 | Unwrapped Instrument Tray with non porous<br>multiple instruments (max. weight of 17 lbs) |

Table 1: Factory programmed Sterilization Cycles

The following table (Table 2) shows SAUTER AG's recommended load by sterilizer size, Series 4 - 8:

| Model<br>single door<br>double door | Sterilizer Chamber Size | Wrapped<br>Instrument Trays<br>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 |
|-------------------------------------|--------------------------------------------|----------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| 6-0-6 VS1<br>6-0-6 VS2 | 26" x 26" x 27.5"<br>(660 x 660 x 700) mm | 4 | 8 | 4 |
| 6-0-9 VS1<br>6-0-9 VS2 | 26" x 26 "x 39.5"<br>(660 x 660 x 1000) mm | 6 | 12 | 6 |
| 6-0-12 VS1<br>6-0-12 VS2 | 26" x 26" x 51.5"<br>(660 x 660 x 1300) mm | 8 | 16 | 8 |

Iable 2: Recommended Loads

The following table (Table 3) is SAUTER AG's guidelines for liquid cycle processing for Series 4 - 8:

| Model<br>single door<br>double door | Sterilizer Chamber Size | Volume of Liquid in One<br>Container | Number of containers |
|-------------------------------------|--------------------------------------------|--------------------------------------|----------------------|
| 6-0-6 VS1<br>6-0-6 VS2 | 26" x 26" x 27,5"<br>(660 x 660 x 700) mm | 1000 ml | 44 |
| 6-0-9 VS1<br>6-0-9 VS2 | 26" x 26" x 39,5"<br>(660 x 660 x 1000) mm | 1000 ml | 66 |
| 6-0-12 VS1<br>6-0-12 VS2 | 26" x 26" x 51,5"<br>(660 x 660 x 1300) mm | 1000 ml | 88 |

Table 3: Guidelines for liquid 250°F cycle processing

:

:

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The Belimed Steam Sterilizer TOP 5000 Series 4 -- 8 is offered in the following size configurations:

| 26" x 26" x 27.5" (660 mm x 660 mm x 700 mm) | Single Door, Prevacuum |
|-----------------------------------------------|------------------------|
| 26" x 26" x 27.5" (660 mm x 660 mm x 700 mm) | Double Door, Prevacuum |
| 26" x 26" x 39.5" (660 mm x 660 mm x 1000 mm) | Single Door, Prevacuum |
| 26" x 26" x 39.5" (660 mm x 660 mm x 1000 mm) | Double Door, Prevacuum |
| 26" x 26" x 51.5" (660 mm x 660 mm x 1300 mm) | Single Door, Prevacuum |
| 26" x 26" x 51.5" (660 mm x 660 mm x 1300 mm) | Double Door, Prevacuum |

The Belimed Steam Sterilizer TOP 5000 Series 4 – 8 is designed to be used for the terminal Sterilization of porous and non porcus, heat and moisture stabile materials in the healthcare facilities.

Depending of the chosen cycle materials as different as textiles, glassware, unwrapped or wrapped instrument trays with single or multiple instruments.

The Belimed Steam Sterilizer TOP 5000 Series 4 – 8 are factory equipped with cycles which has been tested in accordance with AAMI/ANSI ST-8:2001 as well as EN285:1996 Standards under defined load conditions.

## 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 quidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, the Belimed Steam Sterilizer TOP 5000 were validated to meet the requirements of AAMI/ANSI-5T8-2001.

The results of the Belimed Steam 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 5,5.2 AAMI/ANSI-ST8:2001 were qualified according to section 5.5.2.5 ANSI/AAMI-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 ½ cycle, a moisture retention of fess than 3% increase in presterilization test pack weight, and exhibited no wet spots.
- A!! PREVAC cycles verified using full load instruments trays were qualified according to section ୍ଦ 5.5.4 of ANSI/AAMI-ST8: 2001. These cycles demonstrated a sterility assurance level of at least 10 6 through achievement of a time-at-temperature sufficient to produce an F0 of at least 12 by ½ 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 ti 5.5.5.1 AAMI/ANSI-ST8:2001 and ANSI/AAMI ST37:1996 section 7.7.3 . These cycles demonstrated a sterility assurance level of at least 10* through achievement of a time-attemperature sufficient to produce an F0 of at least 12 by ½ cycle and exhibited no wet spots.
- All LIQUID cycles verified using three 1'000 ml flasks, as described in section 5.5.3 of AAMI/ANSIe ST8:2001, were qualified according to section 5.5.3.5. 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 ½ cycle, a water loss not exceeding 50 ml, and automatic sealing of the

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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 complies with the following requirements:

- Underwriter Laboratory (UL) Code UL 61010A-1:2002 and Ul. 61010A-2-041:2002 ﺎ .
- Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 (IEC61010-1:2001) 2.

American Society of Mechanical Engineers (ASME), Section Vill, Division 1 for unfired 3. pressure vessels :2001.

#### 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 safeguards that aborts the cycle and aive 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.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2004

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

Re: K033538

Trade/Device Name: Bellmed Steam Sterilizer Top 5000. Series 4- 8 Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: January 17, 2004 Received: January 22, 2004

Dear Mr. Preiss:

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.

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#### Page 2 -Mr. Preiss

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K033538

#### Device Name: Bellmed Steam Sterlilzer TOP 5000

Indications For Use:

The Belimed Steam Sterilizer TOP 5000, series 4-8, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 Series 4 - 8 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1),

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use x OTC (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K0355K

| CYCLES | STERILIZE<br>TEMP | STERILIZE<br>TIME(min) | DRY TIME<br>(min) | RECOMMENDED LOAD |
|---------------------------|-------------------|------------------------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| PREVAC<br>270° F (132°C) | 270° F<br>(132°C) | 4 | 20 | 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 | 5 | Fabric Packs. |
| LIQUID<br>250° F (121°C) | 250° F<br>(121°C) | 45 | 0 | Liquids not intended for direct patient contact!<br>Refer to Table 3 for Guidelines |
| EXPRESS<br>270° F (132°C) | 270°F<br>(132°C) | 4 | 3 | Single Wrapped Instrument Tray with non<br>porous single instrument |
| FLASH<br>270° F (132°C) | 270° F<br>(132°C) | 3 | 1 | Unwrapped Instrument Tray with a single<br>Instrument |
| FLASH 270° F<br>(132°C) | 270° F<br>(132°C) | 10 | 1 | Unwrapped Instrument Tray with non porous<br>multiple instruments (max. weight of 17 lbs) |

Table 1: Factory programmed Sterilization Cycles

The following table (Table 2) shows SAUTER AG's recommended load by sterilizer size, Series 4 - 8:

| Model<br>single door<br>double door | Sterilizer Chamber Size | 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 |
|-------------------------------------|-------------------------------------------|-------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| 6-0-6 VS1<br>6-0-6 VS2 | 26"x 26" x 27.5"<br>(660 x 660 x 700) mm | 4 | 8 | 4 |
| 6-0-9 VS1<br>6-0-9 VS2 | 26"x 26"x 39.5"<br>(660 x 660 x 1000) mm | 6 | 12 | 6 |
| 6-0-12 VS1<br>6-0-12 VS2 | 26"x 26" x 51.5"<br>(660 x 660 x 1300) mm | 8 | 16 | 8 |

Table 2: Recommended Loads

.. .

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K033538

▲

The following table (Table 3) is SAUTER AG's guidelines for liquid cycle processing for Series 4 - 8:

| Model<br>single door<br>double door | Sterilizer Chamber Size | Volume of Liquid in One<br>Container | Number of containers |
|-------------------------------------|-------------------------------------------|--------------------------------------|----------------------|
| 6-0-6 VS1<br>6-0-6 VS2 | 26"x 26" x 27,5"<br>(660 x 660 x 700) mm | 1000 ml | 44 |
| 6-0-9 VS1<br>6-0-9 VS2 | 26"x 26" x 39,5"<br>(660 x 660 x 1000) mm | 1000 ml | 66 |
| 6-0-12 VS1<br>6-0-12 VS2 | 26"x 26" x 51,5"<br>(660 x 660 x 1300) mm | 1000 ml | 88 |

Table 3: Guidelines for liquid 250°F cycle processing

The Belimed Steam Sterilizer TOP 5000 Series 4 - 8 is offered in the following size configurations:

| 26"x 26" x 27.5" (660 mm x 660 mm x 700 mm) | Single Door, Prevacuum |
|----------------------------------------------|------------------------|
| 26"x 26" x 27.5" (660 mm x 660 mm x 700 mm) | Double Door, Prevacuum |
| 26"x 26 "x 39.5" (660 mm x 660 mm x 1000 mm) | Single Door, Prevacuum |
| 26"x 26 "x 39.5" (660 mm x 660 mm x 1000 mm) | Double Door, Prevacuum |
| 26"x 26" x 51.5" (660 mm x 660 mm x 1300 mm) | Single Door, Prevacuum |
| 26"x 26" x 51.5" (660 mm x 660 mm x 1300 mm) | Double Door, Prevacuum |

Pat Ray Anderson Benard 1/30/0k

(Division ... In-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number

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