The Belimed Steam Sterilizer TOP 5000, model 5-5-9, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).

The Belimed Steam Sterilizer TOP5000 model 5-5-9 is available as a single door prevacuum or a double door prevacuum version.

Device Description

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 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 4 -- 8.

The smaller Chamber size incorporates additional flexibility, in comparison to Series 4 -8, and allows to operate the sterilizer in an economical way.

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

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is offered in the following size configurations:

21″x 21″ x 38″ (535 mm x 535 mm x 965 mm) Single Door, Prevacuum 21"x 21″ x 38″ (535 mm x 535 mm x 965 mm) Double Door, Prevacuum

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is designed to be used for the terminal Sterilization of porous and non porous, 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 model 5-5-9 are factory equipped with cycles which has been tested in accordance with AAMI/ANSI ST-8:2001 under defined load conditions.

AI/ML Overview

The provided document is a 510(k) Special Summary for a medical device called the "Belimed Steam Sterilizer TOP 5000 Model 5-5-9." This document focuses on demonstrating the substantial equivalence of the new model to a predicate device (Belimed Steam Sterilizer TOP 5000 Series 4-8) by highlighting minor modifications and verifying that the device still meets established sterilization standards.

However, the document does not describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the way one would typically define these terms for an AI/ML medical device.

Instead, the "effectiveness" section describes the validation of sterilization cycles based on industry standards, ensuring the sterilizer functions as intended for its core purpose. The "acceptance criteria" here refer to achieving specific sterility assurance levels and performance metrics outlined in these standards, rather than the performance of an AI algorithm with metrics like sensitivity or specificity.

Therefore, many of the requested fields are not applicable to the information provided in this regulatory submission for a steam sterilizer.

Here's an attempt to address the request based on the available information, noting where information is not relevant or not present:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The device in question, the Belimed Steam Sterilizer TOP 5000 Model 5-5-9, is a steam sterilizer and not an AI/ML-driven device. As such, the "acceptance criteria" and "study" described in the document relate to the validation of its physical sterilization capabilities against established industry standards rather than the performance of an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Sterilization Cycle Performance)	Reported Device Performance (Efficacy of Sterilizer Function)
PREVAC cycles (Fabric Test Pack) acc. AAMI/ANSI-ST8:2001 Section 5.5.2	- Qualified according to section 5.5.2.5 ANSI/AAMI-ST8. - Demonstrated a sterility assurance level (SAL) of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle. - Moisture retention: less than 3% increase in pre-sterilization test pack weight. - Exhibited no wet spots.
PREVAC cycles (Full Load Instrument Trays) acc. AAMI/ANSI-ST8:2001 Section 5.5.4	- Qualified according to section 5.5.4 of ANSI/AAMI-ST8:2001. - Demonstrated a SAL of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle. - Moisture retention: less than 20% increase in pre-sterilization weight of the towel. - Exhibited no wet spots on the outer wrapper.
FLASH cycles (Unwrapped Instrument Tray) acc. AAMI/ANSI-ST8:2001 Section 5.5.5.1 and ANSI/AAMI ST37:1996 Section 7.7.3	- Qualified according to the specified sections. - Demonstrated a SAL of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle. - Exhibited no wet spots.
LIQUID cycles (Three 1'000 ml flasks) acc. AAMI/ANSI-ST8:2001 Section 5.5.3	- Qualified according to section 5.5.3.5. - Demonstrated a SAL of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle. - Water loss: not exceeding 50 ml. - Automatic sealing of the flask closure. - Temperature of 121°C achieved and maintained in the liquid for at least 12 minutes.
Bowie-Dick (BD) cycle acc. AAMI/ANSI-ST8 Section 5.6	- Verified using the Bowie-Dick Test Pack. - Demonstrated a uniform color change throughout the test sheet.
Software Validation	- Performed according to FDA's moderate level of concern recommendations in "Guidance for the Content for Pre-market Submissions for Software Contained in Medical Devices (May 2005)". - The technology includes microprocessor controller safeguards that abort the cycle and provide signals/warnings for unmet conditions or malfunctions.
Safety and Performance Requirements	- Designed, constructed, and tested to meet UL 61010A-1:2002, UL 61010A-2-041:2002, CSA C22.2 No. 1010-1 (IEC61010-1.2001), and ASME Section VIII, Division 1 for unfired pressure vessels: 2004.

2. Sample size used for the test set and the data provenance:

Test Set Description: The "test set" in this context refers to the defined load conditions and biological indicators used during the validation experiments.
Sample Size: The document does not explicitly state the number of validation runs or specific biological indicators used for each cycle. It mentions using a "fabric test pack," "full load instruments trays," "unwrapped instrument tray," and "three 1'000 ml flasks."
Data Provenance: The studies were conducted by SAUTER AG to validate its sterilization cycles using recommended practices, standards, and guidelines developed by organizations such as AAMI. The origin is Switzerland (Sauter AG). The studies are inherently "prospective" in the sense that they were conducted to validate the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. The "ground truth" for a sterilizer is defined by scientific principles of sterilization (e.g., complete kill of biological indicators, achieving specific F₀ values, temperature profiles) and adherence to recognized industry standards (like AAMI/ANSI ST-8:2001). This doesn't involve human expert consensus in the way an AI/ML diagnosis would.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods like 2+1 are used for reconciling expert disagreements in AI/ML model ground truth establishment. This is not relevant for a sterilizer validation.

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:

Not Applicable. This is a steam sterilizer, not a device involving human readers or AI assistance in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Partially Applicable (in a different sense): The device (sterilizer) operates in a standalone manner according to its programmed cycles. Its "performance" is assessed directly against the physical and biological outcomes of sterilization, without human intervention in the sterilization process itself once initiated. The software validation was done independently against FDA guidance, representing an assessment of the algorithm (software logic) on its own.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the sterilizer's effectiveness is established through:
- Biological Indicators: Demonstrated complete kill of biological indicators.
- Physical Parameters: Achievement of specific time-at-temperature sufficient to produce a required F₀ (e.g., F₀ of at least 12 by ½ cycle).
- Moisture Retention: Specific limits for moisture increase (e.g., < 3% for fabric packs, < 20% for instrument trays).
- Visual Inspection: Absence of wet spots, uniform color change in Bowie-Dick tests.
- Temperature Measurement: Achieving and maintaining specified liquid temperatures for a given duration.
- Adherence to Industry Standards: Meeting the requirements outlined in AAMI/ANSI ST-8:2001 and ANSI/AAMI ST37:1996.

8. The sample size for the training set:

Not Applicable in the AI/ML sense. There isn't a "training set" for an AI model. The device's "training" or development involved engineering, design, and adherence to established sterilization principles and standards.

9. How the ground truth for the training set was established:

Not Applicable in the AI/ML sense. The device's operational parameters and safety features are based on well-established physical, chemical, and microbiological principles of steam sterilization, codified into national and international standards. The "ground truth" for the device's design and programming comes from these scientific and regulatory consensuses, rather than a data-driven training set.

Summary

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

Special 510(k) Summary 1.2

K060337

Date:	Dec.20, 2005	MAR 8 2006
Submitter's Name / Address:	Sauter AGZelgstrasse 8CH- 8583 Sulgen / Switzerland
Contact Person:	Hans Stadler, Head of Product Development,Email: hst@sauterag.com
Trade Name:	Belimed Steam Sterilizer TOP 5000Model 5-5-9
Classification:	Steam Sterilizer - Class II, as listed per 21C.F.R. 880.6880
Predicate Device:	Belimed Steam Sterilizer TOP 5000Series 4 - 8

DEVICE DESCRIPTION:

The smaller Chamber size incorporates additional flexibility, in comparison to Series 4 -8, and allows to operate the sterilizer in an economical way.

Motorized or manually operated 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 model 5-5-9, is very similar to the predicate device. Modifications made from the predicate device include:

. Smaller chamber size
. Vacuum-pump according to smaller chamber size
Vertical door movement manual actuated or motorized
Software updates .

INDICATIONS FOR USE:

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is equipped with the following factoryprogrammed Sterilization cycles and cycle values, which are identical with Series 4 - 8 (Table 1).

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

CYCLES	STERILIZETEMP	STERILIZETIME(min)	DRYTIME(min)	RECOMMENDED LOAD
PREVAC270° F (132°C)	270° F(132°C)	4	20	Double-wrapped Instrument Trays, max.weight of 17 lbs (7.7 kg) eachor Fabric packs.Refer to Table 2 for recommended quantities.
PREVAC270° F (132°C)	270° F(132°C)	4	5	Fabric Packs.
LIQUID250° F (121°C)	250° F(121°C)	45	0	Liquids not intended for direct patientcontact!Refer to Table 3 for Guidelines
EXPRESS270° F (132°C)	270° F(132°C)	4	3	Single Wrapped Instrument Tray with nonporous single instrument
FLASH270° F (132°C)	270° F(132°C)	3	1	Unwrapped Instrument Tray with a singleInstrument
FLASH 270° F(132°C)	270° F(132°C)	10	1	Unwrapped Instrument Tray with non porousmultiple 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, model 5-5-

Do not sterilize a mix load of instrument trays and Fabric packs.

Modelsingle doordouble door	Sterilizer ChamberSize	WrappedInstrument Trays20"x10"max. 17lb each	WrappedInstrument Trays17"x12"max. 17lb each	FabricPacks11"x11"x9"max. 6.6lbeach	Fabric Packs9"x9"x6"max. 3.3lbeach
5-5-9 VS15-5-9 VS2	21"x 21" x 38"(535 x 535 x 965) mm	2	4	6	12

Table 2: Recommended Loads

The following table (Table 3) is SAUTER AG's guidelines for liquid cycle processing for model 5-5-9:

Modelsingle doordouble door	Sterilizer Chamber Size	Volume of Liquid in OneContainer /Bottle	Number of containers /bottles
5-5-9 VS15-5-9 VS2	21"x 21" x 38"(535 x 535 x 965) mm	1000 ml	36

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

Table 3: Guidelines for liquid 250°F cycle processing

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is offered in the following size configurations:

21″x 21″ x 38″ (535 mm x 535 mm x 965 mm) Single Door, Prevacuum 21"x 21″ x 38″ (535 mm x 535 mm x 965 mm) Double Door, Prevacuum

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is designed to be used for the terminal Sterilization of porous and non porous, 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 model 5-5-9 are factory equipped with cycles which has been tested in accordance with AAMI/ANSI ST-8:2001 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 vaiidates its sterilization cycles by recommented bractions, standards and guidelines developed by various independent organizations such as the Association, for Advancement of Medical Instrumentation (AAMI). Prior to release, the Belilizer TOP 5000 were validated to meet the requirements of AAMI/ANSI-ST8-2001.

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 sterlity assurance level of at least 10f through achievement of a time-at-temperature sufficient to produce an F0 of at least 12 by ½ cycle, a moisture retention of tess 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 5.5.4 . of ANSI/AAMI-ST8: 2001. These cycles demonstrated a sterility assurance level of at least 10through achievement of a time-at-temperature sufficient to produce an F0 of a least 10 by 10 vole, 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 . 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 106 through achievement of a time-attemperature sufficient to produce an F0 of at least 12 by ½ cycle and exhibited no we's spos.
All LIQUID cycles verified using three 1'000 ml flasks, as described in section 5.5.3 of AAMI/ANSI-. ST8:2001, were qualified according to section 5.5.3.5. These cycles demonstrated a sterility assurance level of at least 10-6 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 flask closure. A temperature of 121°C was achieved and maintained in the ligulation 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 teost sheet.

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

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 (May 2005)".
.

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

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

Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 (IEC61010-1.2001)

ന് American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels :2004.

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 cvcle 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 stand rds one me futher assurance of the safe and effective use of steam sterilization equipment in health care facilitio i

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

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with a single snake winding around a staff, which is a common symbol associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 8

2006

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

Re: K060337

Trade/Device Name: Belimed Steam Sterilizer TOP 5000 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam sterilizer Regulatory Class: II Product Code: FLE Dated: March 1, 2006 Received: March 3, 2006

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater over is substantially equivalent (for the It it it a doove and have the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersule conmisered press that have been reclassified in accordance with the provisions of Amendments, or to avrivend Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 00d, Drag, the Connenay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 (1 nr 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.

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

Page 2 – Mr. Stefan Preiss

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issualice of a subscriments with other requirements
mean that FDA has made a determination that your devices with other Federal agencies. mean that FDA has made a deleminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations and rolled to: registration of the Act or any Federal statues and reginations and limited to: registration
You must comply with all the Act s requirements, including, but not ice You must comply with an the Act 3 requirements interest 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); and i and listing (21 CFR Part 807), labelling (21 CFR Parvos), Secon (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 -542 of the Ar requirements as set forth in the quality systems (SS) 10galaxin (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-5 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section This letter will allow you to begin mankting your download many and equivalence of your device and thus 510(k) premarket nothleation. The PDA intuing of bassamment
to a legally marketed predicate device results in a classification for your device and thus, to a logarry in device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your device of (240) 276-0115. Also, please note the regulation please contact the Office of Comphance at (210) = 10 = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 entitled, "Misbranding by reference to premaries ander the Act from the may obtain offer gelleral mionnation on your i app Consumer Assistance at its toll-free Division of Simall Manata. (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sue Sumner

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

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

Indications for Use

510(k) Number (if known):

Device Name: Belimed Steam Sterilizer TOP 5000

Indications For Use:

The Belimed Steam Sterilizer TOP 5000, model 5-5-9, is designed for sterilization of The Bellinou Otoun Clehest and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).

The Belimed Steam Sterilizer TOP5000 model 5-5-9 is available as a single door prevacuum or a double door prevacuum version.

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)

Sheila Murphy MD 3/7/06

logy General Hospit
and Dental Devices
K 966 333

Page 1 of 2

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).