The Belimed Steam Sterilizer TOP 5000, Series 8, model 6-0-12 is designed for sterilization of nonporous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 Series 8, model 6-0-12, is equipped with the following factoryprogrammed Sterilization cycles and values (Tables 1-3).

Device Description

The Belimed Steam Sterilizer TOP 5000 Series 8 is intended for use in hospital and health care facilities.

AI/ML Overview

The provided document describes a medical device (Belimed Steam Sterilizer TOP 5000 Series 8) and its validation, rather than an AI-powered medical device. Therefore, several of the requested categories (e.g., sample size for AI test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

However, I can extract the acceptance criteria and the study results that demonstrate the device's effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for sterilizers are based on achieving a sterility assurance level (SAL) of at least 10⁻⁶ and specific physical parameters. The reported performance indicates that the device met these criteria through various validation studies aligned with AAMI/ANSI-ST8:2001.

Acceptance Criteria (According to AAMI/ANSI-ST8:2001)	Reported Device Performance
Sterility Assurance Level (SAL): At least 10⁻⁶ reduction (typically demonstrated by achieving an F₀ of at least 12 by ½ cycle)	Achieved: All Prevac, Flash, and Liquid 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.
Moisture Retention (Fabric Test Packs): Less than 3% increase in pre-sterilization test pack weight and no wet spots.	Met: Prevac cycles with fabric test packs demonstrated a moisture retention of less than 3% increase in pre-sterilization test pack weight, and exhibited no wet spots.
Moisture Retention (Full Load Instrument Trays): Less than 20% increase in pre-sterilization test pack weight and no wet spots on the outer wrapper.	Met: Prevac cycles with full load instrument trays demonstrated a moisture retention of less than 20% increase in pre-sterilization test pack weight, and exhibited no wet spots on the outer wrapper.
Wet Spots (Flash cycles): No wet spots.	Met: All Flash cycles exhibited no wet spots.
Liquid Cycles (Temperature and Duration): 121°C achieved and maintained in the center of the liquid for at least 12 minutes.	Met: Liquid cycles achieved and maintained a temperature of 121°C in the center of the liquid for at least 12 minutes.
Liquid Cycles (Water Loss and Sealing): Water loss not exceeding 50ml and automatic sealing of the flask closure.	Met: Liquid cycles demonstrated water loss not exceeding 50ml and an automatic sealing of the flask closure.
Bowie-Dick Test (BD cycle): Uniform color change throughout the test sheet.	Met: The BD cycle demonstrated a uniform color change throughout the test sheet.
Software Validation: Compliance with FDA's moderate level of concern recommendations.	Met: Software validation for cycle operation was performed according to the FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (5/29/98)."

The study that proves the device meets the acceptance criteria is detailed under the "Effectiveness" section of the 510(k) summary. Belimed Sauter AG validated its sterilization cycles by recommended practices, standards, and guidelines developed by various independent organizations, specifically the Association for the Advancement of Medical Instrumentation (AAMI).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify a numerical sample size for the test sets (e.g., number of fabric packs, instrument trays, or liquid flasks tested). It describes testing using "fabric test packs," "full load instrument trays," "unwrapped instrument tray," and "three 1000 ml flasks." The implication is that these tests were conducted sufficiently to meet the AAMI/ANSI-ST8:2001 requirements.
Data Provenance: The studies were conducted by Belimed Sauter AG, the manufacturer, as part of their pre-market submission to the FDA. The country of origin for the data is not explicitly stated, but Belimed Sauter AG is identified as Belimed, Inc.'s US Agent, and the device is intended for use in "hospital and health care facilities" (presumably in the US, given the FDA filing). The studies are prospective in nature, as they are qualification/validation tests performed to demonstrate the device's effectiveness before market release.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for sterilizer effectiveness is established through objective physical and microbiological measurements (e.g., F₀ values, temperature logs, biological indicators, moisture retention, color change on test sheets) against predefined standards, not through expert human interpretation in the sense of image analysis or diagnostic assessment.

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

Not applicable. As described above, the validation is based on objective measurements against engineering and microbiological standards, rather than human expert adjudication.

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 sterilizer, not an AI-powered diagnostic device involving human readers.

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

This question is not directly applicable in the context of a sterilizer. However, the entirety of the sterilization validation study can be considered "standalone" performance in that it demonstrates the device's ability to sterilize materials independently, according to its programmed cycles, without human intervention during the active sterilization process itself. The "algorithm" here refers to the pre-programmed sterilization cycles and control software.

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

The ground truth used for sterilizer validation is objective and based on established scientific principles and industry standards for sterilization. This includes:

Microbiological Confirmation: Achieving a Sterility Assurance Level (SAL) of at least 10⁻⁶, often inferred from F₀ values (which relate to the equivalent time at a reference temperature required to kill a population of microorganisms).
Physical Parameters: Verification of specific temperature, pressure, and time profiles within the sterilizer chamber and load.
Biological Indicators: Although not explicitly detailed for every test, biological indicators are typically used to confirm the kill of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) for SAL determination.
Chemical Indicators: Color changes on chemical indicators (like the Bowie-Dick test) demonstrate uniform steam penetration.
Moisture Retention: Quantitative measurement of moisture remaining on sterilized items to ensure effective drying.

These are quantitative, empirical measures derived from standard testing methodologies rather than subjective expert consensus or pathology.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set" in the AI sense. The device's design and factory-programmed cycles were developed through engineering and scientific principles, not by training on a dataset.

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

Not applicable, as there is no "training set" for this type of device. The "ground truth" for the device's design and operation reflects established scientific principles of sterilization and adherence to relevant industry standards (e.g., AAMI/ANSI-ST8:2001).

Summary

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

510 (k) Summary K090339

Date:

Submitters' Name/Address:

September 22, 2009

Belimed, Inc. (as Belimed Sauter AG's US Agent) 2284 Clements Ferry Road Charleston, SC 29492

Contact Person:

Chris Mannarino Product Engineer Belimed, Inc. Phone (843) 216-7424 Fax (843) 216-7707 e-mail: Chris.Mannarino@Belimed.us

Trade Name:

Belimed Steam Sterilizer Top 5000 Series 8, 6-0-12.

Classification:

Predicate Device:

Steam Sterilizer TOP 5000, Series 8, cleared under 510(k) K033538.

Steam Sterilizer - Class II, as listed per 21 CFR 880.6880

Device Description:

The Belimed Steam Sterilizer TOP 5000 Series 8 is intended for use in hospital and health care facilities. _i

Comparison to the Predicate Device:

The Belimed Steam Sterilizer TOP 5000 Series 8 is physically and functionally the same as the predicate device, and uses the same technology, materials, and software as the predicate device cleared under 510 (k) K033538. The only difference is the load claim for wrapped instrument trays. The predicate device has a maximum load capacity of (8) 17lb wrapped instrument trays, and the new claim has a maximum load capacity of (12) 17lb wrapped instrument trays.

Indications for Use:

The Belimed Steam Sterilizer TOP 5000, Series 8, model 6-0-12 is designed for sterilization of nonporous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 Series 8, model 6-0-12, is equipped with the following factoryprogrammed Sterilization cycles and values (Tables 1-3).

Belimed Steam Sterilizer Top 5000, Series 8 510(k) K090339

Rev. E, 9-22-2009 Page 1 of 4

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

Cycles	SterilizeTemp	Sterilize Time(minutes)	Dry Time(minutes)	Recommended Load
Prevac270°F(132°C)	270°F(132°C)	4	30	Double-wrapped instrument trays, max.weight of 17 lbs (7.7kg) each. 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 non-porous single instrument
Flash270°F(132°C)	270°F(132°C)	3	1	Unwrapped instrument tray with a singleinstrument
Flash270°F(132°C)	270°F(132°C)	10	1	Unwrapped instrument tray with non-porousmultiple instruments (max weight of 17lbs).

Table 1: Factory programmed Sterilization Cycles

Note on table 1: Factory set dry time is recommended minimum. Extended dry time may be required depending on local conditions.

The following table (Table 2) is Belimed Sauter AG's recommended load for the Series 8, Models 6-0-12 VS1 and 6-0-12 VS2.

ModelSingle doorDouble door	Sterilizer Chamber Size	Fabric packs,11"x11"x 9",max. 6.6lbs each.	WrappedInstrument Trays,20"x 10", max.17lbs each	Fabric packs,23"x11"x11",max 17lbs each.
6-0-12 VS16-0-12 VS2	26" x 26" x 51.5"(660 x 660 x 1300)mm	16	12*	8

Table 2: Recommended Loads.

The use of twelve (12) Instrument trays was validated using only rigid surgical and simulated instruments. .. .

The following table (Table 3) is Belimed Sauter AG's guidelines for liquid cycle processing for Series 8, Models 6-0-12 VS1 and 6-0-12 VS2.

ModelSingle doorDouble door	Sterilizer Chamber Size	Volume of liquid in OneContainer	Number of Containers
6-0-12 VS1	26" x 26" x 51.5"	1000ml	88
6-0-12 VS2	(660 x 660 x 1300)mm

Table 3, Guidelines for liquid 250°F cycle processing

Rev.E, 9-22-2009 Page 2 of 4

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

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

26" x 26″ x 51.5″ (660mm x 660mm x 1300mm) Single door. Prevacuum 26" x 26" x 51.5" (660mm x 660mm x 1300mm) .Double door, Prevacuum

Effectiveness:

Efficacy of sterilizer function and exposure time recommendations are ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10 reduction. Belimed Sauter AG validates its sterilization cycles by recommended practices, standards and quidelines developed by various independent organizations, such as the Association for the Advancement of Medical Instrumentation (AAMI). Prior to release, the Belimed Steam Sterilizer 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 cvcles verified using fabric test packs as described in Section 5.5.2 of AAMI/ANSI-. ST8:2001, and were qualified according to section 5,5.2.5 of AAMI ST8-2001. These cycles demonstrated a sterility assurance level of at least 10 8 through achievement of a time at femperature sufficient to produce an F0 of at least 12 by 1/2 cycle, a moisture retention of less than 3% increase in pre-sterilization test pack weight, and exhibited no wet spots.
All Prevac cycles verified using full load instrument trays were qualified according to section 5.5.4 t of ANSI/AAMI-ST8:2001. 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 less than 20% increase in pre-sterilization test pack weight, 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 AAMI/ANSI ST36:1996 section 7.7.3. These cycles demonstrated a sterility assurance level of at least 10 ° through achievement of a time at temperature sufficient to produce an F0 of at least 12 by ½ cycle and exhibited no wet spots.
All Liquid cycles were verified using three 1000 ml flasks, as described in section 5.5.3 of . AAMI/ANSI ST8:2001; and were qualified according to section 5.5.3.5. These cycles demonstrated a sterility assurance level of at least 10 8 through achievement of a time to temperature sufficient to produce an FO of at least 12 by 1/2 cycle, a water loss not exceeding 50ml, and an 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.
A BD cvcle was verified using the Bowie-Dick Test Pack and was qualified according to section . ● 5.6 of AAMI/ANSI-ST-8, and demonstrated a uniform color change throughout the test sheet.
The software validation for the cycle operation was performed according to the FDA's moderate ↓ level of concern recommendations provided in the document. Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (5/29/98).

Safety:

Belimed Sauter AG sterilizers including the Belimed Steam Sterilizer TOP 5000 Series 8 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 Series 8 complies with the following requirements:

Underwriters Laboratory (UL) Standard UL61010A-1:2002 and UL 610010A-2-0041:2002 1.
Canadian Standards Association (CSA) Standard C22.2 No 1010-1 (IEC61010-1:2001) ર્ભ
American Society of Mechanical Engineers (ASME) Section VIII, Division I for unfired pressure 3. vessels: 2001.

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

Hazards-Failure of Performance

Failure of the sterilization process can lead to incidence of cross contamination and 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 that the materials, instruments, and devices to be sterilized are thoroughly cleaned, that the manufacturers 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 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 US. The incident of sterilizer malfunction or sterilizer process failure is relatively rare considering the wide spread use of steam sterilizers. The technology designed in the Belimed Steam Sterilizer TOP 5000, Series 8 provides microprocessor controlled safeguards that aborts a cycle and gives appropriate alerts and warnings to the operator when required conditions have not been met or a malfunction has occurred.

· User Information

Belimed Sauter AG provides information to the user that is intended to insure safe and effective use of steam sterilization in its Operators Manuals and other labeling. Belimed 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.

Rev. E, 9-22-2009 Page 4 of 4

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

Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold sans-serif font. The text is centered in the image and is the only element present. The background is plain white.

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

SEP 2:3 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Belimed Sauter AG C/O Mr. Christopher P. Mannarino Product Engineer Belimed Incorporated 2284 Clements Ferry Road Charleston, South Carolina 29492

Re: K090339

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: August 31, 2009 Received: September 9, 2009

Dear Mr. Mannarino:

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 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. Mannarino

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reporta Problem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Antony U. Aase, M.D.
Susan Russell, DDS, MA

Susan Runner, D.D.S. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number: K090339

Device Name: Belimed Steam Sterilizer TOP 5000

Indications for Use:

The Belimed Steam Sterilizer TOP 5000, Series 8, model 6-0-12 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 8, model 6-0-12, is equipped with the following factory-programmed Sterilization cycles and values (Tables 1-3).

Prescription Use (Part 21 CFR B01 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule R Murphy 10

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K040339

Page 1 of 3

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

Cycles	SterilizeTemp	SterilizeTime(minutes)	Dry Time(minutes)	Recommended Load
Prevac270°F(132°C)	270°F(132°C)	4	30	Double-wrapped instrument trays.max. weight of 17 lbs (7.7kg) each.Fabric packs. Refer to table 2 forrecommended 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 directpatient contact. Refer to table 3 forguidelines.
Express270°F(132°C)	270°F(132°C)	4	3	Single-wrapped instrument tray withnon-porous single instrument
Flash270°F(132°C)	270°F(132°C)	3	1	Unwrapped instrument tray with asingle instrument
Flash270°F(132°C)	270°F(132°C)	10	1	Unwrapped instrument tray withnon-porous multiple instruments(max weight of 17lbs).

Table 1: Factory programmed Sterilization Cycles

Note on table 1: Factory set dry time is recommended minimum. Extended dry time may be required depending on local conditions.

The following table (Table 2) is Belimed Sauter AG's recommended load for the Series 8, Models 6-0-12 VS1 and 6-0-12 VS2.

ModelSingle doorDoubledoor	Sterilizer ChamberSize	Fabricpacks,11"x11"x 9",max. 6.6lbseach.	WrappedInstrumentTrays, 20"x 10",max. 17lbs each	Fabric packs,23"x11"x11",max 17lbseach.
6-0-12 VS16-0-12 VS2	26" x 26" x 51.5"(660 x 660 x1300)mm	16	12*	8

Table 2: Recommended Loads.

The use of twelve (12) Instrument trays was validated using only rigid surgical and simulated instruments.

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

The following table (Table 3) is Belimed Sauter AG's guidelines for liquid cycle processing for Series 8, Models 6-0-12 VS1 and 6-0-12 VS2.

ModelSingle doorDouble door	Sterilizer ChamberSize	Volume of liquid inOne Container	Number ofContainers
6-0-12 VS16-0-12 VS2	26" x 26" x 51.5"(660 x 660 x 1300)mm	1000ml	88

Table 3, Guidelines for liquid 250°F cycle processing

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

26" x 26" x 51.5" (660mm x 660mm x 1300mm)	Single door, Prevacuum
26" x 26" x 51.5" (660mm x 660mm x 1300mm)	Double door, Prevacuum

. . .

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).