The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

Device Description

The Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 are intended for use in hospital and health care facilities and are intended to be used in an identical manner as the Belimed Steam Sterilizers Series 4-8.

Modifications made from the predicate device include:

Additional Gravity cycles
Increase of recommended load capacity.
New version of Programmable Logic control (PLC) and new operating panel (MMI)

The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are available as a single door prevacuum/gravity or double door prevacuum/gravity version.

The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are 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, unwrapped or wrapped instrument trays with single or multiple instruments may be sterilized.

The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are factory equipped with cycles which have been tested in accordance with ANSI/AAMI ST8:2008 under defined load conditions. The predicate devices with a chamber volume of 305 l, 440 l, and 595 l have been validated previously.

AI/ML Overview

The provided text describes a 510(k) summary for a steam sterilizer, not an AI/ML-enabled medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/ML device performance (e.g., sensitivity, specificity, AUC) are not applicable here.

Instead, the acceptance criteria for this sterilizer are based on its ability to effectively sterilize various loads and meet established safety and performance standards. The "study that proves the device meets the acceptance criteria" refers to a series of nonclinical verification studies based on recognized standards.

Here's how to interpret the information provided in the context of a steam sterilizer:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ANSI/AAMI ST8:2008 and other standards)	Reported Device Performance (Effectiveness, based on verification studies)
Sterility Assurance Level (SAL) of at least 10-6 reduction: Demonstrated through complete kill of biological indicators and achieving sufficient time-at-temperature (Fo of at least 12 minutes by half cycle).	Achieved for all cycles: Prevac, Prevac Flash, and Gravity 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 minutes by half cycle.
Empty chamber testing (Section 5.4.2.5 of ANSI/AMMI ST8:2008): Capability to provide steady state thermal conditions within the chamber corresponding with predicted SAL in the load. Meets requirements of Section 4.4.2.2 and 4.4.2.5 of ANSI/AAMI ST8.	Performed and met criteria: Demonstrated the sterilizer's capability to provide steady state thermal conditions within the chamber that are corresponding with the predicted sterility assurance level (SAL) in the load.
Prevac cycles verification using fabric test pack (Section 5.5.2 ANSI/AAMI ST8:2008): Moisture retention less than 3% increase in pre-sterilization test pack weight, no wet spots.	Qualified and met criteria: Moisture retention of less than 3% increase in pre-sterilization test pack weight, and exhibited no wet spots.
Prevac and Gravity cycles verification using full load instruments trays (Section 5.5.4 of ANSI/AAMI ST8:2008): Moisture retention less than 20% increase in pre-sterilization weight of the towel, no wet spots on outer wrapper.	Qualified and met criteria: Moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper.
Bowie-Dick Test cycle verification (Section 5.6 of ANSI/AAMI ST8): Uniform color change throughout the test sheet, load temperature devices attained exposure temperature within 10 seconds of progressing into the exposure phase.	Verified and qualified: Demonstrated a uniform color change throughout the test sheet and the load temperature devices attained the exposure temperature within 10 seconds of progressing into the exposure phase.
Software validation: Performed according to FDA's moderate level of concern recommendations ("Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (May 2005)").	Performed and met criteria: "The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations..."
Compliance with Safety Standards: ANSI/AAMI ST8:2008, ANSI/AAMI ST79:2006+A1:2008, IEC EN 62304:2006, EN ISO 14971:2007, ISO 13485:2007, IEC EN 60601-1-2:2007, UL 61010-1:2004, IEC EN 61010-2-040:2005, ASME Section VIII, Division 1 for unfired pressure vessels Ed. 2007+Addenda 2008.	Complies with listed standards: "Belimed Steam Sterilizer MST-V complies with the following safety standards." (Lists all standards).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document doesn't specify a precise numerical "sample size" in terms of cases or images, as would be typical for an AI/ML study. Instead, it refers to performing tests on various "test packs," "instrument trays," and "empty chambers" for different cycles (PreVac, Gravity, Flash, Bowie-Dick, Leak Test, Warm-up). The number of times each test was performed is not explicitly stated, but the implication is that sufficient repetitions were done to demonstrate consistent performance as per the standards.
Data Provenance: The tests were conducted by Belimed Sauter AG. The standards referenced (ANSI/AAMI ST8:2008, etc.) are international/US standards. The document doesn't state specific countries of origin for the data or if it was retrospective/prospective in the clinical sense, as these are non-clinical performance tests on a manufactured device. It seems to be a prospective set of tests performed for regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable in the AI/ML sense. Ground truth here is established by the physical performance of the sterilizer validated against established scientific principles and industry standards (e.g., complete kill of biological indicators, Fo values, temperature and pressure measurements, moisture retention, color change in Bowie-Dick tests).
The "experts" would be the engineers and technicians at Belimed Sauter AG trained to conduct these specific validation tests according to the standards. No medical experts (like radiologists) are involved in establishing this type of physical ground truth.

4. Adjudication Method for the Test Set:

Not applicable in the AI/ML sense. The "adjudication" is inherent in successfully meeting the quantitative and qualitative criteria defined by the relevant standards (e.g., reaching a certain Fo value, achieving uniform color change, staying below a certain moisture retention percentage). There's no human "adjudication" of results in the traditional sense; rather, the device either passes or fails the objective performance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

Not applicable. This is a standalone medical device (a sterilizer), not an AI/ML diagnostic or assistive tool. There are no "human readers" to compare performance with or without AI assistance.

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

Not applicable in the AI/ML sense. The device itself is "standalone" in that it performs its function of sterilization automatically based on programmed cycles. The performance metrics listed are of the device itself (e.g., its ability to maintain specific temperatures, pressures, and times), not of an algorithm generating an output that a human then interprets.

7. The Type of Ground Truth Used:

Established scientific and engineering principles, and validated industry standards:
- Biological efficacy: Complete kill of biological indicators, achieving a sterility assurance level (SAL) of 10-6 reduction.
- Physical parameters: Precise temperature and pressure control, specific exposure times, moisture retention levels, uniform heat distribution (Bowie-Dick test).
- Compliance with published standards: ANSI/AAMI ST8:2008, ANSI/AAMI ST79:2006+A1:2008, various IEC, EN, ISO, UL, and ASME standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a "training set." The device is designed, manufactured, and then validated against pre-defined performance standards.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, no training set for an algorithm. The "ground truth" for the device's design and factory programming is based on extensive engineering knowledge, scientific principles of sterilization, and compliance with the aforementioned industry standards for sterilizer performance.

Summary

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510(k) Summary

Date:	February 21, 2011
Submitter's Name / Address:	Belimed Sauter AGZelgstrasse 8CH- 8583 Sulgen / Switzerland	K103841
Contact Person:	Hans Stadler, Head of R&DEmail: hans.stadler@belimed-sauter.chPhone: +41 71 644 85 97Fax: +41 71 644 85 11
Trade Name:	Belimed Steam Sterilizer MST-V
Models:	6-0-6, 6-0-9, and 6-0-12
Classification:	Steam Sterilizer – Class II, as listed per 21 CFR880.6880Product Code 80 FLE
Predicate Device:	Belimed Steam Sterilizer TOP 5000Series 4-8 (K033538)

DEVICE DESCRIPTION:

NONCLINICAL COMPARISON TO THE PREDICATE DEVICE:

The Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 are very similar to the predicate device.

Modifications made from the predicate device include:

· Additional Gravity cycles
· Increase of recommended load capacity.
· New version of Programmable Logic control (PLC) and new operating panel (MMI)

CLINICAL DATA:

No clinical data is required for this device classification submission.

INDICATIONS FOR USE:

The Belimed Steam Sterilizers MST-V, models 6-0-6, and 6-0-12 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).

Release 1.3 February 21, 2011 Page 1 of 6

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The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are available as a single door prevacuum/gravity or double door prevacuum/gravity version.

CYCLE	PRE-TREATMENT	STERILIZETEMP /PRESSURE	STERILIZETIME	DRYTIME 1)	RECOMMENDED LOAD3)
PreVac 2704S / 30Dry	3 vacuum pulses:80/100/100mbar2 steam pulses:1500/1500mbar	270 °F2880mbar	4 min	30 min	Double wrapped instrument trays,max. weight of 25 lbs per trayFabric packs 2)
PreVac 2704S / 5Dry	3 vacuum pulses:80/100/100mbar2 steam pulses:1500/1500mbar	270 °F2880mbar	4 min	5 min	Fabric packs 2)
PreVac Flash270 3S / 1Dry	3 vacuum pulses:80/100/100mbar2 steam pulses:1500/1500mbar	270 °F2880mbar	3 min	1 min	Unwrapped non-porous singleinstrument orunwrapped non-porous instrumenttrays, max. weight of 25 lbs per tray
PreVac Flash270 4S / 1Dry	3 vacuum pulses:80/100/100mbar2 steam pulses:1500/1500mbar	270 °F2880mbar	4 min	1 min	Unwrapped porous or non-poroussingle instrument orunwrapped mixed porous and non-porous instrument trays, max. weightof 25 lbs per tray
Gravity 27015S / 30Dry	Purge time 4min	270 °F2880mbar	15 min	30 min	Wrapped instrument trays, max.weight of 25 lbs per tray
Gravity 2703S / 1Dry	Purge time 4min	270 °F2880mbar	3 min	1 min	Unwrapped non-porous singleinstrumentor unwrapped non-porousinstrument trays, max. weight of 25lbs per tray
Gravity 27010S / 1Dry	Purge time 4min	270 °F2880mbar	10 min	1 min	Unwrapped porous or non-poroussingle instrument orunwrapped mixed porous and non-porous instrument trays, max. weightof 25 lbs per tray
Bowie-DickTest	3 vacuum pulses:80/100/100mbar2 steam pulses:1500/1500mbar	273 °F3030mbar	3.5 min	1 min	One DART or Bowie-Dick-Test-Pack
Leak Test	Vacuum: 65mbarTest time: 15 min				Empty chamber
Warm up &leak test	Vacuum: 65mbarTest time: 15 min	270 °F2880mbar	3 min	3 min	Empty chamber

Table 1: Factory programmed Sterilization cycles

Notes on Table 1:

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r. Factory set ury time is recommended. Extenced ary time may on required depending on local conations and wraps.

Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
Recommended load: Refer to table 3 and 4.

The Belimed Steam Sterilizer MST-V is offered in the following configurations:

Table 2: Dimensions

Modelsingle doordouble door	Configuration	Chamber size(Volume)(L)	Chamber size(H x W x D)(inch)	Chamber size(H x W x D)(mm)	Overall Dimensions(H x W x D)(inch)	Overall Dimensions(H x W x D)(mm)
6-0-6 VS1	1 door	305	26"x 26"x27.5"	660 x660 x 700	77.5"x 39"x43"	1970 x990 x 1095
6-0-6 VS2	2 door	305	26"x 26"x27.5"	660 x660 x 700	77.5"x 39"x44"	1970 x990 x 1120
6-0-9 VS1	1 door	440	26"x 26"x39.5"	660 x660 x 1000	77.5"x 39"x55"	1970 x990 x 1395
6-0-9 VS2	2 door	440	26"x 26"x39.5"	660 x660 x 1000	77.5"x 39"x56"	1970 x990 x 1420
6-0-12 VS1	1 door	595	26"x 26"x 53"	660 x660 x 1350	77.5"x 39"x69"	1970 x990 x 1750
6-0-12 VS2	2 door	595	26"x 26"x 53"	660 x660 x 1350	77.5"x 39"x70"	1970 x990 x 1775

The following table (Table 3) is Belimed Sauter AG's guidelines for recommended loads for the Belimed Steam Sterilizer MST-V:

Table 3: Recommended Loads

Modelsingle doordouble door	Wrappedinstrument trays,max. 25 lbs each	Unwrapped traywith singleinstrument	Unwrappedinstrument tray,max. 25 lbs each	Fabric Packs,max. 6.6 lbs each	Fabric Packs,max. 9 lbs each
6-0-6 VS16-0-6 VS2	6	1	2	12	8
6-0-9 VS16-0-9 VS2	9	1	2	18	12
6-0-12 VS16-0-12 VS2	12	1	2	24	16

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

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 106 reduction. Belimed 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, Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 were validated to meet the requirements of ANSI/AAMI ST8:2008.

The results of the Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 verification studies demonstrate that the sterilizers perform as intended and are summarized as follows:

. Empty chamber testing performed as described in Section 5.4.2.5 of ANSI/AMMI ST8:2008, for the Prevac, Prevac Flash and Gravity cycles. These cycles demonstrated the sterilizer's capability to provide steady state thermal conditions within the chamber that are corresponding with the predicted sterility assurance level (SAL) in the load. The sterilizer meets the requirements of Section 4.4.2.2 and 4.4.2.5 of ANSI/AAMI ST8.
All Prevac cycles verified using the fabric test pack, as described in Section 5.5.2 . ANSI/AAMI ST8:2008 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 minutes by half cycle, moisture retention of less than 3 % increase in pre-sterilization test pack weight, and exhibited no wet spots.
All Prevac, and Gravity cycles verified using full load instruments trays were qualified . according to section 5.5.4 of ANSI/AAMI ST8:2008. 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 minutes by half cycle, moisture retention of less than 20 % increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper.
All Prevac Flash cycles verified using the unwrapped instrument trays were qualified . according to section 5,5,5,2 ANSI/AAMI ST8:2008. 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 minutes by half cycle.
All Gravity cycles verified using the unwrapped instrument tray were qualified according . to section 5.5.5.1 ANSI/AAMI ST8:2008. 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 minutes by half cycle.
. The Bowie Dick Test cycle was verified using the Bowie-Dick Test Pack was qualified according to section 5.6 of ANSI/AAMI ST8, and demonstrated a uniform color change

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througnout the test sneet and the load temperature devices attained the exposure temperature within 10 seconds of progressing into the exposure phase.

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 Premarket Submissions for Software Contained in Medical Devices (May 2005)".

SAFETY:

Belimed Sauter AG's sterilizers including the Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 have been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The Belimed Steam Sterilizer MST-V complies with the following safety standards:

ANSI/AAMI ST8:2008 1.
1. ANSI/AAMI ST79:2006+A1:2008 .
1. IEC EN 62304:2006
1. EN ISO 14971:2007
1. ISO 13485:2007 Medical Devices - Quality management systems. Requirements for regulatory purposes
IEC EN 60601-1-2:2007 റ.
1. UL 61010-1:2004
1. IEC EN 61010-2-040:2005
1. American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels Ed. 2007+Addenda 2008)

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 MST-V provides microprocessor controller safeguards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.

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USER INFORMATION

Belimed Sauter AG provides information to the user that is intended to insure safe and effective use of steam sterilization in its detailed User's Manual 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.

CONCLUSION

The Belimed Steam Sterilizers MST-V, models 6-0-6, and 6-0-12 are substantially equivalent devices to that of the predicate device. There have been no substantial changes in technology and intended use to the predicate device series 4-8 (K033538). This steam sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 meet the applicable requirements of the applicable standards.

Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate device and is safe and effective when used as intended.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Sauter AG C/O Mr. Olaf Teichert Responsible Third Party Official TÜV SUD America, Incorporated 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891

MAR 15 201

Re: K103841

Trade/Device Name: Belimed Steam Sterilizer MST-V, Models 6-0-6, 6-0-9, 6-0-12 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: February 25, 2011 Received: February 28, 2011

Dear Mr. Teichert:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. 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): K103841

Device Name: Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, 6-0-12

Indications for Use:

The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 are all equipped with the same factory-programmed Sterilization cycles and cycle parameters (Table 1).

The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are available as a single door (VS1) prevacuum/gravity or double door (VS2) prevacuum/gravity version.

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CYCLE	PRE-TREATMENT	STERILIZE	STERILIZE	DRY	RECOMMENDED LOAD
		TEMP /PRESSURE	TIME	TIME 1)	3)
PreVac 2704S / 30Dry	3 vacuum pulses:80/100/100mbar2 steam pulses:1500/1500mbar	270 °F2880mbar	4 min	30 min	Double wrapped instrument trays,max. weight of 25 lbs per trayFabric packs 2)
PreVac 2704S / 5Dry	3 vacuum pulses:80/100/100mbar2 steam pulses:1500/1500mbar	270 °F2880mbar	4 min	5 min	Fabric packs 2)
PreVac Flash270 3S / 1Dry	3 vacuum pulses:80/100/100mbar2 steam pulses:1500/1500mbar	270 °F2880mbar	3 min	1 min	Unwrapped non-porous singleinstrument orunwrapped non-porous instrumenttrays, max. weight of 25 Ibs per tray
PreVac Flash270 4S / 1Dry	3 vacuum pulses:80/100/100mbar2 steam pulses:1500/1500mbar	270 °F2880mbar	4 min	1 min	Unwrapped porous or non-poroussingle instrument orunwrapped mixed porous and non-porous instrument trays, max. weightof 25 lbs per tray
Gravity 27015S / 30Dry	Purge time 4min	270 °F2880mbar	15 min	30 min	Wrapped instrument trays, max.weight of 25 Ibs per tray
Gravity 2703S / 1Dry	Purge time 4min	270 °F2880mbar	3 min	1 min	Unwrapped non-porous singleinstrumentor unwrapped non-porousinstrument trays, max. weight of 25lbs per tray
Gravity 27010S / 1Dry	Purge time 4min	270 °F2880mbar	10 min	1 min	Unwrapped porous or non-poroussingle instrument orunwrapped mixed porous and non-porous instrument trays, max. weightof 25 lbs per tray
Bowie-DickTest	3 vacuum pulses:80/100/100mbar2 steam pulses:1500/1500mbar	273 °F3030mbar	3.5 min	1 min	One DART or Bowie-Dick-Test-Pack
Leak Test	Vacuum: 65mbarTest time: 15 min				Empty chamber
Warm up &	Vacuum: 65mbar	270 °F	3 min	3 min	Empty chamber
CYCLE	PRE-TREATMENT	STERILIZE TEMP/PRESSURE	STERILIZE TIME	DRY TIME 1)	RECOMMENDED LOAD 3)
leak test	Test time: 15 min	2880mbar

Table 1: Factory programmed Sterilization cycles

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Notes on Table 1:

Factory set dry time is recommended. Extended dry time may be required depending on local conditions and wraps.
Fabric load should be preconditioned between 68°F and at a relative humidity of at least 35% to 60% for at least 2 hours.
Recommended load: Refer to table 3 and 4.

The Belimed Steam Sterilizer MST-V is offered in the following configurations:

Table 2: Dimensions

Model	Configuration	Chamber size	Chamber size		Overall Dimensions
single doordouble door		(Volume)(L)	(H x W x D)(inch)	(mm)	(H x W x D)(inch)	(mm)
6-0-6 VS1	1 door	305	26"x 26"x 27.5"	660 x660 x 700	77.5"x 39"x 43"	1970 x990 x 1095
6-0-6 VS2	2 door	305	26"x 26"x 27.5"	660 x660 x 700	77.5"x 39"x 44"	1970 x990 x 1120
6-0-9 VS1	1 door	440	26"x 26"x 39.5"	660 x660 x 1000	77.5"x 39"x 55"	1970 x990 x 1395
6-0-9 VS2	2 door	440	26"x 26"x 39.5"	660 x660 x 1000	77.5"x 39"x 56"	1970 x990 x 1420
6-0-12 VS1	1 door	595	26"x 26"x 53"	660 x660 x 1350	77.5"x 39"x 69"	1970 x990 x 1750
6-0-12 VS2	2 door	595	26"x 26"x 53"	660 x660 x 1350	77.5"x 39"x 70"	1970 x990 x 1775

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The following table (Table 3) is Belimed Sauter AG's guidelines for recommended loads for the Belimed Steam Sterilizer MST-V:

Modelsingle doordouble door	Wrappedinstrument trays,max. 25 lbs each	Unwrapped traywith singleinstrument	Unwrappedinstrument tray,max. 25 lbs each	Fabric Packs,max. 6.6 lbseach	Fabric Packs,max. 9 lbs each
6-0-6 VS1	6	1	2	12	8
6-0-6 VS2
6-0-9 VS1	9	1	2	18	12
6-0-9 VS2
6-0-12 VS1	12	1	2	24	16
6-0-12 VS2

Table 3: Recommended Loads

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)

Elizabeth F. Claine-Will
(Print) Sign

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

510(k) Number: K103841

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).